ISO 13485 :2016 Medical Devises Quality Management Systems(MDQMS)
Requirements for Regulatory purpose

Safety and efficacy of medical devise are non negotiable and that’s why ISO 13485 has been developed


A medical device is a product, which could be a machine, an instrument, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Regulatory requirements in Medical Devices Manufacturing Industry, are increasingly becoming stringent throughout every step of a product’s life cycle, including design, production, service and delivery. More and more, organizations in the Medical Device Industry, are expected to demonstrate their quality management processes and ensure best practice in everything they do. Medical Devices manufacturing sector, requires evidences of documented management system and effective monitoring of all production activities.

What is ISO 13485 ?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001:2008 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system. ISO 13485 was launched to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What does it mean to be ISO 13485 certified ?

“ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has been able to successfully meet all the requirements of ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while focussing on the safety and efficacy of medical devices. Certification to ISO 13485, is an added Value for any Medical Devices Manufacturer. Third-party accredited certification by QCS , can demonstrate to consumers & regulators that the Company have met the requirements of the standard.

Benefits of ISO 13485 Certification

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and demonstrate commitment to quality. Additionally, certifying by QCS also affects:

  • Increase access to more significant markets worldwide
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

Recommendation for industry:

  • • ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry.
  • • ISO 13485 is the quality management system standard accepted as the basis for CE Marking Medical Devices under European Directives.
  • • Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world such as EU Medical devise directive 93/42/EEC superseded by EU medical devise regulation (MDR)- (EU) 2017/745 and USFDA Quality Systems Regulations 21CFR 820 .

How can we help

QCS is an accredited Certification Body for FULL QUALITY ASSURANCE SYSTEM for medical devises Quality management systems requirements for regulatory purpose.
Accreditation is mapped according to Normative Regulation: Directive 93/24 EEC, ISO 13485:2016 & EN ISO 13485:2012. QCS employs competent auditors and technical experts well versed with ISO 13485 international standard.
There are two types of certification: certification of a company’s Quality Management System against the ISO 13485 requirements, and certification of individuals to be able to implement and audit against the ISO 13485 requirements.
ISO 13485 certification for your company involves implementing a QMS based on the ISO 13485 requirements, and then hiring a recognized certification body to audit and approve your QMS as meeting the requirements of the ISO 13485 standard.
Training on ISO 13485 is available, and there are a range of course options for individuals to choose from such as awareness, internal auditors and lead auditors programs . Each of these courses differ in their purpose, but upon the completion of the course, the participant will get the certificate
Besides, we can also conduct gap analysis audits to determine your readiness before the final certification audit.

For more details on our ISO 13485 Certification process please contact our ISO experts