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ISO9001 and the control of Production and Service Provision
Up till now Section 8 of ISO9001:2015 has been really dealing with the planning of the provision of your products and services, in clause 8.5 however that changes to the actual delivery of your products and services and there is a bit to think about here, thankfully you have been working through all the previous clauses in which case this part is easier than you think.
Clause 8.5.1 Control of Production and Service Provision
This clause is all about how you control your products and services to make sure that what you produce does, in fact, realise what you planned to provide and there are 8 things that the standard says you need to include here where they are applicable. Obviously, if it's not applicable to your product or service then you ignore that part of the clause but be sure you can support that decision when it comes time to chat with the auditor. There are two keywords in the requirement Shall as in you must and Control so the 8 items below are the things you need to consider as a minimum to gain the control of your set up.
| a) The availability of documented information that defines: 1) The characteristics of the products to be produced, the services to be provided or the activities to be performed 2) The results achieved | If you have worked through section 8.2 of the standard, you will already have determined this information. To comply here you need to ensure that those are available during the production phase, so you can ensure that the products or services provided meet those requirements. |
| b) The availability & use of suitable monitoring & measurement resource | Way back in section 7.1.5 the standard talked about the requirements to provide resources for monitoring & measuring products or services to ensure they meet the customer requirements. This part of the clause is really just restating that requirement. |
| c) The implementation of monitoring at the appropriate stages to verify the criteria for control of processes or outputs & acceptance criteria for products and services are being met. | Here the standard is looking for information on the methods you are doing to use to essentially test that the product does what it is required to do. This is your decision, so it may be by inspection, it may be testing, it may be further validation work, you need to decide and document how you will do this. You would have reviewed this in earlier sections so now is the time to implement the plan you came up with. |
| d) The use of suitable infrastructure and environment for the operation of the processes | Look back at section 7.1 for answers to what you thought you needed for the environment and infrastructure, for example did you decide you needed a clean room? What there a specific temperature you needed or layout that was required, here again you need to implement those plans |
| e) The appointment of competent people including any required qualifications | I don't know any organisations that go out to hire incompetent people, however what they are meaning here is that you need to have people trained for the role that they play in delivering the product or service, if you have determined previously they need a special qualifications, for example maybe you need a qualified biologist to carry out certain testing then that's what you need to get in place. Have another look at section 7 of the standard for more details. |
| f) The validation & periodic re-validation of the ability to achieve planned results of the process for production and service provision, where the resulting output cannot be verified by subsequent operations. | That's a long way of saying that you need to be able to prove that your validation step you have decided to take to ensure compliance with the requirements actually work. For for example if you manufactured circuit boards and you had decided to use functional test equipment to prove functionality you would need a way of validating that the test equipment still performs within specifications so perhaps a golden sample board or a self-diagnostic routine would be used. |
| g) The implementation of actions to prevent human error | People make mistakes, it's not news to anyone or controversial so it is important you take steps to try and eliminate these where possible. This may mean the use of fixed templates, visual aids, double checks, flow charts and so forth that would make sense in your organisation. |
| h) The implementation of release, delivery and post-delivery activities | Think about what the final steps are that need to be ticked off to ensure you are happy to hand over the product to the customer, is it one final inspection, another test, a mechanical fit? How did you come up with the decision that that would be enough? How will you actually deliver the product? Is it electronic so can be downloaded, if it s a physical thing will it need special packaging or handling, say for chemicals as an example? What activities are required to after sales support, for warranty claims or technical support? |
Summary
It seems like quite an exhaustive list, and it is, but because you have worked through previous sections of the standard you already have the required background information available to comply with this requirement, you just need to put it into place
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