Gap Analysis of ISO:IEC 17020-2012 and ISO:IEC 17020-1998 in the Program of Inspection

Gap Analysis– March 2013 Issued: March 2013

Gap Analysis of ISO/IEC 17020:2012 and ISO/IEC 17020:1998 in the program of Inspection

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Gap Analysis of ISO/IEC 17020:2012 and ISO/IEC 17020:1998

March 2013 Page 3 of 21

This document has been designed to assist both facility staff and the NATA assessment team. It highlights the differences between ISO/IEC 17020:1998 and ISO/IEC 17020:2012. Facility staff can use this document, together with the ISO/IEC 17020 Checklist (also available from the NATA website) as part of their preparation for an assessment to ISO/IEC 17020:2012 in the Inspection Accreditation Program. Refer to Policy Circular 44 – Implementation of ISO/IEC 17020:2012 in the program of Inspection.

SUMMARY OF CHANGES

The most notable differences between ISO/IEC 17020:1998 and ISO/IEC 17020:2012 include:

The re-arrangement of the document structure to separate the requirements into “General”, “Structural”, “Resource”, “Process” and “Management system” sections;

Incorporation of text from the ISO/PAS documents to establish consistent requirements for all ISO/IEC 17000-series standards;

Incorporation of requirements from IAF/ILAC A4:2004;

Revision of the technical requirements;

Two options to meet the management system requirements of the Standard. In relation to specific clauses in the Standard, significant changes have been made to:

Impartiality requirements (4.1);

Confidentiality requirements (4.2);

Records management (7.3.1);

Complaints and appeals (7.5 and 7.6);

Management systems requirements (Section 8, all parts). Requirements for the monitoring of inspectors (clauses 6.1.8 and 6.1.9) have also been introduced.



General comment on the terms and conditions in ISO/IEC 17020:2012

The definition of inspection has been slightly changed. It now allows for design

verification to be applied to processes and services as well as products. The word “plant” has been replaced with “installation”, allowing for both a physical item of equipment or the process of installation to be inspected. Note 2 explicitly allows for inspectors to report findings only, and not make a judgement of conformity, based upon procedures specification or the requirements of a scheme owner. New terms have been added to address Inspection System and Inspection Scheme. This recognises that frequently inspection is used to provide conformity

data in support of a wider assurance activity. Such activities may involve product certification, or be specified through legislation. Scheme owners can be industry bodies, commercial entities, product certification bodies or regulators. Scheme rules and requirements may exist in addition to the technical requirements for the inspection and the requirements set out in ISO/IEC 17020:2012.



ISO/IEC 17020:2012 Clause No.

Corresponding ISO/IEC 17020:1998 Clause No.

Change Summary of text/extract from ISO/IEC 17020:2012

Comments

1 1 Scope 1.1 Clause 1.1 of ISO/IEC 17020:1998 has been

included under Clause 1. In addition, the following changes have been made: „Criteria‟ are now „requirements‟.

2 New Normative References Reference to ISO/IEC 17000 has been made.

3 2 Terms and definitions The terms and definitions given in ISO/IEC 17000 now also apply in addition to the definitions of clauses 3.1 to 3.10.

3.1 2.1 Minor change

Inspection The definition of inspection changed slightly and now explicitly includes service. There is no change however, in meaning or intent. Notes 2, 3 and 4 have been added whilst Note 2 of ISO/IEC 17020:1998 has been deleted.

3.2 New Product

3.3 New Process

3.4 New Service

3.5 No change Inspection Body

3.6 New Inspection system

3.7 New Inspection scheme

3.8 New Impartiality

3.9 New Appeal

3.10 New Complaint

4 General requirements 4.1 Significant

change Impartiality and independence

4.1.1 New Inspection activities shall be undertaken impartially. Text sourced from ISO/PAS 17001:2005.






Comments

4.1.2 4.1 Significant change

The inspection body is responsible for the impartiality of its inspection activities and must not allow commercial, financial or other pressures to compromise impartiality.

Text sourced from ISO/PAS 17001:2005.

4.1.3 New The inspection body must identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel.


4.1.4 New If a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates or minimises risk.


4.1.5 New The inspection body shall have top management commitment to impartiality.


4.1.6 4.2 No change The inspection body is to be independent to the extent that is required with regard to the conditions under which it performs its services.

Refer to Annex A.

4.1.6a 4.2.1 Minor change

Type A. A Type A inspection body is identified as a „third party inspection body‟.

4.1.6b 4.2.2 Minor change

Type B. A Type B inspection body is identified as an „in-house inspection body‟.

