ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection Presentation on the new standard Page 1 2013-05-03 The aim of this presentation is to support all interested parties concerned by the implementation of this new standard, e.g. conformity assessment bodies, accreditation bodies, industries with general information and contribute to an harmonized transition. This is an open presentation without any copyrights and can be used by anyone. We welcome any proposals for improvement of this presentation or translation in national languages. ISO CASCO Secretary Sean MacCurtain Page 2 2013-05-03 ISO CASCO Convenor WG 31 Marcus Schmid Table of content Key activities of inspection History of inspection History of ISO/IEC 17020 Transition period of ISO/IEC 17020:2012 ISO/IEC 17020 / WG 31 - Maintenance Group Aim of the revision The main changes and improvements: • Content • Obligatory requirements of ISO/PAS • Impartiality and independence • Competence of inspectors • Subcontracting • Inspection schemes • Commodity inspections • Inspection reports and certificates • Management system requirements Cross reference 17020:1998 – 17020:2012 Cross reference 17020:2012 – 17020:1998 Page 3 2013-05-03 Key activities of inspection (1) The main objective of the Standard is to promote confidence in bodies performing inspection. Inspection bodies carry out assessments on behalf of private clients, their parent organizations, or authorities, with the objective of providing information about the conformity of inspected items with regulations, standards, specifications, inspection schemes or contracts. Page 4 2013-05-03 Key activities of inspection (2) safety, fitness for purpose, quality, quantity, Page 5 2013-05-03 Inspection parameters continued safety compliance of installations or systems in operation. Key activities of inspection (3) examination of materials, products, installations, plants, processes, work procedures or services, Page 6 2013-05-03 determination of their conformity with requirements and subsequent reporting of results activities to clients, when required, to authorities. Inspection activities of inspection bodies Key activities of inspection (4) Inspection can concern all stages during the lifetime of these items, including the design stage. Inspection normally requires the exercise of professional judgement in performing inspection, in particular when assessing conformity with general requirements. Page 7 2013-05-03 History of inspection Inspection has a long history. With the industrialisation in the 18th century based on the use of steam engines and the accident risk associated the first inspection bodies were established. These bodies named steam boiler inspection bodies were independent of the companies operating the steam engines and their professional judgement resulted in short time in considerable reduction of accidents. Independent inspection is today used in a wide variety of industrial sectors and other branches. Page 8 2013-05-03 History of ISO/IEC 17020 (1) The inspection standard was originally developed by the European Standardisation Organisations CEN/CENELEC as EN 45004 published in March 1995. Page 9 2013-05-03 This standard was taken over by ISO/CASCO without changes as ISO/IEC 17020 and published 1998. In 2008 the CASCO Working Group 31 was established to revise the existing ISO/IEC 17020. After 5 meetings the WG finished in July 2011 The final ballot was positive. The revised standard (2nd edition) was published in March 2012. History of ISO/IEC 17020 (2) Stage Revision Ballot WD1: WD2: CD: DIS: FDIS: 2009-06-03 2010-03-01 2010-05-17 2011-01-13 2011-09-21 - - 2010-08-27 2011-06-13 2012-01-17 Result 81 % 81 % 92 % Comments 444 316 764 539 63 Publication : 2012-03-01 (english and french) 2012-07-01 DIN EN ISO/IEC (german version) Page 10 2013-05-03 Transition period of ISO/IEC 17020:2012 ILAC resolution 2012-07-18: • “The ILAC membership