Free ISO 13485:2016 Gap Analysis Tool

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4.0 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS

1. Have you established a Quality Management System (QMS) meeting the requirements of the ISO 13485 International Standard?

YesNo

A Quality Management System (QMS) needs to be established and its effectiveness improved in accordance with the ISO 13485 requirements.

2. Did the QMS determine the processes, process sequence, and process resources including monitoring and improvement?

YesNo

The QMS needs to include the sequence and interaction of processes, the criteria and methods to ensure effectiveness, and the availability of resources and information for the processes.

3. Do you manage these processes in accordance with the requirements of the ISO 13485 International Standard?

YesNo

Processes need to be managed per the ISO 13485 requirements.

4. Do you manage the processes, including adequate control over any processes the organization has chosen to outsource?

YesNo

The QMS needs to monitor, measure, and analyze the processes, implement actions to achieve planned results, and improve and ensure control over processes that have been outsourced.

4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL

5. Does the QMS documentation include the quality policy, quality objectives, quality manual, documented records, and procedures (required by ISO 13485 and necessary for the processes)?

YesNo

The QMS documentation needs to include a quality policy, quality objectives, quality manual, documented procedures, and records required by ISO 13485 and the organization.

Click here to see samples of the Quality Policy, Quality Objectives, and Quality Manual.

4.2.2 QUALITY MANUAL

6. Is there a quality manual that includes QMS scope, any exclusions, the documented procedures (or references), and interactions between processes?

YesNo

The quality manual must be established, maintained, and contain scope and exclusions, the QMS procedures or reference to them, and it must show how the company processes interact.

Click here to see an example of a Quality Manual.

4.2.3 MEDICAL DEVICE FILES

7. Is a file established and maintained for each medical device type or each family of medical devices? Does it include reference documents showing that you comply with regulations and with ISO 13485? Does it include description, production procedures, inspection specifications, and records of each device type or device family?

YesNo

The organization is required to maintain a medical device file for each device type or family. The medical device file should include a reference document for complying with applicable regulations and ISO 13485, description of device family or type, production procedures, inspection specifications, and records of each device type or device family.

4.2.4 CONTROL OF DOCUMENTS

8. Are documents required by the Quality Management System controlled?

YesNo

The organization needs to have a documented procedure for control of documents, which should include approval, review and update, identification of changes and revision status, and it must ensure that only relevant versions are available.

Click here to see an example of a Procedure for Document and Record Control.

9. Is there a procedure to define the controls needed for effective document control (review, update, changes, and relevant versions available)?

YesNo

The document procedure needs to ensure that documents remain legible and identifiable, that documents of external origin are identified and have controlled distribution, and it must prevent unintended use of obsolete documents.

4.2.5 CONTROL OF RECORDS

10. Are records established and controlled to provide evidence of conformity?

YesNo

Records must be established to show process and product conformity.

11. Is a documented procedure established to define the controls needed for the identification, storage, protection, retrieval, retention, and disposal of records?

YesNo

The organization needs to have a documented procedure for control of records that includes establishment and control, defining the controls for identification, storage, protection, retrieval, retention, and disposal of records.

Click here to see an example of the Procedure for Document and Record Control.

12. Do records remain legible, readily identifiable, and retrievable?

YesNo

Records need to remain legible, identifiable, and retrievable.

5.0 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

13. Does top management show commitment to the QMS, communicating requirements, quality policy, and quality objectives, and conducting management reviews and ensuring resources?

YesNo

Top management must provide evidence of commitment to the QMS and improving its effectiveness by communicating the importance of meeting customer and other requirements, establishing a quality policy and quality objectives, conducting management reviews, and ensuring that resources are available.

5.2 CUSTOMER FOCUS

14. Does top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction?

YesNo

Top management needs to ensure customer requirements are met to enhance customer satisfaction.

5.3 QUALITY POLICY

15. Is there an appropriate quality policy, including commitment to meet requirements, improvement, quality objectives framework, communication, and review for suitability?

YesNo

The quality policy needs to be appropriate to the organization, should include a commitment to comply with requirements and to improve the QMS, and provide a framework for quality objectives. The quality policy must also be communicated and understood in the organization and be reviewed to ensure it continues to be suitable.

Click here to see an example Quality Policy document.

5.4 PLANNING

5.4.1 QUALITY OBJECTIVES

16. Does top management ensure quality objectives are established at relevant functions and levels?

YesNo

Top management needs to ensure quality objectives are established throughout the organization (including product objectives).

Click here to see an example Quality Objectives document.

17. Are the quality objectives measurable and consistent with the quality policy?

YesNo

Quality objectives need to be measurable and consistent with the quality policy.

