Posted by & filed under ISO9001:2015.

Continuing my review of the new clauses, No. 4 Context of the organization includes “Needs and Requirements”.

This is pretty straightforward; you just have to know your customer and your business, and ask the right questions.

“Needs and Requirements” will be those “generally implied or obligatory” for the customer and those who need to know in your internal organization.. These will include specific requirements if they are outside those usually provided for the product or service, such as documented information (records), local, national or international statutes and regulations.

It can also mean

  • social and cultural, financial, technological, economic, natural and competitive environment, whether international, national, regional or local;
  • customers changing needs that can have an impact on the objectives of the organization;  and
  • relationships with, and perceptions, values and expectations of, external and internal interested parties.

All the above can be expressed in clear, concise terms. You can check your current policy against the samples available on the Qualidoc website. A full set of policies and procedures is also available for the very reasonable subscription of £25 per month for current issues.

REGISTER for the free documents – understand where you may have gaps in your quality system or that you have everything covered (unlikely!).


My next clause blog will be SCOPE. This means scope of the quality system, but it can also mean the scope of your business. For example, if you design products or services, do you want this design to fall within the scope of the certification? Study this carefully before you include it or exclude it. If you exclude it without sufficient analysis of its connection to the rest of the processes then you could have to review your certification. Discuss it with anyone involved, including subcontracted designers. The description will be on your certification in the wording you have given to the assessors so the time involved in getting it right it well worthwhile.



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