ISO 13485 Compliance

The International Standards Organization (ISO) creates documents that provide guidelines to ensure that products, processes or services are fit for their manufactured use. Standards ensure the quality we’ve come to expect in goods and services we purchase.

Standards such as ISO 13485 are created by technical committees whose members are experts in their fields. These committees are comprised of ISO members from around the world.

Standards may take years to develop and approve and once approved, they may supplant other well-known standards. For example, FDA is working with the ISO Technical Committee to combine certain parts of 21CFR Part 820 with ISO 13485. Professionals working in quality administration need to stay current on these types of international developments.

ISO 13485 - Change? Do I Have To??

Free Resources

Select all the resources you’re interested in downloading

ISO Standard

  • Although ISO 13485 compliance is voluntary in the United States, it provides a framework for meeting medical device quality requirements in international markets. ISO 13485 compliance also helps meet the requirements outlined in the FDA’s 21 CFR Part 820 for the Quality System Regulations (also known as QSR and cGMP), which is applicable to medical device manufacturers and importers. In the U.S., compliance to FDA QSR is required. Any U.S.-based company that wishes to market its medical device products globally must comply with both 21 CFR Part 820 and ISO 13485.
  • While ISO 13485 compliance is also voluntary in Europe, it outlines the requirements for a comprehensive management system for the design and manufacture of medical devices. Complying with ISO 13485 is often seen as the first step in complying with European regulatory requirements. ISO conformance is important because the conformity of medical devices and in vitro diagnostic medical devices according to EEC Decrees Regulation (EU) 2017/745, Regulation (EU) 2017/746 (MDR and IVDR) must be assessed before the sale of the medical device is allowed. ISO 13485 certification allows devices makers to meet the aforementioned EU Regulations with less difficulty, which expedites market entry.
  • •Unlike Europe and the U.S., ISO 13485 compliance is compulsory in both Canada and Japan. Conformance to ISO 13485 is necessary in order to secure a Canadian Medical Device License for Canadian class II, III or IV medical device. Japanese Ministry of Health, Labour and Welfare (MHLW) Ordinance #169 is based on ISO 13485, and it is required in Japan.

Automation Optimizes ISO 13485 Compliance

Meeting the requirements for ISO 13485 involves completing a great deal of paperwork. ISO registration using automation ensures an orderly compilation of the information in a format that is quick and easy to retrieve and simple to update.

Transforming manual processes into automated processes in areas such a document control and process management can provide dramatic results in terms of assuring ISO 13485 compliance and maintaining ISO 13485 certification.

Business and Operational Benefits of ISO 13485 Compliance

Businesses desiring to be competitive in today’s international markets find implementing and maintain a quality management system imperative for product differentiation. Conforming to ISO 13485 can deliver a number of benefits:

  • Financial benefits: When company processes correspond to the ISO 13485 standard, it means they are transparent. Transparency saves money. Unclear or vague documentation, which is often what keeps company processes and ISO 13485 compliance at odds, is avoided.
  • Reduced cost of sales: ISO 13485 certification establishes a company’s credibility and dedication to quality. Prospects recognize the value the certification and understand the investment in quality a company makes to earn it.
  • Marketing and promotional benefits: Companies deemed ISO 13485 compliant receive a certificate which can be displayed on corporate advertising and marketing materials, leading to increased credibility with customers, employees and stakeholders. Increased credibility ultimately leads to increased brand equity, a desirable competitive advantage.
  • Communication and operational benefits: ISO 13485 compliance promotes harmonization, e.g., a standardized quality vocabulary. When device makers are using the same language to communicate, there is less chance of miscommunication and misunderstandings that can lead to deviations and other quality events than cause patient harm and regulatory sanctions.

End ISO Frustration with MasterControl Quality Excellence

MasterControl’s Quality Excellence solutions are aimed at helping medical device companies ensure that there are compliant with ISO 13485-2016. Quality Excellence solutions automate and accelerate documents and change control, training, CAPA, audits, risk and mitigation and validation throughout the product life cycle from a single centralized system. Learn more about how the MasterControl Quality Excellence system can help you achieve compliance with ISO 13485-2016 guidelines.

MasterControl and the FDA

MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the FDA’s Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).