NEWS - MasterControl European Headquarters Receives ISO 9001:2008 Certification

SALT LAKE CITY, USA - October 4, 2012 - MasterControl Global Limited, a leading provider of quality, audit, and document management software solutions, today announced that its European headquarters located in Basingstoke UK has been approved by ISOQAR for ISO 9001:2008 certification (certificate number 10509). The accreditation, officially received on August 31, 2012, covers the supply, service, and support for both MasterControl and MasterControl QAAD products.

"Not a single instance of nonconformance was recorded or raised during any stage of the certification process," said Karen Tigwell, Global Quality Manager at MasterControl. "This is a superb achievement for an initial ISO audit."

ISO 9001:2008 specifies requirements for a quality management system (QMS) where an organization: needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and; aims to enhance customer satisfaction through effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

To achieve the certification MasterControl selected ISOQAR, a United Kingdom Accreditation Service (UKAS) accredited company, to work with as a preferred partner. Accreditation from UKAS demonstrates that the certification body is competent and impartial.

The formal certification process involved two stages. The first stage of the audit was to assess documented policies and procedures directly against the requirements of the standard(s), and consisted of the following activities:

  • An audit of management system documentation
  • Confirmation that all legal/technical requirements are identified
  • A site "walk around"
  • Planning for the second stage of the audit
  • An evaluation of the location, processes, and conditions at the site
  • Internal audit process
  • Management review
  • Management commitment
  • Identification of objectives and targets

The purpose of the second stage of the certification process was to conduct the formal audit of MasterControl's QMS and the requirements of each applicable standard by gathering objective evidence (Quality Records) to demonstrate compliance. The second stage of the audit consisted of the following activities:

  • An opening meeting
  • Site visits
  • Staff interviews
  • An examination of records
  • Evaluation of audits
  • A closing meeting

Following the completion of both audit stages, MasterControl Global Limited received official written confirmation and congratulations from ISOQAR about the accreditation on September 3, 2012.


ISOQAR was founded in 1991 as one of the first independent certification bodies in the UK. It now enjoys one of the broadest scopes of accreditation in its industry. In October 2010 ISOQAR was acquired by the Alcumus Group, a multi-disciplinary provider of risk management, compliance and certification services. Today ISOQAR has its own regional auditors throughout the UK and a network of operations across the globe.

About MasterControl

MasterControl Global Limited produces software solutions that enable companies doing business in regulatory environments to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include clinical management, quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions document management, clinical trial management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 81 (3) 5422 6665 (Japan).