ISO 13485 has purchasing procedures for suppliers. ISO 13485 purchasing procedure is listed in Section 7.4 and its sub sections. The outstanding feature of this section is that the ISO is not clear about the expected levels of control a supplier has to have in place. It simply states that a documented procedure is required for purchasing and that the purchased products have to be compliant with specified requirements. This leaves scope for a lot of ambiguity and subjectivity in the ISO 13485 purchasing procedure.
The details of ISO 13485 purchasing procedure are spelt out in sections 7.4.1 and 7.4.2. It is important to know what these sections require. As stated; in being unclear, this section leaves a lot of judgmental application, because given the nature of products that suppliers are required to supply; there is scope for interpretation.
“The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained”.
ISO 13485 purchasing procedure is based on the buyer’s requirement. It is the organization that has to decide and set the criteria for selection, evaluation and re-evaluation. This is entirely open and dependent on the particular need. The core areas are prone to be open to personal and individual, organization-based needs. It could source its requirements from its selected supplier. This search for the supplier could be based on advertisements or word of mouth or through any source the buyer is comfortable with. Evaluation and revaluation also carry the same interpretative nature, since there are no rigid criteria by which they can be set.
Section 7.4.2 is the next important part of ISO 13485 purchasing procedure. It states the following:
“Purchasing information shall describe the product to be purchased, including where appropriate requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system.The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.”
Here too, there is no clear explanation of what kind of customer requirements have to be taken into consideration by the supplier. There is mention only of broad requirements, but not of the smaller, less visible points, such as what has to go into the products or packaging.
Given this haziness; ISO 13485 purchasing procedure has turned out to be a procedure that is open to debate. The Global Harmonization Task Force (GHTF) is in the process of making the purchasing procedure and supplier control tighter.
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