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Introduction

ISO-13485The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfil.

ISO 13485:2012 Medical Devices Quality Management Systems – Requirements for Regulatory Purposes – is based on the ISO 9001 standard but with additional requirements in relation to;

  • Design
  • Environmental Control
  • Traceability
  • Documentation
  • Records Control
  • Regulatory Actions
  • Risk management

ISO 13485 contains all the requirements of ISO 9001, with the exception of two items:

  • Customer Satisfaction
  • Continuous Improvement

The principle behind ISO 13485 is to ensure the provision of safe and effective medical devices, not to focus on continuous improvement or customer satisfaction.

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