Click here to see an example Quality Objectives document.

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

18. Does top management plan the QMS in order to meet ISO 13485 requirements and the quality objectives, and maintain the integrity of the QMS when changes are planned?

YesNo

Top management needs to ensure the QMS is carried out in accordance with the ISO 13485 general requirements and the quality objectives, and the integrity must be maintained when changes are made.

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY

19. Does top management ensure that responsibilities and authorities are defined and communicated?

YesNo

Responsibilities and authorities must be defined and communicated.

5.5.2 MANAGEMENT REPRESENTATIVE

20. Is there a management representative who ensures processes are working, reports on QMS performance and need for improvement, and promotes customer requirements?

YesNo

A member of management needs to be appointed to ensure QMS processes are maintained, report to top management on QMS performance and improvement needs, and promote awareness of customer requirements.

5.5.3 INTERNAL COMMUNICATION

21. Does top management ensure that appropriate communication processes are established (especially for QMS effectiveness)?

YesNo

Communication processes need to be established and used to communicate the effectiveness of the QMS.

5.6 MANAGEMENT REVIEW

5.6.1 GENERAL

22. Does top management review the QMS at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness?

YesNo

Top management needs to review the QMS to ensure it remains suitable, adequate, and effective.

23. Does management review include opportunities for improvement and the need for changes, including the quality policy and quality objectives?

YesNo

Management review must include opportunities for improvement and the need for QMS changes, including quality policy and quality objectives.

Click here to see an example Procedure for Management Review.

24. Are records from management reviews maintained?

YesNo

Management review records must be maintained.

Click here to see an example Management Review Minutes.

5.6.2 REVIEW INPUT

25. Do management review inputs include audit results, customer feedback, process and product performance, status of PA & CA, action follow-up, potential QMS changes, and improvement recommendations?

YesNo

Management review inputs should include results of audits, customer feedback, process performance and product conformity, status of PA & CA, follow-up of previous actions, changes that could affect the QMS, and recommendations for improvement.

Click here to see an example Customer Feedback Report, Registry and Status of Corrective and Preventive Action, Matrix of Key Performance Indicators, and Data Analysis Report.

5.6.3 REVIEW OUTPUT

26. Do management review outputs include decisions and actions to improve QMS and process effectiveness, product improvements, and resource needs?

YesNo

Management review outputs need to include QMS process improvement, improvement of product conformity to customer requirements, and resource needs.

Click here to see an example Management Review Minutes.

6.0 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES

27. Are there assigned resources to implement and maintain the QMS, continually improve QMS effectiveness, and enhance customer satisfaction through customer requirements?

YesNo

Resources need to be determined and provided to implement and maintain the QMS, improve its effectiveness, and enhance customer satisfaction by meeting customer requirements.

6.2 HUMAN RESOURCES

6.2.1 GENERAL

28. Are the employees who are responsible for accomplishing the working procedures related with product conformity competent in the meaning of appropriate education, training, skills, and experience?

YesNo

Personnel needs to be deemed competent to perform work that affects product conformity to requirements.

Click here to see an example Procedure for Human Resources.

6.2.2 COMPETENCE, TRAINING AND AWARENESS

29. Have you determined the needed competence, provided the necessary training, evaluated training effectiveness, and maintained appropriate records?

YesNo

The organization needs to determine the competence needed for personnel, provide necessary training to achieve that competence, evaluate the effectiveness of the actions taken, ensure that personnel are aware of the importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriate records of education, training, skills, and experience.

Click here to see an example Training Program and Training Record.

6.3 INFRASTRUCTURE

30. Do you define, provide, and maintain the infrastructure needed to achieve product requirements?

YesNo

The organization needs to define, provide, and maintain the infrastructure needed to achieve product requirements.

31. Does infrastructure include, as applicable, buildings, associated utilities, process equipment (hardware and software), and supporting services (e.g., transport, communication, or IT services)?

YesNo

Infrastructure can include buildings and associated utilities, process equipment (both hardware and software), and supporting services (such as transport, communication, or IT services).

6.4 WORK ENVIRONMENT AND CONTAMINATION CONTROL

6.4.1 WORK ENVIRONMENT

32. Have you established, documented, monitored, and controlled the work environment needed to meet product requirements according to ISO 13845?

YesNo

An organization is required to identify the work environment needed to meet product and regulatory requirements; moreover, these requirements for work environment should be documented. Additionally, the organization is required to identify and document work conditions that can affect product quality, and a procedure is required to monitor and control work conditions. Finally, the organization is required to list those individuals who come into contact with product and work environment, and then establish health, cleanliness, and clothing requirements for these individuals. Those individuals who work temporarily under special conditions should also be controlled.

