Management responsibility

Customer and regulatory focus

Management ensures customer requirements and applicable legal and regulatory requirements are determined and met.

Quality policy and planning

A quality policy appropriate to the organization's purpose, with measurable objectives and system planning to achieve them.

Management review

Review at planned intervals with specific inputs: complaints, surveillance reports, audits and regulatory changes.

What an auditor usually asks for

• A quality policy signed and communicated to staff
• Measurable quality objectives with tracking
• Management review minutes with regulatory inputs
• Evidence of tracking changes to applicable regulation

How to cover management responsibility in Kimobox

1. 1Publish the quality policy as a controlled document, with a read receipt.
2. 2Define quality objectives with an indicator and let the system track them.
3. 3Turn management review into a template with complaints and surveillance already pre-loaded.

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

1. ISO 13485:2016 — Medical devices. Quality management systems ISO · March 2016
2. Regulation (EU) 2017/745 on medical devices EUR-Lex · 5 April 2017
3. ISO 14971:2019 — Application of risk management to medical devices ISO · 2019 ed.