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EUROPEAN ORGANISATION FOR THE SAFETY OF AIR NAVIGATION E U R O C O N T R O L SAFETY REGULATION COMMISSION ESARR ADVISORY MATERIAL/GUIDANCE MATERIAL (EAM/GUI) EAM 3 / GUI 4 MAPPING BETWEEN ISO 9001:2000 AND ESARR 3 Edition : 1.0 Edition Date : 18 May 2004 Status : Released Issue Distribution : General Public Category : ESARR Advisory Material
Transcript
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EUROPEAN ORGANISATION FOR THE SAFETY OF AIR NAVIGATION

EUROCONTROL

SAFETY REGULATION COMMISSION

ESARR ADVISORY MATERIAL/GUIDANCE MATERIAL (EAM/GUI)

EAM 3 / GUI 4

MAPPING BETWEEN ISO 9001:2000 AND ESARR 3

Edition : 1.0Edition Date : 18 May 2004Status : Released IssueDistribution : General PublicCategory : ESARR Advisory Material

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F.2 DOCUMENT CHARACTERISTICS

TITLE

EAM 3 / GUI 4 Mapping between ISO 9001:2000 and ESARR 3

Document Identifier : Reference : EAM 3 / GUI 4

eam3gui4_e10_ri Edition Number : 1.0

Edition Date : 18-05-2004

Abstract :

This document includes a detailed comparison between the provisions of ISO 9001:2000 and the safety regulatory requirements established in ESARR 3. It also provides ATM safety regulators with harmonised guidance to deal with situations where ISO-based approaches are proposed by ATM service providers as possible means of compliance to meet ESARR 3 requirements.

Keywords :

ISO ISO 9001:2000 ISO 10011

ESARR 3 Mapping of Requirements Quality

Quality Management System Means of Compliance Safety Management System

Contact Person(s) : Tel : Unit :

Juan Vazquez Sanz +32 2 729 46 81 DG/SRU

DOCUMENT STATUS AND TYPE

Status : Distribution : Category : Working Draft General Public Safety Regulatory Requirement

Draft Issue Restricted EUROCONTROL Requirement Application Document

Proposed Issue Restricted SRC ESARR Advisory Material

Released Issue Restricted SRU Comment / Response Document

Policy Document

Document

SOFTCOPIES OF SRC DELIVERABLES CAN BE DOWNLOADED FROM : www.eurocontrol.int/src

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F.3 DOCUMENT APPROVAL

The following table identifies all management authorities who have approved this document.

AUTHORITY NAME AND SIGNATURE DATE

Quality Control (SRU)

(Daniel HARTIN)

24-Jun-04

Head Safety Regulation Unit

(SRU)

(Peter STASTNY)

24-Jun-04

Chairman Safety Regulation

Commission (SRC)

(Martin RADUSCH)

24-Jun-04

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F.4 DOCUMENT CHANGE RECORD

The following table records the complete history of this document.

EDITION NUMBER

EDITION DATE REASON FOR CHANGE PAGES

AFFECTED

0.01 25-Oct-03 Creation of document by SRU. Working draft submitted to RTF for review and comment.

All

0.1 21-Jan-04 Draft produced after RTF consultation. Submitted to SRC for review and comment

Section 2 (insertion in

5th para)

1.0 18-May-04

Final released issue produced after SRC consultation. Modifications included to address comments received.

Appendices A and C (various

insertions)

Section 4.10 (references

to ISO updated)

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F.5 CONTENTS

Section Title Page

F.1 Title Page ……………………………………………………………. 1

F.2 Document Characteristics ……………………………………….. 2

F.3 Document Approval ……………………………………………….. 3

F.4 Document Change Record ………………………………………. 4

F.5 Contents …………………………………………………………….. 5

F.6 Executive Summary ……………………………………………….. 6

1. Introduction ………………………………………………………… 7

2. Purpose of Document …………………………………………….. 7

3. Comparison Conducted ……..…..…………………………..…… 3.1 Methodology .....……………………………………………………………….. 3.2 Terminology …...……………………………………………………………….. 3.3 References for Interpretation …………..……….…………………………….

8 8 9 9

4. Summary of Comparison – ESARR 3 with ISO 9001:2000 …. 4.1 General Aspects ……………………………………………………………….. 4.2 Systematic Safety Management ....…………………………………………... 4.3 Safety Policy and Safety Objectives .…..……….…………………………… 4.4 Top Management Commitment ….…………………………………………… 4.5 Safety Responsibilities …….………………………………………………….. 4.6 Safety Managerial Function …………………………………………………... 4.7 SMS Documentation…….………………..……….…………………………… 4.8 Internal Communication ..……………………………………………………... 4.9 Safety Occurrences ………………..……….…………………………………. 4.10 Internal Auditing ……….…………….………………………………………… 4.11 Risk Assessment and Mitigation ..………….………………………………… 4.12 External Services …………………….…..……….……………………………

10 10 10 11 11 12 12 13 13 13 14 14 15

5. Significant Issues Regarding Inter-Relationship between SMS and QMS ………………………………….………………….... 5.1 Verification of Compliance with ESARR 3 ………………………………….. 5.2 Explicitness of the SMS ..………………..……….…………………………… 5.3 Integration of SMS and QMS ……...…………………………………………. 5.4 ISO Certification ….………..……….………………………………..………… 5.5 Small Organisations ………..….………………………………………………

16 16 16 17 18 18

Appendix A …………………………………………………………………......... Summary of Mapping – Table of ISO 9001:2000 Provisions that can Support the Implementation of Specific ESARR 3 Requirements

19

Appendix B …………………………………………………………………......... Summary of Mapping – Table of Conditions to Note Wherever ISO 9001:2000 Provisions are Considered to Implement Specific ESARR 3 Requirements

21

Appendix C …………………………………………………………………......... Detailed Comparison Between ISO 9001:2000 and ESARR 3

23

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F.6 EXECUTIVE SUMMARY

The EUROCONTROL Safety Regulatory Requirement 3 (ESARR 3) ‘Use of Safety Management Systems by ATM Service Providers’, requires the implementation and operation of a safety management system (SMS) as an integral part of the management of ATM services. ESARR 3 also identifies the mandatory elements of any SMS implemented in the provision of ATM services within the EUROCONTROL Member States.

The ISO 9000 family of standards has been developed by the International Organisation for Standardisation (ISO) to assist organisations to implement and operate quality management systems (QMS). ISO 9001:2000 specifies requirements for QMS where an organisation needs to demonstrate its ability to provide products or services that fulfil applicable requirements.

Although the SMS approach involves various aspects not specifically addressed in the most common quality management standards, it has been recognised that quality management standards, notably ISO 9001:2000, can be used to support a successful implementation of ESARR 3. In fact, the use of integrated management systems encompassing safety and quality has been considered in some countries as a possible approach to address the implementation of ESARR 3 in an efficient manner.

As a result, there is a need to compare ESARR 3 and ISO 9001:2000 and provide ATM safety regulators with guidance to deal with situations where ISO-based approaches are proposed by ATM service providers as possible means of compliance to meet ESARR 3 provisions.

This document includes a detailed comparison between the provisions of ISO 9001:2000 and the safety regulatory requirements established in ESARR 3. It also provides ATM safety regulators with harmonised guidance that can be brought into play wherever there is a need for developing national regulatory material on the use of ISO 9001:2000 by ATM service providers to implement SMS.

Appendix C presents the detailed comparison between ISO 9001:2000 and ESARR 3 Section 5. The comparison is shown in form of table. Two additional tables have been produced to summarise the findings and map ISO 9001:2000 and ESARR 3 in a briefer manner.

Generally speaking, the findings of the mapping show that ISO 9001:2000 may provide useful tools to support the implementation of most ESARR 3 requirements. However, some specific conditions have been identified in relation to various ISO provisions.

The issues and conditions identified in this document should be taken into consideration wherever ISO 9001:2000 is considered as a possible means to support the implementation of ESARR 3

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1. INTRODUCTION

In its initial work on the harmonisation of safety regulatory requirements, the SRC identified and focussed on those safety areas which, in their view, needed most urgent attention. On this basis, the SRC Work Programme recognised the need to establish a number of EUROCONTROL Safety Regulatory Requirements (ESARRs), one of which was ESARR 3 “Use of Safety Management Systems by ATM Service Providers”.

ESARR 3 requires ATM service providers to implement and operate a safety management system (SMS) as an integral part of the management of ATM services. ESARR 3 also identifies the mandatory elements of any SMS implemented in the provision of ATM services within the EUROCONTROL Member States.

The ISO 9000 family of standards has been developed by the International Organisation for Standardisation (ISO) to assist organisations of all types and sizes to implement and operate quality management systems (QMS). ISO 9001:2000 specifies requirements for QMS where an organisation needs to demonstrate its ability to provide products or services that fulfil applicable requirements.

The SMS approach involves various aspects not specifically addressed in the most common quality management standards. However, it has been recognised that quality management standards, notably ISO 9001:2000, can be used to support a successful implementation of specific ESARR 3 provisions.

SMS and QMS are both management tools with proactive and reactive elements embedded in performance and capability oriented processes. Their links may offer a variety of possibilities when implementing ESARR 3 in those situations where SMS and QMS are operated simultaneously. In that context, the use of integrated management systems encompassing safety and quality has been considered in some countries as a possible approach to address the implementation of ESARR 3 in an efficient manner.

Consequently, there is a need to compare ESARR 3 and ISO 9001:2000 and provide ATM safety regulators with guidance to deal with situations where ISO-based approaches are proposed by ATM service providers as possible means of compliance to meet ESARR 3 provisions.

2. PURPOSE OF DOCUMENT

This document is part of a series of guidance deliverables developed by SRC for its use by ATM safety regulators when dealing with the implementation of ESARR 3 by ATM service providers.

It includes a detailed comparison between the provisions of ISO 9001:2000 and the safety regulatory requirements established in ESARR 3 Section 5. The document also intends to support ATM safety regulators in dealing with those cases where ISO-based approaches are proposed as means of compliance to implement SMS.

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It should be noted that this document does not represent a SRC recognition of ISO 9001:2000 as an acceptable means of compliance to meet ESARR 3 requirements.

As different approaches based on ISO 9001:2000 can be proposed depending upon local circumstances, specific proposals for possible means of compliance should normally be considered at national level. ATM safety regulators may therefore recognise ISO-based approaches as acceptable means of compliance to meet ESARR 3 requirements.

Any formal recognition of means of compliance should be based on an assessment demonstrating compliance with requirements. This document offers a systematic comparison that may be used as guidance where specific assessments are undertaken by ATM safety regulators. However, all QMS forming a basis for SMS needs to be specifically checked.

The document also provides ATM safety regulators with harmonised guidance that can be brought into play wherever there is a need for developing national regulatory material on the use of ISO 9001:2000 by ATM service providers to implement SMS.

3. COMPARISON CONDUCTED

3.1 Methodology

Appendix C presents the detailed comparison produced between ISO 9001:2000 and ESARR 3 Section 5. The comparison is shown in form of table. It takes each one of the provisions included in ISO 9001:2000 from Section 4 on, and identifies the ESARR 3 requirements related to the specific issue addressed in each ISO statement.

That table includes comments presenting the rationale for each correspondence established as well as conclusions on the possible use of each ISO statement to support the implementation of the ESARR 3 requirement related.

The main conclusions are shown in bold and normally identify two types of situations:

The use of the ISO statement can support the implementation of the ESARR 3 requirement related

Specific issues should be noted wherever the ISO provisions are considered as a possible means to support the implementation of ESARR 3.

Two additional tables have been produced to summarise those findings and map ISO 9001:2000 and ESARR 3 in a briefer manner:

Appendix A includes a table presenting the ISO provisions that could be used to support each ESARR 3 requirement. The comments indicate those cases where specific issues (conditions identified) have been identified;

The table on Appendix B summarises all the conditions identified for each ISO provision. Those conditions should be taken into account wherever ISO is considered as a means to support the implementation of ESARR 3.

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3.2 Terminology

Some terminological aspects have to be taken into account when considering the tables of this document. Definitions used by ISO and SRC may differ1.

In particular, it should be noted that:

ISO uses extensively the term “product” defined as “result of a process”. In other words, a product is an output of a set of interacting actions irrespective of its nature. Within the ISO approach there are four generic product categories: services, software, hardware and processed materials. The notion of “service” as a particular type of product is essential when considering the applicability of ISO 9001:2000 to ATM services.

The term “requirement” has a broad meaning in ISO 9001:2000. It is defined as a “need or expectation that is stated, generically implied or obligatory”. On the other hand the expression “safety requirement” is normally used2 by SRC to refer to the mitigation measures identified through a risk assessment and mitigation process. That difference should be taken into account when considering the mapping of ISO provisions related to risk assessment and mitigation.

No definition for “purchasing” is provided in ISO 9001:2000 or ISO 9000:2000 although the concept is implicitly defined in the provisions of Section 7.4 (Purchasing). The term purchasing needs to be compared with the “external services” concept that appears to be wider.

3.3. References for Interpretation

The comparison between each ISO provision and ESARR 3 requirements has been based on an assessment that considers primarily the exact text of ESARR 3 Section 5 and the set of definitions included in ESARR 3 Appendix A.

In some cases the assessment has made use of two additional sources of interpretation. Wherever that is the case, the comments included on the table of Appendix C make the issue clear. The two additional SRC references used are:

EAM 3 / GUI 1, Guidance Material for ATM Safety Regulators, Explanatory Material on ESARR 3 Requirements, Edition 1.0. June 2001.

ESARR 4, Risk Assessment and Mitigation in ATM, Edition 1.0, April 2001.

Nevertheless, the scope of this document is confined to considering the links between ISO 9001:2000 and ESARR 3. Compliance with ESARR 4 might imply additional aspects not necessarily addressed in this exercise. Wherever that possibility was clearly identified, the issue has been indicated explicitly on the tables.

1 Definitions applicable to ISO 9001:2000 are contained in ISO 9000:2000, Quality Management Systems – Fundamentals and Vocabulary. 2 As utilised in ESARR 4.

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4. SUMMARY OF COMPARISON – ESARR 3 WITH ISO 9001:2000

This section only summarises some of the main aspects identified. The tables of the appendices collect all the findings in a more comprehensive manner:

4.1 General Aspects

Generally speaking, the findings of the mapping show that ISO 9001:2000 may provide useful tools to support the implementation of most ESARR 3 requirements.

On balance, most of the differences identified appear to be caused by the fact that the SMS concept focuses on a very specific aspect –safety-, and is primarily applicable to safety-related industries, while QMS present a more generic approach applicable to any industry. In addition, ESARR 3 is clearly tailored to a service-oriented industry, the provision of ATM services, while ISO 9001:2000 gives a more generic approach applicable to any organisation producing any type of product (services, software, hardware or materials).

Those differences in approach have resulted in different levels of detail to address interconnected issues. In some cases ISO is much more detailed and provides useful means to support the implementation of ESARR 3 without raising specific issues. However, in other situations ESARR 3 gives the interpretation needed for generic concepts, such as the term “appropriate” which is widely used throughout ISO 9000:2001.

4.2 Systematic Safety Management

Several ISO 9001:2000 provisions can be useful to define possible means of compliance to implement the generic ESARR 3 principles3 requiring a “formalised approach” to “systematic” safety management. A case in point is the determination of processes that ISO 9001:2000 requires in Section 4.1 (General Requirements). A process approach based on ISO4 seems a proper means to implement the ESARR 3 requirement for a “systematic” and “formalised” approach.

(Space Left Intentionally Blank)

3 ESARR 3, 5.1.1 a, requires the ATM service provider to have in place a SMS which “ensures a formalised, explicit and pro-active approach to systematic safety management in meeting its safety responsibilities within the provision of ATM services.” 4 Within ISO, the systematic identification and management of the processes employed within an organisation and particularly the interactions between such processes is referred to as the “process approach”

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4.3 Safety Policy and Safety Objectives

ISO requires defining quality objectives, but does not provide detailed guidance as to what is acceptable as an objective5. However, ESARR 3, 5.1.4, identifies an overall safety objective for all ATM service providers. Wherever the use of ISO is considered to support ESARR 3, any objective defined should be consistent with the minimum common safety objective defined for all ATM service providers.

ISO requires top management to ensure that the quality policy is “appropriate” to the purpose of the organisation. However, ISO does not provide guidance as to what constitutes, or is acceptable as, a policy statement. ESARR 3, Section 5.1, contains four high level principles6 that should normally7 be addressed by means of safety policy statements. The safety policy should normally include, as a minimum, statements to cover ESARR 3, 5.1.1, 5.1.2, 5.1.3 and 5.1.4.

ISO requires the quality manual to include the scope of the QMS, including details of and justification for any exclusion. No other ISO requirements exist as regards the minimum QMS scope. However, ESARR 3, 5.1.1 b, requires a specific scope. SMS should cover, necessarily, not only all the ATM services provided but also the supporting services8 which are under the managerial control of the organisation.

4.4. Top Management Commitment

ISO is much more specific and requires specific evidences to demonstrate top management commitment. In particular, ISO requires top management to ensure the availability of resources. The use of that approach may support practically the implementation of the generic statements included in ESARR 3, 5.2.2 d, regarding the “general role” to be played by the highest level of the service provider organisation.

Management reviews are not required explicitly in ESARR 3, although SMS management reviews are identified in EAM 3/GUI 1 as one of the usual elements of the implementation of ESARR 5.4.2 b (Safety Improvement). EAM 3/GUI 1 underlines that SMS management reviews should involve top management as a means to ensure the continuous improvement of safety. ISO provides a detailed framework for management reviews, consistent with EAM 3/GUI 1. The ISO provisions may support the definition of possible means of compliance to meet ESARR 5.4.2 b) in conjunction with 5.2.2 d).

5 Apart from requiring those objectives needed to meet requirements for product 6 5.1.1 Safety Management, 5.1.2 Safety Responsibility, 5.1.3 Safety Priority, 5.1.4 Safety Objective of the ATM Service 7 As pointed out in EAM 3/GUI 1. 8 ESARR 3 defines supporting services as the “systems, services and arrangements, including Communication, Navigation and Surveillance services, which support the provision of an ATM service.”

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4.5 Safety Responsibilities

ISO requires top management to ensure that responsibilities and authorities are defined and communicated within the organisation. No other details are given. On the other hand, ESARR 3 is more specific and emphasises three key aspects:

a) The notion of individuality in the safety responsibility concept

b) The link between responsibility and own actions

c) The safety responsibility of managers is related to the safety performance of their organisations.

Wherever the use of ISO is considered to support ESARR 3, it should be ensured that safety responsibilities are defined for individuals and related to their own actions, and that the responsibilities of managers are related to the performance of the part of the organisation they manage.

4.6. Safety Managerial Function

ESARR 3 requires the safety manager to be independent of line management, while ISO only requires the appointment of a member of the management as quality manager9, irrespective of other responsibilities. Wherever the use of ISO is considered as a means to support ESARR 3, it should therefore be ensured that the safety managerial function is independent of line management (except perhaps in the case of some small organisations).

On the other hand, it should be noted that:

a) ISO explicitly requires the quality manager to be part of the management team. ESARR 3 does not include such explicit specification in regard to the safety manager. However, that notion is stressed in EAM 3/GUI 1 as a key aspect that stems from the requirement of SMS being an integral part of the overall management function (ESARR 3, 5.1).

b) In ISO, the term “authority”10 reinforces significantly the role of the quality manager. Within the context of ESARR 3, its use may provide a positive input to the definition of proper terms of reference for the safety management function.

Consequently, it should be noted that using the ISO expressions ‘member of the management’ and ‘authority’ within the terms of reference of the safety manager could be helpful to support the implementation of ESARR 3, 5.2.2.

9 Management representative is the exact expression used in ISO 9000:2001 10 ISO 9000:2001, Section 5.5.2 states that “top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:

a) ensuring that processes needed for the QMS are established, implemented and maintained, b) reporting to top management on the performance of the QMS and any need for improvement c) ensuring the promotion of awareness of customer requirements throughout the organisation.

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4.7 SMS Documentation

ISO establishes a detailed framework for the control of documents. ESARR 3 only states that the SMS has to be documented “systematically”. Therefore, most of the ISO provisions on documentation, control of documents, quality manual and records can support the implementation of ESARR 3, 5.2.5 by offering possible means of compliance to document the SMS in a systematic manner.

ISO 9001:2000 only requires those records explicitly identified throughout its provisions. ESARR 3, 5.3.3, requires maintaining safety records throughout the SMS operation, that is to say, in relation to all the arrangements required in the 17 requirements of ESARR 3. In addition, ESARR 3, 5.3.4 underlines explicitly the need for producing specific records for the results of risk assessment and mitigation. Therefore wherever the use of ISO is considered, it should be ensured that records are produced for all the ESARR 3 arrangements, and very particularly for the results of risk assessment and mitigation processes.

