SANAS Transition Policy: ISO/IEC 17020: 2012

Transcription

1 SANAS Transition Policy: ISO/IEC 17020: 2012 CONTENTS 1 Introduction 2 Transition to ISO/IEC Specific changes in requirements Appendix A: Summary of changes Appendix B: Cross References: ISO/IEC 17020: 1998 and ISO/IEC 17020: SANAS Page 1 of 11

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. On Wednesday, 18 July 2012 International Laboratory Accreditation Co-Operation (ILAC) ISO/IEC 17020: 2012 published their resolution on the transition period of three (3) years with the final date of transition as 01 March 2015, please see ILAC Secretariat communication below. Dear ILAC members, I am pleased to advise that the resolution on the transition period for the implementation of ISO/IEC 17020: 2012, submitted for a 30 day ballot, has been unanimously agreed by ILAC voting members. The agreed resolution is as follows: The ILAC membership agrees to a three-year transition period for the implementation of, ISO/ IEC 17020: 2012 Conformity assessment Requirements for the operation of various types of inspection bodies performing inspection, 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 The outcome of the ballot and the agreed resolution is also available in the News section of the ILAC website Kind regards Annette Dever ILAC Secretary 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 of SANAS Transition Plan on the SANAS website 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 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 document A 01 will apply SANAS Page 2 of 11

3 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 (existing Inspection Bodies as well as new applicants) shall be conducted against ISO/IEC 17020: 2012 All non-conformances raised during the transition period against requirements in the new standard (ISO/IEC 17020: 2012), that would also have been non-conformances against the old standard (ISO/IEC 17020: 1998), would require corrective actions from the facilities (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 that have not yet started implementation of the new standard (ISO/IEC 17020: 2012), shall start implementation as soon as possible. SANAS expect Inspection Bodies to establish an action plan for implementation. The plan shall be send to SANAS before 01 October 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 which demonstrates that they have analysed the new standard and its implications for their management system and operations and that they have drafted a plan to effectively implement all changes needed to comply before the date set by ILAC, namely 01 March 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. If Inspection Bodies fail to provide the action plan before 01 October 2012, SANAS will raise a finding that the Inspection Body will need to respond to within 25 working days as per SANAS procedures. 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: SANAS Page 3 of 11

4 2.3.1 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 on 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 the documented systems and the progress made towards 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 on this review. The internal audit report shall report clearly and positively on the findings related to implementing ISO 17020: If such an internal audit report cannot be demonstrated, SANAS will raise a finding that the Inspection Body will need to respond to within 25 working days as per SANAS procedures 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 when drafting the action plan; Internal audit of changes; If the Inspection Body has multiple sites the implementation at all sites; Communication of changes to 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; 2.4 Non conformities against new requirements Non-conformities issued against clauses of ISO/IEC 17020: 2012 that are not non-conformities against one of the preceding versions of ISO/IEC or the guidance documents, will be recorded as observations to highlight the gap identified. The Inspection Bodies have until 01 September 2014 to implement corrective actions and provide SANAS with the corrective action report. SANAS shall verify these actions before 01 October 2014 and take its decision before 01 November If SANAS cannot confirm that an Inspection Body complies with the new standard (ISO/IEC 17020: 2012) by 01 November 2014, accreditation against the standard ISO/IEC 17020: 1998 shall be suspended on 01 March No accreditation against ISO/IEC 17020: 2012 shall be granted (refer to 2.6). 2.5 Existing guidance and explanatory documents The Guidance IAF/ILAC A4: 2004 is not applicable to lso/iec 17020: The Technical Requirements (TR documents), as supported by the Regulators remain in force and have been revised to address ISO/IEC 17020: Inspection Bodies shall ensure that they have read and understand the revised requirements. The Technical Requirements (TR documents) are available on the SANAS website and it is the responsibility of Inspection Bodies to download the documents from the SANAS website SANAS Page 4 of 11

5 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. 2.6 Accreditation certificate and schedule 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. Inspection Body accreditation numbers will remain the same. The date on the certificate will be the date of the decision to grant accreditation against the new standard. It is important to note that the four year assessment cycles will remain unchanged, i.e. a new four year cycle will not automatically commence on the date of accreditation to ISO/IEC 17020:2012. This will only happen in the case of initial and reassessments. 3. 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 a complete list of changes because some clauses are not new but have significantly changed in wording. Appendix B contains cross references between the new standard and old standard and the present guidance documents. Appendix A provides explanations for the issues which changed significantly. SANAS however did not intend to provide a complete list of all the changes. It remains the responsibility of each CAB to investigate which changes in the standard are relevant SANAS Page 5 of 11

6 NOTE: Transition Flowchart to be included in Revision 03 of this document SANAS Page 6 of 11

7 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 7 of 11

8 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 8 of 11

9 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 9 of 11

10 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) 7.6 Control of documents Additional requirement Control of records (option A) 12. Records Management review (option A) 7.9 Management review General New requirement New requirement Review inputs - New requirement A4: 7.9a Review outputs - New requirement 8.6 Internal audits (option A) 7.7 Internal audits Additional requirement Additional requirement Additional requirement Additional requirement SANAS Page 10 of 11

11 Comparison between ISO/IEC 17020: 2012 and ISO/IEC 17020:1998 ISO/IEC 17020: 2012 ISO/IEC 17020: Corrective actions (option A) 7.8 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 11 of 11