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ISO 13485 Manual

ISO 13485-2003/ISO 9001-2008 Quality and Procedure Manual for Medical Devices

Download or Hardcopy

(ISBN 1-881006-80-8)

 

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:

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

    The Downloadable Manual contains the following:

    1.  Policies and Objective for each Standard requirement (Quality Manual).
    2.  Procedures for each section of the Standard (Procedure Manual).
    3.  Control Forms, complete set of 42 State of the Art forms, supporting records and verification requirements.
    4.  Quality Policy and Mission Statement
    5.  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.

    Applicable procedures make reference to the Control Form needed and when to use them to create a record utilizing respective control form (s). Each control form is assigned an index number making it easy to make reference in respective procedure and find and use the form then under the assigned Control Form section.

    The complete documentation is compiled into one Manual, nicely organized with respective section tabs indicating the sections and the document category.

    Thirty years of Quality Management and Manufacturing Engineering experience have gone into designing this current and modern interactive and process driven document concept. QCSS Support services via email and telephone are available world wide. 

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ISO 13485 Audit Checklist
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Audit Checklists and Guidelines for ISO 13485-2003
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ISO 13485 Audit Checklist hardcopy and on CD
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ISO 13485-2003 Medical Device Quality Management System Manual
Our Price: $550.00
ISO 13485-2003 Medical Device Quality Management System Manual
Our Price: $850.00
   
 

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