Some scope repair companies are ISO certified. Others aren’t. “So what?” you might ask. Why should you care one way or another? All scope repair companies are the same, right? Certification makes no difference, right?

Wrong. It does matter.

ISO certification puts some companies’ heads above the rest and its requirements have a direct – and very positive – impact on the work and service you receive as a customer. Here’s how it affects you and your scope repair service.

What is ISO, anyway?

ISO (International Organization for Standardization) is a worldwide federation of national standards bodies, representing 127 countries. The object of ISO is to promote the development of standards around the world that facilitate the exchange of goods and services, and develop cooperation in intellectual, scientific, technological and economic activity.

Why is it ISO, and not IOS? Since the “International Organization for Standardization” would have different abbreviations in different languages (e.g. “IOS” in English; “OIN” in French for Organisation Internationale de Normalization), it was decided at the outset to use a word derived from the Greek isos, which means “equal.” Therefore, whatever the country, whatever the language, the short form of the organization’s name is always ISO.

What is ISO 13485?

ISO 13485 is a quality management standard produced by the worldwide ISO federation to ensure consistency in the quality control and assurance process in medical device manufacturing and service industries. These standards are written to fit all medical device businesses regardless of what the organization does and no matter its size or whether it’s in the private or public sector.

ISO certification is very similar to JCAHO. Companies that are ISO certified go through an audit process that is similar to what the hospitals go through for their JCAHO certification. Audits can be conducted annually or semi-annually depending on the size of the company and the complexity of the processes. There is one difference between the ISO and JCAHO certifications though: ISO certification is voluntary. Companies choose to go through the ISO certification process to improve themselves. These companies (like Total Scope) realize the importance of customer focus, consistent quality repairs, continual improvement, etc.

Some companies claim to be ISO “compliant.” This claim means absolutely nothing. No third party has verified that the company does, in fact, meet all the requirements of the ISO standard. This is like a hospital claiming to be JCAHO compliant. Without the audit, there’s no way to prove it.

To become ISO 13485 certified, all companies must meet stated quality requirements in a range of areas. Here’s a rundown of affected company functions:

  1. Management responsibility and quality assurance system
  2. Order review
  3. Document control
  4. Supplier qualification and part verification
  5. Lot identification, traceability, and customer product
  6. Process control
  7. Inspection, testing, and status
  8. Control of measuring devices
  9. Control of nonconforming product
  10. Corrective and preventive action
  11. Handling, storage, packaging, preservation, and delivery
  12. Control of quality records
  13. Internal quality audits
  14. Competence and training
  15. Product servicing
  16. Statistical techniques
  17. Internal communication
  18. Customer feedback system
  19. Risk assessment
  20. Planning
  21. Process based system
  22. Resource management
  23. Continual improvement
  24. Process and software validations

Following are brief explanations of what these requirements mean for each area and how they benefit you, the customer.