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Use an ISO 13485:2016 checklist to help identify process gaps

The iso 13485 2016 checklist covers everything from the identification of risks and vulnerabilities to the management of processes and procedures. It also includes a section on corrective action plans, which will help you track and measure your progress in implementing QMS enhancements. If you’re looking to improve your QMS, then it’s important to make sure that you have all the necessary pieces in place. The iso 13485 2016 checklist can be a useful tool in this process.

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Quality Management System
1.1 General Requirements
1.1.1 Development of a QMS
Maintain the effectiveness of your quality management system.
Identify the documents that ISO 13485 expects you to maintain.
Establish a quality management system (QMS).
Define the requirements for QMS documentation.
Document the company's quality management system.
Identify the documents that regulators need from you.
Identify the roles that medical device regulators expect you to play.
Identify the requirements that ISO 13485 expects you to document.
Identify the procedures that ISO 13485 requires you to document.
Identify the medical device regulations that apply to the organization.
Identify the activities that ISO 13485 expects you to document.
Identify the arrangements that ISO 13485 expects you to document.
1.1.2 Clarify structure
Determine the processes that the company's QMS requires.
Clarify how the QMS processes are applied in the company.
Indicate how the company's processes are interconnected.
Consider what tasks the regulators expect you to perform.
Use a risk-based approach to manage your company's QMS processes.
1.1.3 Support processes
Support QMS Process Operations.
Support of any QMS process.
Support monitoring of QMS processes.
Support of QMS process measurement.
Support of QMS process analysis.
Support of QMS process recording.
1.1.4 Manage changes
Meet the process management requirements of ISO 13485.
Manage changes to the organization's QMS processes.
Meet regulatory process management requirements.
Manage the QMS processes.
Satisfy change control requirements.
1.1.5 Control of outsourcing
Monitor outsourced processes that impact product conformance.
Control outsourced processes that impact product conformance.
Maintain accountability for processes that affect product conformance.
1.1.6 Validate software
Keep records of your software validation and revalidation activities.
Use your procedures to validate and revalidate software applications.
Validate computer software applications for their intended use.
Develop procedures for validating and revalidating QMS software
Develop an approach that is appropriate to the risk taken.
Validate software when its intended use changes (if applicable).
1.2 Documentation requirements
1.2.1 General
Include the documents and records that the regulations require.
Include the documents and records required by ISO 13485.
Include all required documents and records.
Include the documents and records required by the company.
1.2.2 Quality manual
Describe how the QMS processes work together.
Define the scope of the company's QMS.
Describe the structure of the QMS documentation.
Include or reference a QMS procedure.
Prepare a quality manual for the QMS.
1.2.3 Medical device file
Include or reference documents that show compliance with ISO 13485.
Include or reference documents that show compliance with regulations.
Include a file for each medical device type or group of medical devices.
Create a file for each medical device type or group of medical devices.
Include records for medical device types or medical device families.
Include documents for each medical device type or group of medical devices.
Include a description of each medical device type or medical device family.
Establish procedures for medical device types or medical device families.
Establish specifications or procedures for medical device types or families.
1.2.4 Control documents
Document the QMS document control procedure.
Identify and control the distribution of external QMS documents.
Control the company's QMS documents.
Review and approve documents before issuing them.
Establish a procedure to control QMS documents.
Retain obsolete documents for future use.
Prevent unintended or accidental use of outdated documents.
Make the correct version of documents available at points of use.
Implement a QMS document control procedure.
Protect the identity and readability of QMS documents.
1.2.5 Control of records
Create records for the company's QMS.
Document procedures for record control.
Implement procedures for record control.
Develop procedures for controlling QMS records.
Define methods to protect QMS health records.
2. Management Responsibility
2.1 Management commitment
Support the development of a QMS.
Support the maintenance of a QMS.
Demonstrate your ongoing commitment.
Support the implementation of a QMS.