4.8. Internal Communication

ISO requires top management to ensure that “appropriate” communication processes are established within the organisation and that communication takes place regarding the effectiveness of the QMS. No further details are provided about the minimum processes needed. However, ESARR 3 defines at least two specific processes in this regard:

a) Dissemination of lessons learnt (ESARR 3, 5.4.1), and

b) The establishment of mechanisms to ensure that all staff are actively encourage to communicate (ESARR 3, 5.4.2 a)

Wherever the use of ISO is considered as a means to support ESARR 3, it should be ensured that specific internal communication actions are implemented to cover explicitly the requirements of ESARR 3, 5.4.1 and 5.4.2. a).

4.9. Safety Occurrences

Useful provisions have been found in ISO 9001:2000 to support the implementation of ESARR 3, 5.2.7, Safety Occurrences. In particular, Section 8.5.2 (corrective action) states that the organisation shall take action to eliminate the cause of non-conformities in order to prevent recurrence. That generic principle may certainly provide a framework to deal with safety occurrences. However, ESARR 3 is much more specific and requires the immediate investigation of safety occurrences. That notion does not appear in ISO. Therefore, wherever the use of ISO is considered as a means to support ESARR 3, it should be ensured that safety occurrences are immediately investigated.

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4.10 Internal Auditing

EAM 3 / GUI 1 explicitly recognises that internal auditing based on ISO 9001:2000 can be used for designing safety survey processes. EAM 3 / GUI 1 also points out that, in dealing with the implementation of safety surveys, service providers should normally establish processes in a manner which:

a) Ensures independence of the area being surveyed; and

b) Ensures systematic planning, assessment of all factors affecting safety, identification of corrective actions, recording of results, initiation and follow up of corrective actions.

Those aspects are in line with the ISO approach. Therefore the use of internal ISO audits can support the implementation of ESARR 3 Section 5.3.1 by providing possible means of compliance to meet the requirement

ISO 9001:2000 refers to other complementary guidance material on auditing techniques. The use of ISO 19011:2002 provides further detailed guidelines which could be used to support the definition of means of compliance to meet ESARR 3, Section 5.3.1.

4.11 Risk Assessment and Mitigation

ESARR 3 necessarily implies the adoption of a risk-based approach and the use of risk management techniques. SMS cannot be conceived without these features. However, ISO 9001:2000 can be implemented without adopting such approach. Quality management is conceivable without risk management.

In spite of those differences, various ISO provisions could effectively support the risk assessment and mitigation process required in ESARR 3. More particularly, this applies to most of the provisions included in Section 7 (Product Realisation). However, a common condition has been identified in regard to the possible use of most of the provisions of ISO 9001:2000 Section 7 to support the implementation of ESARR 3, 5.2.4 (Risk Assessment and Mitigation). Generally speaking, there is a need to ensure that risk assessment and mitigation is addressed explicitly and differentially throughout the product realisation processes outlined by ISO11.

11 Let us consider, for example, the use of ISO 9001:2000 Section 7.1 (Planning of Product Realisation). ISO requires the organisation to determine, as “appropriate”, the processes needed to produce the product. Wherever those provisions are used to implement ESARR 3, the requirements contained in ESARR 3, 5.2.4 (Risk Assessment and Mitigation) give an interpretation of the term “appropriate”. Explicit risk assessment and mitigation processes are needed to deal with the changes to the ATM system associated to the realisation of that product.

To take another example: ISO 9001:2000 Section 7.2.1 (Determination of Requirements Related to the Product) requires the organisation to determine the various types of requirements in relation to the product. That includes “any additional requirements determined by the organisation”. The requirements of ESARR 3, 5.2.4 c) may give an interpretation for that expression. Normally, mitigation measures (safety requirements in ESARR 4) should be identified explicitly in the light of the results of risk assessment and mitigation processes conducted by the organisation as part of the realisation of the product.

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The scope of this document is confined to considering the links between ISO 9001:2000 and ESARR 3. Therefore it should be noted that compliance with ESARR 4 might imply additional aspects12 not necessarily addressed in this exercise.

4.12 External Services13

The ISO approach proposed in Section 7.4 (Purchasing) appears effective as a means to deal with those situations in which external suppliers can be selected. However, the use of external services in ATM may involve situations14 where there are no options and external inputs need to be used as the only possible ones.

As explained in EAM 3 / GUI 1 (ESARR 3 Guidance Material), even in those situations any external input (product, service, information, etc) can be managed through a risk assessment and mitigation approach. A process can identify the hazards associated with the input and ensure that their risk is mitigated to a tolerable level. Appropriate mitigation measures could include techniques such as monitoring, redundancy, operational or contingency procedures, etc, etc

The use of the ISO provisions on purchasing (Section 7.4) can support the implementation of ESARR 3, 5.2.6, provided that complementary arrangements are put in place to deal with those situations in which external suppliers can not be selected. Those additional arrangements should normally be based on a risk-based approach.

(Space Left Intentionally Blank)

12 For example, when considering ISO 9001:2000 Sections 7.3.4, 7.3.5, 7.3.6, (Design and Development Review, Verification and Validation) it should be noted that, although ESARR 3 is not specific about equivalent activities within risk assessment and mitigation, ESARR 4 contains detailed requirements on equivalent actions. 13 External services are defined in ESARR 3 as “all material and non-material supplies and services, which are delivered by any organisation not covered by the ATM service-provider’s safety management system.” 14 The ESARR 3 definition of “External Services” is wide and may include several categories of external inputs. Some possible examples: services provided by external organisations (e.g. CNS, MET, AIS, telecom, power supply, fire-fighting, etc), procurement of equipment, operational inputs from adjacent sectors, radar data from other organisations, etc, etc.

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5. SIGNIFICANT ISSUES REGARDING INTER-RELATIONSHIP BETWEEN SMS AND QMS

5.1 Verification of Compliance with ESARR 3

The findings of the comparison confirm that ISO 9001:2000 can be used to support the implementation of ESARR 3 in the provision of ATM services.

ATM safety regulators could therefore recognise the use of ISO 9001:2000 as an acceptable means of compliance to meet specific ESARR 3 requirements, provided that the approach proposed demonstrates that it meets all the specific requirements under consideration.

ESARR 3 Section 5 includes 17 requirements. Full compliance with ESARR 3 is only achieved when those 17 requirements are met. Consequently, wherever the use of an ISO-based approach is proposed as a means to meet, totally or partially, those requirements, the practical steps to verify compliance with ESARR 3 would normally involve:

The identification of the specific ESARR 3 requirements that the approach proposed intends to cover;

The identification of the specific ISO 9001:2000 provisions intended to meet those ESARR 3 requirements; and

An assessment that could consider, without excluding any additional input, the issues raised in this document, and notably the “conditions identified” in the table included in Appendix B.

5.2 Explicitness of the SMS

ESARR 3, 5.1.1.a, requires15 the implementation of a SMS which ensures an explicit approach to safety management. In that regard, EAM 3/GUI 1 points out that an intuitive or ad hoc approach is not enough. Safety issues must be dealt with and managed explicitly.

SMS is specifically intended to deal with safety. Safety is its recognised and explicit subject. On the other hand, QMS aims to achieve customer satisfaction by meeting its requirements: this involves the identification of customer requirements, their satisfactory implementation by the prevention and correction of non-conformities, and measurement of achieved quality. Although safety is normally considered as an essential attribute of quality, QMS have a wider scope that might obscure the effective recognition of safety as prime objective.

15 ESARR 3, 5.1.1 a) states that the ATM service provider shall have in place a SMS which “ensures a formalised, explicit and pro-active approach to systematic safety management in meeting its safety responsibilities within the provision of ATM services”.

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Throughout the mapping, it has been useful to compare equivalent statements by replacing the term ”quality”, normally used by ISO, with the term “safety”. In other cases generic actions mentioned in ISO have been compared with ESARR 3 by assuming a scope specifically focused on safety (e.g. monitoring vs. safety monitoring). Therefore the comparison and its results made the assumption that the actions proposed by ISO would be used to deal with safety in a differentiated manner. The need to deal with safety explicitly and specifically is indeed one of the main principles embedded in ESARR 3 and that fact has been reflected in the issues identified in the comparison.

From the comparison, it stems that, wherever ISO 9001:2000 provisions are used to support the implementation of ESARR 3, a way to provide appropriate explicitness is to ensure that safety is addressed as a specific and differentiated subject in the ISO-based processes and arrangements used to implement ESARR 3.

5.3 Integration of SMS and QMS

ESARR 3 does not require any specific level of integration or separation between both management systems (SMS and QMS) when they are simultaneously operated within the same organisation.

Therefore ATM safety regulators may recognise any proposed level of integration between SMS and QMS as an acceptable means of compliance, provided that:

The approach proposed meets the requirements contained in ESARR 3 and,

In particular, safety is addressed as a specific subject in the processes and arrangements proposed16.

Different approaches and arrangements could be acceptable to combine or differentiate the two functions and a mixed Safety and Quality Management System is conceivable although a clear separation between QMS and SMS might ensure a more transparent SMS explicitness when implementing ESARR 3 Section 5.1.1.

Without presenting an exhaustive list, three basic levels of integration may be suggested:

Complete separation and establishment of two different systems, QMS and SMS;

Intermediate approaches in which common subjects would be partially implemented in a shared manner;

Full integration to propose either SMS to be implemented within QMS or quality management elements to be added to SMS.

Any proposed approach, associated with a particular level of integration, should demonstrate that ESARR 3 requirements are met before being recognised as an acceptable means of compliance.

16 As a possible way to ensure appropriate explicitness as required in ESARR 3, 5.1.1 a).

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5.4 ISO Certification

Organisations operating QMS may obtain accreditation of compliance with ISO 9001:2000. Accreditation is normally documented by a certificate issued by a certification body which itself needs to be accredited by a national accreditation body signatory to the European Co-operation for Accreditation (EA) Multilateral Agreement (MLA) for Certification for Quality Systems.

Such accreditation does not imply necessarily compliance with ESARR 3 in those cases where the QMS is used to support the implementation of ESARR 3.

However, when verifying compliance with ESARR 3 safety regulators could make use of accreditation processes comprising ISO 9001:2000 and augmented for ATM service providers by means of ESARR 3. Without excluding any additional input, the issues raised in this document, and notably the “conditions identified” in the table included in Appendix B, could be considered to design such processes.

5.5 Small Organisations

ISO 9001:2000 is applicable to all types of organisations irrespective of their size. No specific provisions exist in ISO 9001:2000 with regard to small organisations.

ESARR 3 includes some specific provisions as regards small organisations. According to ESARR 3, 5.2.2 c) and d), the independence of line management normally required for the safety manager could not be needed under certain conditions in the case of some small organisations17.

It should be noted that ISO 9001:2000 does not require independence of line management for the quality manager.

(Space Left Intentioanlly Blank)

17 EAM 3/GUI 2, Safety Regulatory Aspects of the Implementation of ESARR 3 in Small Organisations, Edition 1.0, provides specific guidance on this matter.

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APPENDIX A – Summary of Mapping

Table of ISO 9001:2000 provisions that can support the implementation of specific ESARR 3 requirements

ESARR 3 requirements ISO 9001:2000 provisions whose

use can support the implementation of ESARR 3 requirements

COMMENTS

5.1. General Requirement 4.1 General Requirement - 5.1 Management Commitment - 5.4.2 QMS Planning Related to bullet a) in ESARR 3

5.1.1. Safety Management

6.1 Provision of resources Related to bullet 5.1 as a whole

5.1.2. Safety Responsibility 5.5.1 Responsibility, authority and communication CONDITIONS IDENTIFIED

5.1.3. Safety Priority - -

5.1.4. Safety Objective ATM Service 5.4.1 Quality Objectives CONDITIONS IDENTIFIED

5.2. Requirements for Safety Achievement 5.2.1. Competency 6.2 Human Resources -

5.1 Management Commitment Related to bullet d) in ESARR 3

5.5.2 Management Representative CONDITIONS IDENTIFIED 5.6 Management Review Related to bullet d) in ESARR 3

5.2.2. Safety. Management Responsibility

6.1 Provision of Resources Related to bullet d) in ESARR 3

5.2.3 Quantitative Safety Levels 5.4.1 Quality Objectives CONDITIONS IDENTIFIED 7.1 Planning of Product Realisation CONDITIONS IDENTIFIED 7.2.1 Determination of Requirements related to the product CONDITIONS IDENTIFIED

7.2.2 Review of Requirements related to the product CONDITIONS IDENTIFIED

7.3.1 Design and Development CONDITIONS IDENTIFIED

7.3.2 Design and Development Inputs CONDITIONS IDENTIFIED

7.3.3 Design and Development Outputs CONDITIONS IDENTIFIED 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation

Full compliance with ESARR 4 might involve additional conditions

7.3.7 Control of Design & Development Changes CONDITIONS IDENTIFIED

7.5.1 and 7.5.2 Control and Validation of Processes for Production and Service Provision

CONDITIONS IDENTIFIED

5.2.4. Risk Assessment and Mitigation

8.3 Control of Non-Conforming Product -

4.2.2 Quality Manual - 4.2.3 Control of Documents - 5.2.5. SMS Documentation

4.2.4 Control of Records -

4.1 General Requirement (last paragraph) CONDITIONS IDENTIFIED 5.2.6. External Services

7.4 Purchasing CONDITIONS IDENTIFIED

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ESARR 3 requirements ISO 9001:2000 provisions whose

use can support the implementation of ESARR 3 requirements

COMMENTS

8.3 Control of Non-Conforming Product (last paragraph) CONDITIONS IDENTIFIED 5.2.7. Safety Occurrences 8.5.2 Corrective Action CONDITIONS IDENTIFIED

5.3. Requirements for Safety Assurance

8.2.2 Internal Audit ISO-19011 can also support the implementation of ESARR 3, 5.3.1

8.2.3 Monitoring and Measurement of Processes -

8.2.4 Monitoring and Measurement of Product -

8.4 Analysis of Data - 8.5.2 Corrective Action -

5.3.1. Safety Surveys

8.5.3 Preventive Action - 8.2.4 Monitoring and Measurement of Product -

5.4.2 Analysis of Data - 8.3 Control of Non-Conforming Product - 8.5.2 Corrective Action -

5.3.2. Safety Monitoring

8.5.3 Preventive Action - 4.2.4 Control of Records -

5.3.3. Safety Records 7.5.3 Identification and Traceability - 4.2.4 Control of Records - 7.3.7 Control of Design & Development Changes CONDITIONS IDENTIFIED 5.3.4. Risk Assessment & Mitigation

Documentation

7.5.3 Identification and Traceability -

5.4. Requirements for Safety Promotion

5.4.1. Lesson Dissemination 5.5.3 Internal Communication CONDITIONS IDENTIFIED 5.1 Management Commitment Related to bullet b) in ESARR 3 5.4.2 QMS Planning -

5.5.3 Internal Communication CONDITIONS IDENTIFIED 5.6 Management Review Related to bullet b) in ESARR 3 8.4 Analysis of Data Related to bullet b) in ESARR 3

5.4.2. Safety Improvement

8.5.1 Continual Improvement Related to bullet b) in ESARR 3

(Space Left Intentionally Blank)

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APPENDIX B – Summary of Mapping

Table of conditions to note wherever ISO 9001:2000 provisions are considered to implement specific ESARR 3 requirements1

ISO 9001:2000 provisions whose use to implement

ESARR 3 should be subject to certain conditions

CONDITIONS IDENTIFIED ESARR 3 related

requirements

4. Quality Management System

4.1. General Requirement (last paragraph)

The paragraph can support the implementation of ESARR 3, 5.2.6 (External Services) but only as regards a very particular type of externally provided services

5.2.6

Any safety objective defined by ATM service providers must be consistent with the minimum common objective defined for all ATM providers in ESARR 3, 5.1.4.

5.1.4 4.2.1. General (Documentation) (bullet a)

The Safety Policy should normally include policy statements to address ESARR 3, 5.1.1, 5.1.2, 5.1.3 and 5.1.4 5.1, 5.1.1 c)

4.2.1. General (Documentation) (bullet e)

Records have to be produced and maintained for all the actions (processes) intended to meet ESARR 3, and in particular for the results of risk assessment and mitigation

5.3.3, 5.3.4

4.2.2. Quality Manual (bullet a) The scope of the SMS must be the one specified in ESARR 3 5.1.1 b)

5. Management Responsibility Any safety objective defined by ATM service providers must be consistent with the minimum common objective defined for all ATM providers in ESARR 3, 5.1.4. 5.3. Quality Policy The Safety Policy should normally include policy statements to address ESARR 3, 5.1.1, 5.1.2, 5.1.3 and 5.1.4

5.1, 5.1.1 c)

5.4.1. Quality Objectives Any safety objective defined by ATM service providers must be consistent with the minimum common objective defined for all ATM providers in ESARR 3, 5.1.4.

5.1.4, 5.2.3

5.5.1. Responsibility and Authority

ISO is more generic than ESARR 3. Safety responsibilities must be defined for individuals in relation to their own actions, and responsibilities of managers must be related to the safety performance of the part of the organisation they manage

5.1.2

5.5.2. Management Representative The safety managerial function should be independent of line management (except perhaps in the case of some small organisations)

5.2.2 a), b)

5.5.3. Internal Communication ISO is more generic than ESARR 3. There are very specific internal communication actions required in ESARR 3 (lessons dissemination, feedback from staff in safety improvement)

5.4.1, 5.4.2 a)

7. Product Realisation

7.1. Planning of Product Realisation Planning of processes should include, explicitly, those processes needed for risk assessment and mitigation in accordance with ESARR 3

5.2.4

7.2.1. Determination of Requirements Related to the Product 7.2.2. Review of Requirements Related to the Product

The requirements determined should include, explicitly, the safety requirements (mitigation measures) derived from risk assessment and mitigation processes

5.2.4

7.3.1. Design and Development Planning

Design and development planning should include, explicitly, the planning of risk assessment and mitigation as regards any associated changes to the ATM system.

5.2.4

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ISO 9001:2000 provisions whose use to implement

ESARR 3 should be subject to certain conditions

CONDITIONS IDENTIFIED ESARR 3 related

requirements

7.3.2. Design and Development Inputs

Design and development inputs should identify, explicitly, the inputs needed to conduct risk assessment and mitigation with regard to any associated changes to the ATM system

5.2.4

7.3.3. Design and Development Outputs

Design and development outputs should identify, explicitly, the outputs from risk assessment and mitigation undertaken in regard to any associated changes to the ATM system (notably the safety requirements, also known as mitigation measures)

5.2.4

7.3.7. Control of Design and Development Changes

The control of design and development should include specific documentation to present the results and conclusions of risk assessment and mitigation related to associated changes to the ATM system.

5.2.4, 5.3.4

7.4. Purchasing

Complementary arrangements are needed to deal with those situations in which external suppliers cannot be selected. Those additional arrangements should normally be based on a risk-based approach

5.2.6

7.5.1. Control of production and service provision

7.5.2. Validation of processes for production and service provisions

These provisions can support the implementation of ESARR 3, 5.2.4, with regard to ATM operational procedures. However, the control and validation of processes for service provision should explicitly include appropriate risk assessment and mitigation activities.

5.2.4

8. Measurement, Analysis and Improvement 8.3. Control of Non-Conforming Product (last paragraph)

8.5.2. Corrective Action

Wherever these ISO statements are considered as possible means to implement ESARR 3, Section 5.2..7 (Safety Occurrences), the actions mentioned in ISO should necessarily include an immediate investigation of occurrences and the implementation of corrective actions resulting from such investigation

5.2.7

Additionally, wherever ISO 9001:2000 provisions are used to support the implementation of ESARR 3, safety should normally be addressed as a specific and differentiated subject in the ISO-based processes and arrangements used to implement ESARR 3.

(Space Left Intentionally Blank)

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 23

of 4

5 A

PPEN

DIX

C –

Det

aile

d C

ompa

rison

bet

wee

n IS

O 9

001:

2000

and

ESA

RR

3

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 4.

1. G

ener

al R

equi

rem

ents

The

orga

nisa

tion

shal

l est

ablis

h, d

ocum

ent a

nd m

aint

ain

a qu

ality

man

agem

ent s

yste

m a

nd c

ontin

ually

impr

ove

its

effe

ctiv

enes

s in

acc

orda

nce

with

the

requ

irem

ents

if th

is

Inte

rnat

iona

l Sta

ndar

d. T

he o

rgan

isat

ion

shal

l:

5.1.

Gen

eral

Req

uire

men

t – A

n A

TM s

ervi

ce p

rovi

der s

hall,

as

an

inte

gral

par

t of t

he m

anag

emen

t of t

he A

TM s

ervi

ce h

ave

in p

lace

a

safe

ty m

anag

emen

t sys

tem

whi

ch:

(als

o re

late

d to

5.4

.2 S

afet

y Im

prov

emen

t)

The

inte

nt o

f the

se s

tate

men

ts is

equ

ival

ent.

