Requirements for the application of ISO/IEC 17020:2012 · PDF fileRequirements for the...

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Requirements for the application of ISO/IEC 17020:2012

for the accreditation of inspection bodies

71 SD 0 012_e | Revision: 1.1 | 28. October 2013

Scope:

This Rule includes requirements for the implementation of ISO/IEC 17020:2012 for the

accreditation of inspection bodies. It provides support to inspection bodies as well as to assessors

and employees of the Deutsche Akkreditierungsstelle GmbH (DAkkS) in interpreting individual

requirements as set out in ISO/IEC 17020:2012 in a uniform manner across all divisions.

Additional sectoral requirements may be specified in further subordinated documents.

Date of confirmation by the Accreditation Advisory Board (AKB): 10.10.2013

Substantive changes to the previous revision of this Rule are marked with a bar on the right-hand

margin or highlighted in yellow.

Requirements for the application of ISO/IEC 17020:2012 for the accreditation of inspection bodies

71 SD 0 012 | Revision: 1.1 | 28. October 2013 2 of 12

Contents

1 Purpose / Scope ................................................................................................................ 3

2 Terms and definitions ........................................................................................................ 3

3 Description ....................................................................................................................... 4

3.1 Testing, inspection, and certification ......................................................................................................... 4

3.2 Independence ............................................................................................................................................ 5

3.3 Identification of type of examination of inspection bodies ....................................................................... 8

3.4 Assessment of examination competence .................................................................................................. 8

3.5 Requirements for personnel .................................................................................................................... 10

3.6 Subcontracting ......................................................................................................................................... 10

3.7 Contents of a general inspection procedure (comp. Clause 3.6 of ISO/IEC 17020,

Inspection System) ................................................................................................................................... 11

3.8 Definition of the scope of accreditation in the accreditation certificate / annex to the

certificate based on objects, type and field of work, procedures and processes as well as

examination background ......................................................................................................................... 11

3.9 Accreditation process – Selected aspects ................................................................................................ 11

4 Applicable documents ..................................................................................................... 12



1 Purpose / Scope

This Rule includes requirements for the implementation of ISO/IEC 17020:2012 for the

accreditation of inspection bodies. It provides support to inspection bodies as well as to assessors

and employees of the Deutsche Akkreditierungsstelle GmbH (DAkkS) in interpreting individual re-

quirements as set out in ISO/IEC 17020:2012 in a uniform manner across all Divisions.

Additional sectoral requirements may be specified in further subordinate documents.

2 Terms and definitions

Examination Verification of the suitability, adequacy and effectiveness of selection

and determination activities, and the results of these activities, with

regard to fulfilment of specified requirements, by an object of conformi-

ty assessment (Clause 5.1 of ISO/IEC 17000:2005)

Inspection Examination of a product design, product, process or installation and

determination of its conformity with specific requirements or, on the

basis of professional judgement, with general requirements

(Clause 4.3 of ISO/IEC 17000:2005)

Inspection system Rules, procedures, and management for carrying out inspections

(Clause 3.6 of ISO/IEC 17020:2012)

Inspection scheme Inspection system to which the same specified requirements, specific

rules and procedures apply (Clause 3.7 of ISO/IEC 17020:2012)

Evaluation Combination of selection and determination functions of conformity assessment activities (Clause 3.3 of ISO/IEC 17065:2013)

NOTE: The “Selection” and “Determination” functions are specified in

Annexes A.2 and A.3 of ISO/IEC 17000:2004.



3 Description

3.1 Testing, inspection, and certification

Unlike the certification process, which is usually composed of the three steps "Testing" (resp. gener-

ally “Examining”), "Reviewing" and "Decision on certification", the inspection process is the combina-

tion of the steps “Testing” and “Examination” (comp. Section 3 of ISO/IEC 17020).

The testing service may be provided by the inspection body, or it is provided by one or more subcon-

tractors (testing laboratories) (comp. Section 6 of ISO/IEC 17020).

