ISO 9001:2000 Quality System Manual

ISO 9001:2000 Quality System Manual

PSM BrownCo

ISO 9001:2000 Quality System Manual
Section 4.2 – Document Requirements
Revision #: 2 Date: May 23, 2003
Issued by: JB Approved by: DB

POLICY OBJECTIVES

The scope of the PSM BrownCo quality management system documentation is defined. Establishment and revision of documents, and their distribution, are controlled. New documents and revisions are reviewed and approved prior to issue; and are identified with respect to their revision level. Appropriate documents are available at locations where they are used. Obsolete documents are removed from points of use. Documents of external origin are identified and their distribution is controlled.

Quality records are identified and indexed to facilitate their retrieval, and are stored in a suitable environment to minimize deterioration. To the extent possible to allow maximum access to applicable documents at all levels of production and administration, PSM BrownCo utilizes the ISOWEBS electronic document control system for storage of manuals, procedures, forms, and documents, as well as a single master copy on file for quality system documentation and history. Quality records are retained for a period of time determined by corporate policies, lifetime of product, the event to which the record pertains, or regulatory and contractual requirements. Documentation for quality records identifies the responsible function, location, and minimum retention.

POLICY

1.Scope <4.2.1>

1.1 The PSM BrownCo quality management system documentation comprises the following types of documents:

  • The Quality System Manual, including a documented quality policy and documented statements of quality objectives;
  • Quality system procedures;
  • Work instructions;
  • Quality forms, which are used to record, maintain and create the records required by the quality system;
  • Quality records;
  • Standards and other technical reference materials;
  • Product realization and control documents such as contracts, customer order requirements, production routers, etc.

The purpose, scope, and responsibility for controlling various types of documents are defined in Quality System Procedure QSP 42-01, Quality System Documentation.

2.Quality System Manual <4.2.2>

2.1 The top-level document defining the overall quality management system is the Quality System Manual. It sets forth the overall management commitment to our quality management system and includes:

  • The scope of the quality management system, including details of and justification for any exclusions (refer to Section 0.3);
  • The PSM BrownCo quality policy as well as other specific policies related to particular elements of the quality management system;
  • Statements of quality objectives;
  • References to documented procedures;
  • A description of and reference to our quality management system processes, their sequence, and interrelation.

3.Document control <4.2.3>

3.1 PSM BrownCo primarily uses electronic documentation, through the ISOWEBS on-line quality management system. This is defined in Quality System Procedure QSP 42-02, Control of Documents. The employee assigned the responsibility for document control keeps a master file for each controlled document.

3.2 New documents and document changes may be recommended and initiated by anyone in the organization, but may only be issued and approved by an authorized function. The authorized functions and the rules governing the issue of documents are defined in procedures QSP 42-01, Quality System Documentation, and QSP 42-02, Control of Documents. All documents are reviewed and approved prior to issue.

3.3 An electronic document is issued by being placed on the ISOWEBS quality management system, accessible from the network. All paper documents, including procedures, work instructions, forms, etc. are officially issued for use when approved by the Management Representative or the Plant Manager. Copies of documents that display the 24-hour footer may be printed but are considered to be controlled documents for only 24 hours following their printing. Paper documents may be posted at workstations and utilized by employees, as long as the most current revision is posted.

3.4 Documents are distributed to personnel and locations where they are used. If hard copies are ever issued, the documents will display a distribution list. Electronic documents are available on the network and are accessible at relevant terminals and computers, or through a supervisory employee with access to the network. Quality System Procedure QSP 42-02 regulates document availability.

3.5 Obsolete documents are removed from points of use. Retained masters or copies of obsolete documents are properly marked and are kept separate from active documents. Obsolete electronic documents are removed from the network and, if retained, are stored in directories that are only accessible to authorized personnel.

3.6 Document changes are reviewed and authorized by the same function that issued the original document. For electronic documents, only the latest issue and revision of a document is available on the network.

4.Control of quality records <4.2.4>

4.1 Quality records are established and maintained to provide evidence that:

  • Materials, components, and production processes meet specified requirements;
  • Finished products conform to specifications; and
  • The quality system is operated in accordance with documented procedures and that it is effective.
  • Where required, quality records also include traceability information.
  • Records are established by personnel performing the task, operation, or activity the results of which need to be recorded. Records are legible; and identify the product, person, or event to which they pertain. Records may be in the form of any type of media.
  • Records are indexed and grouped to facilitate their retrieval.
  • Records are normally stored by the same department that initially established the record. Records are stored in dry and clean areas, and electronic records are regularly backed up.
  • Retention periods for quality records are determined on the basis the lifetime of the product or the event to which the record pertains, regulatory and contractual requirements, or corporate policies.
  • Retention times for records, the location of records and the employee responsible for maintaining the records are indicated on the Forms and Records Master List (QF 00).
  • If contractually required, quality records are made available to our customer or customer’s representative as provided for within the contract.
  • Quality System Procedure QSP 42-03, Control of Quality Records defines the method for maintaining quality system records. Following expiration, the documents may be disposed of in a manner to ensure their removal from the system.

ASSOCIATED DOCUMENTS

  • Quality System Procedure QSP 42-01: Quality System Documentation
  • Quality System Procedure QSP 42-02: Control of Documents
  • Quality System Procedure QSP 42-03: Control of Quality Records

QSM 4.2 Document Requirements

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