To n

ote

that

ES

AR

R 3

em

phas

ises

the

need

to im

plem

ent S

MS

as

a p

art o

f the

ove

rall

man

agem

ent f

unct

ion.

a) id

entif

y th

e pr

oces

ses

need

ed fo

r the

QM

S a

nd th

eir

appl

icat

ion

thro

ugho

ut th

e or

gani

satio

n

b) d

eter

min

e th

e se

quen

ce a

nd in

tera

ctio

n of

thes

e pr

oces

ses

c) d

eter

min

e cr

iteria

and

met

hods

nee

ded

to e

nsur

e th

at

both

the

oper

atio

n an

d co

ntro

l of t

hese

s pr

oces

ses

are

effe

ctiv

e

d) e

nsur

e av

aila

bilit

y of

reso

urce

s an

d in

form

atio

n ne

cess

ary

to s

uppo

rt th

e op

erat

ion

and

mon

itorin

g of

th

eses

pro

cess

es

e) m

onito

r, m

easu

re a

nd a

naly

se th

ese

proc

esse

s, a

nd

5.1.

1 Sa

fety

Man

agem

ent

(hav

e in

pla

ce a

SM

S w

hich

) a)

ens

ures

a fo

rmal

ised

, exp

licit

and

pro-

activ

e ap

proa

ch to

sy

stem

atic

saf

ety

man

agem

ent i

n m

eetin

g its

saf

ety

resp

onsi

bilit

ies

with

in th

e pr

ovis

ions

of A

TM s

ervi

ces

b) o

pera

tes

in re

spec

t to

all A

TM a

nd s

uppo

rting

ser

vice

s w

hich

are

un

der i

ts m

anag

eria

l con

trol

ES

AR

R 3

requ

ires

a fo

rmal

ised

and

exp

licit

appr

oach

to

syst

emat

ic s

afet

y m

anag

emen

t. H

owev

er, E

SA

RR

3 d

oes

not i

nclu

de e

xplic

itly

the

bulle

ts

deve

lope

d in

ISO

. In

parti

cula

r, E

SA

RR

3 d

oes

not i

nclu

de

expl

icit

requ

irem

ents

on

the

iden

tific

atio

n of

pro

cess

es a

nd th

eir

subs

eque

nt m

anag

emen

t as

an e

xplic

it re

quire

men

t.

A p

roce

ss a

ppro

ach,

as

prop

osed

in IS

O, s

eem

s a

prop

er

mea

ns to

impl

emen

t the

ES

AR

R 3

requ

irem

ent f

or a

“s

yste

mat

ic” a

nd “f

orm

alis

ed” a

ppro

ach.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.1.1

. f)

impl

emen

t act

ions

nec

essa

ry to

ach

ieve

pla

nned

resu

lts

and

cont

inua

l im

prov

emen

t of t

hese

pro

cess

es.

5.4.

2. S

afet

y Im

prov

emen

t (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce-p

rovi

der)

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d.

The

inte

nt o

f the

se s

tate

men

ts is

equ

ival

ent

Thes

e pr

oces

ses

shal

l be

man

aged

by

the

orga

nisa

tion

in

acco

rdan

ce w

ith th

e re

quire

men

ts o

f thi

s In

tern

atio

nal

Sta

ndar

d

- N

/A

Whe

re a

n or

gani

satio

n ch

oose

s to

out

sour

ce a

ny p

roce

ss

that

affe

cts

prod

uct c

onfo

rmity

with

requ

irem

ents

, the

or

gani

satio

n sh

all e

nsur

e co

ntro

l ove

r suc

h pr

oces

ses.

C

ontro

l of s

uch

outs

ourc

ed p

roce

sses

sha

ll be

iden

tifie

d w

ithin

the

qual

ity m

anag

emen

t sys

tem

.

5.2.

6 Ex

tern

al S

ervi

ces

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

adeq

uate

and

sat

isfa

ctor

y ju

stifi

catio

n of

the

safe

ty o

f th

e ex

tern

ally

pro

vide

d se

rvic

es, h

avin

g re

gard

to th

eir s

afet

y si

gnifi

canc

e w

ithin

the

prov

isio

n of

the

ATM

ser

vice

. (E

xter

nal S

ervi

ces

are

defin

ed in

ES

AR

R 3

, App

endi

x A

)

The

ISO

sta

tem

ent c

over

s a

parti

cula

r situ

atio

n in

clud

ed in

the

Ext

erna

l Ser

vice

s co

ncep

t. It

shou

ld b

e no

ted

that

ES

AR

R 3

def

ines

Ext

erna

l Ser

vice

s in

a

very

bro

ad m

anne

r (“a

ll m

ater

ial a

nd n

on-m

ater

ial s

uppl

ies

and

serv

ices

whi

ch a

re d

eliv

ered

by

any

orga

nisa

tion

not c

over

ed

by th

e A

TM s

ervi

ce p

rovi

der’s

SM

S”)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.6

(but

onl

y w

ith re

gard

to a

pa

rtic

ular

type

of e

xter

nal s

ervi

ces)

.

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/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

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nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 24

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 4.

2. D

ocum

enta

tion

4.2.

1. G

ener

al

The

qual

ity m

anag

emen

t sys

tem

sha

ll in

clud

e:

a) d

ocum

ente

d st

atem

ents

of a

qua

lity

polic

y an

d qu

ality

ob

ject

ives

5.

1.1.

Saf

ety

Man

agem

ent

(hav

e in

pla

ce a

SM

S w

hich

) …

c)

incl

udes

, as

its fo

unda

tion,

a s

tate

men

t of s

afet

y po

licy

defin

ing

the

fund

amen

tal a

ppro

ach

to m

anag

ing

safe

ty

5.1.

4. S

afet

y O

bjec

tive

of th

e A

TM s

ervi

ce

(hav

e in

pla

ce a

SM

S w

hich

) en

sure

s th

at w

hile

pro

vidi

ng a

n A

TM s

ervi

ce,

the

prin

cipa

l sa

fety

ob

ject

ive

is to

min

imis

e th

e A

TM c

ontri

butio

n to

the

risk

of a

n ai

rcra

ft ac

cide

nt a

s fa

r as

reas

onab

ly p

ract

icab

le

(Als

o 5.

1.2.

(Saf

ety

Res

pons

ibili

ty) a

nd 5

.1.3

. (S

afet

y P

riorit

y) in

clud

e hi

gh le

vel s

tate

men

ts o

f pol

icy

natu

re)

Bot

h do

cum

ents

con

side

r the

nee

d fo

r pol

icy

and

obje

ctiv

es.

ES

AR

R 3

con

tain

s so

me

high

leve

l sta

tem

ents

that

sho

uld

norm

ally

be

addr

esse

d in

the

Saf

ety

Pol

icy

(e.g

. Saf

ety

Prio

rity)

as

poi

nted

out

in E

AM

3/G

UI1

(ES

AR

R 3

Gui

danc

e M

ater

ial).

O

n th

e ot

her h

and

ISO

is v

ery

gene

ric o

n th

e co

nten

ts o

f the

qu

ality

pol

icy.

ISO

Sec

tion

5.3

(see

bel

ow) r

equi

res

the

polic

y to

be

“app

ropr

iate

” for

the

purp

ose

of th

e or

gani

satio

n.

ES

AR

R 3

als

o id

entif

ies

a m

inim

um s

afet

y ob

ject

ive

for a

ll se

rvic

e pr

ovid

ers,

whi

le IS

O o

nly

requ

ires

defin

ing

appr

opria

te

obje

ctiv

es (s

ee 5

.4.1

bel

ow).

Whe

neve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

any

obj

ectiv

e de

fined

by

ATM

ser

vice

pro

vide

rs m

ust

be c

onsi

sten

t with

the

min

imum

com

mon

obj

ectiv

e de

fined

fo

r all

ATM

pro

vide

rs in

ESA

RR

3, S

ectio

n 5.

1.4.

W

here

ver t

he u

se o

f ISO

is c

onsi

dere

d, it

sho

uld

be n

oted

th

at th

e Sa

fety

Pol

icy

shou

ld n

orm

ally

incl

ude

stat

emen

ts

to a

ddre

ss E

SAR

R 3

Sec

tions

5.1

.1, 5

.1.2

, 5.1

.3 a

nd 5

.1.4

.

b) a

qua

lity

man

ual

c) d

ocum

ente

d pr

oced

ures

requ

ired

by th

is In

tern

atio

nal

Sta

ndar

d

d) d

ocum

ents

nee

ded

by th

e or

gani

satio

n to

ens

ure

the

effe

ctiv

e pl

anni

ng, o

pera

tion

and

cont

rol o

f its

pro

cess

es

5.2.

5. S

MS

Doc

umen

tatio

n (w

ithin

the

oper

atio

n of

the

SM

S, t

he s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at th

e S

MS

is s

yste

mat

ical

ly d

ocum

ente

d in

a m

anne

r, w

hich

pro

vide

s a

clea

r lin

kage

to th

e or

gani

satio

n’s

safe

ty p

olic

y;

ES

AR

R 3

is le

ss p

resc

riptiv

e. T

he S

MS

mus

t be

syst

emat

ical

ly

docu

men

ted

but n

o pa

rticu

lar f

orm

at is

requ

ired.

O

n th

e ot

her h

and

ES

AR

R 3

insi

sts

on th

e ne

ed to

ens

ure

a cl

ear l

ink

betw

een

Saf

ety

Pol

icy

and

SM

S.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.5

.

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

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SA

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3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 25

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t e)

reco

rds

requ

ired

by th

is In

tern

atio

nal S

tand

ard

5.3.

3. S

afet

y R

ecor

ds

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

saf

ety

reco

rds

are

mai

ntai

ned

thro

ugho

ut th

e S

MS

op

erat

ion

as a

bas

is fo

r pro

vidi

ng s

afet

y as

sura

nce

to a

ll as

soci

ated

w

ith, r

espo

nsib

le fo

r or d

epen

dent

upo

n th

e se

rvic

es p

rovi

ded,

and

to

the

safe

ty re

gula

tory

aut

horit

y;

5.3.

4. R

isk

Ass

essm

ent a

nd M

itiga

tion

Doc

umen

tatio

n (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at th

e re

sults

and

con

clus

ions

of t

he ri

sk a

sses

smen

t an

d m

itiga

tion

proc

ess

of a

new

or c

hang

ed s

afet

y si

gnifi

cant

sys

tem

ar

e sp

ecifi

cally

doc

umen

ted,

and

that

this

doc

umen

tatio

n is

m

aint

aine

d th

roug

hout

the

life

of th

e sy

stem

.

Thro

ugho

ut it

s te

xt, I

SO

iden

tify

seve

ral r

ecor

ds to

be

mai

ntai

ned

and

in th

ose

case

s a

refe

renc

e to

sec

tion

4.2.

4 (c

ontro

l of r

ecor

ds) i

s do

ne.

ES

AR

R 3

onl

y m

entio

ns a

par

ticul

ar ty

pe o

f saf

ety

reco

rd: t

he

risk

asse

ssm

ent a

nd m

itiga

tion

docu

men

tatio

n. N

ever

thel

ess,

E

SA

RR

3 re

quire

s re

cord

s “th

roug

hout

the

SM

S o

pera

tion”

. Th

at im

plie

s re

cord

s fo

r all

the

actio

ns (p

roce

sses

) tha

t im

plem

ent t

he S

MS

.

Whe

reve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

reco

rds

have

to b

e pr

oduc

ed a

nd m

aint

aine

d fo

r all

the

actio

ns (p

roce

sses

) inc

lude

d in

ESA

RR

3, a

nd p

artic

ular

ly

for t

he re

sults

of r

isk

asse

ssm

ent &

miti

gatio

n

4.2.

2. Q

ualit

y M

anua

l Th

e or

gani

satio

n sh

all e

stab

lish

and

mai

ntai

n a

qual

ity

man

ual t

hat i

nclu

des:

5.2.

5. S

MS

Doc

umen

tatio

n (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at th

e S

MS

is s

yste

mat

ical

ly d

ocum

ente

d in

a m

anne

r, w

hich

pro

vide

s a

clea

r lin

kage

to th

e or

gani

satio

n’s

safe

ty p

olic

y;

ES

AR

R 3

is le

ss p

resc

riptiv

e. T

he S

MS

mus

t be

syst

emat

ical

ly

docu

men

ted

but n

o pa

rticu

lar f

orm

at is

requ

ired.

O

n th

e ot

her h

and

ES

AR

R 3

insi

sts

on th

e ne

ed to

ens

ure

a cl

ear l

ink

betw

een

safe

ty p

olic

y an

d S

MS

.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.5

. a)

The

sco

pe o

f the

QM

S, i

nclu

ding

det

ails

of a

nd

just

ifica

tion

for a

ny e

xclu

sion

s 5.

1.1

Safe

ty M

anag

emen

t (h

ave

in p

lace

a S

MS

whi

ch)

b) o

pera

tes

in re

spec

t to

all A

TM a

nd s

uppo

rting

ser

vice

s w

hich

are

un

der i

ts m

anag

eria

l con

trol

(Sup

porti

ng s

ervi

ces

are

defin

ed in

ES

AR

R 3

, App

endi

x A

)

The

inte

nt o

f the

se s

tate

men

ts is

equ

ival

ent.

ES

AR

R 3

is m

uch

mor

e sp

ecifi

c an

d re

quire

s a

parti

cula

r sco

pe.

Whe

reve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

the

scop

e of

the

SMS

mus

t be

the

one

spec

ified

in

ESAR

R 3

, 5.1

.1 b

)

b) th

e do

cum

ente

d pr

oced

ures

est

ablis

hed

for t

he Q

MS

, or

refe

renc

e to

them

, and

c) a

des

crip

tion

of th

e in

tera

ctio

n be

twee

n pr

oces

ses

of

the

QM

S

5.2.

5. S

MS

Doc

umen

tatio

n (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at th

e S

MS

is s

yste

mat

ical

ly d

ocum

ente

d in

a m

anne

r, w

hich

pro

vide

s a

clea

r lin

kage

to th

e or

gani

satio

n’s

safe

ty p

olic

y;

ES

AR

R 3

is le

ss p

resc

riptiv

e. T

he S

MS

mus

t be

syst

emat

ical

ly

docu

men

ted

but n

o pa

rticu

lar f

orm

at is

requ

ired.

O

n th

e ot

her h

and

ES

AR

R 3

insi

sts

on th

e ne

ed to

ens

ure

a cl

ear l

ink

betw

een

Saf

ety

Pol

icy

and

SM

S.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.5

.

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 26

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 4.

2.3

Con

trol

of d

ocum

ents

D

ocum

ents

requ

ired

by th

e qu

ality

man

agem

ent s

yste

m

shal

l be

cont

rolle

d. R

ecor

ds a

re a

spe

cial

type

of

docu

men

t and

sha

ll be

con

trolle

d ac

cord

ing

to th

e re

quire

men

ts g

iven

in 4

.2.4

.

A d

ocum

ente

d pr

oced

ure

shal

l be

esta

blis

hed

to d

efin

e th

e co

ntro

ls n

eede

d:

a) to

app

rove

doc

umen

ts fo

r ade

quac

y pr

ior t

o is

sue

b) to

revi

ew a

nd u

pdat

e as

nec

essa

ry a

nd re

-app

rove

do

cum

ents

c) to

ens

ure

that

cha

nges

and

the

curr

ent r

evis

ion

stat

us

of d

ocum

ents

are

iden

tifie

d

d) to

ens

ure

that

rele

vant

ver

sion

s of

app

licab

le

docu

men

ts a

re a

vaila

ble

at p

oint

s of

use

e) to

ens

ure

that

doc

umen

ts a

re le

gibl

e an

d re

adily

id

entif

iabl

e

f) to

ens

ure

that

doc

umen

ts o

f ext

erna

l orig

in a

re id

entif

ied

and

thei

r dis

tribu

tion

cont

rolle

d, a

nd

g) to

pre

vent

the

unin

tend

ed u

se o

f obs

olet

e do

cum

ents

, an

d to

app

ly s

uita

ble

iden

tific

atio

n to

them

if th

ey a

re

reta

ined

for a

ny p

urpo

se.

5.2.

5. S

MS

Doc

umen

tatio

n (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at th

e S

MS

is s

yste

mat

ical

ly d

ocum

ente

d in

a m

anne

r, w

hich

pro

vide

s a

clea

r lin

kage

to th

e or

gani

satio

n’s

safe

ty p

olic

y;

ES

AR

R 3

is le

ss p

resc

riptiv

e. T

he S

MS

mus

t be

syst

emat

ical

ly

docu

men

ted

but n

o pa

rticu

lar d

ocum

enta

tion

cont

rol

proc

edur

es a

re re

quire

d.

Som

e re

fere

nces

to d

ocum

enta

tion

cont

rol a

re in

clud

ed in

EA

M

3/G

UI 1

(Gui

danc

e M

ater

ial)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.5

.

4.2.

4 C

ontr

ol o

f Rec

ords

R

ecor

ds s

hall

be e

stab

lishe

d an

d m

aint

aine

d to

pro

vide

ev

iden

ce o

f con

form

ity to

requ

irem

ents

and

of t

he

effe

ctiv

e op

erat

ion

of th

e qu

ality

man

agem

ent s

yste

m.

Rec

ords

sha

ll re

mai

n le

gibl

e, re

adily

iden

tifia

ble

and

retri

evab

le. A

doc

umen

ted

proc

edur

e sh

all b

e es

tabl

ishe

d to

def

ine

the

cont

rols

nee

ded

for t

he id

entif

icat

ion,

st

orag

e, p

rote

ctio

n, re

triev

al, r

eten

tion

time

and

disp

ositi

on o

f rec

ords

.

5.3.

3. S

afet

y R

ecor

ds

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

saf

ety

reco

rds

are

mai

ntai

ned

thro

ugho

ut th

e S

MS

op

erat

ion

as a

bas

is fo

r pro

vidi

ng s

afet

y as

sura

nce

to a

ll as

soci

ated

w

ith, r

espo

nsib

le fo

r or d

epen

dent

upo

n th

e se

rvic

es p

rovi

ded,

and

to

the

safe

ty re

gula

tory

aut

horit

y;

Equ

ival

ent s

tate

men

ts e

xcep

t with

rega

rd to

the

need

of a

do

cum

ente

d pr

oced

ure

requ

ired

by IS

O a

nd n

ot d

eman

ded

expl

icitl

y in

ES

AR

R 3

.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.3.3

, 5.2

.5 a

nd 5

.3.4

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

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SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 27

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 5.

1 M

anag

emen

t Com

mitm

ent

Top

man

agem

ent s

hall

prov

ide

evid

ence

of i

ts

com

mitm

ent t

o th

e de

velo

pmen

t and

impl

emen

tatio

n of

th

e Q

MS

and

con

tinua

lly im

prov

e its

effe

ctiv

enes

s by

a) C

omm

unic

atin

g to

the

orga

nisa

tion

the

impo

rtanc

e of

m

eetin

g cu

stom

er a

s w

ell a

s st

atut

ory

and

regu

lato

ry

requ

irem

ents

b) e

stab

lishi

ng th

e qu

ality

pol

icy

c) e

nsur

ing

that

qua

lity

obje

ctiv

es a

re e

stab

lishe

d

d) c

ondu

ctin

g m

anag

emen

t rev

iew

s, a

nd

e) e

nsur

ing

the

avai

labi

lity

of re

sour

ces

5.2.

2. S

afet

y M

anag

emen

t Res

pons

ibili

ty

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

-pro

vide

r)

d) s

hall

ensu

re th

at th

e hi

ghes

t lev

el o

f the

ser

vice

pro

vide

r or

gani

satio

n pl

ays

a ge

nera

l rol

e in

ens

urin

g sa

fety

man

agem

ent;

5.1.

Gen

eral

Req

uire

men

t A

n A

TM s

ervi

ce p

rovi

der s

hall,

as

an in

tegr

al p

art o

f the

m

anag

emen

t of t

he A

TM s

ervi

ce h

ave

in p

lace

a S

MS

whi

ch:

5.1.

1 a)

(Saf

ety

Man

agem

ent)

ensu

res

a fo

rmal

ised

, exp

licit

and

pro-

activ

e ap

proa

ch to

sys

tem

atic

saf

ety

man

agem

ent i

n m

eetin

g its

sa

fety

resp

onsi

bilit

ies

with

in th

e pr

ovis

ion

of A

TM s

ervi

ces.

5.

4.2.

Saf

ety

Impr

ovem

ent

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

-pro

vide

r)

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d.

ISO

is m

uch

mor

e sp

ecifi

c as

it re

quire

s sp

ecifi

c ev

iden

ces

to

dem

onst

rate

top

man

agem

ent c

omm

itmen

t. M

anag

emen

t rev

iew

s ar

e no

t req

uire

d ex

plic

itly

in E

SA

RR

3

alth

ough

the

SM

S m

anag

emen

t rev

iew

is id

entif

ied

in

EA

M3/

GU

I 1 (E

SA

RR

3 G

uida

nce

Mat

eria

l) as

one

of t

he u

sual

el

emen

ts o

f the

impl

emen

tatio

n of

ES

AR

R 5

.4.2

(saf

ety

impr

ovem

ent)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.2

d, 5

.4.2

b a

nd 5

.1.

