ISO 13485 Certification Services

 An organization that is “ISO 13485 Certified” has established an ISO 13485 Quality Management System and has successfully met all of the ISO 13485 standards. ISO 13485 assesses if your Quality Management System is acceptable and effective, with a focus on medical device safety and efficacy.

A few details about ISO 13485 Certification:

Although some countries have their own set of rules, ISO 13485 is the most common Quality Management System (QMS) standard for medical devices. The Food and Drug Administration (FDA) regulations for medical devices, for example, will be harmonized with ISO 13485 in the United States. Hence it becomes very important to get the ISO 13485 certification services done by a trustworthy organization. ISO 13485:2016 is the most recent version, which was released in March of 2016. Some features of this version are mentioned below

·    It makes no difference how big or little your company is: Whether it’s one person or a million,

·    It is NOT a product standard. It has no influence on the quality of a product. This is a process-based standard, which means that if you use it to govern your operations, your end product should satisfy your expectations.

·    ISO 13485 is not a personal standard; no one person may be certified to it. Instead, a corporation or organization becomes certified. After a 5-day training session, however, an individual can become an ISO 13485 Certified Lead Auditor. This enables them to conduct audits of other businesses.

·    It is not a membership organization. ISO 13485 cannot be “joined” by an organization. To achieve ISO 13485 certification, your company must follow the following

1.Implement an ISO 13485 quality management system by following the steps below.

2.The performance of your organization is then audited against the most recent version of the ISO 13485 Requirements by a Certification Body (CB or Registrar). If you pass the audit, the Registrar will award you an ISO 13485 Certificate, which will show that your company is registered to ISO 13485 for three years.

3.Finally, in order to keep its ISO 13485 certification status, the organization must be re-certified every three years.

Looking at the above criteria it’s very clear that to comply with the rules and regulations you must get your ISO 13485 certification services done by a very reputed and trustworthy service provider.

Location: United States

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