2.2 Customer orientation
Ensure that external requirements are met.
Ensure that external requirements are identified.
2.3 Quality guidelines
Plan quality guidelines.
Design the quality guidelines.
Apply the quality guidelines.
Review the quality guidelines.
2.4 Planning
2.4.1 Quality objectives
Set quality objectives for the company.
Set objectives required to meet product requirements.
Set objectives required to meet regulatory requirements.
2.4.2 Quality management system planning
Plan how you will develop a QMS.
Plan how you will improve the QMS.
Plan how you will manage a QMS.
Plan how you will implement a QMS.
Plan how you will document a QMS.
Plan how you will monitor a QMS.
Plan how you will control a QMS.
Plan how you will maintain a QMS.
2.5 Responsibility, authority, and communication
2.5.1 Responsibility and authority
Determine QMS responsibilities and authorities.
Note how QMS employees are interrelated.
Report QMS responsibilities and authorities.
2.5.2 Management representative
Select a member of management to look over your QMS.
Give management representative power and responsibility.
Select authority and responsibility for filing and documenting your QMS.
Select authority and responsibility for reporting to top management.
Select authority and responsibility for increasing corporate awareness.
2.5.3 Internal communication
Strengthen talks about the effectiveness of your QMS.
Organize proper internal communication processes.
3.6 Management review
3.6.1 General
Establish management review methods.
Plan your reviews at scheduled intervals.
Examine your QMS at planned intervals.
Keep a record of management reviews.
3.6.2 Review input
Examine the results of prior audits.
Examine your complaint handling actions.
Examine prior improving and preventive actions.
Examine changes that could influence the QMS.
Examine controlling and measurement activities.
Evaluate new or revised regulatory demands.
Examine prior management reviews.
Gather information about your QMS (inputs).
Examine recommendations for development.
3.6.3 Review output
Form your management review services and products.
Make decisions and take actions to develop your QMS.
Make decisions and take actions to improve your products.
Make decisions and take actions to handle supervisory changes.
Make decisions and take actions to approach relevant resource requirements.
Develop a record of your management reports.
4. Resource Management
4.1 Provisional resources
Supply the assets that your QMS requires.
Supply the assets needed to use your QMS.
Supply the resources needed to meet customer demands.
Supply the assets required to meet regulatory demands.
Define the equipment/staff/sources/... that your QMS needs.
4.2 Human resources
Build a process to regulate the competence of medical device workers.
Use your process to control if your medical device workers are working perfectly.
Select employees and examine work that could influence product quality.
Select proper methods for assessing your training and knowledge activities.
Sustain records for the competence of medical device workers.
4.3 Infrastructure
Identify sustaining activities that could influence quality.
Manage the structure that your QMS needs to have.
Report QMS infrastructure demands.
Supply the infrastructure that your QMS requires.
4.4 Work environment and contamination control
5.4.1 Work environment
Document your company's demands for this work atmosphere.
Document methods to control these working conditions.
Identify the working circumstances that affect the quality of your products.
Document your company's needs for these working circumstances.
Identify the work environment required to meet product demands.
Identify employees who could influence medical device safety or performance.
Identify those who come into contact with outcomes or connected environments.
Set health, cleanliness, and clothing conditions for these employees.
Check those who work temporarily under that particular environmental conditions regularly.
5.4.2 Contamination control
Plan how you want to control the contamination of sterile medical devices.
Plan how you want to control outcomes that are or could be contaminated.
6. Product Realization
6.1 Planning of product realization
Create outputs that plan product realization.
Develop the methods that you need to produce your products or services.
Generate a risk management process for product accomplishment.
Set up records of product realization activities.
Plan how you want to realize each product.
Plan the methods that are required to realize products.
Define quality objectives for your product.
Clarify particular product realization demands.
6.2 Customer-related processes
6.2.1 Determination of requirements related to product
Identify demands determined by your company.
Define your product demands clearly.