6.4.2 CONTAMINATION CONTROL

33. Has the organization created documented procedures to control contaminated or potentially contaminated products so as to prevent contamination of work environment, personnel, and other products? For sterile medical devices, does the organization have documented procedures for control of contamination with particulate matters or microorganisms during assembly and packaging processes?

YesNo

The organization should create a documented implementation plan as to how they are going to control products that are or may be contaminated. Moreover, the organization should also have a documented implementation plan as to how the organization is going to control the contamination of sterile medical devices in the final processes.

7.0 PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION

34. Do you plan and develop the processes needed for product realization consistent with the requirements of the other processes?

YesNoN/A

The organization needs to plan and develop the processes needed for product realization consistent with the requirements of the other processes of the QMS.

You have indicated that you do not perform product realization planning. You should have an exclusion for this in your Quality Manual.

35. In production planning, are there product quality objectives, processes and documents, resources, product measurement activities, and necessary records?

YesNoN/A

The organization must determine, as appropriate, product quality objectives and requirements, processes and documents, resources for the product, required acceptance activities for the product (with acceptance criteria), and records needed.

36. Is the output of this planning in a form suitable for the organization’s method of operations?

YesNoN/A

The output of this planning needs to be in a form suitable for the organization’s method of operations.

7.2 CUSTOMER-RELATED PROCESSES

7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT

37. Are all product requirements determined (customer, unstated but necessary requirements, statutory and regulatory, and additional requirements considered necessary)?

YesNoN/A

The organization needs to determine all requirements, including those specified by the customer (with delivery and post-delivery activities), not stated by the customer but necessary, statutory and regulatory, and any additional requirements considered necessary.

Click here to see an example Sales Procedure and Product Requirement Review Record.

You have indicated that you do not determine requirements related to the product. You should have an exclusion for this in your Quality Manual.

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

38. Are product requirements reviewed prior to committing to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes)?

YesNoN/A

The organization needs to review the requirements prior to the commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes).

You have indicated that you do not review requirements related to the product. You should have an exclusion for this in your Quality Manual.

39. Does the review ensure product requirements are defined, differing requirements are resolved, and the organization can meet all requirements?

YesNoN/A

The review needs to ensure that product requirements are defined, differing requirements are resolved, and that the organization has the ability to meet the requirements.

40. Are records of the results of the review and actions arising from the review maintained?

YesNoN/A

Records of the results of the review and actions arising from the review must be maintained.

41. Where the customer provides no requirements, are the customer requirements confirmed by the organization before acceptance?

YesNoN/A

Where the customer provides no documented requirements, the customer requirements must be confirmed by the organization before acceptance.

42. Where the product requirements are changed, does the organization ensure documents are amended and personnel are made aware of the changes?

YesNoN/A

Where the requirements are changed, the organization must ensure that relevant documents are amended and that relevant personnel are made aware of the changes.

7.2.3 CUSTOMER COMMUNICATION

43. Do you communicate with customers about product information, inquiries, contract and order handling and amendments, customer feedback, and customer complaints?

YesNoN/A

The organization needs to determine and implement effective arrangements for communicating with customers about product information, inquiries, contracts or order handling, and customer feedback.

Click here to see a Registry of Customer Complaints template.

You have indicated that you do not have customer communication. You should have an exclusion for this in your Quality Manual.

7.3 DESIGN AND DEVELOPMENT

7.3.1 GENERAL

44. Does the organization have a comprehensive documented procedure for design and development of medical devices?

YesNoN/A

An organization is required to have a procedure for design and development that should meet all the requirements of ISO 13485:2016.

You have indicated that you do not perform design work. You should have an exclusion for design and development in your Quality Manual.

7.3.2 DESIGN AND DEVELOPMENT PLANNING

45. Do you plan and control design and development of product?

YesNoN/A

The organization needs to plan and control design and development of product.

Click here to see an example Procedure for Design and Development.

You have indicated that you do not perform design work. You should have an exclusion for design and development in your Quality Manual.

46. Do you determine the stages, reviews, appropriate verification and validation, responsibilities and authorities for design and development?

YesNoN/A

During the design and development planning, the organization must determine the stages, reviews, verification and validation for each stage, and responsibilities and authorities.

Click here to see a sample Project Plan and Review.

47. Are interfaces managed between different groups involved in design and development to ensure effective communication and clear assignment of responsibility?

YesNoN/A

The organization needs to manage interfaces between different groups involved in design and development, and ensure effective communication and clear assignment of responsibility.

48. Is the planning output updated, as appropriate, as the design and/or development progresses?

YesNoN/A

The planning output needs to be updated, as appropriate, as the design and/or development progresses.

