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ISO 13485 Certification

ISO 13485 Certification

About ISO 13485 Standard

International Organization for Standardization (ISO) develops standards for business in quality, safety, and environment management systems. This global organization proposed a special standard ISO 13485 to analyze the defects especially in the quality of medical devices and equipment. ISO 13485 provides requirements to design, develop and distribute medical devices and equipments. Also, its systematic framework helps in operational movements of QMS that ensure the safety of the employees.

ISO 13485 Certification assures the quality of medical devices and equipment. This certification helps improve sales as well as the profit of the business. ISO 13485 includes similar requirements of ISO 9001 Standard. Whereas ISO 9001 focuses on all sectors of an organization’s Quality Management System (QMS) but ISO 13485 Certification only analyzes the quality of medical devices and equipment.

ISO 13485 Certification for Medical Equipment

ISO 13485 Certification guides manufacturers to follow standardized directives, regulations as well as responsibilities to produce quality products. This certification enhances confidence in customers and increases the productivity of your business. Also, it includes specified requirements to improve the safety of medical devices and the performance of the Quality Management System (QMS).

The ISO 13485 standard offers effective improvements in various sections of an organization such as design, development, production, storage, distribution, and installation.  ISO 13485 Certification is suitable for all organizations from small suppliers to big industries. So, the development in QMS enhances the popularity and increase more business opportunities.

What is IAS and why IAS?

Integrated Assessment Services (IAS) is a popular organization among ISO Standard certification bodies. Introduced in 2006 and has 13 years of experience in auditing and issuing globally recognized ISO 13485 Certification.

IAS is a UQAS (Universal Quality Accreditation Services) accredited certification body. So, we audit the organizations effectively and consistently for reliable services.

Other than management system certifications, we also offer product certification, Lead Auditor, Internal Auditor and Awareness and foundation training on various ISO standards.

Our highly experienced, real-time auditing experts evaluate the organization as per the trend of the local market and guide to obtain effective improvements in the management systems. 

We provide ISO Certification Service for various business sectors such as the food industry, IT industry, hospitality industry, aerospace industry, automobile industry, electronics, and telecommunication industry, etc

IAS has its branches and representatives in Bangladesh and also in various Asian countries such as India, Singapore, Malaysia, Indonesia, Oman, Saudi Arabia, UAE, Qatar, Kuwait, Philippines. 

Call us to have a free discussion about the ISO 13485 certification process and procedure.  

You can reach IAS through online or mentioned contact numbers for more queries and detailed information. 

Benefits of ISO 13485 Certification

  • Ensures international standards medical devices and equipment
  • Enhance the reputation of an organization
  • Develops trust in customers for more business opportunities
  • Helps manufactures with directives, regulations, and responsibilities for medical products’
  • ISO 13485 Certification provides global recognition for your medical devices and equipment
  • Minimizes risks and improves the QMS of medical devices
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