iAuditor Mobile App Preview

Inspection

4. Quality Management System
4.1 General Requirements
4.1.1 Develop a QMS

Establish your quality management system (QMS).

Document your organization's quality management system.

Maintain the effectiveness of your quality management system.

Establish your QMS documentation requirements.

Identify the documents that regulators expect you to maintain.

Identify the medical device regulations that apply to your organization.

Identify the roles that medical device regulators expect you to perform.

Identify the documents that ISO 13485 expects you to maintain.

Identity the procedures that ISO 13485 expects you to document.

Identity the activities that ISO 13485 expects you to document.

Identity the arrangements that ISO 13485 expects you to document.

Identity the requirements that ISO 13485 expects you to document.

4.1.2 Clarify structure

Consider the roles that regulators expect you to perform.

Determine the processes that your organization's QMS needs.

Clarify how QMS processes are applied throughout your organization.

Specify how your organization's processes are interconnected.

Use a risk based approach to control your organization's QMS processes.

4.1.3 Support processes

Support each QMS process.

Support QMS process operations.

Support QMS process monitoring.

Support QMS process measuring.

Support QMS process analysis.

Support QMS process record keeping.

4.1.4 Manage changes

Manage your QMS processes.

Comply with ISO 13485 process management requirements.

Manage changes to your organization's QMS processes.

Comply with regulatory process management requirements.

Comply with regulatory change control requirements.

4.1.5 Control outsourcing

Monitor outsourced processes that affect product conformity.

Control the outsourced processes that affect product conformity.

Retain responsibility for processes that affect product conformity.

4.1.6 Validate software

Develop procedures to validate and revalidate your QMS software.

Develop an approach that is proportionate to the risk that is being taken.

Use your procedures to validate and revalidate software applications.

Validate computer software applications for their intended use.

Validate software whenever its intended use changes (as appropriate).

Maintain a record of your software validation and revalidation activities.

4.2 Documentation requirements
4.2.1 General

Include all required documents and records.

Include the documents and records that regulations require.

Include the documents and records that ISO 13485 requires.

Include the documents and records that your organization requires.

4.2.2 Quality manual

Prepare a quality manual for your QMS.

Define the scope of your organization's QMS.

Outline the structure of your QMS documentation.

Include your QMS procedures or refer to them.

Describe how your QMS processes interact.

4.2.3 Medical device file

Establish a file for each medical device type or each family of medical devices.

Include or reference documents showing that you comply with regulations.

Include or reference documents showing that you comply with ISO 13485.

Maintain a file for each medical device type or each family of medical devices.

Include documents for each medical device type or family of medical devices.

Include a description of each medical device type or medical device family.

Include procedures for medical device types or medical device families.

Include specifications or procedures for medical device types or families.

Include records for medical device types or medical device families.

4.2.4 Control documents

Establish a procedure to control QMS documents.

Document your QMS document control procedure.

Implement your QMS document control procedure.

Control your organization's QMS documents.

Review and approve documents before you issue them.

Provide the correct version of documents at points of use.

Protect the identity and legibility of your QMS documents.

Identify and control the distribution of external QMS documents.

Prevent the unintended or inadvertent use of obsolete documents.

Preserve obsolete documents for future reference and use.

4.2.5 Control of records

Establish records for your organization's QMS.

Develop procedures to control QMS records.

Document your record control procedures.

Implement your record control procedures.

Define methods to protect QMS health records.

5. Management Responsibility
5.1 Management commitment

Demonstrate your ongoing commitment.

Support the development of your QMS.

Support the implementation of your QMS.

Support the maintenance of your QMS.

5.2 Customer focus

Ensure that external requirements are determined.

Ensure that external requirements are being met.

5.3 Quality policy

Plan your quality policy.

Draft your quality policy.

Apply your quality policy.

Review your quality policy.

5.4 Planning
5.4.1 Quality objectives

Establish quality objectives for your organization.

Set objectives needed to meet product requirements.

Set objectives needed to meet regulatory requirements.

5.4.2 Quality management system planning

Plan how you're going to develop your QMS.

Plan how you're going to document your QMS.

Plan how you're going to structure your QMS.

Plan how you're going to manage your QMS.

Plan how you're going to monitor your QMS.

Plan how you're going to control your QMS.

Plan how you're going to implement your QMS.

Plan how you're going to maintain your QMS.

5.5 Responsibility, authority, and communication
5.5.1 Responsibility and authority

Define QMS responsibilities and authorities.

