2. DEFINITIONS AND/OR ABBREVIATIONS - service.rina.it · For recognition by RINA of QS9000, TE SUP...

RINA

CERTIFICATION OF QUALITY MANAGEMENT SYSTEMS ACCORDING TO SPECIFIC AUTOMOTIVE SCHEMES

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1. PURPOSE AND SCOPE

This instruction describes the methods for performing activities related to the certification of quality management systems according to the following automotive schemes:

• ISO/TS 16949 • AVSQ-MIA • TE SUPPLEMENT (Unaccredited certification issued upon specific customer request)

This document makes direct reference to instruction IS-CRT-QUA-00 and indicates the specific reference requirements for the above schemes.

In particular, it:

• describes the main stages of the quality management system certification process according to automotive schemes. By main stages, we mean those strictly connected with the implementation of the service;

• concerns the staff of the Operative Network (AOI-AON) and Business Units (BU) of the Certification and Industrial Services Division (DCI), as well as non-exclusive auditors.

All points not specified in this instruction are governed by instruction IS-CRT-QUA-00.

2. DEFINITIONS AND/OR ABBREVIATIONS

AC: Corrective action

AOI: Internatioal Operative Area

AON: National Operative Area

Audit: a systematic, independent and documented process for obtaining evidence and objectively establishing to what extent the audit criteria (set of policies, procedures or requirements) are satisfied

Auditor - QMS auditor, a technician possessing all the requirements indicated on the qualification sheet for Auditors (IS-CRT-AUD-01)

CA: Area Manager

Certificate of Conformity: document certifying the conformity of the Quality Management System of an Organisation with the reference standard (Automotive Schemes)

CTQ: Quality Technical Committee, a committee which deliberates whether or not to validate the certification proposals presented by ROC

CISQ AUTOMOTIVE Committee: Technical Committee which deliberates whether or not to validate ISO/TS16949 certification proposals

CRT: Technical coordination and control

CU: Office Manager

DO: Organisational Provision

GVI: Auditing Team

IPR: Production Engineering Unit

EXTERNAL WORK: Activities performed by individuals or small groups belonging to an Organisation at a customer's premises or any other sites indicated by a customer, or when engaged in an activity that requires them to move around.

Lead Auditor – Auditor possessing all the requirements indicated on the Lead Auditor qualification sheet (IS-CRT-AUD-01)

NC: Non-Conformity

MULTI-SITE ORGANISATION: Organisation with a well-defined central function (hereinafter called head office) where certain activities are planned, controlled or managed, and a network of local offices or branches (sites) where such activities are entirely or partially carried out.

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PVI-Audit plan: all the activities required to plan and organise audits (number and type) on the Quality management system of an Organisation and to provide the resources for performing them effectively and efficiently within the established deadlines.

PVP: Three years surveillance audit program, general planning document, prepared by RPC in collaboration with RGVI, indicating the audits to perform during the validity of the certificate

QI: Informative questionnaire, document completed by the Customer containing all the elements required to allow RINA to prepare an offer

RINA RULES: Rules for the certification of Quality Management Systems and Annex to the Rules for the certification of Quality management systems - Certification schemes for the automotive sector

SCHEME MANAGER: Responsible for managing the specific scheme within the QMA BU

RPC: Job Manager, a technician possessing all the requirements of an RGVI, with technical/managerial responsibility for the certification jobs he/she is given and responsibility for implementing the Audit programme for these certification jobs (appointed by CU).

RVI: Audit report

SEG: Technical and administrative secretarial office of the DCI Operative Network offices

QMS: Quality management systems

PERMANENT SITES: Decentralised sites permanently manned by the organisation's employees for performing functions pertinent to the activities of the organisation.

TEMPORARY SITES: Decentralised sites manned by an organisation for a specific project.

TL/RGVI: Auditing Team Leader, a technician possessing all the requirements indicated on the qualification sheet al Lead auditor (IS-CRT-AUD-01) who has been given responsibility for the audit

3. REFERENCE DOCUMENTS

• RINA documents

− Rules for the certification of Quality Management Systems

− Rules for the certification of Quality Management Systems. Certification Schemes for the car sector

− RINA certificates/accreditation tables

− RINA price list

− DCI Quality Manual

− NEWAGE reports

− Instructions IS-CRT-QUA-0O, IS-SCC-CER-01, IS-CRT-AUD-01 and relative attachments

− RINA organisational provisions

− DCI procedures

• External documents ISO/TS16949

− ISO/TS 16949

− ANFIA Quality AQ-020: Regulations for the certification scheme ISO/TS 16949

− ANFIA Quality AQ-022: ISO/TS 16949 checklist

− AQ009 - FMEA - Application guidelines for FMEA

− AQ012 - PPAPS - Approval procedure for mass production

− AQ011 - SPC - Statistical process control

− AQ012 - Experimental Design Manual

− AIAG: Automotive Certification scheme for ISO/TS 16949 - Rules for achieving IATF recognition

− CISQ AUTOMOTIVE Regulations

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• External Documents QS9000/TE SUPPLEMENT

− QUALITY SYSTEM REQUIREMENTS QS-9000

− QSA - QUALITY SYSTEM ASSESSMENT

− QUALITY SYSTEM REQUIREMENTS - TOOLING & EQUIPMENT SUPPLEMENT

− QSA - QUALITY SYSTEM ASSESSMENT ; TOOLING & EQUIPMENT SUPPLEMENT

− IASG SANCTIONED INTERPRETATIONS

− MSA – MEASUREMENT SYSTEMS ANALYSIS

− APQP – ADVANCED PRODUCT QUALITY PLANNING AND CONTROL PLAN

− FMEA – POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS

− PPAP – PRODUCTION PART APPROVAL PROCESS

− SPC – STATISTICAL PROCESS CONTROL

• External documents AVSQ-MIA

− ANFIA QUALITÀ-001A/I: AVSQ – MIA – Tooling and equipment Guidelines for use

− ANFIA QUALITÀ-001B/I: AVSQ – MIA – Tooling and equipment Check-list

4. DESCRIPTION OF THE MAIN PROCESS STAGES

The main stages of the certification process are the ones closely connected with implementing the service, focussing on achieving the final result. They take place sequentially or depend on the outcome of a previous stage or a customer request and are schematically represented in the two functional flow charts shown below.

The two flow charts graphically represent the entire QMS certification process and relative maintenance. Flow chart n° 1 shows the stages focussed on QMS certification /recertification. Flow chart n° 2 shows the stages focussed on OHSMS certification maintenance.

The stages shown in flow chart n° 2 are generally r epeated in the same way every year.

For recognition by RINA of QS9000, TE SUP and AVSQ MIA Certificates issued by other Accredited bodies, with a view to issuing its own Certificate, refer to Annex 3 of instruction IS-CRT-QUA-00.

For recognition by RINA of ISO/TS16949 Certificates issued by other Accredited bodies, with a view to issuing its own Certificate, RINA must perform an on-site audit according to the times established for recertification in annex 1 - “ISO/TS16949 - Specific requirements for the certification of quality systems” to this instruction.

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KEY TO FLOW CHART

The column headings indicate the operative responsibilities of the stages shown in each column. Each stage is placed in the right column depending on the relative responsibility.

Each stage or decision shown on the 2 flow charts is numbered in order to relate them to the following tables giving a detailed description of each single stage, showing inputs, outputs, critical factors and the relative electronic and/or hard copy records. Flow charts 1 and 2 refer to Tables 1 and 2 respectively.

STAGES

POSSIBLE STAGES Additional stages (performed on request of the customer) that are not an integral part of auditing activities

Moving from one stage to another

Decisions are represented by rhombuses. The rhombus divides the original flow into 2. The main one focuses on achieving the final result while the secondary one comprises one or more phases that must be completed before returning to the main flow.

Sequential stages

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WARNING: for the differences during RECERTIFICATION , see notes at page 14

DOCUMENT MODIFICATION

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The following table describes the various stages shown on the 2 flow charts and defines the inputs, outputs, critical factors and records (hard copy or on electronic data medium). Any points not specified in the following table and in the annexes to this document can be found in instruction IS-CRT-QUA-00 and relative annexes.

