Explained: Management review of ISO 13485

Management review_iso13485

Management review is a management tool for monitoring and evaluating the performances and effectiveness of the quality management system. The top management is using it, and they also have a responsibility to maintain the Quality management system of the organization.

Management review

The main purpose of the management review is to give top management a chance to periodically evaluate the quality management system.

Management review manifests through the organized meeting, where representatives of top management are presented with information and documents regarding the performances of the QMS.

All mentioned topics in the ISO 13485:2016 standard must be covered in the review, for example documentation, human resources, work environment, purchasing, a realization of the product, etc. The information and the data presented to the top management are reviewed on various levels:

  • The need for improvement and changes throughout the quality management system
  • The conformance, suitability, and adequacy of the activities to the quality policy
  • The need for resources in order to maintain an effective quality management system
  • The achievement of quality objectives and the fulfillment of requirements customers’ and regulatory

Quality Objectives

Consideration of quality objectives is one of the purposes of the management of review. For achieving an effective QMS, quality objectives are an efficient tool. On management reviews, the inspection will focus on two areas:

  • The achievement and the contentment of quality objectives, for example, marketing objectives, quality plans, customer-related objectives, etc.
  • The compliance of the objective and their level of effectiveness concerning the quality management system. This examination will determine whether the objectives are truly suited to the nature of the medical device company

Changes and improvements

The assessment of changes and improvements is another the objective of the review:

  • Potential changes and improvements will be discussed and reviewed regarding their applicability to the QMS and to plan required resources and implementation
  • Implemented changes and improvements will be reviewed for their efficiency and suitability to the QMS

Intervals and Participants

The management review is intended to be performed at least once a year. It is important that representatives of top management attend the review. It is intended for the medical device company to define the regularity and participants according to its complexity and nature of events but at least once a year with a chosen member of top management is necessary.
In the meeting all the topics that are mandatory by the standard are intended to be covered and it will provide the required outputs in a year. Top management is intended to review the status of the QMS. In cases when a complex decision or intervention is needed, an unexpected meeting with top management will be requested.

Records

All the records and outputs of the management review activities are intended to be documented. The standard isn’t specified as a particular method for documenting the review. It is the long-term review process, with inputs and outputs of the later stages: a report, form, or presentation. For easier management and maintaining of documentation, create a form for the matter that will consist:

  • The issues that were discussed
  • The participants
  • The date and the location where the review took place
  • Evidence or reference to the evidence
  • Results, agendas, and responsibilities for implementation

The form should be submitted to the process of document control as written in the ISO 13485:2016 standard in subclause Medical Device file and the records of the review will be submitted to the process of record control in the quality management system as required in subclause Control of records.    

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One reply to “Explained: Management review of ISO 13485”

  1. Sofia Nascetti says:

    Just yesterday I’ve read that FDA is not permitted to see management review notes, but NBs may request them. And I was surprised… But, when I think about it, it’s logical. The management reviews discuss important things regarding the company, maybe the confidential. Then I go back to NBs… How come they are asking them? But, according to my experience with them, they just ask to see if the record is there physically. Never check their content.

    I remember when the auditor asked us if we’ve validated QMS software. I opened the file and started scrolling (it has about 100 pages), he just said: “It’s fine, it’s fine!” 🙂

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