Presentation on theme: "Presentation on the new standard"— Presentation transcript:
1Presentation on the new standard ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspectionPresentation on the new standard
2The 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 ISO CASCO Convenor WG 31 Sean MacCurtain Marcus Schmid
3Table of content 2013-05-03 Key activities of inspection History of inspectionHistory of ISO/IEC 17020Transition period of ISO/IEC 17020:2012ISO/IEC / WG 31 - Maintenance GroupAim of the revisionThe main changes and improvements:ContentObligatory requirements of ISO/PASImpartiality and independenceCompetence of inspectorsSubcontractingInspection schemesCommodity inspectionsInspection reports and certificatesManagement system requirementsCross reference 17020:1998 – 17020:2012Cross reference 17020:2012 – 17020:1998
4Key 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.
5Key activities of inspection (2) Inspection parametersquantity,quality,safety,fitness for purpose,continued safety compliance of installations or systems in operation.
6Key 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
7Key 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.
8History of inspection 2013-05-03 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.
9History of ISO/IEC 17020 (1) 2013-05-03 The inspection standard was originally developed by the European Standardisation Organisations CEN/CENELEC as EN published in March 1995.This standard was taken over by ISO/CASCO without changes as ISO/IEC and published 1998.In 2008 the CASCO Working Group 31 was established to revise the existing ISO/IEC After 5 meetings the WG finished in July 2011The final ballot was positive. The revised standard (2nd edition) was published in March 2012.
10History of ISO/IEC 17020 (2) Stage Revision Ballot Result Comments WD1:WD2:CD: % 764DIS: % 539FDIS: %Publication : (english and french)DIN EN ISO/IEC (german version)
11Transition 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.”
12ISO/IEC 17020 / 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)
13Aim of the revision Initiated by the result of the systematic review 2008 The general aims of the revisionmaintaining the proven parts of the existing standardTake into account the CASCO PASimprovements where necessaryCASCO common structureimplementing the relevant parts of the IAF/ILAC Guidance A4 on the implementation of ISO/IEC 17020
14The 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:ScopeNormative referencesTerms and definitionsGeneral requirementsStructural requirementsResource requirementsProcess requirementsManagement system requirements
15The 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 4.1PAS on Confidentiality included in clause 4.2PAS on Complaints and appeals included in clause 7.5PAS on Use of management systems included in clause 8
16The 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.
17The 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.
18The 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.
19The 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.
20The 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.
21The 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).
22The 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.
23The main changes and improvements Inspection reports and certificates Requirements on reports and certificates have been considerably improvedThe 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).
24The 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/IECThe 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.
25Cross reference 17020:1998 – 17020:2012 (1) 17020:1998 17020:2012 remark1.11Applies to Type A, B, C and any stage1.2Introduction, 4. paragraph1.3Introduction, 5. paragraph1.4Introduction, 6. paragraph2.13.1Note 2: restriction to examination possible2.23.5184.108.40.206.220.127.116.11.18.104.22.168.22.214.171.124Not included126.96.36.199 to 4.1.5PAS included4.1 1st sentence188.8.131.52 2nd sentence6.1.12Partly covered184.108.40.206.220.127.116.11 a)18.104.22.168.6 b)22.214.171.124.6 c)
26Cross reference 17020:1998 – 17020:2012 (2) 17020:1998 5 4.2 PAS included126.96.36.199.26.2 1st sentence188.8.131.52 2nd sentence184.108.40.206.220.127.116.11.8Supervision replaced by monitoring18.104.22.168.65.2.778PAS included22.214.171.124.126.96.36.199.188.8.131.52.184.108.40.206.220.127.116.11.18.104.22.168.22.214.171.124/6.1.6/6.1.7
30Cross reference 17020:2012 – 17020:1998 17020:2012 17020:1998 Remark Introduction, 4. paragraph1.2Introduction, 5. paragraph1.3Introduction, 6. paragraph1.411.1Applies to Type A, B, C and any stage2Normative references not included126.96.36.199New definition188.8.131.52.184.108.40.206.220.127.116.11.1PAS included18.104.22.168 1st sentence22.214.171.124.44.1.5
37Presentation preapared by: Marcus Schmidis 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 Schaubis 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)