Everything must go: http://qmsc.net/
Making the move to a custom site with dedicated hosting. this will allow me other options in terms of customization, store options and potentially a healthier SEO platform.
It's a learning process!
So, head over - and calibrate thyself!
Sal
Wednesday, August 21, 2013
Sunday, August 18, 2013
9001:2015 Early Disection - Section 4
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
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
Saturday, August 10, 2013
Next Version of ISO 9001 - my first words
Been reviewing the next version of ISO 9001, the committee draft (CD) of it, anyway; officially ISO/TC 176/SC 2/N 1147 dated 3 June 2013.
I'll do a few more detailed posts on this, and a podcast on my Facebook Page QMSC3 but I'm pretty pleased with two changes in particular.
The first is this whole "continuous/continual" improvement split hair. The 2008 version changed the word "continuous" to "continual" to express the idea that sometimes there are plateaus in the improvement journey and the word "continuous" implied a constantly increasing ramp of continuous. Really?
So now, the word "continual" has been changed to... drumroll - " ". Yep, no word at all; simply "Improvement". Now we can leave the semantics to the... semasiologists.
And that revelation leads me to the second: gone is "Preventive Action". Never liked the lines in the sand drawn by corrective action, preventive action, corrections, continual improvement - enough already. It just confuses people and dilutes the concept of Improvement in general. Now prevention ties nicely with the new (to 9001) concept of Risk.
And more on that in a later installment.
So, just a few quick notes on the next version of ISO 9001 (2015) -
Go forth, and calibrate thyself - Sal
I'll do a few more detailed posts on this, and a podcast on my Facebook Page QMSC3 but I'm pretty pleased with two changes in particular.
The first is this whole "continuous/continual" improvement split hair. The 2008 version changed the word "continuous" to "continual" to express the idea that sometimes there are plateaus in the improvement journey and the word "continuous" implied a constantly increasing ramp of continuous. Really?
So now, the word "continual" has been changed to... drumroll - " ". Yep, no word at all; simply "Improvement". Now we can leave the semantics to the... semasiologists.
And that revelation leads me to the second: gone is "Preventive Action". Never liked the lines in the sand drawn by corrective action, preventive action, corrections, continual improvement - enough already. It just confuses people and dilutes the concept of Improvement in general. Now prevention ties nicely with the new (to 9001) concept of Risk.
And more on that in a later installment.
So, just a few quick notes on the next version of ISO 9001 (2015) -
Go forth, and calibrate thyself - Sal
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