1General requirements of quality management system

Xingye Leather Technology Co., Ltd. has established a quality management system in accordance with ISO9001: 2000 standards. The development, implementation and maintenance of various activities affecting the quality have been orderly arranged and documented, which should be implemented, maintained and continuously improved. The following requirements should be strictly fulfilled:
1.1 The company identifies the processes required by the quality system and prepares corresponding program documents. The process can be a large process from the recognition of customer needs to customer evaluation, or can also be a sub process of specific quality activities.
1.2 The method of process control and the mutual sequence and interface relationship between processes should be defined, while the processes should be managed through identification, determination, monitoring, measurement and analysis.
1.3 The purpose of process management is to implement the quality management system and to achieve the quality policy and objectives of the organization.
1.4 The monitoring, measurement and analysis of the process and the adoption of improvement measures are aimed at achieving the planned results and undertaking continuous improvements.

2The requirements of quality system documents

2.1 General principles
Xingye Leather Technology Co., Ltd. expresses the quality management system and the control requirements for various activities through the following documents, so that all processes can be under control.
a) Quality Manual: including quality policy and quality objectives.
b) Program document: In addition to the control program of document control, record control, nonconforming product control, corrective action, preventive action required by the standard, the program document required by the management and operation of the company is also included.
c) Operational document: including specifications, regulations and plans, which constitutes a part of quality manual and program document.
d) Records: records of all quality activities carried out by the company.

2.2 Quality Manual
a) In order to stipulate the quality management system of the company, the Quality Manual is specially compiled.
b) The Quality Manual is organized and compiled by the management representative and implemented after the approval of the general manager, which serves as the program of all activities to achieve the quality policy and quality objectives of the company.
c) The main functional departments, responsibilities, control points of the activities, and the main relationship between the management processes of the quality management system are specified and elaborated in each chapter of the Quality Manual. More specific control requirements and the relationship between the processes shall be clarified if documents are needed, and these documents are given by reference.
d) As a part of the company’s total quality management system documents, the Quality Manual shall be controlled in the same way as that of other quality management system documents. For details, please refer to “Document Control” in the next section.

2.3 Document Control
Documents must be controlled in order to convey correct information and ensure the effectiveness of activities within the quality management system. The scope of document control includes an appropriate range of external documents in addition to the Quality Manual, program documents and the referenced documents prepared by the company. As a special type of document, the control requirements of the formed records are specified in “Record Control”. The document management group is the main functional department of document control in the company.
The company has formulated the Document Control Program, which not only clarifies the responsibilities of various control activities, but also formulates specific control measures to achieve effective control of documents. The main points of document control are as follows:
a) All the quality management system documents shall be approved by the authorizer before release, and shall be reviewed by the executive functional department and relevant departments before approval to ensure their adequacy and appropriateness.
b) When the document is found to be inapplicable after the release and in each internal audit, or when there are changes in the scope of the quality management system, customer requirements, laws, regulations and standards, the organizational structure of the company, and the distribution of departmental functions, the document shall be reviewed. If necessary, the document shall be revised in accordance with the results of the review and be issued again with the approval of authorizer.
c) Through the version status, seal and other marks on the document, the changes and the current revision status of the document can be correctly identified.
d) The list of document distribution should be prepared or the distribution scope should be specified in the document, according to which the document will be released and recovered, so that all the documents needed within the scope of quality management can obtain the applicable documents in the relevant version.
e) The preparation of similar documents shall apply the uniform format for identification. For the sake of orderly document management, the list or catalog of the document shall be prepared and the document shall be properly kept to keep it clear and easy to identify.
f) For applicable external documents, The List of External Documents shall be prepared to determine whether to distribute and to track their revision status. When distribution is required, it is the same as article b.
g) All the obsolete documents in the company shall be recovered to prevent misuse and those need to be destroyed shall be disposed according to the specified requirements. When the obsolete documents have preservation values or need to be preserved for legal purposes, they should be clearly marked in accordance with the prescribed method to distinguish them from valid documents.

2.4 Record Control
In order to provide evidence for the conformance to requirements and the effective operation of the system, records must be controlled so that the records required by the quality management system can be correctly formed and maintained. The scope of record control includes all records required by the quality management system, whether require formatting or not, and regardless of the use of any type of media. The records shall be kept by those who are responsible for record taking in all departments of the company, while the records for more than one year shall be checked and managed by the document management group.
The company has formulated the Record Control Program to control records, which shall meet the following requirements:
a) The List of Quality Records shall be prepared to clearly specify the departments that form, transfer and preserve records and the retention period. The relevant departments shall, in accordance with the responsibilities stipulated in the documents, form and maintain the records of corresponding activities as stipulated.
b) Records with format requirements shall be filled in according to format requirements, while the records without format requirements shall be given in the form specified in corresponding documents, so as to be complete, accurate and clear.
c) The records shall be numbered, catalogued and placed by category so that they can be easily recognized and retrieved.
d) Records shall be stored in an appropriate environment with clear storage responsibilities to prevent damage and loss.
e) Records that exceed the retention period shall be disposed. Confirmation shall be made before destroying records to prevent mis-destruction.