As the anticipated publication date for the new version of ISO 9001 approaches, UKAS is publishing this update to provide clarification to those Certification Bodies (CBs) that were not involved in the Early Adopter Programme on how UKAS will handle their ISO 9001 transition assessments under ISO/IEC 17021: 2011.
CBs are requested to provide a completed UKAS Extension to Scope application form together with relevant information in order for UKAS to progress the assessment for the updating of the scope of accreditation to the new standard. The relevant information required to be provided is detailed below under “Information Requirements”. The anticipated timeframe/dates for when the CB would like the transition assessments to take place should also be provided.
The IAF has agreed a list of criteria to be demonstrated by CBs as part of the transition process no matter what transition process is being followed (the list is annexed to this bulletin); The UKAS transition process follows this IAF agreement and will include all of the listed criteria.
The IAF has allocated a 3-year transition period (from date of publication of the standard) for CBs to transfer their clients from the 2008 version to the 2015 version of the standard. Following this transition period ISO 9001: 2008 will cease to be valid.
The UKAS transition assessment process remains as previously published, although it is recognised that some CBs may already have demonstrated many of the IAF-listed criteria through the normal surveillance and reassessment process: Where this is the case this will be taken into account when finalising the assessment required for the transition for each individual CB. UKAS expects that a Head Office visit will be required for the majority of CBs, which in most cases will coincide with the normal annual surveillance visit. However where a CB requests an early assessment the need for a head office visit will be determined following a preliminary review of the gap analysis and associated documentation submitted by the CB to support their request for transition and UKAS will also take into account historical knowledge of the CBs processes and performance. In all cases a witnessed assessment of at least one audit conducted to ISO 9001:2015 will be required.
One of UKAS’ main aims is to try to ensure that accredited CBs are given a fair and equitable chance to obtain ISO/IEC 17021 accreditation for the delivery of ISO 9001 certification to the 2015 version of the standard in a timeframe that suits their business.
In planning this transition UKAS has consulted with relevant stakeholder bodies (ABCB, FCB, IIOC) and taken due consideration of “IAF ID 9: 2015 – Transition Planning Guidance for ISO 9001: 2015”http://www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf
This guidance document was published on the 12th January 2015 and provides useful information to all parties affected by the transition from ISO 9001: 2008 to ISO 9001: 2015. The document also strongly emphasises the need for early activity to ensure a smooth transition process.
UKAS Approach to the Transition
The transition process will include the following assessment stages (however please see the note above regarding the IAF discussions)
- Review of transition gap analysis and related documentation (this will be required whether the CB is assessed during the FDIS stage or once the standard is published);
- Head Office Assessment (unless determined by UKAS it is not required);
- Witnessed Assessment (to be conducted following the document review and head office evidence demonstrates readiness consistent with the IAF guidance).
UKAS normally conducts transition assessments at the time of an organisation’s annual surveillance or reassessment visit. In these cases much of the transition assessment can be incorporated into existing assessment time, however extra time will be needed to cover additional activities, such as the review of gap analysis documentation.
However where a certification body requests an earlier assessment this will be considered and, subject to suitable resource availability, will be progressed. In these cases additional costs over and above those for the annual assessment will apply: UKAS expects these to be in the region of 3-5 days (not including witnessed assessment) depending on the size and scope of the certification body’s accreditation.
In both cases the witnessed assessment activity will form part of the certification body’s annual witnessed assessment programme and therefore should not present any additional effort.
Information Requirements
When submitting the Application Form, the certification bodies should submit a gap analysis (detailing what changes and enhancements have been necessary to the CB’s systems and processes) and details of transition arrangements, including timelines, communications with certified customers, training materials, and process for confirming competence; this will be reviewed and used to help formulate the transition programme. Application forms with the supporting documentation should be submitted to [email protected] .
Audits selected for witnessing must be of a client that has implemented ISO 9001: 2015. They will need to be sufficient to demonstrate the certification body’s competence and process to audit in terms of the new standard, covering items such as the approach to risk management and organisational context, as well as the necessary audit planning and reporting activities. Should the witnessed assessment not be deemed suitable to demonstrate the above then UKAS may require further witnessing to take place; such additional assessment is likely incur additional cost.
Planning
Please note that ISO 9001: 2015 certificates cannot be issued until the standard has been formally published, and that these certificates cannot be issued as UKAS accredited until the certification body has ISO 9001: 2015 listed on its scope of accreditation.