Document QMS responsibilities and authorities.

Document how QMS personnel are interrelated.

5.5.2 Management representative

Appoint a member of management to oversee your QMS.

Give management representative authority and responsibility.

Assign authority and responsibility for documenting your QMS.

Assign authority and responsibility for reporting to top management.

Assign authority and responsibility for promoting corporate awareness.

5.5.3 Internal communication

Establish appropriate internal communication processes.

Encourage communication about the effectiveness of your QMS.

5.6 Management review
5.6.1 General

Establish management review procedures.

Schedule your reviews at planned intervals.

Review your QMS at planned intervals.

Keep a record of management reviews.

5.6.2 Review input

Study information about your QMS (inputs).

Review previous management reviews.

Review the results of previous audits.

Review your complaint handling activities.

Review monitoring and measurement activities.

Review new or revised regulatory requirements.

Review previous corrective and preventive actions.

Review recommendations for improvement.

Review changes that could affect the QMS.

5.6.3 Review output

Generate your management review outputs.

Generate decisions and actions to improve your QMS.

Generate decisions and actions to enhance your products.

Generate decisions and actions to deal with regulatory changes.

Generate decisions and actions to address relevant resource needs.

Establish a record of your management reviews.

6. Resource Management
6.1 Provisional resources

Determine the resources that your QMS needs.

Provide the resources that your QMS needs.

Provide the resources needed to implement your QMS.

Provide the resources needed to meet regulatory requirements.

Provide the resources needed to meet customer requirements.

6.2 Human resources

Identify personnel and examine work that could affect product quality.

Establish a process to manage the competence of medical device workers.

Use your process to manage the competence of your medical device workers.

Select suitable methods for evaluating your training and awareness activities.

Maintain records that document the competence of medical device workers.

6.3 Infrastructure

Document QMS infrastructure requirements.

Provide the infrastructure that your QMS needs.

Identify maintenance activities that could affect quality.

Maintain the infrastructure that your QMS needs to have.

6.4 Work environment and contamination control
6.4.1 Work environment

Identify the work environment needed to meet product requirements.

Document your organization's requirements for this work environment.

Identify the working conditions that influence the quality of your products.

Document your organization's requirements for these working conditions.

Document procedures to monitor and control these working conditions.

Identify personnel who could affect medical device safety or performance.

Identify those who come into contact with products or related environments.

Establish health, cleanliness, and clothing requirements for these personnel.

Control those who work temporarily under special environmental conditions.

6.4.2 Contamination control

Plan how you're going to control products that are or may be contaminated.

Plan how you're going to control the contamination of sterile medical devices.

7. Product Realization
7.1 Planning of product realization

Plan the processes that are needed to realize products.

Develop the processes that you need to realize products.

Develop a risk management process for product realization.

Plan how you're going to realize each product.

Formulate quality objectives for your product.

Clarify specific product realization requirements.

Generate product realization planning outputs.

Establish records of product realization activities.

7.2 Customer-related processes
7.2.1 Determination of requirements related to product

Clarify your product requirements.

Identify requirements specified by your customers.

Identify requirements dictated by your product's intended use.

Identify requirements imposed by your regulatory bodies.

Identify requirements defined by your organization.

7.2.2 Review of requirements related to product

Evaluate product requirements before you accept orders.

Review product requirements before you supply products.

Verify product requirements before you agree to accept orders.

Confirm that product requirements can be met before you proceed.

Maintain a record of your product requirement reviews.

7.2.3 Communication

Plan arrangements to communicate with customers.

Document your customer communication arrangements.

Implement your customer communication arrangements.

Maintain your customer communication arrangements.

Establish arrangements to communicate with regulatory authorities.

Use your arrangements to communicate with regulatory authorities.

7.3 Design and development
7.3.1 General

Establish procedures for design and development.

Document procedures for design and development.

7.3.2 Design and development planning

Plan the design and development of your products.

Document your product design and development plans.

Maintain your design and development planning documents.

Control the design and development of your products.

7.3.3 Design and development inputs

Determine product design and development inputs.

Review your product design and development inputs.

Approve your product design and development inputs.

Maintain a record of design and development inputs.

7.3.4 Design and development outputs

Generate suitable design and development outputs.

Verify your product design and development outputs.

Approve your product design and development outputs.

Maintain records of design and development outputs.

7.3.5 Design and development review

Plan your organization's design and development reviews.

Perform reviews in accordance with planned arrangements.

Maintain records of your design and development reviews.

