ISOXpress ISO 13485 Document Control and Quality Management Software Template Documentation

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ISO 13485 & 21 CFR 820 TEMPLATE DOCUMENTATION
Quality Manual, 34 Operational Procedures and 26 Forms

Free Sample Documents

This template documentation consists of an 8-section Quality Manual, 34 Operational Procedures, 18 electronic forms, and 8 manual forms (list of documents). Here are a few sample documents (in the ISOXpress software all documents are available in editable MS Word files):

	Quality Manual QM-00 Index		Operational Procedure QOP-42-01 Control of Documents
	Quality Manual QM-01 Scope		Operational Procedure QOP-82-02 Internal Quality Audits
	Quality Manual QM-06 Resource Management		Operational Procedure QOP-73-02 Design Risk Management

To see how this documentation is managed and controlled in the ISOXpress system watch the Quick Tour slide show or download the 30-day Free Trial.

Thousands of Companies Implemented the Templates

Originally published in 1996, this documentation was the first template quality system for the medical device industry. Now in its third edition, and with over 3,000 copies sold, it has helped thousands of companies to achieve ISO 13485 registration and/or FDA QSR compliance. It is by far the most popular and proven package on the market.

This documentation covers both ISO 13485:2003 and FDA QSR (21 CFR Part 820) requirements, and thus fully complies with both the international and US FDA regulations. It defines a quality system that is simple, intuitive, and free from excessive paperwork, making it easy to operate and maintain (list of documents). Several sample documents are included in the MS Word files above. To view more documents and to see how they are integrated into the ISOXpress software, download the free trial of the ISOXpress ISO 13485 System Software.

Implementation Tutorial

The implementation tutorial (illustrated in the picture below) helps you edit and customize the documentation to fit your company. It comes in the form of extensive notes and tips inserted directly into the documents. These notes:

Identify and explain the requirements which are being addressed in the particular section of the document.
Alert you to sections where you may need to make changes.
Discuss alternative approaches and solutions that may be more suitable for particular types of companies.

It is like having a consultant by your side, anticipating your questions and helping you in real time as you customize the documentation.

List of Documents

Quality Manual
SECTION 0 - INDEX AND REVISION STATUS
SECTION 1 - SCOPE
1.1	Quality Policy
1.2	Introduction
1.3	Application
1.4	Exclusions
SECTION 2 - REFERENCE DOCUMENTS
SECTION 3 - TERMS AND DEFINITIONS
SECTION 4 - QUALITY MANAGEMENT SYSTEM
4.1	Quality System Processes
4.2	Documentation and Records
SECTION 5 - MANAGEMENT RESPONSIBILITY
5.1	Management Commitment
5.2	Customer Focus
5.3	Quality Policy
5.4	Quality System Planning
5.5	Organization and Communication
5.6	Management Review
SECTION 6 - RESOURCE MANAGEMENT
6.1	Provision of Resources
6.2	Competence, Awareness and Training
6.3	Infrastructure
6.4	Work Environment
SECTION 7 - PRODUCT REALIZATION
7.1	Planning of Product Realization
7.2	Customer-related Processes
7.3	Design Control
7.4	Purchasing
7.5	Production Control
7.6	Monitoring and Measuring Equipment
SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1	Planning of Monitoring and Measurement
8.2	Monitoring and Measurement
8.3	Control of Nonconforming Product
8.4	Analysis of Data
8.5	Continual Improvement


Operational Procedures
QOP-42-01	Control of Documents
QOP-42-02	Device Master Record
QOP-42-03	Control of Records
QOP-56-01	Management Review
QOP-62-01	Competence, Awareness and Training
QOP-63-01	Equipment Maintenance
QOP-64-01	Production and Work Environment
QOP-71-01	Production Planning
QOP-71-02	Process Risk Management
QOP-72-01	Order Processing and Review
QOP-73-01	Design Control
QOP-73-02	Design Risk Management
QOP-73-03	Control of Design and Process Changes
QOP-74-01	Supplier Evaluation and Monitoring
QOP-74-02	Purchasing
QOP-74-03	Verification of Purchased Product
QOP-75-01	Production Work Order and History Record
QOP-75-02	Cleanliness and Contamination of Product
QOP-75-03	Validation of Processes and Software
QOP-75-04	Installation and Servicing
QOP-75-05	Product Identification and Traceability
QOP-75-06	Labeling and Packaging
QOP-75-07	Storage and Distribution
QOP-76-01	Measuring and Monitoring Equipment
QOP-82-01	Feedback and Customer Satisfaction
QOP-82-02	Internal Quality Audits
QOP-82-03	In-process Inspections
QOP-82-04	Final Acceptance Inspection
QOP-83-01	Control of Nonconforming Product
QOP-84-01	Analysis of Data
QOP-85-01	Continual Improvement
QOP-85-02	Device Recall and Advisory Notices
QOP-85-03	Customer Complaints
QOP-85-04	Corrective and Preventive Action

Manual Forms (printable, manual forms)
QF-42-02-1	Device Master Record Index
QF-73-01-1	Design Project Plan and Schedule
QF-73-01-2	Design Review Report
QF-73-02-1	Design Risk Analysis
QF-73-03-1	Engineering Change Notice (ECN)
QF-75-01-1	Production Work Order
QF-75-04-1	Service Report
QF-82-02-1	Internal Audit Checklist

Electronic Forms (data entry forms in ISOXpress software)
ER-42-01-1	Document Control Record (ISOXpress Document Control module)
ER-56-01-1	Management Review Record (ISOXpress Management Review module)
ER-56-01-2	Quality Objective/Target Record (ISOXpress Management Review smodule)
ER-62-01-1	Training Program Record (ISOXpress Training module)
ER-62-01-2	Training Event Record (ISOXpress Training module)
ER-62-01-3	Competency Certification Program Record (ISOXpress Training module)
ER-62-01-4	Competency Certification Record (ISOXpress Training module)
ER-62-01-5	Personnel Training/Competency Record (ISOXpress Training module)
ER-74-01-1	Supplier Control Record (ISOXpress Supplier Control module)
ER-74-01-2	Supplier Nonconformity Record (ISOXpress Supplier Control module)
ER-74-01-3	Supplier Corrective Action Request Record (ISOXpress Supplier Control module)
ER-76-01-1	Measuring Equipment Record (ISOXpress Measuring Equipment module)
ER-82-02-1	Internal Audit Record (ISOXpress Internal Audit module)
ER-82-02-2	Internal Audit Plan Record (ISOXpress Internal Audit module)
ER-82-02-3	Internal Audit Finding Record (ISOXpress Internal Audit module)
ER-83-01-1	Nonconforming (NC) Product Record (ISOXpress Nonconforming Product module)
ER-85-02-1	Customer Complaint Record (ISOXpress Customer Complaints module)
ER-85-03-1	Corrective/Preventive Action Record (ISOXpress Corrective Action module)