OH&S_Leaderboard 12/28/16

ISO 13485-2003 Medical Device Quality & Procedure Manual (ISBN 1-881006-80-8)

Available from Quality Control Systems and Services

This all in one Quality and Procedure Manual meets ISO 13485 - 2003 as well as ISO 9001-2008 Standard requirements and is specifically designed for the Medical Devices Engineering and Manufacturing Industries.

The Hardcopy Manual contains the following:
Policies and Objective addressing each Standard requirement (Quality Manual).
Audit Checklist
Procedures for each and every section of the Standard (Procedure Manual), including Configuration and Risk Management Procedures.
Control Forms, complete set of 42 State of the Art Control Forms, supporting records and verification requirements.
Quality Policy and Mission Statement.
Instruction Guide ?How to Implement?.
Certificate for ?Self Declaration of Conformance?.
CD Rom, in MS Word 7.0, contains all of the above documentation.

The Downloadable Manual contains the following:
Policies and Objective for each Standard requirement (Quality Manual).
Procedures for each section of the Standard (Procedure Manual).
Control Forms, complete set of 42 State of the Art forms, supporting records and verification requirements.
Quality Policy and Mission Statement
Instruction Guide - How to Implement?

This Quality and Procedure Manual was designed and is based on current best GMP practices within the context of the ISO 13485/ISO 9001 standard requirements. It is written in an interactive process driven concept, linking one policy to respective procedure to another.

Rate and Review Quality Control Systems and Services

Rating: 0 - 0 reviews
Let users know what you would have wanted to know about this company.
Click on a star to rate this company
Post anonymously
When writing a review, please adhere to the Review Guidelines.