7.3.6 Design and development verification

Plan your design and development verification activities.

Document your design and development verification plans.

Perform verifications in accordance with planned arrangements.

Keep records of your design and development verification activities.

7.3.7 Design and development validation

Plan your organization's design and development validation activities.

Document your organization's design and development validation plans.

Perform validations in accordance with your planned arrangements.

Keep records of design and development validation activities.

7.3.8 Design and development transfers

Develop procedures to control design and development transfers.

Use your procedures to control design and development transfers.

Record design and development transfer results and conclusions.

7.3.9 Control of design and development changes

Establish procedures to control design and development changes.

Use your procedures to control design and development changes.

Maintain a record of medical device design and development changes.

7.3.10 Design and development files

Maintain a design and development file for each family of medical devices.

Include or reference records that document compliance and changes.

7.4 Purchasing
7.4.1 Purchasing process

Establish procedures to control product purchases.

Establish supplier evaluation and selection criteria.

Establish supplier monitoring and re-evaluation plans.

Monitor the performance of your organization's suppliers.

Take action whenever suppliers fail to meet purchasing requirements.

Establish supplier evaluation, selection, and monitoring records.

7.4.2 Purchasing information

Plan your organization's product purchases.

Review purchase requirements before sharing them.

Maintain your organization's purchasing documents and records.

7.4.3 Verification of purchased product

Develop methods and activities to verify purchased products.

Make arrangements to verify the products you plan to purchase.

Verify that your purchased products meet purchase requirements.

Consider what to do when changes are made to purchased products.

Establish and maintain a record of purchased product verifications.

7.5 Production and service provision
7.5.1 Control medical device production and service provision

Plan your production and service provision activities.

Carry out production and service provision activities.

Monitor production and service provision activities.

Control production and service provision activities.

7.5.2 Define requirements for cleanliness or contamination controls

for process agents that must be removed from products during manufacture.

Identify products that you clean prior to sterilization or use.

Document and maintain your cleanliness or contamination control requirements for products that you clean prior to sterilization or use.

Identify products that cannot be cleaned prior to sterilization or use.

Document and maintain your cleanliness or contamination control requirements for products that can't be cleaned prior to sterilization or use.

Identify products supplied non-sterile to be cleaned before sterilization or use.

Document and maintain cleanliness or contamination control requirements for products supplied non-sterile to be cleaned before sterilization or use.

Identify products that must be clean when used but are supplied non-sterile.

Document and maintain cleanliness or contamination control requirements for products that must be clean when used but are supplied non-sterile.

Identify process agents that must be removed from product during manufacture.

Document and maintain cleanliness or contamination control requirements for process agents that must be removed from products during manufacture.

7.5.3 Specify product installation and verification requirements

Establish medical device installation requirements.

Document your medical device installation requirements.

Establish medical device installation verification requirements.

Document your organization's installation verification requirements.

7.5.4 Develop servicing procedures and reference materials

Establish medical device servicing procedures and reference materials.

Document your medical device servicing procedures and reference materials.

Use your procedures and materials to control medical device servicing activities.

Maintain a record of your organization's medical device servicing activities.

Identify improvement opportunities and servicing complaints.

7.5.5 Maintain a record of sterilization process parameters

Establish a record of your organization's sterilization process parameters.

Record sterilization process parameters for each batch of medical devices.

7.5.6 Validate processes used for production and service provision

Identify processes that generate outputs that are not or cannot be verified by subsequent monitoring and measurement until it's too late.

Establish procedures to validate production and service delivery processes and software applications that could affect your products and services.

Validate processes and software applications that could generate output deficiencies and could affect your products and services.

7.5.7 Validate processes for sterilization and sterile barrier systems

Document procedures used to validate processes for sterilization and sterile barrier systems.

Establish procedures used to validate processes for sterilization and sterile barrier systems.

Implement procedures used to validate processes for sterilization and sterile barrier systems.

Maintain procedures used to validate processes for sterilization and sterile barrier systems.

7.5.8 Preserve product identity throughout product realization

Prepare procedures and systems to control the identity of medical devices.

Document your organization's product identification systems and procedures.

Implement your organization's product identification systems and procedures.

7.5.9 Establish suitable traceability procedures and records
7.5.9.1 Establish suitable product traceability procedures

Establish your product traceability procedures.

Implement your product traceability procedures.

Maintain your product traceability procedures.

7.5.9.2 Establish suitable records for implantable devices

Establish your traceability records for implantable medical devices.

