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Implementation of ISO/IEC 17020:2012
RvA-T035-UK Version 1, 04 april 2013
is documented by EA. ILAC or IAF.nl). the RvA will bring its policy en procedures in line with the EA. (www. .A RvA-Explanatory note describes the policy and/or the procedures of the RvA concerning a specific field of accreditation. In case the policy and/or procedures for a specific field of accreditation as described in a RvA Explanatory note.rva. ILAC or IAF-document. A current version of the Explanatory is available through the website of the RvA.
5 3 Introduction __________________________________________________ 4 Transition to ISO/IEC 17020:2012 ________________________________ 4 General ______________________________________________________ 4 RvA assessment of the transition to ISO/IEC 17020:2012 _____________ 5 Non-conformities against new requirements _______________________ 6 Guidelines and explanations ____________________________________ 6 Accreditation certificate ________________________________________ 6 Modifications of this document to the previous edition ______________ 7 Appendix A: Summary of changes_____________________________________ 8 Dutch Accreditation Council (RvA) T035-UK.4 2. version 1 page 3 of 14 last update of this version: 4-4-2013 .Contents 1 2 2.2 2.1 2.3 2.
. is based on: . Besides that. version 1 page 4 of 14 last update of this version: 4-4-2013 .ISO/PAS 17005:2008 “Conformity assessment – Use of management systems – Principles and requirements”. This explanatory document describes the RvA policy and practices for the implementation of ISO/IEC 17020:2012.ISO/PAS 17002:2004 “Conformity assessment – Confidentiality – Principles and requirements”. The international standard ISO/IEC 17020:2012 a. the structure has been harmonized with other accreditation standards. the structure (chapters) has changed completely in comparison with the 1998-version of the standard. .1 Introduction On March 1. . This explanatory document applies to all accreditations of inspection bodies previously accredited against ISO/IEC 17020:1998. The RvA decided to combine the transition to the ISO/IEC 17020:2012 with the regular assessments as much as possible. ISO/IEC 17020:2012 replaces the standard: ISO/IEC 17020:1998 “General criteria for the operation of various types of bodies performing inspection”. Dutch Accreditation Council (RvA) T035-UK.ISO/PAS 17001:2005 “Conformity assessment – Impartiality – Principles and requirements”.IAF/ILAC-A4:2004 “Guidance on the Application of ISO/IEC 17020”.ISO/PAS 17004:2005 “Conformity assessment – Disclosure of information — Principles and requirements”. Based on the decision of the International Laboratory Accreditation Cooperation (ILAC).1 General The amendments mainly concern the inclusion of requirements from ISO/PAS documents as mentioned in the introduction. 2 Transition to ISO/IEC 17020:2012 2. Scheme managers with accepted inspection schemes will need to review their schemes for conformity with the ISO/IEC 17020:2012 requirements (refer to RvA-T033). .o. . 2012 the standard ISO/IEC 17020:2012 “Conformity assessment – Requirements for the operation of various types of bodies performing inspection” has been published. RvA therefore worked out the transitional provisions for the implementation of the ISO/IEC 17020:2012 as follows. Also several texts from the Guidance IAF/ILAC-A4:2004 have now partly or as a whole been included in the standard itself.ISO/PAS 17003:2004 “Conformity assessment – Complaints and appeals – Principles and requirements”.
