ISO 9001:2008 Quality Manual (Section 4)
The following document includes portions for section 4 of our Ultimate Quality Manual product. It is free to use "as is" or you can purchase the complete solution in Microsoft Word format by visiting our Quality Manual product page.This document includes sections 4.
4 Quality Management System Elements
4.1 Purpose of Quality Management system and Quality System Documentation
The quality management system’s purpose is to continually improve the effectiveness and efficiency of the company’s performance by considering the needs of interested parties, most notably the needs and expectations of our customers. We strive to continually improve the above processes as well as the quality management system as a whole. By defining quality objectives and using the quality management system to meet those objectives, this improvement is achieved. Through process monitoring, and measurement where appropriate, and the analysis of data collected during such monitoring, the degree to which the quality objectives are met is determined. We continuously analyze and set quality objectives to improve our services and products, using formal processes in our quest to achieve customer satisfaction, as well as methods and techniques that foster continuous improvement and good business practices.
Control of subcontracted processing is ensured through application of the associated provisions in the Procurement and Supplier Management procedure.
4.2 Document Control
The company has developed all necessary documentation (a quality manual, quality policy, quality objectives, and operating procedures) to ensure the effective planning, operation, and control of its processes. Records are maintained as required of the Record Retention Form.
This Quality Manual contains a description of the scope of the quality management system, including justification for exclusions in Section 2. This manual references procedures that describe the sequence and interaction between the processes of the quality management system.
4.2.2 Control of documents
Our management system and all important information sources are controlled by a formal Document and Data Control procedure, which ensures that outdated or inaccurate information is not used and that appropriate information is available where it is needed. All documentation is reviewed and approved prior to use and changes to documentation are also reviewed, approved, and controlled.. Such documents are maintained in such a manner as to ensure that they remain legible, readily identifiable, and retrievable. Any such documents that become obsolete are disposed of or marked to prevent unintended use.
The Management Representative maintains a master file of all level one and level two documentation, as well as any forms. The most current version of any such document will be maintained in the master file, which will also indicate any further distribution of such documents. The Management Representative also maintains the electronic originals of such documentation.
4.2.3 Quality Records
The Company maintains quality records in order to provide evidence of conformance to requirements as well as to provide evidence of the effective operation of the quality management system. Any records defined as quality records are controlled according to the Document and Data Control procedure, with use of a Record Retention Form. Such records are detailed on the Record Retention Form, which indicates the individual responsible for the records, storage locations, indexing methods, and periods of retention. Retention periods are specified to ensure that the records are being maintained to meet specific business, client, regulatory, and quality system requirements.
Quality Records are maintained and filed in a manner that ensures that they are readily available and protected from loss, damage, and deterioration.
Hard copy records are periodically reviewed and disposed of in accordance with internal and legal retention requirements. Records are only destroyed with the authorization of the Management Representative and the President. Quality Records are retained in according with the following chart.
Record Type Retention
Part Specifications, Assembly Drawings, Bills of Materials, Standard Operation Procedures, Corrective Action Reports 10 years past last production date
All Documents regulated by an external Certifying Body including all documentation for UL, CE, CSA, ATEX and IECEx approved products. 10 Years past last production date
Routing sheets, Vendor qualification sheets, Calibration documents, Training records 2 years past last production date
Inspection Reports, Non-Conforming Materials Reports, Engineering Change Orders 5 years past last production date
Where agreed contractually or by regulations, quality records relating to a specific supplier, customer, or product are made available for evaluation by the customer, customer representative, or regulatory agency.
Associated Documents/Records for section 4:
Engineering Change Order Standard Operating Procedure, SQ00xx
Document and Data Control procedure, SQ00xx