Are Your Medical Devices Up to Code? 14 Tips to Implement ISO 13485:2016

Are Your Medical Devices Up to Code? 14 Tips to Implement ISO 13485:2016

In Spring 2018, the Food and Drug Administration announced it would revise its Quality System regulation for medical devices. The federal agency said it would use the existing requirements and specifications of ISO 13485:2016. An international consensus of experts developed these standards to manufacture medical devices.

The FDA says the revisions would harmonize domestic and international requirements. This step will help reduce compliance and recordkeeping burdens on device manufacturers. It will also modernize regulation at the agency.

In today’s obp blog, you’ll learn about the ISO 13485:2016 standard and how to implement it at your business.

What are Medical Devices?

The Food and Drug Administration defines medical devices under section 201 (h) of the Federal Food Drug & Cosmetic (FD&C) Act. A medical device is an instrument, apparatus, implant, in vitro reagent, or similar tool. Medical professionals use them for the diagnosis, prevention, and treatment of health conditions and diseases.

Medical devices include components, parts, or accessories that meet the following requirements.

  1. The United States Pharmacopoeia, National Formulary, or any supplement recognizes them.
  2. The medical tools’ primary use is to diagnose health conditions. They help mitigate, treat, prevent, or cure diseases in human beings or animals.
  3. The devices can affect the bodily structure or functions of human beings or animals.
  4. Additionally, the medical devices don’t achieve their treatment goals using chemical action or metabolization.

All medical devices are subject to regulation by the Food and Drug Administration. The manufacturers must follow the FDA’s premarketing and postmarketing regulatory controls.

There are a wide variety of medical devices that range from simple to complex. For example, medical tools can be tongue depressors, bedpans, cardiac pacemakers, prosthetic limbs, and lung ventilators. This equipment can also include in vitro diagnostic tools like test kits, x-ray machines, ultrasound products, medical lasers, and reagents.

All medical devices are subject to regulation by the Food and Drug Administration (FDA).

What is ISO 13485 Certification?

The FDA plans to use ISO 13485 for the basis of its quality system legislation. The International Organization for Standardization (ISO) is a voluntary organization whose members establish proprietary, industrial, and commercial standards. Their ISO 13485 document unifies medical device regulatory requirements. It includes regulations that international agencies have passed to help organizations develop quality management systems for their medical tools.

The standards also help companies design, produce, install, and develop services related to medical devices. According to the most-recent ISO survey, the governing group issued 31,520 ISO 13485 certificates in 2017.


How Do Companies Use ISO 13485 Standards?

Organizations may use ISO 13485 standards during the entire development cycle of their medical devices. The regulations assist companies during their product’s initial conception, production, and post-production. These rules also cover aspects such as distribution, installation, servicing, storage, and the provision of associated services. The policies also outline the device’s final decommissioning and disposal.

Companies can use the ISO 13485 certification to help them build safer medical devices that pass certification. Additionally, customers are more likely to trust the quality of certified health tools.

The ISO reviews the ISO 13485 regularly to ensure they keep up with the latest QMS practices and the evolution of medical device technology.

These international organizations base these standards on eight quality management principles:

  • Leadership
  • Customer focus
  • Involvement of people
  • Process approach
  • A management system approach
  • Continual improvement
  • Fact-based decision making
  • Mutually beneficial supplier relationships

What Benefits Does ISO-13485 Bring To Organizations?

Companies must implement safety and performance protocols when they design medical devices. Many countries require quality management systems as a regulatory or legal requirement. Here are some ways the ISO 13485 can help companies.

  • The guidelines will demonstrate that you can comply with regulatory and legal requirements.
  • The standards will help your business establish QMS practices that yield consistent results for medical devices.
  • ISO 13485 rules enable companies to manage their risk effectively.
  • The regulations improve processes and efficiencies.
  • The standards help companies gain a competitive edge.
  • The regulations will streamline the decision-making processes by using facts and data to drive decisions.
  • These guidelines improve customer satisfaction by assessing customer needs, expectations, and striving to meet them.
  • The standards will create a culture of continuous improvement.

ISO 13485 Section 4 Overview: Quality Management System

The ISO requires organizations to document their quality management systems. This information helps the system to maintain its effectiveness according to the ISO’s regulatory requirements.

The ISO 13485:2016 requires companies to use a risk-based approach when using a quality management system to produce medical devices. This approach is mandatory for all outsourced products under Section Four.

Documentation: Section 4.2.2 of the ISO-13485 requires companies to document all QMS procedures. This record keeping includes all software used in the quality management system. Documentation requirements include one or more of the following documentation:

  • Businesses must create documentation about quality control policies and objectives.
  • Companies should develop a quality manual for their medical devices.
  • Organizations must document procedures as required by the ISO 13485.
  • Businesses must keep records and documentation that will ensure effective planning, operation, and control of processes.
  • They must maintain essential documentation specified by applicable regulatory requirements.

Medical Device Files: Companies create reference documentation for every device type or family. The guide will ensure that products conform to ISO regulatory requirements.

The file’s contents should include the following documentation.

  • The product should include a general description of the medical device. This information must describe its use, purpose, labeling, and instructions.
  • The guide should outline the product’s specifications.
  • The files must include manufacturing requirements to manufacture, package, store, handle, and distribute the device.
  • Medical files should have directions to install and monitor the device.
  • Documentation must provide servicing instructions.