The realization and reporting of an internal audit by the inspection body regarding the implementation of the new standard. Subjects of this assessment will be: A cross reference table drawn up by the inspection body. Scheme owners with accepted inspection schemes will have to demonstrate they have reviewed their schemes for conformity with the ISO/IEC 17020:2012 requirements (see RvAT033). indicating the connection between the clauses of the ISO/IEC 17020:2012 standard and with the documented management system. For non-conformities raised against new requirements of the new standard during the transition period (see Annex A). the assessment of the corrective actions for any "(B)" non-conformity will be carried out as an additional assessment and will be invoiced and thus will not take place during the next regular assessment. Demonstration by scheme managers of the review of their accepted schemes for conformity against the requirements of ISO/IEC 17020:2012 (see RvA-T033). all accreditation assessments will be carried out against ISO/IEC 17020:2012. all accreditation assessments will be carried out against ISO/IEC 17020:2012. After March 1. the possibility to be assessed against the ISO/IEC 17020:2012 already existed from January 1. Assessment of the documented management system. 2013. However. RvA will assess the documented management system and files with respect to the implementation of the new standard (see the items in Appendix A). 2013. 2013 onwards. the introduction at all locations. version 1 page 5 of 14 last update of this version: 4-4-2013 . The assessment on these points will be carried out without charges for extra time. personnel files and general files which demonstrate the implementation of the new standard. The RvA will issue a new declaration of accreditation. These special provisions are described in section 2. which would not have been non-conformities against the old standard. Dutch Accreditation Council (RvA) T035-UK. 2. 2013.For existing ISO/IEC 17020:1998-accredited inspection bodies the rules are: After March 1. If the certification body has multiple locations. but only after it has determined that the requirements of ISO/IEC 17020:2012 are met. and a positive decision has been taken (also refer to section 2.3 of this explanatory document. special provisions for corrective action apply.2 RvA assessment of the transition to ISO/IEC 17020:2012 During the first regular assessment after March 1.5 of this explanatory document ). Inspection records. For initial accreditations of inspection bodies.
maintenance or renewal of accreditation has been taken. will be categorised as cat.2. After this suspension withdrawal follows if the nonconformities have still not been closed. The RvA will adapt the current RvA explanatory documents and other RvA documents which apply to accreditation of inspection bodies. The RvA will conduct the follow-up assessment to verify these corrective actions before January 1. The accreditation number will remain unchanged. which would not have been nonconformities against the previous standard. This “Guidance on the Application of ISO/IEC 17020” . 2015 and will take a decision on granting accreditation for ISO/IEC 17020:2012 before March 1. 2. If the RvA has not been able to take a positive decision on granting accreditation for ISO/IEC 17020:2012 as a result of not being able to close the nonconformities.4 Guidelines and explanations The mandatory and informative documents of EA and ILAC remain in force. “(B)”. RvA has made an overview of these new requirements. Dutch Accreditation Council (RvA) T035-UK.5 Declaration of Accreditation The declaration of accreditation will be adjusted to show accreditation against ISO/IEC 17020:2012 . The date of the first accreditation for the previously granted accreditation(s) for inspection (against EN 45004 or ISO/IEC 17020:1998) will also be mentioned on the new declaration of accreditation. References in these current documents to the 1998-version of the ISO/IEC 17020-standard should be read as references to the new ISO/IEC 17020:2012-standard. the accreditation will be suspended for a maximum period of three months. The expiration date for the new accreditation will be the same as the previous accreditation.3 Non-conformities against new requirements Any nonconformities.IAF/ILAC-A4:2004 will be withdrawn with the introduction of the ISO/IEC 17020:2012-standard and therefore will not be used during assessments against the ISO/IEC 17020:2012-standard. the current RvA explanatory and other RvA documents remain in force. 2. The date of the declaration of accreditation will be the date of the decision on accreditation against the new standard. 2015. This overview is included as Appendix A of this explanatory document. Until the changes have been. 2014 according to the rules of RvA-B004/RvA-BR004). version 1 page 6 of 14 last update of this version: 4-4-2013 . The inspection body shall submit corrective actions to the RvA before October 1. after an assessment against the new standard has been successfully completed and a decision on the continuation.
version 1 page 7 of 14 last update of this version: 4-4-2013 . Dutch Accreditation Council (RvA) T035-UK.3 Modifications of this document compared to the previous edition Not applicable. as this is the first version of this explanatory document.
