Meenakshi
Lacking specifics in your query I am making some assumptions, such as this matter has been raised by your Notified Body/ Registrar, since there is no specific requirement from the ISO 13485 : 2016 Standard or Handbook, as Richard has pointed out.
Notified Bodies/ Registrars require to be notified of 'significant' / 'substantial' changes in an organization that may impact the Quality System, so in my opinion your query is related to the "employee count" that could affect, for example, the duration of an audit. Examples of such substantial changes in number of employees that require notification could include a new facility added to the Quality System (multi-site organization), relocation of an existing facility, considerable increase in product range, mergers or acquisitions, etc. So to directly address your query, yes, this would apply only when there are 'large changes in the number of employees'.
See:
https://lne-america.com/library/news/notification-of-changes-how-what-and-when-to-communicate-with-your-notified-body
https://www.iaf.nu/upFiles/IAFMD5QMSEMSAuditDurationIssue311062015.pdf
Hope this helps.
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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
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Original Message:
Sent: 21-Nov-2018 02:41
From: Richard Vincins
Subject: Medical Device_Change in number of employees_Impact on Quality system
Where are you getting this reference to change in number of employees? From the ISO 13485 Handbook or another source? I am not aware of a specific requirement that number of employee needs to be considered as part of changes assessed in the quality management system. With that said, I can understand the intent. This goes back to Section 5.1(e) ensuring availability of resources and Section 6.1 to determine and provide the resources. If there are insufficient resources, number of people, the activities in the quality system do not get done, delays are found, corrective actions not closed, documents not approved, etc. It could also mean that if there are not the right employees in the proper position either through qualification or experience or just missing the right person. I have seen companies where the management representative left and the quality system fell apart for 6 months until they hired another person and took months to get it back to normal. But I would argue that it is not change in number of employees, but more generally change in employees as losing individuals in certain positions can be detrimental to the effectiveness of the quality system.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 20-Nov-2018 10:58
From: Meenakshi Verma
Subject: Medical Device_Change in number of employees_Impact on Quality system
Hi RA folks,
My question is with reference to change to Quality system for a medical device manufacturer. One of the change that falls underneath the Quality system change umbrella is - Change in number of employees. Does this mean like large changes in the number of employees? How to evaluate if a change in number of employees substantially impacts the quality system or not?
Any guidance is highly appreciated!
Thanks,
Meenakshi
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Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
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