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ISO 9001:2008

Date: April 27, 2011
Source: Admin

ISO Standards

The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and Web-based documents on quality management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis. The standards are published by ISO, the International Organization for Standardization and available through National standards bodies.

ISO 9001:2008

ISO 9001:2008 was developed to furnish clarifications on the existing requirements of ISO 9001:2000 and improve compatibility with ISO 14001:2004. ISO 9001:2008 does not furnish additional requirements nor does it change the intent of the ISO 9001:2000 standard. Certification to ISO 9001:2008 does not amount to an “upgrade”, and organizations that are certified to ISO 9001:2000 enjoy the same status as those that have already received a new certificate to ISO 9001:2008.

What does ISO 9001:2008 specify?

ISO 9001:2008 specifies requirements for a quality management system where an organization:

needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements, and
aims to enhance customer satisfaction through the effective application of the system, including processes for continuous improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Nature ISO 9001:2008 requirements

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Concept of exclusion

Where exclusions are made, claims of conformity to this International Standard are not acceptable. Therefore, an organization should consider whether all the requirements of the standard are relevant to its activities, based on the nature of the organization itself, its products, and the processes it uses to meet customer, statutory and regulatory requirements. In addition, the organization should take into account any commitments it has made in its quality policy and objectives and how these could affect the need to undertake particular realization processes. All of these can affect the scope of the organization’s Quality Management Systems (QMS).

Exclusion of requirements

It is possible that in some cases, the organization concerned is not able to comply with all of the requirements of ISO 9001. In such cases, ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2”Application”), but only if it can be shown that these requirements are not applicable to the organization.

Exclusions are limited to the requirements furnished in Section 7 ("Product Realization"), where individual requirements may be excluded only if it can be shown that they do not affect the organization's ability to provide a product that complies with customer and applicable statutory or regulatory requirements. Justification for such exclusions is also required to be furnished within the organization's quality manual.

For example, if design activities are not required by an organization to demonstrate its capability to comply with customer and applicable statutory /regulatory requirements, or if its product is provided on the basis of an established design, then it may be able to exclude some of the "design" requirements and obtain registration / certification to ISO 9001:2008, all the same.

ISO 9001:2008 documentation requirements

Clause 4.1 of this standard requires an organization to “establish, document, implement, and maintain a quality management system.” The quality management system documentation must include:

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

Main objectives of an organization’s documentation

The following are the main objectives behind an organization’s documentation:

Communication of Information: as a tool for information transmission and communication.
Evidence of conformity: evidence of targets achieved.
Knowledge sharing: to disseminate and preserve the organization’s experiences.

Flexibility to document QMS

ISO 9001:2008 allows organizations the flexibility in the way they choose to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continuous improvement of the effectiveness of its QMS. It is to be remembered that ISO 9001 requires a “documented quality management system”, and not a “system of documents”.

QMS documentation across organizations

The extent of the QMS documentation may differ from one organization to another because of:

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

ISO 9001:2008 tips to organizations preparing to implement QMS

For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:

Identifying the processes necessary for the effective implementation of the quality management system
Understanding the interactions between these processes.
Documenting the processes to the extent necessary to assure their effective operation and control.

These processes include the management, resource, product realization and measurement processes that are relevant to the effective operation of the QMS. Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008.

Demonstrating Conformity with ISO 9001:2008

Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system.
Where the organization has no specific internal procedure for a particular activity, it is acceptable for this activity to be conducted using the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Sources:

http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/faqs_on_iso_9001.htm

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

http://www.praxiom.com/iso-9001.htm

http://en.wikipedia.org/wiki/ISO_9000