agrees to a threeyear transition period for the implementation of ISO/ IEC 17020: 2012 from the date of publication of the English language version of the standard. The standard was published on 1 March 2012, therefore the three year transition period will conclude on 1 March 2015.” Page 11 2013-05-03 ISO/IEC 17020 / WG 31 - Maintenance Group Maintenance Group Page 12 2013-05-03 • • • • Keith Mowry (Certification body side) Lal Ilan (accreditation side) Tommy Scriven (Industry) Dr. Monika Wloka (standard development side) • Marcus Schmid (convenor) Aim of the revision Initiated by the result of the systematic review 2008 improvements where necessary Take into account the CASCO PAS maintaining the proven parts of the existing standard Page 13 2013-05-03 CASCO common structure The general aims of the revision implementing the relevant parts of the IAF/ILAC Guidance A4 on the implementation of ISO/IEC 17020 The main changes and improvements Content Alignment with the new structural requirements for standards for conformity assessment bodies decided by CASCO resulting in the following 8 chapters in the revised standard instead of 16 in the existing 17020: • • • • • • • • Scope Normative references Terms and definitions General requirements Structural requirements Resource requirements Process requirements Management system requirements Page 14 2013-05-03 The main changes and improvements Obligatory requirements of ISO/PAS CASCO has established common elements in the form of PAS for the use in standards for conformity assessment bodies. The obligatory requirements of the following PAS are included in the revised standard: • PAS 17001 on Impartiality included in clause 4.1 • PAS 17002 on Confidentiality included in clause 4.2 • PAS 17003 on Complaints and appeals included in clause 7.5 • PAS 17005 on Use of management systems included in clause 8 Page 15 2013-05-03 The main changes and improvements Impartiality and independence (1) The requirements on impartiality and independence which are crucial for performing inspection activities are considerably improved by implementing the relevant parts of the IAF/ILAC guidance A4 in clause 4.1 and the normative Annex A. The three types of inspection bodies (Types A, B and C) describing the different degree of independence are kept. Type A bodies are third-parties independent of the parties involved in the design, manufacture, supply, installation, use or maintenance of inspected items. Page 16 2013-05-03 The main changes and improvements Impartiality and independence (2) Type B are in-house inspection bodies forming a separate independent part of an organisation involved in the mentioned activities. Type C bodies must not be a separate part within the organisation but there must be a clear separation between inspection activities and other activities meaning that a person cannot inspect items designed, manufactured, maintained etc. by him. Page 17 2013-05-03 The main changes and improvements Competence of inspectors (1) The inspectors of the Types A, B and C have to fulfil the same competence requirements which are specified in clause 6.1 of the standard. The inspectors must have appropriate qualifications, training, experience and a satisfactory knowledge of the requirements of the inspections to be carried out. This is of special importance as many inspection activities involve professional judgement to determine conformity with general requirements. Page 18 2013-05-03 The main changes and improvements Competence of inspectors (2) Inspectors shall be trained on a continuing base to keep pace with developing technology and inspection methods. Inspectors have to be monitored (referred to as supervision in the former edition of 17020) by experienced persons including on-site observations. Page 19 2013-05-03 The main changes and improvements Subcontracting The inspection body shall itself normally perform the inspections