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ISO 13485 Quality Management System for Medical Devices Implementation

What is ISO 13485:2016?

ISO 13485:2016 is the Quality Management System for Medical Devices manufacturers. It is most widely used international standard for quality management across the globe.

ISO 13485:2016 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. By adopting ISO 13485 organization will be assured that they have foundation to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.


The ISO 13485:2016 is a standalone standard and it aligns with the previous version of ISO 9001, ISO 9001:2008. ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS), which is published by ISO (the International Organization for Standardization). Its requirements are recognized around the world as an acceptable basis for implementing a QMS. Although the ISO 13485:2016 standard came out after the major update of ISO 9001:2015, the ISO 13485 standard does not align with this new revision of ISO 9001. Instead, it was determined that the most recent changes in ISO 9001:2015 were not necessary for medical devices.

Who should be certified for ISO 13485:2016?


The ISO 13485 certification is an evidence of an organization for the compliance of its Quality Management System with the standard for organizations involved in the Medical Device industry. This approach is not only for Medical Device Manufacturers but also supporting organizations such as Suppliers, Subcontractors, service providers etc. 

Note that ISO 13485:2016 expands the profile of companies to which the standard can apply:  Organizations involved in one or several stages of a Medical Device Life-cycle or a Supplier or other External Parties providing such organizations with products or services like

  • Design and Development service

  • Contact manufacturing

  • Packing, Storage and Distribution of a medical device

  • Installation and Servicing of a medical device

  • Raw materials, components, sub-assemblies, Sterilization services etc.

Additionally, the ISO 13485 standard requires the organization identifies its role as per regulatory requirements e.g. Manufacturer, Representative, Importer and/or Distributor, and identify the applicable regulatory requirements depending on the role, then integrates the same regulatory requirements in the QMS.

What is the difference between ISO 9001 and ISO 13485?


Even though ISO 13485:2016 is a stand-alone standard, it is based on ISO 9001:2008, as mentioned above. So, while ISO 9001 is an internationally recognized standard for any organization in any industry, the ISO 13485 standard includes additional requirements that are specific for companies that manufacture medical devices. Some additional requirements of ISO 13485 for medical devices manufacturers include:

  • Documentation requirements for medical device files,

  • Work environment requirements,

  • Contamination control requirements,

  • Production requirements for cleanliness of products,

  • Production requirements for sterile medical devices, and

  • Requirements for reporting to regulatory authorities.

ISO 9001 was updated in 2015, the changes made in ISO 9001:2015 standard were not seen as appropriate for the medical device industry, hence the ISO 13485 was not updated to align with these new ISO 9001:2015 requirements and has remained to be based on the ISO 9001:2008 standard.


Benefits of Implementing ISO 13485:2016.

  1. Improve your brand image – ISO 13485 is the internationally recognized standard for quality management system for medical device industry. Certification to this standard shows clients and customers that your company takes quality very seriously, and that you have a system in place to ensure it. Your QMS can be a powerful marketing tool, and it has become a requirement in many countries for suppliers to show compliance.

  2. Improved customer satisfaction – The ISO 13485 standard is built on a set of quality management principles, one of which is ensuring customer satisfaction. This can be achieved by assessing customer needs and expectations and striving to meet them. Customers know what they want, and what they need, and many of them will not even entertain a supplier who is not certified.

  3. Improve your processes – Using the process approach outlined in ISO 13485, it is much easier to discover opportunities for improvements. You will be able to identify and eliminate wastes within and between processes, reduce errors, and avoid rework—facilitating greater efficiency and cost savings.

  4. Improve decision-making – Another quality management principle of ISO 13485 regarding the use of fact-based decision making. When you use facts and data to drive your decisions, those decisions tend to be better aligned with the goals of company.

  5. Culture of continual improvement – Quality management principles make up the foundation of ISO 13485 with the concept of continual improvement. When adopted as a culture in organization, management and staff will always find ways to improve on how the things can be done better. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time for resolution of problems, and more time delivering the quality products and services.

  6. Better employee engagement – When employees are asked to look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company. The more your employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency and productivity

Steps to Implement ISO 13485:2016


It is highly recommended to start ISO 13485:2016 implementation only after getting its working knowledge/ Familiarization with it. Please consult HM Consulting team for more details and support related to ISO 13485 awareness training.

  1. 1.Prepare documentation – After finishing all applicable documentation and implementing it, HM consulting recommend an organization should also perform following steps to ensure a successful certification:

  2. 2.Internal audit – The internal audit is the only activity to check your QMS implementation. The goal is to ensure that records are in place to confirm compliance of the processes and to find problems and weaknesses that would otherwise stay hidden. Please consult HM Consulting team for support on Internal audit.

  3. 3.Management review – A formal review by your management to evaluate the relevant facts about the management system processes to make appropriate decisions and assign resources.

  4. 4.Corrective actions – Following the internal audit and management review, you need to correct the root cause of any identified problems and document how they were resolved.

  5. 5.Certification Audit: The company certification process is divided into two stages:

I. Stage One (documentation review) – The auditors from your chosen certification body will check to ensure your documentation meets the requirements of ISO 13485.

II. Stage Two (Final Assessment) – At this stage, the certification body auditors will check whether your actual activities are compliant with both ISO 13485 and your own documentation by reviewing documents, records, and company practices. Defiantly this audit will be harder than the previous one. Best wishes! You may take HM Consulting’s Extended Network Support.

Get in touch with us for more information on ISO 13485:2016 Implementation.

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