What are the major changes to api q1 9th edition

WHAT ARE THE MAJOR CHANGES TO API Q1 9th Edition

While informative index Annex  B of the API Q1 9th Edition clearly gives the summary of the changes between Q1 8th edition and 9th Edition in tabular fashion, however for those  who do not have immediate access to Q1 9th edition annexes – here is the brief summary of what is changed ( Thirteen 13 NEW KEY requirements of API Q1 9th edition)

  Q1 9th Edition Q1 8th Edition
1 Competency determination is to be done formally No requirement
2 Legal( statutory and regulatory) and Other applicable requirements are emphasized through out the standard This is demanded in isolation
3 The QMS is not expected to be established, documented, implemented and maintained These were implicit and hence were hard to audit against
4 Risk assessment is to be done formally and methodically and reviewed periodically No such requirement
5 Risk assessment has to be done for product quality and delivery and has to be communicated to client No such requirement
6 Contingency plan to be developed based on risk assessment and  to be communicated to the client No such requirement
7 Critical products and components to be determined No such requirement
8 Critical Suppliers to be determined and initial evaluation of critical suppliers can be done in one of three defined ways No such requirement
9 Maintain evidence of capability to produce products as per agreed requirements Not so specifically and explicitly required
10 PQP _ Product quality plans to be made and shared with the client No such requirement
11 Storage  is now no more just a “ under  the carpet” activity. The storage area  has to be designated and stocks have to be inspected at predefined interval Storage is not given much attention
12 Preventive maintenance is now comprehensive . It requires a procedure   with frequency and responsible person explicitly called for Preventive maintenance is not given explicit attention and no specific requirements are mentioned
13 Management of change- Major requirement for API Q1 9th edition – this puts the client in control and reduces practical RISKS on site because of product quality – if  implemented  in spirit .. this requirement makes API Q1 9th edition a much more sought after than any other QMS standard in pipeline No such requirement

 

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