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Table 1 - DESCRIPTION OF THE MAIN CERTIFICATION/REC ERTIFICATION PROCESS STAGES

STAGES INPUT1

COMPANY BUSINESS OUTPUT/

OBJECTIVE2

CRITICAL FACTORS3

ELECTRONIC RECORDS HARDCOPY

RECORDS 1 DEFINITION OF

OFFER QI completed by customer

The CU, or who for him, performs the following activities in collaboration with the reference scheme manager: - defines the audit times for stage 1 and stage 2 audits -calculates the cost of certification and relative maintenance on the basis of the price list -if necessary, redefines the amounts on the basis of the time effectively required for the service, as per the documents attached to this document and the automotive scheme in question (E.g.: request for corporate certification or presence of remote support sites, extension from other automotive schemes) -checks the EA sector, the RINA accreditation type and the availability of qualified internal/external auditors -for ISO/TS16949, checks the admissibility of any exclusions -records the data required to prepare the offer on the CONTRACT REVIEW form - registers all the undocumented information received from the customer (e.g.: information given on the telephone) on the informative questionnaire

-Definition of the data to include in the offer -Definition of the sites to audit for corporate or remote support site certification

-EA sector and accredit. -ISOTS16949: the only admissible exclusion refers to point 7.3 of the standard concerning product design. The requirement is always applicable for process design -Extension to ISOTS16949 from other automotive schemes -Reduction in man days depending on the number of sites to audit and the type of extension -Carefully check who provided the consulting service in order to prevent the risk of a conflict of interest For ISOTS16949, the stage 1 audit must be performed on site, unless there are special dispensations from the accreditation body. For other automotive schemes, the stage 1 audit can be performed in the office.

- QUAINFQ completed by customer CONTRACT REVIEW completed by RINA

2 PREPARATION OF OFFER

CONTRACT REVIEW form completed

SEG draws up the offer inclusive of costs and man days. Basic company information means the official name of the Organisation subject to certification (Registered name and address) and the operative units (Sites) where the activities subject to certification are performed (remote sites are also included).

-Offer prepared

-Number of employees -Production site/s and remote sites -Type of accreditation

-Registration of potential customer's data on ANACLI, CAI-C -Registration of the name of the person who drew up the offer

Offer printed by CAI-C

1 Input: Initial event of a phase 2 Output/Objective: Result of the phase, reason why the phase was performed 3 Particularly critical aspects to consider

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STAGES INPUT1


OBJECTIVE2

CRITICAL FACTORS3


RECORDS 3 CONTROL /

SIGNING OF OFFER Offer drawn up CU checks and signs the offer. SEG sends the offer. Offer signed by CU

and sent to the Organisation

- - Offer printed by CAI-C and signed by CU

4 CONTROL OF ORDER / APPOINTMENT OF RPC

-Customer order, or Certification application on RINA form in line with the offer

CU: A) examines the Application/Order to ensure it is complete and consistent with the offer B) allocates job responsibility to an RPC and informs SEG accordingly

-Application/Order complete and consistent with the offer -Job responsibility allocated to RPC

- Workload of RPC - RPC skills

- -Customer order or application for certification (RICCER) filled in and signed by the customer and initialled by CU

5 OPENING OF JOB / SIGNING OF CONTRACT

-Application/ Order complete and consistent with the offer -Job responsibility allocated to RPC

SEG registers acceptance of the offer on CAI-C, enters the name of the RPC and prints the “Confirmation of acceptance” which is automatically generated by CAI-C. CU checks and signs the “Confirmation of acceptance”. SEG sends the “Confirmation of acceptance”.

-Stipulation of contract -QMS Documents request for review where applicable. For ISO/TS16949 in particular, despatch of TSVERDOC document to Organisation

“Field of application of QMS” entered in CAI-C in Italian and English by SEG. Field of application must be limited to automotive sector

-Contract opened on CAI-C and relative job opened on ASCESI -Allocation to an RPC -Preparation of Customer's job file for archiving documents

“Confirmation of acceptance” form printed from CAI-C and signed by CU Customer documents file

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STAGES INPUT1


OBJECTIVE2

CRITICAL FACTORS3


RECORDS 6 PLANNING /

PERFORMING PREAUDIT (ON REQUEST)

Preaudit application by Customer

RPC defines: A)audit times (man days) to agree with the Organisation B)make-up of the auditing team, bearing in mind that the members must be qualified as auditor or lead auditor or TEC and at least one member as lead auditor in the role of TL ("Report from NEWAGE for auditor qualifications"). The auditing team must include at least one person qualified in the specific reference automotive scheme. During the preaudit, the GVI checks that the Organisation' management system complies with the requirements of the reference standard for the specific activity applied for on the QI and on the application for certification.

Preaudit RVI (identified with the job number followed by /P) making observations on the conformity what it has audited and any other considerations

The preliminary audit results must not be considered for certification purposes. The preaudit must be performed in one visit and its duration must not exceed 80% of the initial audit days. The auditors must not belong to the auditing team which will perform the initial certification audit. No more than one preaudit may be performed for each production site involved in certification.

Completion of steps in ASCESI: -“Communication of preaudit date” fax - RVI preparation

-“Communication of preaudit date” fax -RVI printed from ASCESI or, if ASCESI is faulty, completed using the forms on FORMS signed by TL and countersigned by the customer (the original is kept by RINA while the photocopy is kept by the customer)

7 APPOINTMENT OF GVI

Contract between RINA and customer

RPC defines the members of the GVI and the team leader. The stage 1 audit must be performed by an auditor qualified for the specific reference automotive scheme. This auditor must participate in the stage 2 audit. RPC must inform the Organisation in advance of the names of the auditors appointed to carry out the stage 1 and stage 2 audits (the Organisation may reject the appointment). The stage 1 audit must be carried out at the customer’s premises. For the stage 2 audit: -all the team members must be qualified in the specific reference automotive scheme -the members of the team must be qualified as auditor,

lead auditor or TEC4 and one member must be qualified as lead auditor -in overall terms, the GVI must be qualified in the EA sector of the organisation subject to audit. The names of the members of the GVI for the on-site audit are communicated in writing to the Organisation together with the audit plan (certification audit)

- Appointment of technician to perform documents review - Appointment of GVI for the on-site audit

-GVI qualification in the specific automotive scheme for the on-site audit -GVI qualification in the specific EA sector for the on-site visit (stage 2 for ISOTS16949) The appointment of the GVI and RGVI must consider the specific competence and personal characteristics required for the type of Organisation. - Carefully check that the members of the GVI were not involved in delivering the consulting service for the organisation's QMS. -Check the admissibility of any reductions in audit times

-Appointment of GVI in ASCESI - Compilation of step in ASCESI: “Send communication of stage 1 audit date and plan

Print from ASCESI the communication relevant to the step: “Send communication of stage 1 audit date and plan

4 The TEC is not considered for the purpose of calculating man days

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STAGES INPUT1


OBJECTIVE2

CRITICAL FACTORS3


RECORDS 8 STAGE 1 AUDIT -QMS

documents sent by customer -Name of GVI appointed to perform the stage 1 audit

During the stage 1 audit, the appointed GVI checks that the documentation complies with the requirements of the reference automotive scheme and the RINA rules for the specific activity requested in the QI and the certification application. From an examination of the documents requested, customer status and understanding must be evident concerning the requirements of the standard with particular reference to the identification of key performance or of significant QMS aspects, processes, objectives and functioning. If the documentation is not compliant, the Organisation is requested to modify it before the stage 2 audit is performed. The outcome of the stage 1 audit must be notified to the Organisation. The documents must be approved before the stage 2 audit is performed. A checklist may be used to review the manual. For the ISOTS16949:2000 scheme, the documents must be checked for suitability using the relative TSVERDOC checklist as reference. The stage 1 audit report is to be filled in for all automotive schemes. For the ISOTS16949 scheme the stage 1 audit must be directly verified at the customer's site.

