SANAS Transition Policy of ISO/IEC 17020: 2012

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1 SANAS Transition Policy of ISO/IEC 17020: 2012 CONTENTS 1 Introduction 2 Transition to ISO/IEC Specific changes in requirements 4 Modifications of this document to the previous edition Appendix A: Appendix B: Summary of changes Cross Reference new and old SANAS Page 1 of 10

2 1. Introduction On 27 February 2012 the standard ISO/IEC 17020: 2012 Conformity assessment General criteria for the operation of various types of bodies performing inspection has been published by ISO. Based on the resolutions of the International Laboratory Accreditation Co-Operation (ILAC) ISO/IEC 17020: 2012 replaces the standard ISO/IEC 17020: General criteria for the operation of various types of bodies performing inspection ISO/lEC also replaces the guidance documents IAF/ILAC A4: 2004 Guidance on the Application of ISO/IEC It is expected that explanatory documents related to ISO/IEC shall be revised more frequently than other SANAS explanatory documents. Conformity Assessment Bodies (CAB s), accredited against the ISO/IEC 17020: 2012 or it s preceding ISO/IEC 17020: 1998, and other interested parties are advised therefore to periodically check for recent revisions on the website of SANAS The ILAC website should be consulted for publication of new or revised Guidance documents, as it is expected that guidance documents shall be published in near future. This document applies to the accreditation Inspection Bodies that are currently accredited by SANAS based on the ISO/IEC 17020: 1998 standards. For the purposes of this document the definitions in ISO/IEC Conformity assessment Vocabulary and general principles and SANAS A 01 will apply. 2. Transition to ISO/IEC General For the CAB s Accredited for Inspection, the arrangement includes the following: SANAS shall not conduct assessments against the new standard ISO/IEC 17020: 2012 before 01 July Between 01 March and 01 July 2012 SANAS will use ISO/IEC 17020: 1998 for the assessments, unless the Inspection Body explicitly requests assessment against the new standard instead. This request should be done when scheduling the assessment. After 01 July 2012 all assessments shall be conducted against ISO/IEC 17020: 2012 For new applications Assessment conducted after 01 July 2012 shall be performed against the new standard ISO/IEC 17020: The assessment of implementation (office assessment and witnessing) however shall not be conducted before 01 July 2012 For non-conformities raised during the transition period against requirements in the new standard ISO/IEC 17020: 2012 that would not have been a non-conformity against the old standard ISO/IEC 17020: 1998 corrective actions apply (refer to 2.4). SANAS shall issue a new accreditation certificate only after having confirmed compliance with ISO/IEC 17020: 2012 and a positive decision is taken on this (refer to 2.6). It is important that Inspection Bodies, if not already started implementation of the new standard ISO/IEC 17020: 2012, shall start implementation as soon as possible. SANAS expect Inspection SANAS Page 2 of 10

3 Bodies to establish an action plan for implementation. The plan shall be send to SANAS before 01 July 2012 (or, if you have elected to be assessed against ISO/IEC 17020: 2012 between 01 March and 01 July 2012, at least one (1) month before that assessment). Based on the plan SANAS will, for each Inspection Body, decide on the assessment method to verify compliance with the new standard (refer to 2.2). One of the most significant changes is the requirement for Inspection Bodies to identify and manage the risks to their impartiality on a continuous basis, clause 4.1. Another significant change is the requirement for staff to have knowledge of the value chain of the items inspected and the formal authorisation of staff involved in inspection activities. 2.2 The action plan of the Inspection Body Before 01 October 2012 the Inspection Body shall provide SANAS with an action plan by which they demonstrate to have analysed the new standard and its implication for their management system and operations and they have drafted a plan to effectively implement all changes needed to comply before the date set by ILAC which is expected to be 27 February As a minimum the plan shall include: 1. All specific actions to be taken to implement the changes, 2. The time lines and milestones for completion of actions, 3. The persons responsible for the actions, 4. Ways to monitor progress and completion of the actions, For Inspection Bodies that fail to provide the action plan before 01 October 2012, SANAS will raise a finding which the Inspection Body will need to respond to within 25-days as per SANAS procedure. 2.3 SANAS assessment for the purpose of transition The assessment to verify the implementation of the new standard ISO/IEC 17020: 2012 shall consist of: Review of the changes in documentation The review of the action plan of the Inspection Body shall be conducted at the SANAS office to verify that the Inspection Body has analysed the impact for its system and has drafted the plan for implementation (refer to 2.2). During the first surveillance assessment after 01 October 2012, SANAS will review the changes in documented system and the progress in implementation of the action plan. When the Inspection Body has performed an internal audit to assess the effectiveness of the changes and its implementation, SANAS will not spend additional time for this review. The internal audit report should report clearly and positively about the findings related to implementing conformity with ISO 17020: If such an internal audit cannot be demonstrated then SANAS will raise a finding which the Inspection Body will need to respond to within 25-days as per SANAS procedure Assessment at the office of the Inspection Body. During the first Surveillance assessment after 01 October 2012, SANAS will review records concerning the implementation of the new standard. As a minimum these records shall demonstrate: Analysis of impact on system and in drafting the action plan; Internal audit of changes; SANAS Page 3 of 10

