Tools, Technologies and Training for Healthcare Laboratories

ISO

ISO-4: ISO 14001:2004 and Environmental Management

ISO standards do not only govern quality management, but also sustainability. Guest authors Perigo and Rabelo discuss the attraction of an additional ISO certification: the 14001:2004 standard.

Getting your Clinical Lab, from inside to outside, towards sustainable development

May 2005

See the introduction to this series by Dr. James O. Westgard, Ph.D., FACB

Greenhouse effect, Ozone Layer Depletion, Deforesting, Climate Changes, Air, Soil and Water Pollution, Water Sources Shortage… these are some of the main environmental problems countries worldwide are facing nowadays. Most of them caused by the high pressure men are putting in the environment. In this context, public and private companies, including healthcare providers, are requested to assume a socially responsible attitude. Based on this context, regulatory and environmental agencies are also becoming more demanding, requiring organizations to be compliant to the legal requirements related to their activities. Clinical laboratories are part of this scenario because their activities can also contribute to worsen these problems. So, proactive attitudes towards these issues are also expected from them.

Based on the fact that every company and institution is responsible for the environment, the International Organization for Standardization (ISO) developed the ISO14000 family of standards, all related to Environmental Management Systems (EMS). This series of standards was developed by the ISO TC207 committee and grew out of ISO’s commitment to support the objective of sustainable development discussed at the United Nations Conference on Environment and Development, in Rio de Janeiro, Brazil, in 1992. The family 14000 provides a framework for an overall approach of environmental issues in the strategic context of an organization. It can also be used by organizations to provide assurance to management and also to customers and community that the processes having environmental impacts are under control.

The generic standard used for certifying an EMS is the ISO 14001:2004 – Requirements with guidance for use. The ISO 14004:2004 – General guidelines on principles, systems and support techniques were developed to assist organizations with more practical and didactic information about the EMS, helping them to implement the system and complementing the ISO 14001. Together, the standards provide organizations with tools to implement efficient environmental management systems, making them able to achieve financial goals in a sustainable way. Based on ISO14001 requirements, organizations are able to control their environmental aspects and improve their environmental performance continually. In fact, the commitment with continual improvement is one of the requirements of the standards.

The first concepts that must be clarified to implement an EMS are those of “Environmental Aspect” and “Environmental Impact”.

Environmental Aspect is defined as any element resulting from activities, products or services of an organization that can interact with the environment. Environmental Impact is understood as any modification of the environment caused by the environmental aspect. It’s a cause-consequence relation.

Examples of environmental aspects and impacts applicable to clinical laboratories can be found in Table 1:

Environmental Aspect Environmental Impact
Production of infectious waste Contamination of people
Generation of radioactive waste Contamination of soil, water and people
Use of water and energy Depletion of natural resources
Production of chemical waste Pollution of soil and water
Spillage of chemicals Water and soil pollution
Use of CFC in freezers and air-conditioning machines Ozone Depletion
Use and disposal of fluorescent lamps Contamination of the environment with mercury
TABLE 1: Environmental Aspects and Impacts

Identifying the environmental aspects and impacts is the first step to understand how the clinical laboratory can interact with the environment and the correlated legal requirements associated with them. Based on this first evaluation, the laboratory can identify the priorities (usually applying a methodology to score the aspects according to their severity to the environment and the frequency that they happen) and take action to control them. These actions can be:

  • Documented Procedures: describe activities to standardize the processes and use them for training of the employees (for example, procedures for waste management)
  • Monitoring processes: air emissions, quality of effluents and noise level can be monitored periodically in order to minimize the impacts on the environment
  • Environmental management programs: goals and objectives to be achieved in a mid- or long-term period. Examples are the minimization of waste production, reduction on water and energy usage, etc.

The standard also requires:

  • The establishment of and Environmental Policy stating the commitment of the organization with the environmental protection, compliance to legal requirements and pollution prevention
  • The definition and implementation of emergency procedures, like fire control, spillage of infectious, radioactive or chemical substances, etc.
  • The identification of environmental aspects and impacts during project development
  • The establishment of efficient channels of communication with customers, community and other interested parties
  • The development of actions with suppliers in order to minimize the environmental impacts of products and packages.
  • The implementation of procedures for training, internal audits, corrective and preventive actions and monitoring processes.

A summary of the main principles and requirements can be found in Table 2.

ISO 14001:2004 Principles
Identification of Environmental aspects: any element resulting from activities, products or services of an organization that can interact with the environment
Evaluation of Environmental impacts: any modification of the environment caused by environmental aspects
Analysis of legal environmental requirements: the company must achieve compliance to local, state and federal environmental legal requirements.
ISO 14001:2004 Requirements
Introduction
1. Objective and applicability
2. Normative References
3. Terms and definitions
4. EMS Requirements
4.1 General Requirements
4.2 Environmental Policy
4.3 Planning
4.4 Implementation and operation
4.5 Verification
4.6 Management Review
TABLE 2: ISO 14001: 2004 - Principles and Requirements

According to the ISO survey of ISO 9001:2000 and ISO 14001 certificates – 2003, up to the end of December 2003, at least 66 070 certificates of ISO 14001 had been issued, representing an increase of 34 % over 2002. This result suggests that the implementation of an EMS can bring certain advantages for organizations. The main benefits achieved with an Environmental System are:

  • Reduction in the usage of raw material and natural resources (energy and water)
  • Reduction in the waste generation
  • Replacement of toxic products for less hazardous materials and recoverable resources
  • Cost reduction
  • Pollution prevention
  • Reduction of risks associated to environmental impacts or accidents
  • Compliance to regulatory requirements
  • Compliance to environmental requirements of national and international financial organizations for financing and project funding
  • Improvement of the image of the organization for customers and society

The most important thing to know is that ISO14001 is focused on the “triple bottom line”, which means that an organization can be economically viable and at the same time environmentally correct and socially responsible (see figure 1).

This is the principle of sustainability. Implementing an environmental system in your clinical laboratory is a very important first step towards it, demonstrating that the laboratory is moving from the inside to the outside, from the technical area to the surrounding environment and community. Currently, few clinical laboratories are ISO 14001-certified in the world, and your lab can become one of the pioneers in your region. And this movement towards people and society can be an essential differential for laboratories in the competitive market of healthcare providers.

About the Authors and their Institution

Rogério Rabelo, M.D., Ph.D.

Dr. Rabelo is the former Management Representative for Fleury Diagnostics’ Integrated Management System (ISO 9001:2000 and ISO 14001:1996). He is currently the Director of Business Development and also a Medical Consultant in Clinical Chemistry/Medical Biochemistry at Fleury Diagnostics.

He got his M.D. from the Federal University of Goiás, in Brazil and his Ph.D. from the University of São Paulo, Brazil, with a joint research project developed at the Lady Davis Institute for Medical Research, McGill University, Canada. His post-doctoral training in Clinical Chemistry/Medical Biochemistry was done in the Department of Medical Biochemistry/Laboratory Medicine, Jewish General Hospital, McGill University, Canada. He has recently finished his MBA at University of São Paulo, Brazil.

Daniel Marques Périgo, R.Ph.

Mr. Périgo is the Integrated Management System (IMS) Coordinator responsible for Fleury Diagnostics’ Quality and Environmental Department.

He is a Pharmacist, graduated by University of São Paulo, Brazil, with specialization in Clinical Assays. He is also certified as specialist in both Quality Management and Productivity (by Vanzolini Foundation, from University of São Paulo) and Environmental Management (by the College of Public Health, University of São Paulo, Brazil).