Pre-audit – Certification ISO 13485:2016 for medical devices

Medical devices play an important role in hospital which directly influence people’s health. This type of product not only meets producer’s standard but also follow regulations to ensure that medical devices fulfill quality and safety requirement.

What is ISO 13485 ?

ISO 13485 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.

The latest version of ISO 13485:2016 sets out requirement for quality management system applied for organizations providing medical devices. ISO 13485 has the foundation of ISO 9001 standard. 

ISO 13485 focus on the harmony of requirements on quality management of medical devices. Currently, medical equipment producers want to be recognized all over the world, so ISO 13485 is an critical point.

Hospital, medical units can set up ISO 13485:2016 system independently or collaborate with other management systems such as ISO 9001, ISO 14001, OHSAS 18001, etc.

Who can apply ISO 13485?

• ISO 13485:2016 requirements are applicable to organizations regardless of their size and their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, requirements apply equally to associated services as supplied by the organization.
• Establishing and meeting ISO 13485, organizations could have a safety management system to help reduce medical risks in working place, ensure the quality of products, thereby satisfy customers’ demands.

Benefits of ISO 13485:2016 application

• Help enterprise provide consumer with safe products.
• Create competitive advantages, enhance brand image and facilitate exportation.
• Save the cost, increase revenue and sale, maximally reduce risks.
• Systematic operation, internal solidarity, friendly working environment.
• Better ability to meet the customer’s requirements and national and international law as well.
• Improve competiveness of the enterprise and expand the market.
• Enhance effectiveness of current management system.

WHY TO CHOOSE KNA CERT?

• KNA CERT conducts systematically independently audit on management system to determine strengths and weaknesses.
• KNA CERT have planned schedule, thereby ensure management system to reach goals and continuously improve key issues.
• KNA CERT is able to certify combination between ISO 13485 and ISO 9001, bringing about values to organization.

Contact KNA for ISO  PRE-AUDIT – CERTIFICATION

• Contact: KNA Cert Co., Ltd
• Centre: 11^th floor, Ladeco Building, 266 Doi Can street, Ba Dinh District, Ha Noi
• Tell: 093.2211.786 – 02438.268.222
• Email: salesmanager@knacert.com 
• Website: www.knacert.com.vn