17021 2011-overview-2011jun-sp

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  • This is a train-the-trainer program developed by Randy Dougherty, one of the co-conveners of WG 21, which was reviewed and includes input by other members of WG21. This presentation is an overview of the standard and changes, as well as additional information about accreditation . Another presentation addresses the changes related to the audit process, and a third presentation addresses the changes related to competence.
  • When this project was initiated, the convener of WG21 was Lars Waldner of Swedac, appointed by the then chair of CASCO chair, John McDonald. When Lars was unable to continue as convener, CASCO chair Mario Wittner appointed Dalrymple and Dougherty as co-conveners. This was the first time a CASCO WG had co-conveners. This has been a successful team effort lead by individuals working for CBs and ABs. The standard was completed under the leadership of Mario Wittner as the CASCO chair. Graeme Drake, then Peter Dennehy, served as secretary of CASCO during the period of development of this standard when the Dalrymple and Dougherty were co-conveners. Discussions about part 2 were initiated under Wittner and Drake, but concluded under the leadership of Olivier Peyrat as CASCO Chair and Sean MacCurtain as CASCO Secretary.
  • The original intent was to simply replace Guides 62 and 66 while also incorporating applicable IAF guidance. This was soon expanded to make it applicable to any MS standard. CB associations influenced the additional intent to incorporate latest technology, and to have principles-based requirements. WG21 developed 17021 during the same period that WG23 was developing the common elements, so work by WG21 influenced the work of WG23, and the work or WG23 influenced the work of WG 21, for the sections dealing with impartiality, complaints and appeals, confidentiality, and management systems.
  • The standard was published in September 2006 as ISO/IEC 17021:20XX entitled Conformity assessment—Requirements for bodies providing audit and certification of management systems
  • The primary goal is to replace in 17021 any reference to ISO 19011. The secondary goal is to improve the understanding, and management, of competence.
  • This graphic was include in the NWIP for CASCO, and explains in graphic the scope of the NWIP. WG21 will be developing requirements generic to any management system----and not any requirements specific to specific management systems. In other words, WG21 will not specify QMS o rEMS specific requirements. However, it plans to develop a framework for others to add the specific requirements. The best current example is 22003, which adds specific requirements for food safety management systems under ISO 22000: for scoping, competence, audit duration and multi-site sampling.
  • The development of part 2 was approved in September 2006, the same month that ISO/IEC 17021:2006 was published, and the entire process for developing part 2 took about 4.5 years.
  • The standard was published in 1 Febuary 2011 as ISO/IEC 17021:2011 with the same title, Conformity assessment—Requirements for bodies providing audit and certification of management systems
  • It was decided that all other comments received about other requirements in the 2006 first edition will be held over and considered during the systematic review, which will begin in early 2012. So far Dalrymple and Dougherty have agreed to stay on as co-conveners of WG21 for the systematic review.
  • There were no changes to the 10 sections of the standard. However, of the 10 sections, 6 sections had changes. Some, such as Sections 2, 4 and 10, simply has some deletions. So the three sections with significant changes were Section 3 in which definitions had to be added, Section 7 of course to address competence requirements, and Section 9 for the audit processes adding detail that in the past was by reference to ISO 19011.
  • The new standard has 6 annexes: one normative and five informative. The one normative annex and 3 of the 5 informative annexes (A, B, C, and D) all relate to the competence and performance of CB personnel. The other 2 informative annexes, E and F) related to the audit and certification processes.
  • There is one remaining reference to ISO 19011, in addition to the Bibliography, which is the note to, the requirement for the CB to conduct internal audits, but being in a note it is not a normative reference.
  • Many of the new definitions were necessary because we deleted reference to ISO 19011. However, we also had to define a third party certification audit because some members of ISO/TC176 (which is responsible for revising ISO 19011) feel that there are other kinds of third party audits. We also decided on a different definition of competence, deleting the word ‘demonstrated ‘ from the definition. Competence still has to be demonstrated , but this is state in requirements in section 7. We also defined ‘technical area’ and further elaborated with specific examples as notes in section 7.
  • There are only two new clauses added to Section 7 and a very slight revision to another clause, but the changes are quite significant. It takes our industry a few steps further down the road toward competence and away from qualifications. We are now focused on knowledge and skills, having remove personal attributes from the definition. The new requirements are process focused: determine and document competence criteria then evaluate personnel for conformance to the documented criteria.
  • Considering that ISO 19011 was focused on QMS and EMS management system audits, it makes sense that most of the changes are in Section 9, the audit and certification process requirements of the standard. And nearly all of the changes are an expansion of the general requirements in 9.1. There is only one slight change to the initial audit and certification process.
