Introduction
In this post, we will go through the main requirements associated with the management representative role taking into consideration one main standard: ISO 13485 – Medical devices — Quality management systems — Requirements for regulatory purposes.
What is a Management Representative and why is it so important?
A well-established QMS is important especially for a Medical Device company since the customers are patients. It would be unforgivable if there are some inconsistencies in the way it is performing. The situation is critical for the patient but also for the healthcare professional that is looking for guidance. A well-established QMS, based on a well written quality manual, will help you and your company and be sure that all is compliant with the requirements.
What is management responsibility and how it supports the management representative?
Management Responsibility is one of the important clauses defined in ISO 13485. This cause primarily explains;
The main titles of the clause according to ISO 13485 are listed below:
- Management commitment
- Customer focus
- Quality policy
- Planning
- Responsibility, authority, and communication
- Management review
Management commitment
This chapter should be regarded as a basis for self-evaluation of your top management’s status and its role within the quality management system regarding its commitment. In order to approve its commitment, top management will supply evidence of its actions.
- Ensuring the Effectiveness of the Quality Management System
- Communicating
- Defining a Quality Policy
- Quality objectives
- Allocation of resources
The company’s Management Policy Committee should provide evidence of its commitment to the development and implementation of the QMS and maintenance. The overall responsibility belongs to top management with the guidance and direction of the Management Representative and Management Policy Committee.
Customer focus
There are two main goals in this chapter.
- Understanding and implementing customers’ and applicable regulatory requirements
- Realizing a product that will meet customers’ and applicable regulatory requirements
The company should ensure that customers’ and applicable regulatory requirements are determined and met. Top management should plan, implement and control the two issues listed below.
- Determination of the requirements related to the product
- Implementing Feedback Activities
Quality Policy
The company should define a quality policy that will express its quality intentions regarding various issues. Management Policy Committee should ensure that the quality policy: is applicable to the purpose of the organization; includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system; provides a framework for establishing and reviewing quality objectives; is communicated and understood within the organization, and is reviewed for continuing suitability.
Planning
The Management Policy Committee ensures that quality objectives, including those needed to meet applicable regulatory requirements and requirements for the product, are established at relevant functions and levels within the organization. The quality objectives should be measurable and consistent with the quality policy. The Committee ensures that the planning of the quality management system is implemented in order to meet the requirements, as well as the quality objectives; and ensures the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Quality objectives
The purpose of the quality objective is to carry out the quality policy practically and implement it in the quality management system. By planning and implementing quality objectives a meaningful, powerful, and impressive quality policy is integrated. The real proof for implementing the policy is its translation into a set of implementable clear objectives.
Quality Management System planning
The planning should cover all the relevant aspects and areas in which the organization is active: design and development, manufacturing, logistics, sales, installation, service, and support.
Responsibility, authority, and communication
Management Policy Committee or in general the top management , should appoint a management representative who is responsible for: ensuring that processes needed for the quality management system are documented; reporting to the MPC on the effectiveness of the quality management system and any need for improvement and ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Responsibility and authority
The activities of defining authority and responsibilities generate documentation listed below:
- an organizational structure
- Job descriptions
- Identification of qualifications and training needs
- Definition of interrelations
Each document mentioned above should be submitted to the process of documents control in the organization.
Management representative
A part of the management’s responsibility is to appoint an authority that should have the task of imparting the quality policy and expectations of the top management to the organization on one hand and to receive feedback regarding the status and performance of the QMS on the other hand.
The representative might not be a Quality Manager. However, he/she must be a member of top management and shall have the authority to decide. If he/she is a Quality Manager or another role in the organization, then document the fact that he is the representative on their job description.
If he/she is an external party, you must have a document that defines the responsibilities to top management and the organization. An agreement is one of the options.
Internal communication
Management Committee should ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. The internal communication channels should be strategic and might assist in enhancing the effectiveness of processes:
- ERP (Enterprise Resource Planning)
- BPM (Bussiness Process Management)
- PLM (Product Life Cycle Management)
Conclusions
Mostly, employees embraced a true quality mindset that was not supported by top management. Top management sets the tone with respect to your company’s vision and the importance of quality. Top management should support the management representative, Management Policy Committee. True quality has to be part of the culture. The moment top management loses the approach of true quality, it becomes difficult to reestablish.
In conclusion, we have been through the main requirements associated with the role of the management representative, Management Policy Committee, and top management and related topics. Specifically, we went through the requirements associated with ISO 13485.
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