ISO 13485 2003

ISO 13485 2003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH

ISO 13485

 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.

ISO 13485 2003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH

ISO 13485

 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.

ISO 13485 2003