  • This is a list of the 15 general requirements of section 9.1 of ISO/IEC 17021:2006 except that each clause now has a title. With the exception of the title, the subject is the same. However, there are significant additions for each of the clauses shown in color to add in additional requirements based on what was in ISO 19011. And of these, 9.1.9 has been expanded the most. The other clauses have no changes or very minor changes. 9.1.1 1 new requirement 9.1.2 6 new requirements 9.1.3 4 new requirements 9.1.4 1 new requirement 9.1.9 16 new requirements 9.1.10 1 new requirement-content of report 9.1.11 1 new requirement-records of verification of effectiveness
  • As most of you may note, the length of the transition period, 24 months, is the same as we had when we first published ISO/IEC 17021:2006. Many CBs are already close to conformance with this revision. But we expect that some CBs (and perhaps some ABs) will struggle to truly understand competence as compared to qualifications. NOTE THAT THE DEADLINE FOR CONFORMANCE IS 24 MONTHS AFTER PUBLICATION.
  • Roger Bennett who lead the IAF TC TF that developed the IAF guidance on the transition to the 2006 standard also lead the TF that has developed the informative document on the transition to the 2011 standard. The document is informative which means CBs and ABs are not required to follow it.
  • Many have asked if ISO/IEC 17021:2006 made any difference. These were results of the transition to the 2006 standard, as reported to IAF in October 2008. You can see that not all CBs made the transition. What about the transition from ISO/IEC 17021:2006 to ISO/IEC 17021:2011? Will it make a difference? Many certification bodies will need to re-visit their report formats and include more free text areas where the auditor indicates how audit objectives were evaluated and confirmed. Auditors will require further training in  the process approach to auditing (even after all this time), but better audit plans should help. Auditors will be expected to understand the client processes better in order to effectively audit the system to ensure it meets/delivers against customer/contractual requirements, regulatory and statutory requirements. Audit reports should indicate/justify why the audit team are confident to recommend certification, Accreditation bodies will need to review and challenge audit reports more critically to ascertain if the  information confirms all the audit objectives were met and sufficient information is available an informed decision. Accreditation bodies will need to witness more critically to confirm the audit evaluates effectiveness.   This said, we do not anticipate similar drop out due to the 2011 standard.
  • Recognizing that identification of ‘technical areas’ will be one of the more significant challenges, ANAB is working with the IAAR to document key processes related to the products or services identified for the NACE 2 revision of codes, then to document the significant environmental aspects and impacts associated with those processes, and the worker health and safety risks. Our plan it is to make this compendium of information publicly available.
  • Trevor Nash is leading an IAF TC TF to develop an IAF document on how ABs assess CBs to the competence requirements of the 2011 standard. The goal is to have consistent application by all ABs.
  • RABQSA and IRCA are working together to try to develop processes and services related to auditor competence. Their plans included evaluating competence for specific technical areas. Their processes and services will lead to a competence based auditor certification program, but they are planning to make some of the processes available to CBs (and ABs) that may help the CBs and ABs manage competence without necessarily having their auditor s and assessors certified.
  • Questions will arise about a requirement in the standard. Even though the standard was written to be unambiguous, on occasion two individuals will have a different understanding of what is stated, or sometimes upon translation into other languages the requirement may not be as clear. So how do you obtain clarification? The first step would be to contact the CASCO Secretary, probably by email. If Sean cannot answer the question directly, he will send it to the co-conveners, Alister and Randy. Although the response to a question will not be ‘official’, it will come from knowledgeable sources. If there is a question about what the words actually mean, there may be a need for an interpretation. CASCO has a documented process for making interpretations. This process takes about 3 months. Note, however, that the interpretations have no legal status in that no party is obliged to accept or use an interpretation until a standard is revised to take on such wording. If the question is about how the requirement is to be applied by a CB, the question can be put to the IAF Technical Committee for its decision. This is be means of a discussion paper to the IAF TC. This can be initiated by contacting the IAF TC Chair, Norbert Borzek of Dakks, who will send a form to be completed to initiate a discussion paper. Discussion papers are considered twice a year.
