ISO 14000

1. ISO 14000 Dr. Malleswara Rao Associate Professor Department of Pharmaceutics Maratha Mandal’s College of Pharmacy, Belgaum.

2. Contents • ISO 14000 • Introduction, Importance, History and types • ISO 14000 - Elements • ISO 14000 – Benefits • Steps for ISO Registration Process

3. ISO 14000 • Set of standards related to environmental management systems (EMS) developed and published by International organization for standardization (ISO) for business organizations • EMS – Set of policies and procedures designed to help the organizations to • Reduce negative environment impact • Improve the efficacy and operational effectiveness

4. ISO 14000 • Helps the organizations • By providing the guidelines to a better management system to reduce their environmental Impact • Identify and control the activities, products, processes or services negatively impact the environment • Comply with applicable laws, regulations, and other environmentally oriented requirements • Continually improve its environmental performance

5. ISO 14000 – History

6. Development of ISO 14000 Series • The different standards in the series include • ISO 14001 – EMS -Requirements with guidance for use • ISO 14004 – EMS -General guidelines on implementation • ISO 14006 - EMS - Guidelines for incorporating eco-design • ISO 14015 - Environmental assessment of sites and organizations (EASO) • ISO 14020 - Environmental labels and declarations • ISO 14031 - Environmental performance evaluation • ISO 14040 - Life cycle assessment • ISO 14064 Greenhouse gases; measuring, quantifying, and reducing greenhouse gas emissions

7. Elements of ISO 14001 • The six core elements of an EMS, according to the ISO 14001 standard: • Environmental policy • Planning • Implementation • Study & correct • Management review • Continuous improvement

8. Elements of ISO 14001 Environmental policy • Initially, the organization’s top management should have commitment and leadership and • Define the policy – lay the foundation and provide framework for setting the environmental objectives • This is a clearly written statement outlining a business’s objectives and targets, in the context of their environmental policy. • Policy should always be clearly communicated both internally and externally

9. Elements of ISO 14001 Planning • Make complete, thorough plans for implementing the EMS • An initial review of the organization's processes and products - to assist in identifying elements, that may have significant impact on the environment • This review assist the organization • In establishing the environmental objectives, goals and targets • Development of control and management procedures and processes for achieving its objectives and targets

10. Elements of ISO 14001 Implementation • Important that organizations clearly define, document, and communicate their implementation procedures for purposes of training • Identify the resources required and define their roles, responsibilities for EMS implementation and control • Communication and participation across all levels of the organization - vital part • Provide appropriate training to personnel performing the tasks to gain knowledge and competence • Identify potential accidents and emergency situations for preventing and mitigating the environmental impacts that may be associated with them

11. Elements of ISO 14001 Study & correct • To ensure that the organization is performing in accordance with the stated EMS programmes • The organization should • Monitor and measure its operations and activities against the organization’s plans • Record the on-going activities of the EMS. • Conduct periodic EMS audits • Make corrections or optimization as needed

12. Elements of ISO 14001 Management review • The management review is conducted to ensure that the objectives of the EMS are being met, the extent to which they are being met, and that communications are being appropriately managed.

13. Elements of ISO 14001 Continuous improvement • ISO 14001 encourages a company to continually improve its environmental performance. • It is achieved in three ways • Expansion: Business areas increasingly get covered by the implemented EMS. • Enrichment: Activities, products, processes, emissions, resources, etc. increasingly get managed by the implemented EMS. • Upgrading: The structural and organizational framework of the EMS

14. PDCA Cycle • PDCA (plan–do–check–act or plan–do–check–adjust) is four-step management method used in business for the control and continuous improvement of processes and products.

15. Benefits of ISO 14000 The benefits of ISO 14000 certification • Helps to meet the legal obligations towards environmental protection • Resources are used more efficiently • Waste is reduced • Environmental impacts get measured • Customer and stakeholder trust increases • Environmental obligations are managed in the right way

16. ISO Registration Process • Following are the eight essential steps • Finding an ISO 9001 Registrar • Selecting an ISO Registrar • Creating an ISO Application • Conducting a Quality Document Review • Determining Pre-assessment Need • Issuing an ISO Assessment • Completing ISO 9001 Registration • Checking with Surveillance Audits

17. ISO Registration Process • Finding an ISO 9001 Registrar • Search for an ISO registrar during the 2 to 3 months your company is still building its quality system • You can search the BIS – Bureau of Indian Standard web site to select the registrar right for you • Registrars must meet the requirements of the ISO Accreditation Bodies.

18. ISO Registration Process 2. Selecting an ISO Registrar • Select a registrar that has experience within the scope category of your specific industry, which you can also find on the BIS site. • Keep in mind accreditation, scheduling issues, fees and comfort level when selecting the registrar right for you.

19. ISO Registration Process 3. Creating an ISO Application • A company and a registrar will agree on the application contract which defines the rights and obligations of both parties, and includes liability issues, confidentiality and access rights.

20. ISO Registration Process 4. Conducting a Quality Document Review • The registrar will require a copy of your quality manual and procedures to verify that all the requirements of the standard are addressed. 5. Determining Pre-assessment Need • Though optional, this 2-4 week initial review of the system identifies any significant omissions or weaknesses. It saves time and allows the registrar to assess any issues and resolve logistics before the actual assessment audit.

21. ISO Registration Process 6. Issuing an ISO Assessment • During the audit, or physical onsite inspection of procedures in action, the auditors will issue findings if they assess anything that doesn’t meet requirements, or nonconformities. • The flow of activities is as follows • Opening Meeting • Brief tour • Additional Review of documents • Examination • Daily Review • Closing meeting

22. ISO Registration Process 7. Completing ISO 9001 Registration • After all of the findings are put into the ISO audit report and nonconformities are addressed, your company has the option to register as ISO 9001 conformant. You will receive a certificate and can also be listed in a register, which the company can use to publicize its registration and use in advertising. 8. Checking with Surveillance Audits • Registrars perform regular surveillances of the system. Over the three-year period of your certificate, auditors will perform one full and two partial checks of your system.