Like most companies manufacturing medical products, Myriad has to operate under the guidance of certain standards. In October we underwent our annual ISO 13485 audit, conducted by BSI. Some of the areas reviewed were: corporate management, our quality system and manual, incoming inspection records, tool and equipment calibration, CAPA’s, and traceability records. The result of the one day audit was that we passed, and retained our ISO certificate for another year.
In November, at the request of one of our medical customers, we were audited by TUV to determine if Myriad was compliant to JPAL: MHLW Ministerial Ordinance No. 169, 2004. JPAL is the Japanese equivalent to America’s FDA. Being compliant would allow any of our customers to sell their Myriad manufactured product in Japan. Our customer was pleased to get a report that confirmed that Myriad is compliant to the JPAL standard, as well as to ISO 9001.
And then, to close out our year, in December, one of our customers conducted their own on site audit of our overall quality system. The auditor found no deficiencies in our procedures and documentation; and issued a statement that declared that Myriad met all of its quality requirements.