What are ISO 9000 Standards?

ISO 9000 standards are international quality management and quality assurance standards for both products and services. ISO 9000 standards are recognized and followed by industries around the world and are relevant to manufacturers of all kinds, including pharmaceutical, medical device, blood/tissue, laboratory and other types of life sciences organizations.

SOP Management as a Compliance Tool in FDA and ISO Environments

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ISO 9000 Series Foundation

The requirements set forth in the ISO 9001:2015 standard outline the specific aspects of a compliant quality management system (QMS) and frame the basis of the family of ISO 9000 quality standards. Faster compliance, greater compliance control and a higher rate of success with ISO 9000 guidelines can be achieved by implementing a reliable and proven automated compliance solution.

How to Streamline ISO 9000 Processes

Document Management

ISO 9000 quality standards stipulate that any document critical to the delivery of a company’s products and/or services must be controlled. An automated QMS enables organizations to effectively manage and store all essential documentation within a centralized, accessible repository while maintaining compliance with ISO 9000 guidelines for document integrity and security.

Change Control Management

Manufacturers certified to ISO 9000 standards are required to ensure that any change affecting the QMS (including product requirements, design and development changes) is controlled. Whether or not it is deployed for certification purposes, an effective QMS allows for effective change planning, execution and implementation that satisfies ISO 9000 guidelines.

CAPA Management

Efficient corrective and preventive action (CAPA) management is critical to maintaining compliance with ISO 9000 guidelines. QMS software can fulfill the requirements of ISO 9000 quality standards by seamlessly connecting all evaluation, reporting, investigation and other CAPA information in one electronically accessible system.

Customer Complaint Handling

Effective management of complaints is essential to assuring product quality and compliance with ISO 9000 standards. An automated QMS solution can streamline the way a company manages, connects and retrieves the critical information that must be logged when handling complaints, such as investigation details, action items and correspondence.

The Pharma Industry and ISO 9000

Although there is no specific ISO standard for pharmaceutical industry that drug companies are mandated to certify to, adherence to ISO 9000 guidelines helps fulfill the pharma industry’s perpetual need for product quality, safety and compliance. Applying the tenets of the ISO 9000 series in pharmaceutical industry settings allows a drug company to demonstrate that a specific set of criteria for the QMS has been established, maintained and supported by executive management. Compliance with ISO 9000 standards allows companies in the pharmaceutical industry to ensure customer satisfaction by consistently providing high-quality products and services.

While certification to an ISO standard for pharmaceutical industry is not required, adherence to ISO 9000 quality standards is beneficial for pharma companies who wish to strengthen quality management and ensure that their suppliers possess a documented and effective QMS. Many elements of the ISO 9000 series of guidelines are presently found in the pharmaceutical industry’s already robust quality systems that have been established upon other domestic and/or global regulations, regulatory guidance, best practices and industry expectations. Proven QMS software solutions allow pharma companies to reap the benefits of conforming ISO 9000 quality standards without the rigorous demands of ISO certification.

What Standards Comprise the ISO 9000 Series?

The ISO 9000 series is a family of quality management regulations that includes the following individual standards:

  • ISO 9001:2015: Quality management systems – Requirements – This standard designates the general and documentation requirements that must be met when establishing a QMS. Broadly separated into eight clauses, these requirements are designed to be applicable to any organization, regardless of industry, type, size or product/service.
  • ISO 9000:2015: Quality management systems – Fundamentals and vocabulary – The ISO 9000 guidelines provide definitions and terms that apply to all quality management and QMS standards developed by ISO. The definitions proffered in the ISO 9000 standards are indispensable for the application of ISO 9001 and should therefore be used conjointly.
  • ISO 9004:2015: Quality management systems – Managing for the sustained success of an organization – This standard is intended to extend the benefits of a QMS via continuous improvement attained through organizational self-assessments. It focuses on meeting the requirements of customers and any other interested parties for the purpose of achieving sustained success.
  • ISO 19011:2011: Guidelines for auditing management systems – This standard provides guidance on auditing management systems, including the principles of auditing, managing an audit program and conducting management system audits. It offers direction on the evaluation of the competence of individuals involved in audit processes and is applicable to all organizations that conduct internal or external audits of management systems.

MasterControl Features for ISO Compliance

In addition to helping companies meet the requirements of ISO 9000 standards (as well as any other ISO standard), MasterControl software solutions can help companies comply with any other standard prescribed by a regulatory agency. MasterControl automates the control of all the documentation essential for compliance with the ISO 9000 series of standards (i.e., SOPs, quality manuals, risk management plans, etc.) and streamlines and integrates quality processes such as audit, deviations, nonconformance, change control and CAPA management. For more than 25 years, MasterControl has helped hundreds of companies around the world transition from manual paper-based processes to streamlined electronic operations designed to bring safe and compliant products and services to market sooner and more efficiently.

QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).

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