7.3.3 DESIGN AND DEVELOPMENT INPUTS

49. Are inputs relating to product requirements determined and records maintained?

YesNoN/A

Inputs relating to product requirements must be determined and records maintained.

50. Do inputs include functional and performance requirements, statutory and regulatory requirements, information from previous designs, and other essential requirements?

YesNoN/A

These inputs need to include functional and performance requirements, statutory and regulatory requirements, information derived from previous similar designs, and other essential requirements.

51. Are the inputs reviewed for adequacy, and are requirements complete, unambiguous and not in conflict with each other?

YesNoN/A

The inputs need to be reviewed for adequacy and complete, unambiguous, and non-conflicting requirements.

7.3.4 DESIGN AND DEVELOPMENT OUTPUTS

52. Are the outputs of design and development in a form suitable for verification against the design and development input?

YesNoN/A

The outputs of design and development must be able to be verified against the inputs.

53. Are the design and development outputs approved prior to release?

YesNoN/A

Design outputs must be approved prior to release.

54. Do design outputs meet input requirements, provide purchasing, production and service information, include acceptance criteria, and specify essential characteristics?

YesNoN/A

Outputs need to meet the input requirements, provide purchasing, production and service information, include acceptance criteria and specify essential characteristics of the product.

7.3.5 DESIGN AND DEVELOPMENT REVIEW

55. Are systematic planned reviews performed, at appropriate design and development stages, in order to evaluate if the design will meet requirements, and to identify any potential problems?

YesNoN/A

At appropriate stages, planned reviews of design and development need to be performed in order to evaluate that the design will meet requirements, identify any problems, and propose necessary actions.

Click here to see a Design Review Minutes template.

56. Do participants in reviews include representatives of functions concerned with the stage(s) being reviewed?

YesNoN/A

Participants in such reviews need to include representatives of functions concerned with the design and development stage(s) being reviewed.

57. Are records of the results of the reviews and any actions maintained?

YesNoN/A

Records of the results of the reviews and any necessary actions must be maintained.

7.3.6 DESIGN AND DEVELOPMENT VERIFICATION

58. Is verification planned and performed to ensure the design and development outputs meet the input requirements?

YesNoN/A

Verification needs to be planned and performed to ensure the design and development outputs meet the input requirements.

59. Are records maintained of the results of the verification and any actions?

YesNoN/A

Records of the results of the verification and any necessary actions must be maintained.

7.3.7 DESIGN AND DEVELOPMENT VALIDATION

60. Is design and development validation planned and performed to ensure that the resulting product is capable of meeting requirements?

YesNoN/A

Design and development validation needs to be planned and performed to ensure that the resulting product is capable of meeting the requirements.

61. Where practicable, is validation completed prior to the delivery or implementation of the product?

YesNoN/A

Where practicable, validation should be completed prior to the delivery or implementation of the product.

62. Are records of the results of validation and any actions maintained?

YesNoN/A

Records of the results of validation and any necessary actions must be maintained.

7.3.8 DESIGN AND DEVELOPMENT TRANSFER

63. Has the organization developed procedures to control design and development transfers?

YesNoN/A

The organization is required to develop procedures to control design and development transfers and ensure that it can effectively control these transfers. The organization is also required to maintain records for these transfers.

64. Do your procedures control design and development transfers?

YesNoN/A

65. Does the organization record design and development transfer results and conclusions?

YesNoN/A

7.3.9 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

66. Are design and development changes identified, and records maintained?

YesNoN/A

Design and development changes must be identified, and records maintained.

Click here to see a sample Change Review Record.

67. Are the changes reviewed, appropriately verified and validated, and approved before implementation (including the effect of the changes to parts and delivered product)?

YesNoN/A

Changes need to be reviewed, verified and validated, and approved before implementation, including evaluation of the changes to constituent parts and product already delivered.

68. Are records of the review of changes and any actions maintained?

YesNoN/A

Records of the review of changes and any necessary actions must be maintained.

7.3.10 DESIGN AND DEVELOPMENT FILES

69. Does the organization maintain design and development files for each family of medical devices, with compliance records?

YesNoN/A

The organization is required to maintain design and development files for each part of the design and development process. The organization is also required to keep records for the results of design and development, which should be compliant with the design requirements.

7.4 PURCHASING

7.4.1 PURCHASING PROCESS

70. Do you ensure that purchased product conforms to specified purchase requirements?

YesNoN/A

The organization needs to ensure that purchased product conforms to specified purchase requirements.

Click here to see an example Procedure for Purchasing and Evaluation of Suppliers.

You have indicated that you do not need a purchasing process. You should have an exclusion for this in your Quality Manual.

