ISO 13485 2003

ISO 13485 2003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH

ISO 13485

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.

ISO 13485 2003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH

ISO 13485

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.

• Ensure that it makes a commitment to continuous improvement.

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.

ISO 134852003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH

ISO 13485

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 need 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.

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