Category Archives: 9001:2015

“Leadership” – 9001:2015 Draft of Section 5

Leadership: The art of getting someone else
to do something you want done
because he wants to do it. – Dwight D. Eisenhower

ISO 9001:2015 has an entirely new layout and some new content. A few weeks ago, we looked at section 4, “Context. Continuing along in the series, here’s a look at the next section.

ISO 9001:2015 Draft – Section 5 “Leadership”

The entire section borders on an exercise in semantics as this concept is an offshoot of the previous version’s “Management Commitment”, at least as a starting point. There are some definite differences though, so I wouldn’t gloss over it.

Leadership Section 5The section starts out with “Leadership and commitment” and that it shall be demonstrated. One might ask how – well, specifically by eight methods. I’ve decided not to hash into the three that already exist (almost verbatim) as requirements in ISO 9001:2008, but there are a few differences or at least accentuations of previous focus:

  • Promoting awareness of the process approach. An interesting one there. Auditors would expect some level of training. Will likely be a valuable debate as to the difference between “awareness” and “training”. This is an important distinction, because if it is training, then there has to be some measure of training effectiveness.
  • Ensuring that the quality management system achieves its intended outputs. Not exactly new, but it does highlight the focus on the process approach. It implies the outputs have to be defined.
  • Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system. This should be interesting from an audit perspective; some kind of evidence will need to be present.
  • Promoting continual improvement and innovation. I get a small kick out of this one, because it mentions “continual improvement” – when the word “continual” has been stricken from the gospel in the 2015 version. Ultimately, I expect this to read “Promoting improvement and innovation”… and “innovation”? I’m as interested as you are in what one might look for to show innovation. Benchmarking? Innovation in what context? There are some business models that thrive on creating for the status quo. Questions that I hope the next draft iron out.
  • Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. This is referring to a pass-down effect to avoid islands of leadership within the larger organization.

The next subsection is “Leadership and commitment with respect to the needs and expectations of customers”.

Two main concepts here, “customer focus” and “risks”- both are combined to address the determination of customer requirements including any applicable statutory and regulatory requirements, as well as enhancing customer satisfaction by meeting them.

Really, other than risk – which is more deeply ingrained in another section – not too different than what exists.

Quality policy is within element 5, no big surprises with regard to content. Let’s not worry about it for now.

And lastly, the section contains “organizational roles, responsibilities and authorities” again, nothing new here, other than a focus on intended outputs. Very much an expansion of the old section 5.5 with a few related consolidations from other sections.

There you have it, a quick summary of what is currently in the draft of the next version of ISO 9001. Naturally, the content of the draft is likely to change to some degree, so I wouldn’t make too many changes to your current system or documentation. But it does give a good indicator of what direction the standard is going toward, namely one of simplicity and consistency. How far it gets in that endeavor, remains to be seen.

Thanks for following along – go forth now, and calibrate thyself.
Sal

 

9001:2015 Draft of Section 4 – “Context”

“Priority is a function of context.” –  Stephen R. Covey

Even as clients deal with the real-world challenges offered by ISO 9001:2008, the new draft of ISO 9001:2015 will offer a few more concepts to adapt to. I hear about them nearly every day. What this new section reveals is not exactly a new angle for ISO 9001, but it will require some getting used to.

What follows in an overview of the newly drafted Section 4, “Context” in the latest CD (Committee Draft) that will become ISO 9001:2015.

ISO 9001:2015 Draft – Section 4 “Context of the Organization”

Context - Section 44.1 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 the 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

P.S. – Section 5, Leadership – is covered HERE

9001:2015 – the Next Version of ISO 9001 – my first words

I’ve 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. It will eventually become ISO 9001:2015.

ISO 9001:2015 Under Construction

As I audit, and I do about two or three Registration audits per week (sometimes one, sometimes five), people often ask me what changes are coming for them. Between publications like this new draft and discussions with colleagues and the various associations we’re involved with, I do sometimes get a little advance warning. Naturally, some of this has to be taken under caution – even the contents of an official ISO 9001:2015 Draft, because things do change.

I’ll do a few more detailed posts on this, and podcasts here and on my Facebook Page, QMSC – but I’m pretty pleased with two changes in particular.

CONTINUOUS, CONTINUAL – DISCONTINUED

The first is this whole “continuous/continual” improvement split hair. The ISO 9001:2008 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 in ISO 9001:2015; simply “Improvement”. Now we can leave the semantics to the… semasiologists.

PREVENTION – PREVENTED

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 ISO 9001:2015 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

Buy your very own copy of the draft from BSi