Preparing for the Change – Transition to ISO 9001:2015
DAS CERTIFICATION, 20 Januari 2018
As everyone in the quality game is aware, the worldnow has a new version of ISO 9001. ISO standards touch
almost everything we do and they help to make the world a safer and more efficient place. This drives the need to
evaluate the effectiveness of the standard and make changes to drive continual improvement within our own
organizations and industrywide.
The task of understanding the revised standard’s effect on your organization can be overwhelming. We at DAS
want to ease our clients and potential clients into this new standard and have composed this simplified FAQ to
address some of the most pressing questions and address what steps can be taken now to prepare for thecoming
change. In addition to this FAQ, DAS also offers an overview of changes to ISO 9001:2015 webinar on amonthly
ISO 9001:2015 FAQ:
- Why is the ISO 9001 standard changing again?
There are a number of objectives associated with this revision, but there are three that are considered most
critical. 1) The Internal Organization for Standardization (ISO) wants to see the ISO 9001 and all ofits other
standards continue to grow in terms of numbers of registrations. There is a lingering perception thatISO 9001
is somehow overbearing or obtrusive to service organizations. 2) There has been a targeted effort to simplify
language used to aid in understanding and promote consistency between accreditation bodies, certification
bodies, auditors, and clients. 3) There has been a long standing desire to simplify and streamline theprocess for
companies that wish to achieve multiple certifications (such as ISO 9001 and ISO 14001.) For example,many
of these companies currently feel compelled to maintain multiple sets of quality and procedures manuals. This
new re-write is attempting to address these and other concerns.
- What is the expected timeline?
The new standard was published on September 15, 2015. This means that the ISO 9001:2008 standard will
become obsolete on September 14, 2018. As a result, All ISO 9001:2008 certifications issued in late 2015 and
beyond will have to bear an expiry date September 14, 2018. However, it has been emphasized that companies
will be allowed to transition at their own pace, and that certification bodies will have to establish their own
individual cut-off dates for ISO 9001:2008 audits. DAS has established our cut-off plan for ISO 9001:2008 in
two tiers. See also the response to the next question.
- My audits are normally due in late July, and the transition period ends in September. Why can’t my
company have its transition audit in late July 2018?
While it is true that the transition period does not end until September 14, 2018, it is not just required that your
audit is conducted by this date. If any nonconformities are discovered during the audit, they must beaddressed
with corrective action, and DAS’s Executive Committee (decision-making body) must review and approve the
audit package by the transition deadline. A late July 2018 audit does not provide enough time for this to
happen. Thus, your organization could transition in July 2017 or chose to have an earlier audit in 2018, perhaps
May, to allow adequate time for completion of the post-audit process. All transition audits must be completed
within 120 days of the transition end date of September 14, 2018. Thus, all transition audits must becompleted
by May 14, 2018.
- What if we have a Recertification audit in early 2016, should we just plan on performing that audit toISO
This will be a strategic decision that each companymakes on its own, but there are a few key points to bear in
mind. If you have had a chance to examine your quality system against the revised requirements and feel that
you are ready, you can certainly request that a transition audit to ISO 9001:2015 be performed. Timing the
transition to your regular recertification audit is ideal, but not in any way mandatory. You could certainly
perform your 2016 Recertification Audit to ISO 9001:2008, and then complete a transition audit to ISO
9001:2015 in 2017.
- What are the critical changes?
PJR has prepared a separate report showing a clauseby clause analysis on the changes within the ISO 9001
standard, but there are two important standouts. 1) ISO 9001:2015 has eliminated the terms “Documents,”
“Procedures,” and “Records.” All of these terms have been replaced with the ubiquitous “Documented
Information.” The rationale of this change is thatit opens the door to a greater understanding and acceptance of
alternative methods of controlling a quality management system. ISO is not interested in outdated, dogmatic
views of how a process can be controlled or shown to be effective. Consequently, these outdated termshave
been eliminated. 2) The introduction of Risk Management. Risk Management has been talked about a great
deal over the past year. There are already two ISOstandards (ISO 14971 and ISO 31000) and numerous other
published materials on methods that can be used to achieve Risk Management. Our analysis has concluded that
at least two existing processes within ISO 9001:2008 can be applied to an effective Risk Management program.
These are 7.1 Planning of Product Realization and 8.5.3 Preventive Action. Risk Management is being viewed as a system wide component of the quality management system (in much the same way Continual Improvement
was when ISO 9001:2000 was published), but it has been emphasized many times over that a formal Risk
Management process will not be expected.
- What is Annex SL, and what does it have to do with ISO 9001?
Annex SL is a portion of the “ISO/IEC Directives Part 1 – Consolidated ISO Supplement – Procedures Specific
to ISO” document. This standard regulates and controls the process of developing, updating, and issuing ISO
published standard. The full text of Directives Part 1, including the Annex SL text can be found here:
http://www.iso.org/sites/directives/Directives_Consolidated.xhtml#x---Annex-SL--normative---Proposals-formanagement-system-standardsAnnex SL can be thought of as a ten section blueprint to be used for all ISO
standards. It promotes (among other things) commonterms and core definitions for many of the terms used in
the ISO family of standards. It is through the mandatory structure of Annex SL that organizations will be better
enabled to achieve multiple certifications such as ISO 9001, ISO 14001, and OHSAS 18001, because each of
these standards will have the same 10 sections and the same core terms and definitions.
- Will our staff have to complete transition training?
It will depend on the extent of revisions that you make to your quality management system, but generally – yes
you will be expected to provide some form of transition training to your staff. At a minimum, PJR would
expect that awareness training of the new standard would be provided, as well as an assessment of the new
standard’s impact on the various processes and personnel. However, it is entirely conceivable that the majority
of your staff will feel no effect from your company’s transition to ISO 9001:2015.
- What about our internal auditors, will they have tocomplete transitional training?
Internal auditing is viewed in the same light as any other required competency within a quality management
system. Namely, the organization is responsible for determining what competencies are required for its internal
auditors, as well as the methods to be used to achieve those competencies. To put it more plainly, each
organization will have to decide on its own the extent to which transition training will be needed. It is
conceivable that a seasoned team of internal auditors could complete a period of self-study and successfully
transition to auditing ISO 9001:2015. As has always been the case, the competency of your internal auditors
will be judged by the overall effectiveness of yourinternal audit process.
- What steps can we take right now?
The International Accreditation Forum (IAF) has published an Informative Document (ID 9) which
recommends the following steps be taken in a the transition to ISO 9001:2015. 1) A full review of theISO
9001:2015 standard should be performed by Top Management to identify the gaps that need to be addressed.
2) A plan of implementation should be developed with assigned responsibilities. 3) All quality management
system documents (including the quality and procedures manual (if applicable)) should be updated to reflect
any new or revised processes. 4) All necessary awareness and transition training should be completed.4) A
full system internal audit followed by a ManagementReview should be complete. 5) Corrective Actions for all
internal audit findings should be in process or complete. 6) Coordinate with DAS for planning of transition
- Yes, if you plan on transitioning on a normal surveillance or recertification audit, extra time will be added to
your audit. Guidance published by the International Accreditation Forum clearly states the following: “Where
transition audits are carried out in conjunction with scheduled surveillance or recertification (i.e. progressive or
staged approach), additional time is likely to be required to ensure that all activities are covered for the existing
and new standards.”
DAS has completed an analysis of the new requirements and our technical experts have analyzed the timeit
would take to effectively auditthese requirements in different companies.
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