ISO 9001 defines the basic requirements for an organization’s quality management system (QMS), which is necessary to ensure the company consistently provides products that fulfill customers’ needs and expectations. ISO 9001:2000 specifically applies to an organization’s continuous improvement of its quality processes and the assurance of compliance with relevant regulatory requirements.
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ISO standards apply a process approach. The quality management processes within the ISO 9001 standard require the effective management of resources to achieve a consistent, predetermined output. Some of the specific quality management tasks organizations need to perform include:
Deploying a QMS solution that automates these processes is the best way to achieve and maintain compliance with ISO 9001, as well as demonstrate confidence in your organization’s ability to consistently produce quality products.
Part of a company’s QMS requires efficient and accurate management of all documents. MasterControl Documents™ automates the document control and management processes, from document creation through approval, distribution, version control, and end of lifecycle.
Change control touches every other quality management process. MasterControl Change Control™ automates every aspect of managing changes, from submission through implementation, verification, and close of project. MasterControl also provides a time-stamped audit trail for every change.
Corrective and Preventive Action
In the event of a quality nonconformity, corrective and preventive action (CAPA) is needed to identify, resolve and prevent the reoccurrence of the nonconformity. MasterControl CAPA™ automates all CAPA processes, as well as integrates with all other QMS processes for a more holistic approach to quality management.
Documented processes or procedural updates are of no use without sufficient training. Training management involves developing and executing effective training programs that ensure the necessary level of employee competency. MasterControl Training™ automates all training management tasks, enabling companies to eliminate errors or oversights with regulatory training requirements.
A company needs to conduct both internal and external audits to ensure that its QMS meets the ISO 9001 requirements. Verification of compliance to the standard for certification can only be performed by a qualified external auditor. MasterControl Audit™ integrates with all other elements of the QMS for easier management and full visibility of all audit processes.
ISO 9001 requires companies to demonstrate efficient quality management throughout the organization. MasterControl seamlessly integrates all quality management-related processes, including data management, analytics and reporting, change control, training, and document management on one centralized platform.
Document control is a core requirement of the ISO 9001 standard. Document control involves a series of processes that provide a sufficient level of control over all types of documents, including externally-created documents, throughout their lifecycles.
The ISO 9001 standard defines specific document control procedures, which include ensuring documents are available to all relevant stakeholders, changes receive requisite approval signatures, and obsolete documents are pulled from distribution. Obsolete documents that are still in use is the most common document control nonconformance.
The ISO 9000 series as a whole focuses on all stakeholders of a company’s QMS. The focus of the requirements specific to ISO 9001 is customers. Customers not only purchase products and services, they also like to establish long-term relationships. Therefore, it’s critical that your company consistently complies with the ISO 9001 requirements, which include:
More companies are discovering that compliance with the ISO 9001 standard is much easier to achieve and maintain using automated technology. MasterControl’s Quality Excellence™ solutions have functionality that directly aligns with all of the ISO 9001 requirements. Other benefits of using MasterControl include:
MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries. Since 2009, the U.S. Food and Drug Administration (FDA) has been using a variety of MasterControl’s Quality Excellence™ solutions to improve the quality processes of the Office of Regulatory Affairs (ORA) and the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).