that it contracts to undertake. The wellproven requirement in case of Subcontracting are basically kept. The reasons for subcontracting of inspections were specified based on the relevant IAF/ILAC guidance A4 by examples such as unforeseen overload, incapacitated staff members or temporarily unfit equipment. Page 20 2013-05-03 The main changes and improvements Inspection schemes In the process part of the standard (clause 7) it is required that the inspection body uses methods and procedures which are defined in requirements against which inspection is to be performed. It is clarified that such requirements can also be specified in inspection schemes. A definition of inspection schemes is now contained in the standard (clause 3.7). Page 21 2013-05-03 The main changes and improvements Commodity inspections Inspection can provide information about inspected items without determination of conformity. Commodity inspections have been considered in the standard as inspections activities and covered by a note to the definition of inspection (clause 3.1) saying that inspection procedures and schemes can restrict inspection to examination only. Page 22 2013-05-03 The main changes and improvements Inspection reports and certificates Requirements on reports and certificates have been considerably improved The standard provides a list of elements that have to be included in a report or certificate (clause 7.4.2) and of optional elements that can be included (informative Annex B). Page 23 2013-05-03 The main changes and improvements Management system requirements The management system requirements are concentrated in chapter 8. • According to PAS 17005 the certification body has two options to establish and maintain a management system that is capable of achieving the consistent fulfilment of the requirements of ISO/IEC 17020. • The requirements of option A are provided in detail in clauses 8.2 to 8.8. • Option B gives the possibility to use ISO 9001 as an alternative to fulfil the requirements contained in clause 8.2 to 8.8. Page 24 2013-05-03 Cross reference 17020:1998 – 17020:2012 (1) 17020:1998 17020:2012 1.1 1 1.2 Introduction, 4. paragraph 1.3 Introduction, 5. paragraph 1.4 Introduction, 6. paragraph 2.1 3.1 2.2 3.5 3 5.1 3.1 5.1.1 3.2 5.1.2 3.3 5.1.3 3.4 5.1.4 3.5 5.1.5 3.6 Note 2: restriction to examination possible Not included 4.1 4.1.2 to 4.1.5 4.1 1st sentence 4.1 remark Applies to Type A, B, C and any stage 2nd sentence 4.1.2 6.1.12 4.2 4.1.6 4.2.1 4.1.6 a) 4.2.2 4.1.6 b) 4.2.3 4.1.6 c) Page 25 2013-05-03 PAS 17001 included Partly covered Cross reference 17020:1998 – 17020:2012 (2) 17020:1998 17020:1998 5 6 6.1 4.2 5.2 5.2.2 6.2 1st sentence 6.2 2nd sentence 6.3 6.4 6.5 6.6 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 8 8.1 8.2 8.3 5.2.3 5.2.4 5.2.5 6.1.8 5.2.6 5.2.7 8 8.2.1 8.1.1 8.2.1 8.2.3 8.2.3 8.3 8.6 8.7 8.5 6.1 6.1.2 6.1.3 6.1.5/6.1.6/6.1.7 Page 26 2013-05-03 17020:1998 PAS 17002 included Supervision replaced by monitoring PAS 17005 included Cross reference 17020:1998 – 17020:2012 (3) 17020:1998 8.4 8.5 8.6 9 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11 9.12 9.13 9.14 9.15 10 10.1 Page 27 2013-05-03 17020:1998 17020:1998 6.1.10 Not included 6.1.11 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.2.8 6.2.9 6.2.10 6.2.11 6.2.12 6.2.13 6.2.14 6.2.15 7.1 7.1.1 Cross reference 17020:1998 – 17020:2012 (4) 17020:1998 17020:1998 10.2 7.1.2 10.3 7.1.3 10.4 7.1.4 10.5 7.1.5 10.6 7.1.7 10.7 7.1.8 10.9 7.1.9 11 7.2 11.1 7.2.1 11.2 7.2.3 11.3 7.2.2 11.4 7.2.4 12.1 7.3.1 12 7.3 12.2 7.3.1 12.3 8.4.2 13 7.4/Annex B Page 28 2013-05-03 17020:1998 Extended based on IAF/ILAC A4 guidance Cross reference 17020:1998 – 17020:2012 (5) 17020:1998 17020:1998 17020:1998 13.1 7.4.1 13.2 1st sentence 7.4.2 13.2 1st/2nd sent. 7.4.4 13.3 7.4.2 e) 13.4 7.4.5 14 6.3 14.1 6.3.1 1st sentence 14.2 1st sentence 6.3.1 2nd sentence 14.2 3rd sent. 6.3.2 14.3 