First Quality Hygienic Implements ISO 9000 Quality System
First Quality Hygienic, Inc. (FQH) is a leading manufacturer of Feminine Hygiene Products and markets Femtex ® tampons to retailers throughout the United States. Femtex® brand tampons are available in different absorbencies and packaging choices. In addition, First Quality is the leading private label manufacturer for some of the largest retailers in the world. FQH employs 216 people.
In order to continue sales of tampons to Canadian markets, FQH needed to be certified to ISO 9001:1994, ISO 13485:1996 and CMSCAS (Canadian) standards for medical devices. Certification needed to be achieved by 12/31/02 in order to meet the Canadian deadline.
IMC provided analysis, training and consultation to FQH employees. Training included ISO 9001 (& ISO 13485) Quality Awareness Training and When the Auditor Comes Training for all FQH employees. Additional training was provided for selected employees in Internal Auditing and Process Mapping. IMC also helped FQH to locate a trainer to present specialized risk analysis training in HACCP. In addition to the original assessment of the FQH quality management system, IMC conducted a final gap analysis prior to the registrar’s pre-audit. Finally, IMC provided guidance on what questions might be used in finding the right registrar for our organization.
FQH successfully passed the registrar’s final audit on the first try; and we were issued certificates for all of the above-mentioned standards on November 22, 2002.
IMC provided FQH with significant help in achieving the goal of ISO certification. FQH was charged with meeting this challenge within a 12-month period, or potentially see a significant impact in sales. IMC representatives not only provided significant assistance in training, but they also took the time to become familiar with additional standards related to our medical device industry. IMC worked well with all levels of employees. We not only achieved our goal of ISO certification, but all have seen a continuing improvement in FQH operations.
- Mark Loewen, Director Quality Assurance/ Regulatory Affairs, First Quality Enterprises, Inc.