If your business is planning a new process for making medical devices or prescription drugs that may have an impact on the environment, then your company will need ISO 14001 certification.
An ISO 14001 is an Environmental Management System, EMS, that ensures that your company’s processes have as little environmental impact as possible.
The International Organization for Standardization 14001 is transitioning from ISO 14001:2004 to ISO 14001:2015. These steps need to be taken for organizations to maintain or get a certification.
Determining Company’s Context
This requirement is new for ISO 14001:2015, which companies must implement by September 15, 2018. The general context of an organization includes these three items:
- Internal Context – Actions or the products and services that could affect environmental performances.
- External Context – It could include political, economic, social, and legal issues.
- Environmental Context – Other environmental aspects that could sustain damage by a company’s environmental performances.
Many factors will influence the context of an organization, and this new requirement will help organizations realize their possible impact on the physical world around them.
List of Involved Parties
This list is of all the stakeholders, both persons and companies, which influence the organization’s EMS. If clause 4.3.2 from ISO 14001:2004 was completed, then half of the list is done.
Define Range of EMS
This requirement allows organizations to reconsider their EMS’ ranges and to define its boundaries precisely.
Review Organization’s Environmental Policy
Although this requirement is much like the previous version, it requires that an organization’s EMS becomes incorporated within the strategic direction of the company.
A consulting firm like Emma International helps companies of all sizes comply with requirements to receive ISO certifications. To find out more information about how they can help your business with its ISO 14001: 2015 certification, go to https://emmainternational.com/
Align Environmental Objectives with Strategic Policy
ISO 14001:2015 requires organizations to determine the compatibility of their environmental goals with their company’s overall strategy when producing their products or services.
Evaluate Opportunities and Risk
A new requirement assesses the risks and opportunities of a company’s EMS. It considers the environmental attributes, the context of the organization, and compliance responsibilities. After the assessment, plans need to be made to address concerns.
Evaluate Environmental Impact
Another new requirement is to study possible emergency situations and their potential impact on the environment. During the evaluation of the environmental components, it’s also important to consider the lifecycles of products and services.
Establish Compliance Responsibilities
Along with obeying statutory and regulatory requirements, organizations must now consider the needs and anticipations of shareholders, or interested parties, as responsibilities.
Establish Control for Documented Information
Then handling of documented information, which is a new term, should also be considered and updated if necessary. With the new clause numbers, existing documentation will need to align with prior procedures, which may need improvements.
ISO 14001: 2015 requires improving the control of processes, which includes operational criteria and ensuring the control of processes is done per the criteria.
Observations of Environmental Performance
An emphasis is now placed on measuring and monitoring environmental performances to gain a better understanding of the processes and find areas where improvements are needed.
There are stricter requirements for environmental performance documentation. Changes have been made as to what information to include in the management review and what must be audited during an internal audit.
By carefully considering each step, companies can meet the compliance criteria and recertify or get a new ISO 14001: 2015 certification.