ISO 13485 2003

ISO 13485 2003 is now obsolete. See the new ISO 13485 2016 standard.

 

4. Systemic Requirements

4.1
Establish
a quality
system for
medical
devices

 

Develop a quality management system for medical devices.

  • Identify the processes that make up your quality system.

  • Describe your quality management processes.

Implement a quality management system for medical devices.

  • Use quality system processes.

  • Control process performance.

 

Maintain your medical device quality management system.

  • Monitor the effectiveness of your processes.

  • Maintain the effectiveness of your processes.

4.2
Document your
medical device
quality system

4.2.1 Develop quality management system documents.

  • Develop documents to implement your quality system.

  • Develop a file for each model or type of medical device.

  • Develop a file for each type of related service.

 

4.2.2 Prepare quality management system manual.

  • Document your procedures.

  • Describe how your processes interact.

  • Specify the scope of your quality system.

  • Justify exclusions and reductions in scope.

  • Describe how your documentation is structured.

 

4.2.3 Control quality management system documents.

  • Approve documents before you distribute them.

  • Provide the correct version of documents at points of use.

  • Review and re-approve documents when you update them.

  • Specify the current revision status of your documents.

  • Monitor documents that come from external sources.

  • Prevent the accidental use of obsolete documents.

  • Preserve the usability of your quality documents.

  • Retain obsolete documents for medical devices.

 

4.2.4 Maintain quality management system records.

  • Use your records to prove that requirements have been met.

  • Develop a procedure to control medical device records.

  • Ensure that your medical device records are useable.

  • Retain records related to medical devices.

   

 

5. Management Requirements

5.1
Support 
quality

Promote the importance of quality.

  • Promote the need to meet customer requirements.

  • Promote the need to meet medical device requirements.

 

Develop a quality management system.

  • Support the development of a quality system.

  • Formulate your organization's quality policy.

  • Set your organization's quality objectives.

  • Provide needed quality resources.

 

Implement your quality management system.

  • Provide resources to implement quality management system.

  • Encourage people to meet quality system requirements.

 

Maintain your quality management system.

  • Perform quality management reviews.

  • Provide resources to maintain quality system.

5.2
Focus on
customers

Identify customer requirements.

  • Expect people to identify customer requirements.

 

Meet customers requirements.

  • Expect your organization to meet customer requirements.

5.3
Establish
a quality
policy

Define your quality policy.

  • Ensure that it serves your organization's purpose.

  • Ensure that it emphasizes the need to meet requirements.

  • Ensure that it facilitates the development of quality objectives.

 

Manage your quality policy.

  • Communicate your policy throughout your organization.

  • Review your policy to ensure its continued suitability.

5.4
Perform
quality
planning

5.4.1 Formulate quality objectives.

  • Ensure that objectives are set for all functional areas.

  • Ensure that objectives are set at organizational levels.

  • Ensure that objectives facilitate product realization.

  • Ensure that objectives support the quality policy.

  • Ensure that objectives are measurable.

 

5.4.2 Plan quality management system.

  • Plan the development of your quality management system.

  • Plan the implementation of your quality management system.

  • Plan the improvement of your quality management system.

  • Plan the modification of your quality management system.

5.5
Control
your quality
management
system

5.5.1 Define responsibilities and authorities.

  • Document responsibilities and authorities.

  • Communicate responsibilities and authorities.

  • Define how people should interact with each other.

 

5.5.2 Appoint management representative.

  • Oversee your quality management system.

  • Report on the status of your quality system.

  • Support the maintenance of your quality system.

  • Promote the importance of regulatory requirements.

 

5.5.3 Support internal communications.

  • Ensure that communication processes are established.

  • Ensure that communication occurs throughout organization.

5.6
Carry out
management
reviews

5.6.1 Review quality management system.

  • Plan regular reviews of your quality system.

  • Evaluate the effectiveness of your quality system.

  • Maintain a record of your management reviews.

 

5.6.2 Examine management review inputs.

  • Examine audit results.

  • Examine product conformity data.

  • Examine opportunities to improve.

