How can I get ISO 13485 certificate?

6 steps to ISO 13485:2016 certification

  1. Planning the quality system. Section 5.4.
  2. Meeting regulatory requirements. While developing your quality plan, U.S. medical device companies must comply with FDA 21 CFR 820.
  3. Implementing design controls.
  4. Documents, records, and training.
  5. Management processes.
  6. The Certification audit.

Can an individual get ISO 13485 certification?

It is NOT a personal standard – a person cannot get certified to ISO 13485. Instead, an organization or company becomes certified. An individual, however, CAN become an ISO 13485 Certified Lead Auditor after a 5-day training course. This then allows them to audit other companies.

How long does it take to get ISO 13485 certification?

4-6 months
How long does it take to achieve ISO 13485 certification if we have no system in place? Implementation usually takes 4-6 months for companies with fewer than 50 employees.

How do I become a medical device auditor?

Membership. Each participant has to take membership of Institute of Good Manufacturing Practices India (IGMPI) as a part of registration process. All the members will be entitled to receive comprehensive study resources for all the modules along with training guidance in online interactive mode.

What is the difference between ISO 9001 and 13485?

ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices.

What is certified biomedical auditor?

“The Certified Biomedical Auditor is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a biomedical system while using various tools and techniques to examine, question, evaluate, and report on that system’s adequacies and deficiencies.

What is the Mdsap program?

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Can a person be ISO certified?

Individuals cannot get ISO 9001 certified; rather, organizations or companies get certified. Individuals, however, can get certified to become an ISO 9001 Certified Lead Auditor, which enables them to audit other companies. Size of the organization does not matter. It could be 1 person or 100,000.