Preparing for the Change – Transition to ISO 9001:2015

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
basis

ISO 9001:2015 FAQ: 

1. 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.  
2. 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.
3. 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.
   
4. What if we have a Recertification audit in early 2016, should we just plan on performing that audit toISO
   9001:2015?
   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.
5. 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.
6. 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.
7. 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.
   
8. 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.
9. 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
   arrangements.
10. 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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