ISO Standards  >  FDA ISO 13485

FDA ISO 13485

Harmonize and Modernize the Quality System Regulation for Medical Devices with FDA ISO 13485

A practical blueprint aimed to guide organizations in the implementation, development, and maintenance of their quality management system in accordance with ISO 13485

FDA ISO 13485
FDA ISO 13485

ISO 13485:2016 is the global standard determining requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and suitable regulatory requirements. Those organizations can be involved in one or multiple stages of the life-cycle, including production, storage and distribution, design and development, installation, or servicing of a medical device and design and development or provision of associated activities. It can also be used by internal and external suppliers or parties, such as certification bodies, to help them with their auditing processes. ISO 13485 is applicable to organizations regardless of their size and type and accounts for the companies’ QMS system by monitoring, maintaining, and controlling the processes.

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Defining FDA ISO 13485

As medical device supply chains are rapidly globalizing, regulatory bodies have dealt with how to bridge the gap between domestic and foreign regulations. Without an integrated approach to regulations, implementing best practices to ensure that regulatory processes are followed and adequately documented is still more challenging.

In May 2018, FDA first proposed revising its current Quality System Regulations (QSR) under 21 CFR Part 820 to more precisely align with the international ISO 13485:2016 standard as the basis for its quality system legislation. This signals an essential step forward for the international standard, which is already used globally. FDA ISO 13485 QMS standard for medical devices enables controlling processes to ensure that the end product meets the desired quality and safety requirements.

Manufacturers who have not addressed ISO 13485 should start assessing their QMS to find out whether there are any gaps to meet the ISO 13485 guidelines and realign processes for compliance. Organizations should be re-certified every three years to maintain their ISO 13485 certification status.

fda iso 13485 defination

Benefits of Implementing FDA ISO 13485

Safety and performance of medical devices are the most important in this highly regulated industry; this is why quality management systems are a regulatory or legal requirement in many countries. Implementing ISO 13485 can help organizations concerned in any part of a medical device’s life cycle with the following:

Financial Benefits and Universal Recognition: FDA ISO 13485 has become the model QMS standard for the medical industry and is recognized by the Global Harmonization Task Force (GHTF). It has been found that QMS certified companies experience proven improvements in financial performance as compared to uncertified ones. An ISO 13485 quality management system can help an organization:

  • Meet regulatory, contractual, legal, and marketing requirements.
  • Enhanced product safety.
  • Align closely to the FDA QSR standard.

Boost Customer Satisfaction: Many organizations implement ISO 13485 and obtain certification because an organization with an efficient QMS will usually meet customer expectations better than organizations that do not have a proper QMS. If any organizations’ central focus is on the customer, then the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs.

Internal Performance through Process Improvement: FDA ISO 13485 stresses management review, audit processes, and improved processes based on collected data. Using a system of documentation and analysis, improvements can be planned and implemented, ensuring better operations, improved performance, and higher profitability.

Effective Decision Making & Involvement of Top Management: In an organization focused on quality goals, the management has access to data on a continual basis to see progress or lack thereof. With periodic Management Reviews (Clause 5.6), performance is evaluated against goals on a scheduled basis and appropriate action taken where required.To meet the requirements of the standard, top management involvement with regards to the FDA Quality Management System Medical Devices increases. To ensure implementation of the Quality Policy (Clause 5.3), teh management can take action to make sure that the quality goals are met, new targets are set, and continual improvement is accomplished. The quality policy also ensures that corrective action must be taken whenever errors occur.

Employee Involvement: ISO 13485 requires that employees should understand their role in the QMS. Better training and qualification of employees lead to performance consistency, increased involvement and productivity, less scrap and rework. ISO 13485 creates a work environment with feedback and idea-sharing, allowing employees the opportunity to provide their thoughts on on-going processes.

ISO 13485 - Medical Devices Manufacturing

ISO 13485 Medical Devices Manufacturing

Purpose of FDA Quality Management System Medical Devices

The FDA Quality Management System (QMS) for Medical Devices ensures the consistent production of high-quality and safe medical devices. This systematic framework minimizes defects and malfunctions, enhancing patient safety and reducing manufacturer liability.


Enforcing the FDA Quality Management System for Medical Devices (QMSMD) has numerous advantages for manufacturers of medical devices:

Elevated Product Quality and Safety:

The stringent structure of the FDA Quality Management System Medical Devices guarantees the consistent production of top-tier medical devices, mitigating the risk of defects and malfunctions. This results in heightened patient safety and decreased liability for manufacturers.

