Understanding ISO 9001:2008 Quality Management System
Chapter – 1
ISO 9001: 2008 – Introduction
Author – K. R. Singhal
Revised ISO 9001:2008 International Standards has been issued and published, after voting by ISO members, on 15 November 2008. Changes are mostly editorial giving more clarity to the right interpretation of requirements. Users (such as, organizations implementing ISO 9001 QMS, QMS auditors, etc.) will find the new standard useful for right interpretation of the standard’s requirements.
If we read old as well as new standards, we find that ISO 9001:2008 And ISO 9001:2000 use the same numbering system to organize the standard.
In the forward of the ISO 9001:2008, it has been mentioned that international standards are drafted in accordance with the ISO/IEC Directives Part 2. Earlier international standards were being drafted in accordance with the ISO/IEC Directives Part 3. ISO 9001 QMS Standard was first published in 1987, and then was revised in the year 1994 and 2000 respectively. ISO 9001:2000 Standard was the third edition of ISO 9001 QMS. ISO 9001:2008 is now the forth edition of this Standard and it cancels and replaces the third edition of ISO 9001 QMS Standard.
Para 0.1 (General) of the ISO 9001:2000 states: “…..The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives the products provided, the processes employed and the size and structure of the organization……..” ISO 9001:2008 clarifies that design and implementation of an organization’s quality management system is influenced by organization’s business environment, changes in that business environment or risks associated with that business environment, its varying needs, organization’s particular objectives, the products the organization provides, the processes the organization employs, and the size and structure of the organization. Statement of where and who can use the standard now includes statutory requirements as well as regulatory and clarifies that these requirements are restricted to those applicable to the product. Accordingly, ISO 9001:2008 QMS Standard can be used by internal and external parties (including certification bodies). With the use of ISO 9001:2008 QMS Standard internal and external parties (including certification bodies) can assess the organization’s ability to meet following requirements:
customer requirements applicable to the product,
statutory and regulatory requirements applicable to the product, and
the organization’s own requirements.
The text of Para 0.2 (Process approach) is modified and it is emphasized in ISO 9001:2008 the importance of process being capable of achieving desired output. If we compare the language of 2008 version with 2000 version, we find that the word ‘identify’ has been replaced by ‘determine’ and with the term ‘an activity’ the term ‘or set of activities’ has been added. As such, there is no change in the intent, but the meaning is more clarified by the revision. ISO 9001:2000 Standard mentions the meaning of the term ‘process approach’ as the application of a system of processes within an organization, together with the identification and interactions of these processes, and their management. Now, words ‘to produce the desired output’ have been added to the word ‘management’ and ISO 9001:2008 refers to ‘process approach’ as the application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome.
Para 0.3 (Relationship with ISO 9004) – There is editorial change in the contents of this Para and a clarification by adding a note, that ISO 9004 Standard is under revision at the time of publication of ISO 9001:2008 QMS Standard, has been mentioned. A sentence mentioned in this Para of ISO 9001:2000 QMS Standard has also been deleted in ISO 9001:2008 QMS Standard. Accordingly, ISO 9001:2008 QMS Standard does not mentions that ISO 9001 and ISO 9004 Standards have different scopes; these standards have similar structures in order to assist their application as a consistent pair.
Para 0.4 (Compatibility with other management systems) – Now it has been mentioned that during the development of ISO 9001:2008 QMS Standard, due consideration was given to ISO 14001:2004 EMS to enhance the compatibility of ISO 9001 and ISO 14001 Standards. Earlier in ISO 9001:2000 QMS Standard, it was mentioned that ISO 9001 has been aligned with ISO 9001:1996, which has been deleted in ISO 9001:2008.
When ISO 9001:2008 Standard was published?
Is the 2008 version of ISO 9001 the third edition or fourth edition?
What are key changes in Para 0.1 (General) of ISO 9001?
What are key changes in Para 0.2 (Process approach) of ISO 9001?
What are key changes in Para 0.3 (Relationship with ISO 9004) of ISO 9001?
What are the key changes in Para 0.4 (Compatibility with other management systems) 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.