definition 6. Except for information that the client makes publicly available. and payment of a sales commission or other inducement for the referral of new clients. such relationships do not necessarily present an inspection body with a risk to impartiality. or from its relationships. However. NOTE Legally enforceable commitments can be.9 appeal request by the provider of the item of inspection to the inspection body for reconsideration by that body of a decision it has made relating to that item NOTE Adapted from ISO/IEC 17000:2004. 4.1. contracts. or from the relationships of its personnel. This shall include those risks that arise from its activities. 4.1. version 1 page 8 of 14 last update of this version: 4-4-2013 . all other information is considered proprietary information and shall be regarded as confidential.10 complaint expression of dissatisfaction.1 The inspection body shall be responsible. the inspection body shall be able to demonstrate how it eliminates or minimizes such risk. 3. within these texts the most notable changes have been put in italic. 4. Partly because the structure of the standard has been changed significantly.5 The inspection body shall have top management commitment to impartiality. Dutch Accreditation Council (RvA) T035-UK.2 Confidentiality 4.Appendix A: Summary of changes The following (parts of) requirements of ISO/IEC 17020:2012 represent changes with regard to the requirements in ISO 17020:1998 and/or the Guidance IAF/ILAC-A4:2004. governance. through legally enforceable commitments. other than appeal.3 The inspection body shall identify risks to its impartiality on an ongoing basis. for the purpose of responding to complaints). or when agreed between the inspection body and the client (e.2. contractual agreements. management. Finally a remark is made: ILAC is working on a new Guidance document for the ISO/IEC 17020:2012standard. finances.4. it will be added to the applicable documents regarding accreditation against the ISO/IEC 17020:2012-standard.4 If a risk to impartiality is identified. definition 6. all of which have not been mentioned in the summary of changes below. Only the most important changes in the text of the standard have been mentioned. 4. As soon as this new Guidance is published. there are a lot of minor changes in the standard. etc. 3. The inspection body shall inform the client. personnel. of the information it intends to place in the public domain. for example. where a response is expected NOTE Adapted from ISO/IEC 17000:2004. NOTE A relationship that threatens the impartiality of the inspection body can be based on ownership.1. by any person or organization to an inspection body. for the management of all information obtained or created during the performance of inspection activities. marketing (including branding). in advance.g.5. relating to the activities of that body. shared resources.
4. The person(s) fulfilling this function shall be technically competent and experienced in the operation of the inspection body. complainant. and will depend on the nature of inspection activities.2 When the inspection body is required by law or authorized by contractual commitments to release confidential information. the client or individual concerned shall. including requirements for education. technical knowledge.2. be notified of the information provided.1. 5. Results of monitoring shall be used as a means of identifying training needs (see 6. the inspection body shall have procedures for the following: a) selection and approval of suppliers. NOTE Monitoring can include a combination of techniques. Dutch Accreditation Council (RvA) T035-UK. Where the inspection body has more than one technical manager.2. training.1.2. Specifications can include client or in-house requirements. 4. the inspection body shall develop specific methods and procedures to be used (see 7. training. 6. inspection schemes or contracts. 6.1. b) verification of incoming goods and services. and monitoring inspectors and other personnel involved in inspection activities. unless prohibited by law. unless there is sufficient supporting evidence that the inspector is continuing to perform competently. The inspection body shall inform the client if the inspection method proposed by the client is considered to be inappropriate. 6.1 The inspection body shall use the methods and procedures for inspection which are defined in the requirements against which inspection is to be performed.7).3). standards or specifications. version 1 page 9 of 14 last update of this version: 4-4-2013 .2.11 Where relevant for the outcome of inspection activities. especially from the client's viewpoint. formally authorizing. 7.9 Each inspector shall be observed on-site. 6. NOTE This person fulfilling this function does not always have the title of technical manager.5 The inspection body shall have available one or more person(s) as technical manager(s) who have overall responsibility to ensure that the inspection activities are carried out in accordance with this International Standard. simulated inspections and other techniques to assess performance. c) ensuring appropriate storage facilities. 6. NOTE The competence requirements can be part of the job description or other documentation mentioned in 5.1.1 The inspection body shall define and document the competence requirements for all personnel involved in inspection activities. interviews. regulators) shall be treated as confidential.7. report reviews.3 Information about the client obtained from sources other than the client (e. skills and experience.1. Where these are not defined.g.5 The inspection body shall have documented procedures for selecting. NOTE The requirements against which the inspection is performed are normally specified in regulations.1. the specific responsibilities of each manager shall be defined and documented. NOTE It is expected that on-site observations are performed in a way that minimizes the disturbance of the inspections. such as on-site observations.8 Personnel familiar with the inspection methods and procedures shall monitor all inspectors and other personnel involved in inspection activities for satisfactory performance.1.2.
