Environmental Management Systems and ISO 14001 Overview

1. Environmental Management Systems and ISO 14001 Overview Bureau of Medicine & Surgery (BUMED) EMS Implementation Training Webcast Training August & September 2007 Module 1 – Intro to ISO 14001:2004

2. Introduction to ISO 14001:2004 • Environmental Management Systems - Requirements with guidance for use

3. Overview A Process - Not a Performance Standard! Clause 1 - Scope Clause 2 - Normative References Clause 3 – Terms and Definitions Clause 4 - Environmental Management System Requirements

4. Clause 1 - Scope Applicable to any organization that wishes to: • Implement, maintain and improve an environmental management system • Assure itself of its conformance with its stated environmental policy • Demonstrate such conformance to others • Making a self-determination or self-declaration • Seeking confirmation by interested parties (e.g., customers) • Seeking certification/registration of its environmental management system by an external organization

5. Clause 3 – Terms and Definitions Key definitions: • Environment • surroundings in which an organization operates, including air, water, land, natural resources, flora, fauna, humans, and their interrelation • Environmental aspect • element of an organization’s activities, products or services that can interact with the environment

6. Clause 3 – Terms and Definitions • Environmental impact • any change to the environment, whether adverse or beneficial, wholly or partially resulting from an organization’s environmental aspects • Prevention of pollution • use of processes, practices, techniques, materials, products, services, or energy to avoid, reduce, or control (separately or in combination) the creation, emission or discharge of any type of pollutant or waste, in order to reduce adverse environmental impacts • NOTE: Prevention of pollution can include source reduction or elimination, process, product or service changes efficient use of resources, material and energy substitution, reuse, recovery, recycling, reclamation, and treatment.

7. 4.1 General requirements • Establish and maintain an EMS to the requirements of ISO 14001:2004

8. 4.2 Environmental policy • Provides rationale for an organization to pursue environmentally conscious policies. • States overall intentions of the organization regarding environmental issues.

9. 4.2 Environmental policy TOP MANAGEMENT IS STATING ITS COMMITMENT TO: • continual improvement and prevention of pollution; • comply with relevant environmental legislation and regulations; • provide for setting and reviewing its objectives and targets

10. 4.2 Environmental policy Further requirements: • Must be appropriate to nature, scale and impacts of the business • Must be documented, maintained and communicated to all employees • Must be made available to the public

11. 4.3 Planning 4.3.1 Environmental aspects are identified 4.3.2 Legal and other requirements are determined 4.3.3 Objectives, targets and programs are defined

12. 4.3.1 Environmental aspects • Establish, implement and maintain (a) procedure(s) to identify the aspects of activities, products and services • Can control and have an influence, • Taking into account planned or new developments, or new or modified activities products or services, • Determine which have significant impacts to the environment • Keep up-to-date “The organization shall ensure that the significant environmental aspects are taken into account in establishing, implementing and maintaining its environmental management system.”

13. 4.3.2 Legal and other requirements Establish, implement and maintain a procedure(s) • to identify and have access to legal and other requirements to which organization subscribes related to its aspects • to determine how these requirements apply to its environmental aspects Must take into account in establishing, implementing and maintaining the EMS

14. 4.3.3 Objectives, targets and programs • Establish, implement and maintain documented environmental objectives and targets, at each relevant function and level within the organization • Shall be measurable and consistent the environmental policy • Prevention of pollution • Compliance with applicable legal requirements • Continual improvement

15. 4.3.3 Objectives, targets and programs • When establishing and reviewing objective & targets - consider: • legal and other requirements; • significant environmental aspects; • technological options; • financial, operational and business requirements; and • views of interested parties • Shall establish, implement and maintain a program for achieving objectives and targets to include • Designation of responsibility for achieving • Means and time-frame by which they are to be achieved

16. 4.4 Implementation and operation 4.4.1 Resources, roles, responsibility and authority 4.4.2 Competence, training and awareness 4.4.3 Communication 4.4.4 Documentation 4.4.5 Control of documents 4.4.6 Operational control 4.4.7 Emergency preparedness and response

17. 4.4.1 Resources, roles, responsibility and authority • Management shall ensure availability of resources for EMS • human resources and specialized skills • organizational infrastructure • technology • financial resources • Roles, responsibility and authority defined, documented & communicated • Top Management to appoint management representative(s) • Ensure EMS is established, implemented and maintained IAW the Standard • Report to Top Management on the importance of the EMS for review including recommendations for improvement

18. 4.4.2 Competence, training and awareness • Personnel performing tasks with significant impacts shall be competent on basis of appropriate education, training, or experience • Identify training needs and require certain employees receive training • Establish, implement and maintain a procedure for employees to understand • Importance of conformity with the environmental policy and procedures and requirements of the EMS • significant environmental aspects and related impacts of their work & environmental benefits of improved personal performance • Roles and responsibilities in conforming with requirements of the EMS, and • Potential consequences of departure from operating procedures

19. 4.4.3 Communication • Establish, implement and maintain a procedure(s): • Internal communication among various levels/functions • Receiving, documenting and responding - external parties • Consider processes for external communication on its significant aspects and record decision If the decision is to communicate, the organization shall establish and implement a method for this external communication.

