ISO 13485 Certification

Introduction to Quality Management System

Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on the health of the patients, and thus various regulatory bodies across the world also mandate the implementation of the Quality Management System (QMS) for which the most widely recognized and established international standard is ISO 13485. This standard is published by the International Organization for Standardization (ISO) and is currently in the 2016 version.

What are the requirements of the ISO 13485 standard?

SO 13485 standard has eight clauses, with the first three providing scope, references, and definitions, whereas the last five explain the necessary prerequisites for a Quality Management System. The clauses are as follows:

Clause 1: Scope 
Clause 2: References
Clause 3: Definitions
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis, and Improvement

Can a medical device company place products on the market after receiving an ISO 13485?

No, an ISO certification is documentary proof that the company complies with the international standard for QMS related to medical devices. It doesn’t convey that the product can be sold in any particular country. Because, in order to legally sell a medical device in a market, a company also needs regulatory approval in addition to a strong QMS.

Is ISO 13485 a mandatory requirement? Can a manufacturer sell medical devices without ISO 13485?

Mandatory or voluntary compliance with ISO 13485 depends on the target country, the classification of the device, and the involved regulatory body.

E.g. For a CE Mark, ISO 13485 certification is mandatory, except for certain classes of devices. On the other hand, the US FDA does not look for an ISO 13485 certification; however, it wants companies to have a system compliant with 21 CFR Part 820  and recognizes Medical Device Single Audit Program (MDSAP) as well.

Know why CE Marking is an important requirement for the European market. 

Which Regulatory Bodies require ISO 13485 certification?

⦿ European Union: As per the latest Harmonised Standards list released by the EU for MDR 2017/745 dated 01/04/2022, the ISO 13485:2016/EN ISO 13485:2016+A11:2021 standard(s) are included and shall be used to demonstrate compliance with the Quality Management System requirements as stated in Article 8 of MDR 2017/745 regulation. However, it should be kept in mind that the manufacturer shall at all times comply with the ISO 13485 requirements and additional QMS requirements listed throughout the MDR 2017/745 regulation.

⦿ Health Canada: Canadian Medical Device Regulations (SOR 98-282) require QMS for medical device companies (CAN/CSA-ISO 13485:2016) for regulatory purposes. Further, As of January 01, 2019, Health Canada only accepts Medical Device Single Audit Program (MDSAP) certificates as proof of the Manufacturer’s Quality Management System. The MDSAP certification shall include ISO 13485:2016 requirements and the Canadian Medical Device Regulation (CMDR) requirements under its scope.

⦿ US FDA: It has Title 21 Code of Federal Regulation (CFR) Part 820 for regulating the Quality System. As per the latest news from FDA, the ISO 13485 standard will be included in the regulation, 21 CFR Part 820, if finalized. There will be alignment between ISO 13485 and existing requirements in the FD&C Act to make sure there are no inconsistencies.

⦿ Saudi Arabia: Saudi Food & Drug Authority (SFDA) released the guidelines document MDS-35 for implementing the QMS requirement based on ISO 13485:2016. SFDA also released the guidelines MDS-45 which provides information on the requirements of QMS for Distributors, Importers, and Authorized Representatives.

⦿ Japan: Japan has mostly included the clauses of ISO 13485 as the foundation for their QMS needs. Still, the Ministerial Ordinance issued by Japan for medical devices and in-vitro diagnostic devices (MHLW MO 169) has other QMS requirements that companies should comply with.

⦿ Malaysia: The Medical device Act (Act 737) mandates the implementation of a Quality Management System according to ISO 13485 standard.

⦿ Singapore: QMS in compliance with ISO 13485 standard is mandatory as mentioned in the document Health Products (Medical Devices) Regulations 2010.

⦿ Australia: The document “Conformity Assessment Standard for Quality Management Systems” published by TGA describes Quality Management Systems shall be in compliance with ISO 13485:2016.

⦿ Brazil: The medical device companies must meet the Brazilian GMP requirements. The latest resolution RDC No. 665/2022 released by the National Health Surveillance Agency of Brazil(ANVISA) is in line with the ISO 13485:2016 requirements except for a few additional requirements.

⦿ India: The Government of India released the Medical Devices Rules in 2017 which has the QMS requirements based on ISO 13485 standard.

How long does it take to obtain an ISO 13485 certification?

It entirely depends upon the medical device that the company is manufacturing. Also, it depends upon the scope and size of the organization. Typically it takes around 3 to 4 months for smaller organizations whereas it can take up to a year for an organization with more employees.

What are the benefits of ISO 13485 Certification?

⦿  Compliance with QMS requirements

⦿  Improved relationship with customers as their confidence increased

⦿  Increase in business opportunities with other companies/distributors, new customers

⦿  Increases efficiency of the company

⦿  The company can market its products in various jurisdictions

⦿  Improvement in the company’s output/performance

How can Elexes help your organization in getting an ISO certificate?

Given the several benefits of an ISO 13485 certification, many medical device companies choose to get this certification early on. Elexes has been involved and has led several such endeavors in the following ways

  • End-to-end support for ISO 13485 certification while working with your certification body
  • Identification of the scope of the ISO 13485 certificate
  • Draft and review various documents required for ISO 13485 implementation like Quality Manual, Quality policy, Quality objective and applicable Standard Operating Procedures (SOPs), Work instructions, etc.
  • Assist in training the employees for all the created documents and ensure the effective implementation
  • Ensure the compliance of the product with applicable regulatory requirements and performance standards
  • Conduct internal audits to help find the existing non-conformities and support the organization for the Stage I and Stage II external audits for ISO 13485 certification
  • Perform supplier assessments and ensure that the Approved Supplier List (ASL) is up to date


Confused about where to start the process?

We understand that the process of getting ISO 13485 certified is a difficult one for many medical device companies, but it is not impossible! You might also have numerous questions such as

⦿  What is the cost involved in an ISO 13485 certification?

⦿  How long does it take to get a company ISO certified?

Elexes has a dedicated team who are experts at QMS. Elexes will be happy to assist in obtaining your QMS certificate. Please feel free to send us an email at or dial +1 650-503-6615 for further clarifications.

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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