The standards, which update the British Standards Institutions (BSI) 2000 guidelines, set out requirements for quality management systems (QMS) to help manufacturers meet both regulatory provisions and customers’ demands.
The BSI ISO 9001:2008 standards were published in November 2008 and have been rolled out over the last 12 months. According to the BSI website all member companies are required to be compliant with the updated standards by December 31.
Cherwell, which makes the Radipor validity media for drug producers, explained that the accreditation confirms that every batch it supplies to the pharmaceutical industry is certificated and in line with pharmacopeial standards.
Company spokesman Andrew Barrow told in-PharmaTechnologist that: “Our ability to attain the new 2008 standard within just a few weeks of publication shows our customers that our systems are robust and as a company we are proactive in implementing the 2008 improvements well ahead of the deadline.
Barrow explained that: “The majority of the Redipor range of media is used for environmental monitoring of clean room and aseptic isolator manufacturing,” adding that the “range has a long track record of consistently supplying high quality products for use within these critical environments.”
These thoughts were echoed in a press release issued by Cherwell managing director Andrew Whittard who said that: “We are extremely pleased to be able to so successfully demonstrate the quality of our products, facilities and customer service.”
He added that: “At the core of [the ISO9001:2008] system is a desire to continually improve the quality of products and service offered.”