5.2

Cus

tom

er F

ocus

To

p m

anag

emen

t sha

ll en

sure

that

cus

tom

er

requ

irem

ents

are

met

with

the

aim

of e

nhan

cing

cus

tom

er

satis

fact

ion

No

sim

ilar r

equi

rem

ent i

n E

SA

RR

3

N/A

5.3

Qua

lity

Polic

y

Top

man

agem

ent s

hall

ensu

re th

at th

e qu

ality

pol

icy:

5.

1.1.

Saf

ety

Man

agem

ent

(hav

e in

pla

ce a

SM

S w

hich

) …

c)

incl

udes

, as

its fo

unda

tion,

a s

tate

men

t of s

afet

y po

licy

defin

ing

the

fund

amen

tal a

ppro

ach

to m

anag

ing

safe

ty

Equ

ival

ent s

tate

men

ts

(how

ever

, see

bul

lets

in IS

O o

n th

e ne

xt p

age)

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– M

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ng b

etw

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3

Edi

tion

1.0

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ease

d Is

sue

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e 28

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t a)

is a

ppro

pria

te to

the

purp

ose

of th

e or

gani

satio

n

b) in

clud

es a

com

mitm

ent t

o co

mpl

y w

ith re

quire

men

ts

and

cont

inua

lly im

prov

e th

e ef

fect

iven

ess

of th

e qu

ality

m

anag

emen

t sys

tem

c) p

rovi

des

a fra

mew

ork

for e

stab

lishi

ng a

nd re

view

ing

qual

ity o

bjec

tives

d) is

com

mun

icat

ed a

nd u

nder

stoo

d w

ithin

the

orga

nisa

tion,

and

e) is

revi

ewed

for c

ontin

uing

sui

tabi

lity

5.1.

Gen

eral

Req

uire

men

t (T

he G

ener

al R

equi

rem

ent i

nclu

des

high

leve

l sta

tem

ents

that

will

be

norm

ally

con

side

red

at p

olic

y le

vel d

ue to

thei

r pol

icy

natu

re. T

his

conc

erns

5.1

.1 S

afet

y M

anag

emen

t, 5.

1.2

Saf

ety

Res

pons

ibili

ty,

5.1.

3 S

afet

y P

riorit

y, a

nd 5

.1.4

Saf

ety

Obj

ectiv

e of

the

ATM

ser

vice

)

ISO

requ

ires

addr

essi

ng s

ome

spec

ific

aspe

cts

in th

e qu

ality

po

licy.

Alth

ough

the

incl

usio

n of

thos

e as

pect

s at

pol

icy

leve

l is

not e

xplic

itly

requ

ired

in E

SA

RR

3, s

uch

ISO

pol

icy

prin

cipl

es

may

pro

vide

the

SM

S w

ith a

pos

itive

inpu

t. S

econ

dly,

ES

AR

R 3

con

tain

s so

me

high

leve

l sta

tem

ents

that

sh

ould

nor

mal

ly b

e ad

dres

sed

in th

e S

afet

y P

olic

y (e

.g. S

afet

y P

riorit

y) a

s po

inte

d ou

t in

EA

M3/

GU

I1 (E

SA

RR

3 G

uida

nce

Mat

eria

l). H

owev

er, I

SO

is v

ery

gene

ric o

n th

e ac

tual

con

tent

s of

the

qual

ity p

olic

y. IS

O S

ectio

n 5.

3 (s

ee b

elow

) req

uire

s th

e po

licy

to b

e “a

ppro

pria

te” f

or th

e pu

rpos

e of

the

orga

nisa

tion.

Whe

reve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

any

obj

ectiv

e de

fined

by

ATM

ser

vice

pro

vide

rs m

ust

be c

onsi

sten

t with

the

min

imum

com

mon

obj

ectiv

e de

fined

fo

r all

ATM

pro

vide

rs in

ESA

RR

3, S

ectio

n 5.

1.4.

W

here

ver t

he u

se o

f ISO

is c

onsi

dere

d, it

sho

uld

be n

oted

th

at th

e Sa

fety

Pol

icy

shou

ld n

orm

ally

incl

ude

stat

emen

ts

to a

ddre

ss E

SAR

R 3

Sec

tions

5.1

.1, 5

.1.2

, 5.1

.3 a

nd 5

.1.4

.

5.4

Plan

ning

5.4.

1. Q

ualit

y O

bjec

tives

– T

op m

anag

emen

t ens

ure

that

qu

ality

obj

ectiv

es, i

nclu

ding

thos

e ne

eded

to m

eet

requ

irem

ents

for p

rodu

ct a

re e

stab

lishe

d at

rele

vant

fu

nctio

ns a

nd le

vels

with

in th

e or

gani

satio

n. T

he q

ualit

y ob

ject

ives

sha

ll be

mea

sura

ble

and

cons

iste

nt w

ith th

e qu

ality

pol

icy.

(IS

O d

efin

ition

for q

ualit

y ob

ject

ive:

som

ethi

ng s

ough

t, or

ai

med

for,

rela

ted

to q

ualit

y)

5.1.

4. S

afet

y O

bjec

tive

of th

e A

TM s

ervi

ce

(hav

e in

pla

ce a

SM

S w

hich

) en

sure

s th

at w

hile

pro

vidi

ng a

n A

TM s

ervi

ce, t

he p

rinci

pal s

afet

y ob

ject

ive

is to

min

imis

e th

e A

TM c

ontri

butio

n to

the

risk

of a

n ai

rcra

ft as

far a

s re

ason

ably

pra

ctic

able

5.

2.3.

Qua

ntita

tive

Safe

ty L

evel

s (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at, w

here

ver p

ract

icab

le, q

uant

itativ

e sa

fety

leve

ls a

re

deriv

ed a

nd a

re m

aint

aine

d fo

r all

syst

ems

ES

AR

R 3

is m

uch

mor

e sp

ecifi

c as

it id

entif

ies

a m

inim

um

safe

ty o

bjec

tive

for a

ll se

rvic

e pr

ovid

ers

whi

le IS

O o

nly

requ

ires

defin

ing

appr

opria

te o

bjec

tives

In

the

light

of t

he IS

O d

efin

ition

for ‘

qual

ity o

bjec

tive’

, the

ISO

st

atem

ent c

an a

lso

be a

pplic

able

to th

e im

plem

enta

tion

of

ES

AR

R 3

, 5.2

.3 (Q

uant

itativ

e S

afet

y Le

vels

)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.1.4

and

5.2

.3, p

rovi

ded

that

: W

here

ver t

he u

se o

f ISO

is c

onsi

dere

d, it

sho

uld

be n

oted

th

at a

ny o

bjec

tive

defin

ed b

y AT

M s

ervi

ce p

rovi

ders

mus

t be

con

sist

ent w

ith th

e m

inim

um c

omm

on o

bjec

tive

defin

ed

for a

ll AT

M p

rovi

ders

in E

SAR

R 3

, Sec

tion

5.1.

4.

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e 29

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5

ISO

900

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rovi

sion

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AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 5.

4.2.

QM

S pl

anni

ng

Top

man

agem

ent s

hall

ensu

re th

at:

a) th

e pl

anni

ng o

f the

QM

S is

car

ried

out i

n or

der t

o m

eet

the

requ

irem

ents

giv

en in

4.1

,as

wel

l as

the

qual

ity

obje

ctiv

es, a

nd

b) th

e in

tegr

ity o

f the

QM

S is

mai

ntai

ned

whe

n ch

ange

s to

th

e Q

MS

are

pla

nned

and

impl

emen

ted

5.1.

Gen

eral

Req

uire

men

t A

n A

TM s

ervi

ce p

rovi

der s

hall,

as

an in

tegr

al p

art o

f the

m

anag

emen

t of t

he A

TM s

ervi

ce h

ave

in p

lace

a S

MS

whi

ch:

5.1.

1 a)

(Saf

ety

Man

agem

ent)

ensu

res

a fo

rmal

ised

, exp

licit

and

pro-

activ

e ap

proa

ch to

sys

tem

atic

saf

ety

man

agem

ent i

n m

eetin

g its

sa

fety

resp

onsi

bilit

ies

with

in th

e pr

ovis

ion

of A

TM s

ervi

ces.

No

expl

icit

requ

irem

ents

exi

st in

ES

AR

R 3

rega

rdin

g pl

anni

ng,

alth

ough

this

issu

e co

uld

be c

onsi

dere

d as

em

bedd

ed in

the

need

for ‘

syst

emat

ic s

afet

y m

anag

emen

t’.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.1 a

nd 5

.1.1

a)

5.5.

Res

pons

ibili

ty, a

utho

rity

and

com

mun

icat

ion

5.5.

1. R

espo

nsib

ility

and

aut

horit

y To

p m

anag

emen

t sha

ll en

sure

that

resp

onsi

bilit

ies

and

auth

oriti

es a

re d

efin

ed a

nd c

omm

unic

ated

with

in th

e or

gani

satio

n

5.1.

2 Sa

fety

Res

pons

ibili

ty

(hav

e in

pla

ce a

SM

S w

hich

) en

sure

s th

at e

very

one

invo

lved

in th

e sa

fety

asp

ects

of A

TM s

ervi

ce-

prov

isio

n ha

s an

indi

vidu

al s

afet

y re

spon

sibi

lity

for t

heir

own

actio

ns,

and

that

man

ager

s ar

e re

spon

sibl

e fo

r the

saf

ety

perfo

rman

ce o

f the

ir ow

n or

gani

satio

ns;

ES

AR

R 3

is m

uch

mor

e sp

ecifi

c th

an IS

O. E

SA

RR

3

emph

asis

es th

ree

key

aspe

cts:

a)

th

e no

tion

of in

divi

dual

ity in

the

safe

ty re

spon

sibi

lity

conc

ept

b)

the

link

betw

een

resp

onsi

bilit

y an

d ow

n ac

tions

c)

th

e re

spon

sibi

lity

of m

anag

ers

for t

he p

erfo

rman

ce o

f the

ir or

gani

satio

n.

Whe

reve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

saf

ety

resp

onsi

bilit

ies

mus

t be

defin

ed fo

r ind

ivid

uals

in

rela

tion

to th

eir o

wn

actio

ns, a

nd th

at th

e re

spon

sibi

litie

s of

man

ager

s m

ust b

e re

late

d to

the

safe

ty

perf

orm

ance

of t

he p

art o

f the

org

anis

atio

n th

ey m

anag

e.

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ISO

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AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 5.

5.2

Man

agem

ent r

epre

sent

ativ

e To

p m

anag

emen

t sha

ll ap

poin

t a m

embe

r of t

he

man

agem

ent w

ho, i

rres

pect

ive

of o

ther

resp

onsi

bilit

ies,

sh

all h

ave

resp

onsi

bilit

y an

d au

thor

ity th

at in

clud

es:

5.2.

2 Sa

fety

Man

agem

ent R

espo

nsib

ility

(w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

a)

sha

ll en

sure

that

a s

afet

y m

anag

emen

t fun

ctio

n is

iden

tifie

d w

ith

orga

nisa

tiona

l res

pons

ibili

ty fo

r dev

elop

men

t and

mai

nten

ance

of t

he

safe

ty m

anag

emen

t sys

tem

; b)

sha

ll en

sure

that

this

poi

nt o

f res

pons

ibili

ty is

, whe

reve

r pos

sibl

e,

inde

pend

ent o

f lin

e m

anag

emen

t, an

d ac

coun

tabl

e di

rect

ly to

the

high

est o

rgan

isat

iona

l lev

el

d) s

hall

ensu

re th

at th

e hi

ghes

t lev

el o

f ser

vice

pro

vide

r org

anis

atio

n pl

ays

a ge

nera

l rol

e in

ens

urin

g sa

fety

man

agem

ent

ES

AR

R 3

requ

ires

inde

pend

ence

of l

ine

man

agem

ent w

hile

IS

O o

nly

requ

ires

the

appo

intm

ent o

f a m

embe

r of t

he

man

agem

ent i

rres

pect

ive

of o

ther

resp

onsi

bilit

ies.

O

n th

e ot

her h

and,

it s

houl

d be

not

ed th

at IS

O e

xplic

itly

requ

ires

the

qual

ity m

anag

er to

be

part

of th

e m

anag

emen

t te

am. E

SA

RR

3 d

oes

not i

nclu

de e

xplic

it m

anda

tory

pro

visi

ons

in th

at re

gard

. How

ever

, tha

t not

ion

is s

tress

ed in

EA

M3/

GU

I1

(ES

AR

R 3

Gui

danc

e M

ater

ial)

as a

key

asp

ect t

hat s

tem

s fro

m

the

requ

irem

ent f

or a

SM

S a

s pa

rt of

the

over

all m

anag

emen

t fu

nctio

n (E

SA

RR

3, 5

.1).

Bes

ides

, the

use

of t

he te

rm “a

utho

rity”

in IS

O s

eem

s to

re

info

rce

sign

ifica

ntly

the

role

of t

he q

ualit

y m

anag

er. I

ts u

se

with

in th

e co

ntex

t of E

SA

RR

3 m

ay p

rovi

de a

pos

itive

inpu

t to

the

impl

emen

tatio

n of

the

safe

ty m

anag

emen

t fun

ctio

n.

The

use

of th

e IS

O e

xpre

ssio

ns ‘m

embe

r of t

he m

anag

emen

t’ an

d ‘a

utho

rity’

can

sup

port

the

impl

emen

tatio

n of

ES

AR

R 3

, 5.

2.2,

pro

vide

d th

at:

Whe

reve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

the

safe

ty m

anag

eria

l fun

ctio

n sh

ould

be

inde

pend

ent

of li

ne m

anag

emen

t (ex

cept

in th

e ca

se o

f som

e sm

all

orga

nisa

tions

) N

OTE

: ind

epen

denc

e of

line

man

agem

ent c

ould

not

be

requ

ired

in th

e ca

se o

f sm

all o

rgan

isat

ions

in a

ccor

danc

e to

E

SA

RR

3, 5

.2.2

c (F

or fu

rther

det

ails

see

EA

M3/

GU

I2 S

afet

y R

egul

ator

y A

spec

ts o

f the

Impl

emen

tatio

n of

ES

AR

R 3

in S

mal

l O

rgan

isat

ions

, Edi

tion

1.0)

a) e

nsur

ing

that

pro

cess

es n

eede

d fo

r the

QM

S a

re

esta

blis

hed,

impl

emen

ted

and

mai

ntai

ned

b) re

porti

ng to

top

man

agem

ent o

n th

e pe

rform

ance

of t

he

QM

S a

nd a

ny n

eed

for i

mpr

ovem

ent,

and

c) e

nsur

ing

the

prom

otio

n of

aw

aren

ess

of c

usto

mer

sa

tisfa

ctio

n th

roug

hout

the

orga

nisa

tion

5.2.

2 Sa

fety

Man

agem

ent R

espo

nsib

ility

(w

ithin

the

oper

atio

n of

the

SM

S th

e A

TM s

ervi

ce p

rovi

der)

a)

sha

ll en

sure

that

a s

afet

y m

anag

emen

t fun

ctio

n is

iden

tifie

d w

ith

orga

nisa

tiona

l res

pons

ibili

ty fo

r dev

elop

men

t and

mai

nten

ance

of t

he

safe

ty m

anag

emen

t sys

tem

; b)

sha

ll en

sure

that

this

poi

nt o

f res

pons

ibili

ty is

, whe

reve

r pos

sibl

e,

inde

pend

ent o

f lin

e m

anag

emen

t, an

d ac

coun

tabl

e di

rect

ly to

the

high

est o

rgan

isat

iona

l lev

el

The

ISO

sta

tem

ents

are

muc

h m

ore

spec

ific

that

the

expr

essi

on

“dev

elop

men

t and

mai

nten

ance

of t

he S

MS

”. Th

eir u

se m

ay

add

clar

ity to

the

role

of t

he s

afet

y m

anag

emen

t fun

ctio

n an

d ar

e in

line

with

EA

M3/

GU

I1(E

SA

RR

3 G

uida

nce

Mat

eria

l)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.2

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e 31

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5

ISO

900

1:20

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rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 5.

5.3

Inte

rnal

Com

mun

icat

ion

Top

man

agem

ent s

hall

ensu

re th

at a

ppro

pria

te

com

mun

icat

ion

proc

esse

s ar

e es

tabl

ishe

d w

ithin

the

orga

nisa

tion

and

that

com

mun

icat

ion

take

s pl

ace

rega

rdin

g th

e ef

fect

iven

ess

of th

e Q

MS

5.4.

1.Le

sson

Dis

sem

inat

ion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

the

less

ons

aris

ing

from

saf

ety

occu

rren

ce

inve

stig

atio

ns a

nd o

ther

saf

ety

activ

ities

are

dis

sem

inat

ed w

idel

y w

ithin

the

orga

nisa

tion

at m

anag

emen

t and

ope

ratio

nal l

evel

s.

5.4.

2 Sa

fety

Impr

ovem

ent

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

a) s

hall

ensu

re th

at a

ll st

aff a

re a

ctiv

ely

enco

urag

ed to

pro

pose

so

lutio

ns to

iden

tifie

d ha

zard

s, a

nd

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d.

ISO

add

ress

es th

e is

sue

from

a g

ener

ic p

ersp

ectiv

e, w

hile

E

SA

RR

3 h

as d

efin

ed s

ome

very

spe

cific

act

ions

suc

h as

the

diss

emin

atio

n of

less

ons

lear

nt a

nd th

e es

tabl

ishm

ent o

f m

echa

nism

s to

ens

ure

that

all

staf

f are

act

ivel

y en

cour

age

to

com

mun

icat

e.

In th

at c

onte

xt, E

SA

RR

3 g

ives

the

inte

rpre

tatio

n of

the

expr

essi

on “a

ppro

pria

te” t

hat a

ppea

rs o

n IS

O, a

nd d

efin

es

spec

ific

feat

ures

to b

e im

plem

ente

d.

Whe

reve

r the

use

of I

SO is

con

side

red,

it s

houl

d be

not

ed

that

ther

e ar

e sp

ecifi

c in

tern

al c

omm

unic

atio

n ac

tions

that

m

ust b

e im

plem

ente

d in

acc

orda

nce

to E

SAR

R 3

, 5.4

.1 a

nd

5.4.

2 a)

.

5.6

Man

agem

ent R

evie

w

5.6.

1 G

ener

al

Top

man

agem

ent s

hall

revi

ew th

e or

gani

satio

n’s

QM

S, a

t pl

anne

d in

terv

als,

to e

nsur

e co

ntin

uing

sui

tabi

lity,

ad

equa

cy a

nd e

ffect

iven

ess.

Thi

s re

view

sha

ll in

clud

e as

sess

ing

oppo

rtuni

ties

for i

mpr

ovem

ent a

nd th

e ne

ed fo

r ch

ange

s to

the

qual

ity m

anag

emen

t sys

tem

, inc

ludi

ng th

e qu

ality

pol

icy

and

qual

ity o

bjec

tives

.

Rec

ords

for m

anag

emen

t rev

iew

s sh

all b

e m

aint

aine

d

5.6.

2 R

evie

w in

put

The

inpu

t to

the

man

agem

ent r

evie

w s

hall

incl

ude

info

rmat

ion

on:

a) re

sults

of a

udits

b) c

usto

mer

feed

back

c) p

roce

ss p

erfo

rman

ce a

nd p

rodu

ct c

onfo

rmity

d) s

tatu

s of

pre

vent

ive

and

corr

ectiv

e ac

tions

e) fo

llow

-up

actio

ns fr

om p

revi

ous

man

agem

ent r

evie

ws

f) ch

ange

s th

at c

ould

affe

ct th

e Q

MS

g) re

com

men

datio

ns fo

r im

prov

emen

t

5.6.

3 R

evie

w o

utpu

t Th

e ou

tput

of t

he m

anag

emen

t rev

iew

sha

ll in

clud

e an

y de

cisi

ons

and

actio

ns re

late

d to

:

a) im

prov

emen

t of t

he e

ffect

iven

ess

of th

e Q

MS

and

its

proc

esse

s

5.1.

1 Sa

fety

Man

agem

ent

(hav

e in

pla

ce a

SM

S w

hich

) a)

ens

ures

a fo

rmal

ised

, exp

licit

and

pro-

activ

e ap

proa

ch to

sy

stem

atic

saf

ety

man

agem

ent i

n m

eetin

g its

saf

ety

resp

onsi

bilit

ies

with

in th

e pr

ovis

ion

of A

TM s

ervi

ces

5.2.

2 Sa

fety

Man

agem

ent F

unct

ion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

d) s

hall

ensu

re th

at th

e hi

ghes

t lev

el o

f the

ser

vice

pro

vide

r or

gani

satio

n pl

ays

a ge

nera

l rol

e in

ens

urin

g sa

fety

man

agem

ent;

5.4.

