ISO 13485 Standard Management Responsibility Requirements - Responsibility and Authority

 First of all relax. Take a deep breath. I will uncover this mess of requirements. Actually it is quite simple. The organization is required to maintain an organizational structure that describes specifically all the parties within the quality management system. It is not required to be documented, but never the less, document it.  So far, so good. The next requirement is to define the interrelations between the functions. Who reports to whom what and how? Regarding the product, of course. The employees are required to know their responsibilities and authorities regarding the realization process. So, introduce it to them. At least once… the employees do not have to learn it by heart, but they are required to be familiar with the definitions.
This requirement may be achieved throughout several ways. The best way to achieve it is by documenting it: work instructions, procedures, job descriptions etc. It is not a standard requirement to document it, actually, but I highly recommend it.
In some cases, there are some regulatory requirements for specific personnel. When such requirements exist, the top management would have to ensure that these personnel are hired as required.

ISO 13485 Standard Management Responsibility Requirements - Management Representative

The ISO Standard (9001 and 13485) requires that the management representative would be a member of the top management. It is recommended that he representative would have the appropriate background and knowledge relevant to the area of the medical devices produced. His main task (throughout the quality management system) is to examine and report to the top management whether the main processes of the quality management system are achieved according to the requirements.  Which main processes? The ones defined throughout the quality manual. The ones are relevant to the product. There is no exact requirement regarding the reports intervals. They may occur during the management review or as periodical reports.

Another role for the management representative is to promote the awareness of the employees regarding regulatory requirements and customers' requirements.

In cases when the management representative is not the quality manager, it is required to define the relations and application between the two.

The only additional requirement in this paragraph is the promotion of regulatory requirements as well as customers' requirements. As mentioned before and would be mentioned in the future, the ISO 13485 Standard give a large scale to regulatory requirements. It is found throughout the standard requirements. In this paragraph, the top management's representative is required, other than promoting the awareness of customers' requirements,   to promote any regulatory requirements that are relevant to the organization. For example, when the organization is manufacturing under safety requirements dictated by the government, the top management representative is responsible to promote these requirements. He is also responsible to promote new regulations and requirements that are published and are relevant to the organization. How shall he promote? The promotion might be with training, publications, distributing information etc. Whatever is appropriate for your organization. 

ISO 13485 Standard Management Responsibility Requirements - Internal Communication

Sounds simple? It is, but...

The organization must determine (during the planning of the quality management system) the internal communication channels between the top management and the employees. The communication channel shall be in two-ways:

• The management shall report the employees throughout brochures, pamphlets, E-mails, meetings etc. information regarding the effectiveness of the quality management system: quality objective status, customer's complaints, rejections from audits (internal and external) and operational instructions regarding the product and the realization process.  
• Another communication channel shall be established from the employee and the management. The employee shall know to whom he must report when problems arouse or suggestions for improvements. The employee shall know who the responsible parties above him (the organizational structure) and who is authorize to give him instructions.

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