4.1.6c 4.2.3 No change Type C.

4.2 5 Significant change

Confidentiality

4.2.1 (5) New The inspection body is responsible, through legally enforceable commitments, for the management of information obtained or created during the performance of inspection activities. The inspection body must inform the client, in advance, of information it intends to be publicly available. Other information is considered confidential, with some exceptions.







Comments

4.2.2 New When the inspection body is required by law or authorised by contractual commitments to release confidential information, the client or individual concerned shall, unless prohibited by law, be notified of the information provided.

Text sourced from ISO/PAS17002:2004.

4.2.3 New Information about the client obtained from sources other than the client is confidential.


5 Structural requirements 5.1 3 Administrative requirements 5.1.1 3.1 Minor

change The inspection body shall be a legal entity, or defined as part of a legal entity.

A Note has been added concerning governmental inspection bodies.

5.1.2 3.2 No change When part of a legal entity, the inspection body is to be identifiable within the entity.

5.1.3 3.3 Minor change

The inspection body shall have documentation which describes the activities for which it is competent.

The previous statement that the scope of work for a job is determined by the relevant terms of contract has been deleted.


The inspection body shall have adequate provision to cover liabilities arising from its operations.

„insurance‟ has been replaced by „provision‟. Assumption by State has been moved to a Note.


Contractual conditions for services. „contractual‟ has been added and the exemption has been reworded to consider the legal entity.

3.6 Deleted The previous requirement for independently audited accounts now does not appear in ISO/IEC 17020:2012.

5.2 6.1 Organisation and management 5.2.1 New The inspection body shall be structured and

managed so as to safeguard impartiality. Text sourced from ISO/PAS 17001:2005.


The inspection body shall be organized and managed so as to enable it to maintain the capability to perform its inspection activities.

„managed‟ is now additional to „organised‟. The Note under this clause is based upon the Clause 16 requirement for Cooperation in ISO/IEC 17020:1998.






Comments

5.2.3 6.2 No change Responsibilities and reporting structure.


Where the inspection body forms a part of legal entity performing other activities, the relationship between these other activities and inspection activities shall be defined.

ISO/IEC17020:1998 only required relationships to be defined if the “other activity was testing or certification activities; this has been generalised to all activities in ISO/IEC 17020:2012.


Technical manager. The requirement to be a permanent employee has been deleted. There have also been minor changes to the wording of the clause.


Deputies. There have been minor changes to the wording.


Job descriptions. This clause now only includes the requirement to have a job description for each position category within the organisation. Detail requirements relating to position descriptions previously associated with ISO/IEC 17020:1998 Clause 6.6 are now addressed in Clause 6.1 of ISO/IEC 17020.2012.

6 Resource requirements 6.1 8 Personnel 6.1.1 6.6 Minor

change The inspection body shall define and document the competence requirements for all personnel involved in inspection activities.

Text is drawn from Clause 6.6 of ISO/IEC 17020:1998.


The inspection body must have sufficient personnel with the required competencies to perform the type, range and volume of activities.

Applicability to all personnel has been enhanced; „permanent‟ delete;. „competencies‟ replaces „expertise‟; „normal function‟ has been explained.


Qualification, training, experience and knowledge of personnel.

Wording changed to accommodate services.






Comments

6.1.4 New The inspection body shall make clear to each person their duties, responsibilities and authorities.

Corollary of ISO/IEC 17020:1998 Clause 6.6


Procedures for selecting, training, formally authorising and monitoring personnel must be documented.

‟Monitoring‟ has been introduced.


The documented procedures for training must address the three stages of induction, mentoring and continuing training.

There has been a slight rewording of this clause.


The training required for personnel is dependent upon ability, qualification and experience.


Personnel familiar with the inspection methods and procedures shall monitor all inspectors and other personnel involved in inspection activities for satisfactory performance.

„effective supervision‟ is now „monitoring‟.

6.1.9 New Each inspector shall be observed on-site, unless there is sufficient evidence that the inspector is continuing to perform competently.


The inspection body must maintain records related to monitoring, education, training, technical knowledge, skills, experience and authorization of each member of its personnel.

Records of monitoring and authorisations have been added.


Remuneration and influences on the results of inspections.

This clause has been reworded.

6.1.12 New All personnel of the inspection body, either internal or external, that could influence the inspection activities shall act impartially.


6.1.13 New All personnel of the inspection body shall keep confidential all information obtained or created during the performance of the inspection activities confidential, except as required by law.







Comments

6.2 9 Facilities and equipment 6.2.1 9.1 Minor

change Suitable and adequate facilities and equipment to be available in order for activities to be carried out in a competent and safe manner.