Expect suppliers of distribution services to have distribution records.

7.5.10 Protect property supplied for medical devices by customers

Identify property supplied by customers to be used by medical devices.

Verify property supplied by customers to be used by your medical devices.

Safeguard property supplied by customers to be used by medical devices.

Maintain a record of customer property that is lost, damaged, or unsuitable.

Report lost, damaged, or unsuitable customer property to your customers.

7.5.11 Preserve medical device products and components

Establish procedures to preserve the conformity of products.

Document and maintain your product preservation procedures.

Use your procedures to preserve the conformity of products.

Prevent medical device damage, alteration, and contamination.

Protect products when exposed to hazards and expected conditions.

7.6 Control of monitoring and measuring requirements

Identify monitoring and measurement requirements.

Select suitable monitoring and measurement equipment.

Establish your monitoring and measurement procedures.

Prepare your calibration and verification plans and procedures.

Protect your organization's monitoring and measurement equipment.

Develop monitoring and measurement software validation procedures.

8. Measurement, Analysis, and Improvement
8.1 General

Plan monitoring, measurement, and analytical processes.

Plan how monitoring methods will be used ensure conformity and effectiveness.

Plan how measurement will be used to ensure conformity and effectiveness.

Plan how analytics will be used to ensure conformity and effectiveness.

8.2 Monitoring and measurement
8.2.1 Feedback

Establish feedback methods and procedures.

Examine the information you have gathered.

Use your feedback to measure QMS effectiveness.

Use your feedback to facilitate risk management.

Use your feedback to support improvement processes.

Use your feedback to enhance product realization.

8.2.2 Complaint handling

Establish your complaint handling procedures.

Document your complaint handling procedures.

Implement your complaint handling procedures.

Maintain your complaint handling procedures.

8.2.3 Reporting and regulatory authorities

Establish reporting procedures when regulators expect you to report to them.

Document reporting procedures when regulators expect you to report to them.

Implement reporting procedures when regulators expect you to report to them.

Maintain reporting procedures when regulators expect you to report to them.

8.2.4 Internal audit

Establish your organization's internal audit procedure.

Plan your organization's internal audit programme.

Carry out your internal audits at planned intervals.

Maintain a record of audit plans and performance.

Eliminate all detected nonconformities and causes.

Follow-up on steps taken to resolve nonconformities.

8.2.5 Monitoring and measurement of processes

Establish suitable methods to monitor and measure each QMS process.

Apply suitable methods to monitor and measure each QMS process.

8.2.6 Monitoring and measurement of product

Monitor and measure your organization's product characteristics.

Establish a record of product monitoring and measurement activities.

Complete all planned arrangements before you release your products.

Establish a record of implantable medical device testing and inspection.

8.3 Control of nonconforming product
8.3.1 General

Clarify how you intend to prevent unintended product delivery or use.

Prevent the unintended delivery or use of your nonconforming products.

Establish a record of your organization's nonconforming product activities.

8.3.2 Actions in response to nonconforming product detected before delivery

Deal with nonconforming products prior to delivery.

Take action to eliminate detected nonconformities.

Prevent the product's original intended use or application.

Authorize nonconforming product use, release, or acceptance.

8.3.3 Actions in response to nonconforming product detected after delivery

Identify nonconforming products after delivery or after use has started.

Take action that is appropriate to the effects that have been identified.

Establish and maintain a record of the actions that have been taken.

Clarify how your advisory notices should be issued and managed.

Keep a record of actions taken when advisory notices are issued.

8.3.4 Rework

Clarify how product rework should be performed.

Clarify how product rework should be verified.

Clarify how product rework should be reviewed.

Clarify how product rework should be approved.

Clarify how product rework should be recorded.

8.4 Analysis of data

Plan how you're going to evaluate your QMS.

Establish procedures to evaluate your QMS.

Use your analytical results to improve your QMS.

8.5 Improvement
8.5.1 Take action to change QMS and products

Identify any changes that must be made.

Identify changes that maintain QMS suitability, adequacy, and effectiveness.

Identify changes needed to ensure medical device safety and performance.

Make any changes that must be made.

8.5.2 Take action to correct actual nonconformities

Document a corrective action procedure.

Specify how actual problems will be investigated.

Specify how corrective actions will be developed.

Specify how corrective actions will be verified.

Specify how corrective action will be taken.

Specify how corrective action will be reviewed.

Implement your corrective action procedure.

Maintain records of corrective action taken.

