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ISO Standards for Medical Device and Pharmaceutical Industry

ISO Standards for Medical Device and Pharmaceutical Industry

GMP

Applicable ISO Standards for Certification:

  • ISO 13485: Medical Devices Quality Management System
  • ISO 14971: Application of Risk Management to Medical Devices
  • ISO 9001: General Quality Management System
  • ISO 50001: Energy Management System
  • ISO 27001: Information Security Management System (ISMS)
  • GMP (Good Manufacturing Practices): Compliance to pharmaceutical standards

Integrated Management System (IMS):

  • ISO 13485 + ISO 14971: Integrated system for quality and risk management in medical devices.
  • ISO 9001 + ISO 27001: Quality and information security system integration, especially for medical and pharma records management.

Benefits:

  • ISO 13485: Ensures product safety and quality, improves market access, and meets regulatory requirements.
  • ISO 14971: Reduces product risks and enhances regulatory compliance for medical devices.
  • GMP: Ensures safety, efficacy, and quality of pharmaceutical products.
  • ISO 27001: Protects sensitive patient and clinical data from breaches or loss.