TC/22/02 Proposed IAF Guidance on Accreditation Body Witnessing of Certification/Registration Body Audits, and Witnessed Audit Report Charter: To develop specific guidance on the content of a witness audit report by a witnessing accreditation body that would provide another accreditation body the reasonable evidence of conformance with accreditation requirements and confidence in the competence of the witnessed CRB so that the receiving accreditation body may grant accreditation (or extension of a scope category) to the CRB without requiring additional witnessing of an audit. The charter of this project was to also state the purpose of witnessing audits, and the justification for each required element of the witness audit report. Undertaking this project, the project team first reviewed existing requirements as stated in ISO/IEC Guide 61: 1996 and IAF Guidance. ISO/IEC Guide 61: 1996, Clause 3.3.2, states that “…an accreditation body shall witness fully the on-site activities of one or more assessments or audits conducted by an applicant body before an initial accreditation is granted for any function requiring on-site activity by the applicant.” IAF Guidance on the Application of ISO/IEC Guide 61: 1996, has five clauses related to witness audits: Clause G.3.3.2, G.3.3.3, G.3.5.9, G.3.5.10, and G.3.5.11 G.3.3.2 states, “The accreditation body shall require the [certification/registration] body subject to the accreditation assessment to conform to the decision of the accreditation assessment team as to the assessors of the applicant body (chosen from those the applicant body deems competent in a particular scope sector) it wishes to see in action.” G.3.3.3 states, “In witnessing the on-site activities of the applicant body, as required by clause 3.3.2 of ISO/IEC Guide 61, the accreditation body should if possible witness at least one initial assessment or a re-assessment. If it is not possible to witness an initial assessment or re-assessment then a minimum of two surveillance assessments should be witnessed, in which case the witnessed surveillance should cover key requirements of the assessment standard including at least process control and, where applicable, design and development.” G.3.5.9 states, “The accreditation body should define the basis on which it evaluates performance and utilized witness audits. The extent and character of the witnessing should be based on the number and complexity of the accredited scope categories, taking into account the volume of relevant business and any other significant factors.” G.3.5.10 states, “Accreditation bodies shall evaluate the performance of certification/registration body audit teams on a regular basis, in order to evaluate the continued effectiveness of the certification/registration body’s audit program TC/22/02 management. This can be done through a combination of techniques, such as witnessing, analysis of client feedback, post-audit reviews, auditor interviews, auditee interviews.” G.3.5.11 states, “Witnessing is a required part of the surveillance program, although not necessarily at every surveillance. The extent and character of the witnessing should be based on the number and complexity of the accredited scope categories, taking into account the historical data, organizational changes and any other relevant factors. Accreditation bodies shall develop a program of full and partial witness audits in order to develop and maintain confidence in the performance of certification/registration bodies. The accreditation body shall define a program of full or partial observation that enables the accreditation body to assess the planning, management and conduct of certification/registration audits.” ISO/IEC Guide 61: 1996, Section 3.4 states the requirements for the assessment report, which “…shall contain as a minimum 1) the date(s) of the audit(s), 2) the name(s) of the person(s) responsible for the report, 3) the names and addresses of all sites audited, 4) the assessed scope of accreditation or reference thereto, 5) comments on the conformity of the applicant body with the accreditation requirements and, where applicable, any useful comparisons with the results of previous assessments of the body, 6) an explanation of any differences from the information presented to the body at the closing meeting… report shall take into consideration a) the qualification, experience and authority of the staff encountered; b) the adequacy of the internal organization and procedures adopted by the body to give confidence in the quality of its services; c) the actions taken to correct identified nonconformities including, where applicable, those identified at previous assessments.” IAF Guidance on the Application of ISO/IEC Guide 61: 1996 has five clauses related to accreditation assessment reports of audits: G.3.4.1, G.3.4.2, G.3.4.3, G.3.4.4, and G.3.5.8. G.3.4.1 states, “Clause 3.4.1 b) of ISO/IEC Guide 61 requires more than a generic summary statement. The report of findings provided to the accreditation body shall be of sufficient detail to facilitate and support an accreditation decision and should include: Areas covered by the assessment (e.g. areas of the accreditation requirements and locations/units/departments/processes of the certification/registration body subject to assessment) including significant audit trails followed; Observations made, both positive and negative (e.g. noteworthy features) and negative (e.g. potential non-conformities); Report (details) of any nonconformities identified supported by objective evidence. TC/22/02 Completed questionnaires/checklists/observation logs/assessor notes might form an integral part of the report that covers the above. If these methods are used, these documents shall be submitted to the accreditation body as evidence to support