-Compliant documents -Communication to customer

ISOTS16949. -Checking that the reasons for exclusions are adequate. The organisation may exclude product design and therefore only requirements 7.3.2.1 and 7.3.3.1. 7.3 is always applicable to process design. -Checking that the documents requested are adequate - The QMS must have been operative for at least 3 months when the audit is performed (12 months for the ISOTS16949 schemes) - Check the management process of ISOTS 16949 customer specific requirements

Completion of step in ASCESI "Stage 1 audit " -Completion of step “stage 1 audit: verification of TS initial adequacy with positive results” for ISOTS16949 only

-Print stage 1 audit report from ASCESI -The manual and additional documents for ISOTS16949 must be kept for the entire certification process and presented to the Technical committee -Communication “Stage 1 audit: verification of TS initial adequacy with positive results” for ISOTS16949 only

9 PREPARATION AND DESPATCH OF STAGE 2 AUDIT PLAN

Stage 1 audit report

RPC and/or TL performs the following activities (at least 3 days before the audit date): A) verifies audit times (man days) according to the requirements shown in attachments to this document B) agrees on the audit date with the customer C) defines the processes and remote sites to audit D) prepares and sends the audit plan to the customer on the basis of the above elements

Audit plan sent to customer

-The QMS must be operative at least 3 months before the audit (12 months for ISOTS16949 schemes) -The third production shift, if present, must always be audited Production/ service provision processes are audited by the GVI member who is qualified in the relative EA sector - Not more than three months must elapse between approval of the stage 1 audit and the date of the stage 2 audit -An audit day is intended as comprising at least 8 hours, journey times excluded

-Completion of steps in ASCESI: -Audit plan -Despatch of audit plan

Print documents from ASCESI: -Audit plan -Despatch of audit plan

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STAGES INPUT1


OBJECTIVE2

CRITICAL FACTORS3


RECORDS 10

STAGE 2 AUDIT -Audit plan -Compliant documents -Stage 1 audit

The GVI checks that the customer's QMS complies with the requirements of the specific reference automotive scheme and the RINA Rules for the specific activity applied for on the QI and on the application for certification. For audit methods, refer to the specific annexes to this document divided by automotive scheme. The GVI must note any finding and conclusions on the audit report. RGVI signs the RVI. The RVI must be countersigned by the customer’s person responsible. A copy of the RVI must be given to the customer. Checklists can be used for the stage 2 audits and the forms for recording observations must be compiled.

Stage 2 audit report countersigned by customer

See specific annexes divided by automotive scheme. No non-conformities may be open when proposing the organisation for certification. If any non-conformities are found, a supplementary audit or documents review must be performed.

Completion of steps in ASCESI for the audit and RVI: “Stage 2 audit”

-RVI printed from ASCESI signed by the team leader and countersigned by the customer (the original is kept by RINA and the photocopy goes to the customer) -Specific checklist for automotive scheme, if compiled or equivalent document -Observation forms compiled by GVI (Form QUASQA08V available in FORMS or specific observation forms for ISOTS16949)

11

CONTROL AND CONFIRMATION OF RVI

RVI countersigned by customer

A RINA auditor qualified in the specific automotive scheme checks and initials the report. This responsibility can be transferred to auditors qualified in at least one of the automotive schemes mentioned in this document. RPC confirms the contents of the report in writing. After three working days have elapsed from the date the audit finished, the customer may consider the contents of the RVI as confirmed. If RINA decides to make variations to the RVI issued by RGVI to the Organisation, such as a change in the classification of a finding or the need for an audit before the planned date, the Organisation must be informed accordingly.

RVI controlled and confirmed with Customer

No non-conformities may be present when proposing the organisation for certification

Completion of any steps in ASCESI confirming the contents of the RVI

-RVI initialled -Contents of RVI confirmed (if necessary)

12

ACCEPTANCE OF CA PROPOSALS

Treatment, analysis of causes, CA proposals and implementation times

RPC (if qualified for the relative automotive scheme) or the team leader checks that the corrective action and implementation times proposed by the customer are sufficient. If the outcome of the control is positive, RPC confirms this acceptance in writing. This activity may also be done through the software programme ASCESI


CA and failure to eliminate NCs

Stage 2 report updated in ASCESI

-NC forms initialled by RGVI or RPC If proposal and acceptance of CA are made through ASCESI, paper copy not necessary

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STAGES INPUT1


OBJECTIVE2

CRITICAL FACTORS3


RECORDS 13

PLANNING AND PERFORMING SUPPLEMENTARY AUDIT OR DOCUMENT REVIEW OF CORRECTIVE ACTION TAKEN BY THE ORGANISATION

-RVI (QMS NON-CONFORMING) CA proposals and implementation times accepted

RPC or TL defines: A) audit date (in agreement with the customer) B) members of GVI: the team must include at least one member of the GVI that performed the certification audit, chosen according to the type of findings and qualified for the specific reference automotive scheme and as lead auditor. The extent of the supplementary audit and, consequently, the audit times (man days) are assessed by RPC on a case-by-case basis depending on the number and type of NCs discovered. The supplementary audit may be replaced by a document review of the elimination of the non-conformities found during the certification audit (the document review may be performed at RINA offices)

-RVI countersigned by customer (identified by the job number followed by /S)

Members of GVI according to NC -The supplementary audit must be performed within 3 months of the stage 2 audit -If the NCs are not eliminated within three months, the certification procedure must be started from the beginning - No non-conformities may be present when proposing the organisation for certification

Completion of steps in ASCESI: - Communication of need for supplementary audit - Supplementary audit

-RVI (identified by the job number followed by /S) printed from ASCESI or, if ASCESI is faulty, completed using the forms in FORMS signed by RGVI and countersigned by the customer -Findings forms of the previous RVI with evidence that NCs have been eliminated

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CERTIFICATION PROPOSAL

-RVI (QMS COMPLIANT) -Successfully implemented corrective actions

TL or RPC prepares the PVP. RPC checks the file is complete and prepares and signs the “Certification proposal and procedure” document that may also be used to enter justifications for modifications to audit times and clarifications for future use. RPC, assisted by SEG, prepares the file for the Certification committee (CTQ): Certification proposal and procedures, Informative questionnaire, certification request, quality manual extract and for ISO/TS16949 additional documents requested (see attachment 1 to this instruction), proof of stage 1 audit approval, audit plan, audit report, audit check-list, PVP.

The date of the first periodic audit following the stage 2 audit corresponds to the date proposed by the GVI on the last page of the certification RVI. This will be subsequently accepted by CTQ. In all cases, the PVP must involve at least one audit every 12 months, on the basis of a programme which ensures that all the points of the reference standard and every process are audited at least once during the three years of validity of the Certificate. Consult the attachments for the duties of the CTQ relative to the automotive schemes.

-Certification proposal and procedure -PVP -For ISOTS16949 complete file for CISQ AUTOMOTIVE committee

Completeness of documents

-Completion of “periodic audit plan" step in ASCESI -Complete "Certification proposal and procedure" icon

Print from ASCESI: -PVP -Certification proposal and procedure

15

VERIFICATION, APPROVAL OF PROPOSAL AND

-RVI (+ supplementary audit report,

The RINA CTQ checks and approves the certification proposal. See specific annexes divided by automotive scheme and IS-SCC-CER-01.

- Certified customer (Assigned certificate number)

-Certify operation -The competence of the person reviewing the job

-Certificate number allocated through ASCESI (CERTIFY) -Outcome of control of jobs

-Certification proposal and procedure signed for approval by the

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STAGES INPUT1


OBJECTIVE2

CRITICAL FACTORS3


RECORDS ISSUE OF CERTIFICATE N°

where applicable) -Certification proposal and procedure -PVP -Specific documents required by the scheme

The ISO/TS16949 files are all checked during CISQ AUTOMOTIVE Technical Committee meetings by an external veto power appointed by ANFIA. In the event of a negative outcome, it may be necessary to perform an additional supplementary audit or ask the Organisation for additional information before issuing the certificate. If CTQ/CISQ AUTOMOTIVE committee decides to make variations to the RVI issued by RGVI to the Organisation, such as a change in the classification of a finding or the need for an audit before the planned date, the Organisation must be informed accordingly.

- Communication to customer that certificate has been issued (SEG)

and the independence of the auditors and the person checking the report and/or approving the certification proposal must always be ensured.

registered on the checklists available in ASCESI (for automotive schemes only indicate whether certifiable or uncertifiable)

president of CTQ. -Communication of certification/validation(printed from ASCESI) -CTQ report -For ISOTS16949, checklist drawn up by Veto Power

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SIGNING THE CERTIFICATE

Certificate printed

The Scheme Manager checks the text of the certificate. Following the successful outcome of this control, the DCI manager electronically signs the certificate. ISO/TS16949 certificates must also be signed by the CISQ AUTOMOTIVE chairman

Certificate signed - Typing errors - English translation - Correspondence with EA activity -Presence of remote sites -Corporate Certificates -Purpose of certification limited to the automotive sector -For ISOTS16949, IATF logo and in CISQ AUTO layout

-Electronic signature via ASCESI (SIGN) -Print out from ASCESI (PRINT from CERTIFY PROCESS)

-Communication to offices that certificate can be printed (e-mail)

17

PUBLICATION OF CERTIFICATE

Certificate signed

If the payment conditions have been met, ASCESI makes the customer’s certificate automatically available in the “Member Area” and a copy on the RINA internet site for the public. SEG prints from ASCESI the “certificate/validation and PVP publication in the Member Area communication” and sends it to the customer. If requested by the customer, SEG prints and sends the CISQ and IQNet certificates to the customer. Process closed.

