ISO/IEC 170211:2015 Revisions Lori Gillespie, ANAB Director of Accreditation Review and Revision of ISO/IEC 17021 HistorySeptember 2000 to present Replaced ISO/IEC Guide 62 & Guide 66 ISO/IEC 17021:2006 ISO/IEC 17021:2011 ISO/IEC 17021-1:2015 FDIS published 2015/06/15 History Developed by ISO/CASCO Working Group 21
Co-conveners Alister Dalrymple, France-AFNOR AFNOR, a standards development organization and certification body Randy Dougherty, US-ANSI ANAB, an accreditation body for management system certification bodies /IEC O S In I 1-1 2
0 17 Generic Requirements for 3rd Party Auditing & Management of Competence (based on 19011) Framework for Developing Specific Requirements for 3rd Party Auditing & Management of Competence QMS Competent e.g. ISO/TC176 QMS Specific Competence
Requirements EMS Competent Body, e.g. ISO/TC207 EMS Specific Competence Requirements By WG21 and included in 17021 FSMS Competent ISMS Competent Body, e.g. Body e.g. ISO/TC34
ISO/TC178 FSMS Specific Competence Requirements ISMS Specific Competence Requirements xMS Competent Body xMS Specific Competence Requirements
By other competent bodies within WG21 4 ISO/IEC 17021-1 and Additional Competence Requirements
ISO/IEC 17021-1 generic competence for any MS ISO/IEC TS 17021-2 competence for EMS ISO/IEC TS 17021-3 competence for QMS ISO/IEC TS 17021-4 competence for event sustainability MS ISO/IEC TS 17021-5 competence for asset MS ISO/IEC TS 17021-6 competence for business continuity MS ISO/IEC TS 17021-7 competence for road traffic safety MS ISO TS 22003 includes competence for food safety MS ISO 28003 includes comp. for supply chain security MS ISO 50003 includes competence for energy MS
ISO/IEC 27006 includes comp. for information security MS Revision of ISO/IEC 17021 Inputs considered Out-of-scope comments on revision of 2006 CASCO interpretation requests IAF application documents
APG and AAPG papers Outcome of WG33ISO/IEC TS 17022 (reports) Outcome of WG37ISO/IEC TS 17023 (audit duration) CASCO PAS documents 17001-17005 Other CASCO documents17020, 17024, 17065 ISO/IEC 17021-1:2015 Key changes Re-organization of Section 9 Requirements now more in order of how certification audits and services are provided by a CB ISO/IEC 17021-1:2015 Key
changes Improving control by CBs Requirement for a CB to demonstrate effective operational control of its remote offices and personnel regardless of their organizational structure (6.2) Requirement for a CB to demonstrate effective organizational control for persons making certification decisions (9.5) ISO/IEC 17021-1:2015 Key Changes
Allows a statement, but no mark, on product packaging (not on product) and accompanying literature that a company has a certified management system (8.3.3) cannot imply the product is certified by this means to include the name of the CB ISO/IEC 17021-1:2015 Key Changes Defined audit time from planning to reporting (3.16) Defined audit duration from opening to closing meeting (3.17) Focused requirements for justification on
audit duration (220.127.116.11) Consistent with ISO/IEC TS 17023 guidelines Consistent with proposed revision of IAF MD5 Defining audit time ISO/IEC 17021-1:2015 Other Changes Defining/Classifying nonconformities as major (3.12) and minor (3.13) Added one new principle for a risk-based approach (4.8) Adopted the approach in ISO/IEC 17065 and not require, but still allow, an impartiality committee (5.2.3)
ISO/IEC 17021-1:2015 Other Changes Formalized a 2 year separation as a recognized mitigation of many threats to impartiality for internal audits (5.2.6) for relationships with consultancies (5.2.7) Persons that provide consultancy (5.2.10) Allowing a CB to certify another CB for a management system, except for a QMS (5.2.4) ISO/IEC 17021-1:2015 Other
Changes Adopted the approach in ISO/IEC 17024 regarding public information with, or without, request (8.1) No longer requiring a public directory of certifications ISO/IEC 17021-1:2015 Other Changes
New requirement for consideration of shifts in the audit program (18.104.22.168) New requirement on transfers requiring a CB to obtain and retain sufficient evidence such as reports and documentation on corrective actions for prior nonconformities(22.214.171.124) New requirement to plan for adequate auditing when certifying to multiple management systems standards (9.1.6) ISO/IEC 17021-1:2015 Other Changes If a CB is unable to verify effective correction and corrective action 6 months after an initial audit, another Stage 2 shall
be conducted (126.96.36.199) Based on the change above, changed the requirement for the first surveillance audit after initial certification to be 12 months after the initial certification decision date (188.8.131.52) ISO/IEC 17021-1:2015 Other Changes
When recertification is completed prior to expiration, the expiration date can be based on the existing certification (so certification may be longer than 3 years) (184.108.40.206.3) If the recertification audit is not completed, or any major nonconformity not verified, by the expiration date, then recertification cannot be recommended and the validity of the certification cannot be extended (220.127.116.11.4) Six months allowed for recertification following expiration of certification; otherwise, a Stage 2 shall be conducted (18.104.22.168.5) Significant Proposed Revisions of ISO/IEC 17021
New requirement for the audit report requiring a statement of the conformity and effectiveness of the MS (22.214.171.124) from consideration of ISO/IEC TS 17022:2012 Conformity assessmentRequirements and recommendations for content of a third-party audit report on management systems Significant Proposed Revisions of ISO/IEC 17021 Normative Annex A revised to include
expanded statements explaining competence requirements similar to approach in ISO/IEC TS 17021-2 or -3 Eliminated the X and X+ ISO/IEC 17021-1:2015 Training ISO/IEC 17021-1:2015 Full Standard Training (Onsite) 2-day training course based on the new standard ISO/IEC 17021-1:2015 Transition Training (Online) 4-hour session delivered through WebEx New/revised requirements and transition process
http://anab.org/training/#17021 Caroline Trenner, Training Accounts Manager 19 Transition Process with ANAB CBs All IAF ABs IAF Informative Document (Guidance only) http:// www.iaf.nu/upFiles/IAFID11_ISO170211TransitionPublication Version06032015.pdf
ANAB Heads Up 314 http://anab.org/media/53533/hu314.pdf Accreditation Rule ## Coming Soon Transition Process Application / Document Review 2016 Office Assessment / NCRs & CAs / Decision http ://www.iso.org/iso/17021-1-2015_and_1702
1-2011_differences_final-jaz_ans.pdf 21 Questions Lori Gillespie Director of Accreditation [email protected] 414 347 9858 ext 7827 | Cell, 414 870 2391 Skype Id: Lori.Scheid-Gillespie www.anab.org 22
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