71. Are the suppliers evaluated and selected based on criteria that involve the effect of the purchased product on the quality of medical devices?

YesNoN/A

The suppliers should be evaluated and selected based on criteria that involve the effect of the purchased product on the quality of medical devices.

72. Do you evaluate and select suppliers based on their ability to meet the organization's requirements, using established criteria?

YesNoN/A

The organization needs to evaluate and select suppliers based on their ability to meet the organization's requirements, and the criteria must be established.

Click here to see a sample Checklist for Evaluation of Suppliers.

73. Are records of the results of evaluations and any actions arising from the evaluation maintained?

YesNoN/A

Records of the results of evaluations and any necessary actions arising from the evaluation must be maintained.

Click here to see a sample Registry of Complaints about Suppliers.

7.4.2 PURCHASING INFORMATION

74. Does purchasing information describe the purchased product, including appropriate requirements for approval, qualification of personnel, and QMS requirements?

YesNoN/A

Purchasing information needs to describe the product to be purchased, including appropriate requirements for product approval, procedures, processes and equipment, qualification of personnel, and QMS requirements.

Click here to see a sample Request and Order for Purchasing.

75. Do you ensure the adequacy of specified purchase requirements prior to their communication to the supplier?

YesNoN/A

The organization needs to ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

7.4.3 VERIFICATION OF PURCHASED PRODUCT

76. Do you ensure that purchased product meets specified purchase requirements?

YesNoN/A

The organization needs to ensure that purchased product meets specified purchase requirements.

77. If you will perform verification at the supplier’s premises, do you state the intended verification arrangements and method of product release in the purchasing information?

YesNoN/A

Where the organization or its customer intends to perform verification at the supplier’s premises, the purchasing information needs to state the verification arrangements and method of product release.

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

78. Do you plan and carry out production and service provision under controlled conditions?

YesNoN/A

The organization needs to plan and carry out production and service provision under controlled conditions.

Click here to see a sample Product Specification, Record of Product/Service Conformance and Quality Plan.

You have indicated that you do not need to control production or service provision. You should have an exclusion for this in your Quality Manual.

79. Do controls include applicable product description information, work instructions, suitable equipment, monitoring and measurements, product release, delivery and post-delivery activities?

YesNoN/A

The controlled conditions must include availability of information that describes the product, availability of work instructions, use of equipment (including monitoring and measurement), and product release, delivery and post-delivery activities.

Click here to see an example Procedure for Production and Service Provision.

7.5.2 CLEANLINESS OF PRODUCT

80. Does the organization maintain documented requirements for cleanliness of product?

YesNo

The organization is required to determine and document requirements of cleaning and contamination control for devices that are cleaned prior to sterilization, those that cannot be cleaned prior to sterilization, devices supplied as nonsterile to be cleaned before sterilization, devices supplied as nonsterile but must be cleaned when used, and process agents to be removed from product during manufacturing.

7.5.3 INSTALLATION ACTIVITIES

81. Has your organization established and documented medical device installation requirements and a requirements verification system?

YesNoN/A

The organization is required to establish and document medical device installation requirements and a verification requirements system. The organization is also required to maintain records for such installation activities and verification of installation services.

You have indicated that you do not need to control installation activities. You should have an exclusion for this in your Quality Manual.

7.5.4 SERVICING ACTIVITIES

82. Does your organization establish, document, and use medical device servicing procedures and reference materials to control medical device servicing activities?

YesNoN/A

The organization is required to maintain a record of medical device servicing activities, and maintain records and identify improvement opportunities from servicing complaints.

You have indicated that you do not need to control servicing activities. You should have an exclusion for this in your Quality Manual.

7.5.5 PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES

83. Has your organization established a record of its sterilization process parameters, and does it record sterilization process parameters for each batch of medical devices?

YesNoN/A

The organization is required to maintain a record of its medical device sterilization process parameters, and maintain records for each batch.

You have indicated that you do not need to control medical devices sterilization. You should have an exclusion for this in your Quality Manual.

7.5.6 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION

84. Do you validate any processes for production and service provision where the resulting output cannot be verified later?

YesNoN/A

The organization needs to validate production and service provision processes where the resulting output cannot be verified later.

You have indicated that you do not need to validate processes for production or service provision. You should have an exclusion for this in your Quality Manual.

85. Does validation demonstrate the ability of these processes to achieve planned results?

YesNoN/A

Validation must demonstrate the ability of these processes to achieve planned results.

86. Do process arrangements include applicable criteria for process review and approval, equipment approval, personnel qualification, specific methods, records, and revalidation?

YesNoN/A

The organization needs to establish these processes including, as applicable, criteria for review and approval, approval of equipment, qualification of personnel, methods and procedures, records and revalidation.

