ISO 13485-2003 Quality and Procedure Manual For Medical Devices

Quality Control Systems & Services, January 2012, Pages: 327

This all in one Quality and Procedure Manual for the medical devices manufacturer and their suppliers is designed to meet all ISO 13485-2003 and ISO 9001-2008 Quality Management System Standard requirements. It consist of documented quality policies and objectives (Quality Manual) followed by respective procedures (Procedure Manual) that are easy to read and to implement. A complete set of control forms (see table of contents) designed to record carried out activities when required by respective procedure, is included.

The Quality Manual addresses each clause, sub clause and every shall requirement stated in the ISO 13485-2003 and ISO 9001-2008 Standard in form of Policies and Objectives, making reference to respective procedures and Control Forms that are part of the Procedure Manual.

The Procedure Manual addresses each clause, sub clause and every shall requirement stated in the ISO 13485-2003 and ISO 9001-2008 Standard in form of Procedures and Methods based on GMP and MFG best practices in the Medical Devices and related product Manufacturing Industry and their Suppliers. Control Forms to be utilized for recording carried out process and work activities are made reference to in respective procedures. Procedures for ISO 13485-2003 are written in italics, ISO 9001-2008 procedures are written in regular font. At the end of each key procedure the clause and/or sub-clause requiring such procedures or methods description is written in parenthesis ( ), making it easy to identify and assess compliance to respective standard clause or sub-clause.

The complete set of Control Forms is included as an appendix in the Quality and Procedure Manual. Each Control Form is identified with a Control Form (Index) Number, and made reference to in respective procedure with index number and form title. A Table of Contents for Forms identifies each Form with Title and Form number, that makes it easy to find and to use.

Process Approach: The Policies and Procedures are easy to read and implement and are based on a coordinated step by step input output liked process concept. The accompanying Control Forms enable you to record carried out process activities, measure and analyze results and assess standard compliance.

Certification: Certification for ISO 9001-2008 and ISO 13485 Standard can be accomplished by utilizing the complete quality management system documentation and its concept.

The Hardcopy Manual contains the following:
1) Policies and Objectives addressing each Standard requirement (Quality Manual).
2) Procedures for each and every section of the Standard (Procedures Manual).
3) Control Forms: (a) set of 27 Control Forms to be used for meeting mandatory records requirements, (b) set of 15 forms to be used for reference purpose only, and (c) set of 14 Tables and Charts to help organize, implement and to maintain the system.
4) Quality Policy and Mission Statement.
5) Instruction Guide on “How to Implement the Policies and Procedures, and Control Forms”.
6) Certificate for “Self Declaration of Conformance”.
7) CD Rom, in MS Word 7.0, contains all the above outlined documentation, it will aid in implementing, maintaining and when necessary for customizing your Quality Management system.

The Electronic Downloadable Manual contains the following:
1) Policies and Objectives addressing each Standard requirement (Quality Manual).
2) Procedures for each and every section of the Standard (Procedures Manual).
3) Control Forms: (a) set of 27 Control Forms to be used for meeting mandatory records requirements, (b) set of 15 forms to be used for reference purpose only, and (c) set of 14 Tables and Charts to help to organize, implement and to maintain the system.
4) Quality Policy and Mission Statement.
5) Instruction Guide: on “How to Implement the Policies and Procedures, and the Control Forms”.

The Policies and Procedures are easy to read and to implement and are based on a step by step input output linked process concept. The accompanying control forms will enable you to record carried out activities, measure results and assess standard system compliance.

Table of Contents:

Title Sheet
Introduction
Table of Contents, clause 4.0 through 8.5.3, for Policies and Objective (Quality Manual).
Table of Contents, clause 4.0 through clause 8.5.3, for Procedures (Procedure Manual).
Table of Contents, Form “A” through Form “K”, for Managing the complete QMS Documentation
Table of Contents, Form 01 through Form 37, and Table 1 through 5, for creating Records and for organizing the Quality Management System
documentation.

LIST OF TABLES

Management and Control of Quality Management System Documentation: Table of Contents for Policies and Procedures, Table of Content for Forms, Quality Manual Circulation List, Quality Manual Approval List, Revision List, Approvers of Controlled Documents, Form Approval, Control of Mandatory Documents and Records, Control of Standards and Specifications, Control of Work Instructions, Control of Audits and Audit Checklists, Interaction of Key Processes in Sequence.

Organization, Policy and Product Realization: Quality Policy with Key Objectives, Quality Plan, Functional Organization Chart, Key MFG and Control Operations Chart, PC Process Flow Chart, Process Feasibility and Risk Analysis Chart.

PO/Order/Contract Review and Planning: Order/Contract Review Stamp, Order/Contract Amendment Review Log, Assigned Work Order and Work History File, Router, Job Shop Traveler (all part of the Job File).

Calibration: Instrument, Measurement and Test Equipment Calibration File, IMT Calibration Evaluation File, Calibration Recall Schedule, IMT Checkout Log, Calibration Certificate Label, Out of Calibration Label.

Inspection and Testing: Inspection and Test Report for First Article, In Process and Final Inspection and Testing, In Process Inspection Log, Receiving and Incoming Product Verification Inspection Log, Special Process Inspection and Process Validation Report.

Nonconformance Control: Product/Process Nonconformance and Corrective Action Report, Nonconformance Log, Preventive Action Report for Potential Nonconformance.

Drawing/Spec. Review and Release: Drawing Review and Distribution Log (part of Job File), Drawing Review and Release Stamp, Engineering Change Order Stamp, Drawing Configuration and Engineering Change (ECO) Log.

Purchasing/Delivery: Purchasing Document, Certificate of Conformance.

Identification Tags: Acceptance Tag, Reject Tag, Repair/Rework Tag.

Supplier Control: Supplier Audit Questioner for Preapproval, Approved Supplier Log, Supplier Corrective Action Report, Supplier Performance Evaluation and Rating.

Product Shelf Life and Stockroom Control: Shelf Life Item Control Label, Stockroom and Shelf Life Item Control Log.

Manufacturing/Production Equipment Control: MGF and Test Equipment Inventory and Preventive Maintenance Log, Test and Check Fixtures Inventory and Preventive Maintenance Log, Preventive Maintenance Label.

Inspection and Test/Document Control Stamps: Inspection Stamps Log (Accept, Reject and Void Stamps), Job Completed Stamp, Obsolete Document Stamp.

Training: Management Training Log, Employee Orientation Checklist, Employee Job description and Training Requirements, Employee Training Plan, Employee carried out Training/Certification Log, Employee Suggestion and Process Improvement Input Report for Suggestion Box.

Design and Development: D&D Planning Flow Chart, D&D Product Design Input-Output Planning Log, D&D Planning Review and Verification Log, Product Testing and Validation Log, Product Field Service Log, Internal Audit Checklists.

LIST OF FIGURES

Four level QMS Documentation (Pyramid) Concept, Interaction of Key processes in Sequence.
Order/Contract Review Stamp, Drawing Review and Release Stamp, Engineering Change Order Stamp, Inspection Stamp Log, Obsolete Document Stamp, Job Completed/Ready for Shipment Stamp, Identification Tags, Design and Development Planning Chart, Acceptance Tag, Reject Tag, Repair/Rework Tag, Audit Planning and Schedule.

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