Click Here to View Biolab's ISO Registration Certificate

ISO 9001:2000 adopts a process control approach to quality system management. The new standard was developed on a simple process-based structure. ISO 9001 reduces the twenty elements of previous standards to just five. The new process-based structure is more in alignment with the process-based management approach widely used in business today and focuses heavily on customer satisfaction: Quality Management System, Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis and Improvement.

ISO 13485:2003 this standard attests that our Quality Management System complies with international regulatory requirements for the conception and manufacturing of medical devices. ISO 13485 specifies harmonized medical device regulatory requirements for quality management systems. As such, ISO 13485 provides a standard for compliance with the Health Canada’s Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). ISO 13485 is also considered to be fully compatible with the United States Food and Drug Administration (FDA) Quality System Requirements.

As part of our commitment to the ISO standard, we formally survey our customers on a quarterly basis, which provides valuable feedback as to how to continually improve our products and processes.

Achievement of these policies involves all staff, who are individually responsible for the quality of their work, resulting in a continually improving working environment for all. Our management will provide leadership and training to all employees to consistently seek improved quality at reasonable costs that exceed the expectations of our customers.

Our Quality Policy: “Purity, the Vision – Quality, our Direction”

Please take note of the following:

Canada:
In accordance with statute 21CFR parts 207, 607 and 807 Biolab are registered with the USFDA Department of Health & Human Services. Establishment registration number: 9710313

In accordance with the Canadian Food and Drug Act SOR/98-282, Health Canada’s Therapeutic Products Programme. Biolab has a registered Class I Medical Device Establishment License number 667 and the following device licenses.

4400 Series Water Purification Systems [14 Models]
Class III Medical Device License number 60229
Class III Device identification number 414273
Covers both single and two pass systems.
8400 Series Water Purification Systems [30 Models]
Class III Medical Device License number 60230
Class III Device identification number 414320
Covers both single and two pass systems.
Portable Series Water Purification Systems [3 Models]
Class III Medical Device License number 60226
Class III Device identification number 414378
Class IIG, CSA C22.2 risk class registration number FE 7058-5

The Canadian office's 24/7 Emergency response teams are registered with Health Protection Branch, Scarborough, Ontario.

United States:
In accordance with the provisions of the Federal Food, Drug and Cosmetic, we have a registered Class II Medical Device Establishment License number 97-0313, 510 (k) number K030348.