Raad voor Accreditatie (Dutch Accreditation Council RvA

)
 

Implementation of ISO/IEC 17020:2012

Document code:

RvA-T035-UK Version 1, 04 april 2013

the RvA will bring its policy en procedures in line with the EA. In case the policy and/or procedures for a specific field of accreditation as described in a RvA Explanatory note. is documented by EA. ILAC or IAF-document.nl). . A current version of the Explanatory is available through the website of the RvA. (www. ILAC or IAF.rva.A RvA-Explanatory note describes the policy and/or the procedures of the RvA concerning a specific field of accreditation.

1 2. version 1 page 3 of 14 last update of this version: 4-4-2013 .4 2.Contents 1 2 2.5 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.2 2.3 2.

The RvA decided to combine the transition to the ISO/IEC 17020:2012 with the regular assessments as much as possible. This explanatory document describes the RvA policy and practices for the implementation of ISO/IEC 17020:2012. . the structure has been harmonized with other accreditation standards. Based on the decision of the International Laboratory Accreditation Cooperation (ILAC).ISO/PAS 17005:2008 “Conformity assessment – Use of management systems – Principles and requirements”. is based on: . .ISO/PAS 17002:2004 “Conformity assessment – Confidentiality – Principles and requirements”. RvA therefore worked out the transitional provisions for the implementation of the ISO/IEC 17020:2012 as follows. 2 Transition to ISO/IEC 17020:2012 2.1 General The amendments mainly concern the inclusion of requirements from ISO/PAS documents as mentioned in the introduction.ISO/PAS 17003:2004 “Conformity assessment – Complaints and appeals – Principles and requirements”. This explanatory document applies to all accreditations of inspection bodies previously accredited against ISO/IEC 17020:1998.o.1 Introduction On March 1. 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). 2012 the standard ISO/IEC 17020:2012 “Conformity assessment – Requirements for the operation of various types of bodies performing inspection” has been published. . . The international standard ISO/IEC 17020:2012 a. Besides that. version 1 page 4 of 14 last update of this version: 4-4-2013 .ISO/PAS 17001:2005 “Conformity assessment – Impartiality – Principles and requirements”. Also several texts from the Guidance IAF/ILAC-A4:2004 have now partly or as a whole been included in the standard itself.IAF/ILAC-A4:2004 “Guidance on the Application of ISO/IEC 17020”. . the structure (chapters) has changed completely in comparison with the 1998-version of the standard.ISO/PAS 17004:2005 “Conformity assessment – Disclosure of information — Principles and requirements”. 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.

indicating the connection between the clauses of the ISO/IEC 17020:2012 standard and with the documented management system.       Assessment of the documented management system. Dutch Accreditation Council (RvA) T035-UK. the possibility to be assessed against the ISO/IEC 17020:2012 already existed from January 1. personnel files and general files which demonstrate the implementation of the new standard. all accreditation assessments will be carried out against ISO/IEC 17020:2012. 2013. 2013 onwards. After March 1. For non-conformities raised against new requirements of the new standard during the transition period (see Annex A). the introduction at all locations. Demonstration by scheme managers of the review of their accepted schemes for conformity against the requirements of ISO/IEC 17020:2012 (see RvA-T033). For initial accreditations of inspection bodies. but only after it has determined that the requirements of ISO/IEC 17020:2012 are met. 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). and a positive decision has been taken (also refer to section 2. These special provisions are described in section 2. The realization and reporting of an internal audit by the inspection body regarding the implementation of the new standard. 2013. 2. Inspection records.  The RvA will issue a new declaration of accreditation. which would not have been non-conformities against the old standard.2 RvA assessment of the transition to ISO/IEC 17020:2012 During the first regular assessment after March 1.5 of this explanatory document ). RvA will assess the documented management system and files with respect to the implementation of the new standard (see the items in Appendix 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.3 of this explanatory document.For existing ISO/IEC 17020:1998-accredited inspection bodies the rules are:   After March 1. 2013. special provisions for corrective action apply. If the certification body has multiple locations. all accreditation assessments will be carried out against ISO/IEC 17020:2012. However. Subjects of this assessment will be:  A cross reference table drawn up by the inspection body. The assessment on these points will be carried out without charges for extra time. version 1 page 5 of 14 last update of this version: 4-4-2013 .

