1. WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET 56458 TOPIC 6 CH 5 ISO 13485 MANAGEMENT RESPONSIBILITY Philippe Bauwin Medical devices expert Belgium

2. 5. Management responsibility The quality management system (QMS)managing process is under the responsibilty of the management who is in charge (with the management representative) of making the system work, providing the necessary material and human ressources, defining functions and responsibilities, defining the quality policy and setting the quality objectives. The management will make sure that the personal is continuously trained and qualified.

3. 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and performance of the medical device only.

4. The management defines the quality policy based on customer, statutory and regulatory requirements, the quality objectives and defines the ressources. This strategy is communicated to the personal in a commitment letter. The evolution of this strategy is evaluated through management reviews where the management will define if needed new quality objectives and plan the resources

5. 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met (see 7.2.1 and 8.2.1). The management follows customers and market requirements and expectations through the customer process, customer enquiries,market studies, meetings with customers and professional informations and fairs. Customer requirements are examinated when receiving customer requests. The management makes sure that these requirements are understood and met. New product development procedures for example include customer feedback during development process.

6. 5.3 Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability.

7. Top management defines the adequate quality policy and communicates the necessary details to the personal. During management reviews that are planned at regular intervals the evolution of this strategy is reevaluated and new quality objectives are set and communicated to all persons in charge by all suitable means. It might also be reviewed further to unexpected events. Internal audits are made at well defined intervals to evaluate the permanent adequacy of this policy.

8. 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product[see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

9. Top management defines the quality objectives at all levels in the organisation in order to satisfy the customers and to meet the statutory and regulatory requirements. These objectives are defined during management reviews and evaluated according to quality indicators such as numbers of non-conforming products, customer reactions or complaints in order to identify possible improvements.

10. 5.4.2 Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

11. QMS planning is decided and put in place during management reviews or further to any event requiring an improvement plan of the organisation. The management defines and monitors any improvement plan decided in management review. Any change of the QMS system is planned or endorsed (in case of unexpected situation) in management review. These changes are formalised in the management review reports in order to make a follow-up. It is verified that the changes don't affect the functioning of the QMS system.

12. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. Responsibility and authority are generally documented in the relevant procedures and in the function descriptions Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks. It is important that quality personal has the necessary independence and authority and sufficient time to perform his tasks

13. NOTE National or regional regulations might require the nomination of specific persons as responsible for activities related to monitoring experience from the post-production stage and reporting adverse events (see 8.2.1 and 8.5.1). This is the case for example for vigilance in some countries

14. 5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement (see 8.5), and c) ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.

15. The management representative should have full independence and authority for the following tasks : general quality management QMS monitoring and quality problems solving Measuring and customer satisfaction follow-up The management representative participates in the implementation of the Quality Policy and ensures customers quality requirements satisfaction. Therefore he has the organisational independency to solve matters related to QMS

16. He makes sure that the organisation is aware of the regulatory and customers requirements (for example through an updating procedure of these requirements) He must have sufficient time, irrespective of other responsibilities, to perform these tasks NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. For example : the competent authorities, the notified body or external auditors as decided by top management

17. 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. The management will choose means that are adequate for the organisation and the informations that need to be communicated : for example quality policy and objectives management reviews reports, non conforming products evolution charts or others.

18. 5.6 Management review 5.6.1 General Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained

19. The objective of a management review is to give an opportunity to modify the quality policy, to define new quality objectives or to introduce improvements. It needs to be done at the specified intervals. The points that are examined are described in the relevant procedure.

20. 5.6.2 Review input The input to management review shall include information on a) results of audits, including internal audits and audits by notified bodies and authorities b) customer feedback, sometimes difficult to obtain but necessary c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, g) recommendations for improvement, and h) new or revised regulatory requirements. (a follow-up at defined intervals is needed)

21. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvements needed to maintain the effectiveness of the quality management system and its processes, For example new production or quality control procedures b) improvement of product related to customer requirements, For example new products development and c) resource needs. For example new personnel or equipment