ISO 9001:2008

A new standard ISO 9001:2008 was published and enforced for implementation for each and every certified company with effect from 15 November 2008
(the old standard will be expired 2 years after this new release).

Being informed that there is no major changes but yet we are advised to undergone 1-2 days training on Gap Analysis ISO 9001:2000 vs ISO 9001:2008 to understand the additional minor requirements and to amend the organisation's QMS accordingly.

Well, I'm yet to attend such a training course, but was given some handouts from CI Malaysia. Basically, after going through the handouts given and i found that it is only some very minor changes, below are my findings and opinion on the changes :

• re-phrase the sentence to express
  
• switching the word "equipment" to "device" and vice versa
• putting more NOTES at the end paragraph (more on giving examples and/or further explanation)

As far as i can understand, the main issue of this new release is focus on 2 area

• clause 4.1 - Outsourcing (the type and control imposed on outsourcing)
  
• clause 6.4 - Work Environment (include physical, environmental and other factors)
  
• clause 5.5.2 - Management Representative (QMR to be appointed from own management staff, those consultant acting QMR shall no longer have the business opportunity on those small company who unable to manage it)
  

My company is involved in the construction line, outsourcing play a major role in every project undertaken, namely sub-contracting the work package to third party and/or procurement of finished product for installation on site. Hence, my concern is more on what is the specific guideline and/or requirement on how to ensure control over the outsourcing process...Some of the aspect I feel that it is redundant if a new procedure has to be created on this, as there are over-lapping processes which were previously documented :

Control on outsourced Supplier
By undergone a the selection and evaluation of the supplier as stipulated in the Purchasing Procedure.

Control on outsourced Sub-Contract Service
By undergone a the selection and evaluation of the sub-contractor as stipulated in the Tender Procedure Procedure and/or Process Validation in Project Implementation Procedure.