  • 17021 2011-overview-2011jun-sp

    1. 1. 1ISO/IEC 17021:2011ISO/IEC 17021:2011Presentación para IAACpor Mario Llerenas14, Junio, 2011
    2. 2. 2ISO/IEC 17021ISO/IEC 17021 Desarrollado por ISO/CASCO Working Group 21 Co-coordinadores– Alister Dalrymple, France-AFNOR AFAQ, un organismo de certificación en sistemas de gestión– Randy Dougherty, US-ANSI ANAB, un organismo de acreditación para organismos decertificación en sistemas de gestiónNota: CASCO es el “Conformity Assessment Committee”
    3. 3. 3ISO/IEC 17021ISO/IEC 17021Intención del WG21 para 17021 Reemplazar las Guías 62 y 66 Ser aplicable a cualquier sistema de gestión Incorporar los lineamientos de IAF Incorporar las últimas tecnologías Ser consistente con los elementos comunes(WG23) Base en los Principios del desempeño de losrequerimientos (donde sea posible)
    4. 4. 4ISO/IEC 17021:2006ISO/IEC 17021:2006ISO/IEC 17021:2006Evaluación de la Conformidad – Requisitospara los organismos que realizan laauditoría y la certificación de sistemas degestión.Publicado 15 Septiembre 2006
    5. 5. 5ISO/IEC 17021 Parte 2ISO/IEC 17021 Parte 2 Reemplazar las referencias a los lineamientosdel ISO 19011 con requisitos aplicables acualquier auditoría de tercera parte de unsistema de gestión.– Procesos de Auditoría– Gestión de la competencia por el CB, incluyendo lacompetencia de los equipos de auditoría Formato para requisitos específicos que puedenser aplicados a otros Comités Técnicos de ISO– TC 176 para ISO 9001, TC 207 para ISO 14001, TC 34para ISO 22000, etc.
    6. 6. 6Requisitos Generales para Auditorías de3a Parte y Gestión de Competencia(basados en 19011)QMS Requisitosde CompetenciaEspecíficosEsquema para Desarrollar Requisitos Específicos para Auditorías de 3aPartey Gestión de CompetenciaIncluidos en 17021 Parte 2, desarrolladospor WG 21 con información de organismosde competenciasEMS Requisitosde CompetenciaEspecíficosFSMS Requisitosde CompetenciaEspecíficosISMS Requisitosde CompetenciaEspecíficosxMS Requisitosde CompetenciaEspecíficosDesarrollados por un organismos de competenciasusando el esquema 17021 Part e2, en consulta conCASCO, y publicados como documentosindependientes del sectorQMS CompetentBody, e.g.ISO/TC176EMS CompetentBody, e.g.ISO/TC207FSMS CompetentBody, e.g.ISO/TC34ISMS CompetentBody e.g.ISO/TC178xMS CompetentBodyISO/IEC17021Parte 2
    7. 7. WG 21 reuniones para la Parte 2:– Diciembre 2006, Febrero y Junio 2007: WD1– Octubre 2007: WD2– Enero 2008: DC1 para comentarios de cinco-meses– Octubre 2008: CD2 comentarios de votación– Abril y Junio 2009: DIS1 votación– Junio 2010: FDIS– Febrero 2011: Publicación como ISO/IEC17021:20117ISO/IEC 17021 Parte 2ISO/IEC 17021 Parte 2
    8. 8. 8ISO/IEC 17021:2011ISO/IEC 17021:2011ISO/IEC 17021:2011Evaluación de la Conformidad—Requisitospara los organismos que realizan laauditoría y la certificación de sistemas degestiónPublicado 1 Febrero 2011
    9. 9. Como se decidió por ISO/CASCO antes dela votación, habrá una revisión sistemáticadel documento completo 12 meses despuésde su publicación9ISO/IEC 17021:2011ISO/IEC 17021:2011
    10. 10. 10ISO/IEC 17021:2011ISO/IEC 17021:2011 Contenido– 1 Alcance– 2 Referencias Normativas– 3 Términos y definiciones– 4 Principios– 5 Requisitos Generales– 6 Requisitos relativos a la Estructura– 7 Requisitos relativos a los Recursos– 8 Requisitos relativos a la Información– 9 Requisitos relativos a los Procesos– 10 Requisitos relativos al Sistema de Gestión de losOrganismos de Certificación
    11. 11. 11ISO/IEC 17021:2011ISO/IEC 17021:2011 Contenido– Anexo A (normativo) Conocimientos y Habilidadesrequeridos– Anexo B (informativo) Métodos posibles deevaluación– Anexo C (informativo) Ejemplo de un diagrama delproceso para determinar y mantener las competencias– Anexo D (informativo) Comportamientos personalesdeseados– Anexo E (informativo) Auditoría de tercera parte yproceso de certificación– Anexo F (informativo) Elementos a considerar para elprograma, alcance o plan de auditoría– Bibliografía
    12. 12. CambiosCambiosSe eliminan todas las referenciasnormativas al ISO 19011– Sección 2 Referencias Normativas Referencia y nota– Sección 7 7.2.5, 7.2.11– Sección 9 9.1.2, 9.1.3, 9.1.9, 9.1.10– Sección 10 10.2.512
