Management Review Form ISO 13485

55.00

This form provides a structure and guidance for performing Management Review.

Descrizione

The Management review is not only a requirement of ISO 9001 and ISO 13485 but is an important moment for evaluating the implementation and efficienty of the quality management system and the overall business processes of the company.

A well prepared and performed Management Review can have a positive impact on the company performance and interelation between the different functions and processes.

The management review must address the possible need for changes to policy, objectives, targets, and other elements of the QMS. The management review process must ensure that the necessary information is collected ahead of time to  allow management to effectively carry out this evaluation.

The management review process requires that top management periodically review the QMS to ensure its continuing suitability, adequacy, and effectiveness. The frequency or intervals of the top management review must be defined in the QMS or in business plans.

Information that should be reviewed includes:

  • Outcome of external audits last year
  • Outcome of internal audits last year
  • Complaints, non-conformities, corrective and preventive actions last year
  • Changes to the management system in the last year
  • Resources Management (Human Resources, production, equipment / facilities, structures / work environment, suppliers, etc.)
  • Business performance (analysis of the indicators) last year
  • Progress state of objective and improving plans of last year
  • Management Commitment (review / confirmation of company policy)
  • Objectives Definition and improvement plans for new year
  • Schedule of ordinary activities / periodical (training, internal audits, qualifying suppliers, etc.)
  • Forecast update of the management system