5 Declaration of Accreditation The declaration of accreditation will be adjusted to show accreditation against ISO/IEC 17020:2012 . which would not have been nonconformities against the previous standard. the accreditation will be suspended for a maximum period of three months. “(B)”.3 Non-conformities against new requirements Any nonconformities. The expiration date for the new accreditation will be the same as the previous accreditation. 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. 2015.4 Guidelines and explanations The mandatory and informative documents of EA and ILAC remain in force. after an assessment against the new standard has been successfully completed and a decision on the continuation. The RvA will adapt the current RvA explanatory documents and other RvA documents which apply to accreditation of inspection bodies. This overview is included as Appendix A of this explanatory document.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. RvA has made an overview of these new requirements. Dutch Accreditation Council (RvA) T035-UK. The date of the declaration of accreditation will be the date of the decision on accreditation against the new standard. The inspection body shall submit corrective actions to the RvA before October 1. This “Guidance on the Application of ISO/IEC 17020” . Until the changes have been. 2015 and will take a decision on granting accreditation for ISO/IEC 17020:2012 before March 1. will be categorised as cat. After this suspension withdrawal follows if the nonconformities have still not been closed. 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. 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. The RvA will conduct the follow-up assessment to verify these corrective actions before January 1. maintenance or renewal of accreditation has been taken. 2. version 1 page 6 of 14 last update of this version: 4-4-2013 .2. the current RvA explanatory and other RvA documents remain in force. 2014 according to the rules of RvA-B004/RvA-BR004). The accreditation number will remain unchanged. 2.

version 1 page 7 of 14 last update of this version: 4-4-2013 . as this is the first version of this explanatory document.3 Modifications of this document compared to the previous edition Not applicable. Dutch Accreditation Council (RvA) T035-UK.

Finally a remark is made: ILAC is working on a new Guidance document for the ISO/IEC 17020:2012standard. 4. 4. However. Dutch Accreditation Council (RvA) T035-UK. definition 6. definition 6.4. or from the relationships of its personnel. contractual agreements. or when agreed between the inspection body and the client (e.10 complaint expression of dissatisfaction.1. all of which have not been mentioned in the summary of changes below. personnel. Partly because the structure of the standard has been changed significantly. and payment of a sales commission or other inducement for the referral of new clients. This shall include those risks that arise from its activities. NOTE Legally enforceable commitments can be. all other information is considered proprietary information and shall be regarded as confidential. NOTE A relationship that threatens the impartiality of the inspection body can be based on ownership.1. Only the most important changes in the text of the standard have been mentioned. Except for information that the client makes publicly available. where a response is expected NOTE Adapted from ISO/IEC 17000:2004. by any person or organization to an inspection body. such relationships do not necessarily present an inspection body with a risk to impartiality.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. other than appeal. for example. there are a lot of minor changes in the standard.4 If a risk to impartiality is identified. for the purpose of responding to complaints). the inspection body shall be able to demonstrate how it eliminates or minimizes such risk. through legally enforceable commitments. 3. management. finances.2 Confidentiality 4. or from its relationships. within these texts the most notable changes have been put in italic. for the management of all information obtained or created during the performance of inspection activities. version 1 page 8 of 14 last update of this version: 4-4-2013 . of the information it intends to place in the public domain. 4. shared resources.1.5. governance. in advance.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. As soon as this new Guidance is published.5 The inspection body shall have top management commitment to impartiality.1 The inspection body shall be responsible. marketing (including branding). etc.2. relating to the activities of that body. it will be added to the applicable documents regarding accreditation against the ISO/IEC 17020:2012-standard.3 The inspection body shall identify risks to its impartiality on an ongoing basis. 3. contracts. 4. The inspection body shall inform the client.g.