8.5.3 Take action to prevent potential nonconformities

Document a preventive action procedure.

Specify how potential problems will be investigated.

Specify how preventive actions will be developed.

Specify how preventive actions will be verified.

Specify how preventive action will be taken.

Specify how preventive action will be reviewed.

Implement your preventive action procedure.

Maintain records of preventive action taken.

Completion

General comments

Name and signature

ISO 13485:2016 Standard Checklist

Created by: SafetyCulture Staff | Industry: General | Downloads: 219

An ISO 13485:2016 standard checklist can help quality managers find gaps in the organization’s current processes. This digital checklist is divided into 5 sections following ISO 13485:2016’s key clauses. This converted digital checklist allows you to select “Done,” “In Progress,” "Not Started," and, for sections 6, 7, & 8, “Not Applicable.”

Signup for a free iAuditor account to download and edit this checklist. It will be added to your free account and you will be able to conduct inspections from your mobile device.

Download and edit this free checklist

Browse for other checklists


iauditor logo

The World's #1 Cloud-Based Inspection Software and App

chevron logo
coles logo
emirates logo
overground logo
tesla logo
toyota logo

Inspection

4. Quality Management System
4.1 General Requirements
4.1.1 Develop a QMS

Establish your quality management system (QMS).

Document your organization's quality management system.

Maintain the effectiveness of your quality management system.

Establish your QMS documentation requirements.

Identify the documents that regulators expect you to maintain.

Identify the medical device regulations that apply to your organization.

Identify the roles that medical device regulators expect you to perform.

Identify the documents that ISO 13485 expects you to maintain.

Identity the procedures that ISO 13485 expects you to document.

Identity the activities that ISO 13485 expects you to document.

Identity the arrangements that ISO 13485 expects you to document.

Identity the requirements that ISO 13485 expects you to document.

4.1.2 Clarify structure

Consider the roles that regulators expect you to perform.

Determine the processes that your organization's QMS needs.

Clarify how QMS processes are applied throughout your organization.

Specify how your organization's processes are interconnected.

Use a risk based approach to control your organization's QMS processes.

4.1.3 Support processes

Support each QMS process.

Support QMS process operations.

Support QMS process monitoring.

Support QMS process measuring.

Support QMS process analysis.

Support QMS process record keeping.

4.1.4 Manage changes

Manage your QMS processes.

Comply with ISO 13485 process management requirements.

Manage changes to your organization's QMS processes.

Comply with regulatory process management requirements.

Comply with regulatory change control requirements.

4.1.5 Control outsourcing

Monitor outsourced processes that affect product conformity.

Control the outsourced processes that affect product conformity.

Retain responsibility for processes that affect product conformity.

4.1.6 Validate software

Develop procedures to validate and revalidate your QMS software.

Develop an approach that is proportionate to the risk that is being taken.

Use your procedures to validate and revalidate software applications.

Validate computer software applications for their intended use.

Validate software whenever its intended use changes (as appropriate).

Maintain a record of your software validation and revalidation activities.

4.2 Documentation requirements
4.2.1 General

Include all required documents and records.

Include the documents and records that regulations require.

Include the documents and records that ISO 13485 requires.

Include the documents and records that your organization requires.

4.2.2 Quality manual

Prepare a quality manual for your QMS.

Define the scope of your organization's QMS.

Outline the structure of your QMS documentation.

Include your QMS procedures or refer to them.

Describe how your QMS processes interact.

4.2.3 Medical device file

Establish a file for each medical device type or each family of medical devices.

Include or reference documents showing that you comply with regulations.

Include or reference documents showing that you comply with ISO 13485.

Maintain a file for each medical device type or each family of medical devices.

Include documents for each medical device type or family of medical devices.

Include a description of each medical device type or medical device family.

Include procedures for medical device types or medical device families.

Include specifications or procedures for medical device types or families.

Include records for medical device types or medical device families.

4.2.4 Control documents

Establish a procedure to control QMS documents.

Document your QMS document control procedure.

Implement your QMS document control procedure.

Control your organization's QMS documents.

Review and approve documents before you issue them.

Provide the correct version of documents at points of use.

Protect the identity and legibility of your QMS documents.

Identify and control the distribution of external QMS documents.

Prevent the unintended or inadvertent use of obsolete documents.

Preserve obsolete documents for future reference and use.

4.2.5 Control of records

Establish records for your organization's QMS.

Develop procedures to control QMS records.

Document your record control procedures.

Implement your record control procedures.

