Published 28 Nov 2022
What is an ISO 14971 Checklist?
An ISO 14971 checklist is a form based on the guidelines of ISO 14971, a voluntary international standard that details how to apply risk management practices for medical devices. This ISO standard was developed by different experts in medicine, engineering, and quality management.
Use this template to better manage your medical devices and their risk management. You can also use this checklist to:
- Standardize quality and risk management inspections
- Report problems in manufacturing and risk management as you see them
- Ensure your medical devices are safe for use by your staff and possible end users
In this article
- What to Include in an ISO 14971 Checklist
- FAQs about ISO 14971 Checklists
- Managing Medical Devices with a Digital Auditing Tool
- Related ISO 14971 Checklists
While ISO 14971 is a voluntary standard, conforming to it ensures that good manufacturing processes are followed in the creation and risk management of medical devices. However, ISO 14971 is a nine-part standard, and keeping up with it can be challenging. For this reason, it can be beneficial to have a dedicated ISO 14971 checklist.
Having an ISO 14971 checklist can help streamline the workflows of medical device manufacturers, as it can assist them in better identifying which framework to use for product analysis, evaluation, review, and control. An ISO 14971 checklist can also help quality-check each stage or phase of a medical device’s life cycle, as it can help in analyzing risks related to data and system security, electricity management, radiation, biocompatibility, and overall usability.
An ISO 14971 checklist can also help with:
- Identifying issues with risk management and assessment
- Complying with internal standards and other ISO standards, such as ISO 13485, which details the creation and distribution of medical devices and related services
- Ensuring all proper procedures for creating and disposing of medical devices and related parts are followed
- Following risk management guidelines, such as that of ISO 31000
What to Include in an ISO 14971 Checklist
Before anything else, a risk management plan should be set in place for all employees to follow. Each medical device and its parts should have its own risk management plan to guide employees on how to manage risks at every stage of its life cycle. The risk management plan should also detail what levels of risks are acceptable or manageable and should be put together in a Risk Management File (RMF) for easier access later on. The ISO 14971 checklist will then be used in conjunction with the risk management plans in place.
There are many ways to create an ISO 14971 checklist, as each manufacturer has different procedures, standards, and guidelines. However, a simple ISO 14971 checklist will ideally contain sections for the following:
- Description of the product: What is the product or part being managed or questioned?
- Risk analysis: What hazard(s) or risk(s) can this product or part bring to the company or its intended user?
- Risk evaluation: How can the identified hazard(s) or risk(s) harm the company or its users?
- Risk control or mitigation: What measures should be taken to reduce or eliminate risks?
- Evaluation of overall residual risk: What other kinds of risks are left behind or can be left behind after implementing mitigation plans?
- Risk management review: What conclusion can be drawn after taking the necessary steps to reduce or eliminate risks and hazards?
- Post-production review: Are there any recommendations for future risk management plans, uses, and the like?
After conducting a risk management inspection, the ISO 14971 checklist should be cross-referenced with the risk management plans. This is to identify other possible risks and problems in manufacturing, as well as ensure that all proper plans were followed.
FAQs about ISO 14971 Checklists
Manufacturers of medical devices are the primary audience for the ISO 14971 standard. However, some medical device users and sellers also refer to it as a basis for following good manufacturing procedures and standards.
Yes, ISO 14971 is a harmonized standard. A harmonized standard means that it is accepted by the European Commission and is compliant with the European Directives’ standards and requirements for use.
“EN” standards for the “European Norm” and is the equivalent of ISO in the European market. EN ISO 14971 is essentially the same as ISO 14971 but with different annexes. If you are manufacturing and doing other businesses in Europe, it is best to follow the EN ISO standards.
Managing Medical Devices with a Digital Auditing Tool
Follow ISO 14971 standards and properly implement risk management quality inspections on your medical devices using a digital checklist tool such as SafetyCulture (formerly iAuditor). SafetyCulture is a risk management and quality assurance software that offers free ISO 14971 checklists to help manufacturers conduct risk management practices on medical devices anytime and anywhere, all from a mobile-first app.
SafetyCulture’s Public Library offers a wide array of checklist templates that can be edited as needed and stored in the cloud. Alternatively, users can create their own ISO 14971-based checklists, if they prefer, or convert their existing Word, PDF, Excel, and PowerPoint ones for SafetyCulture use to get the same benefits. All iAuditor checklists can be accessed from any internet-powered device and shared across different employees and teams as necessary, ensuring everyone is on the same page.
With SafetyCulture, you can also:
- Attach media and notes to your checklists to provide proof of compliance and noncompliance
- Raise issues in risk management and assessment in-app and notify the necessary people in one place
- Address problems by directly assigning corrective actions to those who can solve them
- Improve workplace communication by using the Heads Up feature to share announcements across your entire organization or team
- Generate analytical reports to better understand problems in risk management and quality control
Related ISO 14971 Checklists
This general gap analysis template converted using SafetyCulture (iAuditor) can be used to evaluate the employee's current performance and identify target goals. Use this checklist template to assess the areas for improvement and create action plans on how to achieve these goals.