4.2       Documentation Requirements

 

4.2.1      General

The quality management system documentation includes:

a.          documented statements of a quality policy and quality objectives (see 5.3 and 5.4.1),

b.          this quality manual,

c.          documented procedures required by the ISO 9001:2000 and AS 9100 Rev. A standards,

d.          documents needed by MII to ensure the effective planning, operation and control of its processes (see 7.0),

e.          records required by ISO 9001:2000 and AS 9100 Rev. A standards (see 4.2.4), and

f.           quality system requirements imposed by the applicable regulatory authorities (see 2.0, Scope).

 

4.2.2      Quality Manual

MII has established and maintains a quality manual that includes:

a.          the scope of the quality management system, including details of and justification for any exclusions,

Exclusions include:

·      7.3 Product Design – Mallory does not design product.

·      7.5.1.5 Control of Service Operations – Mallory does not service product.

b.          the documented procedures established for the quality management system, or reference to them (see Procedures Manual Index), and

-            when referencing the documented procedures, the relationship between the requirements of ISO 9001:2000 and AS 9100 Rev. A standards and the documented procedures shall be clearly shown.

c.          a description of the interaction between the processes of the quality management system (see Process Flow Chart below).

MALLORY INDUSTRIES PROCESS FLOW CHART

 

 

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 (Procedure P4.5, Document and Data Control) shall be established to define the controls needed:

a.          to approve documents for adequacy prior to issue,

b.          to review and update as necessary and re-approve documents,

c.          to ensure that changes and the current revision status of documents are identified,

d.          to ensure that relevant versions of applicable documents are available at points of use,

e.          to ensure that documents remain legible and readily identifiable,

f.           to ensure that documents of external origin are identified and their distribution controlled, and

g.            to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

 

MII shall coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements.

 

4.2.4      Control of Records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. The Quality Records Procedure (P4.16) shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

 

The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers. MII requests all required records from subcontractors and are filed in accordance to procedures (Purchasing P4.6).

 

Records shall be available for review by customers and regulatory authorities in accordance with contract or regulatory requirements, through the right of access clause on the purchase order.

 

4.3       Configuration Management

MII has established, documented and maintains a configuration management process appropriate to the product through the Process Control (P4.9) and Document Control procedures (P4.5).