7.5.7 PARTICULAR REQUIREMENTS FOR VALIDATION OF PROCESSES FOR STERILIZATION AND STERILE BARRIER SYSTEMS

87. Has your organization developed a procedure for validation of processes for sterilization and for sterile barrier systems?

YesNoN/A

The organization is required to develop a procedure for validation of processes for sterilization and for sterile barrier systems. Validation records should be maintained along with actions arising from those validation results.

You have indicated that you do not need to control medical devices sterilization, as it is done by some third party. You should have an exclusion for this in your Quality Manual.

7.5.8 IDENTIFICATION

88. Do you identify the product, where appropriate, by suitable means throughout product realization?

YesNoN/A

The organization needs to identify the product, where appropriate, by suitable means throughout product realization.

You have indicated that you do not require identification of products. You should have an exclusion for this in your Quality Manual.

89. Do you identify the product status with respect to monitoring and measurement requirements throughout product realization?

YesNoN/A

The organization needs to identify the product status with respect to monitoring and measurement requirements throughout product realization.

90. Where identification is a requirement, does the organization control and record the unique identification of the product, and maintain records?

YesNoN/A

Where identification is a requirement, the organization needs to control and record the unique identification of the product, and maintain records.

7.5.9 TRACEABILITY

91. Do you maintain traceablity of the product, where appropriate, by suitable means throughout product realization?

YesNoN/A

The organization needs to maintain treaceablity of the product, where appropriate, by suitable means throughout product realization.

You have indicated that you do not require traceability of products. You should have an exclusion for this in your Quality Manual.

92. Do you maintain traceablity of product status with respect to monitoring and measurement requirements throughout product realization?

YesNoN/A

The organization needs to maintain traceability of the product status with respect to monitoring and measurement requirements throughout product realization.

93. Where traceability is a requirement, does the organization control and record the traceablity of the product, and maintain records?

YesNoN/A

Where traceability is a requirement, the organization needs to control and record the traceability of the product, and maintain records.

7.5.10 CUSTOMER PROPERTY

94. Do you exercise care with customer property while it is under your control or being used by the organization?

YesNoN/A

The organization needs to exercise care with customer property while it is under the organization’s control or being used by the organization.

You have indicated that you do not deal with customer property. You should have an exclusion for this in your Quality Manual.

95. Do you identify, verify, protect, and safeguard customer property provided for use or incorporation into the product?

YesNoN/A

The organization needs to identify, verify, protect, and safeguard customer property provided for use or incorporation into the product.

96. If customer property is lost, damaged, or otherwise found to be unsuitable for use, is it reported to the customer and records maintained?

YesNoN/A

Any customer property that is lost, damaged, or otherwise found to be unsuitable for use must be reported to the customer and records maintained.

Click here to see a sample Notification to a Customer about Changes on his Property.

7.5.11 PRESERVATION OF PRODUCT

97. Do you preserve product during processing and delivery in order to maintain conformity to requirements?

YesNoN/A

The organization needs to preserve the product during internal processing and delivery to maintain conformity to requirements.

98. As applicable, does preservation include identification, handling, packaging, storage, and protection for the product and its constituent parts?

YesNoN/A

As applicable, this preservation needs to include identification, handling, packaging, storage, and protection for the product and its constituent parts.

Click here to see an example Warehousing Procedure.

7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT

99. Do you determine the monitoring and measurement to be undertaken, and define equipment needed to provide evidence of conformity of product?

YesNoN/A

The organization needs to determine the monitoring and measurement to be undertaken, and the equipment needed to provide evidence of product conformity.

Click here to see an example List of Equipment.

You have indicated that you do not deal with monitoring and measurement equipment. You should have an exclusion for this in your Quality Manual.

100. Do you establish processes to ensure that monitoring and measurement can be carried out consistent with the monitoring and measurement requirements?

YesNoN/A

The organization needs to establish processes to ensure that monitoring and measurement can be carried out consistent with the requirements.

101. Where necessary to ensure valid results, is the measuring equipment calibrated and a valid calibration system maintained?

YesNoN/A

Where necessary, measuring equipment needs to be calibrated and/or verified against traceable standards (where no standards exist, record the basis for calibration), adjusted or re-adjusted, identified for calibration status, safeguarded from invalid adjustments, and protected from damage and deterioration.

Click here to see an example Procedure for Equipment Maintenance and Measurement Equipment, Plan for Preventive Maintenance of Equipment, and Maintenance and Calibration Record,

102. Do you assess and record the validity of previous measuring results when the equipment is found not to conform to requirements?

YesNoN/A

The organization needs to assess and record the validity of the previous measurements when equipment is found out of conformance.