Define methods to protect QMS health records.

5. Management Responsibility
5.1 Management commitment

Demonstrate your ongoing commitment.

Support the development of your QMS.

Support the implementation of your QMS.

Support the maintenance of your QMS.

5.2 Customer focus

Ensure that external requirements are determined.

Ensure that external requirements are being met.

5.3 Quality policy

Plan your quality policy.

Draft your quality policy.

Apply your quality policy.

Review your quality policy.

5.4 Planning
5.4.1 Quality objectives

Establish quality objectives for your organization.

Set objectives needed to meet product requirements.

Set objectives needed to meet regulatory requirements.

5.4.2 Quality management system planning

Plan how you're going to develop your QMS.

Plan how you're going to document your QMS.

Plan how you're going to structure your QMS.

Plan how you're going to manage your QMS.

Plan how you're going to monitor your QMS.

Plan how you're going to control your QMS.

Plan how you're going to implement your QMS.

Plan how you're going to maintain your QMS.

5.5 Responsibility, authority, and communication
5.5.1 Responsibility and authority

Define QMS responsibilities and authorities.

Document QMS responsibilities and authorities.

Document how QMS personnel are interrelated.

5.5.2 Management representative

Appoint a member of management to oversee your QMS.

Give management representative authority and responsibility.

Assign authority and responsibility for documenting your QMS.

Assign authority and responsibility for reporting to top management.

Assign authority and responsibility for promoting corporate awareness.

5.5.3 Internal communication

Establish appropriate internal communication processes.

Encourage communication about the effectiveness of your QMS.

5.6 Management review
5.6.1 General

Establish management review procedures.

Schedule your reviews at planned intervals.

Review your QMS at planned intervals.

Keep a record of management reviews.

5.6.2 Review input

Study information about your QMS (inputs).

Review previous management reviews.

Review the results of previous audits.

Review your complaint handling activities.

Review monitoring and measurement activities.

Review new or revised regulatory requirements.

Review previous corrective and preventive actions.

Review recommendations for improvement.

Review changes that could affect the QMS.

5.6.3 Review output

Generate your management review outputs.

Generate decisions and actions to improve your QMS.

Generate decisions and actions to enhance your products.

Generate decisions and actions to deal with regulatory changes.

Generate decisions and actions to address relevant resource needs.

Establish a record of your management reviews.

6. Resource Management
6.1 Provisional resources

Determine the resources that your QMS needs.

Provide the resources that your QMS needs.

Provide the resources needed to implement your QMS.

Provide the resources needed to meet regulatory requirements.

Provide the resources needed to meet customer requirements.

6.2 Human resources

Identify personnel and examine work that could affect product quality.

Establish a process to manage the competence of medical device workers.

Use your process to manage the competence of your medical device workers.

Select suitable methods for evaluating your training and awareness activities.

Maintain records that document the competence of medical device workers.

6.3 Infrastructure

Document QMS infrastructure requirements.

Provide the infrastructure that your QMS needs.

Identify maintenance activities that could affect quality.

Maintain the infrastructure that your QMS needs to have.

6.4 Work environment and contamination control
6.4.1 Work environment

Identify the work environment needed to meet product requirements.

Document your organization's requirements for this work environment.

Identify the working conditions that influence the quality of your products.

Document your organization's requirements for these working conditions.

Document procedures to monitor and control these working conditions.

Identify personnel who could affect medical device safety or performance.

Identify those who come into contact with products or related environments.

Establish health, cleanliness, and clothing requirements for these personnel.

Control those who work temporarily under special environmental conditions.

6.4.2 Contamination control

Plan how you're going to control products that are or may be contaminated.

Plan how you're going to control the contamination of sterile medical devices.

7. Product Realization
7.1 Planning of product realization

Plan the processes that are needed to realize products.

Develop the processes that you need to realize products.

Develop a risk management process for product realization.

Plan how you're going to realize each product.

Formulate quality objectives for your product.

Clarify specific product realization requirements.

Generate product realization planning outputs.

Establish records of product realization activities.

7.2 Customer-related processes
7.2.1 Determination of requirements related to product

Clarify your product requirements.

Identify requirements specified by your customers.

Identify requirements dictated by your product's intended use.

Identify requirements imposed by your regulatory bodies.

Identify requirements defined by your organization.

7.2.2 Review of requirements related to product

Evaluate product requirements before you accept orders.

Review product requirements before you supply products.

Verify product requirements before you agree to accept orders.

Confirm that product requirements can be met before you proceed.

