ISO 13485: 2016 consulting service

When an organization builts and ISO 13485, it can create a work environment that minimizes risks related to medical product’s safety. Moreover, medical products made are ensured safe level, scarify the customer’s needs and law’s requirements.
ISO 13485: 2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes applies for medical device production.
ISO 13485 is an international standard that was first published by the ISO organization in July 2003 (and has been approved by Vietnam as a Vietnam national standard TCVN. ISO 13485). This standard has recently been revised and released in March 2016.
Medical equipments and instruments directly play a important role related to human health. There are stricter and stricter regulatory requirements for medical devices, including service and delivery. Products in this field shall not only comply with the producer’s requirements but also obey the rule of law.
ISO 13485 gives the requirements for a specific quality management system applied for organization producing, providing medical equipments and related services to ensure the ability of production complying requirements of customers and law. In addition, ISO 13485 is also used for certificated bodies to evaluate and certify.
Although ISO 13485 has been established and maintained a management system, in accordance with ISO 9001, it emphasizes a suitable combination between the quality management system requirements and the regulatory requirements for the medical devices. In Vietnam, this is a mandatory standard for medical device producers because of clause 68 of Decree 36/2016 / ND-CP: “Medical equipment producer shall complete the application of quality management system based on ISO 9002 before January 1, 2018 and quality management system depended on ISO 13485 before January 1, 2020 ”.This standard also plays an important role in the current period if organizations want their products to keep a specific position in the world market.
By dint of the ISO 13485 application, the organization can create a positive work environment that minimizes risks related to health product safety. Moreover, medical products made are ensured safe level, scarify the customer’s needs and law’s requirements.
Applying ISO 13485 creates many benefits such as:
- Achieve Customer satisfaction through the distribution of products that complies the requirements of customer, quality, safety and legal requirements.
- Produce good quality and safe products for users.
- Reduce operating costs through continuous improvement of processes and results.
- Improve relationships with interested parties - including employees, customers and suppliers.
-  Obey Laws - through understanding how regulatory requirements and rules affect organization and customers.
- Improve risk management - through more consistency and traceability of the product as well as the application of risk management techniques.
- Enhance the effectiveness and efficiency of the current management system.
All ISO standards are reviewed in each 5 years to determine the suitability of the current version to the market context.
ISO 13485: 2016 is designed to comply the latest quality management systems, including changes in technology, management requirements and organization’s expectations.ISO 13485 version 2016 is based on ISO 9001: 2008 and refers to some clauses in ISO 9001: 2015. There are some changes compared to the old version to optimize the quality management system for the compliance of the strict requirements. The new version emphasizes hazard and risk management based on decision making, as well as the changes related to stricter requirements for organizations in the supply chain.
Organization can build an independent quality management system in accordance with ISO 13485 or combine with other requirements of other Standards such as ISO 9001, etc. KIS is a professional company for supplying a consultancy service of ISO 13485/ ISO 13485: 2016.
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Translator: Department of Administration

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