It is of particular importance to note that the inspection service does not require any separation of

personnel between testing and examination. This needs to be differentiated against the

requirements for certification bodies for products, where a separation of personnel is required for

“Evaluation” on the one hand and certification (“Review and Certification Decision”) on the other

hand.

Note: This does not exclude that the inspection process may be involved in the certification process.

For example, several providers of testing services may determine a wide variety of characteristic

values on various components of a plant, also service providers may determine the static strength for

calculations and subsequently the inspection body may confirm the conformity with the requirement

of (defined) (customer) specifications, normative documents etc., or as a result of a professional

judgement. This confirmation may serve the certification body as a basis for the certification deci-

sion.

The assessment as part of the accreditation of inspection bodies with associated test areas is carried

out in such a way that a multiple assessment of already accredited scopes is avoided. In evaluating

the extent of assessment, the accreditation body always uses existing, valid accreditations of areas

according to ISO/IEC 17025 with an identical technical scope. In these cases, the assessment of Test-

ing comprises only the interfaces between the individual steps "Testing" and "Examination". This,

however, does not discharge the DAkkS from its obligation to depart from it in justified individual

cases (e. g. in case of findings or determinations before and during the assessment) in order to be

able to fully evaluate the conformity with the requirements.



3.2 Independence

The classification of inspection bodies according to Types A, B, C only represents the characterization

of the status of independence. In this context, it is not to be understood as a measure of the compe-

tence or quality of the inspection body.

An inspection body of Type A is an independent "Third Party" which receives external orders for the

inspection of (not own/external) products or also processes or services and provides inspection

reports back to the external client.

An inspection body of Type B, however, is always a (separated and identifiable) part of an organiza-

tion concerned with the products to be inspected. This Type of inspection body inspects only the own

(internal) products of the organization, of which it is the identifiable part, and provides inspection

reports only to the internal client.

An inspection body of Type C is a not clearly separated, but identifiable part of an organization

concerned with the products to be inspected. This Type of inspection body inspects both the

own/internal products and also similar or external products and provides its inspection reports both

to internal and external clients.

The independence of the inspection body is defined as follows:

Type A: The Type A inspection body shall be independent of the parties involved in the inspection. It

is an „independent Third Party", equivalent to a third party institution

(comp. Clause 4.1.6 a) and Annex A, A.1 of ISO/IEC 17020).

Type B: The Type B inspection body forms a clearly separated and identifiable part of an organization

involved in the design, manufacture, supply, installation, use, operation or maintenance of

the items it inspects. It was founded to provide inspection services to its parent organization

(in-house inspection body)

(comp. Clause 4.1.6 b) and Annex A, A.2 of ISO/IEC 17020).

Type C: The Type C inspection body is involved in the design, manufacture, supply, installation, use,

operation or maintenance of the items it inspects or that are similar to those it inspects.

It may provide inspection services to the parent organization and other parties

(comp. Clause 4.1.6 c) of and Annex A, A.3 of ISO/IEC 17020).

For all types of inspection bodies, the top management shall define and document a commitment to

provide and maintain impartiality. It shall ensure that risks to the impartiality shall be identified and

identified risks shall be eliminated or minimized. An annual cycle is typically considered to be an

appropriate interval for such a regular examination. The examination shall be additionally required

for relevant changes that could affect impartiality.



Conclusion for Type A:

On the one hand, the Type A inspection body can be a (legally) independent organization; on the

other hand, it can also be a separated and identifiable part of an organization. Both shall not be

involved in design, manufacture, supply, installation, use, operation and maintenance of items or

similar items the inspection body inspects.

Type A shall only be considered to exist, if, in addition to the formal legal independence of the client,

the evidence of the de facto independence has been fully provided.

