ISO 13485:2016 Medical devices — Quality management systems

Overview ISO 13485 is intended to simplify meeting medical device regulatory requirements for quality management systems. It covers specific standards for medical devices while excluding some ISO requirements that are relevant as regulatory requirements. Organizations must provide proof that their devices are safe and meet standards for a quality management system. This standard ensures an organization’s ability to consistently deliver medical devices and related services that meet customer and regulatory requirements. ISO 13485 encompasses various safety regulations to ensure the quality and reliability of medical equipment. While each country has its regulations for medical device design and development, ISO 13485 remains the primary Quality Management System (QMS) standard for medical devices. Companies in the medical device sector can achieve certification by aligning their processes with these standards.

Procedure to obtain ISO 13485 Certification The process involves:

  • Procedure and documentation for verifying the use of computer software for measuring and monitoring.
  • Installation requirements for medical devices and installation verification.
  • Transfer of design and development outputs to manufacturing processes.
  • Control of design and development change procedures and records.
  • Plans to manage contamination or potential contamination of the product.
  • Aligning with relevant regulatory requirements.
  • Processes and documentation for management reviews.
  • Risk management during product realization.
  • Records of traceability, including consignee’s name and address for the shipping package.
  • Identification of personnel approving product release.
  • Non-conforming product control procedures and documentation.

ISO 13485 aims to harmonize the healthcare industry to cut costs, improve access to treatment, and enhance efficiency. It enables medical device manufacturers to establish a QMS that maintains operational effectiveness. This ensures medical devices are designed, developed, manufactured, installed, and distributed consistently and safely from inception through disposal. The ISO 13485 standard is a comprehensive framework outlining best practices for the medical device industry.

Benefits

  • Instant Business Growth.
  • Usable by both small and large organizations.
  • Enhanced internal management.
  • Reduced waste.
  • Increased production efficiency and profit.
  • Reduced errors.
  • Improved product and service quality.
  • Better delivery and production schedules.
  • Annual evaluations uphold standards.
Benefits of having ISO 13485 Certification Adherence to ISO 13485 offers numerous advantages, including:
  • Improved manufacturing reliability.
  • Reduced waste and enhanced reputation for dependability within the medical industry.
  • Enhanced customer satisfaction through quality and process excellence programs.
  • Faster supply chain and production processes.
  • Improved communication channels and systematic methodologies.
  • Quicker cycle times and better administrative efficiency.

Implementing a quality management system fosters a culture of continuous improvement, helping employees across all levels enhance operational efficiency and effectiveness.

How to implement ISO 13485 Certification? Implementing ISO 13485 Certification involves several steps:
  • Scoping the project.
  • Securing senior leadership commitment to allocate necessary resources.
  • Conducting awareness training for all employees.
  • Developing internal skills.
  • Creating policies and procedures to support actions.
  • Conducting risk assessments and implementing required controls.
  • Implementing technical measures to mitigate risks.
  • Continuously monitoring and auditing internal controls.
Advantages of ISO 13485 Certification
  • Improved internal communication and process management.
  • Guaranteed quality, safety, and reliability of medical devices.
  • Cost savings from avoiding recalls of defective products.
  • Enhanced market image and brand loyalty.
  • Greater trust in disclosures.
  • Prevention of medical device-related issues.
  • Increased employee morale.
  • Effective resource utilization.
  • Timely and effective control of safety hazards.
  • Systematic administration of prerequisite programs.
  • Improved decision-making.

Our Advice If you are considering how to obtain ISO 13485 Certification, please contact Let Certify, a leading global organization providing consultations, certifications, audits, and other related support worldwide. Reach out to Let Certify by visiting www.letcertify.com to speak with an expert or write to contact@letcertify.com. Our specialists will connect with you promptly to provide the best solution in the market.

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