Maintain a record of your product requirement reviews.

7.2.3 Communication

Plan arrangements to communicate with customers.

Document your customer communication arrangements.

Implement your customer communication arrangements.

Maintain your customer communication arrangements.

Establish arrangements to communicate with regulatory authorities.

Use your arrangements to communicate with regulatory authorities.

7.3 Design and development
7.3.1 General

Establish procedures for design and development.

Document procedures for design and development.

7.3.2 Design and development planning

Plan the design and development of your products.

Document your product design and development plans.

Maintain your design and development planning documents.

Control the design and development of your products.

7.3.3 Design and development inputs

Determine product design and development inputs.

Review your product design and development inputs.

Approve your product design and development inputs.

Maintain a record of design and development inputs.

7.3.4 Design and development outputs

Generate suitable design and development outputs.

Verify your product design and development outputs.

Approve your product design and development outputs.

Maintain records of design and development outputs.

7.3.5 Design and development review

Plan your organization's design and development reviews.

Perform reviews in accordance with planned arrangements.

Maintain records of your design and development reviews.

7.3.6 Design and development verification

Plan your design and development verification activities.

Document your design and development verification plans.

Perform verifications in accordance with planned arrangements.

Keep records of your design and development verification activities.

7.3.7 Design and development validation

Plan your organization's design and development validation activities.

Document your organization's design and development validation plans.

Perform validations in accordance with your planned arrangements.

Keep records of design and development validation activities.

7.3.8 Design and development transfers

Develop procedures to control design and development transfers.

Use your procedures to control design and development transfers.

Record design and development transfer results and conclusions.

7.3.9 Control of design and development changes

Establish procedures to control design and development changes.

Use your procedures to control design and development changes.

Maintain a record of medical device design and development changes.

7.3.10 Design and development files

Maintain a design and development file for each family of medical devices.

Include or reference records that document compliance and changes.

7.4 Purchasing
7.4.1 Purchasing process

Establish procedures to control product purchases.

Establish supplier evaluation and selection criteria.

Establish supplier monitoring and re-evaluation plans.

Monitor the performance of your organization's suppliers.

Take action whenever suppliers fail to meet purchasing requirements.

Establish supplier evaluation, selection, and monitoring records.

7.4.2 Purchasing information

Plan your organization's product purchases.

Review purchase requirements before sharing them.

Maintain your organization's purchasing documents and records.

7.4.3 Verification of purchased product

Develop methods and activities to verify purchased products.

Make arrangements to verify the products you plan to purchase.

Verify that your purchased products meet purchase requirements.

Consider what to do when changes are made to purchased products.

Establish and maintain a record of purchased product verifications.

7.5 Production and service provision
7.5.1 Control medical device production and service provision

Plan your production and service provision activities.

Carry out production and service provision activities.

Monitor production and service provision activities.

Control production and service provision activities.

7.5.2 Define requirements for cleanliness or contamination controls

for process agents that must be removed from products during manufacture.

Identify products that you clean prior to sterilization or use.

Document and maintain your cleanliness or contamination control requirements for products that you clean prior to sterilization or use.

Identify products that cannot be cleaned prior to sterilization or use.

Document and maintain your cleanliness or contamination control requirements for products that can't be cleaned prior to sterilization or use.

Identify products supplied non-sterile to be cleaned before sterilization or use.

Document and maintain cleanliness or contamination control requirements for products supplied non-sterile to be cleaned before sterilization or use.

Identify products that must be clean when used but are supplied non-sterile.

Document and maintain cleanliness or contamination control requirements for products that must be clean when used but are supplied non-sterile.

Identify process agents that must be removed from product during manufacture.

Document and maintain cleanliness or contamination control requirements for process agents that must be removed from products during manufacture.

7.5.3 Specify product installation and verification requirements

Establish medical device installation requirements.

Document your medical device installation requirements.

Establish medical device installation verification requirements.

Document your organization's installation verification requirements.

7.5.4 Develop servicing procedures and reference materials

Establish medical device servicing procedures and reference materials.

Document your medical device servicing procedures and reference materials.

Use your procedures and materials to control medical device servicing activities.

Maintain a record of your organization's medical device servicing activities.

Identify improvement opportunities and servicing complaints.

7.5.5 Maintain a record of sterilization process parameters

Establish a record of your organization's sterilization process parameters.

Record sterilization process parameters for each batch of medical devices.