In order to prove independence of related bodies, an inspection body of Type A shall demonstrate

that it is not linked to those parties that are engaged in the design, manufacture, supply, installation,

purchase, ownership, use or maintenance of the items inspected by it or of similar competing items,

by the following (comp. Annex A, A.1 d) of ISO/IEC 17020):

common ownership (except where the owners have no ability to influence the outcome of an

inspection);

common shareholders (or equivalent persons, except where these have functions that have

no influence on the outcome of an inspection);

directly reporting to the same higher level of management;

contractual and informal commitments or other means that could have an ability to influence

the outcome of an inspection.

This analysis of the related bodies shall be documented adequately as part of the above risk analysis

(comp. Clause 4.1.3 of ISO/IEC 17020). For this analysis, the following chart (created by the Certifica-

tion Committee of the European co-operation for Accreditation (EA CC)) may be helpful:





3.3 Identification of type of examination of inspection bodies

The scope of accreditation specified on the accreditation certificate including its annexes shall

always be concluded by the type of examination in the frame of the inspection service, i. e.

(from the definition of inspection, comp. Clause 3.1 of ISO/IEC 17020) either

Type of examination identified in accordance with specified requirements, only characterized by

the „declaration of conformity with specific requirements“ (conformity assessment based on the

simple comparison with standards or with parameters specified in a comparable manner),

Text on the accreditation certificate / annex to the accreditation certificate:

… and determination of their conformity with specific requirements

and / or

type of expert examination „describing the determination of conformity, on the basis of profes-

sional judgement, with general requirements“.

Text on the accreditation certificate / annex to the accreditation certificate:

... and determination of their conformity, on the basis of professional judgement, with general

requirements

3.4 Assessment of examination competence

Examination

The examination determines the total volume of inspection activities, i. e. it determines which

investigations have to be carried out and which results and specifications are used for the inspection.

Examination is in particular the process that determines the result of the inspection.

An examination shall always be preceded by an investigation. This may be, for example, a functional

test or an analytical (chemical, physical) test of a product or material, but also the review of

documentation, such as design drawings, calculations, designs or procedural characteristics.

The examination shall include the adequacy and completeness of testing carried out with a view to

the inspection target.



Examination competence

The examination competence does not only require knowledge of the relevant testing activity, but

also knowledge of the following (comp. Clause 6.1.3 of ISO/IEC 17020):

manufacturing of the products inspected, etc.

the operation of the product inspected, etc.

the way of use of the products inspected, etc.

any defects which may occur during the use of the product

the consequences of identified defects for the use or the operation of the products, etc.

the requirements of relevant legislation for the products, etc.

the general requirements from the appropriate standardization for the products, etc.

Qualification requirements for the personnel of the inspection body who carries out the examination

Qualification requirements for the examination activity shall include at least the following:

Professional education completed in the field which concerns the inspection activity, or

equivalent skills.

Generally, several years of professional experience after the training in the work area in

which the examination shall be carried out.

Basic knowledge of the technique used for the examination of the results, either by participa-

tion in appropriate training courses, or by observing, and by activities accompanied by expe-

rienced staff members of the inspection body.

Traceable and documented evaluation and verification of the skills by an experienced staff

member of the inspection body.

The entire training course shall be fully documented in a comprehensible manner.

Assessment of the examination competence

The assessment of the examination competence can only be performed by an assessor, who has

sufficient knowledge and experience in the relevant field of inspection or in an equivalent inspection

area.

The assessor shall have sufficient knowledge and experience in the application of conformity assess-

ment procedures.

When assessing the type of examination, assessment tasks may be assigned, if necessary, in the

sense of a proficiency test, which the person being assessed has to perform.



3.5 Requirements for personnel

The inspection body shall ensure that the personnel involved in the inspection process is monitored

on a regular basis, is competent and operates in accordance with the quality management system of

the inspection body (comp. Clause 6.1.8 of ISO/IEC 17020).

In the context of performance evaluation, in general, each active inspector shall be observed during

the on-site inspection activity by the inspection body once during the accreditation cycle (comp.

Clause 6.1.9. of ISO/IEC 17020). Deviations from this are possible, if the observations carried out (at

least two) and other records relating to the performance evaluation or further training

sufficiently support evidence that the inspector is continuing to perform competently.

