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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

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