MasterControl Earns ISO 9001:2015 Certification

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.

MasterControl reiterated its commitment to continued innovation and leadership in the field of quality and compliance software when it attained the milestone as one of the first companies in the world to successfully complete a certification audit to ISO 9001:2015 standard.

“All companies certified to ISO 9001:2008 have three years to transition to the new standard due to the complexity of the new requirements,” said Lillian Erickson, MasterControl’s global quality manager for the U.S., U.K., and Japan. “We are pleased to tell our customers that MasterControl continues to lead the industry in compliance and innovation.”

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White Paper: Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean White Paper: 6 Must-Haves for a Quality Management System (QMS)
Industry Brief: SOP Management as a Compliance Tool in FDA and ISO Environments
Summary: ISO 9001 Compliance Requirements

What is ISO 9001:2015?

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.

“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,” said Erickson.

QMS Processes in Compliance

MasterControl’s processes have been designed to be risk-focused and compliant. Its core QMS procedures also focus on customer and stakeholder requirements. 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
Training Management

Find More Information on ISO 9001 Standards

To learn more about MasterControl's quality standards like ISO 9001 standards and product lifecycle management software solutions, please feel free to contact a MasterControl representative. Why not make compliance with ISO 9001 an automated habit?