A flyby of section 4 in the latest draft of ISO 9001:
Title: Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system
"Context" - new word for ISO 9001; the conditions in which an entity exists. My definition, the standard doesn't give one specifically.
It divides context into both Internal and External.
There's a note that covers what External Context entails very well, "legal, technological, competitive, cultural, social, economic and natural environment, whether international, national, regional or local."
This would be an expansion of the current pieces referring to Statutory and Regulatory. For most this will include the Code of Federal Regulations (CFR); OSHA, DOT and the International Traffic in Arms Regulations (ITAR), typically. There are other examples, of course - I have California clients that must address requirements for earthquake resistance to comply with the "California Building Code".
Massachusetts clients must comply with that state's General Law Chapter 93H and its new regulations 201 CMR 17.00 for Personal Information Security - these are just a few. The point being that the standard expects the question of what external forces are relevant to the business and how do they impact the ability to meet customer needs - to be answered. This is a slight shift, by the way, from the 2008 stance of treating these external concerns as customers, if obliquely.
External context would also imply benchmarking as a standard practice (want to know more about benchmarking? Leave a note in the comments or send me an email and I'll make a blog entry on it).
Customer feedback would tie here as well, and market analysis in general. To me this would imply something along the lines of "House of Quality" and "Quality Functional Deployment" (QFD) tools and techniques.
An analysis of those involved with the supply chain is also a required consideration.
Internal Context refers to perceptions, values and culture of the organization. These are going to be the more familiar elements of a Process-based quality system; defining inputs, processes, and outputs. And, of course, defining the scope of the QMS (within limits).
So, the major addition is the concept of External Context, and this is merely a logical expansion of what already exists in 9001: 2008.
For companies wishing to be ready for the next version a deeper review of the context in which they do business would be in order. Most auditors won't have any specific knowledge of what these would be, but they could certainly ask the question, "By what means have you investigated the context of the business, and what external laws or regulations apply here?" They will, of course have some knowledge from similar companies...
As always, if there's something in particular you'd like covered, drop me a note or comment. And check out my Facebook page: QMSC
Thank you - go forth, and calibrate thyself.
Sal
No comments:
Post a Comment