  • Examine feedback from customers.

  • Examine process performance information.

  • Examine corrective and preventive actions.

  • Examine changes that might affect your system.

  • Examine changes in your regulatory requirements.

  • Examine previous quality management reviews.

 

5.6.3 Generate management review outputs.

  • Generate actions to improve maintenance of quality system.

  • Generate actions to improve your organization's products.

  • Generate actions to address your resource needs.

   

 

6. Resource Requirements

6.1
Provide quality
resources

Identify quality management system resource requirements.

  • Identify resources needed to support the quality system.

  • Identify resources needed to meet customer requirements.

  • Identify resources needed to meet regulatory requirements.

 

Provide quality management system resources.

  • Provide resources needed to support the quality system.

  • Provide resources needed to implement the quality system.

  • Provide resources needed to maintain the quality system.

  • Provide resources needed to meet regulatory requirements.

6.2
Provide quality
personnel

6.2.1 Use competent personnel.

  • Ensure that your personnel have the right experience.

  • Ensure that your personnel have the right education.

  • Ensure that your personnel have the right training.

  • Ensure that your personnel have the right skills.

 

6.2.2 Support competence.

  • Define acceptable levels of competence.

  • Identify your training and awareness needs.

  • Establish training needs assessment procedures.

  • Deliver your training and awareness programs.

  • Evaluate effectiveness of training and awareness.

  • Maintain a record of competence.

6.3
Provide quality
infrastructure

Identify infrastructure needs.

  • Identify your building needs.

  • Identify your workspace needs.

  • Identify your hardware needs.

  • Identify your software needs.

  • Identify your utility needs.

  • Identify your equipment needs.

  • Identify your support service needs.

  • Identify your maintenance needs.

 

Provide needed infrastructure.

  • Provide needed buildings.

  • Provide needed workspaces.

  • Provide needed hardware.

  • Provide needed software.

  • Provide needed utilities.

  • Provide needed equipment.

  • Provide needed support services.

  • Provide needed maintenance services.

 

Maintain your infrastructure.

  • Maintain your buildings.

  • Maintain your workspaces.

  • Maintain your hardware.

  • Maintain your software.

  • Maintain your utilities.

  • Maintain your equipment.

  • Maintain your support services.

  • Maintain your maintenance services.

  • Maintain a record of maintenance activities.

6.4
Provide quality
environment

Identify needed work environment.

  • Identify work environment for medical products.

  • Identify your organization's health requirements.

  • Identify your organization's clothing requirements.

  • Identify your organization's cleanliness requirements.

  • Identify your organization's working condition requirements.

 

Implement needed work environment.

  • Meet your organizations work environment needs.

  • Meet your organization's health requirements.

  • Meet your organization's clothing requirements.

  • Meet your organization's cleanliness requirements.

  • Meet your organization's working condition requirements.

 

Manage needed work environment.

  • Control your organization's work environment.

    • Control your organization's health practices.

    • Control your organization's clothing practices.

    • Control your organization's cleanliness practices.

  • Implement procedures to monitor working conditions.

  • Establish special arrangements for contaminated products.


 

 7. Realization Requirements

7.1
Control
realization
planning

Plan product realization processes.

  • Identify product quality objectives and requirements.

  • Identify product realization needs and requirements.

  • Identify product realization risk management requirements.

  • Identify product realization record keeping requirements.

 

Develop product realization processes.

  • Develop product realization documents.

  • Develop product realization record keeping systems.

  • Develop methods to control quality during product realization.

7.2
Control
customer
processes

7.2.1 Identify your customers' product requirements.

  • Identify the requirements that customers want you to meet.

  • Identify the requirements that are dictated by the product's use.

  • Identify the requirements that are imposed by external agencies.

  • Identify the requirements that your organization wants to meet.

 

7.2.2 Review your customers' product requirements.

  • Review requirements before you accept orders from customers.

  • Document customer requirements before you supply products.

  • Maintain a record of your product requirement reviews.

  • Control changes in product requirements.