-Certificates -PVP -Certification logos -The certificate of conformity and the PVP are made available to the customer via the “Member Area” reserved for him/her on the RINA portal. -A copy of the certificate is available to the public on the RINA site

ISO/TS16949: the certificates must be printed on a special CISQ AUTOMOTIVE support

-Publication of certificates on RINA internet site and “Member Area” for customers Completion in ASCESI of: “certificate/validation and PVP publication in the Member Area communication”

-Letter of accompaniment of certificate (print from ASCESI) -Copy of certificates in Member Area and RINA internet site (ISOTS16949 to be sent to the CISQ AUTOMOTIVE secretarial department)

18

CHECKING DOCUMENTS FOR COMPLETENESS/ END OF PROCESS

Job documents Documentation checked for completeness and completed if necessary (according to QUASQA2). Check that all the steps in ASCESI have been completed (Completed). Process closed.

Process closed - Check that all the steps in ASCESI have been completed (Completed). Process closed.

RECERTIFICATION NOTES:

The phases in table 1 also apply to the recertification process, taking into account the following differences:

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PHASE 1: in the case of contracts without expiry date, the Office Manager, upon receiving the IQ during the recertification activity, checks for the existence of any changes that may entail a contract change; if the contract must be modified, a new offer must be prepared, otherwise the current contract remains valid; PHASES 2, 3, 4, 5: applicable only if, during PHASE 1, the Office Manager, while checking the IQ, deems it necessary to revise the current contract

PHASE 8: it is not mandatory to split the audit into stage 1+ stage2; it may be necessary in the case of significant changes PHASE 9: the reference document in ASCESI is DESPATCH RECERTIFICATION AUDIT PLAN PHASE 10: among the input documents, include the audit reports for the previous three years; the relevant step in ASCESI is RECERTIFICATION AUDIT PHASE 15: the entire recertification process, including any additional audits, must be completed prior to expiry date of the certificate.

Table 2 - DESCRIPTION OF THE MAIN STAGES OF THE SUR VEILLANCE PROCESS

STAGES INPUT COMPANY BUSINESS OUTPUT/ OBJECTIVE

CRITICAL FACTORS ELECTRONIC RECORDS HARDCOPY RECORDS

1 OPENING OF UPCOMING SURVEILLANCE AUDIT PROCESS

PVP

RPC opens the upcoming process in ASCESI. Audits must be performed within the month indicated on PVP. On receipt of a justified written request by the organisation, RPC (following approval by the scheme manager) may postpone periodic surveillance audits by no more than three months. Justified reasons means: - lack of orders, - staff layoffs, - large-scale organisational changes - integrated audit Certification is suspended upon expiry of the extension.

Process opened Respect of PVP deadlines. A postponed audit does not affect the dates of the subsequent visits.

Process opened via ASCESI -

2 PVP REVIEW -PVP -Previous audit documents

When preparing each audit, RPC, together with TL, decides whether or not to update the PVP as a result of any problems that may have emerged during previous audits.

PVP checked by RPC/TL

- - -

3 APPOINTMENT OF GVI AND COMMUNICATION OF AUDIT DATE

Customer contacts RPC or vice-versa

RPC assigns the audit team in relation to TABLE 1 – PHASE 7. TL or RPC performs the following activities: A) checks audit times (man days) on PVP B) agrees the audit date with the customer C) defines the sites to audit according to the PVP D) prepares and sends to the customer, together with the TL, the communication “Despatch surveillance audit plan” and “Audit plan” (the Organisation may reject the GVI if it so desires).

-PVI: Audit plan -Send surveillance audit plan

Remote design sites must be audited every time SEE TABLE 1 – PHASE 7

Compilation of steps in ASCESI: -PVI: Audit plan -Send surveillance audit plan

Print from ASCESI : -PVI: Audit plan -Despatch of surveillance audit plan

4 SURVEILLANCE AUDIT

-PVP -PVI: Audit plan -Despatch of surveillance audit plan -RVI of previous

The GVI checks that the customer's Management System complies with the requirements of the reference automotive scheme and the RINA Rules for the specific certified activity. For audit methods, refer to the specific annexes divided by automotive scheme.

RVI of surveillance audit countersigned by customer

In the event of major non-conformities, a supplementary audit must be made on the site within three months from the audit date.

Completion of step: “Periodic audit” in ASCESI

SEE STAGE 10 IN TABLE 1

Implementation of containment action and definition of a corrective action plan

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audit

All open non-conformities must be eliminated before the process can be successfully terminated.

In the event of minor non-conformities, at least one document review of the containment action implemented by the organisation and of the corrective action plan defined by the company must be performed in order to make such action effective and prevent repetitions of non-conformities (within two months of the audit date)

is verified by sending the organisation the “AUTO: CA implementation approval fax”

5 CONTROL AND CONFIRMATION OF RVI

Surveillance audit report countersigned by the customer

SEE STAGE 11 IN TABLE 1 SEE STAGE 11 IN TABLE 1




6 ACCEPTANCE OF CORRECTIVE ACTION PROPOSALS ACCEPTED (IF NCs ARE PRESENT) OR COMMUNICATION OF POSITIVE OUTCOME OF AUDIT


RPC (if qualified for the scheme) or TL checks that the corrective action and implementation times proposed by the customer are sufficient. If the outcome of the control is positive, RPC confirms this acceptance in writing. If no NCs have been found the Communication of Positive Outcome may be sent immediately. This activity may be done through the software programme ASCESI

Treatment, analysis of causes, CA proposals and implementation times accepted

If the Organisation does not send its CA proposals within the agreed date, after 10 days have elapsed from that date, the RPC will send a written reminder to the Organisation informing it that if the proposals are not sent within a further 5 working days, the RPC will send a suspension proposal to the CTQ (IS-SCC-CER-01).

Completion of step in ASCESI -”AUTO: CA proposal approval” or -”Communication of positive outcome” (if no NCs have been found)

-Non-conformity forms signed by RGVI or RPC -Printout of documents from ASCESI

7 APPROVAL OF IMPLEMENTATION OF CORRECTIVE ACTION

Documents proving elimination of minor NCs sent by the Customer

RPC (if qualified for the scheme) or RGVI controls the adequacy of the corrective action performed in order to eliminate minor non-conformities found during the audit. If the outcome of the control is positive, RPC or RGVI confirms this acceptance in writing.

-Acceptance of implemented CA

Evidence consistent with that proposed by the Organisation and with that indicated by the NC evaluation team

Completion of step in ASCESI -AUTO: Approval of CA implementation fax

-AUTO: Approval of corrective action implementation fax

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8 PLANNING AND PERFORMING SUPPLEMENTARY AUDITS


SEE STAGE 13 IN TABLE 1. If a supplementary audit on a certified customer is unsuccessful, the certificate must be suspended (see specific annexes for Automotive Scheme).




SEE STAGE 13 IN TABLE 1 In the event of a supplementary audit during a periodic audit and successful outcome, communication to the Organisation printed from ASCESI

9 SUSPENSION PROPOSAL/APPROVAL OF PROPOSAL

-Supplementary RVI (NON-CONFORMING QMS)

Following approval by the scheme manager, RPC prepares the suspension proposal and sends it to CTQ, specifying the reason. CTQ defines a deadline for the suspension period (see IS-SCC-CER-01) and for ISO/TS16949 Accreditation rules

Certificate suspended Reason for suspension request

Suspension operation certified via ASCESI

Suspension proposal signed by RPC and the CTQ chairman.

10

CHECKING DOCUMENTS FOR COMPLETENESS / TERMINATION OF PROCESS

Job documents Documentation checked for completeness and completed if necessary (according to QUASQA2). Check that all the steps in ASCESI have been completed (Completed). Process closed.

Process closed - Check that all the steps in ASCESI have been completed (Completed). Process closed.

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5. INVOICING

Depending on the contract, invoices are issued at various stages of the certification process by the Administrative secretary of the office, using the CAI-C software application.

6. AMENDMENTS TO CERTIFICATION

Customers requiring a modification of certification (for example, modification of the subject of certification, extension to another site, changing the operative headquarters, etc…) must compile all parts of the informative questionnaire and send it to RINA. The RPC will assess the situation on a case-by-case basis.

The RPC must treat this request as an extension of certification.

In the event of significant changes to the quality management system can 'be decided to carry out a Stage 1 audit on site.

The certificate must always be reissued.

7. PROCESS MEASUREMENT

The certification process is economically, operatively and technically controlled by the various operative units, as indicated in the organisational instructions (the Automotive Schemes are considered as an integral part of the Quality sector).

The management and technical aspects of processes are monitored by the IPR Manager who defines performance indicators for pertinent levels and functions, in collaboration with the Scheme Manager (e.g.: a performance indicator for RPCs in respect of the deadlines defined in the audit programme).

