ISO 9001:2015 – Clause 5 – Leadership
By Jim Moran, BRC Quality Consultant
We’ve seen the ‘foundation’ for our management system in sections 1, 2, 3 and 4, including this new concept of describing the ‘context’ of our organization. Now let’s take a look at Leadership – the ‘make it or break it’ component of any management system.
Leadership is one of the 8 Management Principles we’ve used for years as the guiding lights for our system. They are now described in the Annex of ISO 9001:2015 and have been reduced to 7 by combining ‘Process Approach’ and ‘Systems Approach’ into one Principle. These are found in Annex A, A QMP-1 through A QMP-7. You’ll recognize all of them.
To meet the Leadership requirements, we’ll have to show how our Quality Policy and Objectives are ‘…compatible with the strategic direction…’ of our organization. This additional requirement will help us weave our management system into the fabric of our organization. It also heads us in the direction of making this a ‘business management system’ rather than just a ‘quality management system’. This concept is supported by another new requirement to make sure that the requirements of ISO 9001:2015 are integrated ‘…into the organization’s business processes…’ not just the ‘quality’ processes.
Next we see a specific requirement to ‘…promote awareness of the process approach…’ Very helpful, in my opinion, to get more Engagement of People (Annex – A.4 QMP 3) and tap into the expertise in our organizations to find improvement opportunities (Clause 10 – Improvement).
There are similar requirements for resources but there’s some new language around management’s involvement, specifically ‘…engaging, directing and supporting persons to contribute to the effectiveness of the quality management system…’.
This suggests, in my opinion, that we’ll have to have some evidence of management’s understanding and support of the system. Evidence might bee seen in Management Review (new clause 9.3).
The word ‘innovation’ shows up here, too. We can demonstrate this through analysis and ‘improvement’ to our system. Management will need to find ways to demonstrate their leadership, and auditors are going to have to decide what kind of evidence would meet this requirement. Be sure to check with your Registrar to find out what they’re thinking and how they’ll audit these new requirements. There’s going to be some give and take here, for sure.
The customer ‘needs and expectations’ section is pretty much the same, except for that new phrase. It’s not actually a ‘new’ phrase – early versions of ISO 9001:2000 used the phrase ‘customer needs and expectations’, but in the final version, ‘needs and expectations’ was replaced with ‘requirements’. It’ll be interesting to see what happens this time. I always tell this story to remind trainees that customers want more than just what’s in the contract (needs). They also want us to return phone calls, be reliable and show empathy (expectations).
Here’s where risk language appears, as management must ensure “…that the risks which can affect conformity of goods and services and customer satisfaction are identified and addressed…”.
This will help many organizations get their risk management activities better organized. At this point there’s no requirement for a formal risk management procedure, but it may help some of us to consider a bit of structure in this area. We can consider risks to our customers, our processes and even a SWOT analysis to consider our competitors. Some may want to consider a tour of Failure Modes Effects and Analysis (FMEA) for some ideas on how to approach this important activity.
We’re already familiar with the balance of this clause – Quality Policy availability has been expanded to ‘interested parties’ from ‘employees’ but the other requirements will be familiar to you. I found one of the ‘Notes’ rather interesting. It suggests that the 7 Management Principles could be used as a basis for our Quality Policy. Probably worth considering.
To wrap up this Clause, you’ll be right at home with the ‘Roles and Responsibilities’ requirements and will have them in place already. There is no longer a named position for what we refer to as the ‘Quality Management Representative’ but the same requirements still have to be met by someone.