Implementation of management responsibility process in ISO 9001, this method provides basic guidance for effectively implementation of process to define management responsibility in ISO 9001 quality system requirements.
(1) Role of Management in Quality objective
The management team must ensure that the quality objectives may include in those requirements to meet the specifications of product. The product establish at relevant functions and levels within the organization. You have to sure that the quality objectives are measurable and consistent with quality policy.
Top management should ensure that the quality objectives:
- Is appropriate to the purpose of the quality management system and organization.
- Provide a framework for establishing & reviewing quality objective i.e. key performance indicators (KPI)
- Is there communicate through display at various area and departments sharing through training and understood within the organization.
- Is there review at least once in year for continuing suitability.
Actually, there are two types of quality objectives are generally shows in the organization. First is company level objective and department level objectives. The top management should ensure that quality objectives including those requirement meeting needs of product. This article focuses the company level objective and target it the same.
(2) Management Commitment for compliance of standard requirements
Management must have committed to communicate the importance of meeting customers. As well as statutory and regulatory requirements. Generally, management is appointing management representative to communicate and performance, behalf of management. Hence the management representative is responsible for implementing the commitment by increase awareness of common requirements of customers. Some points that needs to ensure and implement accordingly:
- Make sure that, the establish a quality policy is suitable. Even and communicable at all working level in the organization.
- Ensure that the all statutory and regulatory requirements through communication channels is establish.
- Ensure that the establishment to quality objective at all level and functions within the organization.
The review evaluates current status and performance of the quality system. Initiates actions to further improvement the system. You have to define the operational procedures for the management reviews. The role in the quality system of the management is important. Due to all the resources requirements, and allocation of resources are providing for specific activities and projects.
(3) Customer Focus, pivot of quality management system
The principal objective of the quality management is to focus on the customer and in particular, on customer satisfaction. The key to achieving high customer satisfaction is an accurate determination of customer requirements. Even an effective verification that the requirements are met.
Management should ensure that the customer requirements may determine and are well understand. That can be complete through contract review, as define in standard system. The quality management system also needs to determine that the whole system end point must be customer satisfaction through quality and commitment.
(4) Establishment of quality policy
Role of management responsibility: Generally, quality policy establishes in organization by higher authority, such as director or equal ant personnel. Quality policy provides a framework for establishing specific quality objectives, and direction for the continual improvement effort. Hence the authority must ensure that the policy is appropriate to the purpose of the company and includes a commitment to comply with the requirements. Continually improve the quality effectiveness of the quality management system.
(4.1) Quality Policy review
Quality policy is post throughout the company, and its role is explain and discuss at the general orientation training provide to all employees. The quality policy may be also communicate to customers, consumers and other interested parties, as consider appropriate. Quality policy is periodically review within the framework of management reviews of the quality system. This is to ensure its continual relevance and suitability. The process for reviewing the quality policy is define in Operational Procedure, management responsibility Review.
(5) Quality system planning for quality system management implement & Responsibility
The quality objectives are establish throughout the organization to implement the quality policy. To meet requirements for products and processes. To improve quality system and quality performance quality objective is play major role. Hence the quality system planning is conduct on reviews of quality objectives to maintain the planning on track and focus on key requirements of system. Quality system processes are plan to ensure that the system is appropriate for its intend purpose, and effective and efficient.
(5.1) Quality System planning purpose
The purpose of the quality system is to:
- Achieve the quality policy.
- Ensure and demonstrate our ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.
- Ensure high level of customer satisfaction.
- Facilitate continual improvement.
The output of quality system planning is document in this quality manual, in associate operational procedures, and in other reference documents.
(5.2) Quality system planning documentation
These documents identify and define all processes of the quality system. Changes to the quality system are plan within the framework of management reviews & responsibility. These changes may be in response to changing circumstances, such as product, process, capacity, or other operational or organizational changes. Or to improve the effectiveness and efficiency of the quality system.
(6) Organization and communication
Interrelation of all personnel who manage, perform and verify work affecting quality is identify in the Organizational Chart. As well as in operational procedures and other related documents defining these activities. Management ensures that the personnel related to processes should have sufficient independence and authority to perform these tasks.
All departments and functions in the company are responsible for implementing, maintaining, and improving the quality system. Authorities and responsibilities for specific processes of the quality management system.
(7) Management Reviews
Generally, management reviews of Q.M.S management need to be done at least once a year. Schedules should be set if any technical, product or other changes need to be repeatedly reviewed.
The purpose of management reviews is to:
- Evaluate the suitability, adequacy and effectiveness of the quality system;
- Consider changes to the quality management system and to the quality policy and quality objectives; and
- Identify opportunities for improvement of the quality system, processes and products.
(7.1) Review input
Input into the management reviews consists of information and data related to quality performance of the organization. At a minimum, this includes:
- Results of audits,
- Customer feedback and complaints,
- Process performance and product conformity data,
- Status of preventive and corrective actions,
- Status of quality objectives,
- Changes that could affect the quality system,
- New or revise regulatory requirements,
- Follow the actions raised from the previous management review meeting.
- Recommendations for improvement.
Department head personnel present information as input to management review agenda at the specify frequency. Generally, there may be changes in the Management Review Input source’s previous management review, audit, customer feedback, product relevance, process performance, and status of improvement tasks and quality management system.
(7.2) Review output
Management reviews are conclude with setting new quality objectives and initiating actions to improve the quality management system, processes, and products. Results of management reviews are document in minutes of the review meeting. The minutes include improvement actions, and assign responsibilities and allocate resources for implementation of these actions. Records of the output of the management review are maintain. The review includes all the requirements specify in the international standard. The frequency of the review is define in the related document procedure.