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Various changes have been incorporated into the ISO9001:2015 standard which was published in September 2015, in this first article we shall look at how you can understand the context of your organisation and how to identify factors, both internal and external, that can impact on the QMS. There is no requirement for documented procedures to meet the requirements of clause 4 of the new standard but you must be able to demonstrate an effective process is in place to identify, monitor and review these factors, and to retain records to provide confidence that the process is being carried out.
Understanding the organisation and its context
Context of the organisation is a new requirement in ISO 9001:2015, your organisation must consider both the internal and external issues that can affect the objectives and intended outcomes of the QMS, and that are relevant to the organisation’s purpose and strategic direction. This is meant to be a high-level approach, so you should not get bogged down in fine detail; it should include issues that affect the business in general not just Quality related issues; such issues can be found in business continuity plans, business plans and the like.
Basically, all this information is in the heads of the Managing Director, CFO and other members of senior management, but it was never put on paper; the best way to gather it is by organising some brainstorming. Systematisation of all this information can be very valuable and demonstrate where you stand as an organisation, and where the business is going.
To determine external context, you should consider issues arising from its social, technological, environmental, political, legal, and economic environment (the PESTLE model). Examples of issues may include:
- Political – changes in the political landscape, including Brexit (trade embargoes or restrictions for example)
- Economic – cost of labour, materials, energy etc. or fluctuations in exchange rates
- Social – issues relating to the organisation or its products/services – restriction of certain chemicals, social attitudes to your products
- Technological – development of new products or alternative technologies that could affect sales
- Legal – Government regulations and changes in the law, restriction of trade through Intellectual Property or Patents
- Environmental – product lifecycle, recycling, environmental effects and impacts of the organisation’s activities.
Another category that is beneficial to include is:
- Operations – lack of trained staff, accidents, manufacturing capacity, availability of resources.
Internal and External Issues Register
A good way to record this issues is to establish a simple register based on the PESTLE model and recording each issue and the corresponding possible effects, an additional column noting positive or negative impacts can also be useful.
This register can be used later when determining interested parties and associated needs and expectations. It is important to establish and maintain a link between the issues determined, interested parties identified and the risks/opportunities considered in clause 6.
Monitoring and Reviewing
Once these issues have been determined it could be useful to revisit the brainstorming exercise to determine any changes that have occurred, again senior management will know the issues that affect the business at a high level.
Ensure that the issues are monitored periodically, the process of determine relevant issues should be included in the internal audit programme; and remember a review of any changes must be undertaken at the Management Review Meeting chaired by senior management.