2 Sa

fety

Impr

ovem

ent

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d

ISO

is m

uch

mor

e sp

ecifi

c ab

out h

e m

inim

um m

echa

nism

s ne

eded

to im

plem

ent c

ontin

uous

impr

ovem

ent w

ithin

the

orga

nisa

tion

and

invo

lve

the

high

est l

evel

of t

he o

rgan

isat

ion.

N

o sp

ecifi

c re

quire

men

ts e

xist

in E

SA

RR

3 to

exp

licitl

y m

anda

te m

anag

emen

t rev

iew

s.

How

ever

, som

e so

rt of

man

agem

ent r

evie

w m

ay b

e ne

eded

to

impl

emen

t ES

AR

R 3

, 5.2

.2 a

nd 5

.4.4

. Con

sequ

ently

, SM

S

man

agem

ent r

evie

ws

have

bee

n id

entif

ied

in E

AM

3/G

UI1

(E

SA

RR

3 G

uida

nce

Mat

eria

l) as

one

of t

he e

lem

ents

to b

e no

rmal

ly fo

und

in th

e im

plem

enta

tion

of E

SA

RR

3.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, S

ectio

ns 5

.2.2

d) a

nd 5

.4.4

b).

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RR

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e 32

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5

ISO

900

1:20

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rovi

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AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t b)

impr

ovem

ent o

f the

pro

duct

rela

ted

to c

usto

mer

re

quire

men

ts, a

nd

c) re

sour

ce n

eeds

(see

pre

viou

s pa

ge)

(see

pre

viou

s pa

ge)

6.1

Prov

isio

n of

Res

ourc

es

The

orga

nisa

tion

shal

l det

erm

ine

and

prov

ide

the

reso

urce

s ne

eded

a) to

impl

emen

t and

mai

ntai

n th

e Q

MS

and

con

tinua

lly

impr

ove

its e

ffect

iven

ess,

and

No

sim

ilar r

equi

rem

ent i

n E

SA

RR

3

No

expl

icit

requ

irem

ents

exi

st in

ES

AR

R 3

requ

iring

the

prov

isio

n of

reso

urce

s, a

lthou

gh th

is n

otio

n co

uld

be c

onsi

dere

d as

em

bedd

ed in

som

e re

quire

men

ts (n

otab

ly E

SA

RR

3, 5

.1 a

nd

5.1.

1a)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, p

artic

ular

ly in

rega

rd to

ES

ARR

3, 5

.1, 5

.1.1

a) a

nd 5

.2.2

d).

b)

to e

nhan

ce c

usto

mer

sat

isfa

ctio

n by

mee

ting

cust

omer

re

quire

men

ts

No

sim

ilar r

equi

rem

ent i

n E

SA

RR

3

N/A

6.2.

Hum

an R

esou

rces

6.2.

1 G

ener

al

Per

sonn

el p

erfo

rmin

g w

ork

affe

ctin

g pr

oduc

t qua

lity

shal

l be

com

pete

nt o

n th

e ba

sis

of a

ppro

pria

te e

duca

tion,

tra

inin

g, s

kills

and

exp

erie

nce

Equ

ival

ent s

tate

men

ts, a

lthou

gh E

SA

RR

3 e

xplic

itly

mak

es

refe

renc

e to

the

licen

sing

issu

e.

6.2.

2 C

ompe

tenc

e, a

war

enes

s an

d tr

aini

ng

The

orga

nisa

tion

shal

l:

a) d

eter

min

e th

e ne

cess

ary

com

pete

nce

for p

erso

nnel

pe

rform

ing

wor

k af

fect

ing

prod

uct q

ualit

y

b) p

rovi

de tr

aini

ng to

m ta

ke o

ther

act

ions

to s

atis

fy th

ese

need

s

c) e

valu

ate

the

effe

ctiv

enes

s of

the

actio

ns ta

ken

d) e

nsur

e th

at it

s pe

rson

nel a

re a

war

e of

the

rele

vanc

e an

d im

porta

nce

of th

eir a

ctiv

ities

and

how

they

con

tribu

te

to th

e ac

hiev

emen

t of t

he q

ualit

y ob

ject

ives

, and

e) m

aint

ain

appr

opria

te re

cord

s of

edu

catio

n, tr

aini

ng,

skill

s an

d ex

perie

nce

5.2.

1 C

ompe

tenc

y (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at s

taff

are

adeq

uate

ly tr

aine

d, m

otiv

ated

and

co

mpe

tent

for t

he jo

b th

ey a

re re

quire

d to

do,

in a

dditi

on to

bei

ng

prop

erly

lice

nsed

if s

o re

quire

d;

ISO

is m

uch

mor

e de

taile

d th

an E

SA

RR

3. H

owev

er,

EA

M3/

GU

I1 (E

SA

RR

3 G

uida

nce

Mat

eria

l) id

entif

ies

a ve

ry

sim

ilar s

erie

s of

act

ions

as

one

of th

e el

emen

ts to

be

norm

ally

fo

und

in th

e im

plem

enta

tion

of E

SA

RR

3.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.1

N

OTE

: ES

AR

R 5

incl

udes

furth

er d

etai

ls a

bout

pro

cess

es to

be

cond

ucte

d by

the

serv

ice-

prov

ider

to e

nsur

e co

mpe

tenc

y.

6.3.

Infr

astr

uctu

re

The

orga

nisa

tion

shal

l det

erm

ine,

pro

vide

and

mai

ntai

n th

e in

frast

ruct

ure

need

ed to

ach

ieve

con

form

ity to

pro

duct

re

quire

men

ts. I

nfra

stru

ctur

e in

clud

es, a

s ap

plic

able

:

a) b

uild

ings

, wor

kspa

ce a

nd a

ssoc

iate

d ut

ilitie

s

b) p

roce

ss e

quip

men

t (bo

th h

ardw

are

and

softw

are)

No

sim

ilar r

equi

rem

ent i

n E

SA

RR

3

The

use

of th

ese

ISO

pro

visi

on m

ay a

ddre

ss c

ompl

emen

tary

as

pect

s no

t tac

kled

in E

SA

RR

3.

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UI 4

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ng b

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SA

RR

3

Edi

tion

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ease

d Is

sue

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5

ISO

900

1:20

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rovi

sion

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AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t c)

sup

porti

ng s

ervi

ces

(suc

h as

tran

spor

t or

com

mun

icat

ion)

(s

ee p

revi

ous

page

) (s

ee p

revi

ous

page

)

6.4

Wor

k en

viro

nmen

t Th

e or

gani

satio

n sh

all d

eter

min

e an

d m

anag

e th

e w

ork

envi

ronm

ent n

eede

d to

ach

ieve

con

form

ity to

pro

duct

re

quire

men

ts

No

sim

ilar r

equi

rem

ent i

n E

SA

RR

3

The

use

of th

ese

ISO

pro

visi

ons

may

add

ress

com

plem

enta

ry

aspe

cts

not t

ackl

ed in

ES

AR

R 3

.

7.1

Plan

ning

of p

rodu

ct re

alis

atio

n Th

e or

gani

satio

n sh

all p

lan

and

deve

lop

the

proc

esse

s ne

eded

for p

rodu

ct re

alis

atio

n. P

lann

ing

of p

rodu

ct

real

isat

ion

shal

l be

cons

iste

nt w

ith th

e re

quire

men

ts o

f the

ot

her p

roce

sses

of t

he Q

MS

. In

plan

ning

pro

duct

re

alis

atio

n, th

e or

gani

satio

n sh

all d

eter

min

e th

e fo

llow

ing,

as

app

ropr

iate

:

a) q

ualit

y ob

ject

ives

and

requ

irem

ents

for t

he p

rodu

ct

b) th

e ne

ed to

est

ablis

h pr

oces

ses,

doc

umen

ts a

nd

prov

ide

reso

urce

s sp

ecifi

c to

the

prod

uct

c) re

quire

d ve

rific

atio

n, v

alid

atio

n, m

onito

ring,

insp

ectio

n an

d te

st a

ctiv

ities

spe

cific

to th

e pr

oduc

t crit

eria

for

prod

uct a

ccep

tanc

e

d) re

cord

s ne

eded

to p

rovi

de e

vide

nce

that

the

real

isat

ion

proc

esse

s an

d re

sulti

ng p

rodu

ct m

eet r

equi

rem

ents

The

outp

ut o

f thi

s pl

anni

ng s

hall

be in

a fo

rm s

uita

ble

for

the

orga

nisa

tion’

s m

etho

d of

ope

ratio

ns

(NO

TE: I

SO

def

initi

on fo

r pro

duct

: res

ult o

f a p

roce

ss)

No

spec

ific

ES

AR

R 3

requ

irem

ents

add

ress

the

plan

ning

of t

he

proc

esse

s ne

eded

for s

ervi

ce-p

rovi

sion

real

isat

ion.

H

owev

er, t

o no

te th

at:

5.2.

4 R

isk

Ass

essm

ent a

nd M

itiga

tion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

a) s

hall

ensu

re th

at ri

sk a

sses

smen

t and

miti

gatio

n is

con

duct

ed to

an

app

ropr

iate

leve

l to

ensu

re th

at d

ue c

onsi

dera

tion

is g

iven

to a

ll as

pect

s of

ATM

; b)

sha

ll en

sure

that

cha

nges

to th

e A

TM s

yste

m a

re a

sses

sed

for

thei

r saf

ety

sign

ifica

nce,

and

ATM

sys

tem

func

tions

are

cla

ssifi

ed

acco

rdin

g to

thei

r saf

ety

seve

rity;

c)

sha

ll en

sure

app

ropr

iate

miti

gatio

n of

risk

s w

here

ass

essm

ent h

as

show

n th

is to

be

nece

ssar

y du

e to

the

safe

ty s

igni

fican

ce o

f the

ch

ange

;

ES

AR

R 3

doe

s no

t req

uire

pla

nnin

g, b

ut re

quire

s ris

k as

sess

men

t and

miti

gatio

n in

the

prov

isio

n of

ATM

ser

vice

s.

Ther

efor

e w

hen

an IS

O-b

ased

app

roac

h is

impl

emen

ted,

any

pl

anni

ng o

f the

pro

cess

es n

eede

d fo

r ATM

ser

vice

pro

visi

on

shou

ld d

eter

min

e th

e ris

k as

sess

men

t and

miti

gatio

n ac

tions

in

tend

ed to

mee

t ES

AR

R 3

, 5.2

.4 (n

otab

ly 5

.2.4

a).

Ther

efor

e, th

e “n

eed

to e

stab

lish

proc

esse

s” a

s re

ferr

ed to

in

ISO

sho

uld

incl

ude

the

need

for r

isk

asse

ssm

ent a

nd m

itiga

tion

proc

esse

s in

tend

ed to

mee

t ES

AR

R 3

, 5.2

.4.

Add

ition

ally

, the

det

erm

inat

ion

of th

e ot

her r

elat

ed e

lem

ents

m

entio

ned

in IS

O (r

ecor

ds, v

erifi

catio

n, re

quire

men

ts, e

tc)

shou

ld a

lso

be c

onsi

dere

d as

rega

rds

risk

asse

ssm

ent a

nd

miti

gatio

n pr

oces

ses

in a

ny IS

O-b

ased

pla

nnin

g of

the

proc

esse

s ne

eded

for A

TM s

ervi

ce p

rovi

sion

.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.4

, pro

vide

d th

at:

Whe

reve

r the

use

of I

SO is

con

side

red,

any

ISO

-bas

ed

plan

ning

of t

he p

roce

sses

nee

ded

for A

TM s

ervi

ce

prov

isio

n sh

ould

pla

n (e

xplic

itly)

the

proc

esse

s ne

eded

for

risk

asse

ssm

ent a

nd m

itiga

tion

in a

ccor

danc

e to

ESA

RR

3,

5.2.

4.

(NO

TE: E

SA

RR

4 p

rovi

des

mor

e de

taile

d re

quire

men

ts w

ith

rega

rd to

risk

ass

essm

ent a

nd m

itiga

tion

proc

esse

s)

(NO

TE: i

n th

e lig

ht o

f the

ISO

def

initi

on fo

r qua

lity

obje

ctiv

es,

the

ISO

bul

let a

) is

also

rela

ted

to th

e im

plem

enta

tion

of

ES

AR

R 3

, 5.2

,3.)

(See

als

o 5.

4.1

in IS

O)

Page 34: EAM 3 / GUI 4 MAPPING BETWEEN ISO 9001:2000 … · ISO ISO 9001:2000 ISO 10011 ... EAM 3 / GUI 4 – Mapping between ISO 9001:2000 and ESARR 3 Edition 1.0 Released Issue Page 7 of

EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 34

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 7.

2 C

usto

mer

rela

ted

proc

esse

s 7.

2.1

Det

erm

inat

ion

of re

quire

men

ts re

late

d to

the

prod

uct

the

orga

nisa

tion

shal

l det

erm

ine:

a) re

quire

men

ts s

peci

fied

by th

e cu

stom

er, i

nclu

ding

the

requ

irem

ents

for d

eliv

ery

and

post

-del

iver

y ac

tiviti

es

b) re

quire

men

ts n

ot s

tate

d by

the

cust

omer

but

nec

essa

ry

for s

peci

fied

or in

tend

ed u

se, w

here

kno

wn

c) s

tatu

tory

and

regu

lato

ry re

quire

men

ts re

late

d to

the

prod

uct,

and

d) a

ny a

dditi

onal

requ

irem

ents

det

erm

ined

by

the

orga

nisa

tion

7.2.

2 R

evie

w o

f req

uire

men

ts re

late

d to

the

prod

uct

The

orga

nisa

tion

shal

l rev

iew

the

requ

irem

ents

rela

ted

to

the

prod

uct.

This

revi

ew s

hall

be c

ondu

cted

prio

r to

the

orga

nisa

tion’

s co

mm

itmen

t to

supp

ly a

pro

duct

to th

e cu

stom

er (e

.g. s

ubm

issi

on o

f ten

ders

, acc

epta

nce

of

cont

ract

s or

ord

ers)

and

sha

ll en

sure

that

:

a) p

rodu

ct re

quire

men

ts a

re d

efin

ed

b) c

ontra

ct o

r ord

er re

quire

men

ts d

iffer

ing

from

thos

e pr

evio

usly

exp

ress

ed a

re re

solv

ed, a

nd

c) th

e or

gani

satio

n ha

s th

e ab

ility

to m

eet t

he d

efin

ed

requ

irem

ents

Rec

ords

of t

he re

sults

of t

he re

view

and

act

ions

aris

ing

from

the

revi

ew s

hall

be m

aint

aine

d

Whe

re th

e cu

stom

er p

rovi

des

no d

ocum

ente

d st

atem

ent

of re

quire

men

t, th

e cu

stom

er re

quire

men

ts s

hall

be

conf

irmed

by

the

orga

nisa

tion

befo

re a

ccep

tanc

e

Whe

re p

rodu

ct re

quire

men

ts a

re c

hang

ed, t

he

orga

nisa

tion

shal

l ens

ure

that

rele

vant

doc

umen

ts a

re

amen

ded

and

that

rele

vant

per

sonn

el a

re m

ade

awar

e of

th

e ch

ange

d re

quire

men

ts

5.2.

4 R

isk

Ass

essm

ent a

nd M

itiga

tion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

c) s

hall

ensu

re a

ppro

pria

te m

itiga

tion

of ri

sks

whe

re a

sses

smen

t has

sh

own

this

to b

e ne

cess

ary

due

to th

e sa

fety

sig

nific

ance

of t

he

chan

ge;

With

in ri

sk a

sses

smen

t and

miti

gatio

n, E

SA

RR

3 re

quire

s ap

prop

riate

miti

gatio

n of

risk

s.

ES

AR

R 4

has

dev

elop

ed th

at id

ea fu

rther

and

mad

e cl

ear t

hat

risk

miti

gatio

n sh

ould

be

base

d on

the

dete

rmin

atio

n of

a s

et o

f sa

fety

requ

irem

ents

. The

se s

afet

y re

quire

men

ts (s

omet

imes

kn

own

as “m

itiga

tion

mea

sure

s” to

o) a

re d

efen

ces

inte

nded

to

mee

t saf

ety

obje

ctiv

es a

nd re

duce

or e

limin

ate

risks

indu

ced

by

haza

rds.

Th

ose

are

addi

tiona

l req

uire

men

ts to

be

dete

rmin

ed b

y th

e or

gani

satio

n in

the

light

of t

he re

sults

of i

ts ri

sk a

sses

smen

t and

m

itiga

tion

proc

esse

s (in

line

with

bul

let d

. in

ISO

)

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, p

rovi

ded

that

: W

here

ver t

he u

se o

f ISO

is c

onsi

dere

d, a

ny IS

O-b

ased

de

term

inat

ion

(and

revi

ew) o

f req

uire

men

ts s

houl

d in

clud

e (e

xplic

itly)

the

dete

rmin

atio

n of

saf

ety

requ

irem

ents

(als

o kn

own

as m

itiga

tion

mea

sure

s) d

eriv

ed fr

om ri

sk

asse

ssm

ent a

nd m

itiga

tion

proc

esse

s.

7.2.

3 C

usto

mer

com

mun

icat

ion

The

orga

nisa

tion

shal

l det

erm

ine

and

impl

emen

t effe

ctiv

e ar

rang

emen

ts fo

r com

mun

icat

ing

with

cus

tom

ers

in

rela

tion

to:

No

sim

ilar r

equi

rem

ent i

n E

SA

RR

3

The

use

of th

ese

ISO

pro

visi

ons

may

add

ress

com

plem

enta

ry

aspe

cts

not t

ackl

ed in

ES

AR

R 3

.

Page 35: EAM 3 / GUI 4 MAPPING BETWEEN ISO 9001:2000 … · ISO ISO 9001:2000 ISO 10011 ... EAM 3 / GUI 4 – Mapping between ISO 9001:2000 and ESARR 3 Edition 1.0 Released Issue Page 7 of

EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 35

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t a)

pro

duct

info

rmat

ion

b) e

nqui

ries,

con

tract

s or

han

dlin

g, in

clud

ing

amen

dmen

ts,

and

c) c

usto

mer

feed

back

, inc

ludi

ng c

usto

mer

com

plai

nts

(see

pre

viou

s pa

ge)

(see

pre

viou

s pa

ge)

7.3

Des

ign

and

deve

lopm

ent

7.3.

1 D

esig

n an

d de

velo

pmen

t pla

nnin

g th

e or

gani

satio

n sh

all p

lan

and

cont

rol t

he d

esig

n an

d de

velo

pmen

t of p

rodu

ct.

Dur

ing

the

desi

gn a

nd d

evel

opm

ent p

lann

ing,

the

orga

nisa

tion

shal

l det

erm

ine:

a) th

e de

sign

and

dev

elop

men

t sta

ges

b) th

e re

view

, ver

ifica

tion

and

valid

atio

n th

at a

re

appr

opria

te to

eac

h de

sign

and

dev

elop

men

t sta

ge, a

nd

c) th

e re

spon

sibi

litie

s an

d au

thor

ities

for d

esig

n an

d de

velo

pmen

t

The

orga

nisa

tion

shal

l man

age

the

inte

rface

s be

twee

n di

ffere

nt g

roup

s in

volv

ed in

des

ign

and

deve

lopm

ent t

o en

sure

effe

ctiv

e co

mm

unic

atio

n an

d cl

ear a

ssig

nmen

t of

resp

onsi

bilit

y.

Pla

nnin

g ou

tput

sha

ll be

upd

ated

, as

appr

opria

te, a

s th

e de

sign

and

dev

elop

men

t pro

gres

ses.

5.2.

4. R

isk

Ass

essm

ent a

nd M

itiga

tion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

a) s

hall

ensu

re th

at ri

sk a

sses

smen

t and

miti

gatio

n is

con

duct

ed to

an

app

ropr

iate

leve

l to

ensu

re th

at d

ue c

onsi

dera

tion

is g

iven

to a

ll as

pect

s of

ATM

; b)

sha

ll en

sure

that

cha

nges

to th

e A

TM s

yste

m a

re a

sses

sed

for

thei

r saf

ety

sign

ifica

nce,

and

ATM

sys

tem

func

tions

are

cla

ssifi

ed

acco

rdin

g to

thei

r saf

ety

seve

rity;

c)

sha

ll en

sure

app

ropr

iate

miti

gatio

n of

risk

s w

here

ass

essm

ent h

as

show

n th

is to

be

nece

ssar

y du

e to

the

safe

ty s

igni

fican

ce o

f the

ch

ange

;

ES

AR

R 3

requ

ires

risk

asse

ssm

ent a

nd m

itiga

tion

and

refe

rs to

th

e ch

ange

s to

the

ATM

sys

tem

as

the

subj

ect f

or a

sses

smen

t (E

SA

RR

3, 5

.2.4

b).