    13. 13. CambiosCambiosSe reemplazan la mayoría de las referenciasnormaticas al ISO 19011 con requisitosespecíficos relacionados con la competenciay auditorías de certificación de tercera parte13
    14. 14. CambiosCambiosSección 3 Términos y definiciones– Agrega 7 nuevas definiciones 3.4 auditoría de certificación de tercera parte 3.5 cliente 3.6 auditor 3.7 competencia 3.8 guía 3.9 observador 3.10 área técnica14
    15. 15. CambiosCambiosSección 4 Principios– Se editó el 4.3 para eliminar un párrafo que noera consistente con la nueva definición decompetencia (3.7)15
    16. 16. CambiosCambios Sección 7 Requisitos relativos a los Recursos– Se agregan 2 nuevos requisitos 7.1.2 Determinación de los criterios de competencia,con referencia al Anexo A el cual es normativo 7.1.3 Procesos de Evaluación, con referencia al AnexoB el cual es informativo– Revisión del 7.2.4 Eliminación de “atributos personales aplicables” Se agrega una nota haciendo referencia alcomportamiento deseado del personal en el Anexo Del cual es informativo 16
    17. 17. CambiosCambiosSección 9 Requisitos relativos a los Procesos– 9.1 Requisitos Generales– 9.2 Auditoría Inicial y Certificación– 9.3 Actividades de Vigilancia– 9.4 Renovación de la Certificación– 9.5 Auditorías Especiales– 9.6 Suspender, Retirar o Reducir el alcance de la Certificación– 9.7 Apelaciones– 9.8 Quejas– 9.9 Registros relativos a solicitantes y clientes17
    18. 18. 18CambiosCambios9.1 Requisitos Generales– 9.1.1 Programa de Auditoría– 9.1.2 Plan de Auditoría– 9.1.3 Selección del equipo auditor y asignación de tareas– 9.1.4 Determinación del tiempo de auditoría– 9.1.5 Muestreo Multi-sitio– 9.1.6 Comunicación de las tareas del equipo auditor– 9.1.7 Comunicación relativa a los miembros del equipo auditor– 9.1.8 Comunicación del plan de auditoría– 9.1.9 Realización de auditorías in-situ– 9.1.10 Informe de Auditoría– 9.1.11 Análisis de las causas de las no conformidades– 9.1.12 Eficacia de las correcciones y acciones correctivas– 9.1.13 Auditorías adicionales– 9.1.14 Decisión de certificación– 9.1.15 Acciones previas a la toma de decisión
    19. 19. 19CambiosCambios9.2 Auditoría inicial y certificación– Se agrega 1 nuevo requisito documentar las razones para rechazar unasolicitud
    20. 20. Un grupo de trabajo del Comité Técnico deIAF recomendó el período de transición de24 meses después de la publicación, lo cualfué aprobado por el IAF TC, IAF GeneralAssembly, y IAF-ILAC-ISO Joint WorkingGroupJoint IAF-ISO Communiqué– Fecha límite para la transición:1 de Febrero del2013 20TransiciónTransición
    21. 21. IAF ID2:2011Information on the Transitionof Management System Accreditation toISO/IEC 17021:2011 from ISO/IEC17021:2006– Publicado el 1 de Febrero 201121TransiciónTransición
    22. 22. 22ISO/IEC 17021:2006 TransiciónISO/IEC 17021:2006 TransiciónSuspensiones y Retiros GlobalesSuspensiones y Retiros Globales 19 de 52 Organismos de Acreditaciónmiembros de IAF suspendieron o retiraron laacreditación de 68 Certificadores– UKAS (12)– RENAR (8)– CAI (7)– EMA (6)– ENAC (5)– ANAB, SINCERT, SAS (4 c/u)– NAT, RVA (3 c/u)– OAA, COFRAC, IPAC (2 c/u)– CGRE/INMETRO, JAS-ANZ, BAS ESYD,INAB, LA (1 c/u)
    23. 23. IAAR-ANAB planean identificar y aprobar“áreas técnicas” y cómo aplicarlas a QMS,EMS y OHSMS para cumplir con losnuevos requisitos de competencia delISO/IEC 17021 parte 2– www.anab.org23Competencia de auditores deCompetencia de auditores deOCsOCs
    24. 24. El grupo de trabajo del Comité Técnico deIAF harmonizará las evaluaciones de losAcreditadores en la competencia de los Ocs,de acuerdo al ISO/IEC 17021:201124Evaluación de la competenciaEvaluación de la competenciade un OCde un OC
    25. 25. Program conjunto por RABQSA / IRCAcon base en ISO/IEC 17021:2011– Plan para ofrecer certificación de auditores conbase en la competencia para áreas técnicasespecíficas.– Las herramientas estarán disponibles para losOrganismos de Acreditación y de Certificación25Competencia del auditorCompetencia del auditor
    26. 26. Como resolver dudasComo resolver dudasCASCO para hacer preguntasCASCO para una interpretación– Sean MacCurtain (maccurtain@iso.org)IAF referente a la aplicación– Norbert Borzek (norbert.borzek@dakks.de)26