Dutch Accreditation Council (RvA) T035-UK. Specifications can include client or in-house requirements. Where the inspection body has more than one technical manager.5 The inspection body shall have documented procedures for selecting. 6. especially from the client's viewpoint.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. 6. formally authorizing.2 When the inspection body is required by law or authorized by contractual commitments to release confidential information. regulators) shall be treated as confidential.2. the inspection body shall develop specific methods and procedures to be used (see 7.9 Each inspector shall be observed on-site. 7. NOTE The requirements against which the inspection is performed are normally specified in regulations.g.1. NOTE The competence requirements can be part of the job description or other documentation mentioned in 5. be notified of the information provided. 6. 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.4.1. inspection schemes or contracts. unless prohibited by law.7). the client or individual concerned shall.2. b) verification of incoming goods and services. report reviews. including requirements for education. Results of monitoring shall be used as a means of identifying training needs (see 6.1. 5. NOTE It is expected that on-site observations are performed in a way that minimizes the disturbance of the inspections. the inspection body shall have procedures for the following: a) selection and approval of suppliers. interviews. 6. version 1 page 9 of 14 last update of this version: 4-4-2013 .1. training. such as on-site observations. NOTE This person fulfilling this function does not always have the title of technical manager. c) ensuring appropriate storage facilities.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.3). simulated inspections and other techniques to assess performance. training.3 Information about the client obtained from sources other than the client (e.2.11 Where relevant for the outcome of inspection activities.1.2. and will depend on the nature of inspection activities. complainant. NOTE Monitoring can include a combination of techniques. Where these are not defined.1 The inspection body shall define and document the competence requirements for all personnel involved in inspection activities. skills and experience. standards or specifications.1.7.2. technical knowledge. 4. The person(s) fulfilling this function shall be technically competent and experienced in the operation of the inspection body.8 Personnel familiar with the inspection methods and procedures shall monitor all inspectors and other personnel involved in inspection activities for satisfactory performance. and monitoring inspectors and other personnel involved in inspection activities. the specific responsibilities of each manager shall be defined and documented.1. 6.

6. and deciding what actions are to be taken in response to it.2 A description of the handling process for complaints and appeals shall be available to any interested party upon request. 7.5.6 Complaints and appeals process 7.6.5 Whenever possible. version 1 page 10 of 14 last update of this version: 4-4-2013 .3 Upon receipt of a complaint.1 Options 8. Dutch Accreditation Council (RvA) T035-UK. the inspection body shall give formal notice of the end of the complaint and appeals handling process to the complainant or appellant. the inspection body shall acknowledge receipt of the complaint or appeal. or reviewed and approved by.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. investigating the complaint or appeal.6.6 When the inspection body uses information supplied by any other party as part of the inspection process.1. shall deal with it. 7. 7. individual(s) not involved in the original inspection activities in question.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.4 The inspection body shall be responsible for all decisions at all levels of the handling process for complaints and appeals.4 The decision to be communicated to the complainant or appellant shall be made by. it shall verify the integrity of such information.6. 7. b) tracking and recording complaints and appeals. 7. the inspection body shall confirm whether the complaint relates to inspection activities for which it is responsible and.5. validating. evaluate and make decisions on complaints and appeals. and shall provide the complainant or appellant with progress reports and the outcome.1 The inspection body shall have a documented process to receive. including actions undertaken to resolve them.5 Complaints and appeals 7.7. 8 Management system requirements 8. 7. if so.6. 7. 7.5 Investigation and decision on appeals shall not result in any discriminatory actions.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.1.3 Whenever possible.5.5. c) ensuring that any appropriate action is taken. 7. 7.5.

etc. shall have responsibility and authority that include the following: a) ensuring that processes and procedures needed for the management system are established. 8. ・ control of documents (see 8.7). records.2. ・ corrective actions (see 8. 8.5).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. related to the fulfilment of the requirements of this International Standard shall be included. document.1 The inspection body's top management shall establish. in accordance with the requirements of ISO 9001.3. version 1 page 11 of 14 last update of this version: 4-4-2013 . 8.8. ・ preventive actions (see 8.2.2. ・ internal audit (see 8. policies. referenced. 8.4). systems.6). and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of this International Standard.1. processes. 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.1.3 The inspection body's top management shall appoint a member of management who.5 and 7.4 All documentation. definition of responsibilities. fulfils the management system clause requirements (see 8. 8. 8. irrespective of other responsibilities.1 The inspection body shall establish procedures to control the documents (internal and external) that relate to the fulfilment of this International Standard.2. ・ control of records (see 8.2 Management system documentation (Option A) 8.g.8). ・ management review (see 8.3 Option B An inspection body that has established and maintains a management system. and b) reporting to top management on the performance of the management system and any need for improvement.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. manual.2 Option A The management system of the inspection body shall address the following: ・ management system documentation (e.8).2 to 8.3). or linked to documentation of the management system.2. Dutch Accreditation Council (RvA) T035-UK. ・ complaints and appeals (see 7.6).3 Control of documents (Option A) 8. implemented and maintained. see 8. 8.2).

