ISO 13485 2003 Plain English Overview

ISO 13485 2003 is a global quality management standard for medical devices.
The following material starts with part 4 because ISO's requirements start there.

 

4 Systemic Requirements

4.1
Establish a quality
system for your

medical devices

  Develop a quality management system for medical devices.

  Implement a quality management system for medical devices.

  Maintain your medical device quality management system.

4.2
Document your 
medical device
quality system

4.2.1 Develop quality management system documents.

4.2.2 Prepare quality management system manual.

4.2.3 Control quality management system documents.

4.2.4 Maintain quality management system records.

   

 

5 Management Requirements

5.1
Support 
quality

  Promote the importance of quality.

  Develop a quality management system.

  Implement your quality management system.

  Maintain your quality management system.

5.2
Focus on
customers

  Identify customer requirements.

  Meet customer requirements.

5.3
Establish a 
quality policy

  Define your quality policy.

  Manage your quality policy.

5.4
Perform
quality planning

5.4.1 Formulate quality objectives.

5.4.2 Plan quality management system.

5.5
Control your 
quality system

5.5.1 Define responsibilities and authorities.

5.5.2 Appoint management representative.

5.5.3 Support internal communications.

5.6
Carry out
management
reviews

5.6.1 Review quality management system.

5.6.2 Examine management review inputs.

5.6.3 Generate management review outputs.

   

 

6 Resource Requirements

6.1
Provide quality
resources

  Identify your quality resource requirements.

  Provide quality management system resources.

6.2
Provide quality
personnel

6.2.1 Use competent personnel.

6.2.2 Support competence.

6.3
Provide quality
infrastructure

  Identify your infrastructure needs.

  Provide needed infrastructure.

  Maintain your infrastructure.

6.4
Provide quality
environment

  Identify needed work environment.

  Implement needed work environment.

  Manage needed work environment.

   

7 Realization Requirements

7.1
Control planning

  Plan product realization processes.

  Develop product realization processes.

7.2
Control customer
processes

7.2.1 Identify customers' product requirements.

7.2.2 Review customers' product requirements.

7.2.3 Communicate with your customers.

7.3
Control product
development

7.3.1 Plan design and development.

7.3.2 Define design and development inputs.

7.3.3 Generate design and development outputs.

7.3.4 Carry out design and development reviews.

7.3.5 Perform design and development verifications.

7.3.6 Conduct design and development validations.

7.3.7 Manage design and development changes.

7.4
Control 
purchasing 
function

7.4.1 Control purchasing process.

7.4.2 Document product purchases.

7.4.3 Verify purchased products.

7.5
Manage
production
and service
provision

7.5.1 Control production and service provision.

7.5.1.1 Plan Production and service provision.

7.5.1.2 Manage product installation and servicing.

7.5.1.2.1 Clean products prior to installation.

7.5.1.2.2 Install products and verify installation.

7.5.1.2.3 Service products after installation.

7.5.1.3 Maintain product sterilization records.

7.5.2 Validate production and service provision.

7.5.2.1 Validate production and service processes.

7.5.2.2 Validate product sterilization processes.

7.5.3 Identify and track your products.

7.5.3.1 Develop procedures to identify products.

7.5.3.2 Establish procedures to track products.

7.5.3.2.1 Establish product traceability procedures.

7.5.3.2.2 Establish records for implantable devices.

7.5.3.3 Preserve product identity and status.

7.5.4 Protect property supplied by customers.

7.5.5 Preserve your products and components.

7.6
Control 
monitoring 
and measuring
devices

  Identify monitoring and measuring needs.

  Select monitoring and measuring devices.

  Develop monitoring and measuring procedures.

  Calibrate monitoring and measuring devices.

  Protect monitoring and measuring devices.

  Validate monitoring and measuring software.

  Use monitoring and measuring devices.

 

 

8 Remedial Requirements

8.1
Perform remedial
processes

  Plan remedial processes.

  Implement remedial processes.

8.2
Monitor and
measure
quality

8.2.1 Gather feedback from your customers.

8.2.2 Plan and perform regular internal audits.

8.2.3 Monitor and measure quality processes.

8.2.4 Monitor and measure your products.

8.2.4.1 Monitor and measure characteristics.

8.2.4.2 Identify testers and inspectors.

8.3
Control
nonconforming
products

  Establish a nonconforming products procedure.

  Identify and control your nonconforming products.

  Re-verify nonconforming products that were corrected.

  Control nonconforming products after delivery or use.

  Maintain records of nonconforming products.

8.4
Analyze quality
information

  Define quality management information needs.

  Collect quality management system data.

  Provide quality management information.

8.5
Take remedial
action

8.5.1 Maintain quality management system.

8.5.2 Correct actual nonconformities.

8.5.3 Prevent potential nonconformities.

 

 

Also check out a more detailed version of ISO 13485 2003
and see the
ISO 14971 medical device risk management standard.

Attention

This page summarizes the ISO 13485 2003 standard. It highlights
the main points. It does not present detail. To get the complete
plain English standard, please consider purchasing our
Title 45: ISO 13485 2003 Translated into Plain English.

Title 45 is detailed, accurate, and complete. It uses language
that is clear, precise, and easy to understand. We guarantee it

Title 45 can be delivered to you on CD or as an email attachment.
Title 45 is 104 pages long and comes in pdf and MS doc file formats.

Title 45 Contents

Place an Order

Check our Prices

Product License


MORE ISO 13485 WEB PAGES

Introduction to ISO 13485 Standard

Medical Device Quality Management Definitions

ISO 13485 2003 Standard Translated into Plain English

How to Develop a Quality Management System for Medical Devices

Quality Management Gap Analysis Tool for Medical Devices

Quality Management Audit Program for Medical Devices


Home Page

Our Libraries

A to Z Index

Customers

How to Order

Our Products

Our Prices

Guarantee

Praxiom Research Group Limited         help@praxiom.com        780-461-4514

Updated on November 30, 2013. First published on December 11, 2004.

Legal Restrictions on the Use of this Page
Thank you for visiting this webpage. You are welcome to view our material as often as
you wish, free of charge. And as long as you keep intact all copyright notices, you are also
welcome to print or make one copy of this page for your own personal, noncommercial,
home use. But, you are not legally authorized to print or produce additional copies or to
copy and paste any of our material onto another web site or to republish it in any way.

Copyright 2004 - 2013 by Praxiom Research Group Limited. All Rights Reserved.

Praxiom Research Group Limited