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Configuration Management Guidelines and Kit Product Image

Configuration Management Guidelines and Kit

  • ID: 2110023
  • January 2011
  • Quality Control Systems & Services

The new AS 9100C-2009 Aerospace Quality Management System Standard requires a process that describes methods and procedures to comply with Configuration Management requirements under clause 7.1.3-Configuration Management. A similar configuration management concept may be applied to ISO 13485, clause 7.1, 7.3 and 7.5.

The organization shall establish, implement and maintain a process for configuration management that includes as appropriate to the product:
a) Configuration management planning
b) Configuration identification
c) Change control
d) Configuration status accounting, and
e) Configuration audit

The following illustration shows a simple step by step configuration management process based on Configuration Methods, Procedures and Control Forms designed by QCSS:

Input:

1. QMS Standard and Customer order and/or product requirements
2. Product Design requirements (applicable if you have your own designed product)
3. Drawings. Standards, Specifications, Design baseline Metrics, Product Samples, etc.
4. Special Product and Process requirements, including critical product requirements determined by customer or organization
5. Regulatory READ MORE >

- Introduction to Configuration Management Requirements.

Policies and Procedures:
1. Policies and Procedures for clause 7.1.3-Configuraton Management
2. Work Instruction: How to apply and implement Configuration Management Processes

Forms:
1. Configuration Management Plan
2. Flow Chart for Interaction of Key Processes in Sequence, covering the key Standard clauses within a MFG environment (this chart also meets AS 9100C clause 4.1b interaction in sequence of key processes requirements)
3. Organization Chart
4. Inspection and Test Report for First Article, In Process and Final Inspection
5. Process Feasibility Review of Critical and Special Product Characteristics

Audit Checklists:
1. Audit Checklists addressing respective Standard requirements,

CD ROM:
1. Documentation is saved on CD ROM for customization and for reference purpose

A practical straightforward approach to meeting Configuration Management requirements. This ready to use documentation will save you many hours of research and eliminates a trial and error approach. It is relatively easy to implement and to comply with.

This concept was developed by QCSS under the auspices of Gunther B. Gumpp, Senior Consultant and President of QCSS.

(Copyright © 2011 Gunther Gumpp/ QCSS/ ISBN 1-881006-84-0)

Note: Product cover images may vary from those shown

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