ISO 13485 Standard Management Responsibility Requirements - Management Review

The review shall be performed at least once a year. The organization shall determine the frequency according to its needs and activities. Of course, members of the top management shall attend the review. The subjects in hand shall be:

• The relevance of the quality policy to the nature of the organization.
• Status and competence of quality objectives.

The need for resources in order to maintain an effective quality management system – the evaluation shall be with relation to the quality policy.
It is not required that all subjects are to be reviewed at once but they all must be reviewed in a defined time frame. And yes, it is required to document the inputs (I am getting there right away…) and the outputs (I will be there right after the inputs…)

ISO 13485 Management responsibility  - Management Review Inputs

Inputs the management's review are the topic and issues that the management must refer to when conducting a management review.  This list of inputs is a direct outcome of a management system. The list involves control aspect of the quality management system with topics that requires management's interference and decision

The inputs are the information and data required for review during the management review. These inputs are actually the outcomes and effects of your quality management system.
As mentioned, the inputs shall include:
The audits' results; internal, external, and customer's audits. The review shall refer to failures as well as successes. Remember to always point out where your organizations succeed in achieving the Standard requirements and not only the rejections. By that, you may try to "duplicate" successes.

Customer's feedback – may include customer's complaints as well as customers' satisfaction survey.  The ISO 13485 Standard gives a lower scale to the customers' satisfaction but more whether the organization met the customer and regulatory requirements. So try to find a way to measure that. More on that subject in the relevant articles…
Processes' conformance and products' conformity –the information shall Include data about the processes, quality of products and nonconformities regarding the process and the medical devices. In other words, evaluate your processes in comparison with your objectives.
The status of the corrective and preventive actions (CAPA); the corrective and preventive actions which were initiated throughout the organization. In particular, you shall relate to the effectiveness of the corrective and preventive actions,
Follow ups from previous reviews – what was decided, what was executed and what was left aside or turned down. As well, examine whether the decisions were effective and reached their objectives. At this point some people may try to bury themselves in their chair…
Any change that might affect the quality management system – if any changes occur in the quality management system, examine whether the change had an effect on the medical device (the product).
Recommendation for improvements – If someone have some suggestions, this is the time propose them.
New or revised regulatory requirements - Same as mentioned before, the ISO 13485 Standard gives a large (almost massive) scale to regulatory requirements. It is found throughout the standard's requirements. The top management is required to review any new or revised regulatory requirements that are relevant to the organization. The top management is required to review whether these new requirements may have an effect on the quality management system and its components (products, processes, procedures, work instructions, trainings etc.)

ISO 13485 Management responsibility  - Management Review Outputs

After any "ISO kind of" meeting, plenary session, parliamentary session, or conference there are supposed to be outputs. Management review is included under this definition and requirement.  What the outputs shall are required? Here the ISO standard is very clear about the outputs. There are no surprises or unexpected matters. 

Bottom line, the outputs are decisions for actions made by the top management after reviewing data and information regarding the quality management system (the management's review inputs). These actions shall relate and include the next issues:
The effectiveness of the quality management system must be under continual improvement. As mentioned before, the ISO 13485 Standard requires the effectiveness of the quality management system would be maintained. Therefore the top management must regard the maintenance during the management review and when decisions are made – document them and perform follow-ups.
Improvements in products and processes. The improvements shall increase the competence of the medical devices to the regulatory requirements, and therefore would increase customer's satisfaction (according to the ISO 13485 Standard doctrine).
Resources required and approved by the top management in order to obtain improvements and achieve quality objectives. 

View the next articles about the ISO 13485 Resource Management requirement