ISO 13485:2016

Medical Devices Quality Management System Certificate

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support)

Benefits of ISO Certification:

Benefits of Food Safety Certification has many benefits for organizations with environmental management systems. Organizations and companies find that using the standard helps them:

  • Cuts investigation time to a minimum
    The management system helps you to reduce food safety breach investigation time.

  • Customer satisfaction
    Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.

  • Global recognition as a reputable supplier
    Certification is recognized internationally and accepted throughout industry supply chains, setting industry benchmarks for sourcing suppliers.

  • Proven business credentials
    Independent verification against a globally recognized industry standard speaks volumes.

  • Legal compliance
    Understand how statutory and regulatory requirements impact your organization and its customers.

  • Ability to win more business
    Procurement specifications often require certification as a condition to supply, so certification opens doors.

ISO CERTIFICATION PROCESS

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Document Required For ISO Certification

Business Registration Certificate

Letter Head or Visiting Card

Sales & Purchase Invoice

Description of Business