What Is the ISO 14000 Standard?

ISO 14000 is a series of environmental management standards developed by the International Organization for Standardization (ISO). The guidelines in the standard are intended to be a step-by-step approach for companies to continuously measure and improve their environmental management efforts.

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ISO 14000 Certification

Of all the standards in the ISO 14000 series, ISO 14001 is the only standard that specifies the requirements for a company’s EMS, and it is the only standard in which companies can be registered or certified. While certification is voluntary, it does enable companies to demonstrate their proactive commitment to making a positive impact on the environment. This is particularly valuable to customers who prefer to work with ISO 14000-compliant suppliers.

ISO 14000 Requirements

Environmental Management Policy:

Develop a policy that defines your organization’s commitment to maintain awareness of and continuously improve its impact on the environment.

EMS:

Develop a framework your entire organization can follow to manage all aspects of its environmental impact, fulfill compliance obligations, address risks, and mitigate deficiencies.

Employee Training:

Ensure your employees are aware of the relevance and importance of their activities and contribution to achieving compliance with ISO 14000 guidelines. This includes identifying training needs and keeping employee training records current and accurate.

Document Management:

Establish a document control system that stores and manages documentation about your environmental management policy and EMS in accordance with the ISO 14000 requirements.

Corrective and Preventive Action (CAPA):

The ISO 14000 guidelines require the identification and timely corrective and preventive action of nonconformances. This includes changes to documentation about your environmental management policy.

Audits:

Compliance with ISO 14000 guidelines requires an organization to conduct internal environmental management audits to review the suitability, adequacy, and effectiveness of its EMS.

ISO 14000 History

The ISO 14000 series of standards was first published in 1996, driven by global concerns about the environment. The standards were designed to establish guidelines for companies to follow regarding their impact on the environment, including the company’s EMS, environmental audits, and environmental performance evaluations.

The ISO has made several revisions to the guidelines in the ISO 14000 series. One of the primary revisions was to align the ISO 14000 series with the more generalized ISO 9000:2000 standard. The alignment with ISO 9000:2000 allows companies to combine an EMS with a quality management system (QMS).

ISO 14000 Software

The ISO does not prescribe specific software for setting up and maintaining an EMS. A primary goal of ISO 14000 is to make organizations more aware of and accountable for their environmental impact. The advantages of using automated quality management software include:

  • Document control – Easily manage, route, and store documentation regarding your environmental policy and processes.
  • Change control – Automatically create an audit trail of all data and every change made to EMS-related documentation.
  • Training management – Create a multi-format training program, including computer-based and instructor-led training. Resolve training gaps and deficiencies. Generate reports to track the status of employee training.
  • CAPA – Track, organize, and resolve audit findings and other nonconformance issues. Launch CAPA procedures from any solution module. Allow stakeholders to view nonconformance issues and mitigation efforts in real time.
  • Audit management – Effectively manage audit schedules and inspections, consolidate audit data, and gather all information necessary to quickly respond to audit findings.
  • Communicate effectively at all levels – Ensure that all stakeholders have immediate access to relevant information and up-to-date data. This fosters transparency and consistency among all business units and EMS processes.

ISO 14000 Software and MasterControl

Ongoing research and revisions to the ISO 14000 standard show that organizations around the world are making the environment a higher priority. More manufacturers are discovering how implementing technology, such as MasterControl’s Quality Excellence Solution™, simplifies all EMS-related tasks.

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).