ISO 14001 internal auditor qualifications
ISO 14001 internal auditor helps a client company meet ISO 14001 standards

FDA medical device audits


ISO 13485

ISO 13485 matrix

ISO 14001

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Alpha Quality Assurance can help you conform to and obtain ISO 14001 self-certification


Alpha Quality Assurance Associates
111 Nataqua Avenue
Pacifica, CA 94044
Phone 650.359.4297
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ISO 14001:2004 Environmental Management Systems

ISO 14001 has become an important part of Medical Device Manufacturing. ISO14000 is actually a SERIES of international standards on environmental management. It provides a framework for the development of both the system and the supporting audit program. ISO 14001 specifies environmental management system requirements, and applies to environmental aspects that the organization has control and over which it can be expected to have an influence.
  • ISO 14001 is the cornerstone of the ISO 14000 series. It specifies an Environmental Management System that an organization can obtain through third party certification.
  • ISO 14004 provides guidance on the development and implementation of environmental management systems
  • ISO 14010 provides general principles of environmental auditing (now superseded by ISO 19011)
  • ISO 14011 provides specific guidance on audit an environmental management system (now superseded by ISO 19011)
  • ISO 14012 provides guidance on qualification criteria for environmental auditors and lead auditors (now superseded by ISO 19011)
  • ISO 14013/5 provides audit program review and assessment material.
  • ISO 14020+ labeling issues
  • ISO 14030+ provides guidance on performance targets and monitoring within an Environmental Management System
  • ISO 14040+ covers life cycle issues

Alpha Quality Assurance can help you conform to and obtain ISO 14001 self-certification.

General description of ISO 14001

ISO 14001 requires a company to have a defined Environmental Policy supported by senior management. The policy must describe how it complies with current environmental legislation and stress a commitment to continuous improvement.


ISO 14001 standards and enforcement stand in contrast to ISO9000 quality provisions with which many companies are familiar. During ISO9000 assessments, the staff is simply asked if they are aware of or understand the policy. Enforcement of the policy is seldom serious.


ISO 14001 is different. The Environmental Policy must be stated in non-technical language that can be understood by the majority of readers. It should include all aspects included in the Management System. It should present a clear picture of the company�s operations and how each one conforms to the The Environmental Policy. The staff is expected to fully understand the provisions and comply with them.


Any ISO 14001 audit necessarily starts with a comprehensive preparatory review that examines all processes and outputs at the site. This audit identifies all relevant environmental issues relating to past (i.e. contamination of land), present, and future operations. This information is compared to current environmental legislation.


Part of the ISO 14001 audit is to improve verbal and written communication between management (who establish and enforce the company's environmental policies) and staff (who carry out these policies). Alpha Quality can help improve this vital communication link, making staff aware of the policies and helping them find ways to carry them out. 


ISO 14001:2004 audit checklist - what changed?

 ISO 14001:2004 and ISO14004:2004 revisions were released on November 15, 2004.  ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed to jointly develop the transition plan and have announced the period of making the transition from certificates of conformity to the ISO14001:2004 version to 18 months from the revision publication date.  Beyond this period, the IAF will recognize only certificates to ISO 14001:2004.

What are the essential ISO 13485 system requirements? (iso 140001 audit checklist)


ISO 14001:2004

Overview of Change

4.1 General Requirements

4.3.1 Environmental Aspects

Restated to clarify meaning, enhanced terminology.

4.2    Environmental Policy
4.4.6 Operational Control
4.4.7 Emergency  Preparedness and Response

Updated to reflect terminology enhancements and clarification of the requirements.
4.3.2 Legal and Other Requirements Clarifies requirements, divides them into sub paragraphs for ease of understanding.
4.3.3 Objectives, Targets and
The program(s) bring together the key activities of the system.
4.4.1 Resources, Roles,
Responsibility And Authority
The title is updated and includes terminology enhancement for clarification of the requirements.
4.4.2 Competence, Training and
The title is updated and includes an emphasis on demonstrating competence and training documentation. <
4.4.3 Communication This section includes "internal" as well as external communication
4.4.4 Documentation The Environmental Management System Documentation has been updated and re-titled to Documentation and includes a clearer intent of the significant environmental aspects documentation.
4.4.5 Control of Documents The title is updated and includes enhanced clarity to the requirement, allowing for ease of understanding.
4.5.1 Monitoring and Measurement A re-write of the paragraph for clearer meaning and the addition of calibration
4.5.2 Evaluation of Compliance The revision adds Evaluation of Compliance as a separate requirement within the Environmental Management System. The emphasis on compliance requires a documented process that performs periodic evaluations of compliance with applicable legal requirements, and evaluating and maintaining the results of these evaluations.
4.5.3 Nonconformity, Corrective
Action and Preventive Action
Provides clarification and restructures the requirement into sub paragraphs, allowing for ease of understanding.
4.5.4 Control of Records Updated title, with a restructure of the paragraph and terminology for ease of understanding with an emphasis on control of conformity records.
4.5.5 Internal Audit Updated title and an emphasis on independent auditors.
4.6   Management Review Management Review process is updated to include the identification of inputs and outputs. The addition of identifying inputs and outputs aligns ISO14001:2004 with ISO 9000:2000. Also, the revision clarifies the information that needs to be collected and reviewed by top management.


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