ISO Certification for Medical Devices & Laboratory Testing

  

ISO offers several standards related to medical devices and laboratory testing. Here are some of the most common ISO standards for Medical Devices industries:

 

ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes: This standard specifies requirements for a quality management system for medical devices, including design, development, production, installation, and servicing. It is intended for organizations that design, manufacture, and distribute medical devices.

 

ISO 14971: Medical Devices - Application of Risk Management to Medical Devices: This standard outlines the requirements for a risk management system for medical devices, including risk analysis, risk evaluation, risk control, and risk management review.

 

ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories: This standard specifies the general requirements for the competence of testing and calibration laboratories. It includes requirements for the quality management system, personnel, facilities, equipment, and measurement traceability.

 

ISO 15189: Medical Laboratories - Requirements for Quality and Competence: This standard specifies requirements for quality management and technical competence for medical laboratories. It includes requirements for personnel, equipment, facilities, quality control, and proficiency testing.

 

To obtain certification for these standards, organizations must demonstrate compliance with the requirements of the standard through an audit by an accredited certification body. The certification process typically involves a pre-audit, an initial certification audit, and periodic surveillance audits to ensure ongoing compliance.

 

It is important to note that ISO certification is not mandatory, but it can provide benefits such as improved customer confidence, increased efficiency, and better risk management. Organizations can choose which ISO standards are most relevant to their business and work with an experienced consultant or certification body to guide them through the certification process.