Spectrum certified to ISO 9001:2015 Quality Assurance Standard by BSI

Spectrum Regulatory Solutions has recently been certified to the new ISO 9001:2015 standard, following a rigorous external audit to best practice measures by the global business standards company, British Standards Institute (BSI).
By: Spectrum Regulatory Solutions Ltd
 
 
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Tags:
* Iso9001
* British Standards Institute
* Spectrum Regulatory Solutions

Industry:
* Medical

Location:
* Horsham - Sussex - England

Subject:
* Services

HORSHAM, U.K. - April 18, 2016 - PRLog -- ISO 9001:2015 ensures that a business meets its customers' requirements to the highest standards. Key principles of ISO 9001 certification to this Standard are customer focus, risk and opportunity management, and continual review and improvement of all aspects of the business. Previously certified to the ISO 9001:2008 Standard, Spectrum is well-versed in the need for continual awareness of, and response to, changing legislative hurdles and their impact on the healthcare sector, and ensures that staff are adequately trained and supported by top management to fulfil client requirements.

"We are extremely proud to be among the first companies to have successfully transitioned to ISO 9001:2015. The transition gives us the opportunity to improve the alignment of our business objectives with those of our Quality Management System. It's a Standard that suits our business particularly well, placing emphasis on the needs of our customers and all our other stakeholders also. It enables us to engage everyone in the organisation in the task of identifying and managing the risks and opportunities that impact our business, putting us in the best possible position to provide a service that meets and exceeds customer and statutory requirements" said Dr Angela Gisby, Managing Director.

Spectrum

Spectrum Regulatory Solutions was established in 2005 and provides a full-service consultancy to the healthcare industry. Uniquely, this comprises a suite of services which support manufacturers both during the run-up to obtaining marketing approval, and in post-marketing activities. Key services include regulatory affairs and compliance across the EU, medical & regulatory writing, and readability testing. Spectrum's experience covers both medicinal products - pharmaceutical, biologicals/biosimilars, OTC, cosmetics, herbals and nutritionals - and medical devices. Visit Spectrum's website to find out more http://www.spectrumrs.com/

Contact
Ellie Coutts
***@spectrumrs.com
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