INSTITUTE FOR STANDARD AND QUALITY DEVELOPMENT STUDIES
The ISO 13485 standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide medical devices and related services that meet customer requirements and applicable regulatory requirements.
Such 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).
ISO 13485:2016 certification – the Medical Device Safety Management System has been widely accepted and implemented by medical device manufacturers worldwide. These requirements are essential at the current stage if organizations producing medical instruments, medical supplies, and medical equipment want their products to gain wide recognition across global markets.
ISO 13485:2016 is an international certification developed by the International Organization for Standardization (ISO) in the field of medical device product quality and safety. This certification is closely related to the ISO 9001 quality management system standard. It helps minimize risks related to medical products, ensuring the creation of safe products that meet customer expectations and comply with current legal requirements.
Purpose: To help enterprises and organizations manufacturing medical devices control potential hazards from the production stage until the product reaches the end consumer.
Applicable to all products in the medical field, including facilities, companies, enterprises, distributors, and organizations engaged in the manufacturing and trading of medical devices such as masks, syringes, medical gloves, face masks, etc.
ISO 13485 certification applies to organizations manufacturing and trading medical devices regardless of their size or scale, except for certain clearly specified exclusions.
Enterprises whose products are manufactured under ISO 13485 certification will be recognized as organizations with effective management systems and assured device safety and quality, thereby gaining consumer trust when using their products.
To obtain ISO 13485 certification, the following steps are required:
Step 1: Collect information to confirm the system requiring certification.
Step 2: Conduct a preliminary assessment: consultancy and initial evaluation through on-site inspection to determine the level of compliance with standard requirements.
Step 3: Formal assessment (including two stages):
Stage 1: Assessment of documents and records or on-site evaluation to determine system readiness.
Stage 2: Comprehensive on-site assessment of all requirements according to certification criteria.
Step 4: Issuance of certification
If the enterprise fully meets the requirements of the third-party certification body, a certificate will be granted.
ISO 13485 certification specifies essential requirements for a Medical Device Safety Management System when enterprises need to demonstrate their capability to supply medical devices and related services that meet customer needs as well as applicable legal regulations.
Such organizations may participate in one or multiple stages of the product life cycle, including design, development, manufacturing, storage, distribution, installation, and servicing of medical devices, as well as designing, developing, and providing related activities.
According to Decree No. 36/2016/ND-CP: “Medical device manufacturing facilities must complete the implementation of the ISO 9001 quality management system before January 1, 2018, and the ISO 13485 quality management system before January 1, 2020.”
With the motto “Quality creates class”, ISSQ Institute not only supports customers during the certification assessment process but also continues to provide consultation and assistance after certification whenever customers encounter difficulties, with the best support policies.
Support with legal procedures related to customers’ certification
Price support for customers who have used ISSQ Institute’s services
Free consultation support for other services available at ISSQ Institute
24/7 consultation support in compliance with current legal regulations
Reasonable certification costs suitable for most enterprises
The above information about ISO 13485 certification – Medical Device Safety Management System is shared by ISSQ Quality Research Institute with organizations and enterprises.
ISSQ Institute is always ready to accompany companies during integration and development.
Please contact hotline +84 981 851 111 or email vienchatluong@issq.org.vn | tcvn@issq.org.vn — we are honored to serve you!
Posted date: 01/11/2022