6.3.4 14.4 6.3.3 15 7.5/7.6 16 5.2.2 Note Annex A Annex A.1 Based on IAF/ILAC guidance A4 Annex B Annex A.2 Based on IAF/ILAC guidance A4 Annex C Annex A.3 Based on IAF/ILAC guidance A4 Annex D 8 Page 29 2013-05-03 Note 1 added based on IAF/ILAC guidance A4 PAS 17003 included Cross reference 17020:2012 – 17020:1998 17020:2012 17020:1998 Introduction, 4. paragraph 1.2 Introduction, 5. paragraph Introduction, 6. paragraph 1.3 1.4 1 2 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 1.1 Page 30 2013-05-03 Remark Applies to Type A, B, C and any stage Normative references not included 2.1 New definition New definition New definition 2.2 New definition New definition New definition New definition New definition 4 4.1 1st sentence PAS 17001 included PAS 17001 included PAS 17001 included PAS 17001 included PAS 17001 included Cross reference 17020:2012 – 17020:1998 (2) 17020:2012 4.1.6 4.1.6 a) 4.1.6 b) 4.1.6 c) 4.2 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.2 5.2.1 5.2.2 5.2.2 Note 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 Page 31 2013-05-03 17020:1998 4.2 4.2.1 4.2.2 4.2.3 5 3 3.1 3.2 3.3 3.4 3.5 6 Remark PAS 17002 included PAS 17001 included 6.1 16 6.2 1st sentence 6.2 2nd sentence 6.3 6.5 6.6 Cross reference 17020:2012 – 17020:1998 (3) 17020:2012 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.1.8 6.1.9 6.1.10 6.1.11 6.1.12 6.1.13 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 Page 32 2013-05-03 17020:1998 Remark 8 8.1 8.2 8.3 8.3 8.3 6.4 8.4 8.6 4.1 2nd sentence 5 9 9.1 9.2 9.3 9.4 9.5 Supervision replaced by monitoring Based on IAF/ILAC guidance A4 PAS 17001 included PAS 17002 included Cross reference 17020:2012 – 17020:1998 (4) 17020:2012 17020:1998 6.2.6 6.2.7 9.6 9.7 6.2.8 9.8 6.2.9 9.9 6.2.10 9.10 6.2.11 9.11 6.2.12 9.12 6.2.13 9.13 6.2.14 9.14 6.2.15 9.15 6.3 14 6.3.1 1st sentence 14.1 6.3.1 2nd sentence 14.2 6.3.1 Note Based on IAF/ILAC guidance A4 6.3.2 14.2 6.3.3 14.4 6.3.4 14.3 7.1 10 7.1.1 10.1 7.1.2 10.2 Page 33 2013-05-03 Remark 3rd sentence Cross reference 17020:2012 – 17020:1998 (5) 17020:2012 17020:1998 7.1.3 10.3 7.1.4 10.4 7.1.5 10.5 Remark 7.1.6 7.1.7 10.6 7.1.8 10.7 7.1.9 10.8 7.2 11 7.2.1 11.1 7.2.2 11.3 7.2.3 11.2 7.2.4 11.4 7.3 12 7.3.1 12.1/12.2 7.3.2 7.4 13 7.4.1 13.1 7.4.2 13.2 1st sentence Page 34 2013-05-03 Extended based on IAF/ILAC A4 guidance Cross reference 17020:2012 – 17020:1998 (6) 17020:2012 7.4.2 e) 17020:1998 Remark 13.3 7.4.3 7.4.4 13.2 2nd/3rd sentence 7.4.5 13.4 7.5 15 PAS 17003 included 7.6 15 PAS 17003 included 8 7/Annex D PAS 17005 included 8.1.1 8.1.2 7.2 8.1.3 8.2.1 8.2.2 8.2.3 8.2.4 8.3 PAS 17005 included PAS 17005 included 7.1/7.3 7.4/7.5 7.6 8.4 8.4.2 Page 35 2013-05-03 12.3 Cross reference 17020:2012 – 17020:1998 17020:2012 17020:1998 8.5 7.9 8.6 7.7 8.7 7.8 Remark 8.8 Annex A.1 Annex A Based on IAF/ILAC guidance A4 Annex A.2 Annex B Based on IAF/ILAC guidance A4 Annex A.3 Annex C Based on IAF/ILAC guidance A4 Annex B Page 36 2013-05-03 Based on IAF/ILAC A4 guidance Presentation preapared by: Marcus Schmid is Director Management Systems Voith Turbo GmbH & Co KG, and Director Quality Management Voith Turbo Rail Division. Mr. Schmid is Convenor of ISO/CASCO working group WG 31, which developed ISO/IEC 17020. He is also member of the DIN Quality Management, Statistics and Certification Standards Committee, and chairs the DIN mirror committee to WG 31. Tel. +49 (0) 7321 37-8155 [email protected] Page 37 2013-05-03 Gerd-Hinrich Schaub is a consultant of the Association of the TÜV (VdTÜV) and technical advisor of the International Confederation of Inspection and Certification Organisations (CEOC). His main focus is conformity assessment, product marking and accreditation. He is a member of several ISO/CASCO working groups and committees of accreditation associations (ILAC and EA). Tel. +49 (0) 201-49 39 22 [email protected]
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