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ISO 9001:2000 questions

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ISO 9001:2000 questions

The following three questions relates to a Malaysian ISO 9001:2000 certified company in Dec 2001, with four certified sites all at different locations. Quality Objectives has been formulated by the various depts/sites, with some depts having two Objectives whilst most of them has only one.

I have my opinions stated but I would like any further advice any professionals could offer under the following circumstances.

(Question 1) One of the company's dept formulated 2 Quality Objectives at the implementation (year 2001) of the Quality Management System (QMS). Q Obj 1 and 2 was run concurrently at the start. Q Obj 1 went on well and was closed within the time-frame, ie on March 2002. However, Q Obj 2 went on well for the first few months but was stopped many months ago (on Feb 2002)without any good reasons nor was it told to the Quality Management Representative (QMR)or the Chief Executive Officer (CEO). And worse, during each and every Management Review Meetings (in March, June and August 2002), all the Company's Heads Depts confirmed the suitability of their QMS.

Questions arises are :

(a) is it acceptable to run Quality Obj 1 and temporary abandon Q Obj 2 in Feb 2002)? Or should it not be run concurrently because two Objectives were formulated?

(b) what is the best approach to address this non-conformity as recorded by the Internal Quality Auditor (IQA) on Oct 2002?

[My opinion is that :

(Q 1a) I would think that if this department wishes to handle one Objective at a time (or unable to handle more than one Objectives), then this dept should not have formulated two Objectives at its implementation stage.

The Objectives form the pillars to support the Quality Policy and this takes into account of all the departments' Objectives approved by the CEO during that time.

If this dept cannot handle Q Obj 2, then it should advise the QMR and the CEO or informed the members of the Management Review Team in the first place and not just conclude that the QMS is "suitable". I see it as being unacceptable.

(Q 1b) This inadequacy should be recorded as a Non-Conformity (NC) as this dept now no longer has an ongoing Objective to gauge the suitability of the QMS.

Since the error has been committed by this Head of Dept (HOD), I suggest that an immediate meeting is convened after the internal quality audit to address this NC and quickly document the necessary changes. (It was said by this HOD that Q Obj 2 is unsuitable in his reponsed to the IQA).]

(Question 2) As all suppliers are currently used by the Company when implementing the QMS in 2001, this Company inadvertently left out the Selcetion of New Suppliers, an inadequacy pointed out by the Certifying Body as Observation. Now, management has decided to have only ONE Quality Form to fulfil the requirements of Selecting New Suppliers and Evaluating Current Suppliers.

[My opinion is that this is possible as long as the purpose of the Form is served and that the criteria laid down for Selecting (new) and of Evaluating (current) the Suppliers are clearly stated.]

(Question 3) The appointed Quality Management Representative (QMR) in 2001 did not undergo any formal training on Quality Management Representative courses. All the QMR has attended is the ISO 9001:2000 standards courses. QMR has conducted himself very well throughout the implementation till certification stage and has led the company to being ISO 9001:2000 certified. Even the certifying body assessor praised this QMR for his knowledge and capabilities.

QMR has been evaluated by the CEO as deemed suitable and capable in implementing and maintaining the QMS system, having led a team of internal quality auditors to successfully audit the company's QMS. In other words, management is satisfied with the output of the QMR.

Would there be any reasons to fault the QMR and issue an NC or Observations?

[In my opinion, as long as ISO clause 6.2.2 has been satisfied and that the QMR has been able to demonstrate suffient knowledge of the ISO clauses and understanding of the Company's QMS and Documentation, this being the basic requirement fulfilled, I reckoned that is all it takes to make a capable QMR per ISO requirements.]


WL Loh

2 Responses

  1. Questions
    We appreciate this is a long an complex question and contains a great deal of background information. We have passed it to our quality manager and if you can email us with an email address we are happy to give an opinion.

    You can email us at [email protected]
    http://www.tbdglobal.com
    0870 241 3998

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