ISO 13485 specifies requirements for a quality management system when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.

These organizations may be involved in one or more stages of the medical device life cycle, including design and development, production, storage and distribution, installation, servicing of medical devices, as well as the design and development or provision of related activities (e.g., technical support).

What is ISO 13485?

ISO 13485 is a standard on safety management systems for medical products within the ISO 13485:2003 standards series issued by ISO.

The latest version, ISO 13485:2016, specifies requirements for quality management systems applicable to organizations involved in manufacturing and supplying medical devices and related services to ensure their ability to provide products that meet customer requirements and legal regulations.
ISO 13485 is developed based on the foundation of the ISO 9001 standards series.

ISO 13485 emphasizes harmonizing quality management system requirements with regulatory requirements applicable to the medical device sector.
The ISO 13485 standard has been widely accepted and applied by medical device manufacturers worldwide and is considered a necessary requirement in the current context for organizations that wish their medical device products to be widely recognized globally.

Hospitals and healthcare facilities may establish an independent ISO 13485 system or integrate it with other management systems such as ISO 9001, ISO 14001, OHSAS 18001, etc.

Scope of Application of ISO 13485

ISO 13485 is applicable to all organizations regardless of type, location, or size.
Specifically, it includes establishments/companies/factories/distributors engaged in the production and business of medical devices and healthcare services in general (e.g., syringes, sterilization equipment for medical products, medical gloves, infusion sets, feeding tubes, etc.).

ISO 13485 is voluntary in nature and focuses on managing the safety of medical products.

When an organization establishes and complies with ISO 13485, it develops a safety management system that can create a working environment minimizing risks related to medical product safety.
Products are produced safely to satisfy customer needs and legal requirements.

Benefits of Implementing ISO 13485

• Helps enterprises provide safe products for users

• Creates competitive advantages, enhances brand reputation, and facilitates export opportunities

• Saves costs, increases revenue and profit while minimizing risks

• Ensures systematic operations, promotes teamwork, and creates a comfortable working environment

• Improves labor productivity

• Enhances the ability to meet customer requirements and regulatory requirements at national, regional, and international levels for medical devices and equipment

• Improves competitiveness and expands markets

• Enhances the effectiveness and efficiency of the current management system

Reasons to Choose ISSQ Certification Body

• ISSQ Certification Body conducts systematic and independent assessments of management systems to identify strengths and areas for improvement

• ISSQ uses pre-planned audit schedules to ensure management systems meet objectives and achieve continuous improvement in key areas

• ISSQ can certify ISO 13485 in combination with ISO 9001 and many other management systems, bringing practical benefits to organizations

• Organizations are allowed to use the ISSQ certification logo after certification, helping enhance their image with consumers

• ISSQ Certification Body always supports customers with minimal cost and optimal effectiveness

Certification process

Contact ISSQ immediately via Hotline: +84 981 851 1111 / +84 24 2266 1111 for the most detailed support on ISO training and certification.