ES

AR

R 4

has

dev

elop

ed th

at id

ea fu

rther

and

mad

e cl

ear t

hat

the

orga

nisa

tion

shou

ld c

ondu

ct ri

sk a

sses

smen

t and

miti

gatio

n fo

r any

cha

nges

to th

ose

parts

of t

he A

TM s

yste

m a

nd

supp

ortin

g se

rvic

es w

ithin

the

man

ager

ial c

ontro

l of t

he

orga

nisa

tion.

O

n th

e ot

her h

and,

ISO

incl

udes

pro

visi

ons

with

rega

rd to

“d

esig

n an

d de

velo

pmen

t” w

hich

is d

efin

ed a

s “a

set

of

proc

esse

s th

at tr

ansf

orm

s re

quire

men

ts in

to s

peci

fied

char

acte

ristic

s or

into

the

spec

ifica

tion

of a

pro

duct

, pro

cess

or

syst

em”.

The

outc

ome

of d

esig

n an

d de

velo

pmen

t will

nor

mal

ly in

volv

e pr

opos

als

for c

hang

es to

the

ATM

sys

tem

. The

refo

re, p

aral

lel

risk

asse

ssm

ent a

nd m

itiga

tion

will

nee

d to

be

cond

ucte

d in

as

soci

atio

n w

ith d

esig

n an

d de

velo

pmen

t.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.4

, pro

vide

d th

at:

Whe

neve

r the

use

of I

SO is

con

side

red,

the

ISO

-bas

ed

desi

gn a

nd d

evel

opm

ent p

lann

ing

shou

ld in

clud

e (e

xplic

itly)

the

plan

ning

of r

isk

asse

ssm

ent a

nd m

itiga

tion

in re

gard

to a

ny a

ssoc

iate

d ch

ange

s to

the

ATM

sys

tem

.

(N

OTE

: ES

AR

R 4

pro

vide

s m

ore

deta

iled

requ

irem

ents

with

re

gard

to ri

sk a

sses

smen

t and

miti

gatio

n. F

ull c

ompl

ianc

e w

ith

ES

AR

R 4

may

invo

lve

addi

tiona

l asp

ects

whe

n us

ing

ISO

)

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 36

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 7.

3.2

Des

ign

and

deve

lopm

ent i

nput

s In

puts

rela

ted

to p

rodu

ct re

quire

men

ts s

hall

be d

eter

min

ed

and

reco

rds

mai

ntai

ned.

The

se in

puts

sha

ll in

clud

e:

a) fu

nctio

nal a

nd p

erfo

rman

ce re

quire

men

ts

b) a

pplic

able

sta

tuto

ry a

nd re

gula

tory

requ

irem

ents

c) w

here

app

licab

le, i

nfor

mat

ion

deriv

ed fr

om p

revi

ous

sim

ilar d

esig

ns, a

nd

d) o

ther

requ

irem

ents

ess

entia

l for

des

ign

and

deve

lopm

ent

Thes

e in

puts

sha

ll be

revi

ewed

for a

dequ

acy.

R

equi

rem

ents

sha

ll be

com

plet

e, u

nam

bigu

ous

and

not i

n co

nflic

t with

eac

h ot

her.

5.2.

4. R

isk

Ass

essm

ent a

nd M

itiga

tion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

a) s

hall

ensu

re th

at ri

sk a

sses

smen

t and

miti

gatio

n is

con

duct

ed to

an

app

ropr

iate

leve

l to

ensu

re th

at d

ue c

onsi

dera

tion

is g

iven

to a

ll as

pect

s of

ATM

;

ES

AR

R 3

requ

ires

risk

asse

ssm

ent a

nd m

itiga

tion

and

refe

rs to

th

e ne

ed to

ens

ure

that

due

con

side

ratio

n is

giv

en to

all

aspe

cts

of A

TM (E

SA

RR

3, 5

.2.4

a)

ES

AR

R 4

has

dev

elop

ed th

at id

ea fu

rther

and

mad

e cl

ear t

hat

risk

asse

ssm

ent a

nd m

itiga

tion

shou

ld in

volv

e a

dete

rmin

atio

n of

the

scop

e, b

ound

arie

s an

d in

terfa

ces,

as

wel

l as

an

iden

tific

atio

n of

func

tions

to b

e pe

rform

ed a

nd th

e en

viro

nmen

t of

ope

ratio

ns. T

hose

are

inpu

ts to

be

norm

ally

con

side

red

in

any

risk

asse

ssm

ent a

nd m

itiga

tion

proc

ess.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.4

, pro

vide

d th

at:

Whe

neve

r the

use

of I

SO is

con

side

red,

the

ISO

-bas

ed

desi

gn a

nd d

evel

opm

ent i

nput

s sh

ould

iden

tify

(exp

licitl

y)

the

inpu

ts n

eede

d to

con

duct

risk

ass

essm

ent a

nd

miti

gatio

n w

ith re

gard

to a

ny a

ssoc

iate

d ch

ange

s to

the

ATM

sys

tem

.

(N

OTE

: Ful

l com

plia

nce

with

ES

AR

R 4

may

invo

lve

addi

tiona

l as

pect

s w

hen

usin

g IS

O)

7.3.

3 D

esig

n an

d de

velo

pmen

t out

puts

Th

e ou

tput

s of

des

ign

and

deve

lopm

ent s

hall

be p

rovi

ded

in a

form

that

ena

bles

ver

ifica

tion

agai

nst t

he d

esig

n an

d de

velo

pmen

t inp

ut a

nd s

hall

be a

ppro

ved

prio

r to

rele

ase.

D

esig

n an

d de

velo

pmen

t out

puts

sha

ll:

a) m

eet t

he in

put r

equi

rem

ents

for d

esig

n an

d de

velo

pmen

t

b) p

rovi

de a

ppro

pria

te in

form

atio

n fo

r pur

chas

ing,

pr

oduc

tion

and

for s

ervi

ce p

rovi

sion

c) c

onta

in o

r ref

eren

ce p

rodu

ct a

ccep

tanc

e cr

iteria

d) s

peci

fy th

e ch

arac

teris

tics

of th

e pr

oduc

t tha

t are

es

sent

ial f

or it

s sa

fe a

nd p

rope

r use

.

5.2.

4. R

isk

Ass

essm

ent a

nd M

itiga

tion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

c) s

hall

ensu

re a

ppro

pria

te m

itiga

tion

of ri

sks

whe

re a

sses

smen

t has

sh

own

this

to b

e ne

cess

ary

due

to th

e sa

fety

sig

nific

ance

of t

he

chan

ge;

With

in ri

sk a

sses

smen

t and

miti

gatio

n, E

SA

RR

3 re

quire

s ap

prop

riate

miti

gatio

n of

risk

s.

ES

AR

R 4

mak

es c

lear

that

risk

miti

gatio

n sh

ould

be

base

d on

th

e de

term

inat

ion

of s

afet

y re

quire

men

ts (m

itiga

tion

mea

sure

s).

Thos

e ou

tput

s ob

tain

ed fr

om th

e ris

k as

sess

men

t and

m

itiga

tion

proc

ess

shou

ld n

orm

ally

be

rela

ted

to th

e ou

tput

s id

entif

ied

by IS

O (t

he fo

ur b

ulle

ts li

sted

) if a

n IS

O-b

ased

ap

proa

ch is

use

d.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.4

, pro

vide

d th

at:

Whe

reve

r the

use

of I

SO is

con

side

red,

the

ISO

-bas

ed

desi

gn a

nd d

evel

opm

ent o

utpu

ts s

houl

d id

entif

y (e

xplic

itly)

th

e ou

tput

s fr

om ri

sk a

sses

smen

t and

miti

gatio

n un

dert

aken

in re

gard

to a

ny a

ssoc

iate

d ch

ange

s to

the

ATM

sys

tem

(not

ably

the

safe

ty re

quire

men

ts).

(NO

TE: F

ull c

ompl

ianc

e w

ith E

SA

RR

4 m

ay in

volv

e ad

ditio

nal

aspe

cts

whe

n us

ing

ISO

)

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 37

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 7.

3.4

Des

ign

and

deve

lopm

ent r

evie

w

At s

uita

ble

stag

es, s

yste

mat

ic re

view

s of

des

ign

and

deve

lopm

ent s

hall

be p

erfo

rmed

in a

ccor

danc

e w

ith

plan

ned

arra

ngem

ents

a) to

eva

luat

e th

e ab

ility

of t

he re

sults

of d

esig

n, a

nd

b) to

iden

tify

any

prob

lem

s an

d pr

opos

e ne

cess

ary

actio

ns

Par

ticip

ants

in s

uch

revi

ews

shal

l inc

lude

repr

esen

tativ

es

of fu

nctio

ns c

once

rned

with

the

desi

gn a

nd d

evel

opm

ent

stag

e(s)

bei

ng re

view

ed. R

ecor

ds o

f the

resu

lts o

f the

re

view

s an

d an

y ne

cess

ary

actio

ns s

hall

be m

aint

aine

d

7.3.

5 D

esig

n an

d de

velo

pmen

t ver

ifica

tion

Ver

ifica

tion

shal

l be

perfo

rmed

in a

ccor

danc

e w

ith p

lann

ed

arra

ngem

ents

to e

nsur

e th

at th

e de

sign

and

dev

elop

men

t ou

tput

s ha

ve m

et th

e de

sign

and

dev

elop

men

t inp

ut

requ

irem

ents

. Rec

ords

of t

he re

sults

of t

he v

erifi

catio

n an

d an

y ne

cess

ary

actio

ns s

hall

be m

aint

aine

d.

7.3.

6 D

esig

n an

d de

velo

pmen

t val

idat

ion

Des

ign

and

deve

lopm

ent v

alid

atio

n sh

all b

e pe

rform

ed in

ac

cord

ance

with

pla

nned

arr

ange

men

ts to

ens

ure

that

the

resu

lting

pro

duct

is c

apab

le o

f mee

ting

the

requ

irem

ents

fo

r the

spe

cifie

d ap

plic

atio

n or

inte

nded

use

, whe

re

know

n. W

here

ver p

ract

icab

le, v

alid

atio

n sh

all b

e co

mpl

eted

prio

r to

the

deliv

ery

or im

plem

enta

tion

of th

e pr

oduc

t. R

ecor

ds o

f the

resu

lts o

f val

idat

ion

and

any

nece

ssar

y ac

tions

sha

ll be

mai

ntai

ned.

No

spec

ific

ES

AR

R 3

requ

irem

ents

add

ress

the

revi

ew, v

erifi

catio

n an

d va

lidat

ion

step

s sp

ecifi

cally

rela

ted

to ri

sk a

sses

smen

t and

m

itiga

tion

or d

esig

n an

d de

velo

pmen

t pro

cess

es.

The

use

of

thes

e IS

O

prov

isio

ns

can

supp

ort

the

impl

emen

tatio

n of

ES

AR

R 3

, 5.2

.4.

(NO

TE: E

SA

RR

4 p

rovi

des

mor

e de

taile

d re

quire

men

ts w

ith

rega

rd to

risk

ass

essm

ent a

nd m

itiga

tion.

Ful

l com

plia

nce

with

E

SA

RR

4 m

ay in

volv

e ad

ditio

nal a

spec

ts w

hen

usin

g IS

O.

(e.g

. ES

AR

R 4

requ

ires

risk

asse

ssm

ent a

nd m

itiga

tion

proc

esse

s to

incl

ude

verif

icat

ion

that

all

iden

tifie

d sa

fety

ob

ject

ives

and

requ

irem

ents

hav

e be

en m

et. W

here

ver t

he u

se

of IS

O is

con

side

red,

ISO

bas

ed re

view

, ver

ifica

tion

and

valid

atio

n sh

ould

con

side

r thi

s E

SA

RR

4 re

quire

men

t)

7.3.

7 C

ontr

ol o

f des

ign

and

deve

lopm

ent c

hang

es

Des

ign

and

deve

lopm

ent c

hang

es s

hall

be id

entif

ied

and

reco

rds

mai

ntai

ned.

The

cha

nges

sha

ll be

revi

ewed

, ve

rifie

d an

d va

lidat

ed, a

s ap

prop

riate

, and

app

rove

d be

fore

impl

emen

tatio

n. T

he re

view

of d

esig

n an

d de

velo

pmen

t cha

nges

sha

ll in

clud

e ev

alua

tion

of th

e ef

fect

of

the

chan

ges

on c

onst

ituen

t par

ts a

nd p

rodu

cts

alre

ady

deliv

ered

Rec

ords

of t

he re

sults

of t

he re

view

of c

hang

es a

nd a

ny

nece

ssar

y ac

tions

sha

ll be

mai

ntai

ned

5.3.

4. R

isk

Ass

essm

ent a

nd M

itiga

tion

Doc

umen

tatio

n (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at th

e re

sults

and

con

clus

ions

of t

he ri

sk a

sses

smen

t an

d m

itiga

tion

proc

ess

of a

new

or c

hang

ed s

afet

y si

gnifi

cant

sys

tem

ar

e sp

ecifi

cally

doc

umen

ted,

and

that

this

doc

umen

tatio

n is

m

aint

aine

d th

roug

hout

the

life

of th

e sy

stem

.

ES

AR

R 3

req

uire

s sp

ecifi

c do

cum

enta

tion

of t

he r

esul

ts f

rom

ris

k as

sess

men

t and

miti

gatio

n pr

oces

ses.

Th

e co

mpa

rison

co

nduc

ted

abov

e co

nclu

ded

that

ris

k as

sess

men

t an

d m

itiga

tion

need

s to

be

spec

ifica

lly a

ddre

ssed

w

ithin

the

use

of

ISO

-bas

ed d

esig

n an

d de

velo

pmen

t. Th

e do

cum

enta

tion

rela

ted

need

s to

be

addr

esse

d sp

ecifi

cally

too.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.4

, 5.3

.4, p

rovi

ded

that

: W

here

ver t

he u

se o

f ISO

is c

onsi

dere

d, th

e co

ntro

l of

desi

gn a

nd d

evel

opm

ent s

houl

d in

clud

e sp

ecifi

c do

cum

enta

tion

to p

rese

nt th

e re

sults

and

con

clus

ions

of

the

risk

asse

ssm

ent a

nd m

itiga

tion

rela

ted

to a

ssoc

iate

d ch

ange

s to

the

ATM

sys

tem

7.4

Purc

hasi

ng

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 38

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 7.

4.1

Purc

hasi

ng p

roce

ss

The

orga

nisa

tion

shal

l ens

ure

that

pur

chas

ed p

rodu

ct

conf

orm

s to

spe

cifie

d pu

rcha

se re

quire

men

ts. T

he ty

pe

and

exte

nt o

f con

trol a

pplie

d to

the

supp

lier a

nd th

e pu

rcha

sed

prod

uct s

hall

be d

epen

dent

upo

n th

e ef

fect

of

the

purc

hase

d pr

oduc

t on

subs

eque

nt p

rodu

ct re

alis

atio

n or

the

final

pro

duct

The

orga

nisa

tion

shal

l eva

luat

e an

d se

lect

sup

plie

rs

base

d on

thei

r abi

lity

to s

uppl

y pr

oduc

t in

acco

rdan

ce w

ith

the

orga

nisa

tion’

s re

quire

men

ts. C

riter

ia fo

r sel

ectio

n,

eval

uatio

n an

d re

-eva

luat

ion

shal

l be

esta

blis

hed.

Rec

ords

of

the

resu

lts o

f eva

luat

ions

and

any

nec

essa

ry a

ctio

ns

aris

ing

from

the

eval

uatio

n sh

all b

e m

aint

aine

d

7.4.

2 Pu

rcha

sing

info

rmat

ion

Pur

chas

ing

info

rmat

ion

shal

l des

crib

e th

e pr

oduc

t to

be

purc

hase

d in

clud

ing

whe

re a

ppro

pria

te:

a) re

quire

men

ts fo

r app

rova

l of p

rodu

ct, p

roce

dure

s,

proc

esse

s an

d eq

uipm

ent

b) re

quire

men

ts fo

r qua

lific

atio

n of

per

sonn

el, a

nd

c) Q

MS

requ

irem

ents

The

orga

nisa

tion

shal

l ens

ure

the

adeq

uacy

of s

peci

fied

purc

hase

requ

irem

ents

prio

r to

thei

r com

mun

icat

ion

to th

e su

pplie

r.

7.4.

3 Ve

rific

atio

n of

pur

chas

ed p

rodu

ct

The

orga

nisa

tion

shal

l est

ablis

h an

d im

plem

ent t

he

insp

ectio

n or

oth

er a

ctiv

ities

nee

ded

for e

nsur

ing

that

pu

rcha

sed

prod

uct m

eets

spe

cifie

d pu

rcha

se

requ

irem

ents

Whe

re th

e or

gani

satio

n or

its

cust

omer

inte

nds

to p

erfo

rm

verif

icat

ion

at th

e su

pplie

r’s p

rem

ises

, the

org

anis

atio

n sh

all s

tate

the

inte

nded

ver

ifica

tion

arra

ngem

ents

and

m

etho

d of

pro

duct

rele

ase

in th

e pu

rcha

sing

info

rmat

ion.

5.2.

6 Ex

tern

al S

ervi

ces

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

adeq

uate

and

sat

isfa

ctor

y ju

stifi

catio

n of

the

safe

ty o

f th

e ex

tern

ally

pro

vide

d se

rvic

es, h

avin

g re

gard

to th

eir s

afet

y si

gnifi

canc

e w

ithin

the

prov

isio

n of

the

ATM

ser

vice

. To

not

e th

e de

finiti

on o

f Ext

erna

l Ser

vice

s in

clud

ed in

ES

AR

R 3

, A

ppen

dix

A:

Ext

erna

l Ser

vice

s –

All

mat

eria

l and

non

-mat

eria

l sup

plie

s an

d se

rvic

es, w

hich

are

del

iver

ed b

y an

y or

gani

satio

n no

t cov

ered

by

the

ATM

ser

vice

pro

vide

r’s S

MS

.

The

ES

AR

R 3

def

initi

on o

f “E

xter

nal

Ser

vice

s” i

s w

ide

and

may

incl

ude

vario

us t

ypes

of

exte

rnal

inpu

ts.

Som

e po

ssib

le

exam

ples

: -

Ser

vice

s pr

ovid

ed b

y ex

tern

al o

rgan

isat

ions

(e.g

. CN

S,

ME

T, A

IS, t

elec

om, p

ower

sup

ply,

fire

-figh

ting,

etc

), -

Pro

cure

men

t of e

quip

men

t, -

Ope

ratio

nal i

nput

s fro

m a

djac

ent s

ecto

rs, r

adar

da

ta fr

om o

ther

org

anis

atio

ns, e

tc, e

tc.

Th

e IS

O a

ppro

ach,

bas

ed o

n go

od p

rocu

rem

ent p

ract

ices

, ap

pear

s ef

fect

ive

as a

mea

ns to

dea

l with

thos

e si

tuat

ions

in

whi

ch e

xter

nal s

uppl

iers

can

be

sele

cted

. H

owev

er, t

he u

se o

f ext

erna

l ser

vice

s in

ATM

may

invo

lve

som

e si

tuat

ions

whe

re th

ere

are

no o

ptio

ns a

nd e

xter

nal i

nput

s ne

ed to

be

used

as

the

only

pos

sibl

e on

es.

As

expl

aine

d in

EA

M3/

GU

I1 (E

SA

RR

3 G

uida

nce

Mat

eria

l), in

th

ose

situ

atio

ns a

ny e

xter

nal i

nput

(pro

duct

, ser

vice

, in

form

atio

n, e

tc) c

an b

e m

anag

ed th

roug

h a

risk

asse

ssm

ent

and

miti

gatio

n ap

proa

ch. A

pro

cess

sho

uld

iden

tify

the

haza

rds

asso

ciat

ed w

ith th

e in

put a

nd e

nsur

e th

at th

eir r

isk

is m

itiga

ted

to a

tole

rabl

e le

vel.

App

ropr

iate

miti

gatio

n m

easu

res

coul

d in

clud

e te

chni

ques

suc

h as

mon

itorin

g, re

dund

ancy

, ope

ratio

nal

or c

ontin

genc

y pr

oced

ures

, etc

, etc

.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.6

, pro

vide

d th

at:

Whe

reve

r the

use

of I

SO is

con

side

red,

com

plem

enta

ry

arra

ngem

ents

are

put

in p

lace

to d

eal w

ith th

ose

situ

atio

ns

in w

hich

ext

erna

l sup

plie

rs c

an n

ot b

e se

lect

ed. T

hose

ad

ditio

nal a

rran

gem

ents

sho

uld

norm

ally

be

base

d on

a

risk-

base

d ap

proa

ch.

7.5

Prod

uctio

n an

d se

rvic

es p

rovi

sion

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 39

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 7.

5.1

Con

trol

of p

rodu

ctio

n an

d se

rvic

e pr

ovis

ion

The

orga

nisa

tion

shal

l pla

n an

d ca

rry

out p

rodu

ctio

n an

d se

rvic

e pr

ovis

ion

unde

r con

trolle

d co

nditi

ons.