„competent and safe manner‟ has been added. The Note has also been added.


The inspection body must have rules for the access to, and use of, facilities and equipment used to perform inspections.

„used to perform inspections‟ has been added.

6.2.3 9.3 No change The inspection body must ensure continued suitability of facilities and equipment.


All equipment having a significant influence on the results of the inspection shall be defined and, where appropriate, uniquely identified.

„having a significant influence on the results of the inspection „ has been added.

6.2.5 9.5 No change All equipment shall be maintained in accordance with documented procedures and instructions.


Equipment calibration. „having a significant influence on the results of the inspection „ has been added.


Calibration traceability.

6.2.8 9.8 No change Reference standards.

6.2.9 9.9 No change In-service checks.


Traceability of references materials. „where they exist‟ has been added.


Purchased materials. „issuing purchase document‟ has been removed and there has been slight rewording to include services supplied.

6.2.12 9.12 No change Condition of stored items and their assessment at appropriate intervals.


Use of computers or automated equipment with inspections.

There has been slight rewording of this clause with the adequacy of software to be ensured, not just the testing of software. A Note has also been added.






Comments


Dealing with defective equipment. Added has been a requirement to „take appropriate corrective action‟.


Equipment records. Software added and an exemption included „where appropriate‟.

6.3 14 Subcontracting 6.3.1 14.1 and 14.2 Significant

change Where an inspection body subcontracts any part of the inspection, it shall ensure that the subcontractor is competent and where applicable, complies with ISO/IEC 17020:2012.

There has been significant rewording of this clause. Notes have been added.

6.3.2 New The inspection body shall inform the client of its intention to subcontract any part of the inspection.


The responsibility for any determination of conformity remains with the inspection body.


The inspection body must retain records of its investigation of the competence of its subcontractors and their conformity with the applicable requirements of ISO/IEC 17020:2012. A register is also to be maintained of all subcontractors.

This clause has been reworded, however, there is no change to the intent of the requirement.

14.4 Deleted Clause 14.4 of ISO/IEC 17020:1998 now does not appear in ISO/IEC 17020:2012.

7 Process requirements 7.1 10 Inspection Methods and Procedures 7.1.1 10.1 Minor

change The inspection body shall use the methods and procedures for inspection which are defined in the requirements against which inspection is to be performed. Where these are not defined, the inspection body shall develop specific methods and procedures to be used.

There has been some incorporation of IAF/ILAC A4 into this clause.

7.1.2 10.2 No change Instructions on planning, sampling and inspection techniques.

7.1.3 10.3 No change Non-standard methods and procedures are to be appropriate and documented.






Comments

7.1.4 10.4 No change All information is to be kept up-to-date and readily available to personnel.

7.1.5 10.5 No change The inspection body is to have a contract or work order control system.

7.1.6 New When the inspection body uses information supplied by any other party as part of the inspection process, it shall verify the integrity of such information.

7.1.7 10.6 No change Observations and data are to be recorded in a timely manner.


Calculations and data transfers are to be checked. A note has been added.


The inspection body shall have documented instructions for carrying out inspection in a safe manner.

„in a safe manner‟ has replaced „safely‟.

7.2 11 Handling inspection items and samples 7.2.1 11.1 No change Items and samples are to be uniquely identified.


The inspection body shall establish whether the item to be inspected has been prepared.

Reference to the inspection body preparing the item has been removed.


Any apparent abnormalities are to be recorded. The client must be notified if there is any doubt regarding the suitability of the item or if it does not conform to the description provided.

„before commencement of the inspection‟ has been deleted.

7.2.4 11.4 No change There must be documented procedures and appropriate facilities to avoid deterioration or damage to items.

7.3 12 Inspection records 7.3.1 12.1 Significant

change The inspection body shall maintain a record system (see 8.4) to demonstrate the effective fulfilment of the inspection procedures and to enable an evaluation of the inspection.

„demonstrate the effective fulfilment of the inspection procedures‟ replaces „suit its particular circumstances‟. Clause 12.2 of ISO/IEC 17020:1998 has been added to this clause.






Comments

7.3.2 New The inspection report or certificate shall be internally traceable to the inspector(s) who performed the inspection.

7.4 13 Inspection reports and inspection certificates

7.4.1 13.1 No change The work carried out is to be covered by a retrievable inspection report or inspection certificate.

7.4.2 New Inspection report/certificate inclusions. A specific list of inclusions has been added. The text, whilst modified, has been drawn from ISO Guide 57. It should be noted, however, that Clause 13.3 from ISO/IEC 17020:1998 is now Clause 7.4.2e) in ISO/IEC 17020:2012.

