{"id":4143,"date":"2021-07-26T12:00:20","date_gmt":"2021-07-26T05:00:20","guid":{"rendered":"https:\/\/gmpgroups.com.vn\/solution\/dich-vu-tu-van-iso-13485\/"},"modified":"2022-04-20T13:12:28","modified_gmt":"2022-04-20T06:12:28","slug":"iso-13485-certification-consulting-service","status":"publish","type":"mona_solution","link":"https:\/\/gmpgroups.com.vn\/en\/solution\/iso-13485-certification-consulting-service\/","title":{"rendered":"ISO 13485 Certification Consulting Service"},"content":{"rendered":"

GMP Groups supports all organizations to adopt ISO 13485 or achieve ISO 13485 certification. We with years of experience in the field of Quality Consulting will provide you with guidance & professional know-how, coaching & mentoring, online and on-site training everything you need to achieve ISO 13485 Certification.<\/span><\/p>\n

1. What is ISO 13485?<\/b><\/span><\/h2>\n

ISO 13485 is one of the leading standards in the world dedicated to businesses 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.<\/span><\/p>\n

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<\/a>, the latest version of ISO 13485 is ISO 13485:2016<\/span>.<\/p>\n

2. Legal Regulations with ISO 13485:2016<\/b><\/span><\/h2>\n

Article 68. The transitional provisions of Decree No. 36\/2016\/ND-CP on the management of medical equipment’ stipulate as follows:<\/span><\/p>\n

“Medical equipment production facilities that have been operating before the effective date of this Decree may resume production activities but must complete the announcement 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.”<\/span><\/p>\n

Thus, January 1, 2020 is the last time for enterprises to build and certify iso 13485:2016.<\/span><\/p>\n

3. Iso 13485:2016\u00a0<\/b><\/span><\/h2>\n

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 produce and trade medical equipment.<\/span><\/p>\n

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.<\/span><\/p>\n

4. Benefits of enterprises when applying<\/span><\/p>\n

ISO 13485:2016 System<\/b><\/p>\n

– Meet the mandatory requirements of Decree No. 36\/2016\/ND-CP on management of medical equipment. It requires medical equipment manufacturing establishments to complete the application of quality management system according to ISO 13485:2016<\/span><\/p>\n

– 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.<\/span><\/p>\n

– Make a good impression on customers, is a competitive advantage for other products of the same type.<\/span><\/p>\n

– Improve production efficiency, product quality, control hazards, control hygiene and contamination into products and have specific implementation plans.<\/span><\/p>\n

Create the ability to enter international markets. ISO 13485 certification is seen as the first step towards achieving compliance with European statutory requirements.<\/span><\/p>\n

Effective control of internal processes and minimize the risk of errors.<\/span><\/p>\n

5. GMP Groups ISO 13485:2016 Certification Consultancy Process<\/b><\/span><\/h2>\n

– Survey and assess the situation of the organization\/ enterprise: Survey the facilities, personnel, production process and documents to understand the situation and the ability to respond to ISO 13485 conditions.<\/span><\/p>\n

– Establishment of ISO 13485 steering committee: including representatives of departments and departments of enterprises. This board plays the role of drafting documents, conducting internal system evaluations.<\/span><\/p>\n

– Plan in detail the consulting items according to the standard requirements based on the status of the organization \/ enterprise.<\/span><\/p>\n

– General awareness training on ISO 13485 for management teams and employees.<\/span><\/p>\n

– Developing quality management system documents according to ISO 13485 standards: Establishing quality policies and objectives for quality management systems, building additional missing text systems, helping to maintain and control and operate the processes of quality management systems.<\/span><\/p>\n

– Training organization guiding the application of quality management system to relevant units.<\/span><\/p>\n

– Implementing the application of ISO 13485 in practice.<\/span><\/p>\n

– Organize internal review and evaluation to improve and improve the system.<\/span><\/p>\n

– Select a certification assessment organization in accordance with the requirements of the organization\/enterprise.<\/span><\/p>\n

– Fix and improve the system after certification assessment (if any).<\/span><\/p>\n

– Receive ISO 13485:2016 certificate.<\/span><\/p>\n

– Plan to maintain and improve the quality management system every year.<\/span><\/p>\n

6. Selection of prestigious ISO 13485 certification consultancy\u00a0<\/b><\/span><\/h2>\n

Organizations\/businesses will take a lot of time and manpower if they study iso 13485 on their own.<\/span><\/p>\n

ISO 13485 sets out the conditions requirements to be met but does not specifically instruct the organization\/business to do so.<\/span><\/p>\n

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).<\/span><\/p>\n

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.<\/span><\/p>\n

7. Some frequently asked questions about ISO 13485 certification consultancy\u00a0<\/b><\/span><\/h2>\n

– How much does it cost to consult iso 13485:2016 certification?\u00a0<\/strong><\/span><\/p>\n

– ISO 13485 certification time: 2016<\/strong><\/span><\/p>\n

– How long is ISO 13485:2016 valid?\u00a0<\/strong><\/span><\/p>\n

 <\/p>\n

\n","protected":false},"excerpt":{"rendered":"

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.<\/p>\n","protected":false},"author":1,"featured_media":4009,"comment_status":"open","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"tags":[],"class_list":["post-4143","mona_solution","type-mona_solution","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nISO 13485 Certification Consulting Service<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gmpgroups.com.vn\/en\/solution\/iso-13485-certification-consulting-service\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 Certification Consulting Service\" \/>\n<meta property=\"og:description\" content=\"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? 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