103. Do you take appropriate action on the equipment and any product affected, and are records of calibration and verification maintained?

YesNoN/A

When equipment is not compliant, you need to take action on the equipment and affected product, and maintain records.

104. When used in the monitoring and measurement of requirements, is the ability of software confirmed prior to initial use and reconfirmed as necessary?

YesNoN/A

When used in the monitoring and measurement of requirements, the ability of computer software needs to be confirmed prior to initial use and reconfirmed as necessary.

8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL

105. Do you plan and implement monitoring, measurement, analysis, and improvement processes for the product, the QMS, and continual improvement?

YesNo

The organization needs to plan and implement monitoring, measurement, analysis, and improvement processes needed for the product and the QMS, and to continually improve.

106. Does this include determining applicable methods, like statistical techniques, and how they will be used?

YesNo

The planning of monitoring and measurement needs to include determination of applicable methods including statistical techniques, and the extent of their use.

8.2 MONITORING AND MEASUREMENT

8.2.1 FEEDBACK

107. Has your organization established feedback methods and procedures as identified in the standard?

YesNo

The organization is required to establish feedback methods and procedures. The organization should examine information gathered. The feedback should be used to measure QMS effectiveness, facilitate risk management, support improvement processes, and enhance product realization.

8.2.2 COMPLAINT HANDLING

108. Does you organization has documented system to report to the regulators when it is needed?

YesNo

The organization is required to develop a comprehensive documented procedure for complaint handling that should identify how complaints are received and recorded, evaluation of received information to check whether it is a complaint, complaints investigation, the need to report complaints to regulatory authorities, handling of complaints, returned product, and the need to initiate corrections and corrective actions. All records should be maintained.

8.2.3 REPORTING TO REGULATORY AUTHORITIES

109. Does your organization have a documented procedure to report an incident to regulatory authorities when an incident is required to be reported?

YesNo

The organization is required to establish a systematic procedure as to how and when an incident should be reported to regulatory authorities. Records for such actions to be maintained should also be identified in procedure.

8.2.4 INTERNAL AUDIT

110. Do you conduct internal audits at planned intervals to determine if the QMS conforms to the ISO 13485 standard and to the planned QMS requirements?

YesNo

The organization needs to conduct planned internal audits to determine whether the QMS meets planned arrangements, the ISO 13485 standard and, the QMS requirements, and is effectively implemented and maintained.

Click here to see an example of Procedure for Internal Audit and Internal Audit Checklist.

111. Is there an audit program that considers process importance, as well as previous audit results, and are the audit criteria, scope, frequency, and methods defined?

YesNo

An audit program needs to be planned considering the status and importance of processes/areas to be audited and results of previous audits, and with the audit criteria, scope, frequency, and methods defined.

Click here to see an example Internal Audit Program.

112. Does the selection of auditors and conducting of audits ensure objectivity and impartiality of the audit process, and is it ensured that auditors do not audit their own work?

YesNo

The selection of auditors and conduct of audits needs to ensure objectivity and impartiality of the audit process (auditors shall not audit their own work).

113. Are records of audits and their results maintained?

YesNo

Records of audits and their results must be maintained.

Click here to see an example Internal Audit Report.

114. Does the management of the audited area ensure that any corrections and corrective actions are taken without delay, and do follow-up activities verify the actions taken?

YesNo

The management of the audited area needs to ensure that corrections and corrective actions are taken without delay to eliminate nonconformities and their causes, and follow-up activities must include action verification.

8.2.5 MONITORING AND MEASUREMENT OF PROCESSES

115. Do you apply suitable methods for monitoring, and where applicable, measurement of the QMS processes?

YesNo

The organization needs to apply suitable methods for monitoring, and where applicable, measurement of the QMS processes.

116. Do these methods demonstrate the ability of the process to achieve planned results, and when planned results are not achieved, are appropriate corrections and corrective actions taken?

YesNo

Monitoring and measurement methods need to demonstrate that processes achieve planned results, and when planned results are not achieved, appropriate corrections and corrective actions are taken.

8.2.6 MONITORING AND MEASUREMENT OF PRODUCT

117. Do you monitor and measure the characteristics of the product to verify that product requirements have been met?

YesNo

The organization needs to monitor and measure the characteristics of the product to verify that product requirements have been met.

118. Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements, and is evidence maintained?

YesNo

Planned product monitoring and measurement needs to be carried out at appropriate stages of the process and evidence maintained.

119. Do records indicate the person(s) authorizing product release, and do you ensure product release and service delivery do not proceed if results are unsatisfactory, unless approved?

