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Free ISO 13485:2016 Gap Analysis Tool

Free ISO 13485:2016 Gap Analysis Tool

Find out your level of compliance with ISO 13485. Please reach out to us with the details and we will provide you the solution.

Management Systems

Find out your level of compliance with ISO 13485. Please reach out to us with the details and we will provide you the solution.

Product Realization

Find out your level of compliance with ISO 13485. Please reach out to us with the details and we will provide you the solution.

Measurement, Analysis and Improvement

Find out your level of compliance with ISO 13485. Please reach out to us with the details and we will provide you the solution.

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  • Management
  • Product Realization
  • Analysis & Improvement

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Quality Management System

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

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

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

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

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)?

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

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?

Are documents required by the Quality Management System controlled?

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

Are records established and controlled to provide evidence of conformity?

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

Do records remain legible, readily identifiable, and retrievable?

Management Responsibility

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

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

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

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

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

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?

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

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

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

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

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

Are records from management reviews maintained?

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?

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

Resource Management

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

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?

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

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

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

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

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?

Quality Management System

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

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

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

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

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

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

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

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

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

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

Measurement, Analysis and Improvement

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

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

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

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

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

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?

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?

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?

Are records of audits and their results maintained?

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?

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

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?

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

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

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?

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

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

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

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

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

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

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?

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

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

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

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

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?

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

Are corrective actions appropriate to the effects of the nonconformities?

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?

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

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

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?