Quality Manual

4. Quality Management System

June 6, 2006; Issue 1

4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records

4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall

1. identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
2. determine the sequence and interaction of these processes,
3. determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
4. ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
5. monitor, measure and analyze these processes, and
6. implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

NOTE. Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

The company has prepared and published a Quality Manual.

The Quality Manual addresses all areas of the ISO9001: 2000 standard and is a description of the Company's Quality Assurance Policies.

4.1 General requirements

Management has identified the processes to be included in the management system, which is described in the Quality Manual.

Management ensures there are sufficient resources to ensure the satisfactory completion of these processes.

Management sets goal and targets for these processes and monitors and analyzes the results achieved. Actions are taken to achieve the planned results and continually improve the processes.

The company controls the outsourcing of any process that affects the product conformity by specifying purchasing requirements for products and services.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include

1. documented statements of a quality policy and quality objectives,
2. a quality manual,
3. documented procedures required by this International Standard
4. documents needed by the organization to ensure the effective planning, operation and control of its processes, and
5. records required by this International Standard (see 4.2.4).

NOTE 1 where the term "documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

1. the size or organization and type of activities,
2. the complexity of processes and their interactions, and
3. the competence of personnel.

NOTE 3 The documentation can be in any form or type of medium.

4.2 Documentation requirements

4.2.1 General

The company has issued a Quality Policy, which includes quality objectives.
The company has issued procedures and work instructions and other quality documents to adequately implement the company's Quality Manual and policies. (QSP-0424)

4.2.2 Quality manual

The organizations shall establish and maintain a quality manual that includes

1. the scope of the quality management system, including details of and justification for any exclusions (see 1.2).
2. the documented procedures established for the quality management system, or reference to them, and
3. a description of the interaction between the processes of the quality management system.

4.2.2 Quality manual

The Company's Quality Manual details the justification of exclusions to the ISO9001:2000 standard and references documented procedures in the quality management system.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed

1. to approve documents for adequacy prior to issue,
2. to review and update as necessary and re-approve documents,
3. to ensure that changes and the current revision status of documents are identified,
4. to ensure that relevant versions of applicable documents are available at points of use,
5. to ensure that documents remain legible and readily identifiable
6. to ensure that documents of external origin are identified and their distribution controlled, and
7. to prevent the unintended use of obsolete documents, and to apply suitable identifications to them if they are retained for any purpose.

4.2.3 Control of documents

The company has issued procedures for controlling documents that support the quality system.

Preparation, approval, and issue of quality documents are controlled, including regular review status and master document index. (QSP-0423}

4.2.4 Control of records

4.2.4 Control of records

The company has established firm rules and procedures for retaining quality records. The procedures detail routines for retention, storage, identification, filing, maintenance, access and disposal of quality records.

Adequate facilities are made available to protect the condition and legibility of the records. (QSP-0424)