Responsibility of management against QMS

Management Resposibility

Senior management is responsible for assigning a management representative to develop and maintain the QMS, acting as representative in all issues concerning quality.

Conflicts of interest should be avoided, and the management representative shall be given sufficient authority.

The necessary resources shall be available to the management representative, and the responsibilities placed on any one individual shall not be so extensive as to present any risk to product quality.

Senior management should ensure:

• The QMS takes into account all applicable guidelines and regulations
• Management reviews are performed on a regular basis
• The quality manual, quality policies, and quality objectives are all in place
• Job descriptions, responsibilities, and authorities are clearly understood within the organization
• All necessary resources are provided
• Communication flows are timely within the organization and the supply chain

Quality Management System Planning

The organization should take into account applicable regulatory requirements, the size of the company, the complexity of materials and products, and other critical activities when developing the QMS structure.

The QMS should be designed to maintain its robustness, even when changes occur. The quality policy, quality objectives, and quality risk management are essential in
developing a QMS and should be defined by senior management.

An appropriate QMS should include, but is not limited to:

• An organizational structure capable of supporting the elements of the quality policy and quality objectives 
• Written policies, procedures, records, and agreements that can demonstrate how materials, products, and services will meet established quality specifications 
• Qualification monitoring and review of outsourced activities 
• Competence development of personnel through training and promoting awareness of individual job impact on quality 
• Deviations and complaints handling Continuous improvement through corrective action and preventative action (CAPA), audits, and management reviews, and QMS planning and commitment

Communication   

The organization should establish communication channels that ensure the timely flow of information within the organization and to supply chain partners. 

Customers should be notified of any changes in packaging, handling, storage, transportation, or documentation (e.g., material safety data sheets or labels). 

Communication within the supply chain should be coordinated to determine proper timing of transported and received products, taking into account holiday schedules, weekends, and other interruptions.