The fulfilment of the requirements established for education and training as well as for qualification

and experience for the defined inspection area (as specified for example in the job descriptions) shall

be examined in the context of on-site observations.

ISO/IEC 17020 only states that a sufficient number of persons shall be available (comp. Clause 6.1.2

of ISO/IEC 17020). Therefore, there is basically no reason why the inspection bodies should not be

accredited irrespective of the number of employees, provided that the requirements as set out in the

standard are met.

Managerial and technical personnel for inspections may be identical but the functions and responsi-

bilities shall be clearly regulated in written specifications.

Similarly, the management of the inspection body and the quality manager may be identical, but the

functions and responsibilities shall be clearly regulated in written specifications.

Inspection bodies which are operated by one person can only be accredited if useful arrangements

are implemented for the requirements set out in the clauses 5.2.6, 6.1.8, 6.1.9, 6.1.11, 8.5 and 8.6 of

the standard and if external persons may be involved on a contractual basis, if necessary. In addition,

this person shall have a sufficient examination competence for all activities conducted in the inspec-

tion body.

3.6 Subcontracting

According to Clause 6.3 of ISO/IEC 17020, subcontracting for an inspection body can be described in

a way that subcontracts can generally be given only in exceptional cases (comp. Clause 6.3.1. of

ISO/IEC 17020). Tests within the meaning of ISO/IEC 17025, however, can permanently be subcon-

tracted, unless this is precluded by technical or sector-specific requirements.

The inspection body shall be able to independently assess the results of the subcontracted works.

The responsibility for establishing the conformity with the requirements remains with the inspection

body (comp. Notes of Clause 6.3.1 of ISO/IEC 17020).

Clients shall be informed of subcontracting in advance (comp. Clause 6.3.2 of ISO/IEC 17020).



3.7 Contents of a general inspection procedure

(comp. Clause 3.6 of ISO/IEC 17020, Inspection System)

Basically, an inspection body to be accredited shall document its procedures on inspection activities.

Typical contents of such procedures are as follows:

Title for the procedure on the inspection activity

Content and aim of an inspection, scope, specifications, standards, normative documents,

etc.

Organization, personnel and operation

Inspection scheme (planning of the inspection activities, conducting the inspection)

Testing activities (inclusion of external services, subcontracting)

Facilities and equipment

Examination of inspection results

Inspection report

3.8 Definition of the scope of accreditation in the accreditation certificate / annex to the

certificate based on objects, type and field of work, procedures and processes as well as

examination background

The scope of accreditation shall always contain the following information:

Items and fields of inspection (for example processes, plants, parts of plants, design, prod-

ucts, etc.)

Type and range of inspection, for example inspection under operating or service conditions

(in-service inspection), inspection of new products

Designation of the type of examination

3.9 Accreditation process – Selected aspects

The assessment of the competence of an inspection body is established by:

document review

assessing the office of the inspection body

assessing relevant specific structures of the inspection body, such as requirements

for the management system, locations, organization, work processes, etc.



witness-audits of on-site inspections

Note: The type of independence (classification of Type A, B, C) shall be determined by the

inspection body and specified in the application for accreditation.

Note: The extent of random assessment of an inspection body shall be determined before the

assessment starts. The representative coverage of the locations and inspection areas

shall be established and documented by the DAkkS in a monitoring matrix.

Before granting accreditation, at least one witness-audit shall be conducted. If the inspection body

covers several technical inspection areas, has a large number of inspectors / locations or if certain

witness-audits cannot be performed due to practical reasons, the required number of witness-audits

shall be determined individually before granting the accreditation and based on sector-specific

requirements.

4 Applicable documents

ISO/IEC 17000:2005 Conformity assessment – Vocabulary and general principles

ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of

various types of bodies performing inspection

ISO/IEC 17011:2005 Conformity assessment – General requirements for accreditation

bodies accrediting conformity assessment bodies

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