What Do ISO 9001 Revisions Mean For Manufacturers?
Following the latest update to the revision process for ISO 9001, the global Quality Management System (QMS) standard, LRQA’s Senior Technical Manager for North America, Michael Harder, talks about what ISO issuing ISO/DIS 9001:2014 means for organizations.
Q: Now that the ISO/DIS 9001:2014 has been issued, what is the first thing that ISO 9001:2008 certified organizations should be thinking about or doing?
A: Firstly, start by obtaining a copy of the Draft International Standard which is available from ISO.org. The publication of ISO/DIS 9001:2014 is a signal for organizations to formally start their transition planning. It is also the first time that most of our clients will be looking for information on the changes and what they mean.
The introduction of Annex SL, which establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS), is the biggest change, as this will apply to all ISO MSS, not only 9001. In fact, Annex SL is already present in some of the other ISO standards, including ISO 27001, the global IT security standard.
I would also strongly advise organizations to read the communications from ISO to understand the stage of development and the proposed transition guidance. At LRQA, we are also providing a range of information and tools to make the transition process for our clients easier and more transparent. Change is never an easy thing, and we view it as our responsibility to make it as easy as possible for our clients. With over a year to go before the final ISO 9001:2015 is set to be published, now is the perfect time for organizations to start their planning process and begin involving interested parties across their organization
Lastly, individuals responsible for managing the QMS should start thinking about training for themselves as well as the key people involved in the management system.
Q: What are some of the other new topics in ISO /DIS 9001:2014?
A: Annex SL is the single biggest change to the ISO/DIS 9001:2014 document. Other topics that are new to ISO 9001 include: a] organizational context, which is covered in clause 4, b] knowledge and how organizations manage it, addressed in clause 7, c] the control of externally provided products and services, outsourcing in other words, which is found in clause 8 and the formal introduction of a risk-based approach, which is located in several of the clauses in the document, among others.
Among the areas of the standard that have been revised or now contain more specific information, we will be advising our clients to ensure they are looking at the following areas: a] increased emphasis on top management engagement with ISO 9001, clause 5. This is a very important change as it formally requires the active involvement of top management in the development and implementation of ISO 9001, b] managing change, clause 5 is another one, as is, c] clause 7’s performance and evaluation. Finally, look at d] clause 9, as management review has changed as has the requirements relating to the process-based approach, which are now much stronger throughout the standard. There is much to look at but that doesn’t necessarily mean that there will be a lot of change necessary for all organizations, it just means they will need to evaluate whether or not their current ISO 9001:2008 already meets the requirements or if there are gaps that they will need to address.
Q: What tools can organizations apply to help them get ready for the transition?
A: It’s never too early to begin understanding topics that can make your management system more effective and provide even greater benefit for your organization. This revision to ISO 9001 is bringing the requirements up-to-date with good management practice. A lot has changed in 15 years since the last significant revision to ISO 9001. So, training to understand the new direction and topics introduced within ISO/DIS 9001:2014 should benefit both the individual and the organization. If as an organization, youwould like to be among the first to be certified to ISO 9001:2015, then we suggest you start thinking about training now.
Q: Who are the most important internal interested parties for organizations in relation to the ISO 9001 revision?
A: Probably the most important internal interested party is top management. The revision of ISO 9001 requires greater understanding of the external environment, addressing risk and greater top management "quality leadership" responsibility tied to closer links between the management system and product/service quality. So there is more emphasis on their direct involvement or oversight for the design, implementation and performance of the organization’s management system and to ensure the QMS is an integral part of the organization’s business processes. When this is done well, the QMS provides a valuable mechanism for top management to meet their responsibilities for internal governance and control as well as providing an excellent source of performance data for use in decision making forums.
Q: Will all organizations have to go through the same degree of change to meet the new requirements?
A: The potential organizational impact of the ISO 9001 revision is dependent upon the organization and their individual QMS. Factors such as the maturity and complexity of the existing ISO 9001:2008, the existence of other management systems (such as ISO 14001 or OHSAS 18001) and the organization’s current evaluation and management of risk will all heavily influence the degree of change that an organization will need to undertake in order to meet these future requirements of ISO 9001:2015.
Q: Could things still change before the final ISO 9001:2015 is issued?
A: The publication of the Draft International Standard (DIS) is an important stage for any standard. The revision process so far has consulted with users through surveys and discussions with industry groups to gain their views on what needed to stay the same and what needed to change. LRQA’s global team, based out of the UK, has been instrumental in helping to ensure that the standard is updated in a manner that reflects the changing needs of today’s business world.
The ISO committee responsible for managing the revision will need to demonstrate how it has addressed any comments received related to ISO 9001 specific topics, including some of the ones that we have mentioned here. If, however, the comments are in relation to Annex SL, then it will be more difficult, as those elements are now being implemented across all ISO MSS.
Q: Can you summarize the next steps that organizations should be taking?
A: Start with the DIS and focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in any transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL will bring to the standard as well as other MSS.
Organizations should ensure that their certification body not only understands the DIS, but more importantly, understands what the DIS means to your QMS and wider organization. Again, the changes are not a one-size-fits-all situation.
Next, engage your certification body to find out how a gap analysis and training on specific areas of ISO 9001:2015 can benefityour organization.
Finally, and most importantly, begin formalizing a transition plan and process and ensure that top management is involved from the start.