ISO 9001

What is the ISO 9001 Standard for Quality Management?

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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Automate Compliance With the ISO 9001 Standard

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:

  • Document control
  • Change control
  • Audit management
  • Corrective and preventive action (CAPA)
  • Product lifecycle management

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.

MasterControl’s QMS Features Specific to ISO 9001 Certification

Document Control

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

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.

Training 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.

Audit Management

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.

Integrated QMS

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 Requirements for ISO 9001 Standard

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.

Compliance With ISO 9001 Requirements

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:

  • QMS: A system that establishes the various internal processes for identifying, measuring, controlling, and improving your core business functions, leading to consistently developing quality products and improving business performance.
  • Document control: Involves efficient control of all organizational documentation. ISO 9001-required documents include a quality policy, quality objectives, and the scope of the quality management system.
  • CAPA: Includes established policies and procedures for identifying, resolving, and preventing recurrences of quality nonconformities.
  • Training: Employees must be trained with the knowledge and skills necessary to do their jobs. This includes awareness of how their activities contribute to your organization’s quality objectives.
  • Audits: ISO 9001 requires your organization to demonstrate that your QMS is effective and sustainable. This is verified by both internal and external auditors.
  • Continuous improvement: Ensure that your organization sustains an ongoing effort to improve your quality management processes, business performance, and products.

How to Achieve ISO 9001 Compliance With MasterControl

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:

  • Unified platform: A fully connected and collaborative organization is essential for regulated companies. MasterControl connects every department in each phase of the product lifecycle from concept to commercialization – and beyond.
  • Risk management: MasterControl Risk™ unifies all risk-related activities for a more complete and accurate picture of the risk landscape across products, business processes, and business units.
  • Accelerates compliance: Increases operational efficiency, improves product quality, and speeds time to market.
  • Scalable: flexible solutions that meet the needs of companies of every size.

QMS Provider for the FDA

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).

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