4 If the Inspection Body has multiple sites the implementation at all sites; Communication of changes in the system to interested parties; Identification of risks to impartiality on an on-going basis Personnel records reflecting competence rather than only meeting qualification requirements; 3.3 Non conformities against new requirements Non-conformities issued against clauses of ISO/IEC 17020: 2012 that are not a nonconformities against one of the preceding standard ISO/IEC 17020: 1998 or the guidance documents will be recorded as an observation to highlight the gap identified. The Inspection Bodies has until 01 September 2013 to implement corrective actions and provide SANAS with the corrective action report. SANAS shall verify these actions before 01 October 2013 and take its decision before 01 November If before this date, SANAS cannot confirm that the Inspection Body complies with the new standard ISO/IEC 17020: 2012, the accreditation for the standard ISO/IEC 17020: 1998 shall be suspended on 27 February 2014 but no accreditation for lso/iec 17020: 2012 shall be granted (refer to 2.6). 3.4 Existing guidance and explanatory documents The Guidance IAF/ILAC A4: 2004 is not applicable for lso/iec 17020: The guidance documents as support by the Regulators remain in force and are the process of revision to address ISO/IEC 17020: SANAS shall in due time revise its current explanatory documents applicable for Inspection Body Accreditation, until revision has taken place the documents remain in force. References to the previous standards should be read as references to the new standard. 3.5 Accreditation certificate The Certificate and Schedule of Accreditation will be adapted to reflect accreditation against ISO/IEC 17020: 2012 after the assessment against the new standard has been successfully completed and a decision for continuation / maintenance / renewal of accreditation has been taken. The accreditation number will remain the same. The date on the certificate will be the date of the decision to grant accreditation for the new standard. 4 Specific changes in requirements Appendix A of this document contains the clauses which are new compared to the previous standards and guidance documents. This list can however not be considered the complete list of changes because some clauses are not new but have significantly changed in wording. Appendix B gives a cross reference of the new standard with the old standard and the present guidance documents. Appendix A provides for an explanation for the issues which are significantly changed. SANAS has however not the intention to provide a complete list of all the changes in the next paragraphs. It remains the responsibility of each CAB to investigate which changes in the standard are relevant SANAS Page 4 of 10

5 ISO/IEC 17020: 2012 Transition Flow Chart Issue Accreditation Certificate Issue Accreditation Certificate Yes Yes Notification of the transition 01 March Plan submitted to SANAS before 01 October Determine assessment method Assessment at CAB offices After 01 October Complies? Non-conformity cleared? No Suspension by 27 February No Buy the SANS Develop Implementation plan Non-conformity Clear nonconformity Before 01 November SANAS Page 5 of 10

6 Appendix A: Summary of changes Clause ISO/IEC 17020: 2012 Details of changes SANAS explanation 4.1 Impartiality and independence Identification of risks to IB s impartiality 4.2 Confidentiality Legally enforceable commitments 5.1 Administrative requirements Adequate provision (e.g. insurance or reserves) 6.1 Personnel Define and document the competence requirements for all personnel Relevant knowledge of significance of deviations found with regard to the normal use of the products, the operation of the processes and the delivery 7.1 Inspection methods and procedures 8 Management system requirements of services Documented procedures for selecting, training, formally authorizing, and monitoring inspectors and other personnel Inform the client if the inspection method proposed by the client is considered to be inappropriate Traceable to performing inspector(s) Inspection report/certificate shall include all of the following: a) to g) 7.5 Complaints and appeals and 7.6 Complaints and appeals process Management system options A or B available. 8.8 Preventive actions Preventive actions procedure required Considered a new requirement, management system documentation must be revised to address the identification of risks and actions taken to minimise / eliminate the risk Legally enforceable commitments can be, for example, contractual agreements. See note in How are liabilities covered arising from its operations? Not only insurance The competence requirements can be part of the job description or other documentation. Personnel must Records must include a formal declaration of competence, see clause as well Evidence of customer interaction required, formal or informal Traceability Inspection report/certificate to be revised to comply with clause Additional and new requirements, management system to be updated accordingly. Selection of management system options A or B and system revised accordingly New to management system SANAS Page 6 of 10