The economic aspects of processes are measured by the COD manager who checks turnover, costs, the services rendered by the Operative Network and budget variations.

8. PRESERVATION OF RECORDS

The hard-copy and electronic records relative to certified Organisations are kept by the operative offices as follows:

- for audit jobs, the records of the activities performed both in the current three-year period and in the previous one must be preserved

- the QMS manual must be kept for the time required for its review until the certificate is issued

- copies of issued certificates must be kept indefinitely

CTQ meeting minutes are kept for at least 10 years.

Auditor qualification documents are kept for at least 3 years from the date the auditor ceased providing services on behalf of DCI.

9. ATTACHMENTS

� Attachment 1 to IS-QMA-AUT-01 – ISO/TS 16949 – SPECIFIC REQUIREMENTS

� Attachment 2 to IS-QMA-AUT-01 – AVSQ-MIA AND TE SUPPLEMENT – SPECIFIC REQUIREMENTS

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ATTACHMENT 1 - ISO/TS 16949 – SPECIFIC REQUIREMENTS

1. SCOPE

This attachment illustrates the specific requirements for certifying Quality Management Systems according to ISO/TS16949. For any specific requirements not mentioned in this document, refer to ANFIA AQ-020 rules or corresponding IATF rules

Certification according to ISO/TS 16949 Technical Specification can be applied to all organisations working in the car sector which supply:

• Production materials

• Production components or spare parts

• Heat treatments, galvanic treatments, painting or other surface treatments

• Other specific customer products

The sites for which the Organisations request certification must show they are able to adapt to all the requirements of ISO/TS 16949.

Any remote locations (warehouses, buying offices, design departments, etc.) are an integral part of the site under audit; these may never obtain ISO/TS 16949 certification independently.

The certification process must be extended to all the elements of the organisation’s Quality System in order to satisfy the requirements of customers in the car sector, also where such elements go beyond the requirements indicated in the ISO/TS 16949 technical specification.

For ISO/TS16949 only requirement 7.3 referring to product design can be excluded. This requirement is applicable to process design.

The certificate may only be issued if the system has been applied for at least 12 months, otherwise, if the organisation shows it complies with the requirements of ISO/TS16949, a substitutive declaration, valid for a year, may be issued.

2. AUDIT PLANNING

The number of work days required to perform audits on Organisations for this specific Scheme are defined in the following table.

The following special instructions apply to the above table:

• The number of work days indicated in the above table should be considered as minimum times. When calculating man days, the result must always be rounded up to the half day above.

• A full-time working day of eight hours is considered as an audit day. The number of audit days may not be reduced by calculating a higher number of hours per working day, unless more than one production shift is planned.

• The times indicated in the table can only be reduced if third party QS9000 or VDA 6.1 certification is updated/converted or if the “corporate” scheme is adopted. The methods used to reduce the times indicated in the table are shown in paragraphs 2.1 and 2.2.

• The above times do not include the assessment on Quality Management System documents (Stage 1) and any pre-audits.

• For stage 1, 1 or 2 days can be used per production sites depending on the complexity of the company.

• To calculate the times, employees working at non-productive remote sites must be added to those operating on the production site.

• This table applies to ISO/TS 16949 together with ISO 9001; if requirement 7.3 concerning project design is excluded, the above times may be reduced by 15%.

• Surveillance visits must be performed within 12 months from the previous visit according to the agreements made with the organisation.

• If an organisation has more than one production site, all the sites must be audited at least once every 12 months. Remote locations must be audited at least once every 12 months only if design activities are carried out there.

• The time required to perform a supplementary audit following the implementation of corrective action by the organisation must be added to the work days indicated in the table. Supplementary visits must be made by an auditing team comprising at least one member of the team that performed the previous visit.

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• Audits must be performed on all work shifts. If there are fixed work teams at weekends, an audit must also be performed on these work shifts.

• If a translator is used, audit days must be increased by 20%.

• The Scheme includes certification renewal and therefore ISO/TS 16949 certification is validated every three years and connected with that issued by RINA according to the applicable ISO 9000 standard.

Man day table for certification / surveillance / recertification audits

N° of employees

Audit visit (Work days

on site)

Surveillance visits (Work days on site for every 12 month

period)

Surveillance visits

(Work days on site for every 6 month period)

N° of employees

Recertification audit (Man days

on site)

1 – 6 2 1 0.5 1 - 14 2 7 – 11 2.5 1.5 0.5 15 - 28 2.5

12 – 18 3 1.5 1 29 - 49 3 19 – 27 3.5 2 1 50 - 80 3.5 28 – 39 4 2 1 81 -122 4 40 – 54 4.5 2.5 1 123 – 176 4.5 55 – 71 5 2.5 1 177 – 246 5 72 – 93 5.5 3 1.5 247 – 332 5.5 94 – 117 6 3 1.5 333 – 436 6

118 – 146 6.5 3.5 1.5 437 – 562 6.5 147 – 179 7 3.5 1.5 563 – 710 7 180 – 216 7.5 4 1.5 711 – 883 7.5 217 – 257 8 4 2 884 – 1082 8 258 – 304 8.5 4.5 2 1083 – 1310 8.5 305 – 348 9 4.5 2 1311 – 1569 9 349 – 422 9.5 5 2 1570 – 1860 9.5 423 – 507 10 5 2 1861 – 2187 10 508 – 602 10.5 5.5 2.5 2188 – 2551 10.5 603 – 711 11 5.5 2.5 2552 – 2953 11 712 – 832 11.5 6 2.5 2954 – 3398 11.5 833 – 968 12 6 2.5 3399 – 3886 12 969 – 1119 12.5 6.5 2.5 3887 – 4419 12.5

1120 – 1286 13 6.5 3 4420 – 5001 13 1287 - 1470 13.5 7 3 5002 – 5632 13.5 1471 – 1673 14 7 3 5633 – 6317 14 1674 – 1895 14.5 7.5 3 6318 – 7057 15.5 1896 – 2138 15 7.5 3 > 7058 15 2139 – 2402 15.5 8 3.5 2403 – 2688 16 8 3.5 2689 – 2999 16.5 8.5 3.5 3000 – 3334 17 8.5 3.5 3335 – 3695 17.5 9 3.5 3696 – 4084 18 9 4 4085 – 4502 18.5 9.5 4 4503 – 4949 19 9.5 4 4950 – 5427 19.5 10 4 5428 – 5937 20 10 4 5938 – 6482 20.5 10.5 4.5 6483 – 7061 21 10.5 4.5 7062 – 7676 21.5 11 4.5

> 7677 22 11 4.5

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2.1 UPDATING A VALID AUTOMOTIVE CERTIFICATE

The certification scheme allows the time required for the initial audit to be reduced if a QS9000 and/or VDA 6.1 certificate, issued by an IATF-recognised certification body, is updated.

The following reduction methods may only be implemented if the automotive certificate possessed by the organisation during updating to ISO/TS 16949 was issued by RINA, bearing in mind the following points:

• If the purpose of certification has changed, time reductions cannot be applied. In this case, all the requirements of ISO/TS 16949 must be audited.

• For certification to ISO/TS16949 and if the purpose of certification remains unchanged a reduction may be applied as indicated in the following table. The audit must, however, completely include all the additional requirements of ISO/TS16949 and the special requirements of the customer and assess the remaining requirements on a random basis.

QS9000 / VDA 6.1

ISO 9001 CERTIFICATION UPDATE

AUDIT TIMES

YES MAXIMUM REDUCTION OF 30%

YES RENEWAL AUDIT

YES YES MAXIMUM REDUCTION OF 50%

2.2 CORPORATE / MULTI-SITE SCHEME

The certification scheme allows site audit times to be reduced in the event that a multi-site organisation requires a single certificate (“Corporate” audit scheme). Times are reduced as follows:

• Each site of the Organisation must be audited;

• The number of man days for auditing each site must be calculated by reducing the times indicated in the tables in point 2. The reduction percentages are indicated in the following table:

Number of sites Reduction percentage

2-9 20

10-19 30

20 or more 40

These reductions are also applicable to surveillance and renewal visits.

In order to issue a “Corporate” certificate to an Organisation the following conditions must be present:

• The Quality System must be structured and managed centrally and must be subjected to internal audits on all the sites covering all the requirements of ISO/TS 16949

• The activities that can be managed centrally are:

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• Contract review • Supplier management • Quality System documents management • Management review • Management of corrective and preventive action, continuous improvement activities • Audit planning and assessment of results • Design activities • Training management

Certain aspects of the above activities can be handled locally.

