Clause 1: Scope

Clause 1.1 General

The scope of a standard establishes where this standard can be applied or used. It defines the applicability of the standard.
Year 2008 edition of ISO 9001 defines the requirements for a quality management system as:

Where an organization:

- Needs to demonstrate the ability to provide consistently, product that meets customer and applicable statutory and regulatory requirements, and,

- aims to enhance customer satisfaction through the effective application of system including processes for continual improvement and the assurance of conformity to customer and applicable statutory and regulatory requirements. 

In year 2000 edition term "regulatory requirements" was used, which is replaced by "statutory and regulatory requirements" in 2008.
This is as such not a major change because even in 2000 edition need to meet statutory and regulatory requirements was mentioned at following places:

• In clauses 5.1 Management commitment is required in relation to "statutory and regulatory requirements"
• In clause 7.2.1 it is required to consider "statutory and regulatory requirements" while determining requirements related to the product.
• In clause 7.3.2 design and development inputs are required to consider applicable "statutory and regulatory requirements".

This is should be seen as a correction only.

The scope of 1994 edition of ISO 9001 was primarily:
- To demonstrate capability to design and supply conforming product.
- Achieving customer satisfaction by preventing nonconformity.

• The scope of the standard is now more generic and "product" base terms like "design and supply" are replaced with generic terms "provide", which is suitable for product as well as services.
• "Applicable statutory and regulatory requirements" is added, which means your product must at least meet the statutory and regulatory requirement like (for India) IS 14543 for drinking water, IS 2418 (Part 1) for tube lights, IS 418 for electric bulbs etc., before getting ISO 9001 certification. You must have appropriate regulatory approvals to manufacture your products.
• This should noted here that statutory and regulatory requirements includes legal requirements (Note to this effect is added in 2008 edition).
• Aiming to "achieve customer satisfaction" is replaced with "enhancing customer satisfaction" as customers' perception of his/her satisfaction changes with time.
• Demand for "continual improvement" instead of "continuous improvement". Standard now recognizes that there should be a stabilization period between two improvements (or changes), this way standard is more realistic than idealistic.

Till 2000 edition of the standard, continuous improvement was the buzz word, a new term, continual improvement was used in 2000 edition. Difference between the two terminologies can be understood from the figure on right.
Continuous improvement means making constant efforts for improving, while continual improvement recognizes the facts of reality that a period of sustenance is required after every change.

Scope of a quality management system (QMS)

ISO 9001 clause 1 ("Scope") defines the scope of the standard itself. This should not be confused with the scope of the quality management system (QMS), which is a term commonly used within the context of QMS certification/registration to describe the products and product realization processes to which the QMS is applied.

The scope of the QMS should be based on the nature of the organization's products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements. An organization is not obliged to include all the products that it provides within the scope of its QMS, or to address the realization processes for products that are not included within the QMS.

If an organization chooses to implement a QMS with a limited scope, however, this should be clearly defined in the organization's Quality Manual and any other publicly available documents to avoid confusing or misleading customers and end users (this includes, for example, certification/registration documents and marketing material). 

1.2 Application

The requirements defined in ISO 9001 are generic and applicable to all types of organizations, be it manufacturing, trading or service.

However, in many cases because of the "nature of the organization or its product" if some of the requirements can not be applied than they may be considered for exclusions subject to following condition:

"Exclusions should not affect the organizations ability or responsibility, to provide product that fulfils customer and applicable regulatory requirements"

Further, the exclusions are permitted only within the clause 7.

These exclusions may be an entire sub-clause or only a part of it, an example could be under clause 7.5.3 Identification of product may be applicable while traceability may be considered for exclusion.

An example for exclusion of whole clause could be clause 7.3, Design and development.

Technical Committee ISO/TC 176 has made it clear that design and development can not be excluded from the scope of quality management system even if it is outsourced. Click here to see ISO/TC 176 Approved Interpretation.

Application of ISO 9001:2008

It is intended that organizations seeking to implement ISO 9001:2008 should comply with all the requirements of the standard that are applicable to the products and product realization processes within the scope of the QMS.
However, even when an organization includes all its products and processes in the scope of its QMS, it may be found that some of the requirements of clause 7 of ISO 9001:2008 ("Product realization") cannot be applied. This could be due to the nature of the organization, or that of its products or realization processes. In such circumstances, the organization would need to limit the application of the requirements of ISO 9001:2008, in accordance with clause 1.2.

Justification of exclusions

Where an organization finds that it is necessary to limit the application of the requirements of ISO 9001:2008, this must be defined and justified in the organization's Quality Manual. As with the case of a reduced scope of the QMS, the application of ISO 9001:2008 requirements must also be clear in any other publicly available documents, such as certification/registration documents or marketing materials, to avoid confusing or misleading customers and end users.
Also See Clause 4.2.2 (a) of ISO 9001:2008 ("Quality manual")

Most likely exclusions

Within clause 7 ("Product realization"), the following are the most likely requirements (though not the only ones) that could be considered as not being applicable in certain circumstances:

7.3 Design and development
where the organization has no responsibility for the design and development of the products it provides.

7.5.3 "Identification and traceability
this clause would only be partially applicable where there is no specific traceability requirement for the organization's products

7.5.4 Customer property
where the organization uses no customer property in its product or product realization processes. Note that if the customer provides a proprietary design for the product, this may constitute intellectual property and must be covered by the organization's QMS.

7.6 Control of monitoring and measuring devices
where the organization needs no monitoring or measuring devices to provide evidence of conformity of its product. This may be the case for some service organizations, among others.

Requirements that may not be excluded

If an organization excludes from its QMS ISO 9001:2000 requirements that do not meet the criteria established in clause 1.2 ("Application"), then conformity to ISO 9001:2000 may not be claimed or implied. This includes the following situations:

• Where an organization fails to comply with the requirement in clause 4.2.2 (a), ("Quality Manual") to provide justification for the exclusion of specific clause 7 ("Product realization") requirements.
• Where an organization decides not to apply a requirement in clause 7 based only on the justification that this was not a requirement of either ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, and had not been previously included in the organization's QMS.
• Where requirements in clause 7 have been excluded because they are not required by regulatory bodies, but this affects the organization's ability to meet customer requirements.

Subcontracted or "Out-sourced" processes

Where the overall responsibility for product realization belongs to an organization, the fact that a specific product realization process (such as product design and development or any part of service provision or manufacturing such as data processing, teat treatment etc.) is outsourced or subcontracted to an external organization is not an adequate justification for the exclusion of this process from the QMS. Instead, the organization must be able to demonstrate that it exercises sufficient control to ensure that such processes are performed according to the relevant requirements of ISO 9001:2008.

The nature of this control will depend on the nature of the Out-sourced or subcontracted process and the risk involved. It may include, for example, the specification and/or validation of processes as part of the contractual agreement with the supplier, requirements for the supplier's QMS, on-site inspections or verifications, and/or audits. Clause 7.4 of ISO 9001:2008 ("Purchasing") must be used to monitor the output of these Out-sourced or subcontracted processes.

In these circumstances, the organization should include such processes in the scope of its QMS and make it clear in its Quality Manual and any other publicly available documents that the QMS covers the management of these out-sourced or subcontracted activities for which the organization retains overall responsibility. 

See more details on outsourcing in clause 4.1 where standards now (in 2008 edition) requires you to defined type and extent of control on any process of quality management system that is outsourced (not limited to product realization processes)

External Document Reference: Documentation Kit

Quality Manual Section: Scope of quality management system and exclusions