Regarding the new standards, one of the first new concepts you will identify is the establishment of context at Clause 4. We are frequently asked by our clients ‘what are we supposed to do here?’ and ‘Do we need to create new documented information or records?’.
Many organisations already have a good understanding of the market place within which they operate. The market place should be considered in its broadest sense as it may not always be a commercial one and includes public sector and third sector activities. To operate you need to understand the market, your clients, what your competitors are doing and what you might have to do to survive! This is part of any organisation’s ‘thought process’ and is not something new to be done as part of ISO 9001 and ISO 14001.
The standard requires you to consider what is the context within which you operate. This means, for example, demonstrating an understanding of key legal issues, technological change, market trends, environmental concerns, society’s view of your activities, political change etc. The exact list of issues will depend on your organisation, what you do and how integrated you are with external bodies.
To meet the requirements of clause 4 you must show that you have considered such issues and how they may, or may not, have an impact on your quality and/or environmental management system. This can be done on a document presented at management review; a distinct piece of work by your quality/environmental departments etc. It could, however, simply be top management providing robust and detailed understanding of these issues verbally, during audit. We would recommend having documented evidence that shows you have identified your key issues. A simple list of items under broad headings on economics, market, technology etc. will suffice.
The second part of clause four then asks you to consider interested parties. This means identifying all individuals and organisation who can have an impact on the QMS/EMS or who may be affected by it. There are obvious interested parties such as customers, suppliers, neighbours etc.
The clause also requires you to think what requirements are linked to each, for example, customers’ requirements might include the receipt of goods of the correct type, quantity and price, on time and without faults. A Neighbour may expect to not be adversely affected by your poor environmental performance, suffering from your pollution for example. For each requirement of an interested party you need to consider and demonstrate this requirement is fulfilled.
Note that the context you establish and understand makes it easier for you to consider risk and other unforeseen circumstances. Actions against these risks must be considered and relevant actions taken under the risk management clause of the standards (clause 6).
If you need some guidance on what the new clauses mean to your organisation, then you may be interested in attending one of our one-day courses on the new standards. These are great value and can be booked on our website or by giving us a call on 01236-734447