In the event of more than one organisation under the control of a holding, but with different company names, CRT must be consulted before the activities are planned, who will involve IATF in the decision-making process if necessary.

3. STAGE 1 AUDIT (STAGE 1 – READNESS REVIEW)

The stage 1 audit (STAGE 1 – Readness review) must be performed on-site before the stage 2 audit. In special cases, the stage 1 audit may be performed at the same time as the stage 2 audit (though this is not recommended).

During the stage 1 audit the following pieces of information/documents must be checked in order to verify whether the requirements necessary to start the certification process exist:

• Quality Manual in compliance with ISO/TS 16949 requirements (the “ISO/TS 16949 – ANFIA Checklist” can be used as a reference)

• Informative questionnaire together with the description of the product/service supplied and of the company processes (e.g.: list of remote sites, sites to certify, type of products per site and per customer, responsibility for product design, etc.)

• Description of the Organisation's processes, including the sequence and interactions

• Description of the management process of the ISO/TS 16949 customer specific requirements

• Management performance in the last 12 months. As a minimum indicators relative to the following must be presented:

• customer satisfaction and customer claims management; • staff motivation and awareness; • product realisation processes • supplier performance

• Planning and results of audits and management reviews over the last 12 months of activity

• Qualifications of internal auditors

• List of customers and of any specific requirements

The above documents must be checked (Compilation of the documents review form, TSVERDOC) and approved before performing the stage 2 audit.

The stage 1 report is to be filled in and left with the Organisation.

The outcome of the document review must be notified, by means of a specific communication, to the Organisation in writing by RINA.

In the event of a positive outcome, proceed with Stage 2.

In the event of a negative outcome, the certification procedure is suspended and the organisation must resubmit its application for certification.

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4. PREPARING AN AUDIT

4.1 AUDITING TEAM

The auditors appointed to perform audits according to the ISO/TS 16949 Certification Scheme must satisfy the following requirements:

• qualification as auditor or lead auditor, as indicated in IS-CRT-AUD-00;

• they must be qualified according to the IATF qualification procedures; this consists in attending and successfully concluding the IATF-recognised ISO/TS 16949 qualification course;

• at least one auditor in the auditing team must be qualified in the EA sector to which the organisation belongs;

• at least one auditor in the auditing team must participate in all the visits made in a three year cycle;

• if the visit lasts more than 5 work days the team must comprise at least two auditors.

An ANFIA representative may be included in the auditing team as an observer, subject to the approval of the Organisation under audit (the organisation may not prevent this observer from participating).

4.2 AUDIT PLAN

An audit plan, prepared on ASCESI and including all the supplementary elements required by the reference standard document, must be sent to the organisation.

In particular, specific customer requirements must be audited.

The stage 2 audit must be performed within three months from the date of approval of the stage 1 audit.

5. PERFORMING THE STAGE 2 AUDIT

5.1 AUDIT

The audit is performed using the documents QUASQA08TS1 and QUASQA08TS2

As well as auditing the subjects contained in the reference standard documents, registrations of customer complaints and the replies of the organisation are also examined, together with the actions taken and their outcomes, following the internal audits and management review.

Additionally, the progress of continual improvement objectives and the implementation of all the specific customer requirements are also assessed (In the audit report all the customer specific requirements checked shall be clearely stated)

In particular for ISO/TS16949, the auditing team must check the admissibility of the exclusion of requirement 7.3 concerning product design. All the requirements are applicable, in fact (7.3 applicable to process design).

The consultant of the organisation may not be present during the audit.

6. CRITERIA USED TO APPLY THE SCHEME

6.1 FINDINGS

Quality Management System findings according to the ISO/TS 16949 scheme are classified as follows:

6.1.1 A-TYPE FINDINGS (MAJOR NON-CONFORMITIES)

• The absence or total inadequacy of the Quality System to satisfy an ISO/TS 16949 requirement. A certain number of minor non-conformities concerning a single requirement may point to the total inadequacy of the System and therefore be considered as a major non-conformity.

• Any failure that may lead to the delivery of non-conforming products. A situation that may determine the failure or limited use of the product/service for its original purpose.

• A non-observance, which in the Auditing team’s opinion and experience, is likely to cause a failure in the Quality System or materially reduce its ability to assure controlled processes or products.

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• Non-compliance with one or more points requirements of the RINA rules for the certification of Quality Systems and the Appendix to the rules for the certification of Quality Systems - Certification schemes for the automotive sector.

6.1.2 B-TYPE FINDINGS (MINOR NON-CONFORMITIES)

• An ISO/TS 16949 non-conformity which, in the Auditing team’s opinion and experience, is not likely to cause a failure in the Quality System or reduce its ability to assure controlled processes or products or lead to the delivery of non-conforming product. It may be:

− a failure of the System Quality management documentation to satisfy an ISO/TS 16949 requirement;

− a single slight failure observed regarding a requirement of the company Quality Management System.

6.1.3 RECOMMENDATIONS

• Findings or observations that, in the Auditing team’s opinion and experience, provide an opportunity for improvement. The auditors will ascertain whether the Organisation has implemented the recommendations or not and will include their findings on the subsequent audit report.

6.2 AUDITING A QUALITY SYSTEM

A Quality management system is audited positively when no major or minor non-conformities (“A” or “B” types) are found during the audit.

If at least one major and/or minor non-conformity is found, a supplementary audit must be performed within three months in order to check that the proposed corrective action has been applied correctly and effectively; if this audit is successful the certification process is renewed.

In particular, certification may be issued if all the non-conformities are eliminated. This means:

− Limiting the condition for preventing risks to the Customer

− Documentary evidence (action plan, instructions, records) demonstrating the elimination of the non-conformities, including allocated responsibilities or checking during subsequent audits

The above deadlines may never be extended more than three months from the certification audit.

If the agreed deadline is not respected, the audit must be repeated on the whole Quality Management System. If the non-conformity is not closed within the agreed time, the audit will be considered as “failed” and the whole of the Quality Management System will have to be audited again.

6.3 AUDIT DOCUMENTS

The reports must be written with ASCESI. In the event of Internet faults, the report may be written on paper, using the ISO 9001 series of forms.

The following information must always be indicated on the report:

− Work shifts checked

− Specific customer requirements considered and verified during the audit, indicating the revision index (During the stage 2, all the customer specific requirements shall be checked)

− Purpose of certification, products and sites involved in certification

− Indication of the processes subject to audit

− List of OEM IATF supplier codes (if existing)

7. CERTIFICATION

At the end of the auditing stage in the certification procedure, and in the event of a positive judgement by the Auditing Team, the Job Manager, assisted by the technical secretary’s office, prepares the following documentation to present to the Quality Technical Committee:

• Stage 2 audit report (plus supplementary audit report, where applicable)

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• Certification proposal and procedure signed by RPC or deputy

• PVP

• Audit Plan

• Extract of Quality Manual including: justification of exclusions, description of processes

• Additional documents for ISO/TS16949 collected from the company by the auditing team (Management Review, previous year's audit programme, internal auditor qualifications, list of customers in the automotive sector, list of customer complaints, process identification scheme and correlation with company performance indicators, last 12 months of company performance indicators). For foreign companies with non English/Italian documentation, it is sufficient to have a translation into English of the process scheme, the list of automotive customers and related specific requirements and a table summarising company performance indicators over the last 12 months

• Approval of stage 1 audit results communication, stage 1 audit report and TSVERDOC checklist

• Audit observation sheets and checklists (if compiled)

• Informative questionnaire

• Certification application

• Contract review form

The certification proposal must be presented for approval to the CISQ AUTOMOTIVE Quality Technical Committee, of which IATF is a veto-holding member. The RINA scheme manager (also a member of RINA CTQ) for the automotive sector participates in the CISQ AUTOMOTIVE committee.

The veto power deliberates on the certification. The outcome of the deliberation is indicated in a special checklist archived by RINA.

The date of the deliberation is considered as the date of issue and signature of the certificate.

However, the certification job is also approved by the Quality Technical Committee of RINA after the CISQ AUTOMOTIVE committee which issued the deliberation (the certificates will be indicated on the RINA CTQ report). The RINA CTQ does not review the job, but takes note of the decisions of the Veto Power. If the Veto Power requires any clarifications or modifications to be made to the documentation, the scheme manager informs the RPC and the Team leader who contact the organisation if necessary.

A special certificate must be used for the certificate of conformity. This contains the IATF logo together with that of CISQ AUTOMOTIVE, a consortium of which RINA is a member.

ISO/TS 16949 is valid for three years starting from the date of the CISQ AUTOMOTIVE technical committee.

