Documented information is the carrier of quality management system. The establishment of documented information system in science and technology quality management system in colleges and universities can effectively implement the quality management system.
Key words quality management system; scientific research management; Higher education management
- Introduction
Scientific research is the main function of colleges and universities, and the quality of scientific research is an important evaluation index to test the performance of scientific research function in colleges and universities. The introduction of quality management system into scientific research in colleges and universities is conducive to the improvement of the quality of scientific research achievements and the efficiency of scientific research management process. It is one of the effective means for the reform of scientific and technological quality management system in colleges and universities. It is also conducive to the continuous improvement of scientific research work in colleges and universities and the continuous satisfaction of customers' requirements and expectations, so that the scientific research management work in colleges and universities can achieve leapfrog development and move towards standardization.
- Composition of documented information
The establishment of quality management system depends on documented information. According to the definition of ISO 9000–2015 quality management system basis and terminology, documented information refers to the information and its carrier that the organization needs to control and maintain. The documented information has no restriction on the carrier and format, and can come from any source, mainly consisting of three parts:
a) The management system (including relevant processes) is a set of elements in the process of establishing quality policies and objectives and realizing them. It specifies the structure, post responsibilities, planning, operation, policies, practices, rules, concepts, objectives of the organization and the process of realizing the objectives. These elements usually need to be grasped and controlled by the top management of the organization. The organization usually implements them in the form of issuing quality manual and organizational documents, and monitors and reviews them regularly to ensure the continuous suitability and keep consistent with the strategic direction of the organization.
b) The information generated for the operation of the organization is reflected in a set of documents, usually in two forms:
1) Procedure documents, rules and regulations are usually implemented at the organizational level and generally cross parts.
2) Specification: operation instruction, operation specification, drawing, etc. are usually implemented at the organizational unit level (quality manual and procedure documents are also specification documents, but are generally listed separately as organization level documents).
c) The evidence of the realization of the results is embodied in various records of the system operation process, which can realize the trace ability of the system operation process.
Table 1
List covered in the documented information system of science and technology quality management system in colleges and universities.
|
Documented information |
Content covered |
|
Quality manual |
organization profile, organization structure, issuing order, scope of application, organization vision, quality policy, medium and long term objectives, quality management process established by the organization in accordance with the requirements of quality management system and its operation form, realization process of products and services, quality assurance process and function allocation of the organization |
|
Program file |
Organizational environment management, related party management, risk and opportunity response, human resource management (including personnel ability, awareness and training), infrastructure management (including equipment), work environment management, monitoring and measuring equipment management, organizational knowledge management, communication process, documented information management, quality information management, operation management (quality plan requirements), and products and services Requirements management, design and development management, design and development management, procurement management (including outsourcing management), production and service provision process management (including development process management), release management (process inspection, final acceptance), non conformity management, process monitoring, internal audit, management review, system improvement management |
|
Other specifications |
product specifications, design specifications, drawings, operation instructions, etc |
|
Quality record |
system operation process record |
- Management requirements for documented information
a) Creation and update of documented information
1) All documented information shall have identification and description (such as title, date, author, index number).
2) The form of documented information can be language, chart or software version, and it can be paper or electronic.
3) Before the document is released, the authorized personnel shall review and approve its adequacy and suitability. If the document is unsuitable after implementation, the document issuing department shall organize to revise and review the original document, and the changed document shall be approved again.
b) Control of documentedinformation
Control the documented information of the quality management system to ensure that:
1) Available and applicable when necessary. The document distribution department shall keep the document distribution records, and the controlled documents shall be marked with the controlled documents, so as to ensure that the appropriate and effective versions of the documents are available at the place of use.
2) It shall be properly protected (such as preventing leakage, improper use or missing). Each document department shall designate a special person to manage the implementation, distribution, recovery and storage of documents, establish a list of document directories, and be responsible for the identification of document change status, so as to prevent the improper use of invalid or obsolete documents.
c) Record management
As the documented information to be retained, quality records shall not only implement the relevant control requirements of the above documented information, but also:
1) The records are complete and traceable. The quality records must be filled in truthfully, accurately and timely, the filled items shall be complete, the signature date, etc. shall not be omitted, no space shall be left, the handwriting shall be clear, neat and not scrawled.
2) The storage and protection of records shall ensure that the environment is suitable to prevent damage, loss and deterioration. The quality records of external documents shall be collected, kept and filed by the centralized management department.
3) The printing of «quality record format» and the reproduction, destruction and disposal of quality records shall be approved and recorded by the competent leader.
Acknowledgements This work is supported by the project Research on the Construction of Science and Technology Quality Management System in Colleges and Universities provided by Education Science Planning Subject in Jilin Province of China under grant number GH16125.
References:
- ISO 9001:2015 Quality management systems —Requirements.
- Jia Baoshan, Wu Shufang. Study on GJB 9001B-2009 quality management system process monitoring and measurement, Morden Business Trade Industry, 2014, 19,195.
