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Page 1 ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection Presentation on the new.

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Presentation on theme: "Page 1 ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection Presentation on the new."— Presentation transcript:

1 Page 1 ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection Presentation on the new standard

2 Page 2 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 SecretaryISO CASCO Convenor WG 31 Sean MacCurtainMarcus Schmid

3 Page 3 Table of content Key activities of inspectionHistory of inspectionHistory of ISO/IEC 17020Transition period of ISO/IEC 17020:2012ISO/IEC / WG 31 - Maintenance GroupAim of the revisionThe 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 – 17020:2012Cross reference 17020:2012 – 17020:

4 Page 4 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

5 Page 5 Key activities of inspection (2) Inspection parameters quantity,quality,safety, fitness for purpose, continued safety compliance of installations or systems in operation

6 Page 6 Key activities of inspection (3) determination of their conformity with requirements and subsequent reporting of results activities to clients, when required, to authorities. examination of materials, products, installations, plants, processes, work procedures or services, Inspection activities of inspection bodies

7 Page 7 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

8 Page 8 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

9 Page 9 History of ISO/IEC (1) The inspection standard was originally developed by the European Standardisation Organisations CEN/CENELEC as EN published in March This standard was taken over by ISO/CASCO without changes as ISO/IEC and published In 2008 the CASCO Working Group 31 was established to revise the existing ISO/IEC After 5 meetings the WG finished in July 2011 The final ballot was positive. The revised standard (2 nd edition) was published in March

10 Page 10 History of ISO/IEC (2) StageRevision Ballot Result Comments WD1: WD2: CD: %764 DIS: %539 FDIS: % 63 Publication : (english and french) DIN EN ISO/IEC (german version)

11 Page 11 Transition period of ISO/IEC 17020:2012 ILAC resolution : “The ILAC membership agrees to a three- year 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.”

12 Page 12 ISO/IEC / WG 31 - Maintenance Group Keith Mowry (Certification body side) Lal Ilan (accreditation side) Tommy Scriven (Industry) Dr. Monika Wloka (standard development side) Marcus Schmid (convenor) Maintenance Group

13 Page 13 Aim of the revision Initiated by the result of the systematic review 2008 The general aims of the revision maintaining the proven parts of the existing standard Take into account the CASCO PAS improvements where necessary CASCO common structure implementing the relevant parts of the IAF/ILAC Guidance A4 on the implementation of ISO/IEC

14 Page 14 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

15 Page 15 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 on Impartiality included in clause 4.1 PAS on Confidentiality included in clause 4.2 PAS on Complaints and appeals included in clause 7.5 PAS on Use of management systems included in clause

16 Page 16 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

17 Page 17 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

18 Page 18 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

19 Page 19 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

20 Page 20 The main changes and improvements Subcontracting The inspection body shall itself normally perform the inspections that it contracts to undertake. The well- proven 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

21 Page 21 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)

22 Page 22 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

23 Page 23 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)

24 Page 24 The main changes and improvements Management system requirements The management system requirements are concentrated in chapter 8. According to PAS 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 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

25 Page 25 Cross reference 17020:1998 – 17020:2012 (1) 17020: :2012remark 1.11Applies to Type A, B, C and any stage 1.2Introduction, 4. paragraph 1.3Introduction, 5. paragraph 1.4Introduction, 6. paragraph Note 2: restriction to examination possible Not included to 4.1.5PAS included 4.1 1st sentence nd sentence6.1.12Partly covered a) b) c)

26 Page 26 Cross reference 17020:1998 – 17020:2012 (2) 17020: PAS included st sentence nd sentence Supervision replaced by monitoring PAS included /6.1.6/

27 Page 27 Cross reference 17020:1998 – 17020:2012 (3) 17020: Not included

28 Page 28 Cross reference 17020:1998 – 17020:2012 (4) 17020: /Annex BExtended based on IAF/ILAC A4 guidance

29 Page 29 Cross reference 17020:1998 – 17020:2012 (5) 17020: st sentence st /2 nd sent e) st sentence st sentence nd sentenceNote 1 added based on IAF/ILAC guidance A rd sent /7.6PAS included Note Annex AAnnex A.1Based on IAF/ILAC guidance A4 Annex BAnnex A.2Based on IAF/ILAC guidance A4 Annex CAnnex A.3Based on IAF/ILAC guidance A4 Annex D

30 Page 30 Cross reference 17020:2012 – 17020: : :1998Remark Introduction, 4. paragraph1.2 Introduction, 5. paragraph1.3 Introduction, 6. paragraph Applies to Type A, B, C and any stage 2 Normative references not included New definition 3.3 New definition 3.4 New definition New definition 3.7 New definition 3.8 New definition 3.9 New definition 3.10 New definition PAS included st sentencePAS included PAS included PAS included PAS included

31 Page 31 Cross reference 17020:2012 – 17020:1998 (2) 17020: :1998Remark a) b) c) PAS included PAS included Note st sentence nd sentence

32 Page 32 Cross reference 17020:2012 – 17020:1998 (3) : :1998Remark Supervision replaced by monitoring Based on IAF/ILAC guidance A nd sentencePAS included PAS included

33 Page 33 Cross reference 17020:2012 – 17020:1998 (4) 17020: :1998Remark st sentence nd sentence Note Based on IAF/ILAC guidance A rd sentence

34 Page 34 Cross reference 17020:2012 – 17020:1998 (5) 17020: :1998Remark / Extended based on IAF/ILAC A4 guidance st sentence

35 Page 35 Cross reference 17020:2012 – 17020:1998 (6) 17020: :1998Remark e) nd /3 rd sentence PAS included 7.615PAS included 87/Annex DPAS included PAS included PAS included / /

36 Page 36 Cross reference 17020:2012 – 17020: : :1998Remark Annex A.1Annex ABased on IAF/ILAC guidance A4 Annex A.2Annex BBased on IAF/ILAC guidance A4 Annex A.3Annex CBased on IAF/ILAC guidance A4 Annex B Based on IAF/ILAC A4 guidance

37 Page 37 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 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) 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)


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