Professional Documents
Culture Documents
Gap Analysis of ISO/IEC 17020:2012 and ISO/IEC 17020:1998 in the program of Inspection
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.
March 2013
Page 3 of 21
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.
March 2013
Page 4 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No. 1 1
1.1
Comments
Scope
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. Reference to ISO/IEC 17000 has been made. The terms and definitions given in ISO/IEC 17000 now also apply in addition to the definitions of clauses 3.1 to 3.10. 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.
2 3
3.1
New
2
2.1 Minor change
Inspection
New New New No change New New New New New Significant change New
Product Process Service Inspection Body Inspection system Inspection scheme Impartiality Appeal Complaint
4
4.1
4.1.1
General requirements
Impartiality and independence
Inspection activities shall be undertaken impartially. Text sourced from ISO/PAS 17001:2005.
March 2013
Page 5 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
4.1.2 4.1 Significant change
Comments
4.1.3
New
4.1.4
New
New No change
4.2
4.2.1
5
(5)
The inspection body is responsible for the impartiality of its inspection activities and must not allow commercial, financial or other pressures to compromise impartiality. 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. If a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates or minimises risk. The inspection body shall have top management commitment to impartiality. The inspection body is to be independent to the extent that is required with regard to the conditions under which it performs its services. Type A. Type B. Type C.
A Type A inspection body is identified as a third party inspection body. A Type B inspection body is identified as an in-house inspection body.
Confidentiality
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. Text sourced from ISO/PAS 17002:2004.
March 2013
Page 6 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
4.2.2 New
Comments
4.2.3
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. Information about the client obtained from sources other than the client is confidential.
5
5.1
5.1.1 5.1.2 5.1.3
Structural requirements
3
3.1 3.2 3.3 Minor change No change Minor change Minor change Minor change Deleted
Administrative requirements
The inspection body shall be a legal entity, or defined as part of a legal entity. When part of a legal entity, the inspection body is to be identifiable within the entity. The inspection body shall have documentation which describes the activities for which it is competent. The inspection body shall have adequate provision to cover liabilities arising from its operations. Contractual conditions for services. A Note has been added concerning governmental inspection bodies.
5.1.4
3.4
5.1.5
3.5
3.6
The previous statement that the scope of work for a job is determined by the relevant terms of contract has been deleted. insurance has been replaced by provision. Assumption by State has been moved to a Note. contractual has been added and the exemption has been reworded to consider the legal entity. The previous requirement for independently audited accounts now does not appear in ISO/IEC 17020:2012. Text sourced from ISO/PAS 17001:2005. 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.
5.2
5.2.1 5.2.2
6.1
New 6.1 Minor change
March 2013
Page 7 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
5.2.3 5.2.4 6.2 6.2 No change Significant change
Comments
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. Technical manager.
5.2.5
6.3
Minor change
5.2.6 5.2.7
6.5 6.6
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. The requirement to be a permanent employee has been deleted. There have also been minor changes to the wording of the clause. There have been minor changes to the wording. 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
6.1
6.1.1
Resource requirements
8
6.6 Minor change Minor change
Personnel
The inspection body shall define and document the competence requirements for all personnel involved in inspection activities. The inspection body must have sufficient personnel with the required competencies to perform the type, range and volume of activities. Qualification, training, experience and knowledge of personnel. Text is drawn from Clause 6.6 of ISO/IEC 17020:1998. Applicability to all personnel has been enhanced; permanent delete;. competencies replaces expertise; normal function has been explained. Wording changed to accommodate services.
6.1.2
8.1
6.1.3
8.2
Minor change
March 2013
Page 8 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
6.1.4 6.1.5 8.3 New Minor change Minor change Minor change Significant change
Comments
6.1.6
8.3
6.1.7 6.1.8
8.3 6.4
6.1.9
New
6.1.10
8.4
Minor change
6.1.11 6.1.12
8.6
6.1.13
New
The inspection body shall make clear to each person their duties, responsibilities and authorities. Procedures for selecting, training, formally authorising and monitoring personnel must be documented. The documented procedures for training must address the three stages of induction, mentoring and continuing training. 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. 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. Remuneration and influences on the results of inspections. All personnel of the inspection body, either internal or external, that could influence the inspection activities shall act impartially. 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.
This clause has been reworded. Text sourced from ISO/PAS 17001:2005.
March 2013
Page 9 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
6.2
6.2.1
Comments
9
9.1 Minor change Minor change No change Minor change No change Minor change Minor change No change No change Minor change Minor change No change Minor change
6.2.2
9.2
6.2.3 6.2.4
9.3 9.4
having a significant influence on the results of the inspection has been added.
having a significant influence on the results of the inspection has been added.
where they exist has been added. issuing purchase document has been removed and there has been slight rewording to include services supplied.
