Quality Repairs for Flexible Endoscopes: Why ISO Certification Is Important

In the medical device industry, every step of a product’s life cycle, including service and delivery, faces increasing scrutiny to ensure safety and quality. Endoscope repair companies that can provide an alternative to the OEM while demonstrating their quality management processes and ensure best practices are more apt to meet the needs of health care systems for safety, product performance, and reliability.

What is ISO?

The International Organization for Standardization (ISO) is an independent, non-governmental organization with a membership of over 160 countries that establishes international standards to ensure quality, safety, and efficiency.

ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It is designed to be used by organizations involved in multiple aspects of the industry, including the servicing of medical devices. It therefore applies to third-party endoscope repair companies. ISO 13485 has recently been revised, with the new version published in March 2016.

Certification to ISO 13485 requires a company to demonstrate its quality management processes and ensures best practices. Certification is not a requirement of the standard; however, certification can demonstrate that a company has met the requirements of the standard. ISO 13485 certification is achieved via onsite audits of a company’s quality management system, verifying records to ensure the company fulfills the requirements of the standard.

Third-party Endoscope Repair

Third-party endoscope repair businesses operate under limited market regulation, and not all have the same quality and safety standards. A company with ISO 13485 certification has demonstrated a commitment to ensuring quality.

Healthcare providers must make independent, informed evaluations of third-party repair companies before choosing to work with one. When assessing prospective companies, determining their value involves evaluating the quality of the parts used to repair the devices, the training of the staff, and the processes used to ensure quality and safety.

Providers should work with the third party to understand what models they can service and make sure replacement components meet OEM specifications.

Partnering with an independent, third-party endoscope repair company* that is focused on quality, customer service, and turnaround time provides a solution that can also drive cost efficiencies for healthcare systems. Today, healthcare providers need reliable solutions for endoscope repair that will also meet the future quality and economic needs of a value-based healthcare environment. Voluntary ISO 13485 certification, company scale and experience, and industry partnerships underscore a company’s commitment to the quality service that make third-party service an attractive option. For more information on ISO, scope repair, and certified pre-owned scopes, visit our scope solutions page.