Identify the demands dictated by your product's proposed use.
Identify the demands required by your regulatory bodies.
Identify the demands specified by your buyers.
6.2.2 Review of requirements related to product
Sustain a record of your product specification reviews.
Review product conditions before you provide products.
Check product specifications before you agree to accept orders.
Confirm that you can keep your product demands before you proceed.
Assess product demands before you accept orders.
6.2.3 Communication
Plan meetings to talk to customers.
Meet your customers.
Report your customer meetings.
Keep your customer communication meetings.
Plan meetings to talk to regulatory authorities.
Use your meetings to talk with regulatory authorities.
6.3 Design and development
6.3.1 General
Establish schemes and plans for design and development.
Document schemes for design and development.
6.3.2 Design and development planning
Plan the design and improvement of your products.
Note down your product design and development projects.
Manage your design and development planning documents.
Observe the design and improvement of your products.
6.3.3 Design and development inputs
Examine your product design and development information.
Confirm your product design and development inputs.
Define product design and development information.
Sustain a document of design and development inputs.
6.3.4 Design and development outputs
Create suitable design and development outputs.
Verify your product design and improvement outputs.
Confirm your product design and development outputs.
Sustain records of design and improvement outputs.
6.3.5 Design and development review
Plan your company's design and improvement reviews.
Perform studies in accordance with scheduled arrangements.
Sustain records of your design and improvement reviews.
6.3.6 Design and development verification
Document your design and improvement verification plans.
Implement verifications in accordance with planned systems.
Keep documents of your design and improvement verification activities.
Organise your design and improvement verification activities.
6.3.7 Design and development validation
Plan your company's design and improvement in validation activities.
Document your company's design and development validation plans.
Accomplish validations in accordance with your planned agreements.
Maintain records of design and improvement validation activities.
6.3.8 Design and development transfers
Develop methods to control design and improvement transfers.
Use your methods to control design and improvement transfers.
Record design and improvement transfer results and conclusions.
6.3.9 Control of design and development changes
Establish processes to control design and improvement changes.
Apply your processes to control design and development changes.
Sustain a record of medical device design and improvement changes.
6.3.10 Design and development files
Include or reference documents that document compliance and changes.
Keep a design and developing file for every family of medical devices.
6.4 Purchasing
6.4.1 Purchasing process
Establish supplier assessment, selection, and monitoring records.
Verify supplier assessment and selection criteria.
Establish methods to control product purchases.
Verify supplier controlling and re-evaluation plans.
Control the performance of your company's suppliers.
Do something about the suppliers that fail to meet purchasing necessities.
6.4.2 Purchasing information
Plan your company's product purchases.
Review purchase conditions before sharing them.
Keep your company's purchasing documents and records.
6.4.3 Verification of purchased product
Make arrangements to check the products you plan to buy.
Check that your purchased products meet purchase demands.
Think about what to do when changes are made to the products you bought.
Improve methods and activities to check purchased products.
Verify and sustain a record of purchased product verifications.
6.5 Production and service provision
6.5.1 Control medical device production and service provision
Monitor production and service provision activities.
Implement production and service provision activities.
Make plans for your production and service provision activities.
Control production and service provision actions.
6.5.2 Define demands for cleanliness or contamination controls
Identify outcomes that you clean before sterilization or use.
Document and sustain your cleanliness or contamination control demands for products that you clean before sterilization or use.
Document and sustain cleanliness or contamination control demands for products supplied non-sterile to be cleaned prior to sterilization or use.
Define demands for cleanliness or contamination checks for process agents that must be excluded from products throughout manufacture.
Report and maintain your cleanliness or contamination control demands for products that cannot be cleaned before sterilization or use.
Find out which products cannot be cleaned before sterilization or use.
Document and sustain cleanliness or contamination control demands for process agents that must be excluded from products during production.
Find out which products supplied non-sterile to be cleaned before sterilization or use.