If during the audit, the organisation does not demonstrate it has applied the management system for at least 12 months, the certificate may be not be issued. A declaration of conformity may be issued according to IATF/ANFIA rules. This declaration of conformity may be converted into a certificate following a new certification audit (stage 1 not necessary) using up to 50% less man days.

As regards Organisations that have already been certified for conformity with ISO 9001 standards, the ISO 9001 certificate must be reissued at the same time.

The fact that the certificate only covers products for the automotive sector must be clearly specified on the purpose of the certificate.

8. SURVEILLANCE AUDITS

Surveillance audits on the Quality Management Systems certified to ISO/TS 16949 must be performed at intervals not greater than 12 months according to the agreements made with the organisations in question on a case-by-case basis.

As regards Organisations with more than one production site, a surveillance audit must be performed on each single site at least once every 12 months.

Each surveillance audit must examine all the production shifts.

Audits are performed according to a programme that is sent to the Organisation together with the certificate (during a new audit or renewal).

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The dates for performing the surveillance audits must be communicated to IATF not later than 15 days from the date of the visit.

The time criteria indicated in the previous point 2 are followed when planning periodic audits.

The criteria established in this instruction are valid for the management of surveillance audits.

As well as the contents of the above instruction, each periodic maintenance audit must include:

• Implementation of the specific requirements of new customers from the last visit and, in all cases, random analysis of those active at the moment of the audit (all the specific customer requirements in the three-year period must be covered). The customer specific requirements checked shall be stated on the audit report.

• Supplier development programme (Requirement: 7.4.1.2)

If, during the validity of the certificate, the organisation receives notifications from subscriber customers to the scheme, such as CHRYSLER - Needs Improvement Status, FORD - Q1 Revocation status, GM New Business Hold and CSLII, FIAT New Business Hold and CSLII/III, the organisation must inform RINA within five days.

In the event of CHRYSLER - Needs Improvement Status, FORD - Q1 Revocation status, GM New Business Hold and/or CSLI/CLSII, FIAT New Business Hold and/or CSLI/CLSII/CSLIII or other specific requirements, RINA must work according to the reference IATF rules and valid specific customer requirements.

In particular, in the case of:

- CSLI, RINA must verify during the surveillance audit how the Organisation has dealt with the notification and if pertinent, assign a non conformity if inadequately dealt with;

- CSLII/CSLIII: having received a communication from the Organisation, RINA must request documentary evidence of the actions implemented by the Organisation or carry out a supplementary verification audit and assign a major non conformity (type A)

If any non-conformities are found during the surveillance audits, RINA will evaluate the management of these non-conformities as follows:

• If major non-conformities (TYPE A) are found, the Organisation will be subjected to a supplementary audit within the deadline established by RINA, depending on the importance of the non-conformities, but always within three months from the surveillance audit.

• If minor non-conformities are found (TYPE B), the organisation may be subjected to a supplementary audit at the auditor’s discretion and within the deadline established by RINA. The Organisation must show RINA it has effectively implemented the action required to close non-conformities by sending written evidence of the action taken within 60 days from notification of the non-conformities.

The audit report must be checked by staff qualified to ISO/TS16949 or by the Veto Power.

9. SUSPENSION, RELINQUISHMENT AND/OR WITHDRAWAL OF CERTIFICATION

The criteria established in instruction IS-SCC-CER-01 and in annex 4 to the ANFIA document “ISO/TS16949 certification scheme rules for certification bodies” (AQ020) remain valid for the suspension, relinquishment and/or withdrawal of certificates.

In particular, the validity of the certificate must be immediately suspended if one of the following cases is found during the periodic surveillance visits:

• major non-conformities not adequately closed within three months of the audit;

• during the surveillance stage, the organisation has not implemented the proposed corrective action relative to minor non-conformities found during the previous audit (effectiveness check);

• notification from CHRYSLER - Needs Improvement Status, FORD - Q1 Revocation status, GM New Business Hold, FIAT New Business and/or other similar notifications of customers belonging to the ISO/TS16949 scheme;

In the case of

• notification of GM CSLI/II or FIAT CSLII/I and/or other similar notifications of customers belonging to the ISO/TS16949 scheme not managed as required by customers and/or the Certification rules

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RINA will assess the situation, on a case by case basis, according to the RINA Rules and to the specific requirements of car manufacturers. However, in the case of CSLII/CSLIII for which major non conformities (TYPE A) have been found and have not been resolved either adequately or within the time limit allowed, the certificate will be suspended and subsequently withdrawn.

If the organisation fails to comply by the deadline, and agreed with the customer, established by the CHRYSLER - Needs Improvement Status, FORD - Q1 Revocation status, GM New Business Hold, FIAT New Business and/or other similar notifications of customers belonging to the ISO/TS16949 scheme, the certificate must be withdrawn.

Withdrawal of the certificate may only be avoided following an exception made by the accreditation body or by the customer who issued the notification.

If the validity of the ISO/TS 16949 certification is suspended or the certificate is withdrawn or relinquished by the organisation, this decision must be communicated to IATF within 10 days. The notification must be sent to CISQ-AUTOMOTIVE which handles contacts with IATF.

10. RENEWAL OF CERTIFICATION: RECERTIFICATION

At the end of the renewal audit for continuing the certification procedure, and in the event of a positive judgement by the Auditing Team, the Job Manager, assisted by the technical secretary’s office, prepares the following documentation to present to the Quality Technical Committee:

• RVI (plus supplementary audit report, where applicable)

• Certification proposal and procedure signed by RPC or deputy

• PVP

• Audit Plan

• Audit observation sheets and checklists (if compiled)

• Informative questionnaire/Certification request

• Contract review form and offer, only if the offer was not prepared with CAI-C

• Excerpt from the quality manual indicating the company process scheme and exclusions

• Additional documents for ISO/TS16949 collected from the company by the auditing team (Management Review, List of customers in the automotive sector, Process identification scheme, last 12 months of company performance indicators). In the case of foreign companies, the paragraph related to certification applies.

The recertification proposal must be presented for approval to the CISQ AUTOMOTIVE Quality Technical Committee, of which IATF is a veto-holding member.

In particular, extensions to certificate expiry dates are not allowed.

11. PUBLICATION

The certificates of the organisations certified according to the ISO/TS 16949 scheme are listed on the RINA website.

All the data concerning issued certificates must be collected and communicated to CISQ AUTOMOTIVE which keeps a database of certificates issued by member bodies which can be accessed by IATF.

12. REFERENCE TECHNICAL DOCUMENTATION

The external reference documents required to perform audits or referred to in the IATF/ANFIA and RINA rules are updated by the Scheme manager.

A special Community on the RINA web portal contains all internal/external reference documents and special links to external sites from where specific customer requirements, FAQs notices and Sanctioned Interpretations can be obtained.

Qualified auditors enjoy direct access to the portal for downloading updates.

The documentation sent to the CTQ committee for certification/recertification is filed in Head Office for at least 10 years on electronic support

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ATTACHMENT 2 – AVSQ-MIA AND TE SUPPLEMENT – SPECIFI C REQUIREMENTS

1. SCOPE

This document illustrates the specific requirements for certifying Quality Management Systems according to AVSQ-MIA and/or TE SUPPLEMENT to QS9000. For any specific requirements not mentioned in this document, reference must be made to the ANFIA/AIAG rules.

TE SUPPLEMENT certificates will be issued unaccredited starting from 15/12/2006, if requested by the customer, as indicated in this attachment.

This document applies to all the organisations working in the car sector which supply equipment, machinery, plants and production/processing and measuring instruments. The certification process must be extended to all the elements of the Organisation’s Quality System in order to satisfy the requirements of Customers in the car sector, also where such elements go beyond the requirements indicated in the reference Scheme.

2. AUDIT PLANNING

The number of work days required to perform audits on Organisations for the AVSQ–MIA and TE SUPPLEMENT Schemes are defined in the following table:

N° of employees Audit visit

(Work days on site)

Surveillance visit (every 6 months)

Surveillance visit (every 12 months)

1 - 15 2 1 2 16 - 30 4 1 2 31 – 60 5 1.5 3 61- 100 6 1.5 3 101- 250 8 2 4 251 – 500 10 2.5 5 501 – 1000 12 3 6

1001 – 2000 15 3.5 7 2001 – 4000 18 4.5 9

more than 4001 21 5.5 11

The following special instructions apply to the above table:

• The number of work days indicated in the above table should be considered as minimum times.

• The above times do not include the Quality Management System document assessment and any pre-audits.

• This table only applies to TE SUPPLEMENT and AVSQ – MIA audits based on ISO 9001; if the organisation excludes product design, the above times may be reduced by 20%.

