ISO 9000 Certification

The ISO 9000 family of standards is one of the most popular series in the world. It’s applicable to almost any type of business that values quality management for the purpose of regulatory compliance or to fulfill customer requirements or both. A nongovernmental entity called International Organization for Standardization, with a membership of 162 national standards bodies, publishes the series. The group is known as ISO, which is not an acronym, but derived from isos (the Greek word for equal).

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ISO 9000 Compliance

ISO 9000 compliance is voluntary, but most companies embrace it as a foundation for quality and the basis for compliance with other regulations. ISO 9000 defines the basic concepts and principles of quality management. It defines quality management system (QMS) as a set of interrelated elements that organizations use to attain quality policies and objectives. The latest version, ISO 9000:2015, supersedes ISO 9000:2000 and other old versions.

ISO 9001 Contains ISO 9000 Requirements

ISO 9000 compliance. Companies get certified to ISO 9001, not ISO 9000.The latest version, ISO 9000:2015, contains basic principles, which are summarized below.

Customer Focus: Quality management’s primary focus is to fulfill customer requirements.

Leadership: Leaders should establish a united purpose and direction to help the organization achieve its quality objectives.

Engagement of People: The organization’s personnel should be competent, empowered and engaged in delivering value.

Process Approach: The quality management system is composed of interrelated processes. Understanding the processes is key to optimizing performance.

Improvement: The organization must focus on continuous improvement.

Evidence-based Decision Making: Analysis of facts and evidence leads to greater objectivity in making decisions.

Relationship Management: Effective management of relationships with suppliers and other interested parties is essential to overall success

ISO 9000 Training

Continual improvement is a key principle under this standard. It should be a goal and a priority throughout the organization. ISO 9000 training and ISO 9000 course development are effective tools for achieving such a goal. The leadership principle also calls for leaders to provide the necessary resources for ISO 9000 training of personnel and to encourage responsibility and accountability.

MasterControl and ISO 9000 Quality Management System

Regulated companies worldwide use MasterControl Quality Excellence as the platform for their ISO 9000 quality management system. The solution facilitates adherence to the standards and provides the essential tools to increase efficiency and reduce overall costs.

Documents and Records: Automate your document-based processes, from creation through obsolescence. Automation of routine tasks will reduce your document cycle time, while a streamlined process will make compliance easier for all stakeholders.

Training and Exams: Allow your training coordinators to focus on the quality and effectiveness of the curriculum instead of administrative tasks by automating your training process, from distribution of materials to exams and verification. MasterControl provides the capability to add pictures to exams to help explain complex questions.

Incidents and Corrective Action: MasterControl provides robust tools to manage the corrective action and preventative action (CAPA) process and integrate it with other processes, such as document control and change control for a holistic approach to quality management. The system allows users to launch a CAPA from another process or form.

Audits and Preventative Action: MasterControl aligns the audit process to an organization’s business objectives and strengthens risk assessment throughout the enterprise by providing an integrated platform for managing all audit-related tasks, from preparation and scheduling through execution, collection of observations, verification, and completion.

Risk and Mitigation: Unify all your risk monitoring, assessment, and mitigation activities under a centralized system. MasterControl provides standardized risk calculation tools and powerful analytics and reporting capability for monitoring of trends.

MasterControl Adheres to ISO 9000

MasterControl software solutions help companies comply with ISO standards. Most of all, MasterControl itself adheres to the ISO 9000 standard. The company was among the first to be certified to ISO 9001: 2015 in November 2015 and also one of the first to re-certify in 2017.

Leader in ISO 9000 Compliance

Regulated companies worldwide trust MasterControl as the leading software provider for organizations that comply with ISO 9000. State and federal agencies in the United States, including two divisions of the Food and Drug Administration, also use MasterControl as their quality management system.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

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