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Keshav Ram Singhal

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Wednesday, December 17, 2008

Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter – 5

RESOURCE MANAGEMENT

Author – K. R. Singhal

There are following clauses under this section:
6.1 – Provision of resources
6.2 – Human resources
6.3 – Infrastructure
6.4 – Work environment

Provision of resources
(Please refer to Clause 6.1 of ISO 9001:2008)

The organization must (i) determine, and (ii) provide the following:
resources needed to implement the QMS,
resources needed to continually improve the QMS, and
resources needed to enhance customer satisfaction by meeting customer requirements

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 6.1.


Human resources
(Please refer to Clause 6.2 of ISO 9001:2008)

There are following sub-clauses in this clause:
6.2.1 – General
6.2.2 – Competence, training and awareness

General
(Please refer to Clause 6.2.1 of ISO 9001:2008)

In an organization, personnel perform work affecting conformity to product requirements, and such personnel must be competent on the basis of appropriate education, training, skills and experience.

Note mentioned at the end of clause 6.2.1 of ISO 9001:2008 clarifies that conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS.

Competence, training and awareness
(Please refer to Clause 6.2.2 of ISO 9001:2008)

The organization must:
determine the necessary competence for personnel (who perform work affecting conformity to product requirements),
provide training to personnel or take other actions, where applicable, so that such personnel achieve the necessary competence,
evaluate the effectiveness of the actions taken,
ensure that the personnel of the organization are aware of the relevance and importance of the activities of the organization,
ensure that how personnel of the organization contribute to the achievement of the quality objectives, and
maintain appropriate records of education, training, skills and experience

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that in sub clause 6.2.1 and 6.2.2, the words ‘product quality’ have been replaced by ‘conformity to product requirements.’ Although the old version also requires the importance of competence, but now new version makes it more clear that the personnel performing work affecting conformity to product requirements must be competent and the organization needs to determine the necessary competence for personnel performing work affecting conformity to product requirements. Sub-clause 6.2.2 (b) now states that ‘where applicable’ training needs to be provided to achieve the ‘necessary competence’. The wordings of clause title of sub-clause 6.2.2 ‘Competence, awareness and training’ (in ISO 9001:2000 Standard) has been reframed as ‘Competence, training and awareness’ in ISO 9001:2008.

A note is added after sub clause 6.2.1 mentioning that product requirement may be affected directly or indirectly by personnel performing any task within the quality management system.




Infrastructure
(Please refer to Clause 6.3 of ISO 9001:2008)

The organization must determine the infrastructure needed to achieve conformity to product requirements and the organization must provide and maintain such infrastructure as determined.

Infrastructure (as applicable) includes the following:
buildings,
workspace,
associated utilities,
hardware process equipment,
software process, and
supporting services

Supporting services include transport, communication and information systems.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that in sub clause 6.3 (c), information systems has been included in the supporting services in the new version. In the old version, the term infrastructure includes building, workspaces, equipment, software, utilities, and support services such as transportation and communication. The new version has added information systems to the previous list of support services.



Work environment
(Please refer to Clause 6.4 of ISO 9001:2008)

The organization must determine the work environment needed to achieve conformity to product requirement and the organization must manage such work environment.

Note mentioned at the end of clause 6.4 of ISO 9001:2008 clarifies that the term ‘work environment’ relates to those conditions under which work is performed. Such conditions include physical, environmental and other factors, such as noise, temperature, humidity, lighting or weather.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we find that there is no change in the requirement of this clause; however a note has been added to make clearer the conditions under which the work is performed. The new version states that the term work environment refers to working conditions. These working conditions include physical, environmental and other factors such as noise, temperature, humidity, lighting, weather.

Questions

What are the key changes in clause 6.1 (Provision of resources) in ISO 9001?
What are the key changes in clause 6.2 (Human resources) in ISO 9001?
What are the key changes in clause 6.3 (Infrastructure) in ISO 9001?
What are the key changes in clause 6.4 (Work environment) in ISO 9001?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.

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