Heightened Regulatory Compliance:

The FDA Quality Management System Medical Devices aligns seamlessly with international standards such as ISO 13485, facilitating a smooth journey toward regulatory compliance and market access. This simplifies the approval process, reducing the likelihood of regulatory delays or penalties.

Enhanced Efficiency and Cost-Efficiency:

The systematic approach of the FDA Quality Management System Medical Devices fosters process optimization, minimizing waste and leading to cost savings. This not only improves manufacturing efficiency but also enhances overall organizational productivity.

Improved Customer Satisfaction:

Consistently delivering high-quality and safe products enables manufacturers to cultivate robust customer trust and satisfaction. This results in an augmented brand reputation and an expanded market share.

Continuous Enhancement:

The FDA Quality Management System Medical Devices underscores continuous improvement through data analysis and feedback mechanisms. Manufacturers can proactively identify and address quality issues, further refining their products and processes.

Global Market Reach:

Implementing a QMSMD aligned with ISO 13485 opens avenues to global markets, enabling manufacturers to broaden their reach and market share. This encourages international collaboration and knowledge sharing within the medical device industry.

What are FDA ISO 13485 Requirements?

Requirements for regulatory purposes are becoming more stringent throughout every step of a product’s life cycle, including service and delivery. Organizations are expected to illustrate their QMS processes and ensure best practice in everything they do. For each QMS, the organization should:

  • Define the processes needed for the QMS and apply a risk-based approach.

  • Establish criteria and methods needed to ensure that both the operation and control of these processes are efficient.

  • Ensure the availability of information and resources essential to support the operation and monitoring of these processes.

  • Implement actions to achieve desired results and maintain the effectiveness of these processes.

  • Monitor, analyze, and measure the impact of these processes.

ISO 13485, an internationally accepted standard, specifies the requirements for a QMS, particularly for the medical devices industry. FDA is aligning its requirements to this standard to drive a global convergence of medical device regulatory processes.



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Best Practices for FDA ISO 13485

Manufacturers must follow and establish QMS to ensure their products can meet desired requirements and specifications. The FDA has determined in the QS regulation the vital elements that a quality system shall incorporate as the QS regulation includes a wide spectrum of production processes, devices, etc. Manufacturers should determine the necessity of some quality elements to develop and implement specific procedures tailored to their particular processes and devices.

Medical device training delivers the knowledge and skills that you need to comply with global requirements and boost your organization’s performance. By integrating with CQ Document Management, ComplianceQuest’s interactive and comprehensive training programs provide a learning experience for quality assurance or regulatory affairs professionals by giving appropriate permission for users on any device anywhere, anytime.

fda iso 13485 best practices

All the QMS processes in one software, excellent choice.

We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.

Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.

Laura Granados,
QMS Systems Development Consultant

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fda iso 13485 key features

CQ Key Features in FDA ISO 13485

ComplianceQuest helps you organize your company’s ISO 13485:2016 requirements to manage and maintain the applicable regulatory requirements for quality, regulations and responsibilities as well as demonstrates a commitment to the safety and quality of medical device products. ISO 13485 adapts the ISO 9001 PDCA (Plan, Do, Check, Act) process model designed for regulatory compliance. It is prescriptive, requiring a more demanding QMS and documentation to improve productivity while easily helping auditors and notified bodies to find what they need quickly and effortlessly.

ComplianceQuest’s document management solution enables an organization to create, revise, collaborate, and maintain all important documents and medical device files and can provide the latest version to appropriate permission users on any device anywhere, anytime.

ComplianceQuest also helps the top management to gain insights from the QMS embedded in their organization and maintain its effectiveness by monitoring operational and performance key metrics.

Meet customer needs and applicable regulatory requirements for medical devices and related services with CQ's integrated cloud-based ISO 13485 software solution

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Frequently Asked Questions

  • Generally, all ISO standards are being reviewed every five years to establish if a revision is needed to keep it updated and relevant for the marketplace. ISO 13485:2016 is designed to address the latest QMS practices, including changes in regulatory requirements and technology. The revised version emphasizes on risk-based decision-making as well as changes related to the increased regulatory requirements for organizations in the supply chain.

  • ISO 13485 is important because this standard enables companies to reduce safety and legal risks while creating more economical work environments. ISO 13485 emphasizes more in-depth specifics to improve safety and customer satisfaction as the outcome of a quality-driven culture. Validation of process, risk management, equipment, and cleanliness throughout the product life cycle are important drivers of quality. ISO 13485 has been reviewed every five years and revised according to new requirements and requirements of the industry.

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