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ISO 13485 is widely applied to medical device manufacturers. This is also a requirement if the manufacturing facility of medical instruments, medical devices, medical supplies wants its products to be widely recognized globally. The current version of ISO 13485 is ISO 13485:2016. What is ISO 13485? What are the benefits of applying ISO 13485 and which unit advises on prestigious standards? Join GMP Groups to find out in the following content.

01

What is ISO 13485?

ISO 13485 is one of the leading standards in the world dedicated to enterprises working in the medical equipment industry. Under the newly enacted government regulations, medical equipment manufacturers and traders need to achieve ISO 9001-2015 and ISO 13485 to be eligible to produce and bring products to market.

ISO 13485 has been developed and issued by the International Organization for Standardization of ISO to control and manage activities in the field of medical equipment. ISO 13485 is based on the basis of ISO 9001, the latest version of ISO 13485 is ISO 13485:2016.

02

The law with ISO 13485

“Article 68. The transitional provisions of Decree No. 36/2016/ND-CP on the management of medical equipment’ stipulate as follows:

Medical equipment production facilities that have been operating before the effective date of this Decree may resume production activities but must complete the declaration of production eligibility by July 1, 2017. Particularly for regulations on quality management systems: Medical equipment manufacturing establishments must complete the application of ISO 9001 quality management system by January 1, 2018 and ISO 13485 quality management system by January 1, 2020.

Thus, January 1, 2020 is the last time for enterprises to build and certify iso 13485:2016.

03

Iso 13485 adopter

This is a completely voluntary set of standards, applicable to organizations and businesses regardless of type, location and scale. These may include: Facilities/companies/factories/distributors that manufacture and trade medical equipment.

When the organization builds and meets ISO 13485, the organization has a safety management system that can create a working environment that minimizes the risks associated with the safety of medical products, products are created safely, in order to satisfy the needs of customers and legal requirements.

04

Business benefits of applying ISO 13485:2016 system

– Meeting the mandatory requirements of Decree No. 36/2016/ND-CP on management of medical equipment which requires medical equipment manufacturing establishments to complete the application of quality management system under ISO 13485:2016

– Favorable procedures and simple dossiers when carrying out procedures for announcing eligibility for medical equipment production, publication of quality standards, classification of medical equipment, registration of circulation of medical equipment.

– Make a good impression on customers, is a competitive advantage for other products of the same type.

– Improve production efficiency, product quality, control hazards, control hygiene and contamination into products and have specific implementation plans.

Create the ability to enter international markets. ISO 13485 certification is seen as the first step towards achieving compliance with European statutory requirements.

Effective control of internal processes and minimize the risk of errors.

05

Iso 13485:2016 implementation process at GMP Groups

dịch vụ tư vấn ISO

Step 1: Receive customer information, make quotes, sign contracts

Step 2: Survey the reality and situation at the business

Step 3: Plan consultancy, assign tasks to the consulting department

Step 4: Cognitive training, ISO content, building on-demand documentation system in accordance with business reality

Step 5: Promulgate the system of documents and instructions for application

Step 6: Training experts, internal assessment guidance at the enterprise

Step 7: Support to overcome the inappropriate points in the internal assessment and improve the system.

Step 8: Guide registration, certification assessment with certification organization and monitor assessment.

Step 9: Acceptance of consulting contracts.

Step 10: Support businesses to improve their systems during operation.

06

Selection of prestigious ISO 13485 certification consultancy

Organizations/businesses will take a lot of time and manpower if they study iso 13485 on their own. ISO 13485 sets out the conditions requirements to be met but does not specifically instruct the organization/business to do so.

Come to GMP GROUPS where there is a team of dedicated consultants, many years of experience, supporting the needs of customers: Supporting the procedure of classifying medical equipment (type A, B, C, D) and supporting the procedure of announcing eligibility for medical equipment production at the Department of Health. Support records and procedures for publication of applicable standards (for class A medical equipment) and product circulation announcements (for type B, C, D medical equipment).

Tư vấn chứng nhận ISO 13485

GMP Groups advises ISO 13485 certification for Best Pacific Vietnam 

Choosing a suitable consulting unit to build you a quality management system of international standards to be able to implement management and supervision tasks well, bringing high efficiency is a necessary job to help your company and business be competitive in the market.

Đội ngũ chuyên môn tư vấn tiêu chuẩn hệ thống quản lý chất lượng

At GMP Groups, we offer ISO consulting services with the same standards:

ISO 9001:2015: Quality Management System

FSSC 22000: Food Safety System

ISO 22000: 2005 Food Safety Management System

ISO 17025:2005: Laboratory/Calibrate Quality Management

ISO 15189: 2012: Medical Laboratory Quality Management

HACCP Codex: Critical and critical checkpoint analysis

We commit to reasonable costs, fast time, maximum support and cutting fees incurred to deliver the most reasonable cost according to the size and status of the business. GMP Groups will be the orientation unit, helping businesses choose the right system as the evaluation process achieves ISO certification quickly and effectively to help businesses achieve the desired business efficiency.

07

Some frequently asked questions about ISO 13485 certification consultancy

  • How much does it cost to consult iso 13485:2016 certification? 
  • ISO 13485 certification time: 2016
  • How long is ISO 13485:2016 valid?
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