MasterControl, Inc., a global provider of quality management software solutions and services, announced today the milestone of being one of the first companies in the world to successfully complete a certification audit to the newly revised ISO 9001:2015 standard.
"To our and our assessors' knowledge, MasterControl is the first company in the world to have completed a full-certification audit to ISO 9001:2015," said Lillian Erickson, MasterControl's global quality manager for the U.S., U.K., and Japan.
"All companies certified to ISO 9001:2008 have three years to transition to the new standard due to the complexity of the new requirements," she added. "We are pleased to tell our customers that MasterControl continues to lead the industry in compliance and innovation."
MasterControl completed its certification audit on Nov. 12, 2015, just one week after individual ISO assessors began performing audits based on the revised standard published on Sept. 23, 2015.
Compliant QMS Processes
"This standard focuses largely on risk management. MasterControl has always believed that quality should be an accelerator of business, and as such, resources should be applied where risk necessitates them. Over the past year, our processes have been designed to be risk-focused and compliant not only with the verbiage of the standard, but with the intent," said Erickson. "In addition, the standard focuses strongly on customer and stakeholder requirements. MasterControl has rewritten its core QMS procedures with these interested parties clearly defined and managed."
A comprehensive audit was conducted for four days in MasterControl’s headquarters in Salt Lake City, Utah, and for one day in its office in Basingstoke, England, during the week of Nov. 9-12, 2015.
The following core QMS processes were among those which were reviewed in-depth: change control, corrective actions and deviation management, customer feedback and complaints, document control and record management, internal communication, product development, testing, validation, servicing and support, risk management, supplier management, and training management.
Maintaining High Quality
MasterControl's U.K. office was first to earn ISO 9001 certification in August 2012. Led by Erickson, the company is completing a year-long initiative in preparing for the addition of its U.S. headquarters to the certificate and in transitioning from the ISO 9001:2008 standards to the 2015 requirements.
"This certification shows the effectiveness of this year-long project, and allows us to move forward with additional continuous improvements, knowing that we are on the right track," she said.
To maintain certification, MasterControl will undergo a surveillance audit every year, and a re-certification audit every three years. The company plans to include its Japan office in next year’s assessment process.
Alcumus ISOQAR, based in Manchester, England, conducted the audit and will be awarding certification to MasterControl. "It was an exhaustive audit, but our assessor was well-versed in the new standard and able to perform the audit effectively and efficiently," Erickson stated.
ISO 9001:2015 is the latest revision of the world’s most widely applied international standard on quality management systems. Companies worldwide adhere to the standard to demonstrate to their customers that their products and services maintain the highest quality.
MasterControl (mastercontrol.com) is a committed team of quality, regulatory and software experts who work to empower regulated companies to get their products to market faster. MasterControl’s quality management software solutions reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage for customers. Drawing upon unparalleled industry experience, MasterControl offers a suite of seamlessly integrated and scalable software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management and much more. MasterControl’s complete quality management solution is designed for easy implementation, validation and use, continually improving on the promise of Compliance Accelerated. For more information about MasterControl call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); +81 (03) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).