7 Appendix B: Cross Reference Comparison between ISO/IEC 17020: 2012 and ISO/IEC 17020:1998 ISO/IEC 17020: 2012 ISO/IEC 17020: 1998 Foreword Foreword Introduction Introduction 1. Scope 1. Scope 2. Normative references 3. Terms and definitions 2. Definitions 4. General requirements 4. Independence, impartiality and integrity 4.1 Impartiality and Independence General New requirement, identify risk New requirement, minimise risk New requirement, management commitment Annex A 4.2 Independence a) Type A Inspection Body b) Type B Inspection Body c)type C Inspection Body 4.2 Confidentiality 5. Confidentiality New requirement, legally enforceable arrangements Additional; customer notification A4: 5. Confidentiality New requirement 5. Structural requirements 5.1 Administrative requirements 3. Administrative requirements Not only liability insurance Organization and management 6. Organization and management & & A4: 6.3a Resource requirements 6.1 Personnel 8 Personnel New requirement. Competence Expanded. Knowledge of value chain New requirement. Formally authorising SANAS Page 7 of 10

8 Comparison between ISO/IEC 17020: 2012 and ISO/IEC 17020:1998 ISO/IEC 17020: 2012 ISO/IEC 17020: Alternative. On-site observation unless? Expanded. Records required Expanded. All personnel impartial Confidentiality 6.2 Facilities and equipment 9. Facilities and equipment Additional requirement for competent and 9.1 & A4: 9.1a safe manner Expanded. Significant influence defined 9.4 and uniquely identified Additional. Significant influence, calibrate Additional notes on adequacy of software Expanded. Examine effects on defects 9.14 and action Sub-contracting 14. Sub-contracting See Notes 14.1, 14.2 & A4: 14.2a Expanded. Customer informed? Process requirements 10. Inspection methods and procedures 7.1 Inspection methods and procedures Additional. Customer informed if considered inappropriate 10.1 & A4: 10.1a See Notes on Standard and Non-standard 10.3 & A4: 10.3a method New. Use of information from other parties Handling inspection items and samples 11. Handling inspection samples and items Expanded. IB establish preparation Inspection records 12. Records See also & New. Traceability to performing inspector SANAS Page 8 of 10

9 Comparison between ISO/IEC 17020: 2012 and ISO/IEC 17020:1998 ISO/IEC 17020: 2012 ISO/IEC 17020: Inspection reports and inspection 13. Inspection reports and inspection certificates certificates Additional requirements New requirement, report/certificate Additional requirements Complaints and appeals 15. Complaints and appeals Additional requirements 15.1 & New requirement, availability New requirement New requirement New requirement 7.6 Complaints and appeals procedure 15. Complaints and appeals Additional requirement New requirement New requirement New requirement New requirement 8. Management system requirements 7. Quality System 8.1 Options New System option for Inspection Body Option A Option B - New 8.2 General Management System Documentation (option A) & New requirement New requirement 8.3 Control of documents (option A) 7.5 Control of documents Additional requirement Control of records (option A) 12. Records Management review (option A) 7.9 Management review General New requirement Review inputs - New requirement Review outputs - New requirement 8.6 Internal audits (option A) 7.6 Internal audits Additional requirement Additional requirement Additional requirement Additional requirement SANAS Page 9 of 10

10 Comparison between ISO/IEC 17020: 2012 and ISO/IEC 17020:1998 ISO/IEC 17020: 2012 ISO/IEC 17020: Corrective actions (option A) 7.7 Corrective actions Additional requirement Additional requirement Additional requirement 8.8 Preventive actions (option A) New New requirement New requirement New requirement Annex A (normative) Independence requirements 4.1 for Inspection Bodies A.1 Requirements for Inspection Bodies (Type A) Annex A (normative) A.2 Requirements for Inspection Bodies (Type B) Annex B (normative) A.3 Requirements for Inspection Bodies (Type Annex C (normative) C) Annex B (informative) Optional elements of inspection reports and certificates Bibliography APPENDIX 3: Elements of Inspection Reports and Inspection Certificates IAF/ILAC-A4: Guidance on the Application of ISO/IEC SANAS Page 10 of 10

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