Quality management system
Determine the general requirements for establishing, implementing,
and maintaining a quality management system and the general requirements
for document management.
Applicable to the management of our company's quality management
system and documents.
3.1 General Manager
1) Responsible for the establishment, implementation and maintenance of
the leadership quality management system;
2) Approved quality manuals and quality guidelines and quality
3.2 Management representative
1) ensure the establishment, implementation and maintenance of the
processes required for the quality management system;
2) Report to the general manager the performance of the quality
management system and any improvement needs;
3) Ensure that our company meets the formation and improvement of
4) External liaison on matters related to the quality management system.
1) Responsible for the normal operation of the quality management
2) Responsible for the management of quality management system
4 Program Overview
4.1 General requirements for quality management systems
Our company has established a quality management system based on the
company's actual management requirements and ISO9001:2008 requirements,
formed appropriate documents, implemented and maintained, and evaluated
its effectiveness, suitability and adequacy, and continued to improve.
To this end, our company should meet the following requirements:
1) Determine the processes required for the quality management
system and prepare corresponding documents. These processes include
management activities, resource management, product and service
implementation and monitoring, measurement and improvement of large
processes, and sub-processes of quality activities.
2) Determine the sequence of processes and their inter-interface
relationships, ensure input, output and required resources, information,
and develop control methods and guidelines to support the operation of
the process and monitor the process.
3) Manage the process through identification, monitoring, measurement
and analysis, and use the various methods including statistical methods
to obtain the necessary information to achieve continuous improvement.
4) At present, the transportation process of some of our products is
outsourced. Implement control in accordance with Clause 7.4 of this
manual, sign the transportation agreement, and clarify the control
requirements. The type and extent of outsourcing process control can be
affected by the potential impact of the outsourcing process on the
company's ability to provide products that meet the requirements, the
degree of sharing of outsourced process control, etc., to ensure control
of the outsourcing process, and does not exempt it from meeting customer
and legal requirements. Responsibility.
4.2 General requirements for quality management system documentation
4.2.1 Our company forms system documents according to the requirements
of the quality management system, and implements and continuously
improves to ensure the effective operation of the system.
4.2.2 My company's quality management system document structure
1) Quality Manual (including quality policy and quality objectives and
procedures). The scope of the quality management system coverage and the
description of the deletion; the quality management system procedures
that form the document; the interaction between the quality management
2) Manage files. Common implementation rules for the quality management
system of each post, such as various management systems, quality
records, and foreign documents.
4.2.3 The quality management system documents should be compatible with
the actual management of our company, and have operability, and should
be reviewed regularly for their effectiveness, suitability and adequacy.
Execute the File Control Program.
4.2.4 The quality management system documentation determines the
quantity and level of detail based on the size of the company and the
type of activity, the complexity of the process and its interactions,
and the capabilities of the personnel.
4.2.5 The carrier of the file is paper, or it can be a disk or a
picture, etc., and it should be effectively controlled.
4.2.6 Records established to provide evidence of compliance with the
requirements and effective operation of the quality management system
shall be controlled. The Record Control Procedure is prepared to define
the controls required for the identification, storage, protection,
retrieval, retention and disposal of records.
Records should be kept clear, easy to identify and retrieve.
4.3 To ensure the above requirements, the following procedure documents
are specially formulated:
4.1 File Control Program
4.2 Record Control Program