Medical Device QMS Responsibilities and Management Review
A quality system works more consistently when decisions have named owners. An organization chart shows reporting relationships, but it may not explain who can stop production, approve a change or commit resources to an unresolved problem. Responsibility definitions and management review connect those decisions with evidence.
Define decision authority
For each important process, identify the person accountable for its effectiveness, the people carrying out the work and the approvals needed at key stages. Include deputies and escalation paths. Check interfaces with outside manufacturers, consultants and service providers so responsibility does not disappear between organizations.
Make review produce decisions
Assemble a concise review package using quality results, open actions and changes affecting the business. Show trends alongside their context: product mix, production volume or reporting periods can change how a number should be interpreted. Record the decision, resources, owner and due date for each action. At the next review, assess what changed rather than simply confirming that the previous meeting occurred.
Practical checklist
Name process owners and approval authorities.
Identify resource and competency gaps.
Prepare trends with comparable time periods.
Record decisions and action ownership.
Follow up on overdue and ineffective actions.
Example
If complaint investigations repeatedly wait for engineering support, management review should expose the capacity problem. A useful output might assign additional investigation resources and a follow-up date, with a measure of whether the delay decreased.
Common mistakes
Avoid agendas that list topics without evidence, minutes that record discussion without decisions, and responsibility statements that assign the same final authority to several people without explaining how disagreements are resolved.
Choose the relevant A.P. Lyon documents
Use the responsibilities and authority procedure to define management and departmental roles, then tailor the assignments to your organization.
Use the management review procedure and forms to organize inputs, decisions and follow-up records.
Connect role assignments with the training process so people receive training appropriate to the work and decisions assigned to them.
Review the product page, document previews and any content list before choosing. Adapt the selected documents to your device, processes and applicable requirements; the organization must generate and review its own implementation evidence.
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