7.5.6 Validate processes used for production and service provision

Identify processes that generate outputs that are not or cannot be verified by subsequent monitoring and measurement until it's too late.

Establish procedures to validate production and service delivery processes and software applications that could affect your products and services.

Validate processes and software applications that could generate output deficiencies and could affect your products and services.

7.5.7 Validate processes for sterilization and sterile barrier systems

Document procedures used to validate processes for sterilization and sterile barrier systems.

Establish procedures used to validate processes for sterilization and sterile barrier systems.

Implement procedures used to validate processes for sterilization and sterile barrier systems.

Maintain procedures used to validate processes for sterilization and sterile barrier systems.

7.5.8 Preserve product identity throughout product realization

Prepare procedures and systems to control the identity of medical devices.

Document your organization's product identification systems and procedures.

Implement your organization's product identification systems and procedures.

7.5.9 Establish suitable traceability procedures and records
7.5.9.1 Establish suitable product traceability procedures

Establish your product traceability procedures.

Implement your product traceability procedures.

Maintain your product traceability procedures.

7.5.9.2 Establish suitable records for implantable devices

Establish your traceability records for implantable medical devices.

Expect suppliers of distribution services to have distribution records.

7.5.10 Protect property supplied for medical devices by customers

Identify property supplied by customers to be used by medical devices.

Verify property supplied by customers to be used by your medical devices.

Safeguard property supplied by customers to be used by medical devices.

Maintain a record of customer property that is lost, damaged, or unsuitable.

Report lost, damaged, or unsuitable customer property to your customers.

7.5.11 Preserve medical device products and components

Establish procedures to preserve the conformity of products.

Document and maintain your product preservation procedures.

Use your procedures to preserve the conformity of products.

Prevent medical device damage, alteration, and contamination.

Protect products when exposed to hazards and expected conditions.

7.6 Control of monitoring and measuring requirements

Identify monitoring and measurement requirements.

Select suitable monitoring and measurement equipment.

Establish your monitoring and measurement procedures.

Prepare your calibration and verification plans and procedures.

Protect your organization's monitoring and measurement equipment.

Develop monitoring and measurement software validation procedures.

8. Measurement, Analysis, and Improvement
8.1 General

Plan monitoring, measurement, and analytical processes.

Plan how monitoring methods will be used ensure conformity and effectiveness.

Plan how measurement will be used to ensure conformity and effectiveness.

Plan how analytics will be used to ensure conformity and effectiveness.

8.2 Monitoring and measurement
8.2.1 Feedback

Establish feedback methods and procedures.

Examine the information you have gathered.

Use your feedback to measure QMS effectiveness.

Use your feedback to facilitate risk management.

Use your feedback to support improvement processes.

Use your feedback to enhance product realization.

8.2.2 Complaint handling

Establish your complaint handling procedures.

Document your complaint handling procedures.

Implement your complaint handling procedures.

Maintain your complaint handling procedures.

8.2.3 Reporting and regulatory authorities

Establish reporting procedures when regulators expect you to report to them.

Document reporting procedures when regulators expect you to report to them.

Implement reporting procedures when regulators expect you to report to them.

Maintain reporting procedures when regulators expect you to report to them.

8.2.4 Internal audit

Establish your organization's internal audit procedure.

Plan your organization's internal audit programme.

Carry out your internal audits at planned intervals.

Maintain a record of audit plans and performance.

Eliminate all detected nonconformities and causes.

Follow-up on steps taken to resolve nonconformities.

8.2.5 Monitoring and measurement of processes

Establish suitable methods to monitor and measure each QMS process.

Apply suitable methods to monitor and measure each QMS process.

8.2.6 Monitoring and measurement of product

Monitor and measure your organization's product characteristics.

Establish a record of product monitoring and measurement activities.

Complete all planned arrangements before you release your products.

Establish a record of implantable medical device testing and inspection.

8.3 Control of nonconforming product
8.3.1 General

Clarify how you intend to prevent unintended product delivery or use.

Prevent the unintended delivery or use of your nonconforming products.

Establish a record of your organization's nonconforming product activities.

8.3.2 Actions in response to nonconforming product detected before delivery

Deal with nonconforming products prior to delivery.

Take action to eliminate detected nonconformities.

Prevent the product's original intended use or application.

Authorize nonconforming product use, release, or acceptance.

8.3.3 Actions in response to nonconforming product detected after delivery

Identify nonconforming products after delivery or after use has started.

Take action that is appropriate to the effects that have been identified.

Establish and maintain a record of the actions that have been taken.