ISO 9001 - Understanding ISO 9001 Requirements

1.2 Application
All requirements of this Standard are generic and are intended to be applied to all organizations, regardless of the type, size and product manufactured or supplied.

Certain requirements from this Standard may be excluded from your QMS, if they are not applicable due to the nature of your organization and its product

You cannot claim conformity to this Standard unless your exclusions:
Þare limited to sub-clauses within Product Realization (clause 7)
Þdo not affect your organization’s ability, or responsibility, to provide product that meets your customer and applicable regulatory requirements

Key Explanation Points and Tips:
ÞThe scope of the QMS should be based on the nature of your organization's products and realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements.

ÞYou must begin with the premise that all requirements of the ISO 9001 standard are generic and applicable to your QMS. You are then allowed to make specific exclusions depending upon the nature of your business and scope of product or services provided.
These exclusions can only be made from sub-clauses within clause 7 - Product Realization.

ÞFor example, if you do not design product, but only manufacture product from customer provided specifications, then clause 7.3 Product Design and Development may not be applicable to you. However, if you buy a complete design and manufacture a product to that design and sell it under your own brand name, then you must include Product Design and Development in the scope of your QMS.

ÞThe rationale here is that if a capability is required or responsibility implied, to meet customer requirements, then that capability must be included in your QMS. It is your responsibility to perform the required capability whether you purchase, outsource or do it yourself.

ÞIf you do make any exclusion and these exclusions affect your ability or responsibility to meet contracted customer requirements or applicable regulatory requirements, then you cannot claim conformity to ISO 9001. All exclusions, with appropriate justification must be specified in your Quality manual (see clause 4.2.2).

ÞOther examples of exclusions - If you are in the financial service or knowledge based business, you may not need any monitoring or measuring devices, then clause 7.6 Control of Monitoring and Measurement Devices may be excluded. If in doubt about whether or not to exclude any clause, then get direction from your Registrar.

ÞAnother example is - where you do not use any customer property (materials, equipment, packaging containers, intellectual property; etc.) to make or deliver your product, then clause.7.5.4 Customer Property may be excluded.

ÞYou do not have to include all your products or product groups within your QMS. However, you must be careful that you don’t give customers the perception that the excluded product is manufactured under a QMS that is ISO 9001certified. Your Quality Manual; ISO 9001 registration certificate; marketing materials; your website; etc. must be clear on the scope of your QMS certification to avoid confusing or misleading customers.

ÞYour Quality Manual must clearly specify the scope of your QMS (see clause 4.2.2). Your QMS scope must include - specific products; processes; locations; any exclusions from the ISO 9001 standard with appropriate justification; etc.

2 NORMATIVE REFERENCE DOCUMENTS
ISO 9000:2005 - Fundamentals and vocabulary

Key Explanation Points and Tips:
ÞThe ISO 9000:2000 is a reference document that describes quality management system fundamentals and vocabulary.

ÞOnly the terms and definitions (section 3) of ISO 9000:2000 apply to ISO 9001:2000

3 TERMS AND DEFINITIONS
Terms and Definitions
New “supply chain” terms:
supplier ® organization ® customer
Use of “product” can also mean “service”

Key Explanation Points and Tips:
ÞA supplier is an organization that supplies your organization with product or services, e.g., a distributor, retailer or vendor. A supplier can be internal or external to your organization.

ÞIn this standard, wherever the term ‘organization’ is used, it refers to your facility and includes the people and resources with associated responsibilities, authorities and relationships.

ÞCustomer refers to a person or organization to whom you provide product and services. A customer can be internal or external to your organization.

ÞProduct is used in a broader context and includes service.



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