Role Of Management Leader In Iso 13485 Certification

By Author: Charles Wilson
Total Articles: 128
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The task – “Management Review” during ISO 13485 Certification is an unpleasant requirement of many companies for maintaining compliance with ISO 13485. Regardless of how management review is organized, either through more continuous review process or routinely scheduled meetings, the act of reviewing the available data can be key drivers of improvement in the Quality Management System.

The ISO 13485 standard defines the management review, but the organization during ISO 13485 Certification, can also add other elements if it finds them important for the QMS. The management review requires to be conducted at planned intervals to make sure the effectiveness of a QMS based on ISO 13485.

As well as it also requires including the assessment of opportunities for improvement, and changes in QMS. Finally, the management leader must review record requires to be kept as evidence of compliance. To consider all things above of the management review is used to relevant with implementation of ...
... ISO 13485 certification.

With considering all this points we can also say that management review is the key driver for improvement. The Management Review process highlights all the areas to ensure the top management are monitoring and controlling the necessary resources to make the company function.

Instead of being a burden, Management Review should become one of the main elements of Quality management system improvement. Management Review is all about reviewing the available data to confirm that are presenting sufficient resources to ensure satisfaction of the customer and improve the QMS and the product.

Following are the mandatory steps that should take care by Management Leader during ISO 13485 Certification:

After completion of all ISO 13485 documentation and implementing it, Following are the steps that organization also requires to perform these steps to ensure a successful ISO 13485 certification:

Internal audit– The internal audit is used to check QMS processes. The main aim is to ensure that records are in place to confirm compliance of the processes and to identify problems and weaknesses that would otherwise stay hidden.
Management review– A formal review by management to judge the relevant facts about the management system processes in order to make appropriate decisions and assign resources.
Corrective actions– Following the internal audit and management review that require correcting the root cause of any identified problems and ISO 13485 documents were resolved.


Management Leader Should Focus on two stages of ISO 13485 Audit Process:

Documentation review– here is the stage-1 where the auditors from your chosen certification body will check to make sure your ISO 13485 documentation meets the requirements of ISO 13485.
Main audit– Here is the stage-2 where the certification body auditors will check whether your actual activities are compliant with both ISO 13485 and own ISO 13485 documentation by reviewing documents, records, and company practices.


Importance of ISO 13485 documentation

The ISO 13485 documentation has the purpose in the QMS is to make sure that critical processes, where you need to make sure that all employees consistently do the same thing, are understood and repeatable.
It is wise to have these processes as uncomplicated as possible and it is presented in the simplest manner to make easy to understand. Often, using a graphical flow chart can be adequate to transfer all the relevant information quickly and easily.
The less complicated the process of preparing ISO 13485 documents, the easier it will be to ensure that all employees can deliver repeatable, quality outcomes for the processes.