Management Responsibilities Procedure - ISO 13485

ISO 13485: 2016 + A11 2021 

QMS.5.0.0 – QP – Management Responsibilities Procedure

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What is a Management Responsibilities Procedure?

• A Management Responsibilities Procedure is a part of the Quality Management System (QMS) that sets out the commitments and responsibilities of your organisation’s top management.
• The Management Responsibilities Procedure template will help you/your organisation determine commitments and responsibilities for procedures such as
  • Establishing the Quality Policy (QMS.5.3.0)
  • Meeting customer, statutory and regulatory requirements
  • Maintaining the effectiveness of the QMS
• This procedure will help you/your organisation to identify the requirements of the Management Team (MT), and in communicating the expectations of the organization.

Does the Management Responsibilities Procedure need to list all managerial responsibilities?

• No, only the responsibilities of your organisations top management in supporting the QMS.

How does it show my organisation’s compliance with ISO 13485?

• This template is specifically designed to help you satisfy clause 5.1 of ISO 13485which states: “Top management shall provide evidence of it’s commitment to the development of the quality management system and maintenance of its effectiveness”.
• By using this template, you will be able to put in place an effective Management Responsibilities Procedure in order to satisfy the requirements of ISO 13485.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.