How to identify roles and responsibilities in a QMS based on ISO 13485?

Posted by Charles Wilson on November 30th, 2019

It is necessary to assign and document the roles and responsibilities of your management system when you are developing a Quality Management System. ISO 13485 highlights these roles and responsibilities as shown primarily in the requirements as per clauses.

The ISO 13485 standard requirements of regarding roles and responsibilities are very loose, so the organization can define them in any way it finds the most suitable. The top management must ensure the responsibilities and authorities are defined, documented and communicated within the organization.

The top management awareness and commitment to the implementation and maintenance of an ISO 13485 based Quality Management System is often the cause of implementation failure and it is one type of lack. It can also mean that the ISO 13485 standard is implemented only informally. The primary concern of the top management is to ensure the long-term success of their organization, increase profitability, control of new initiatives, decreasing the risks, etc.

An increment of the involvement can be achieved by explaining to them the benefits that ISO 13485 implementation can have for a business, and the potential negative consequences of a poorly established QMS. Most of these ISO 13485 requirements for engagement of the top management in the QMS are stated in clause 5.

Following ISO 13485 requirements that demonstrate the commitment of the management to the QMS:

• Communicate the importance of meeting customer & ISO 13485 requirements: here the focus is on the customer but, considering how highly regulated the medical device industry is important that top management ensures the compliance to these requirements by communicating with the rest of the organization such as in any other QMS.
• Establish the Quality Policy: when establishing quality policy by top management in which they will define the intention of the QMS.
• Establish the objectives: Through the establishment of objectives, top management defines which direction the QMS will follow. These objectives which are established also provide a clear measure of whether the system is effective.
• Conduct the management reviews: whether the QMS is effective, and what actions need to be taken for its improvement is the final check by Management reviews.
• Provide all the necessary resources:  The ISO 13485 project will fail if there is no enough money or employee time, and support from the management must become very real and tangible and this is exactly the point where the management usually fails – they usually redirect the resources into other projects.

The ISO 13485 requirements are severe and getting the certification is a complex process which requires professional assistance. To achieve ISO 13485 certification it is advisable to hire a consulting firm specializing in ISO 13485 that can help you build and implement an effective QMS or 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 as well asinternal audits and auditor training in order to ensure successful ISO 13485 certification.

Source: 13485certificationprocedures.wordpress.com