Ongoing support to achieve speedy accreditation in the healthcare sector
The challenge: Spectrum Regulatory Services help companies in the healthcare sector – including pharmaceutical and medical device manufacturers – meet mandatory regulations. They were preparing for ISO 9001 accreditation and asked us to undertake a Gap Analysis to identify where they were meeting the standard and where they needed to concentrate their resources.
The solution: Our Gap Analysis demonstrated that Spectrum Regulatory Services had been approaching the process from a regulatory perspective, rather than a quality analysis. We were able to explain to them how they needed to develop their quality management system to meet the standard. Over the next few months the client was contacted several times by the regulatory body; they were able to call us a sounding point to make sure they had understood the communication correctly and were still on track with developing an appropriate quality process.
The benefits: The client gained a better understanding of Quality Management Systems and achieved speedy accreditation at the first attempt.
- QMS Gap Analysis
- QMS consultancy
- Problem solving
We engaged Ian Edwards to guide us through the process of obtaining ISO 9001:2008 certification. Ian was quick to understand the nature of our business and his deep experience was evident in the advice he gave and the way in which he got us thinking about our approach to quality management. After the initial consultation he remained close to us and was always ready to clarify issues and answer questions. He provided practical help with the logistics of the application and on stage 1 day he got in touch to wish us luck. We are now well on the way to obtaining certification, thanks to the professional and friendly service provided by Ian. I would not hesitate to approach him on any quality issue, nor to recommend his services. He is a true asset. Many thanks again Ian!