YesNo

Records of conformity need to indicate the person(s) authorizing release of product, and the organization needs to ensure that product release and service delivery do not proceed if results are unsatisfactory, unless approved.

8.3 CONTROL OF NONCONFORMING PRODUCT

8.3.1 GENERAL

120. Do you ensure that product that does not conform to product requirements is identified and controlled to prevent unintended use or delivery?

YesNo

The organization needs to ensure that product that does not conform to product requirements is identified and controlled to prevent unintended use or delivery.

121. Is a documented procedure established to define the controls and related responsibilities and authorities for dealing with nonconforming product?

YesNo

A documented procedure must be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

Click here to see an example of Procedure for Control of Non-Conforming Products.

8.3.2 ACTIONS IN RESPONSE TO NONCONFORMING PRODUCT DETECTED BEFORE DELIVERY

122. Does your organization take action to eliminate detected nonconformities with nonconforming products prior to delivery?

YesNo

The organization, in its procedure of control of non-conforming product, is required to list action items for non-conforming product detected before delivery. The procedure and non-conforming product control records shall identify that your organization takes action to remove nonconformities, prevent unintended use of nonconforming product, and authorize its use, release, and acceptance.

123. Does your organization manage to prevent the nonconforming product's unintended use or application?

YesNo

124. Does your organization authorize nonconforming product use, release, or acceptance?

YesNo

8.3.3 ACTIONS IN RESPONSE TO NONCONFORMING PRODUCT DETECTED AFTER DELIVERY

125. Does your organization identify and then take recorded actions to eliminate detected nonconformities in products after delivery or use?

YesNo

When nonconforming product is corrected, it must be recorded to demonstrate conformity to the requirements.

126. Does your organization check and authorize how advisory notices are issued against nonconforming product after use or delivery, and maintain records of actions taken against advisory notices?

YesNo

Advisory notices should be managed by the organization to control nonconforming product after delivery or use. Actions taken on these notices shall be recorded.

8.3.4 REWORK

127. Does your organization clarify in its procedure of rework how product rework should be performed, verified, reviewed, approved, and recorded?

YesNo

The organization is required to maintain a documented procedure that should clarify how rework is performed, verified, reviewed, approved, and recorded.

8.4 ANALYSIS OF DATA

128. Do you collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where improvement can be made?

YesNo

The organization needs to determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and evaluate where continual improvement can be made.

129. Do analyses include data generated as a result of monitoring and measurement and from other relevant sources?

YesNo

The analysis must include data generated as a result of monitoring and measurement and from other relevant sources.

130. Does data analysis include customer satisfaction, conformity of product, characteristics and trends of processes and products, opportunities for preventive action, and suppliers?

YesNo

The organization needs to analyze this data to provide information on customer satisfaction, conformity to product requirements, characteristics and trends of processes and products, preventive action opportunities, and suppliers.

8.5 IMPROVEMENT

8.5.1 GENERAL

131. Do you continually improve the effectiveness of the QMS through the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review?

YesNo

The organization needs to continually improve the effectiveness of the QMS through the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.

8.5.2 CORRECTIVE ACTION

132. Do you take action to eliminate the cause of nonconformities in order to prevent recurrence?

YesNo

The organization must take action to eliminate the cause of nonconformities to prevent recurrence.

133. Are corrective actions appropriate to the effects of the nonconformities?

YesNo

Corrective actions need to be appropriate to the effects of the nonconformities.

134. Is there a documented procedure to review nonconformities, determine the causes, evaluate the need for action, take action, record results of actions, and review effectiveness?

YesNo

A documented procedure must define requirements for reviewing nonconformities (including customer complaints), determining the causes, evaluating the need for action to prevent recurrence, taking action, recording results of actions taken, and reviewing the effectiveness of these actions.

Click here to see an example of the Procedure for Corrective and Preventive Action and the Corrective/Preventive Action Request.

8.5.3 PREVENTIVE ACTION

135. Do you determine action to eliminate the causes of potential nonconformities in order to prevent their recurrence?

YesNo

The organization must take action to eliminate the causes of potential nonconformities to prevent their recurrence.

136. Are preventive actions appropriate to the effects of the potential problems?

YesNo

Preventive actions need to be appropriate to the effects of the potential problems.

137. Is there a documented procedure to determine potential nonconformities and causes, evaluate the need for action, take necessary action, record results of actions, and review effectiveness?

YesNo

The documented procedure for preventive action must define requirements for determining potential nonconformities and their causes, evaluate the need for action to prevent recurrence, take necessary actions, record results of action taken, and review the effectiveness of these actions.

Click here to see an example of the Procedure for Corrective and Preventive Action and the Corrective/Preventive Action Request.

According to our gap analysis tool you have implemented

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