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  • Writer's pictureMoshe Yuval Shapiro

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

Updated: Oct 18, 2022

In Part I I discussed the disabiguities that are releated with the EN/ISO1385: 2016 –Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes requirement for a Medical Device File and how I think the requirement should be fixed in a manner that reduces the misalignment with Regulations (21CFR820 and EU-MDR)

In this part I would like to emphasize that the standard’s editors neglected the crucial part of “Management” in the “Quality Management System.”


On a meeting
On a meeting

How could one state that? There is an entire section for Management Responsibility!?

Lets look at the Section 5.2 - Customer Focus. This requirement appears in additional 3 sections (at least: 7.2, 8.2.1, 8.2.2). Each one of those are mere extensions of the previous sections. The ability of an organization to anticipate customer needs is inherent to its managerial process in order to succeed regardless of the purpose of the organization (medical devices, defense, communications, fin-tech, etc.)! Why separate them when they are crucial to Management in the first place?


Management is always with the face to the customer (at least in major leading enterprises)!


I would recommend to consolidate them into one section under Management Responsibility and the results of the Customer Focus are part of the Inputs to Managerial Reviews and to Design and Development.


Another indicator for my claim is depicted in Section 5.6 – Management Review and especially in Section 5.6.2 – Review Input “The input to management review shall include, but is not limited to, information arising from:


a) feedback;

b) complaint handling;

c) reporting to regulatory authorities;

d) audits;

e) monitoring and measurement of processes;

f) monitoring and measurement of product;

g) corrective action;

h) preventive action;

i) follow-up actions from previous management reviews;

j) changes that could affect the quality management system;

k) recommendations for improvement;

l) applicable new or revised regulatory requirements.”


However, when reviewing the list, one easily indicates that it is tumble of requirements that a manager, especially – Top Management manager, cannot see through the status of hers/his organization.


Managerial processes tend to start with a review of the previous decisions and a follow-up of the effectiveness of their own decisions and implementation by organization (oddly enough - that approach was adopted for Corrective Actions and Preventive Actions….) so why this is 10th (!) Input to the review? Why aren’t the inputs structured in a manner that “tells the story of Quality”? Where has the Quality of Design gone? What about Cost of Quality? Why Section 8 - Measurement, analysis and improvement is preferable to all other sections of the standard (and even then – not in a sequential manner…)?


In my eyes, this section should be aligned with all other sections of the standard, by first presenting the Follow-up on Previous Management reviews, then discuss changes to the Management System (Personnel, Facilities, Regulations, Standards, etc.), Management Policy, Customer Communications, Quality of Design, Design Changes, etc… then conclude with prime question: “Is the QMS Effective? What should be done to Improve?”




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