• Surveillance audits can be performed every 6 months or within and not over 12 months depending on the agreements made with the Organisation.

• Times for any supplementary visits made to solve non-conformities cannot be included in those indicated in the above table, as long as they are performed within 3 (three) months from the relative audit. Supplementary visits must be made by an auditing team comprising at least one member of the team that performed the previous visit.

• Audits must be performed on all work shifts. If there are fixed work teams at weekends, an audit must also be performed on these work shifts.

• For multi-site Organisations, audits must be performed on all the sites. All sites must be audited at least once every 12 months.

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• The above table is valid for Organisations with one or more sites which require a certificate for each site.

• For extensions from ISO 9001 to AVSQ-MIA and/or TE SUPPLEMENT, initial audit times may be reduced to a maximum of 30%.

• The complete review of the quality management system is directly connected with that issued by RINA according to ISO 9001.

• The complete review of the quality management system generally takes more time than an annual surveillance visit and less time than an initial audit.

2.1 CORPORATE / MULTI-SITE SCHEME

The certification scheme allows site audit times to be reduced in the event that a multi-site organisation requires a single certificate (“Corporate” audit scheme). Times are reduced as follows:

• Each site of the Organisation must be audited;

• The number of work days required to audit each site must not be less than the percentage shown in the following table multiplied by the number of work days per site indicated in the table in paragraph 6 and rounded off to the higher whole number. The reduction percentages are indicated in the following table:

Number of sites Reduction percentage multiplier

2-9 70

10-19 60

20 or more 50

These reductions are also applicable to surveillance visits.

In order to issue a “Corporate” certificate to an Organisation the following conditions must be present:

• The Quality System must be structured and managed centrally and must be subjected to internal audits on all the sites covering all the requirements of the reference Scheme

• The activities that can be managed centrally are:

• Contract review • Supplier management • Quality System documents management • Management review • Management of corrective and preventive action, continuous improvement activities • Audit planning and assessment of results • Design activities • Training management

Certain aspects of the above activities can be handled locally.

In the event of more than one organisation under the control of a holding, but with different company names, the scheme manager must be consulted before the activities are planned, who will involve the Accreditation Body in the decision-making process if necessary.

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3. STAGE 1 AUDIT

As regards the documents review, the contents of instruction IS-CRT-AUT-00 apply, with the following changes:

− for AVSQ – MIA use the ANFIA QUALITA’ 001B/I checklist (compilation optional) as a reference and prepare the “Documents review report”

− for TE SUPPLEMENT use the QUASQA6QTE checklist (compilation optional) as a reference and prepare the “Documents review report”

4. PREPARING AN AUDIT

4.1 AUDITING TEAM

The auditors appointed to perform audits according to the above schemes must satisfy the following requirements:

• must be qualified as auditor or lead auditor as per IS-CRT-AUD-00;

• must have successfully attended the following courses and possess the relative certification:

- AVSQ – MIA: special ANFIA AVSQ training course and subsequent refresher course on AVSQ – MIA;

- TE SUPPLEMENT: must have attended and successfully overcome the relative QS-9000 and/or TE Supplement training course approved by the Companies or Bodies that approved the specific Scheme. After 15/12/2006, qualification will be maintained for auditors possessing the TE SUPPLEMENT qualification prior to 15/12/2006 (for any unaccredited certificates)

• at least one auditor in the auditing team must be qualified in the EA sector to which the Organisation belongs.

A representative appointed by ANFIA or SINCERT may be included in the auditing team as an observer, subject to the approval of the Organisation under audit. (The organisation may not prevent the observer from participating)

4.2 AUDIT PLAN

An audit plan, prepared using ASCESI and including all the supplementary elements required by the reference standard document, must be sent to the organisation.

5. CARRYING OUT THE AUDIT

5.1 AUDIT

The audit is performed using:

- AVSQ – MIA: checklist ANFIA QUALITA’ 001B/I (compilation mandatory)

- TE SUPPLEMENT: QUASQA6QTE of RINA (compilation optional).

Any additional notes to those included in the above-mentioned checklists, made during the audit, are to be recorded on the QUASQA08V observation sheets.

As well as auditing the subjects contained in the reference standard documents, registrations of customer claims and supplier answers are also examined, together with the actions taken and their outcomes, following the internal audits and management review.

Progress made as regards continuous improvement aims is also audited.

If a consultant of the Organisation is present during the visit, it must be made clear that his role will be limited to that of an observer.

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5.2 AUDITING A QUALITY SYSTEM

Whether or not each single element of the AVSQ - MIA standard has been satisfied is assessed by giving a score of 0, 2.5, 5, 7.5 or 10 for the answer to each question indicated on the relative checklists; scoring criteria are indicated on this form.

The arithmetic mean of the questions covering each element is then calculated in order to give each element an “IE” conformity index.

Lastly, the weighted average of the indexes of each element is calculated in order to find the assessment result or the Global Conformity Index (IG).

Depending on the value of the Global Conformity Index, a rating in decreasing order from A to D is given, according to the table shown in the Checklist.

An Organisation only passes the assessment when:

- all the answers to the questions contained in the relative checklists obtain a score higher than 5;

- it is classified “A” and therefore the Global Conformity index IG is ≥ “90”.

If at least one non-conformity is found (an answer with a score equal to or less than 5), a supplementary audit (documents review or site audit) must be performed within three months in order to check that the proposed corrective action has been applied correctly; if this audit is successful the certification process is renewed.

For TE SUPPLEMENT, a Quality system is audited positively when no major or minor non-conformities (“A” or “B” types) are found during the audit.

If at least one major and/or minor non-conformity is found, a supplementary audit (documents review or site audit) must be performed within three months in order to check that the proposed corrective action has been applied correctly and effectively; if this audit is successful the certification process is renewed.

The above deadlines may never be extended more than three months from the certification audit.

If the agreed deadline is not respected, the audit must be repeated on the whole Quality Management System. If the non-conformity is not closed within the agreed time, the audit will be considered as “failed” and the whole of the Quality Management System will have to be audited again.

5.3 AUDIT DOCUMENTS

The documents relative to AVSQ’94 and TE SUPPLEMENT audits comprise:

− RINA audit report compiled on ASCESI

− For AVSQ-MIA, the completed checklist including IG calculation (not to send to the organisation)

− Observation sheets QUASQA8V

If the Organisation also requires certification of conformity with ISO 9000:2000, the recommendations, Non-Conformities and relative corrective actions are recorded on the above documents.

6. CERTIFICATION

At the end of the auditing stage in the certification procedure, and in the event of a positive judgement by the Auditing Team, the Job Manager, assisted by the technical secretary’s office, prepares the documentation to present to the Quality Technical Committee:

The certification proposal is examined by the RINA Quality Technical Committee as indicated in instruction IS-SCC-CER-01.

The usual certification procedure is then followed as shown in instruction IS-SCC-CER-01.

Following the successful outcome of the certification procedure, the relative certificate, complementary to ISO 9000, is issued; for AVSQ-MIA this also indicates the IG value obtained by the Organisation (please note that the IG value to indicate on the certificate, if it was necessary to perform a supplementary audit within 3 months of the audit visit and that during the audit visit an IG<“90” was obtained, must be equal to “90”).

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As regards Organisations that have already been certified for conformity with ISO 9001 standards, the ISO 9001 certificate must be reissued.

7. SURVEILLANCE AUDITS

Quality System surveillance visits are performed every 6 months or within and not over 12 months depending on the agreements made with the Organisation.

Audits are performed according to a programme that is sent to the Organisation together with the certificate (during a new audit or renewal).

The time criteria indicated in the previous point 2 are followed when planning surveillance audits.

The criteria established in this instruction (IS-CRT-AUT-00) remain valid for the management of periodic audits.

If any non-conformities are found during periodic audits, RINA will evaluate the management of these non-conformities as foreseen also for the ISO/TS16949 scheme.

The audit report must be checked by staff qualified in at least one of the automotive schemes managed by RINA.

8. SUSPENSION, RELINQUISHMENT AND/OR WITHDRAWAL OF CERTIFICATION

The criteria established in instruction IS-SCC-CER-01 remain valid for the suspension, relinquishment and/or withdrawal of certificates.

In particular, the AVSQ-MIA certificate must be suspended if ≤ 5 non-conformities are found that have not been eliminated within the established time or in the event of notification of revocation/requirement for improvement by Customers adhering to the scheme.

9. PUBLICATION

The certificates of the organisations certified according to the AVSQ-MIA and QS9000/TE SUPPLEMENT schemes are listed on the RINA website.

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