Quality Professionals know that there has been much discussion over the last two years regarding impending changes in the ISO 9001:2015 standard
Understanding the revised standard’s impact on an organization can be a bit overwhelming.
Quality Resource Center is committed to assisting our clients and potential clients in achieving both compliance and maximum value added in transitioning to this new standard, and thus has drafted this FAQ to address some of the essential questions and issues and present guidance on steps needed to prepare for the coming change.
Additionally, Quality Resource Center has published several articles regarding changes to ISO 9001:2015 that are currently available at www.QRCCentral.com
Quality Resource Center offers a complimentary toll free call regarding ISO 9001:2015 transitioning –
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A – Why is the ISO 9001 Standard Changing Again?
There are a number of important objectives imbedded with this revision.
There remains an unfortunate and erroneous perception that ISO 9001 is not fully compatible with service organizations. This is key, and there has been a targeted movement to streamline language used in order to improve understanding and promote consistency between accreditation bodies, certification bodies, auditors, and clients.
Simplifying and making the process more efficient for Organizations seeking multiple certifications (such as ISO 9001 and ISO 14001) has been addressed. Many of these Organizations have felt compelled to maintain multiple sets of quality and procedures manuals, SOP’s, Work Instructions, and Forms and Records. The new revision addresses these and other concerns. Quality Resource Center has been a pioneer in the development of Integrated Management Systems, and has developed and deployed more systems of this type than any other firm.
B – Will Other Standards (AS9100, ISO/TS 16949, etc.) Should Be Updated As Well?
The major sector specific standards, including ISO/TS 16949, AS9100, and TL9000 have indicated their intentions to transition and continue their alignment with ISO 9001. Timelines for these other standard updates are not fully known at this time; that said, a 2016 publication date seems likely for all three. At present only ISO 13485 has not announced plans to maintain alignment with ISO 9001, although it is in the midst of its own update with a targeted publication of early 2016. Continued alignment is expected.
C – What Are The Critical Changes?
Quality Resource Center has conducted analysis and prepared several separate reports detailing key changes, but there are two noteworthy elements:
1 – ISO 9001:2015 has eliminated the terms “Documents, “Records”, and “Procedures,”. They have been replaced with the expansive terms “Documented Information.” The reasoning here is that it offers opportunities for greater understanding and acceptance of alternative methods of controlling a quality management system. ISO is no longer concerned with a process is controlled or shown to be effective. Thus, these terms have been removed.
2 – There has been a great deal of discussion regarding the introduction of Risk Management. There are already two ISO standards (ISO 14971 and ISO 31000) and numerous other published materials on methods that can be used to design and implement Risk Management. Quality Resource Center’s analysis has concluded that at least two existing processes within ISO 9001:2008 can be applied to an effective Risk Management program. These processes are 7.1 Planning of Product Realization and 8.5.3 Preventive Action.
Formal Risk Management is now required as a system wide element of the quality management system, similar in fashion as was Continual Improvement was when ISO 9001:2000 was published).
D – What is “Annex SL” and How Does It Relate to ISO 9001?
Annex SL is part 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. Annex SL is basically a ten section template to be used for all ISO standards. It establishes common terms and core definitions for much of the language used in the ISO family of standards. The mandatory structure of Annex SL enables organizations to be better positioned to attain multiple certifications such as ISO 9001, ISO 14001, and OHSAS 18001, as each of these standards will now contain the same 10 sections and include the same core terms and definitions.
E – What is the Timeline?
The projected publication dates for the FDIS (Final Draft International Standard) and the actual ISO 9001:2015 document are July 2015 and September 2015, respectively. It is Quality Resource Center’s contention that most organizations should wait until the final approved ISO 9001:2015 standard is published to make a purchase and obtain the Standard. Once the ISO 9001:2015 standard is published, a 36 month transition timeline will begin. Thus, if the ISO 9001:2015 standard is published on September 15, 2015, the ISO 9001:2008 standard will be viable until September 15, 2018.