Identify outcomes that must be clean when used but are supplied non-sterile.
Document and maintain cleanliness or contamination checks needed for products that must be clean when used but are supplied non-sterile.
Identify process agents that must be excluded from product during production.
6.5.3 Specify product installation and verification requirements
Document your company's installation verification demands.
Report your medical device installation demands.
Establish medical device installation demands.
Establish medical device installation verification demands.
6.5.4 Develop servicing procedures and reference materials
Report your medical device servicing procedures and reference supplies.
Identify development opportunities and servicing complaints.
Develop medical device servicing methods and reference supplies.
Use your methods and materials to check medical device servicing activities.
Sustain a record of your company's medical device servicing actions.
6.5.5 Maintain a record of sterilization process parameters
Document sterilization process parameters for each bunch of medical devices.
Develop a record of your company's sterilization process parameters.
6.5.6 Validate processes used for production and service provision
Approve processes and software applications that could create output deficiencies and could affect your products and services.
Identify processes that create outputs that are not or cannot be confirmed by subsequent controlling and measurement until it's too late.
Establish processes to verify production and service delivery processes and software applications that could influence your products and services.
6.5.7 Validate processes for sterilization and sterile barrier systems
Document procedures used to validate processes for sterilization and sterile barrier systems.
Establish methods used to validate processes for sterilization and sterile barrier systems.
Sustain procedures used to verify processes for sterilization and sterile barrier systems.
Perform procedures used to validate processes for sterilization and sterile barrier systems.
6.5.8 Preserve product identity throughout product realization
Prepare methods and systems to control the identification of medical devices.
Document your company's product identification systems and methods.
Apply your company's product identification systems and procedures.
6.5.9 Establish suitable traceability procedures and records
6.5.9.1 Establish suitable product traceability procedures
Sustain your product traceability methods.
Establish your product traceability methods.
Apply your product traceability methods.
6.5.9.2 Establish suitable records for implantable devices
Assume that suppliers of distribution services have distribution records.
Establish your traceability documents for implantable medical devices.
6.5.10 Protect property supplied for medical devices by customers
Document lost, damaged, or unsuitable customer property to your customer.
Document property supplied by buyers to be used by your medical devices.
Safeguard property supplied by buyers to be utilised by medical devices.
Classify property supplied by buyers to be used by medical devices.
Sustain a record of customer property that is lost, broken, or unsuitable.
6.5.11 Preserve medical device products and components
Defend products when exposed to dangers and expected hazard situations.
Document and sustain your product preservation methods.
Use your methods to preserve the conformation of products.
Establish methods to preserve the conformity of products.
Limit medical device harm, alteration, and contamination.
6.6 Control of monitoring and measuring requirements
Choose suitable controlling and measurement equipment.
Develop controlling and measurement software validation methods.
Establish your controlling and measurement methods.
Develop your calibration and verification plans and methods.
Identify the controlling and measurement demands.
Protect your company's controlling and measurement equipment.
7. Measurement, Analysis, and Improvement
7.1 General
Think about how analytics will be used to assure conformity and effectiveness.
Plan controlling, measurement, and analytical methods.
Think about how measurement will be used to assure conformity and effectiveness.
Plan how controlling methods will be used to assure conformity and effectiveness.
7.2 Monitoring and measurement
7.2.1 Feedback
Develop feedback methods and procedures.
Examine the information you have collected.
Use your feedback to measure QMS effectiveness.
Use your feedback to improve product realization.
Use your feedback and critics to facilitate risk management.
Use your feedback to help develop processes.
7.2.2 Complaint handling
Establish your customer complaint handling methods and systems.
Use your complaint handling methods.
Report your complaint handling methods.
Sustain your complaint handling methods.
7.2.3 Reporting and regulatory authorities
Establish reporting methods when regulators want you to report to them.
Document reporting methods when regulators want you to report to them.
