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ISO 13485 Certification

ISO 13485 Certification

Scope of ISO 13485 Certification 

ISO 13485 Standard is a well-described standard to analyze the quality of medical devices and equipment. It has a similar connection with another ISO standard, ISO 9001. ISO 13485 Certification focuses on the design, manufacture, and distribution of medical devices. The quality of these devices certainly provides safety and a secure working environment for the employees. Also, the systematic framework of ISO 13485 helps to define and analyze the operational improvements of the QMS.

ISO 13485 Certification is an honor for the organization with high-quality medical devices and equipment. This certification is a powerful tool to impress more clients. In other words, the quality of the medical devices recognized with the help of the ISO 13485 certification. 

Integrated Assessment Services (IAS) is one of the top-searching ISO Certification Bodies in Asian countries. We offer an easy yet effective process to achieve a globally recognized ISO 13485 Certification. It is the popular Quality Management System (QMS) certification for medical devices followed by many organizations in Asia. This ISO 13485 Certification is a great treasure for an organization that supplies medical equipment. Moreover, it assists organizations to reach the next level in the Asian business market. 

Importance of ISO 13485 Certification

International Organization for Standardization (ISO) is famous for developing standards for businesses in quality, safety, and environment management system. The purpose of ISO 13485 is to identify the problems in the Quality Management System of an organization. This standard also provides solutions for manufacturers and suppliers with quality measures to make products that meet international standards. In addition, ISO 13485 also offers high-quality procedures and processes in a simple form for a better understanding of the organization.

ISO 13485 includes all the requirements and specifications that satisfy customers’ expectations. It not only improves QMS performance but also ensures consistent improvements in the quality of medical devices and equipment. Most importantly, ISO 13485 Standard offers directives, regulations, and responsibilities that manufacturers need to follow while addressing the medical devices. 

ISO 13485 Certification for Medical Devices is applicable to all organizations from small to large. ISO 13485 provides suggestions for suppliers or external parties which involve in providing medical products. It helps improve the quality and performance of medical equipment. So, the improvements in the QMS increase the quality of medical devices and equipment.

ISO 13485 Certification in Asia

IAS is an internationally recognized certification body that audits and issues certificates in various countries across the world. It offers ISO 13485 Certification in Asia and also in various standards. This certification is perfect for all organizations from small to large. It makes the organization popular in the business industry (from local to global markets).

IAS also offers ISO 13485 Certification in many countries including India, Bangladesh, Philippines, Thailand, and Vietnam. With professional experts in auditing, it also provides ISO13485 Lead Auditor Training, ISO 13485 Internal Auditor Training, and ISO 13485 Awareness/Foundation Training.

Roles of IAS 

IAS is a famous, trustworthy ISO certification body that was established in 2006. It is a UQAS accredited globally recognized platform for auditing and issuing ISO standard certificates. 

IAS is also the best platform for Lead Auditor, Internal Auditor, and awareness and foundation training. It conducts audits effectively and helps with standardized solutions in a well and understandable way. 

This ISO 13485 Certification Body offers genuine guidance with professional experts for constructive auditing.

IAS ensures effective yet convenient services as per the trend and nature of the local markets. It conducts auditing and provides ISO 13485 Certification across the world and also in various ISO Standards.

The versatile platform provides services in the Automobile industry, Consumer electronics, Chemical Industry, Steel production, Industrial equipment, FMCG Industry, Aerospace manufacturing, Healthcare Industry, Food Industry, Textile Industry, Oil and Gas, Energy, Telecommunication, IT Industry, Hospitality industry and so on. 

For detailed information, call the below mentioned contact numbers to have a free discussion with our coordinators

To know more about the certification process and procedure details.

Benefits of ISO 13485 Certification

  • Improves the quality of medical devices and equipment to international standards
  • Provides directives, regulations, and responsibilities for medical products’ manufacture 
  • Enhances QMS performance and profit of the organization.
  • Ensures customer’s satisfaction
  • Reduces malfunctioning and risks
  • Expands business resources to get global recognition
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