the accreditation decision. G.3.4.2 states, “The first element of clause 3.4.1.e5) ISO/IEC Guide 61 requires the report to contain comments on the conformity of the applicant body with accreditation requirements. This can be satisfied by a brief ‘written’ statement summarizing the overall findings (conclusion) of the assessment and a statement of the judgement as to the body’s capability of systematically meeting the requirements. G.3.4.3 states, “The final element of clause 3.4.1.e5)…results of previous assessments…does not apply to initial assessments…” G.3.4.4 states, “In addition to the requirements for reporting in clause 3.4.1e)…this information should cover:… A summary of the most important observations, positive as well as negative, regarding the implementation and effectiveness of the applicants’s procedures and system, The conclusions reached by the audit team.” G.3.5.8 states, “…reports of surveillance and reassessment visits should contain a report on the clearing of each nonconformity revealed previously.” Conclusions. Witnessing audits of CRB audit teams is a requirement for accreditation (ISO/IEC Guide 61: 1996, Clause 3.3.2) The purpose of witness audits is the same as any audits of a CRB, which is “…to give confidence in the certifications or registrations of the body.” (ISO/IEC Guide 61: 1996, Clause 3.2.5). This is reinforced by current IAF Guidance: “Accreditation bodies shall evaluate the performance of certification/registration body audit teams on a regular basis, in order to evaluate the continued effectiveness of the certification/registration body’s audit program management. (G.3.5.10) “…Accreditation bodies shall develop a program of full and partial witness audits in order to develop and maintain confidence in the performance of certification/registration bodies…(G.3.5.11) The following is suggested as additional IAF guidance to Clause 3.3 of ISO/IEC Guide 61: 1996: G.3.3.3. The purpose of a witness audit is to confirm that a CRB’s audit team conducted an effective audit and made an appropriate recommendation for registration based on a TC/22/02 determination that the audited organization was substantially in conformance with the requirements of the management systems standard. It is not possible for an accreditation body to determine, solely from a review of a file of the registrar’s client, if the registrar’s audit team satisfactorily pursued audit trails to obtain the audit evidence to confirm substantial conformance with the management system standard; and it is not a reasonable expectation that a CRB’s audit report will have full documentation of the questions, answers, audit trails, and observed audit evidence. Therefore, it is necessary for an accreditation body audit team to observe a CRB audit team conducting an audit; to confirm effective audit planning, and to observe audit technique, attributes and demonstrated knowledge, in order for the accreditation body to gain confidence in the effectiveness of the CRB’s audit program management. The following is suggested as additional definition for IAF guidance to ISO/IEC Guide 61: 1996: Witness audit report: The report by an accreditation body of observing a CRB’s audit team conducting a certification/registration audit of one of the CRB’s clients. The following is suggested as additional IAF guidance for Clause 3.4 of ISO/IEC Guide 61: 1996: G.3.4.5. The witness audit report shall include, in addition to the audit report requirements of ISO/IEC Guide 61 and related IAF guidance, as a minimum: 1. the name of the CRB being witnessed, 2. the date(s) of the accreditation witness audit, 3. the name, qualification, and role of each member of the AB’s audit team, including industry experts, translators and observers, 4. the name, qualification, and role of each member of the CRB’s audit team, including industry experts, translators and observers, 5. a copy of the CRB’s audit report for the witnessed facility, 6. the scope and a description of the activities of the witnessed facility (if not included in the CRB’s audit report), 7. the CRB’s audit plan showing what elements were audited (if not included in the CRB’s audit report) 8. the AB audit team’s comments on the adequacy of the audit preparation and planning by the CRB audit team, 9. the AB audit team’s comments on the impartiality and competence of the CRB’s audit team, 10. the AB audit team’s agreement or disagreement with the recommendation/conclusion of the CRB audit team related to certification/registration of the witnessed facility, and 11. the AB audit team’s comments on the CRB’s audit report TC/22/02 12. records about nonconformities the AB audit team had about the CRB’s audit team, and the subsequent correction and corrective action and disposition of the nonconformities. Note: Some of the items 1-12 may not be a part of the AB’s report, but should be information the AB has on file. Justification for the additional requirements for a witness audit report: 1. For an AB (to be known as a “Receiving AB”) to accept a witness audit report by another AB (to be known as the “Originating AB”), the receiving AB must have reasonable information about the originating AB’s audit team. 2. For a receiving AB to accept the witness audit report of the originating AB for a sensitive industry sector, it will need reasonable information about the qualifications of the CRB’s audit team as well as the professional judgement by the originating AB audit team of the CRB audit team’s competence. 3. The receiving AB needs the copy of the CRB’s audit report in order to have sufficient information about audited organization, and the scope of the audit by the CRB, in order for the receiving AB to determine that this audit satisfies the receiving AB’s criteria, especially for a sensitive industry sector.