Medical Devices

ISO 28000

WHAT IS ISO 28000?

This standard identifies the requirements for a supply chain security management system, relating security management to many other aspects of business management. These include all activities controlled or influenced by organizations that impact supply chain security, which includes the transportation of these goods along the supply chain.

ISO 22301

WHAT IS ISO 22301 BUSINESS CONTINUITY MANAGEMENT?

ISO 22301 is the international standard for business continuity management and builds on the success of British Standard BS 25999 and other regional standards. It’s designed to protect your business from potential disruption.  This includes extreme weather, fire, flood, natural disaster, theft, IT outage, staff illness, or terrorist attack.

ISO 15189

WHY ISO 15189?

Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.

ISO 13485

WHAT IS ISO 13485?

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation, and servicing such as added requirements on record-control, sterilization, and risk management.

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