What is ISO 13485 – Medical Devices-Quality Management?

What is ISO 13485 - Medical Devices-Quality Management


In this article, you will learn what is ISO 13485 – Medical Devices-Quality Management Services.

It is an internationally agreed standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry.

It has recently been revised, with the new version published in March 2016.


A medical device is a product, such as an instrument, machine, implant,  or in vitro reagent, that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.

What is the INTENDED USE of the ISO 13485?

ISO 13485 Applicability

The ISO 13485 is harmonized with ISO 9001, in particular focusing on the following specific areas of the quality management systems (QMS).

  • the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
  • controls in the work environment to ensure product safety.
  • focus on risk management activities and design control activities during product development.
  • specific requirements for inspection and traceability for implantable devices.
  • specific requirements for documentation and validation of processes for sterile medical devices.
  • specific requirements for verification of the effectiveness of corrective and preventive actions.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

How to obtain the CERTIFICATION TO ISO 13485?

It is a third-party certification that demonstrates to regulators that you have met the requirements of the standard.

ISO or CIQA does not perform certification.

Read more about a certification to ISO’s management system standards.

The ISO 13485 is not a public domain document available free on the internet.

It is a copyrights document which can be purchased directly from the ISO store.


ISO 13485:2016 is available from your national ISO member or the ISO Store.

Need ISO 13485 Training

Need help & support during your ISO 13485 certification or need templates to create a quality manual and other procedures, visit us,

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For more details on specific FDA expectations and how to create quality management system documents necessary, follow us.

Quality procedures templates

Three (3) Options to Create Quality Management Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the ISO 13485?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Management Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.



For more information about ISO13485, refer to:




Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!