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 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 that issues can positively or negatively affect your organisation.
Recognise the requirements of your relevant interested parties
Ultimately, quality is given as a result of a product or service that satisﬁes all key stakeholders 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
"Now that ISO 9001:2015 has been published, organisations looking to transition to the new standard can really beneﬁt from a performance based management system which delivers competitive advantage."
Richard Crute Morris, Assessment Services Capability Development Manager
As in the 2008 standard, ISO 9001:2015 still stipulates that your organisation needs to determine and document its scope to outline your quality management system boundaries.
The scope is now better deﬁned and as well as considering the external and internal issues and the requirements of interested parties as mentioned previously, your organisation must state the products and services covered by 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 the 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.
Key change from ISO 9001:2008
Although ISO 9001:2015 standard does not refer to ‘exclusions’, your organisation will be required to justify where a requirement cannot be applied. You must evaluate the applicability on the basis that decisions do not result in failure to achieve conformity to product or service requirements.
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