ISO 13485 Certification

About ISO 13485 Certification

The ISO 13485 International Standard provides requirements for medical device and equipment manufacturers to improve their quality management systems. It lays forth procedures for reducing manufacturing processes and system failures. This guideline also ensures that medical equipment continues to improve in quality. It is important to understand that ISO 13485 Certification does not specify quality requirements. It only specifies the requirements for a manufacturer’s quality management system (QMS). A company that implements and adheres to this standard will improve its product and service.

ISO 13485:2016 is the most recent version of the ISO 13485 standard, which was developed with a process-oriented approach in mind to reduce operational errors and hazards in the management system. Because it is presented with a high-level framework and PDCA cycle, ISO 13485:2016 is compatible with other ISO management system standards. Furthermore, its risk-based thinking style helps businesses to satisfy the demands of their customers on a continuous basis.

Purpose of ISO 13485 Certification

Companies that have received ISO 13485 certification protect the safety of professionals and patients in clinics, hospitals, and other medical facilities. ISO 13485 certification focuses on the requirements for establishing and maintaining a quality management system for companies that design and manufacture medical devices and equipment. It is needed by the US Food and Drug Administration for medical device manufacturers who need ISO 13485 Certification before shipping their goods to the US.

ISO 13485 Certification

ISO 13485 Certification Process

To achieve ISO 13485 certification, a company must satisfy specific requirements of ISO 13485 standards. Medical devices and ISO 13485 certification process are covered by a number of ISO clauses. The ISO 13485 certification confirms that a medical device producer is ISO compliant and has adopted ISO processes. Some of the ISO 13485 certification standards are as follows:

  • Review of Design Controls
  • Development of ISO-Compliance Documentation and Management
  • Risk Analysis
  • Identifying ISO-Required Documents
  • Using Peer Review to Demonstrate ISO 13485 Compliance
  • Plan for ISO 13485 Internal Audit
  • ISO 13485 Training

IAS will examine your paperwork and procedures once your business has implemented ISO 13485 standards. IAS will perform external audits in accordance with this method to guarantee that your business is correctly applying ISO 13485 standards. IAS will give ISO 13485 certification to your firm when these audits are completed successfully.

Online Audits to Achieve ISO 13485 Certification

IAS currently uses an online web testing platform to conduct ISO 13485 certification audits. IAS offers ISO 13485 certification once the audit is successfully completed, stating that your company is ISO 13485 certified under various criteria, based on online test scenarios for your system documentation, policy testing, and other related procedures. Once you successfully achieve ISO certification, you can check the status of your certificate by visiting our ISO 13485 certification Search Page!

Which Organizations Can Apply for ISO 13485 Certification?

All companies and industries that produce and distribute medical devices and equipment, regardless of size or location, must comply with the ISO 13485 certification criteria. Additionally, ISO 13485 certification is applicable to industries that provide related services.

Why Choose IAS for ISO 13485 Certification?

The International Organization for Standardization (ISO) creates and publishes ISO 13485 standards, however they do not provide certification. As a result, companies need third-party certification bodies like IAS to achieve ISO 13485 certification. In Australia, IAS is a prominent ISO 13485 Certification organization that helps firms ensure that their ISO 13485 quality management system is successful by performing conformity assessments with certified experts who are experienced auditors. IAS examines your operations against the criteria of the standard to guarantee that you receive ISO 13485 certification in a timely way.

Advantages of ISO 13485 Certification

The following are just some of the numerous benefits to achieving ISO 13485 certification:

  • Improvements in the quality and safety of medical devices
  • Reduces operational waste and mistakes
  • Demonstrates compliance with local laws and regulations
  • Increases client pleasure and trust
  • Maximizes business efficiency
  • Stakeholder relationships are enhanced
  • It opens up new commercial opportunities on a worldwide scale

For more information on ISO 13485 certification, please contact us or visit our ISO 13485 certification frequently asked questions page to learn more.