 

7.2.3 Communicate with your customers.

  • Develop a process to control communications with customers.

  • Make sure that your process controls customer advisory notices.

  • Implement your customer communications process.

7.3
Control product
design and
development

7.3.1 Plan design and development.

  • Define your product design and development stages.

  • Establish procedures to control product design and development.

  • Clarify design and development responsibilities and authorities.

  • Manage interactions between design and development groups.

  • Update your design and development plans as changes occur.

  • Document your planning outputs as changes occur.

 

7.3.2 Define design and development inputs.

  • Specify product design and development inputs.

  • Record product design and development input definitions.

  • Evaluate product design and development input definitions.

  • Make sure that definitions support the product's intended use.

  • Make sure that definitions include risk management outputs.

  • Review input definitions before you approve them.

 

7.3.3 Generate design and development outputs.

  • Create product design and development outputs.

  • Approve design and development outputs prior to release.

  • Use design and development outputs to control product quality.

  • Maintain a record of your design and development outputs.

 

7.3.4 Carry out design and development reviews.

  • Perform product design and development reviews.

  • Involve specialists in design and development review process.

  • Record your product design and development reviews.

 

7.3.5 Perform design and development verifications.

  • Carry out product design and development verifications.

  • Record your product design and development verifications.

 

7.3.6 Conduct design and development validations.

  • Perform product design and development validations.

  • Conduct clinical evaluations of medical devices (if required).

  • Conduct performance evaluations of devices (if required)

  • Record product design and development validations.

 

7.3.7 Manage design and development changes.

  • Identify changes in product design and development.

  • Record changes in product design and development.

  • Review changes in product design and development.

  • Verify changes in product design and development.

  • Validate changes in product design and development.

  • Approve changes before they are implemented.

7.4
Control your
purchasing
function

7.4.1 Control purchasing process.

  • Ensure that your purchased products meet requirements.

  • Create a procedure to ensure purchases meet requirements.

  • Ensure that your suppliers meet requirements.

 

7.4.2 Document product purchases.

  • Describe the products being purchased.

  • Specify the requirements that purchases must meet.

  • Maintain purchasing information for traceability purposes.

 

7.4.3 Verify purchased products.

  • Verify purchased products at your own premises.

  • Verify purchased products at suppliers' premises (when required).

  • Maintain a record of your product verification activities.

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.

  • Identify property supplied to you by customers.

  • Verify property supplied to you by customers.

  • Safeguard property supplied to you by customers.

 

7.5.5 Preserve your products and components.

  • Preserve products and components during internal processing.

  • Establish procedures to preserve products during processing.

  • Preserve products and components during final delivery.

  • Establish procedures to preserve products during delivery.

  • Establish procedures for products with limited shelf-life.

  • Establish procedures for products that need special storage.

  • Control storage conditions whenever products need protection.

7.6
Control
monitoring
devices

 

Identify monitoring and measuring needs.

  • Identify the monitoring and measuring that should be done.

Select monitoring and measuring devices.

  • Select devices that meet monitoring and measuring needs.

 

Develop monitoring and measuring procedures.

  • Establish procedures to control monitoring and measuring.

  • Implement procedures to control monitoring and measuring.

  • Maintain procedures to control monitoring and measuring.

 

Calibrate your monitoring and measuring devices.

  • Perform calibrations.

  • Record calibrations.

 

Safeguard your monitoring and measuring devices.

  • Safeguard your devices from unauthorized adjustment.

  • Safeguard your devices from damage or deterioration.

 

Validate your monitoring and measuring software.

  • Validate monitoring and measuring software before you use it.

  • Revalidate monitoring and measuring software when necessary.

 

Use your monitoring and measuring devices.

  • Use devices to ensure that your products meet requirements.

   

 

 8. Remedial Requirements

8.1
Perform
remedial
processes

Plan remedial processes.

  • Plan how remedial processes will be used to assure conformity.

  • Plan how remedial processes will be used to maintain system.

 

Implement remedial processes.

  • Use remedial processes to demonstrate conformance.

  • Use remedial processes to maintain your quality system.