ISO 13485 Section 5: Management Responsibility

This section requires companies to document administrative responsibilities related to management, verification, or work related to quality. Companies should record all procedures for the management review of medical devices. The management team must maintain its effectiveness by taking the following steps (as required by 5.1 under Management Commitment).

  • Communicating with their organization about the importance of meeting customer and applicable regulatory standards.
  • Companies must establish quality policies.
  • Businesses must meet quality objectives.
  • They must conduct a management review.
  • They should ensure that resources are available for QMS implementation.

ISO 13485 Section 6: Resource Management

This section requires organizations to provide the resources necessary to implement a QMS and maintain its effectiveness. All systems should adhere to applicable regulatory requirements.

Under 6.2, the ISO requires organizations to document training processes that establish workers’ competence. Organizations should:

  • Determine whether the personnel’s competence affects the quality of products.
  • Provide training to employees. Take other actions to ensure they remain competent on the job.
  • Evaluate the effectiveness of the training-related programs.
  • Ensure that workers know about the relevance and importance of ISO 13485 implementation.
  • Staff must be aware of how they contribute to the achievement of the company’s quality objectives.
  • Companies must maintain the appropriate records about education, skills, and experience.

Under this section, companies must also keep records about their infrastructure and work environment.

ISO 13485 Section 7: Product Realization

The ISO requires organizations to plan and develop processes needed for product realization. They should be consistent with the requirements of other processes of their QMS.

Organizations should document their product development process. It will help them to manage risks associated with their products.

Companies should keep records about the following:

  • Quality objectives and requirements for their product.
  • Documentation about established processes, manuals, and resources specific to the product, including the required infrastructure and work environment.
  • There must be information about required verification, validation, monitoring, and measurement. Additionally, companies should have documentation about testing, handling, storage, distribution, and traceability activities specific to their medical product. Finally, businesses should have proper criteria for the product’s acceptance according to ISO standards.
  • Files that show the realization process and resulting product meet ISO requirements.
  • Documentation should describe the output of planning in a suitable form related to their organization’s operations.

ISO 13485 Section 8: Measurement, Analysis, and Improvement

This section addresses how companies should measure, analyze, and improve their medical devices. This standard requires companies to develop processes to monitor, measure, analyze, and improve their medical devices. These steps will help companies to:

  • Demonstrate their product’s conformity to ISO 13485 standards.
  • Ensure their quality management system adheres to ISO 13485 requirements.
  • Maintain the effectiveness of their QMS.


Checklist to Implement ISO 13485 at Your Company

Here is an administrative checklist companies should follow when implementing ISO 13485.

  1. Get administrative support at the start of the ISO 13485 process. Before your company implements ISO 13485 standards, you’ll need to convince upper-level management about their benefits. This step will encourage administrators to participate in the ISO 13485 process.
  2. Next, identify all ISO 13485 requirements that your quality management system must satisfy. These include regulatory, legal, and customer-related standards. These guidelines should fit your company’s culture and goals.
  3. Develop clear QMS policies and manuals for your company. This information will help your business establish a scope for your QMS.
  4. Complete a reasonable QMS scope. It should only apply to specific areas that benefit your business. You’ll know what your business needs to do to implement these policies after you finish the scope.
  5. Define your QMS procedures and processes. The ISO 13485 says this is a mandatory requirement. Companies should identify which ones be defined to ensure consistent quality. Next, study how these processes interact with each other. This step will help you identify any problems.
  6. The ISO requires companies to document all processes and procedures for their medical devices. This step will ensure they meet ISO 13485 standards. It will help your company consistently deliver quality services and goods. Select the processes that your company should record step-by-step.
  7. Implement ISO 13485 training programs for employees. Workers must learn why your company implemented these new standards. They should also learn about policies and procedures your business will take to meet ISO standards. These education programs are critical: they will ensure QMS launch succeeds.
  8.  Select an organization to certify your QMS and ISO 13485-related policies. The right certification group can evaluate your QMS to see if it conforms to standards. Evaluators will measure the system’s effectiveness to see if it improves over time.
  9. Launch your company’s QMS, and record detailed information about its operations. This data will help auditors evaluate your QMS system. This documentation will show your processes are effective and meet ISO 13485 requirements.
  10. Conduct an internal QMS audit. Your company will need to perform this internal check before the official one. It will help your company learn whether your QMS behaves as planned. After identifying issues, you can correct any problems.
  11. Complete a management review. Administrators should examine data collected from your QMS operations. They must provide the system with the necessary resources to stay effective.
  12. Correct any problems you found during the internal audit. Find the root problems that caused errors in measurements and the management process. Take corrective action to address these issues. This step will improve your process.
  13. Finish a Stage 1 certification audit. Select an auditing board to verify your paperwork and documentation according to the ISO 13485 requirements your QMS uses. The agency should send you a report telling you which standards you complied with and the areas where you still have issues. You’ll have an opportunity to correct any problems.
  14. Conduct Stage 2 certification audit. The auditors will examine any records you collected during the QMS process. These include the management review, internal audits, and corrective actions.


obp sells medical devices that adhere to ISO 13485 standards. Our quality products are used by more than 10,000 physician’s offices and surgical centers throughout the United States and international communities. Contact us for more information.

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