Q. What are the requirements of ISO 9001?

ISO 9001 is designed to enable organisations to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation of the effectiveness of its Quality Management System (QMS), including ongoing improvement.

 

A QMS is therefore necessary in order to meet the requirements of ISO 9001. Your organisation's QMS should contain the processes, documents, resources, and monitoring systems that direct the work of an organisation regarding product and service quality.

 

To achieve certification, organisations must demonstrate that they have effective procedures which are consistently applied for activities such as:

 

4.2 Documentation requirements
4.2.1 General

The organization needs to document – either electronically or on paper – the quality policy, quality objectives, and quality manual. Written procedure, plans, and operations need to describe how product and service quality is attained. Certain records, providing evidence of activities that were carried out (i.e. purchase orders, sales contracts, inspection records, design review notes, etc.), have to be retained

The quantity, detail, and form of the documentation can differ from one organization to another depending on size, type of activities, or complexity of processes.
4.2.2 Quality manual

The quality manual describes the extent of the QMS and may exclude certain sections of the Standard that don't pertain to the organization. All of the quality procedures are either included in the quality manual or are referenced by it. The interaction between processes making up the QMS is also described.
4.2.3 Control of documents

All of the documents in your QMS must be legible, identified, reviewed, authorized, up-to-date, issued, distributed, and periodically updated. Obsolete documents have to be identified and protected from unintended use. Documents that come from outside the organization also have to be identified and controlled.
4.2.4 Control of records

Certain records need to be kept to demonstrate how the QMS is operating. These records must be legible, and easy to identify and retrieve. A written procedure must describe how they are identified, stored, protected, retrievable, and define their retention and disposal times.

 

 

 

 

 

 

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

* documented statements of a quality policy and quality objectives;
* a quality manual
* documented procedures required by this International Standard
* documents needed by the organization to ensure the effective planning, operation and control of its processes, and
* records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

* the size of organization and type of activities;
* the complexity of processes and their interactions, and
* the competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

 

 ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

* documented statements of a quality policy and quality objectives;
* a quality manual
* documented procedures required by this International Standard
* documents needed by the organization to ensure the effective planning, operation and control of its processes, and
* records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

* the size of organization and type of activities;
* the complexity of processes and their interactions, and
* the competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

4 Guidance on Clause 4.2 of ISO 9001:2008

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.

a) Documented statements of a quality policy and objectives:

* Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
* Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.

b) Quality Manual:

* Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
* A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
* Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
* The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.

c) Documented procedures:

* ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
* These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
* Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
* Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
* Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.

d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:

* In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
* There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
* All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable

e) Records:

* Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
* Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
* Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.

 

More Information

 

If you need to know all of the ISO 9001 requirements in detail, you can purchase the full requirements from the International Standards Organisation (ISO) catalogue as a PDF download. Please click on the link below to visit the ISO website.

 

http://www.iso.org/iso/catalogue_detail?csnumber=46486

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Further Reading

Q. What is ISO 9001:2008?

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