7.4.3 New An inspection body shall issue an inspection certificate that does not include the inspection results (see 7.4.2g) only when the inspection body can also produce an inspection report containing the inspection results, and when both the inspection certificate and inspection report are traceable to each other.

7.4.4 13.2 No change Information in reports is to be correct, accurate and clear. Results supplied by subcontractors are to be clearly identified.


Corrections or additions to an inspection report or inspection certificate after issue shall be recorded in accordance with subclause 7.4. An amended report or certificate shall identify the report or certificate replaced.

The need for justification has been removed, however, a link to the replaced certificate is required.






Comments

7.5 15 Significant change

Complaints and appeals

7.5.1 15.1 and 15.2 Significant change

The inspection body shall have a documented process to receive, evaluate and make decisions on complaints and appeals.

Text sourced from ISO/PAS 17003:2004 with the incorporation of Clauses 15.1 and 15.2 of ISO/IEC 17020:1998. There is however, no change in the intent of the requirement.

7.5.2 New A description of the handling process for complaints and appeals shall be available to any interested party upon request.


7.5.3 New Upon receipt of a complaint, the inspection body shall confirm whether the complaint relates to inspection activities for which it is responsible and, if so, shall deal with it.


7.5.4 New The inspection body shall be responsible for all decisions at all levels of the handling process for complaints and appeals.


7.5.5 New Investigation and decision on appeals shall not result in any discriminatory actions.


7.6 Significant change

Complaints and appeals process

7.6.1 New The handling process for complaints and appeals shall include a number of elements and methods.


7.6.2 New The inspection body receiving the complaint or appeal shall be responsible for gathering and verifying all necessary information to validate the complaint or appeal.


7.6.3 New Whenever, possible, the inspection body shall acknowledge receipt of the complaint or appeal, and shall provide the complainant or appellant with progress reports and outcome.







Comments

7.6.4 New The decision to be communicated to the complainant or appellant shall be made by, or reviewed and approved by, individuals(s) not involved in the original inspection activities in question.


7.6.5 New Whenever possible, the inspection body shall give formal notice of the end of the complaint and appeals handling process to the complainant or appellant.


8 Management system requirements 8.1 Options

8.1.1 New General

Significant change

The inspection body shall establish and maintain a management system that is capable of achieving the consistent fulfilment of the requirements of the International Standard in accordance with either Option A or Option B.

Previously, there was only one way to meet the management system requirements of ISO/IEC 17020:1998 (i.e. what is now Option A in ISO/IEC 17020:2012.

8.1.2 Option A

The management system of the inspection body shall address Clauses 8.2, to 8.8, 7.5 and 7.6 of the International Standard.

8.1.3 Option B

An inspection body that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirement of this International Standard, fulfils the management system clause requirements (see 8.2 to 8.8).






Comments

8.2 Management system documentation (Option A)

8.2.1 7.1 No Change Policies and objectives to fulfil the requirements of the International Standard are to be established, documented, acknowledged and implemented.



There must be evidence of top management commitment.

Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.1 and 7.2 of ISO/IEC 17020:1998


The inspection body‟s top management shall appoint a member of management who shall have responsibility and authority for ensuring the process and procedures for the management system are implemented and maintained and for reporting on the performance of the management system.

Text sourced from ISO/PAS 17005:2008 and replaces Clauses 7.4 and 7.5. The general intent, however, remains.


All documentation, processes, systems, records etc. related to fulfilment of the requirements of the International Standard shall be referenced, or linked to documentation of the management system.

Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.3. The intent, however, remains unchanged.


All personnel involved in inspection activities shall have access to the parts of the management system documentation and related information that are applicable to their responsibilities.

Text sourced from ISO/PAS 17005:2008 and is analogous to Clause 10.1. The general intent, however, remains.

8.3 Control of documents (Option A)


The inspection body shall establish procedures to control the documents (internal and external) that relate to the fulfilment of this International Standard.

Text sourced from ISO/PAS 17005:2008 however, the general intent remains.


Relates to detailed requirements of document control procedures.

Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.6. The general intent, however, remains.






Comments

8.4 Control of records (Option A)


The inspection body shall establish procedures to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of its records related to the fulfilment of this International Standard.



The inspection body shall establish procedures for retaining records for a period consistent with its contractual and legal obligations. Access to these records shall be consistent with the confidentiality arrangements.


8.5 Management review (Option A)

8.5.1 General

8.5.1.1 7.9 Significant change

There must be procedures to review the management system at planned intervals in order to ensure its continuing suitability, adequacy and effectiveness and for compliance with the International Standard.


