ISO 9001:2015 – Clause 7 – Support
By Jim Moran, BRC Quality Consultant
In our last article in this series, we looked at ISO 9001:2015’s Clause 6: Planning.
“If you fail to prepare, you are preparing to fail.”
– Benjamin Franklin.
And Deming, of course, based his structured approach for quality on the PDCA model. Shewart was right in there, too. Now we’ll take a look at another one of the requirements that will support our processes – Clause 7: Support.
Since we all need ‘resources’ to make any process produce outcomes, this requirement is no surprise whatsoever. We’ve been audited for ‘adequate resources’ for 27 years now, and nothing has changed, really. Just a few twists in the language, like ‘knowledge’.
We see outsourcing mentioned here. Makes sense – why not consider all the possibilities in one section rather than having them spread out over a number of different procedures? After all, outsourced goods and services are becoming more and more prevalent.
Another interesting tweak here is the use of the phrase, ‘existing internal resources, capabilities and limitations’. We are glad to see the use of the term ‘capabilities’ to remind us to assess our process capabilities while reviewing customer needs and expectations. It’s always tempting to say, “Let’s get the business first, and then try to figure out how to deliver it”. None of OUR readers have ever thought this way, but many of us know some suppliers who do this!
Just as we saw in the 2008 version, we have to provide a suitable infrastructure with the right work environment to ‘assure conformity of goods and services and customer satisfaction’. Pretty much what we’d expect.
Now here’s an interesting new emphasis on what we’ve seen previously as the ‘Process Approach’, one of the 8 Management Principles. The new Standard pushes a bit harder on this concept.
We have to ‘determine, provide and maintain the process environment necessary for its operations and to assure conformity of goods and services and customer satisfaction‘. We really like the way they have emphasized the focus on processes leading to customer satisfaction. That’s got to be a good move – the more emphasis on ‘process’ the better, in my opinion. Calibration is included in here, too – nothing really new, except the inclusion of customer surveys as a measurement device (Note 1).
‘Knowledge‘ is a new term, separate from ‘Competence‘, sub clause 7.2, so we’ll need to review our use of these words to make sure we haven’t missed any inferred requirements. We also see the use of that new term ‘documented information‘ with regard to training or other interventions. Furthermore, we now have to ensure that our employees can demonstrate ‘Awareness‘ of the Quality Policy and Objectives as well as each person’s impact on quality. We can hear the phrases from ISO 14001 and OHSAS 18001 (and others) echoing through this clause.
‘Communication‘ rounds out this section of requirements, and we can use whatever was relevant from the 2008 version around 5.5.3, Internal Communication. The clause ends with a description of the requirements around ‘Documented Information‘. It’s exactly what we would expect and are already doing for our current Document Control and Control of Records.
No new requirements here but the requirement to ‘identify changes’ has been removed! This will save a ton of anguish and wasted effort on the part of QMRs trying to meet this antiquated idea. Current software has features to compare versions that can meet even the 2008 requirement.
One last note on ‘Documented information’. There are a number of requirements to have documented information, but ‘Procedures’ is not one of them. There are no requirements in this draft to document any procedures, just like ISO 14001 and OHSAS 18001.
We see the same wording here for ‘…documented information determined by the organization as being necessary for the effectiveness of the quality management system.’ We suspect this won’t reduce ‘management by the pound’ (the more procedures the better) but we hope it will make organizations start to think about the power of training and how it can reduce the need for documented procedures.
A binder never saved a life – people save lives, training saves lives, but not binders. We would never see a fire fighting crew hop off of a pumper and yell, “Where’s the binder that shows us how to hook this hose up to the pump?!?”.
“Train, train, train and train some more.”
– W. Edwards Deming