8.2
Monitor and
measure
quality

8.2.1 Gather feedback from your customers.

  • Create a procedure to gather feedback from customers.

  • Create a feedback system to monitor emerging problems.

 

8.2.2 Plan and perform regular internal audits.

  • Set up an internal audit program.

  • Develop an internal audit procedure.

  • Plan your internal audit projects.

  • Perform regular internal audits.

  • Solve problems discovered by audits.

  • Verify that problems have been solved.

 

8.2.3 Monitor and measure quality processes.

  • Use suitable methods to monitor and measure processes.

  • Take action when processes fail to achieve planned results.

 

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 your
nonconforming
products

Establish a nonconforming products procedure.

  • Define how nonconforming products should be identified.

  • Define how nonconforming products should be controlled.

 

Identify and control your nonconforming products.

  • Eliminate or correct product nonconformities.

  • Prevent the delivery or use of nonconforming products.

  • Avoid the inappropriate use of nonconforming products. 

  • Grant concessions only if regulatory requirements are met.

 

Re-verify nonconforming products that were corrected.

  • Prove that corrected products now meet requirements. 

 

Control nonconforming products after delivery or use.

  • Control events when you deliver or use nonconforming products. 

  • Develop a work instruction to control product rework process.

 

Maintain records of nonconforming products.

  • Document your product nonconformities.

  • Describe the actions taken to deal with nonconformities. 

  • Maintain a record of product concessions granted.

8.4
Analyze quality
information

Define quality management information needs.

  • Develop procedures to identify your quality information needs.

  • Define the information you need to evaluate the quality system.

  • Define the information you need to maintain the quality system.

 

Collect quality management system data.

  • Establish procedures to collect quality system information.

  • Monitor and measure the suitability of your quality system. 

  • Monitor and measure the effectiveness of your quality system.

 

Provide quality management information.

  • Provide information about your customers.

  • Provide information about your suppliers.

  • Provide information about your products.

  • Provide information about your processes.

  • Develop procedures to analyze information.

  • Maintain a record of your analytical results.

8.5
Take required
remedial
actions

8.5.1 Maintain your quality management system.

  • Use audits to help maintain the effectiveness of system.

  • Use quality data to help maintain system effectiveness.

  • Use quality policy to help maintain system effectiveness.

  • Use quality objectives to help maintain system effectiveness.

  • Use management reviews to help maintain system effectiveness.

  • Use corrective actions to help maintain system effectiveness.

  • Use preventive actions to help maintain system effectiveness.

 

8.5.2 Correct actual nonconformities.

  • Review your nonconformities.

  • Figure out what causes your nonconformities.

  • Evaluate whether you need to take corrective action.

  • Develop corrective actions to prevent recurrence.

  • Take corrective actions when they are necessary.

  • Record the results that your corrective actions achieve.

  • Examine the effectiveness of your corrective actions.

 

8.5.3 Prevent potential nonconformities.

  • Detect potential nonconformities.

  • Identify the causes of potential nonconformities.

  • Study the effects of potential nonconformities.

  • Evaluate whether you need to take preventive action.

  • Develop preventive actions to eliminate causes.

  • Take preventive actions when they are necessary.

  • Record the results that your preventive actions achieve.

  • Examine the effectiveness of your preventive actions.


OUR ISO 13485 2016 PAGES

Introduction to ISO 13485 2016

Outline of ISO 13485 2016 Standard

Overview of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality Management Checklist

ISO 13485 2016 Quality Management Gap Analysis

ISO 13485 2016 Quality Management Audit Program

Skills and Knowledge Internal Auditors Should Have

OTHER RELATED STANDARDS

ISO 14971 Medical Device Risk Management Requirements

ISO IEC 20000 2011 Service Management Requirements

ISO 9001 2015 Quality Management Requirements

ISO 9004 2009 Quality Management Guidelines

ISO 19011 2011 Auditing Guidelines


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 May 12, 2016. 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 - 2016 by Praxiom Research Group Limited. All Rights Reserved.

Praxiom Research Group Limited