4.2.3

2
Purpose: The Document Control procedure is in place to store internal and external information relevant to product quality. Scope: This procedure covers documents related to the (product) and (product). Definitions: ECN/R – Engineering Change Request/Notice (see attached form) Responsibility: Document Control is the responsibility of the Quality Manager. Procedure: All controlled documents are given a unique name and number to identify them. All internal documentation is controlled in electronic form, and available on company computers. Documents are made available at point of use to relevant employees by their respective department head. Inputs for creation of a controlled document or changes to an existing document may come from any employee in the form of an ECR. ECR’s are submitted on a standard form to the Document Control Specialist. Weekly meetings are held as necessary for the review and approval of ECN’s. All relevant employees must sign off on new or changed documents. It is the responsibility of each department head to inform their employees of changes and to ensure point of use documents are up to date.

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Page 1: 4.2.3

Purpose:The Document Control procedure is in place to store internal and external information relevant to product quality.

Scope:This procedure covers documents related to the (product) and (product).

Definitions:ECN/R – Engineering Change Request/Notice (see attached form)

Responsibility:Document Control is the responsibility of the Quality Manager.

Procedure: All controlled documents are given a unique name and number to identify them. All internal documentation is controlled in electronic form, and available on company computers. Documents are made available at point of use to relevant employees by their respective department head.

Inputs for creation of a controlled document or changes to an existing document may come from any employee in the form of an ECR. ECR’s are submitted on a standard form to the Document Control Specialist. Weekly meetings are held as necessary for the review and approval of ECN’s. All relevant employees must sign off on new or changed documents. It is the responsibility of each department head to inform their employees of changes and to ensure point of use documents are up to date.

Flow:

ECRSubmitted by employee to

Document Control Specialist.

ECR Meeting

Meeting held for review and approval

of ECR's by department heads.

ECNOnce an ECR has approval from all

necessary parties it is executed and a

copy is stored elctronically.