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

•  Plan product realization processes.

•  Develop product realization processes.

7.2.1 Identify customers' product requirements.

7.2.2 Review customers' product requirements.

7.2.3 Communicate with your customers.

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.

7.4.1 Control purchasing process.

7.4.2 Document product purchases.

7.4.3 Verify purchased products.

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.

•  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.