ISO 9001-clause 1,2,3

ISO 9001-clause 1,2,3

Clause 1 Scope

Clause 1.1 General

ISO 9001-Requirement

This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including  processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only  applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.


Your organization must meet requirements consistently and enhance customer satisfaction by effective application of QMS, continual improvement of  QMS and providing assurance of conformity to customer and applicable regulatory requirements which can be expressed as legal requirements .Product means any product  or service which is required by a customer or intended for a customer and can be output of product realization processes. Ability means that the organization has the capability to determine customer’s needs and requirements; design and develop product; know-how and capacity to manufacture product; package product; deliver on time; provide service and support; etc.. Consistency is being able to repeat your capability within specified parameters for quality as defined by customers, your own organization or regulatory bodies.

Clause 1.2 Application:

ISO 9001-Requirement

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.


All requirements of ISO 9001 are generic and are intended to be applicable to all organisations, regardless of type, size and product provided. Where any requirements of this standard can not be applied, due to the nature of an organisation and its product, this can be considered for exclusion.  Where exclusions are made, claims of conformity to ISO 9001 are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organisation’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. This clause requires to state clearly if any areas of the standard do not apply to the organisation, together with an explanation of the reason for this exclusion.For 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. The 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.The standard  mentioned specifically that in case of exclusions, the organisation’s ability will not be affected to supply a product or service that will meet customer expectations.If 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.Your QMS scope must include – specific products; processes; locations; any exclusions from the ISO 9001 standard with appropriate justification; etc.

Clause 2 Normative references

ISO 9001-Requirement

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
This clause explains that the Fundamentals and vocabulary given  ISO 9000:2005 Quality Management Systems -fundamentals and vocabulary, apply.

Clause 3 Terms and definitions

ISO 9001-Requirement

For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean“service”.

ISO 9000:2005 Quality Management Systems -fundamentals and vocabulary, apply. for service industries or for industries where service is also part of customer requirement, wherever the terms product occurs, it will also include service provided by the organization

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