20. 4.4.4 Documentation Purpose of documentation: • makes the system auditable and provides a training tool • describe the core elements of the EMS • provide direction to related documentation Documentation shall include: • Environmental policy, objectives and targets • Description of the scope of the EMS • Description of the main elements of the EMS and their interaction, and reference to related documents • Documents, including records, required by the Standard • Documents, including records, required by the organization to be necessary to ensure effective planning, operation and control of processes that relate to its significant environmental aspects

21. 4.4.5 Control of Documents • Documents related to the EMS must be controlled. NOTE: records are a special type of document and must meet Section 4.5.4. • Establish, implement and maintain a procedure(s) to • Approve documents for adequacy prior to use • Review and update as necessary and re-approve documents • Ensure that changes and the current revision status of the documents are identified • Ensure that relevant versions of applicable documents are available at the point of use • Ensure that documents remain legible and readily identifiable • Ensure that documents of external origin necessary for the EMS are identified and their distribution is controlled • Prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained

22. 4.4.6 Operational control Identify and plan those operations associated with significant aspects to ensure they are carried out under specified conditions • Establish and maintain documented procedures to control situations where their absence could lead to deviations from the policy and objectives and targets • Stipulate operating criteria in the procedure(s) • Establish, implement and maintain a procedure(s) related to significant aspects of goods and services used by the facility • Communicate relevant procedures and requirements to suppliers and contractors

23. 4.4.7 Emergency preparedness and response • Establish, implement and maintain a procedure(s) to identify the potential for accidents and emergency situations that can impact the environment and document how to respond • Respond to actual emergency situations and accidents and prevent/mitigate associated adverse impacts • Periodically review and (if necessary) revise procedure(s), in particular after occurrence of emergency situation • Periodically test procedures (where practicable)

24. 4.5 Checking 4.5.1 Monitoring and measurement 4.5.2 Evaluation of compliance 4.5.3 Nonconformity, corrective action and preventive action 4.5.4 Control of records 4.5.5 Internal audit

25. 4.5.1 Monitoring and measurement • Documented procedures • to monitor and measure on regular basis key characteristics of operations that can have a significant impact on the environment • to include information to monitor performance, applicable operational controls and conformity with the organization’s objectives & targets • Measure parameters that characterize environmental impacts. • Calibrated or verified monitoring and measurement equipment is used and maintained, and associated records are retained.

26. 4.5.2 Evaluation of compliance • Establish, implement and maintain a procedure(s) for periodically evaluating compliance with applicable legal requirements. • Evaluate compliance with other requirements to which it subscribes. • Two types of evaluations can be prescribed via the same procedure or separate procedures. • Keep records of the results of these evaluations.

27. 4.5.3 Nonconformity, corrective action and preventive action Establish, implement and maintain a procedure(s) for dealing with actual or potential nonconformity(ies) and for taking corrective action and preventive action – defining requirements for: • Identifying and correcting nonconformity(ties) and mitigating impacts • Investigating nonconformity(ties), determining causes and taking actions in order to avoid their recurrence • Evaluating need for actions to prevent nonconformity(ties) • Recording results of corrective actions and preventive actions taken, and • Reviewing the effectiveness of corrective actions and preventive actions Actions taken should be appropriate to the size of the problem. Ensure EMS documentation is changed as appropriate.

28. 4.5.4 Control of records • Records must be maintained to provide to demonstrate conformity to the requirements of the EMS, and the results achieved. • Establish, implement and maintain a procedure(s) for the identification, storage, protection, retrieval, retention and disposal of records • Records may include: • Training records • Measurement and evaluation results • Management review records • Audit results • Records shall be and remain legible, identifiable and traceable

29. 4.5.4 Internal audit • Internal audits of the EMS to be conducted annually to • Determine if the EMS conforms to the standard and is properly implemented and maintained • Provide information on the results of the audit to management • Audit programs shall be planned, established, implemented and maintained by the facility based on • Environmental importance of operation(s) concerned • Results of previous audits • Audit procedure(s) to address • Responsibilities/requirements for planning and conducting audits, reporting results, and retaining associated records • Determination of audit criteria, scope, frequency and methods • Selection of auditors shall ensure objectivity and impartiality of the audit process

30. 4.6 Management review • Review the EMS annually to ensure its continuing suitability, adequacy and effectiveness • Input to management reviews shall include: • results of internal audits, compliance w/legal requirements • communication(s) from external interested parties • environmental performance of organization • extent to which objectives & targets have been met • status of corrective and preventive actions • follow-up actions from previous management reviews • changing circumstances (e.g., developments in legal requirements) • recommendations for improvement • Outputs shall include the need for revisions to policy, objectives, targets and other elements of EMS consistent with the commitment to continual improvement • Records of the management reviews shall be maintained