Certification bodies must also ensure that expiry dates on certificates issued following initial certification or recertification referencing ISO 9001:2008 do not exceed the published end of transition date: At this point any remaining certificates to the 2008 standard shall become invalid. Any organisation wishing to be certified to ISO 9001: 2015 after the cut-off date will be subject to a full initial audit.
Combined Audits
Publication of ISO 14001: 2015 is expected around the same time as ISO 9001: 2015, and it is recognised that some CBs may wish UKAS to carry out a combined ISO/IEC 17021 assessment covering their ability to audit and certify using the new versions of both ISO 9001 and ISO 14001. UKAS is developing processes to accommodate such requests.
Projected Timescales
The following timetable is based on current knowledge with regard to the issue status of ISO 9001: 2015; UKAS will keep CBs updated on this.
July 2015: Publication of ISO FDIS 9001
Mar to Sept 2015: UKAS internal preparation activities
July to Nov 2015: UKAS to complete early adoption activities to ISO/IEC 17021 for certification to ISO 9001: 2015, based on the FDIS and post publication validation.
Sept 2015: Expected publication of ISO 9001: 2015
(Sept 2015: Expected publication of ISO 14001: 2015)
Sept 2018: End of ISO 9001 transition (based on ISO 9001: 2015 being published in September 2015)
ISO 9001: 2008 ceases to be valid (based on ISO 9001: 2015 being published in September 2015)
Any queries should be directed to Kevin Belson – UKAS Technical Manager [email protected]
Annex – List of Criteria to be demonstrated during the Transition Process
Taken from IAF discussion paper IAF-TC-12.3.1-15
It is recognized that ABs methodology may differ; however, the following should be demonstrated:
Each CAB has to demonstrate the ability to deliver effective certification against the requirements of ISO 9001:2015 with the intent to improve the credibility of accredited certification.
This paper defines possible evidence to be obtained by the AB prior to accrediting the CAB to deliver certification to the new standard as well as expectations of the AB throughout the transition process.
The following items should be considered by the AB when transitioning a CAB:
- Where needed, amended internal procedures and documents of the CAB, which reflects the changed requirements of the standard;
- Demonstration of appropriate skills and knowledge, as identified by the CAB, based on the requirements of ISO 9001:2015, including evaluation of achieved competence. Skills and knowledge should be tailored and delivered to all relevant functions of the CAB;
- Ability to audit the application of risk based thinking by the certified client. Understanding of risk analysis techniques (SWOT, FMEA etc.) will be necessary where required by the industry;
- Ability to verify the identified risks and opportunities, as well as actions to mitigate risks;
- The style of reporting and the information submitted to decision making;
- Ensuring consistent process based approach among its audit teams;
- Ability to analyse whether the management system reflects the context of the organization;
- Ability to plan audits based on the context of the organization, with more emphasis on stage 1 audit, during initial certification audits and recertification audits (when applicable), which is used to understand organisational context;
- Alignment of audit program to reflect the requirements of new standard;
- Understanding by auditors of internal and external factors, needs and expectations of related interested parties;
- Recognition of organisational boundaries;
- Time interval between stage 1 and stage 2 audits during initial certification audits and recertification audits (when applicable);
When witnessed audits are completed to ISO 9001:2015, the following should be specifically considered:
- Evidence of process approach used, e.g. auditing starts from the system up to the standard;
- Instead of focus on documentation, focus should be on good techniques for interviewing andunderstanding the method of auditing an organization without a documented system or with a limited documented system;
- Planning and organising the audit are essential;
- Risks are identified throughout the processes and in the context of the organization;
- Selection of relevant interviewees to cover leadership;
- Understanding the implications of the new terminologies in the standard;
- Interaction between audit team members is vital.
The previous knowledge of AB regarding the performance of CABs should be considered during establishing the approach to transition.
The effective communication between ABs and sharing information on their approaches regarding the transition is welcomed. It is also important to share its transition assessment results on a higher level, not violating confidentiality requirements
In working with the IAF Informative Document 9, AB’s may have differing transition approaches; however, AB’s are expected to:
- consider the history of other transitions when developing its transition process
- have competent resources for the new standard in order to fulfil its transition process
- have the necessary resources to support CAB’s when ready for transition without causing undue delay
- consider the history of the CAB when transitioning a given CAB
- cooperate with other AB’s for a CAB’s transition, when requested and appropriate.