Implement a reporting plan when regulators require you to report to them.
Sustain reporting methods when regulators want you to report to them.
7.2.4 Internal audit
Plan your company's internal audit schedule.
Monitor steps taken to address nonconformities.
Implement your internal audits at prepared intervals.
Sustain a record of audit plans and performance.
Eliminate all noticed nonconformities and causes.
Establish your company's internal audit method.
7.2.5 Monitoring and measurement of processes
Implement suitable procedures to observe and measure each QMS process.
Establish proper methods to observe and measure each QMS process.
7.2.6 Monitoring and measurement of product
Establish a record of fixable medical device testing and inspection.
Establish a document of product controlling and measurement activities.
Control and measure your company's product characteristics.
End all scheduled arrangements before you release your products.
7.3 Control of nonconforming product
7.3.1 General
Define how you plan to prevent unintended product shipping or use.
Establish a document of your company's nonconforming product activities.
Check the unintended shipping or use of your nonconforming products.
7.3.2 Actions in response to nonconforming product detected before delivery
Empower nonconforming product use, release, or acceptance.
Take action to remove detected nonconformities.
Handle nonconforming products before delivery.
Limit the product's first intended use or application.
7.3.3 Actions in response to nonconforming product detected after delivery
Establish and sustain a record of the efforts that have been taken.
Classify non-conforming products after shipment or after use has started.
Take action that is suitable to the effects that have been classified.
Define how your advisory notes should be handled and managed.
Keep a document of actions taken when advisory notices are handled.
7.3.4 Rework
Define how product rework should be documented.
Clarify how product rework should be established.
Explain how product rework should be examined.
Clarify how product rework should be implemented.
Explain how product rework should be approved.
7.4 Analysis of data
Plan how you will assess your QMS.
Establish methods to assess your QMS.
Take your analytical results to develop your QMS.
7.5 Improvement
7.5.1 Take action to change QMS and products
Recognize changes required to assure medical device safety and performance.
Find changes that sustain QMS suitability, fitness, and effectiveness.
Find out any changes that must be made.
Make those changes that must be made.
7.5.2 Take action to correct actual nonconformities
Record a corrective action process.
Specify how improving actions will be established.
Specify how the actual problems will be reviewed.
Explain how improving action will be investigated.
Explain how improving actions will be checked.
Explain how improving action will be taken.
Use your corrective action process.
Sustain records of corrective action taken.
7.5.3 Take action to prevent potential nonconformities
Report a preventive action method.
Sustain documents of preventive action taken.
Explain how possible problems will be investigated.
Explain you are going to take those preventive action.
Explain how defensive actions will be revealed.
Explain how preventive actions will be authenticated.
Explain how preventive action will be examined.
Use your preventive action procedure.
Confirmation
Any further comments/observations?
Name Auditor
Signature Auditor
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Improve your QMS with an iso 13485 2016 checklist


Medical devices are critical to the safety of patients, users, and others. These products are regulated by the medical device regulation (MD) in order to ensure their safety, effectiveness, quality, and security. The iso 13485 2016 checklist is used to help identify gaps in your Quality Management System (QMS). By using the iso 13485 checklist, you will be able to assess your system’s compliance with the MD requirements. This will help to ensure that your medical devices are safe and effective for use by patients and others.


If you’re a company that manufactures or offers medical devices, you’ll want to make sure that your products are certified as being of high quality. This is especially important if you want to sell your products in important markets such as the United States and Europe. Iso 13485 2016 certification is the standard used to certify the quality of medical devices. If your products don’t meet this standard, it’s likely that they will be refused access to these markets.


The iso 13485 2016 checklist can be structured and customized in such a way that all areas can be processed step by step without omitting important aspects. For this purpose, Lumiform’s provided iso 13585 checklist contains the basic audit questions for all standard requirements of the current Iso 13485:2016 and supports companies in meeting individual requirements.

Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.

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