It is important to note that ALL ISO 9001:2008 certifications issued in late 2015 and beyond will be required to bear an expiration date that matches the cut-off for ISO 9001:2008. Companies may be permitted to transition at their own pace, and certification bodies may establish their own individual cut-off dates for ISO 9001:2008 audits. That said, Quality Resource Center has declared there will be no cut-off in our support for ISO 9001:2008 audits. Quality Resource Center will be there to support our clients as long as that support is needed.
F – Our Organization Has a Re-certification Audit in Early 2016. Should It Conducted in Accordance with ISO 9001:2015?
This is a strategic decision that each Organization must determine, but there are several key points to consider. If the Organization has had a chance to perform an ISO 9001:2015 GAP Analysis, upgrade systems to comply with the revised requirements, and has confidence in the Organization’s ability to succeed, a request that a transition audit to ISO 9001:2015 be performed can be submitted.
Coordinating the timing of the transition to the existing recertification audit is ideal, but isn’t mandatory. An Organization could certainly perform its’ 2016 Re-certification Audit to ISO 9001:2008, and then complete a transition audit to ISO 9001:2015 in 2017.
G – Our organization has been certified for quite some time and our procedures are well implemented;
Will they need to be changed?
Quality Resource Center’s analysis has concluded that for the average ISO 9001:2008 certified company, the impact of the revised standard will be varied but quite manageable. It is important to bear in mind that the ISO is seeking greater inclusion for the ISO 9001 standard. They want to see it continue to grow into new sectors and be even more user friendly than it is now. Requiring a company to aggressively overhaul their current ISO 9001:2008 system is not consistent with this objective.
H – Should Our Staff Complete Transition Training?
It depends on the extent of revisions made to your quality management system, but generally speaking – of course you will be expected to provide some form of transition training to your staff. At a minimum, Quality Resource Center recommends that awareness training of the new standard would be conducted, as well as an assessment of the new standard’s impact on the various processes and personnel. Ideally, an ISO 9001:2015 GAP analysis would be conducted by Quality Resource Center’s certified Auditors. However, it is entirely conceivable that the majority of your staff will feel no effect from your company’s transition to ISO 9001:2015.
I – Where Can Internal Auditors Obtain Complete Transitional Training and Certification?
Internal auditing remains the cornerstone of demonstrating compliance to requirements within a quality management system. Organizations remain responsible for determining what competencies are required for its internal auditors, as well as the methods to be used to achieve those competencies. Simply stated, each organization must decide the extent to which transition training is required. It is conceivable that a seasoned team of internal auditors could conduct an ISO 9001:2015 GAP Analysis and period of self-evaluation to facilitate the successful transition to auditing ISO 9001:2015. The competency of internal auditors is judged by the overall effectiveness of the internal audit process.
Over the last 25 years Quality Resource Center has trained and certified thousands of Internal Auditors.
Contact Quality Resource Center immediately to schedule your training and certification project.
J – What Immediate Steps Can Be Taken?
Preparation must include a comprehensive review of the currently available DIS, or the soon to be available FDIS. Quality Resource Center can and does provide extensive early planning assistance and analysis. Expect to see an official transition guide from the ISO itself, and likely additional written materials from other bodies such as ANAB and RABQSA. The International Accreditation Forum (IAF) has published an Informative Document (ID 9) which recommends the following steps be taken in the transition to ISO 9001:2015. A full review of the ISO 9001:2015 standard should be performed by Top Management to identify the gaps that need to be addressed. A plan of implementation should be developed with assigned responsibilities. All quality management system documents (including the quality and procedures manual (if applicable)) should be updated to reflect any new or revised processes. Necessary awareness and transition training should be completed. A full system Internal Audit followed by a Management Review should be completed. Corrective Actions for all internal audit findings should be completed.
Only Quality Resource Center offers a full suite of transition and training options, including on-site, web based, and our state of the art training center in northern California. Contact Quality Resource Center for all planning of transition arrangements and training.