6.2.12 6.2.13
9.12 9.13
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.
March 2013
Page 10 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
6.2.14 6.2.15 9.14 9.15 Minor change Minor change Significant change
Comments
Added has been a requirement to take appropriate corrective action. Software added and an exemption included where appropriate. There has been significant rewording of this clause. Notes have been added.
6.3
6.3.1
14
14.1 and 14.2
Subcontracting
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. 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
7.1
7.1.1
Process requirements
10
10.1 Minor change
7.1.2 7.1.3
10.2 10.3
No change No change
March 2013
Page 11 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
7.1.4 7.1.5 7.1.6 10.4 10.5 No change No change New
Comments
All information is to be kept up-to-date and readily available to personnel. The inspection body is to have a contract or work order control system. 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. Observations and data are to be recorded in a timely manner. Calculations and data transfers are to be checked. The inspection body shall have documented instructions for carrying out inspection in a safe manner.
7.2
7.2.1 7.2.2 7.2.3
11
11.1 11.3 11.2 No change Minor change Minor change
7.2.4
11.4
No change
7.3
7.3.1
12
12.1 Significant change
Inspection records
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.
March 2013
Page 12 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
7.3.2 New
Comments
The inspection report or certificate shall be internally traceable to the inspector(s) who performed the inspection.
7.4
7.4.1 7.4.2
13
13.1 No change New
7.4.3
New
7.4.4
13.2
No change
7.4.5
13.4
Minor change
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. 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.
March 2013
Page 13 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
7.5
7.5.1
Comments
15
15.1 and 15.2
7.5.2
New
7.5.3
New
7.5.4
New
7.5.5
A description of the handling process for complaints and appeals shall be available to any interested party upon request. 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. The inspection body shall be responsible for all decisions at all levels of the handling process for complaints and appeals. Investigation and decision on appeals shall not result in any discriminatory actions.
7.6
7.6.1 7.6.2
7.6.3
New
March 2013
Page 14 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
7.6.4 New
Comments
7.6.5
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. 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
8.1 8.1.1
New Significant change
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).
March 2013
Page 15 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
8.2
8.2.1 7.1 No Change
Comments
8.2.2
8.2.3
Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.1 and 7.2 of ISO/IEC 17020:1998 Text sourced from ISO/PAS 17005:2008 and replaces Clauses 7.4 and 7.5. The general intent, however, remains.
8.2.4
7.3
Significant change
Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.3. The intent, however, remains unchanged. Text sourced from ISO/PAS 17005:2008 and is analogous to Clause 10.1. The general intent, however, remains.
8.2.5
10.1
Significant change
8.3
8.3.1 7.6 Significant change Significant change
8.3.2
7.6
March 2013
Page 16 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
8.4
8.4.1 12.3 Significant change
Comments
8.4.2
12.3
Significant change
Text sourced from ISO/PAS 17005:2008 and replaces Clause 12.3. The general intent, however, remains.
8.5 8.5.1
8.5.1.1 7.9 Significant change
8.5.1.2
New
8.5.1.3
12.3
Minor change
Text sourced from ISO/PAS 17005:2008 and replaces Clause 7.9. The intent, however, remains unchanged. Text sourced from ISO/PAS 17005:2008.
8.5.2
New
Review inputs
Management review must include a number of inputs as outlined in the International Standard.
8.5.3
New
Review outputs
Management review must include decisions and actions related to a number of outputs. Text sourced from ISO/PAS 17005:2008.
March 2013
Page 17 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
8.6
8.6.1 8.6.2 7.7 Significant change Minor change
Comments
8.6.3
Minor change
8.6.4
New
8.6.5
Significant change
8.7
8.7.1 7.8
8.7.2
8.7.3
New
March 2013
Page 18 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
8.7.4 New
Comments
The procedures for corrective actions must define a number of requirements as outlined in the International Standard.
8.8
8.8.1
New New
8.8.2 8.8.3
New New
Text sourced from ISO/PAS 17005:2008. Text sourced from ISO/PAS 17005:2008.
4.2.1
A.1 No change
b)
Minor change
c)
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, purchase, ownership, use or maintenance of the items inspected. 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.
March 2013
Page 19 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
d) No change
Comments
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
a) b)
B.3 B.1
No change No change
c)
B.2
No change
The inspection services shall only be supplied to the organisation of which it is part. A clear separation of the responsibilities of the inspection personnel from those of the personnel employed in the other functions shall be established. 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.
A.3
4.2.3 a) C.1 No change
b)
New
March 2013
Page 20 of 21
ISO/IEC Corresponding Change 17020:2012 ISO/IEC Clause No. 17020:1998 Clause No.
New
Comments
Annex B (informative)
March 2013
Page 21 of 21