Maintaining ISO 13485 certification
The company has just been certified with the 13485. HOW do i maintain this certification and what are the documents I need for the day to day maintenance
Our certification requires an annual audit can i just start a few months prior or this a constant full time day to day effort.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Maintaining a quality system is a day-to-day business. Every quality system has some kind of records that are proof of some work done. For example, if you need to procure something (raw materials, equipment) you have a purchase order, communication with the supplier. Then, when those goods arrive at your company you have an invoice, a receipt at the warehouse, a check to see if the goods that arrived are in line with what was ordered and the like. All of this is evidence that some work has been done, but so are the elements of the quality system.
If there are (non-conformities) omissions related to daily work, it is necessary to record such omissions and resolve them. Therefore, there are records of non-compliance, on the basis of which it is necessary to initiate corrective or preventive actions. This is also a day-to-day business.
As far as audits are concerned, an internal audit usually takes place once a year. When that will depend on your business. This can be at the end of one year, or at the beginning of another year, before submitting the final accounts and the like, whichever suits you. Management review is also conducted mostly once a year and is most often after an internal audit is conducted.
So the maintenance of the quality system takes place throughout the year.
The following articles can be helpful:
- How to perform management review according to ISO 13485 https://advisera.com/13485academy/blog/2017/11/09/how-to-perform-management-review-according-to-iso-13485/
- How to fulfill management responsibilities in ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-fulfill-management-responsibilities-in-iso-13485/
- Five main steps in the ISO 13485:2016 internal audit https://advisera.com/13485academy/knowledgebase/five-main-steps-in-the-iso-134852016-internal-audit/
- How to create a checklist for an ISO 13485 internal audit for your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/
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Feb 11, 2021