ISO 13485: 2016 Consultancy - Quality management system in the field of manufacturing and providing medical devices. Introduction of the consulting process, Registration procedure of Quotation for Training and Consulting Services ISO 13485: 2016

ISO 13485: 2016 Consultancy - Introduction of the consulting process, Registration procedure of Quotation for Training and Consulting Services according to ISO 13485: 2016

I. General introduction to consulting services and benefits from consultancy of Quality Management System (QMS) according to ISO 13485: 2016

Training and consulting activities to apply and deploy QMS according to ISO 13485: 2016 of VINTECOM International to help customers understand the  terms, definitions, basic principles and requirements of QMS that customers registered to apply to its organization. We have an expert team who will consult and guide customers to establish a document system and procedures, which includes fully the scope of production and business activities of registered customers.

Our experts will make recommendations and give suggestions to each customer on the information of QMS based on the context of the organization; reviewing and auditing the organization's processes and resources that related to the establishment, implementation and application of the quality management system to help the organization achieve its objectives.

In the process of implementing the service, we always apply the 8D principle to solve problems and offer comprehensive management consulting solutions to help customers quickly and reasonably solve the problems that arise in the management system or the more difficult problems that your organization is facing.

In addition, the training and consulting activities of VINTECOM International helps customers understand the basic requirements of  ISO 13485: 2016 QMS in order to ensure the implementation capacity are applied effectively, minimizing risks and waste and obtaining benefits from applying QMS, improving the performance of operational processes in the organization.

II. Subjects & schedule for application of ISO 13485: 2016 standard

Training and consulting activities according to ISO 13485: 2016 standard are often used by organizations involved in the design, manufacture, installation and maintenance of medical devices and related services (medical equipment packaging, disinfection, storage, distribution, installation of medical devices), manufacturers of material for medical devices, designers and / or manufacturers of semi-finished materials or components for medical devices.

The organization should determine requirements of customers, partners and its products and services in the supply chain and global supply chain, including legal requirements.

Schedule of applying ISO 13485: 2016 QMS depends on the type, size, complexity level or products and services are provided by the organization. The organization should determine a reasonable schedule that's enough for QMS is inspected, audited the conformity and meet the requirements.

III. Contents need to be prepared by customers for ISO 13485: 2016 consultancy

1. Assigning the person in charge to contact, deploy ISO at the organization.

2. Arranging the time and necessary resources to coordinate with the expert team of VINTECOM International in the working sessions.

3. Assigning responsibilities for personnel to draft, establish a document system and implement application.

4. Improving some infrastructure conditions to improve process performance, reduce risks.

5. Effective coordination and regular interaction with VINTECOM International office to ensure meeting the schedule.

IV. Procedure of consulting ISO 13485: 2016

1. Confirming the customer information: location, size, scope of application.

2. Auditing the conditions and context of the organization (can be implemented at the customer location).

3. Training awareness of ISO 13485: 2016 standard, training QMS internal auditor.

4. Guidance on establishing document and procedure system, implementing ISO 13485: 2016.

5. Guidance on application of document and procedure system, maintenance of implementation results.

6. Guidance on internal audit of QMS in accordance with ISO 19011, making the audit report.

7. Guidance on measures to take corrective, preventive actions and solve risks.

8. Guidance on completing the document system that is prepared for certification audit activities.

9. Certification audit, taking corrective action after certification and receipt of ISO 13485: 2016 certificate.

V. Certification audit of Quality Management System according to ISO 13485: 2016

Customers will be supported registration procedures by VINTECOM International until the ISO 13485: 2016 certification audit is completed to issue certificate according to regulations. Customers can choose one of the National Accreditation Marks (VICAS) or the International Accreditation Marks (UKAS, ANAB, CAI ...) on ISO 13485: 2016 certificate.


13485: 2016

certificate is valid for 3 years and customers will be surveillance audited twice/ 3 years to maintain the validity of the issued certificate.

📶📶📶 Contact us to register for ISO 13485 Training, Consulting and Certification services.

Customers, organizations and enterprises require Training course, Consulting or Certification services of Quality Management System ISO 13485: 2016, please click on "Registration - Quotation" or on the right toolbar below the PC screen to receive a quotation for training, consulting and certification services.

📶📶📶 Further information, Please contact us as below:

🌐  VINTECOM International Office in Ha Noi City: 16th Floor - Green Stars City, 234 Pham Van Dong, Bac Tu Liem District, Ha Noi City. Hotline 094-886-5288/ (024) 730-588-58

🌐  VINTECOM International Office in Ho Chi Minh City: Golden City House - 182 Ha Huy Giap, 12 District, Ho Chi Minh City. Hotline 0938-083-998/ (028) 7300-7588


Head Office: No. 5 Hoang Sam treet, Nghia Do, Cau Giay district, Ha noi City


Address:   16th Floor - Green Stars City

234 Pham Van Dong Street, Bac Tu Liem District, Ha noi City

Tel       :    (024) 730.588.58/ (024) 730.333.86

Hotline:     094 886 5288

Skype:       kd.vintecom 

Email :

Web :


Address : Golden City House 

182 Ha Huy Giap Street, District 12, Ho Chi Minh City

Contact:   Ms. Pham Thu Ha

Tel:          (028) 7300 7588  

Hotline:   0938 083 998

Email :

Web :


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