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
- 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environmental auditing (now superseded by ISO 19011)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environmental management system (now superseded by ISO 19011)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superseded by ISO 19011)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
- 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.
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.
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.
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.
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.
14001:2004 audit checklist - what changed?
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
are the essential ISO 13485 system requirements? (iso
140001 audit checklist)
to clarify meaning, enhanced terminology.
4.4.6 Operational Control
4.4.7 Emergency Preparedness and Response
to reflect terminology enhancements and clarification of the
Legal and Other Requirements
requirements, divides them into sub paragraphs for ease of
Objectives, Targets and
program(s) bring together the key activities of the system.
Responsibility And Authority
title is updated and includes terminology enhancement for
clarification of the requirements.
Competence, Training and
title is updated and includes an emphasis on demonstrating
competence and training documentation. <
section includes "internal" as well as external
Environmental Management System Documentation has been updated
and re-titled to Documentation and includes a clearer intent
of the significant environmental aspects documentation.
Control of Documents
title is updated and includes enhanced clarity to the
requirement, allowing for ease of understanding.
Monitoring and Measurement
re-write of the paragraph for clearer meaning and the addition
Evaluation of Compliance
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.
Action and Preventive Action
clarification and restructures the requirement into sub
paragraphs, allowing for ease of understanding.
Control of Records
title, with a restructure of the paragraph and terminology for
ease of understanding with an emphasis on control of
title and an emphasis on independent auditors.
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.