ISO 13485 Quality Manual, Operational Procedures, and Forms

Since 1992, AQA's ISO systems have been implemented and certified in thousands of companies

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ISO 13485
System
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Complete Software Package includes:

Document Control
ISO Management Modules
Template Manual & Procedures
Internal Audit Checklist
Employee Training Booklets
Tutorials and Guides (PDF)

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ISO 14971
Risk Management
Software

Also fully complies with
21 CRF 820 (FDA QSR)

ISO 13485 TEMPLATE DOCUMENTATION
Quality Manual, 34 Operational Procedures and Forms

5th Edition
55 MS Word files

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Free Sample Documents

This product consists of 55 MS Word files (list of documents). To download free sample documents (MS Word files), click on the links below. Your browser will do the rest.

Sample pages
Quality Manual

Sample Procedures

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 can be integrated into the ISOXpress software, download the free trial of the Complete 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 Records/Forms (These forms are included in the MS Word file set)
QF-42-01-1	Document Control Master List
QF-42-02-1	Device Master Record Index
QF-56-01-1	Quality Objectives Records
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 Request
QF-75-01-1	Production Work Order
QF-75-04-1	Service Report
QF-82-02-1	Internal Audit Plan
QF-82-02-2	Audit Finding Report
QF-82-02-3	Internal Audit Checklist (separate product)
QF-83-01-1	Product Nonconformity Report
QF-85-03-1	Corrective Action Request

ISOXpress Software Records/Forms (These electronic forms and reports are included in the Complete System Software)
QF-42-01-1	Document Control Records
QF-56-01-1	Management Review Reports
QF-56-01-2	Quality Objectives Records
QF-62-01-1	Training Program Records
QF-62-01-2	Personnel Training Records
QF-62-01-3	Competency Certification Program Records
QF-62-01-4	Personnel Competency Certification Records
QF-74-01-1	Approved Supplier List
QF-74-01-2	Supplier Nonconforming Product Records
QF-74-01-3	Supplier Corrective Action Requests
QF-76-01-1	Measuring Equipment Records
QF-82-02-1	Internal Audit Plans
QF-82-02-2	Internal Audit Reports
QF-82-02-3	Internal Audit Finding Reports
QF-83-01-1	Product Nonconformity Reports
QF-85-02-1	Customer Complaint Reports
QF-85-03-1	Corrective/Preventive Action Requests

ISO 14971
Risk Management

Quick FAQs

Is this documentation the same as the one preloaded into the ISOXpress software and offered in the Complete System Package?
The manual and procedures are the same, but the forms are different. In this product the forms are MS Word and/or Excel files, while in the Complete System Software most forms are superseded by electronic data entry screens.
Is there a discount when I buy this template documentation together with other products in the Complete System Software Package?
Yes, you save nearly $600 when you purchase the 'Complete System Package', which includes this template documentation, ISOXpress software, ISO 13485/21 CFR 820 audit checklist, and training booklets.
Can I return the template documentation and get my money back?
Template Documentation cannot be returned because it consists of MS Word files that cannot be protected against copying. Before you buy, check out the samples in the Ms Word files above or, even better, download the free trial of the Complete System Software.
How do I take the Implementation Tutorial out of the text?
As you are editing the documents, just delete the blue italic paragraphs before saving the document. There is no automated way to do it.
Can I get help with customizing this documentation to fit my company?
Help with editing the documentation requires consulting time, and is not included in the price of the package. However, if you just have a quick question, please call us at 626-796-9000 and we should be able to give you a quick answer. The Implementation Tutorial will give you a lot of help as you go through the documents.


Products	Support	Customer Support		Other Systems
Complete Package	Downloads	Satisfied Customers	Purchase Orders	ISO 9001
ISOXpress Software	Support Center	Return Guarantee	International Orders	ISO 14001
Template Documentation	Support Request	Support Policy	About AQA Co.	ISO 9001+14001
Internal Audit Checklist		Privacy Policy	Contact AQA Co.	ISO 13485
Employee Training				ISO 14971

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