Understanding ISO 9001:2000 QMS Requirements and HR's Role in Compliance Transition

Hi All,

ISO 9001:2000 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide products that meet customer and applicable regulatory requirements. The organization also aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement and assurance of conformity to customer and regulatory requirements.

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. However, where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7. Such exclusions should not affect the organization's ability or responsibility to provide products that meet customer and regulatory requirements.

Furthermore, the HR part falls into clause 6.2 (6.2.1)(6.2.2).

I am attaching the ISO 9001:200 Quality requirements.

Furthermore, the terminologies used are as follows:
- MR: Management Representative
- NCR: Non-Conformity Report (Non-compliances of Section)
- AOI: Area of Improvement (Compliance is there but improvement or improvisation is required)
- Observations

- Major NCR: Repeated NCRs or non-compliances
- Minor NCR: Issues that can be closed immediately or do not affect the system as a whole.

Also, please note that there is a new ISO standard as we are transitioning from ISO 9001:2001 to 9001:2008.

If there is anything else you need, please let me know. Thanks for now.

Hi,

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Hi Pramod,

Thank you for the valuable document. I myself am an external auditor of ISO 9000 quality series. One important issue in ISO is that you may or may not apply all the subclauses of Clause 7 (product realization part) but cannot exclude any other clause or subclause. Another important thing is that the ISO 9000 standard was amended in 2008, and the new standard is ISO 9001:2008. Please try to procure the new standard. I have the hard copy. If I can't manage to get a soft copy of the same, I will scan the document and send it to you.

Regards,

Souvik Gupta
Sr. Consultant
Health Care Division
Institute of Applied Quality Management
Kolkata

HRTEP, the document attached is not written by me or stolen from anywhere. It outlines the compliances or standards to be followed in ISO. If you have a different standard, please do share.

The Origin of ISO

The International Organization for Standardization decided not to use an acronym for their organization because it would differ in different languages. Instead, they used the word "ISO," which is derived from the Greek word "isos," meaning "equal." This standard is used for companies doing business across global boundaries.