4 The decision to be communicated to the complainant or appellant shall be made by. including actions undertaken to resolve them. and deciding what actions are to be taken in response to it. it shall verify the integrity of such information.7.6.5 Whenever possible. shall deal with it. 8 Management system requirements 8. 7.4 The inspection body shall be responsible for all decisions at all levels of the handling process for complaints and appeals.1 Options 8.1.1 General The inspection body shall establish and maintain a management system that is capable of achieving the consistent fulfilment of the requirements of this International Standard in accordance with either Option A or Option B. 7. version 1 page 10 of 14 last update of this version: 4-4-2013 . 7. and shall provide the complainant or appellant with progress reports and the outcome.5. 7. 7.3 Upon receipt of a complaint. b) tracking and recording complaints and appeals. 7. validating. the inspection body shall confirm whether the complaint relates to inspection activities for which it is responsible and. the inspection body shall acknowledge receipt of the complaint or appeal.6 When the inspection body uses information supplied by any other party as part of the inspection process.5 Investigation and decision on appeals shall not result in any discriminatory actions.1 The inspection body shall have a documented process to receive.3 Whenever possible. 7. 7.6.6 Complaints and appeals process 7. evaluate and make decisions on complaints and appeals. the inspection body shall give formal notice of the end of the complaint and appeals handling process to the complainant or appellant.1. investigating the complaint or appeal.6. or reviewed and approved by. individual(s) not involved in the original inspection activities in question.2 A description of the handling process for complaints and appeals shall be available to any interested party upon request.6. 7.5.2 The inspection body receiving the complaint or appeal shall be responsible for gathering and verifying all necessary information to validate the complaint or appeal.1 The handling process for complaints and appeals shall include at least the following elements and methods: a) a description of the process for receiving. c) ensuring that any appropriate action is taken.5.5 Complaints and appeals 7.6. if so.5. Dutch Accreditation Council (RvA) T035-UK. 7.5.
8.2. ・ preventive actions (see 8. 8.3. or linked to documentation of the management system.4 All documentation. ・ internal audit (see 8. 8. fulfils the management system clause requirements (see 8.5). manual. records. document.4). 8. in accordance with the requirements of ISO 9001.g. etc. 8. ・ corrective actions (see 8. irrespective of other responsibilities. related to the fulfilment of the requirements of this International Standard shall be included.2 to 8.1.2 Option A The management system of the inspection body shall address the following: ・ management system documentation (e. referenced. systems.2. and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of this International Standard. 8.2.3 Option B An inspection body that has established and maintains a management system. processes.3).5 All personnel involved in inspection activities shall have access to the parts of the management system documentation and related information that are applicable to their responsibilities. version 1 page 11 of 14 last update of this version: 4-4-2013 . shall have responsibility and authority that include the following: a) ensuring that processes and procedures needed for the management system are established.8. and b) reporting to top management on the performance of the management system and any need for improvement.8). ・ control of records (see 8.5 and 7. see 8.2).3 The inspection body's top management shall appoint a member of management who.8).2 The top management shall provide evidence of its commitment to the development and implementation of the management system and its effectiveness in achieving consistent fulfilment of this International Standard. implemented and maintained.2. ・ control of documents (see 8. definition of responsibilities.1 The inspection body shall establish procedures to control the documents (internal and external) that relate to the fulfilment of this International Standard. policies.6). and maintain policies and objectives for fulfilment of this International Standard and shall ensure the policies and objectives are acknowledged and implemented at all levels of the inspection body's organization. ・ complaints and appeals (see 7. Dutch Accreditation Council (RvA) T035-UK. ・ management review (see 8.2.6).1. 8.3 Control of documents (Option A) 8.2 Management system documentation (Option A) 8.1 The inspection body's top management shall establish.7).
