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Free ISO 13485:2016 Gap Analysis Tool

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4.0 QUALITY MANAGEMENT SYSTEM
4.1 GENERAL REQUIREMENTS








4.2 DOCUMENTATION REQUIREMENTS
4.2.1 GENERAL

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

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


4.2.4 CONTROL OF DOCUMENTS

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.


4.2.5 CONTROL OF RECORDS



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.


5.0 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT


5.2 CUSTOMER FOCUS


5.3 QUALITY POLICY

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

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

Click here to see an example Quality Objectives document.

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

Click here to see an example Quality Objectives document.
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING


5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 RESPONSIBILITY AND AUTHORITY


 5.5.2 MANAGEMENT REPRESENTATIVE


5.5.3 INTERNAL COMMUNICATION


5.6 MANAGEMENT REVIEW
5.6.1 GENERAL



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.

Management review records must be maintained.

Click here to see an example Management Review Minutes.
5.6.2 REVIEW INPUT

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

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


6.2 HUMAN RESOURCES
6.2.1 GENERAL

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

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




 6.4 WORK ENVIRONMENT AND CONTAMINATION CONTROL
6.4.1 WORK ENVIRONMENT


6.4.2 CONTAMINATION CONTROL


7.0 PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION







7.2 CUSTOMER-RELATED PROCESSES
7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT

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.

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT











7.2.3 CUSTOMER COMMUNICATION

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.

7.3 DESIGN AND DEVELOPMENT
7.3.1 GENERAL



7.3.2 DESIGN AND DEVELOPMENT PLANNING

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

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


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.




7.3.3 DESIGN AND DEVELOPMENT INPUTS






7.3.4 DESIGN AND DEVELOPMENT OUTPUTS






7.3.5 DESIGN AND DEVELOPMENT REVIEW

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.




7.3.6 DESIGN AND DEVELOPMENT VERIFICATION




7.3.7 DESIGN AND DEVELOPMENT VALIDATION






7.3.8 DESIGN AND DEVELOPMENT TRANSFER






7.3.9 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

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

Click here to see a sample Change Review Record.




7.3.10 DESIGN AND DEVELOPMENT FILES


7.4 PURCHASING
7.4.1 PURCHASING PROCESS

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.




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.

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

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.


7.4.3 VERIFICATION OF PURCHASED PRODUCT




7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

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

Click here to see a sample Product SpecificationRecord of Product/Service Conformance and  Quality Plan.


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


7.5.3 INSTALLATION ACTIVITIES



7.5.4 SERVICING ACTIVITIES



7.5.5 PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES



7.5.6 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION







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



7.5.8 IDENTIFICATION




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

Click here to see a sample Record of Traceability.


7.5.9 TRACEABILITY




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

Click here to see a sample Record of Traceability.


7.5.10 CUSTOMER PROPERTY






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



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

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.




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,






8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 GENERAL




8.2 MONITORING AND MEASUREMENT
8.2.1 FEEDBACK


8.2.2 COMPLAINT HANDLING


8.2.3 REPORTING TO REGULATORY AUTHORITIES


 8.2.4 INTERNAL AUDIT

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.

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.



Records of audits and their results must be maintained.

Click here to see an example Internal Audit Report.


8.2.5 MONITORING AND MEASUREMENT OF PROCESSES




8.2.6 MONITORING AND MEASUREMENT OF PRODUCT






8.3 CONTROL OF NONCONFORMING PRODUCT
8.3.1 GENERAL



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






8.3.3 ACTIONS IN RESPONSE TO NONCONFORMING PRODUCT DETECTED AFTER DELIVERY




8.3.4 REWORK


8.4 ANALYSIS OF DATA






8.5 IMPROVEMENT
8.5.1 GENERAL


8.5.2 CORRECTIVE ACTION





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





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
% of the requirements of ISO 13485 in your medical devices Quality Management System. Here are some notes on what is still needed.

NOTE: Please open all the elements that you want to be e-mailed to you.

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strahinja-iso-expert

Strahinja Stojanovic
Lead ISO 13485 expert

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