January 19, Loveland Colorado. Tonight, the Northern Colorado ASQ (American Society for Quality) demonstrated the leading nature of their management team by holding a presentation looking at the future of management and management systems. Simultaneously CPR was interviewing a Northern Colorado business leader on the importance of and revival of manufacturing. A good day for Northern Colorado business.
The ASQ Presentation was held at the premises of major northern Colorado manufacturer, and attendees were crammed to standing room only. Management topics were discussed by industry leaders and quality professionals with the emphasis on the future – systems for managing organizations.
ISO is responsible for thousands of standards. One frequent example is management system standards (27001, 9001, 14001, 45001, 22000) One complaint against ISO was the subtle difference between the standards, which are not substantive but which cause effort to address. Also an organization has a single was of operating. A single management system. That system has to/could meet different standards but with meaningful differences in standards it is difficult and costly to maintain.
The solution is to publish a guide for the developers of all ISO standards that are management system standards. This resulted in a document (annex SL) that outlines the structure of an organizational management system. The structure will cope with different objectives (quality, environmental control, information security, safety, etc.) but assures consistency. All management system standards will be developed around this structure and common terminology. Standards developers may change the content of the requirements but they have to justify the change and the change has to be restricted.
Annex SL is the solution. It ensures consistency between different standards, assures common terminology and greater consistency (changes will be rarer)
This has been incorporated into 9001:2015
Many standards are committed to this new approach while others have not. For instance 13485 will not adopt the new approach and sticks with the old structure of 9001:2008. Their argument, among others was that they were ahead of the 9001 development and thus they had to stick with their approach. Eventually we will see all management systems adopt this approach. “it just makes sense”
During development of ISO 9001:2015, the committees and groups voiced their logic about the development. They talked about how they expected the new standard to be adopted. Some of these expectations got the backing of specific requirements in the standard. Others got commentary in Annex A and others got less traction.
This annex provides commentary and help. A1 – relates to the adoption of annex SL A2 – emphasizes the applicability to services as well as products. A3 – is a description of a requirement 4.2 about interested parties and clarifies that you should understand their needs but need not address them. A4 – describes the requirement for risk but emphasizes a practice approach. Risk “management” is not mandatory A5 – replaces exclusions A6 – gives mention to some awkward terminology replacing records and documents with documented information A7 – discusses knowledge which is an obvious resource but which is new to ISO 9001. A8 – covers new terminology for purchasing and suppliers but also extends the need to in house/excluded, corporate provide services, etc.
Note – a) is similar to g) (but different of course)
Accountability is difficult to implement and audit – focus on effectiveness.
c. Not a separate system – managements fault if it is.
d. Must lead and commit to the process approach (no more ISO numbered procedures, focus on processes [inputs, outputs, controls, metrics, objectives, etc.] risk (preventive thinking)
g. Focus on success.
Demonstrate leading and committing to the principle of improving things.
j. Demonstration of support
Summary of the changes
These occur in various places and are examples of the greater flexibility that ISO provides. Its down to you to consider but decide, and to do until its good enough for you – but be prepared to justify this and be wary that some auditors may not be as clear about this in the early days of auditing the standard.
Basically the same… focus on PDCA
One of the most important issues is that the restructuring of the QMS provides significant interaction and interdependency on processes. Way more that it has ever emphasized.
For instance – here are places that your analysis of Issues could impact. And its vice versa. For instances, when a change occurs, you need to consider if that came about because of a change in environment/issues, what risks might change and does that mean different communication?
Potentially extremely complicated. You cannot simply develop processes to meet the requirements (lilsted here) and operate them in isolation. Its complicated.
Attention of management. Properly resourced, clear authority, focus on tangible business success True integration of a single system
Ask your Certification Body. Soon.
They would ideally provide a document that explains how they will treat some of the issues mentioned earlier – how will they look at “less or no” documentation, what about verbal evidence? What will/wont they accept to demonstrate “accountability”. They don’t have to do this but its not unreasonable to ask. Actually if they don’t do this they will have huge variation in how their auditors perform.
A lot of effort.
Longer than you think. Work back from your planned transition audit Start early
Summary of the things to focus on
Management understanding that this is not a simple paperwork fix is critical and the most significant.
New processes (for which many quality people have been excluded and will have to learn before they adopt) are not insignificant.
If you have a standards based documentation set – e.g. numbered after the standard, they redeleoping all documents for the process approach is significant.