![iso 13485 registrar iso 13485 registrar](https://img.yumpu.com/43144299/1/190x245/iso-134852003-iso-134851996-most-significant-qmiicom.jpg)
(See Who is able to grant certification)įinally, the organization must be re-certified every three years in order to maintain its ISO 13485 certification status. If you pass this audit, the Registrar issues an ISO 13485 Certificate demonstrating that your organization is Registered to ISO 13485 for a three year period. Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 13485 Requirements.
![iso 13485 registrar iso 13485 registrar](https://cardiomed.com/wp-content/uploads/2018/06/Screen-Shot-2018-06-14-at-1.48.50-PM.png)
To become ISO 13485 certified, your organization must:įollow the steps to implement an ISO 13485 quality management system. This then allows them to audit other companies. An individual, however, CAN become an ISO 13485 Certified Lead Auditor after a 5-day training course. Instead, an organization or company becomes certified. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings. It is NOT a personal standard – a person cannot get certified to ISO 13485. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results. It does NOT matter what size your organization is: 1 person or 1 million people The current version is ISO 13485:2016, which was published in March of 2016 (thus the: 2016). The scope of the QMS can be tailored for an organization, particularly in Section 7. As an example, the United States plans to harmonize the Food and Drug Administration (FDA) requirements for medical devices with ISO 13485. Diazyme currently sells their standing products throughout the world, both by selling direct and through various domestic and international distributors.It is the main Quality Management System (QMS) standard for medical devices, although several countries have their own set of regulations. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. as their registrar and was officially certified on June 17, 2004. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. Diazyme Laboratories chose TUV Rheinland of North America, Inc.
#Iso 13485 registrar registration
TUV Rheinland of North America, Inc., headquartered in Newtown, Conn., USA, is a subsidiary of TÃœV Rheinland Group, Germany, and is a global leader in compliance engineering, testing and quality registration services for domestic and foreign markets. STE Technology® is also used to develop protein pharmaceuticals, especially receptor antagonists for treatment of immune related diseases and cancers. Diazyme Laboratories, through its STE Technology, focuses on the areas of small molecule (metabolites and drugs) detection, single nucleotide polymorphism (SNP) identification, and recombinant enzyme based diagnostic reagents. This includes the implementation a quality management system (QMS) addressing staff training, design and development of products, certification and purchasing of materials and services, and product labeling and delivery.ĭiazyme Laboratories is a Division of General Atomics headquartered in La Jolla, California. To be certified to the standard, companies need to demonstrate their ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The ISO 13485:2003 standards, released in July 2003 as the successor to ISO 13485:1996, is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO). SAN DIEGO, CA – JDiazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that it has received ISO 13485:2003 certification from TUV Rheinland of North America, Inc.