Con

trolle

d co

nditi

ons

shal

l inc

lude

as

appl

icab

le:

a) th

e av

aila

bilit

y of

info

rmat

ion

that

des

crib

es th

e ch

arac

teris

tics

of th

e pr

oduc

t

b) th

e av

aila

bilit

y of

wor

k in

stru

ctio

ns a

s ne

cess

ary

c) th

e us

e of

sui

tabl

e eq

uipm

ent

d) th

e av

aila

bilit

y an

d us

e of

mon

itorin

g an

d m

easu

ring

devi

ces

e) th

e im

plem

enta

tion

of m

onito

ring

and

mea

sure

men

t, an

d

f) th

e im

plem

enta

tion

of re

leas

e, d

eliv

ery

and

post

-del

iver

y ac

tiviti

es

7.5.

2 Va

lidat

ion

of p

roce

sses

for p

rodu

ctio

n an

d se

rvic

e pr

ovis

ion

The

orga

nisa

tion

shal

l val

idat

e an

y pr

oces

ses

and

serv

ice

prov

isio

n w

here

the

resu

lting

out

put c

anno

t be

verif

ied

by

subs

eque

nt m

onito

ring

or m

easu

rem

ent.

This

incl

udes

an

y pr

oces

ses

whe

re d

efic

ienc

ies

beco

me

appa

rent

onl

y af

ter t

he p

rodu

ct is

in u

se o

r the

ser

vice

has

bee

n de

liver

ed

Val

idat

ion

shal

l dem

onst

rate

the

abili

ty o

f the

se p

roce

sses

to

ach

ieve

pla

nned

resu

lts

The

orga

nisa

tion

shal

l est

ablis

h ar

rang

emen

ts fo

r the

se

proc

esse

s in

clud

ing,

as

appl

icab

le:

a) d

efin

ed c

riter

ia fo

r rev

iew

and

app

rova

l of t

he

proc

esse

s

b) a

ppro

val o

f equ

ipm

ent a

nd q

ualif

icat

ion

of p

erso

nnel

c) u

se o

f spe

cific

met

hods

and

pro

cedu

res

d) re

quire

men

ts fo

r rec

ords

and

e) re

valid

atio

n

No

spec

ific

ES

AR

R 3

requ

irem

ents

add

ress

exp

licitl

y th

e m

eans

to

cont

rol o

r val

idat

e th

e pr

oces

ses

for s

ervi

ce p

rovi

sion

(tha

t is

to s

ay,

the

mea

ns to

con

trol o

r val

idat

e th

e A

TM o

pera

tiona

l pro

cedu

res)

H

owev

er, t

o no

te th

at:

5.2.

4 R

isk

Ass

essm

ent a

nd M

itiga

tion

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

a) s

hall

ensu

re th

at ri

sk a

sses

smen

t and

miti

gatio

n is

con

duct

ed to

an

app

ropr

iate

leve

l to

ensu

re th

at d

ue c

onsi

dera

tion

is g

iven

to a

ll as

pect

s of

ATM

; …

c)

sha

ll en

sure

app

ropr

iate

miti

gatio

n of

risk

s w

here

ass

essm

ent h

as

show

n th

is to

be

nece

ssar

y du

e to

the

safe

ty s

igni

fican

ce o

f the

ch

ange

;.

The

appr

oach

pro

pose

d by

IS

O c

ould

be

used

in

the

risk

asse

ssm

ent

and

miti

gatio

n pr

oces

ses

cond

ucte

d as

reg

ards

A

TM o

pera

tiona

l pro

cedu

res.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.2.4

, with

rega

rd to

ATM

op

erat

iona

l pro

cedu

res,

pro

vide

d th

at:

Whe

reve

r the

use

of I

SO is

con

side

red,

the

valid

atio

n of

pr

oces

ses

for s

ervi

ce p

rovi

sion

sho

uld

(exp

licitl

y) in

clud

e ap

prop

riate

risk

ass

essm

ent a

nd m

itiga

tion

activ

ities

.

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 40

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 7.

5.3

Iden

tific

atio

n an

d tr

acea

bilit

y W

here

app

ropr

iate

the

orga

nisa

tion

shal

l ide

ntify

the

prod

uct b

y su

itabl

e m

eans

thro

ugho

ut p

rodu

ct re

alis

atio

n

The

orga

nisa

tion

shal

l ide

ntify

the

prod

uct s

tatu

s w

ith

resp

ect t

o m

onito

ring

and

mea

sure

men

t req

uire

men

ts

Whe

re tr

acea

bilit

y is

a re

quire

men

t, th

e or

gani

satio

n sh

all

cont

rol a

nd re

cord

the

uniq

ue id

entif

icat

ion

of th

e pr

oduc

t

5.3.

3. S

afet

y R

ecor

ds

(with

in th

e op

erat

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

saf

ety

reco

rds

are

mai

ntai

ned

thro

ugho

ut th

e S

MS

op

erat

ion

as a

bas

is fo

r pro

vidi

ng s

afet

y as

sura

nce

to a

ll as

soci

ated

w

ith, r

espo

nsib

le fo

r or d

epen

dent

upo

n th

e se

rvic

es p

rovi

ded,

and

to

the

safe

ty re

gula

tory

aut

horit

y;

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, 5

.3.3

, 5.3

.4.

7.5.

4 C

usto

mer

pro

pert

y Th

e or

gani

satio

n sh

all e

xerc

ise

care

with

cus

tom

er

prop

erty

whi

le it

is u

nder

the

orga

nisa

tion’

s co

ntro

l or

bein

g us

ed b

y th

e or

gani

satio

n. T

he o

rgan

isat

ion

shal

l id

entif

y, v

erify

, pro

tect

and

saf

egua

rd c

usto

mer

pro

perty

pr

ovid

ed fo

r use

or i

ncor

pora

tion

into

the

prod

uct.

If an

y cu

stom

er p

rope

rty is

lost

, dam

aged

or o

ther

wis

e fo

und

to

be u

nsui

tabl

e fo

r use

, thi

s sh

all b

e re

porte

d to

the

cust

omer

and

reco

rds

mai

ntai

ned.

No

spec

ific

ES

AR

R 3

requ

irem

ents

add

ress

exp

licitl

y th

is is

sue

The

use

of th

ese

ISO

pro

visi

ons

may

add

ress

com

plem

enta

ry

aspe

cts

not t

ackl

ed in

ES

AR

R 3

.

7.5.

5 Pr

eser

vatio

n of

pro

duct

Th

e or

gani

satio

n sh

all p

rese

rve

the

conf

orm

ity o

f pro

duct

du

ring

inte

rnal

pro

cess

ing

and

deliv

ery

to th

e in

tend

ed

dest

inat

ion.

Thi

s pr

eser

vatio

n sh

all i

nclu

de id

entif

icat

ion,

ha

ndlin

g, p

acka

ging

, sto

rage

and

pro

tect

ion.

Pre

serv

atio

n sh

all a

lso

appl

y to

the

cons

titue

nt p

arts

of t

he p

rodu

ct.

No

spec

ific

ES

AR

R 3

requ

irem

ents

add

ress

exp

licitl

y th

is is

sue

The

use

of th

ese

ISO

pro

visi

ons

may

add

ress

com

plem

enta

ry

aspe

cts

not t

ackl

ed in

ES

AR

R 3

.

7.6

Con

trol

of m

onito

ring

and

mea

surin

g de

vice

s Th

e or

gani

satio

n sh

all d

eter

min

e th

e m

onito

ring

and

mea

sure

men

t und

erta

ken

and

the

mon

itorin

g an

d m

easu

ring

devi

ces

need

ed to

pro

vide

evi

denc

e of

co

nfor

mity

of p

rodu

ct to

det

erm

ined

requ

irem

ents

.

The

orga

nisa

tion

shal

l est

ablis

h pr

oces

ses

to e

nsur

e th

at

mon

itorin

g an

d m

easu

rem

ent c

an b

e ca

rrie

d ou

t and

are

ca

rrie

d ou

t in

a m

anne

r tha

t is

cons

iste

nt w

ith th

e m

onito

ring

and

mea

sure

men

t req

uire

men

ts

5.3.

2 Sa

fety

Mon

itorin

g (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at m

etho

ds a

re in

pla

ce to

det

ect c

hang

es in

sys

tem

s or

ope

ratio

ns w

hich

may

sug

gest

any

ele

men

t is

appr

oach

ing

a po

int

at w

hich

acc

epta

ble

stan

dard

s of

saf

ety

can

no lo

nger

be

met

, and

th

at c

orre

ctiv

e ac

tion

is ta

ken.

Equ

ival

ent s

tate

men

ts

To n

ote

the

need

for a

n ex

plic

it m

onito

ring

of s

afet

y.

Whe

re n

eces

sary

to e

nsur

e va

lid re

sults

, mea

surin

g eq

uipm

ent s

hall:

a) b

e ca

libra

ted

or v

erifi

ed a

t spe

cial

inte

rval

s, o

r prio

r to

use,

aga

inst

mea

sure

men

t sta

ndar

ds tr

acea

ble

to

inte

rnat

iona

l or n

atio

nal m

easu

rem

ent s

tand

ards

; whe

re

no s

uch

stan

dard

s ex

ist,

the

basi

s us

ed fo

r cal

ibra

tion

or

verif

icat

ion

shal

l be

reco

rded

.

b) b

e ad

just

ed o

r re-

adju

sted

as

nece

ssar

y

5.3.

2 Sa

fety

Mon

itorin

g (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at m

etho

ds a

re in

pla

ce to

det

ect c

hang

es in

sys

tem

s or

ope

ratio

ns w

hich

may

sug

gest

any

ele

men

t is

appr

oach

ing

a po

int

at w

hich

acc

epta

ble

stan

dard

s of

saf

ety

can

no lo

nger

be

met

, and

th

at c

orre

ctiv

e ac

tion

is ta

ken.

To n

ote

that

the

expr

essi

on “m

etho

ds” i

n E

SA

RR

3 c

ould

em

bed

the

actio

ns li

sted

by

ISO

in re

gard

to m

easu

ring

equi

pmen

t.

The

use

of th

ese

ISO

pro

visi

ons

may

add

ress

com

plem

enta

ry

aspe

cts

not t

ackl

ed in

ES

AR

R 3

.

Page 41: EAM 3 / GUI 4 MAPPING BETWEEN ISO 9001:2000 … · ISO ISO 9001:2000 ISO 10011 ... EAM 3 / GUI 4 – Mapping between ISO 9001:2000 and ESARR 3 Edition 1.0 Released Issue Page 7 of

EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 41

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t c)

be

iden

tifie

d to

ena

ble

the

calib

ratio

n st

atus

to b

e de

term

ined

d) b

e sa

fegu

arde

d fro

m a

djus

tmen

ts th

at w

ould

inva

lidat

e th

e m

easu

rem

ent r

esul

t

e) b

e pr

otec

ted

from

dam

age

and

dete

riora

tion

durin

g ha

ndlin

g, m

aint

enan

ce a

nd s

tora

ge

In a

dditi

on th

e or

gani

satio

n sh

all a

sses

s an

d re

cord

the

valid

ity o

f the

pre

viou

s m

easu

ring

resu

lts w

hen

the

equi

pmen

t is

foun

d no

t to

conf

orm

to re

quire

men

ts. T

he

orga

nisa

tion

shal

l tak

e ap

prop

riate

act

ion

on th

e eq

uipm

ent a

nd a

ny p

rodu

ct a

ffect

ed. R

ecor

ds o

f the

re

sults

of c

alib

ratio

n sh

all b

e m

aint

aine

d

Whe

n us

ed in

the

mon

itorin

g an

d m

easu

rem

ent o

f sp

ecifi

ed re

quire

men

ts, t

he a

bilit

y of

com

pute

r sof

twar

e to

sa

tisfy

the

inte

nded

app

licat

ion

shal

l be

conf

irmed

. Thi

s sh

all b

e un

derta

ken

prio

r to

initi

al u

se a

nd re

conf

irmed

as

nece

ssar

y

(see

pre

viou

s pa

ge)

(see

pre

viou

s pa

ge)

8.1

Mea

sure

men

t, A

naly

sis

and

Impr

ovem

ent (

Gen

eral

) Th

e or

gani

satio

n sh

all p

lan

and

impl

emen

t the

mon

itorin

g,

mea

sure

men

t, an

alys

is a

nd im

prov

emen

t pro

cess

es

need

ed

a) to

dem

onst

rate

con

form

ity o

f the

pro

duct

b) to

ens

ure

conf

orm

ity o

f the

QM

S

c) T

o co

ntin

ually

impr

ove

the

effe

ctiv

enes

s of

the

QM

S

This

sha

ll in

clud

e de

term

inat

ion

of a

pplic

able

met

hods

, in

clud

ing

stat

istic

al te

chni

ques

, and

the

exte

nt o

f the

ir us

e.

5.3.

1. S

afet

y Su

rvey

s (w

ithin

the

prov

isio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at s

afet

y su

rvey

s ar

e ca

rrie

d ou

t as

a m

atte

r of r

outin

e,

to re

com

men

d im

prov

emen

ts w

here

nee

ded,

to p

rovi

de a

ssur

ance

to

man

ager

s of

the

safe

ty o

f act

iviti

es w

ithin

thei

r are

as a

nd to

con

firm

co

nfor

man

ce w

ith a

pplic

able

par

ts o

f the

ir S

afet

y M

anag

emen

t S

yste

ms.

5.

3.2.

Saf

ety

Mon

itorin

g (w

ithin

the

prov

isio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at m

etho

ds a

re in

pla

ce to

det

ect c

hang

es in

sys

tem

s or

ope

ratio

ns w

hich

may

sug

gest

any

ele

men

t is

appr

oach

ing

a po

int

at w

hich

acc

epta

ble

stan

dard

s of

saf

ety

can

no lo

nger

be

met

, and

th

at c

orre

ctiv

e ac

tion

is ta

ken.

5.

4.2.

Saf

ety

Impr

ovem

ent

(with

in th

e pr

ovis

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d.

Equ

ival

ent s

tate

men

ts

To n

ote

the

need

for e

xplic

it m

onito

ring,

ana

lysi

s an

d im

prov

emen

t with

rega

rd to

saf

ety.

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 42

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 8.

2 M

onito

ring

and

mea

sure

men

t

8.2.

1 C

usto

mer

sat

isfa

ctio

n A

s on

e of

the

mea

sure

men

ts o

f per

form

ance

of t

he Q

MS

, th

e or

gani

satio

n sh

all m

onito

r inf

orm

atio

n re

latin

g to

cu

stom

er p

erce

ptio

n as

to w

heth

er th

e or

gani

satio

n ha

s m

et c

usto

mer

requ

irem

ents

. The

met

hods

for o

btai

ning

an

d us

ing

this

info

rmat

ion

shal

l be

dete

rmin

ed

No

spec

ific

ES

AR

R 3

requ

irem

ents

add

ress

exp

licitl

y th

is is

sue

The

use

of th

ese

ISO

pro

visi

ons

may

add

ress

com

plem

enta

ry

aspe

cts

not t

ackl

ed in

ES

AR

R 3

.

8.2.

2 In

tern

al a

udit

The

orga

nisa

tion

shal

l con

duct

inte

rnal

aud

its a

t pla

nned

in

terv

als

to d

eter

min

e w

heth

er th

e Q

MS

sys

tem

:

a) c

onfo

rms

to th

e pl

anne

d ar

rang

emen

ts (s

ee 7

.1),

to th

e re

quire

men

ts o

f thi

s In

tern

atio

nal S

tand

ard

and

to th

e Q

MS

requ

irem

ents

est

ablis

hed

by th

e or

gani

satio

n, a

nd

b) is

effe

ctiv

ely

impl

emen

ted

and

mai

ntai

ned

An

audi

t pro

gram

me

shal

l be

plan

ned,

taki

ng in

to

cons

ider

atio

n th

e st

atus

and

impo

rtanc

e of

the

proc

esse

s an

d ar

eas

to b

e au

dite

d, a

s w

ell a

s th

e re

sults

of p

revi

ous

audi

ts. T

he a

udit

crite

ria, s

cope

, fre

quen

cy a

nd m

etho

ds

shal

l be

defin

ed. S

elec

tion

of a

udito

rs a

nd c

ondu

ct o

f au

dits

sha

ll en

sure

obj

ectiv

ity a

nd im

parti

ality

of t

he a

udit

proc

ess.

Aud

itors

sha

ll no

t aud

it th

eir o

wn

wor

k.

The

resp

onsi

bilit

ies

and

requ

irem

ents

for p

lann

ing

and

cond

uctin

g au

dits

, and

for r

epor

ting

resu

lts a

nd

mai

ntai

ning

reco

rds

shal

l be

defin

ed in

a d

ocum

ente

d pr

oced

ure.

The

man

agem

ent r

espo

nsib

le fo

r the

are

a be

ing

audi

ted

shal

l ens

ure

that

act

ions

are

take

n w

ithou

t und

ue d

elay

to

elim

inat

e de

tect

ed n

on-c

onfo

rmiti

es a

nd th

eir c

ause

s.

Follo

w-u

p ac

tiviti

es s

hall

incl

ude

the

verif

icat

ion

of th

e ac

tions

take

n an

d th

e re

porti

ng o

f ver

ifica

tion

resu

lts (s

ee

8.5.

2)

5.3.

1. S

afet

y Su

rvey

s (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at s

afet

y su

rvey

s ar

e ca

rrie

d ou

t as

a m

atte

r of r

outin

e,

to re

com

men

d im

prov

emen

ts w

here

nee

ded,

to p

rovi

de a

ssur

ance

to

man

ager

s of

the

safe

ty o

f act

iviti

es w

ithin

thei

r are

as a

nd to

con

firm

co

nfor

man

ce w

ith a

pplic

able

par

ts o

f the

ir S

afet

y M

anag

emen

t S

yste

ms.

EA

M3/

GU

I1 (E

SA

RR

3 G

uida

nce

Mat

eria

l) ex

plic

itly

reco

gnis

es

that

inte

rnal

aud

iting

bas

ed o

n IS

O-9

001:

2000

can

be

used

for

desi

gnin

g sa

fety

sur

vey

proc

esse

s.

EA

M3/

GU

I1 a

lso

poin

ts o

ut th

at in

dea

ling

with

the

impl

emen

tatio

n of

saf

ety

surv

eys,

ser

vice

pro

vide

rs s

houl

d no

rmal

ly e

stab

lish

proc

esse

s in

a m

anne

r whi

ch:

- E

nsur

es in

depe

nden

ce o

f the

are

a be

ing

surv

eyed

; and

-

Ens

ures

sys

tem

atic

pla

nnin

g, a

sses

smen

t of a

ll fa

ctor

s af

fect

ing

safe

ty, i

dent

ifica

tion

of c

orre

ctiv

e ac

tions

, rec

ord

of

resu

lts, i

nitia

tion

and

follo

w u

p of

cor

rect

ive

actio

ns, a

s th

e ke

y el

emen

ts o

f saf

ety

surv

eys.

Th

ose

aspe

cts

are

in li

ne w

ith th

e IS

O a

ppro

ach.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3 S

ectio

n 5.

3.1

The

use

of IS

O-1

9011

:200

2 ca

n al

so s

uppo

rt th

e im

plem

enta

tion

of E

SAR

R 3

, Sec

tion

5.3.

1, a

s it

prov

ides

de

taile

d gu

idan

ce to

sup

port

the

impl

emen

tatio

n of

thos

e IS

O p

rovi

sion

s.

(NO

TE: I

SO

-900

1:20

00 re

fers

to g

uida

nce

mat

eria

l on

audi

ting

tech

niqu

es. A

t the

tim

e of

dev

elop

ing

this

doc

umen

t, IS

O-

1900

1:20

02 in

clud

ed th

e la

test

ISO

mat

eria

l ava

ilabl

e on

that

m

atte

r)

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 43

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 8.

2.3

Mon

itorin

g an

d m

easu

rem

ent o

f pro

cess

es

The

orga

nisa

tion

shal

l app

ly s

uita

ble

met

hods

for

mon

itorin

g an

d, w

here

app

licab

le, m

easu

rem

ent o

f the

Q

MS

pro

cess

es. T

hese

met

hods

sha

ll de

mon

stra

te th

e ab

ility

of t

he p

roce

sses

to a

chie

ve p

lann

ed re

sults

. Whe

n pl

anne

d re

sults

are

not

ach

ieve

d, c

orre

ctio

n an

d co

rrec

tive

actio

n sh

all b

e ta

ken,

as

appr

opria

te, t

o en

sure

co

nfor

mity

of t

he p

rodu

ct

The

Saf

ety

Sur

veys

can

be

cons

ider

ed a

s a

“sui

tabl

e m

etho

d”

to a

chie

ve th

e ob

ject

ives

sta

ted

in IS

O a

s re

gard

s S

MS

pr

oces

ses.