8.5.1.2 New These reviews shall be conducted at least once per year. Alternatively, a complete review broken up into segments (a rolling review) shall be completed within a 12-month time frame.


8.5.1.3 12.3 Minor change

Records of reviews shall be maintained. Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.9. The intent, however, remains unchanged.

8.5.2 Review inputs

New Management review must include a number of inputs as outlined in the International Standard.


8.5.3 Review outputs

New Management review must include decisions and actions related to a number of outputs.







Comments

8.6 Internal audits (Option A)


The inspection body must establish procedures for internal audits.

Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.7.

8.6.2 Minor change

An audit programme shall be planned, taking into consideration the importance of the processes and areas to be audited, as well as the results of previous audits.


8.6.3 Minor change

The inspection body shall conduct periodic internal audits covering all procedures in a planned and systematic manner, in order to verify that the management system is implemented and is effective.


8.6.4 New Internal audits shall be performed at least once every 12 months. The frequency of internal audits may be adjusted depending on the demonstrable effectiveness of the management system and its proven stability.


8.6.5 Significant change

The inspection body must ensure that internal audits are conducted by qualified personnel, auditors do not audit their own work, the outcomes of audits are communicated, corrective actions arising are taken in a timely manner, improvement opportunities are identified and the result of audits are documented.


8.7 Significant change

Corrective actions (Option A)


The inspection body shall establish procedures for identification and management of nonconformities in its operations.

Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.8. The intent, however, remains unchanged.

8.7.2 New The inspection body shall also, where necessary, take actions to eliminate the causes of nonconformities in order to prevent recurrence.


8.7.3 New Corrective actions shall be appropriate to the impact of the problems encountered.







Comments

8.7.4 New The procedures for corrective actions must define a number of requirements as outlined in the International Standard.


8.8 New Preventive actions (Option A)

8.8.1 New The inspection body shall establish procedures for taking preventive actions to eliminate the causes of potential nonconformities.


8.8.2 New Preventive actions taken shall be appropriate to the probable impact of the potential problems.


8.8.3 New The procedures for preventive actions must define a number of requirements as outlined in the International Standard.


Annex A (normative) - Independence requirements for inspection bodies

A.1 4.2.1 Requirements for inspection bodies (Type A)

a) A.1 No change The inspection body shall be independent of the parties involved.

There is no change to the wording, however, the second paragraph of A.1 of ISO/IEC 17020:1998 has been deleted since it is now redundant.

b) A.2 and A.3 Minor change

The inspection body and its personnel must ensure there is no engagement in activities that may conflict with their independence of judgement and integrity. In particular, they must not be engaged in the design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected.

„purchase‟ and „ownership‟ have been added to the list. There have also been Notes added. Equality of access has been deleted.

c) No change An inspection body shall not be part of a legal entity that is engaged in conflicting activities.

There is no change in requirements for NATA accredited facilities. This requirement has been drawn from IAF/ILAC A4.






Comments

d) No change The inspection body shall not be linked to a separate legal entity engaged in conflicting activities.

There is no change in requirements for NATA accredited facilities. This requirement has been drawn from IAF/ILAC A4.

A.2 Requirements for inspection bodies (Type B)

The inspection body referred to in 4.1.6b) shall meet the requirements below.

The definition of Type B has been relocated to the body of the Standard, with the clauses slightly reworded.

a) B.3 No change The inspection services shall only be supplied to the organisation of which it is part.

b) B.1 No change A clear separation of the responsibilities of the inspection personnel from those of the personnel employed in the other functions shall be established.

c) B.2 No change The inspection body and its personnel must ensure there is no engagement in activities that may conflict with their independence of judgement and integrity. In particular, they must not be engaged in the design, manufacture, supply, installation, use or maintenance of the items inspected.

There is no change to the requirements, however, Notes have been added.

A.3 Requirements for inspection bodies (Type C)

4.2.3 The inspection body referred to in 4.1.6c) shall meet the requirements below.

The definition of Type C has been relocated to the body of the Standard.

a) C.1 No change The inspection body shall provide safeguards to ensure adequate segregation of responsibilities and accountabilities.

b) New The design/manufacture/supply/installation/servicing/ Maintenance and the inspection of the same item carried out by a Type C inspection body shall not be undertaken by the same person, except where a regulatory requirement explicitly allows it provided the inspection results are not compromised.






Comments

New Annex B (informative)

Documents

Gap Analysis of ISO:IEC 17020-2012 and ISO:IEC 17020-1998 in the Program of Inspection