5. in order to ensure its continuing suitability. d) follow-up actions from previous management reviews. 8. f) changes that could affect the management system. 8. f) ensure that documents of external origin are identified and their distribution controlled. 8.2 Review inputs The input to the management review shall include information related to the following: a) results of internal and external audits.1. 8.5. and includes proprietary and in-house developed software. g) appeals and complaints.4 Control of records (Option A) 8. c) ensure that changes and the current revision status of documents are identified. a complete review broken up into segments (a rolling review) shall be completed within a 12-month time frame.1 The inspection body's top management shall establish procedures to review its management system at planned intervals. e) ensure that documents remain legible and readily identifiable.5. Alternatively.8. adequacy and effectiveness.2 The inspection body shall establish procedures for retaining records for a period consistent with its contractual and legal obligations.1. Access to these records shall be consistent with the confidentiality arrangements. 8.3. c) the status of preventive and corrective actions.2 The procedures shall define the controls needed to: a) approve documents for adequacy prior to issue. d) ensure that relevant versions of applicable documents are available at points of use. 8.4. retrieval.5. including the stated policies and objectives related to the fulfilment of this International Standard. Dutch Accreditation Council (RvA) T035-UK.1.5 Management review (Option A) 8. b) review and update (as necessary) and re-approve documents.4. and apply suitable identification to them if they are retained for any purpose.1 General 8.5.1 The inspection body shall establish procedures to define the controls needed for the identification. b) feedback from clients and interested parties related to the fulfilment of this International Standard. NOTE Documentation can be in any form or type of medium. e) the fulfilment of objectives. retention time and disposition of its records related to the fulfilment of this International Standard. storage. g) prevent the unintended use of obsolete documents.2 These reviews shall be conducted at least once a year.3 Records of reviews shall be maintained. version 1 page 12 of 14 last update of this version: 4-4-2013 . protection.
7.6. 8.7. f) the results of the audit are documented. Dutch Accreditation Council (RvA) T035-UK.6. 8. as well as the results of previous audits.3 Corrective actions shall be appropriate to the impact of the problems encountered. 8.4 Internal audits shall be performed at least once every 12 months.3 The inspection body shall conduct periodic internal audits covering all procedures in a planned and systematic manner. auditing and the requirements of this International Standard.3 Review outputs The outputs from the management review shall include decisions and actions related to: a) improvement of the effectiveness of the management system and its processes. c) resource needs. e) any opportunities for improvement are identified. The frequency of internal audits may be adjusted depending on the demonstrable effectiveness of the management system and its proven stability.5 The inspection body shall ensure that: a) internal audits are conducted by qualified personnel knowledgeable in inspection. version 1 page 13 of 14 last update of this version: 4-4-2013 . 8.1 The inspection body shall establish procedures for identification and management of nonconformities in its operations.2 The inspection body shall also.6. b) auditors do not audit their own work. 8.7 Corrective actions (Option A) 8. 8.7. 8. 8. b) improvement of the inspection body related to the fulfilment of this International Standard.1 The inspection body shall establish procedures for internal audits to verify that it fulfils the requirements of this International Standard and that the management system is effectively implemented and maintained.6 Internal audits (Option A) 8. taking into consideration the importance of the processes and areas to be audited.2 An audit programme shall be planned. d) any actions resulting from internal audits are taken in a timely and appropriate manner. take actions to eliminate the causes of nonconformities in order to prevent recurrence.8. c) personnel responsible for the area audited are informed of the outcome of the audit. in order to verify that the management system is implemented and is effective.5.6. where necessary.6. NOTE ISO 19011 provides guidelines for conducting internal audits.
4 The procedures shall define requirements for the following: a) identifying nonconformities.8. b) determining the causes of nonconformity.7. Dutch Accreditation Council (RvA) T035-UK.8 Preventive actions (Option A) 8.8. e) reviewing the effectiveness of the preventive actions taken. d) evaluating the need for actions to ensure that nonconformities do not recur. b) evaluating the need for action to prevent the occurrence of nonconformities.8. version 1 page 14 of 14 last update of this version: 4-4-2013 .1 The inspection body shall establish procedures for taking preventive actions to eliminate the causes of potential nonconformities. f) recording the results of actions taken.8. c) correcting nonconformities. 8. e) determining the actions needed and implementing them in a timely manner. g) reviewing the effectiveness of corrective actions. c) determining and implementing the action needed. NOTE The procedures for corrective and preventive actions do not necessarily have to be separate.2 Preventive actions taken shall be appropriate to the probable impact of the potential problems.3 The procedures for preventive actions shall define requirements for the following: a) identifying potential nonconformities and their causes. 8. d) recording the results of actions taken. 8.
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