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  • Writer's pictureMoshe Yuval Shapiro

EN/ISO13485 – Quality Management Systems: What went Wrong? (Part III)

In this Part I would like to discuss the actual claim of the Standard's Process Approach.

Logistics managers know that the initiation of Production doesn’t start with the WIP instruction to start production. It starts way long before, when the customer submits a formal request to purchase the product (PO – Purchase Order).


electronic assembly line

Oddly enough, we meet the Customer in Section 7 – Product Realization:

a. Section 7.2.1 - Determination of requirements related to product – a set of requirements the refer to the Design and Development of the product and some to regulatory requirements;

b. Section 7.2.2 Review of requirements related to product – a set of requirements of how to commit to the supply products and provide support later (AKA: “Contract Review”); and

c. Section 7.2.3 Communication - a set of requirements dealing with the ways to communicate with the customer.



But, if one observes the requirements and their position in the standard – they precede the Design & Development meaning – this section is meant to satisfy the Design and Development process, not the Production process, as depicted in Section 7.4 – Purchasing.



Another thing – once a Purchase Order is received and Reviewed, Material Resources Processing is initiated, ensuring that enough raw material is procured in a manner that products are manufactured and supplied on time.


That means that Section 7.2 should be broken into several parts, as recommended in Part II, as follows:

  • Section 7.2.1 should be consolidated with Section 7.3.2 and Section 8.2.1 to provide maximum information to the Design Process.

  • Section 7.2.3 will be merged into Section 5.2 and 8.2.2 – to deal with Customer Relationships in general.

  • Section 7.2.2, 7.4 and 7.5 will be merged into a “Supply Chain Section” that will depict the overall process of Production Line.



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