How

ever

, IS

O is

mor

e de

taile

d an

d m

ay h

elp

to

defin

e th

e sc

ope

and

inte

nt o

f the

Saf

ety

Sur

veys

as

rega

rds

mon

itorin

g of

pro

cess

es

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3 S

ectio

n 5.

3.1

8.2.

4 M

onito

ring

and

mea

sure

men

t of p

rodu

ct

The

orga

nisa

tion

shal

l mon

itor a

nd m

easu

re th

e ch

arac

teris

tics

of th

e pr

oduc

t to

verif

y th

at p

rodu

ct

requ

irem

ents

hav

e be

en m

et. T

his

shal

l be

carr

ied

out a

t ap

prop

riate

sta

ges

of th

e pr

oduc

t rea

lisat

ion

proc

ess

in

acco

rdan

ce w

ith th

e pl

anne

d ar

rang

emen

ts (s

ee 7

.1)

Evi

denc

e of

con

form

ity w

ith th

e ac

cept

ance

crit

eria

sha

ll be

mai

ntai

ned.

Rec

ords

sha

ll in

dica

te th

e pe

rson

(s)

auth

oris

ing

rele

ase

of p

rodu

ct

Pro

duct

rele

ase

and

serv

ice

deliv

ery

shal

l not

pro

ceed

un

til th

e pl

anne

d ar

rang

emen

ts (s

ee 7

.1) h

ave

been

sa

tisfa

ctor

ily c

ompl

eted

, unl

ess

othe

rwis

e ap

prov

ed b

y a

rele

vant

aut

horit

y an

d, w

here

app

licab

le, b

y th

e cu

stom

er.

5.3.

1. S

afet

y Su

rvey

s (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at s

afet

y su

rvey

s ar

e ca

rrie

d ou

t as

a m

atte

r of r

outin

e,

to re

com

men

d im

prov

emen

ts w

here

nee

ded,

to p

rovi

de a

ssur

ance

to

man

ager

s of

the

safe

ty o

f act

iviti

es w

ithin

thei

r are

as a

nd to

con

firm

co

nfor

man

ce w

ith a

pplic

able

par

ts o

f the

ir S

afet

y M

anag

emen

t S

yste

ms.

5.

3.2.

Saf

ety

Mon

itorin

g (w

ithin

the

prov

isio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at m

etho

ds a

re in

pla

ce to

det

ect c

hang

es in

sys

tem

s or

ope

ratio

ns w

hich

may

sug

gest

any

ele

men

t is

appr

oach

ing

a po

int

at w

hich

acc

epta

ble

stan

dard

s of

saf

ety

can

no lo

nger

be

met

, and

th

at c

orre

ctiv

e ac

tion

is ta

ken.

ES

AR

R 3

Sec

tion

5.3.

2 co

vers

the

issu

e po

inte

d ou

t by

ISO

. H

owev

er, I

SO

is m

ore

deta

iled

and

may

pro

vide

use

ful c

riter

ia

to c

ondu

ct th

e sa

fety

mon

itorin

g of

sys

tem

s an

d op

erat

ions

. To

not

e th

at E

SA

RR

3 S

ectio

n 5.

3.1

may

com

plem

ent S

ectio

n 5.

3.2

in a

chie

ving

the

obje

ctiv

es o

utlin

ed b

y IS

O.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3 S

ectio

ns 5

.3.2

, 5.3

.1

8.3

Con

trol

of n

on-c

onfo

rmin

g pr

oduc

t Th

e or

gani

satio

n sh

all e

nsur

e th

at p

rodu

ct w

hich

doe

s no

t co

nfor

m to

pro

duct

requ

irem

ents

is id

entif

ied

and

cont

rolle

d to

pre

vent

its

unin

tend

ed u

se o

r del

iver

y. T

he

cont

rols

and

rela

ted

resp

onsi

bilit

ies

and

auth

oriti

es fo

r de

alin

g w

ith n

on-c

onfo

rmin

g pr

oduc

t sha

ll be

def

ined

in a

do

cum

ente

d pr

oced

ure.

The

orga

nisa

tion

shal

l dea

l with

non

-con

form

ing

prod

uct

by o

ne o

r mor

e of

the

follo

win

g w

ays:

a) b

y ta

king

act

ion

to e

limin

ate

the

dete

cted

non

-co

nfor

mity

b) b

y au

thor

isin

g its

use

, rel

ease

or a

ccep

tanc

e un

der

conc

essi

on b

y a

rele

vant

aut

horit

y an

d, w

here

app

licab

le,

by th

e cu

stom

er

c) b

y ta

king

act

ion

to p

recl

ude

its o

rigin

al in

tend

ed u

se o

r ap

plic

atio

n

Rec

ords

of t

he n

atur

e of

non

-con

form

ities

and

any

su

bseq

uent

act

ions

take

n, in

clud

ing

conc

essi

ons

obta

ined

, sha

ll be

mai

ntai

ned

No

equi

vale

nt re

quire

men

ts e

xplic

itly

incl

uded

in E

SA

RR

3

How

ever

, to

note

:

5.3.

2. S

afet

y M

onito

ring

(with

in th

e pr

ovis

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

met

hods

are

in p

lace

to d

etec

t cha

nges

in s

yste

ms

or o

pera

tions

whi

ch m

ay s

ugge

st a

ny e

lem

ent i

s ap

proa

chin

g a

poin

t at

whi

ch a

ccep

tabl

e st

anda

rds

of s

afet

y ca

n no

long

er b

e m

et, a

nd

that

cor

rect

ive

actio

n is

take

n.

It sh

ould

be

note

d th

at th

e A

TM s

ervi

ces

prov

ided

in re

al ti

me

can

not b

e ve

rifie

d be

fore

bei

ng d

eliv

ered

. Th

e A

TM s

ervi

ces

are

inde

ed th

e fin

al “p

rodu

ct” p

rodu

ced

by

the

ATM

ser

vice

pro

vide

rs.

How

ever

, “pr

oduc

t” is

def

ined

by

ISO

as

“res

ult o

f a p

roce

ss”.

Ther

efor

e th

ese

ISO

pro

visi

ons

may

als

o be

app

licab

le to

any

in

term

edia

te p

roce

ss w

hose

out

puts

are

use

d to

pro

duce

the

final

ATM

ser

vice

(e.g

. rad

ar d

ata

is a

n ou

tput

of a

par

ticul

ar

proc

ess,

and

is n

orm

ally

use

d to

pro

vide

the

final

ATC

ser

vice

s ou

tput

). Th

ese

ISO

pro

visi

ons

can

ther

efor

e pr

ovid

e us

eful

gui

danc

e w

hen

deal

ing

with

inte

rmed

iate

out

puts

, and

sup

port

the

safe

ty

mon

itorin

g ac

tions

requ

ired

in E

SA

RR

3.

The

use

of th

ese

ISO

pro

visi

ons

can

supp

ort t

he

impl

emen

tatio

n of

ESA

RR

3, p

artic

ular

ly a

s re

gard

s ES

ARR

3

Sect

ion

5.3.

2 (a

nd 5

.2.4

)

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EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 44

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t W

hen

non-

conf

orm

ing

prod

uct i

s co

rrec

ted

it sh

all b

e su

bjec

t to

re-v

erifi

catio

n to

dem

onst

rate

con

form

ity to

the

requ

irem

ents

. (s

ee p

revi

ous

page

) (s

ee p

revi

ous

page

)

Whe

n no

n-co

nfor

min

g pr

oduc

t is

dete

cted

afte

r del

iver

y or

us

e ha

s st

arte

d, th

e or

gani

satio

n sh

all t

ake

actio

n ap

prop

riate

to th

e ef

fect

s, o

r pot

entia

l effe

cts,

of t

he n

on-

conf

orm

ity.

5.2.

7. S

afet

y O

ccur

renc

es

(with

in th

e pr

ovis

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

ATM

ope

ratio

nal o

r tec

hnic

al o

ccur

renc

es w

hich

are

co

nsid

ered

to h

ave

sign

ifica

nt s

afet

y im

plic

atio

ns a

re in

vest

igat

ed

imm

edia

tely

, and

any

nec

essa

ry c

orre

ctiv

e ac

tion

is ta

ken.

Ther

e is

a c

orre

spon

denc

e be

twee

n th

is IS

O s

tate

men

t and

E

SA

RR

3 S

ectio

n 5.

2.7.

How

ever

, ES

AR

R 3

is m

ore

deta

iled

and

spec

ific.

Whe

neve

r thi

s IS

O s

tate

men

t is

cons

ider

ed a

s a

poss

ible

m

eans

to im

plem

ent E

SAR

R 3

, Sec

tion

5.2.

7, it

sho

uld

be

note

d th

at th

e ap

prop

riate

act

ions

men

tione

d in

ISO

sho

uld

nece

ssar

ily in

clud

e an

imm

edia

te in

vest

igat

ion

of

occu

rren

ces

and

the

impl

emen

tatio

n of

cor

rect

ive

actio

ns

resu

lting

from

suc

h in

vest

igat

ion.

8.4

Ana

lysi

s of

dat

a

The

orga

nisa

tion

shal

l det

erm

ine,

col

lect

and

ana

lyse

ap

prop

riate

dat

a to

dem

onst

rate

the

suita

bilit

y an

d ef

fect

iven

ess

of th

e Q

MS

and

to e

valu

ate

whe

re c

ontin

ual

impr

ovem

ent o

f the

effe

ctiv

enes

s of

the

QM

S c

an b

e m

ade.

Thi

s sh

all i

nclu

de d

ata

gene

rate

d as

a re

sult

of

mon

itorin

g an

d m

easu

rem

ent a

nd fr

om o

ther

rele

vant

so

urce

s.

The

anal

ysis

of d

ata

shal

l pro

vide

info

rmat

ion

rela

ting

to:

a) c

usto

mer

sat

isfa

ctio

n

b) c

onfo

rmity

to p

rodu

ct re

quire

men

ts

c) c

hara

cter

istic

s an

d tre

nds

of p

roce

sses

and

pro

duct

s in

clud

ing

oppo

rtuni

ties

for p

reve

ntiv

e ac

tion,

and

d) s

uppl

iers

No

equi

vale

nt re

quire

men

ts e

xplic

itly

incl

uded

in E

SA

RR

3

How

ever

, to

note

:

5.4.

2. S

afet

y Im

prov

emen

t (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce-p

rovi

der)

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d.

(in a

dditi

on, t

hese

ISO

sta

tem

ents

are

rela

ted

to a

ctio

ns re

quire

d in

5.

3.2

Saf

ety

Mon

itorin

g an

d 5.

3.1

Saf

ety

Sur

veys

)

ISO

is m

uch

mor

e sp

ecifi

c.

To n

ote

that

man

agem

ent r

evie

ws

are

not r

equi

red

expl

icitl

y in

E

SA

RR

3 a

lthou

gh E

AM

3/G

UI 1

(ES

AR

R 3

Gui

danc

e M

ater

ial)

iden

tifie

s S

MS

man

agem

ent r

evie

ws

as o

ne o

f the

usu

al

elem

ents

of t

he im

plem

enta

tion

of E

SA

RR

3 S

ectio

n 5.

4.2

(Saf

ety

Impr

ovem

ent).

In th

at c

onte

xt, E

AM

3/G

UI 1

poi

nts

out

that

ATM

ser

vice

pro

vide

rs s

houl

d no

rmal

ly u

se S

MS

m

anag

emen

t rev

iew

s:

- To

revi

ew th

e S

MS

-

To a

gree

and

aut

horis

e ch

ange

s in

the

SM

S.

The

colle

ctio

n an

d an

alys

is o

f dat

a ex

plic

itly

sugg

este

d by

ISO

ca

n su

ppor

t tha

t rev

iew

.

The

use

of th

ese

ISO

sta

tem

ents

can

sup

port

the

impl

emen

tatio

n of

ESA

RR

3, S

ectio

n 5.

4.2

(and

5.3

.1, 5

.3.2

)

8.5

Impr

ovem

ent

8.5.

1 C

ontin

ual i

mpr

ovem

ent

The

orga

nisa

tion

shal

l con

tinua

lly im

prov

e th

e ef

fect

iven

ess

of th

e Q

MS

thro

ugh

the

use

of th

e qu

ality

po

licy,

qua

lity

obje

ctiv

es, a

udit

resu

lts, a

naly

sis

of d

ata,

co

rrec

tive

and

prev

entiv

e ac

tions

and

man

agem

ent r

evie

w

5.4.

2. S

afet

y Im

prov

emen

t (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce-p

rovi

der)

b) s

hall

ensu

re th

at c

hang

es a

re m

ade

to im

prov

e sa

fety

whe

re th

ey

appe

ar n

eede

d.

ISO

is m

uch

mor

e sp

ecifi

c ab

out t

he m

eans

to u

se fo

r ac

hiev

ing

impr

ovem

ent.

The

use

of th

ese

ISO

sta

tem

ents

can

sup

port

the

impl

emen

tatio

n of

ESA

RR

3, S

ectio

n 5.

4.2

Page 45: EAM 3 / GUI 4 MAPPING BETWEEN ISO 9001:2000 … · ISO ISO 9001:2000 ISO 10011 ... EAM 3 / GUI 4 – Mapping between ISO 9001:2000 and ESARR 3 Edition 1.0 Released Issue Page 7 of

EA

M 3

/ G

UI 4

– M

appi

ng b

etw

een

ISO

900

1:20

00 a

nd E

SA

RR

3

Edi

tion

1.0

Rel

ease

d Is

sue

Pag

e 45

of 4

5

ISO

900

1:20

00 p

rovi

sion

s ES

AR

R 3

requ

irem

ents

rela

ted

Com

men

ts/A

sses

smen

t 8.

5.2

Cor

rect

ive

actio

n Th

e or

gani

satio

n sh

all t

ake

actio

n to

elim

inat

e th

e ca

use

of n

on-c

onfo

rmiti

es in

ord

er to

pre

vent

recu

rren

ce.

Cor

rect

ive

actio

ns s

hall

be a

ppro

pria

te to

the

effe

cts

of th

e no

n-co

nfor

miti

es e

ncou

nter

ed.

A d

ocum

ente

d pr

oced

ure

shal

l be

esta

blis

hed

to d

efin

e re

quire

men

ts fo

r:

a) re

view

ing

non-

conf

orm

ities

(inc

ludi

ng c

usto

mer

co

mpl

aint

s)

b) d

eter

min

ing

the

caus

es o

f non

-con

form

ities

c) e

valu

atin

g th

e ne

ed fo

r act

ion

to e

nsur

e th

at n

on-

conf

orm

ities

do

not r

ecur

d) d

eter

min

ing

and

impl

emen

ting

actio

n ne

eded

e) re

cord

s of

the

resu

lts o

f act

ion

take

n

f) re

view

ing

corr

ectiv

e ac

tion

take

n

5.2.

7. S

afet

y O

ccur

renc

es

(with

in th

e pr

ovis

ion

of th

e S

MS

, the

ATM

ser

vice

pro

vide

r)

shal

l ens

ure

that

ATM

ope

ratio

nal o

r tec

hnic

al o

ccur

renc

es w

hich

are

co

nsid

ered

to h

ave

sign

ifica

nt s

afet

y im

plic

atio

ns a

re in

vest

igat

ed

imm

edia

tely

, and

any

nec

essa

ry c

orre

ctiv

e ac

tion

is ta

ken.

(a

lso

rela

ted

to 5

.3.1

Saf

ety

Sur

veys

)

Ther

e is

a c

orre

spon

denc

e be

twee

n th

is IS

O s

tate

men

t and

E

SA

RR

3 S

ectio

n 5.

2.7.

How

ever

, ES

AR

R 3

is m

ore

deta

iled

and

spec

ific.

Whe

neve

r thi

s IS

O s

tate

men

t is

cons

ider

ed a

s a

poss

ible

m

eans

to im

plem

ent E

SAR

R 3

, Sec

tion

5.2.

7, it

sho

uld

be

note

d th

at th

e ac

tions

pro

pose

d by

ISO

sho

uld

nece

ssar

ily

incl

ude

an im

med

iate

inve

stig

atio

n of

occ

urre

nces

. To

not

e th

at th

e st

eps

prop

osed

in IS

O c

an a

lso

be u

sefu

l to

addr

ess

non-

conf

orm

ities

rais

ed b

y ot

her S

MS

mec

hani

sms

(e.g

. Saf

ety

Sur

veys

). In

fact

, tha

t app

roac

h de

velo

ps fu

rther

th

e ge

neric

indi

catio

ns p

rovi

ded

in E

AM

3/G

UI1

(ES

AR

R 3

G

uida

nce

Mat

eria

l) in

rela

tion

to th

e co

nduc

t of S

afet

y S

urve

ys.

8.5.

3 Pr

even

tive

actio

n Th

e or

gani

satio

n sh

all d

eter

min

e ac

tion

to e

limin

ate

the

caus

es o

f pot

entia

l non

-con

form

ities

in o

rder

to p

reve

nt

thei

r occ

urre

nce.

Pre

vent

ive

actio

ns s

hall

be a

ppro

pria

te

to th

e ef

fect

s of

the

pote

ntia

l pro

blem

s.

A d

ocum

ente

d pr

oced

ure

shal

l be

esta

blis

hed

to d

efin

e re

quire

men

ts fo

r:

a) d

eter

min

ing

pote

ntia

l non

-con

form

ities

and

thei

r cau

ses

b) e

valu

atin

g th

e ne

ed fo

r act

ion

to p

reve

nt o

ccur

renc

e of

no

n-co

nfor

miti

es

c) d

eter

min

ing

and

impl

emen

ting

actio

n ne

eded

d) re

cord

s of

resu

lts o

f act

ion

take

n, a

nd

e) re

view

ing

prev

entiv

e ac

tion

take

n

5.3.

1. S

afet

y Su

rvey

s (w

ithin

the

oper

atio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at s

afet

y su

rvey

s ar

e ca

rrie

d ou

t as

a m

atte

r of r

outin

e,

to re

com

men

d im

prov

emen

ts w

here

nee

ded,

to p

rovi

de a

ssur

ance

to

man

ager

s of

the

safe

ty o

f act

iviti

es w

ithin

thei

r are

as a

nd to

con

firm

co

nfor

man

ce w

ith a

pplic

able

par

ts o

f the

ir S

afet

y M

anag

emen

t S

yste

ms.

5.

3.2.

Saf

ety

Mon

itorin

g (w

ithin

the

prov

isio

n of

the

SM

S, t

he A

TM s

ervi

ce p

rovi

der)

sh

all e

nsur

e th

at m

etho

ds a

re in

pla

ce to

det

ect c

hang

es in

sys

tem

s or

ope

ratio

ns w

hich

may

sug

gest

any

ele

men

t is

appr

oach

ing

a po

int

at w

hich

acc

epta

ble

stan

dard

s of

saf

ety

can

no lo

nger

be

met

, and

th

at c

orre

ctiv

e ac

tion

is ta

ken.

(a

lso

rela

ted

to 5

.2.4

Ris

k A

sses

smen

t and

Miti

gatio

n, n

otab

ly a

s re

gard

s th

e m

itiga

tion

of ri

sks

requ

ired

in 5

.2.4

bul

let b

)

EA

M 3

/GU

I 1 (E

SA

RR

3 G

uida

nce

Mat

eria

l) po

ints

out

that

a

safe

ty s

urve

y is

a p

reve

ntiv

e ac

tivity

whi

ch m

ain

purp

ose

is to

co

nfirm

that

an

exis

ting

situ

atio

n is

sat

isfa

ctor

y. It

is th

eref

ore

a “r

outin

e” a

ctiv

ity to

iden

tify

prob

lem

s an

d fa

cilit

ate

the

defin

ition

of

rem

edia

l act

ions

whe

n pr

oble

ms

are

iden

tifie

d or

sus

pect

ed.

Acc

ordi

ng to

EA

M 3

/GU

I 1, s

urve

ys a

re c

ompl

emen

tary

to

inci

dent

inve

stig

atio

n, s

ince

they

exa

min

e sy

stem

s un

der

norm

al c

ondi

tions

to id

entif

y w

eakn

esse

s th

at h

ave

not y

et

been

see

n to

con

tribu

te d

irect

ly o

r ind

irect

ly to

an

occu

rren

ce.

The

step

s pr

opos

ed in

ISO

can

als

o be

use

ful t

o de

velo

p fu

rther

the

gene

ric in

dica

tions

pro

vide

d in

EA

M3/

GU

I1 (E

SA

RR

3

Gui

danc

e M

ater

ial)

in re

latio

n to

the

cond

uct o

f Saf

ety

Sur

veys

. To

not

e th

at th

e S

afet

y M

onito

ring

requ

ired

in E

SA

RR

3,

sect

ion

5.3.

2 is

als

o fo

cuse

d on

det

ectin

g pr

oble

ms

befo

re th

ey

appe

ar.

The

use

of th

ese

ISO

sta

tem

ents

can

sup

port

the

impl

emen

tatio

n of

ESA

RR

3 S

ectio

n 5.

3.1,

5.3

.2.

***

End

of D

ocum

ent *

**


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