1 The inspection body's top management shall establish procedures to review its management system at planned intervals.4.5. g) prevent the unintended use of obsolete documents.1 The inspection body shall establish procedures to define the controls needed for the identification. 8. and apply suitable identification to them if they are retained for any purpose. f) ensure that documents of external origin are identified and their distribution controlled. Dutch Accreditation Council (RvA) T035-UK.1. b) feedback from clients and interested parties related to the fulfilment of this International Standard. e) the fulfilment of objectives. in order to ensure its continuing suitability. f) changes that could affect the management system. and includes proprietary and in-house developed software. g) appeals and complaints. a complete review broken up into segments (a rolling review) shall be completed within a 12-month time frame. 8. retention time and disposition of its records related to the fulfilment of this International Standard.1. 8.5 Management review (Option A) 8.2 Review inputs The input to the management review shall include information related to the following: a) results of internal and external audits. b) review and update (as necessary) and re-approve documents.2 The inspection body shall establish procedures for retaining records for a period consistent with its contractual and legal obligations.5. Alternatively. storage. c) ensure that changes and the current revision status of documents are identified. retrieval. d) follow-up actions from previous management reviews. including the stated policies and objectives related to the fulfilment of this International Standard. d) ensure that relevant versions of applicable documents are available at points of use.2 The procedures shall define the controls needed to: a) approve documents for adequacy prior to issue. 8.2 These reviews shall be conducted at least once a year.5. adequacy and effectiveness.5.1.1 General 8.8.5. c) the status of preventive and corrective actions. e) ensure that documents remain legible and readily identifiable.4.4 Control of records (Option A) 8. Access to these records shall be consistent with the confidentiality arrangements. version 1 page 12 of 14 last update of this version: 4-4-2013 .3 Records of reviews shall be maintained. 8.3. NOTE Documentation can be in any form or type of medium. protection. 8.

in order to verify that the management system is implemented and is effective. taking into consideration the importance of the processes and areas to be audited.8. 8. Dutch Accreditation Council (RvA) T035-UK.6. b) auditors do not audit their own work. 8. d) any actions resulting from internal audits are taken in a timely and appropriate manner. 8. The frequency of internal audits may be adjusted depending on the demonstrable effectiveness of the management system and its proven stability. 8.6.7 Corrective actions (Option A) 8. f) the results of the audit are documented.5 The inspection body shall ensure that: a) internal audits are conducted by qualified personnel knowledgeable in inspection. c) resource needs.2 An audit programme shall be planned.7.1 The inspection body shall establish procedures for identification and management of nonconformities in its operations. 8.6.3 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. 8.1 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.2 The inspection body shall also. NOTE ISO 19011 provides guidelines for conducting internal audits. b) improvement of the inspection body related to the fulfilment of this International Standard.3 Corrective actions shall be appropriate to the impact of the problems encountered.4 Internal audits shall be performed at least once every 12 months. take actions to eliminate the causes of nonconformities in order to prevent recurrence. as well as the results of previous audits.6.7. 8.5. e) any opportunities for improvement are identified. where necessary. c) personnel responsible for the area audited are informed of the outcome of the audit. 8. version 1 page 13 of 14 last update of this version: 4-4-2013 .7.3 The inspection body shall conduct periodic internal audits covering all procedures in a planned and systematic manner.6. auditing and the requirements of this International Standard.6 Internal audits (Option A) 8.

c) correcting nonconformities. e) reviewing the effectiveness of the preventive actions taken.4 The procedures shall define requirements for the following: a) identifying nonconformities.2 Preventive actions taken shall be appropriate to the probable impact of the potential problems.8 Preventive actions (Option A) 8.7. 8.8. 8. b) evaluating the need for action to prevent the occurrence of nonconformities.8.3 The procedures for preventive actions shall define requirements for the following: a) identifying potential nonconformities and their causes.1 The inspection body shall establish procedures for taking preventive actions to eliminate the causes of potential nonconformities. g) reviewing the effectiveness of corrective actions. version 1 page 14 of 14 last update of this version: 4-4-2013 .8. d) evaluating the need for actions to ensure that nonconformities do not recur. b) determining the causes of nonconformity. 8. f) recording the results of actions taken. c) determining and implementing the action needed. Dutch Accreditation Council (RvA) T035-UK. d) recording the results of actions taken. NOTE The procedures for corrective and preventive actions do not necessarily have to be separate.8. e) determining the actions needed and implementing them in a timely manner.

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