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ISO 13485 Verification of purchased product requirements |
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This chapter refers to the control over purchased products related to the realized product. The additional requirement here is to maintain documents of the process. Let's review.
ISO 9001
| ISO 13485
| There is a definition of the purchased products verifications activities to compete the predetermined purchased requirements.
| There is a definition of the purchased products verifications activities to compete the predetermined purchased requirements.
| Acceptance verifications are performed according to the requirements.
| Acceptance verifications are performed according to the requirements.
| When validation of products required at the suppliers premises, it is required to be documented.
| When validation of products required at the suppliers premises, it is required to be documented.
| | | Evidences of the verification and records must be maintained and introduced to the records control procedure as required in chapter 4.2.4 – control of records.
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When part of the medical device's production or development is delivered to outsourcing, the organization is required to set the method to verify and validate the requirements of the purchased goods. When the organization assembles goods with purchased goods, these processes are to be considered as well and the organization must validate them to. The reason is that the purchased goods are required to be validated together with other parts. The effectiveness is needed to be measured when they are assembled. When defining the purchased product verification activities, the organization shall: - Define the requirements from the purchased product – which areas or issues are to be tested by the purchased product.
- The method for conducting the tests – for every test it is required to determine the method - test instructions, a list of tests,
- Define the documentation requirements – where it is required to document the test, by whom and if there any quality documents required.
It is required by the ISO 13485 Standard to maintain a documented procedure (chapter 7.4.1). I always recommend it. Just to put things in a defined frame. It damages no one… As mentioned above, the additional requirement here is to maintain records of verification of purchased product. The ISO 9001 Standard requires performing the verification to purchased goods or services. It is not required to maintain records as long as the organization can prove verification without them. The ISO 13485 Standard on the other hand, requires evidences of verification in any case. This is one part of the traceability chain that the ISO 13485 Standard creates. Documenting the verification provides the approval for the next process. Where problem may arise, the organization could trace where it started. I always say that documentation is our statement of defense. Let's hope we would never have to use it.
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