ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

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 13485:2016 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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

Why is ISO 13485 important?

In the medical devices industry, quality management goes hand-in-hand with safety, and both are non-negotiable.

Requirements like those set out by ISO 13485 are strictly enforced throughout every stage of a medical device’s life-cycle, including stages after manufacturing like delivery, service, and maintenance.

Organizations using ISO 13485 can be involved in any stage of the medical devices' life-cycle. Design, development, production, distribution, servicing; even supporting activities like maintenance and customer service.

Increasingly, ISO 13485 is becoming necessary for medical device companies to compete for customer attention. This is because audits by customers (2nd party audits) are becoming less common due to the rise of 1st party (internal) and 3rd party (external, for certification) audits.

Why is ISO 13485 useful?

When implemented properly, ISO 13485 can be used to reap large cost and efficiency savings.
Here are some examples of how ISO 13485 can benefit your business or organization:

  • Customers will recognize ISO 13485 as a symbol of quality control and assurance.

  • Beyond the public image, customers see direct benefits from the focus on customer satisfaction that ISO 13485 champions.

  • ISO 13485 is a BPM approach, which means you don’t just look at individual processes, but how they interact with one another.

  • Making “good decisions” isn’t straightforward; however, you can strive to make “better decisions” by using evidence to inform your decision-making process.

  • Continuous improvement is more than a framework; it’s a mentality that can be cultivated in a workplace environment towards common goals.

  • Adopting ISO 13485 means your workforce takes ownership for managing and innovating on the processes they’re using most often

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

Why choose ISB-K2A Cambodia for ISO 13485 certification?
We provide a full range of services to support your path to certification in Cambodia. Our business development staff can help you and your organization understand each phase of the assessment and certification process to ensure you fully understand the ISO 13485 process and its available guidelines. Our training courses allow you to develop a thorough understanding of the complexities of complying with the standard, as well as the laws and regulations the standard helps to address.

We are a company known for offering Accredited Certification services in all global locations. In Cambodia, we offer our services in all major locations like Phnom Penh, Siem Reap, Sihanoukville, Battambang, and other provinces of Cambodia.

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ISO Certification Body ( ISB-K2A) is the certification division of K2A Management providing ISO certification Audits & ISO Training Service as an independent organization specializing in helping SMEs improve their businesses through providing auditing & Training services to improve their quality management systems against ISO Standards Like ISO 9001 QMS, ISO 14001 EMS, ISO 45001 OHSMS, ISO 22000 FSMS, ISO 27001 ISMS in Cambodia and other parts of the World.

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