Some of the terminology in the new ISO 9001:2015 standard is unfamiliar. In this article we will help you understand context, interested parties and leadership.
ISO 9001:2015 requires an organisation to construct its quality management system for the specific context it operates in. This means, among other things, that, as an organisation, you have to take into account the needs and expectations of interested parties and that you evaluate and deal with internal and external strategic questions. You have to show that, as an organisation, you understand and respond to the expectations of all the parties concerned. An example would be a food manufacturer supplying both retail and food service – the business model is different and therefore the management system that supports the sales cycle must also be different.
What should you do:
Develop a context statement which defines the role your organisation plays, what internal issues you have to consider, what external issues are you affected by. A SWOT analysis can help you with internal issues. A PEST analysis can help you with external issues. If you have a strategy document, you have probably covered both.
In ISO 9001:2008, customers were often named as being the only interested party. This concept has been extended in ISO 9001:2015. Suppliers, personnel, shareholders, legislative bodies, society, internal customers, etc. are now included as interested parties, in addition to customers.
As an organisation, you have to be aware of the importance of these interested parties’ (changing) requirements and standards, and anticipate them in the features of your products and services.
What should you do:
Create a list of interested parties and their requirements
ISO 9001:2015 also places more emphasis on leadership and management commitment. Gone is management responsibility. It requires greater involvement by top managers and business leaders in controlling the quality management system. This is a good thing! Many food safety systems go wrong because this is not the case.
ISO 9001:2015 is intended to encourage integration and harmonisation with business processes and business strategies. The top management now has to take more responsibility for the effectiveness of the quality management system.
Because ISO 9001:2015 pays more attention to risk management, interested parties and the context of the organisation, the quality management system also fits in better with the needs of the top management.
The quality management system should now actively support strategy by addressing the needs of interested parties and by managing opportunities and threats.
The ‘management representative’ of ISO 9001:2008 was a member of the management committee who had the responsibility and authority for steering the quality management system along the right lines. ISO 9001:2015 does not mention this aspect any more. The idea behind the change is that quality is a matter for everyone and for all levels within the organisation. Food safety management systems have always used a team approach which will be helpful in the implementation of ISO 9001. Does it mean we may lose the food safety team leader in the next version of ISO 22000? Maybe in name but not in function to co-ordinate the activities of the food safety team. What must go though, is the thinking that it’s system belongs to the food safety team leader. This is now official in the new version of ISO 9001.
Next time in Part 3: Dealing with the paperwork – what goes and what stays?