ISO 9001 requirements - Context of an organisation

For an organisation to successfully steer their future success, there must be a clear understanding of where they are and where they want to go. That is why defining organisational context is so important in ISO 9001.

Understand your external and internal issues

To fully understand your organisation and its purpose, it is necessary to determine your external and internal issues which may affect your organisation’s ability to meet its intended strategic objectives. This is the flagstone of your organisation’s quality management system as it underpins why your organisation is here.

External issues that may affect your organisation and therefore you need to consider, are your economic, political, legislative, regulatory, environmental, technological and social factors. 

For example, the economy can affect the success of your business and the ability of your customers to pay for your product or service which then directly impacts on your bottom line. 

Whether the economy is specific to your industry or a global trend, it can still have an optimistic or detrimental impact on meeting your strategic objectives. Your organisation may need to offer sales promotions, diversify your product line or recruit new staff to cater for the increase in demand. 

Internal issues are also likely to fall into the same basic areas as external issues. For example, the economic issues may relate to employee benefits or bonus related pay, whereas social issues may relate to an ageing workforce and issues relating to succession planning. 

When looking at understanding your organisation and its context in relation to your quality management system, make sure you consider issues can positively or negatively affect your organisation.

Recognise the requirements of your relevant interested parties

Ultimately, quality is determined by a product or service that satisfies all stakeholder requirements. Your organisation will therefore be required to identify all relevant interested parties (the new terminology for stakeholders) and their relevant requirements. 

Interested parties who can affect or be affected by the activities and decisions of an organisation are likely to be linked to the external and internal issues previously identified.

Determination and documentation of scope

ISO 9001 requirements stipulate that your organisation needs to determine and document its scope to outline your quality management system boundaries. As well as considering the external and internal issues and the requirements of interested parties, your organisation must outline the products and services contained in your quality management system, the applicability of specific requirements and justification for any case where a requirement cannot be applied (exclusion). 

The processes that form the quality management system must address the applicable requirements and expectations of interested parties, which are considered by your organisation as integral to meeting its purpose and required outcomes. 

These processes must include monitoring and measuring processes to ensure all interested party requirements are identified and understood and all activities undertaken by your organisation are meeting these requirements.

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