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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