Main responsibilities of the person in charge of laboratory quality of the "inspection and testing institution"
Date:2022-04-27 14:02:17Views:1052
The criteria for accreditation and review of laboratory qualification stipulates: "the laboratory shall appoint a quality director (or quality director), whose main responsibility is to be responsible for the establishment and effective operation of the" documented "quality management system. It should be given the responsibility and power to ensure the effective operation of the quality management system at any time, so as to make decisions and solve the problems existing in the quality management system ". The person in charge of laboratory quality is authorized by the top management of the company to fully perform the healthy operation of the company's quality management system.
1、 Requirements of the approval criteria for the person in charge of quality
1.5. As for the establishment of the quality policy and the allocation of resources by the principal, i.e. the awareness of the total person in charge of the quality policy and the management of the laboratory should be fully met in the process of establishing the quality policy and the allocation of resources.
The quality director is mainly responsible for the quality management during the operation of the laboratory, including the establishment, implementation and continuous improvement of the laboratory quality management system, the preparation of quality manuals and procedure documents, and the reporting of the performance and improvement needs of the quality management system to the top leadership.
In addition, the more important responsibility is to be responsible for the internal quality review of the laboratory and assist the top leaders of the laboratory to complete the management review of the laboratory. Therefore, the person in charge of quality is required to meet the requirements of the code in terms of qualification, ability and experience. The internal auditors of the laboratory should be qualified to ensure the normal operation of the internal audit of the laboratory.
2、 Responsibilities of the person in charge of quality
The quality management system of the laboratory covers all testing or calibration work of the laboratory and the equipment, facilities, environmental conditions, personnel, methods and places involved in the work. As the person in charge of quality, he shall prepare the system documents and relevant management documents of the laboratory according to the actual situation and development direction of the laboratory.
The quality management system documents shall be conducive to providing unified requirements and procedures for the activities carried out by the laboratory; It shall be ensured that all activities are recorded as an objective basis to help the quality of the laboratory be traceable.
The person in charge of quality shall be fully responsible for the quality management of the laboratory, and urge the quality supervisor to supervise and record the quality of each test.
1. Responsibilities of the person in charge of quality
Be responsible for the quality work of the laboratory, and organize the preparation and revision of quality manual and procedure documents;
Organize the establishment and operation of laboratory management system, prepare internal audit plan and audit report, appoint internal auditors and organize the implementation of internal audit;
Organize the control of nonconformities, and track and verify the implementation of corrective measures;
Organize the handling of the client's handling opinions and quality accidents in the testing work;
Participate in the management review, prepare the management review plan and report and organize the implementation;
Approve the format of management quality records;
Be responsible for accepting the complaints of the entrusting party and organizing the handling of the complaints;
You can apply to become an authorized signatory and issue test reports.
2. Implement the requirements of quality system documents
Quality system document is the internal law of laboratory quality management, which is normative and systematic. The person in charge of quality shall assist the top leader of the laboratory to make all staff seriously implement the quality documents. For the defects or errors in the system documents, they can be changed according to the modification requirements of the procedure documents, and strive to achieve "two unification", that is, the requirements of the procedure documents are unified with the actual equipment level, and the standard implementation procedures are unified with the laboratory operation mechanism.
3. Promote continuous improvement of quality system
If the operation of the laboratory quality system is just a formality, there is no intention to really implement the laboratory accreditation criteria, but only to obtain a certificate of "Laboratory Accreditation", then the work of the laboratory quality system is false and empty. Therefore, it is required that continuous improvement must be carried out during the operation of the laboratory system, and the person in charge of quality shall comprehensively supervise and urge the work of continuous improvement. Take corrective or preventive measures in time for the problems existing or found in the operation of the quality system. The person in charge of quality shall comprehensively track the implementation and completion of corrective and preventive measures. In addition, it should be noted that the person in charge of quality is different from the person in charge of technology. There can be more than one person in charge of technology and one person in charge of quality.
In conclusion, the person in charge of quality is an important and non negligible position in the company's organization. The person in charge of quality only has professional level, personal quality and management experience. At the same time, he should be in place and not offside in his usual work post; Only in this way can the person in charge of quality play a unique role in the testing organization, make the company's quality management system operate healthily and stably, and truly be the person in charge of quality in the testing organization.