ISO 9001 Standard / ISO 9001 Standards – ISO 9000 Standard / ISO 9000 Standards Certification & Implementation

In 1988, Dr. Karl-Henrik Robert began the process of developing the principles and objectives that have become known as The Natural Step.

Robert convened a group of over 100 Swedish scientists and asked them to develop a vision for a sustainable society based on the scientific principles. The Natural Step framework (Robert, 1991) was the result of this effort and is becoming widely recognized.

In this framework, there are four underlying principles or conditions and four guiding objectives.

These system conditions are:

Nature should not be subject to systematically increasing concentrations of substances extracted from the Earth’s crust;

Nature should not be subject to increasing concentrations of substances produced by society;

Nature should not be subject to systematically increasing degradation by physical means; and

People should not be subject to conditions that systematically undermine their capacity to meet their needs.

These conditions can be converted to four objectives that are more easily understood:

Eliminate our community’s contribution to fossil fuel dependency and to the wasteful use of scarce metals and minerals;

Eliminate our community’s contribution to dependency upon persistent chemicals and the wasteful use of synthetic substances;

Eliminate our community’s contribution to encroachment upon nature; and Meet human needs fairly and efficiently.

To apply The Natural Step, Boisvert et al. (1999) recommend an A-B-C-D approach: Awareness, Baseline Analysis, Compelling Vision, and Down to Action. Kent County chose to align its program with The Natural Step because of its simplicity and scientific basis.

An environmental management system (EMS) is a set of processes and practices that enable an organization to reduce the environmental impacts from its operations and increase efficiency. It helps the organization to systematically manage its environmental “footprint.” Alternatively, according to the ISO definition (ISO, 2004) an EMS is “a part of an organization’s management system used to develop and implement its environmental policy and manage its environmental aspects.” It is built upon the concept of continuous improvement and follows a four element Plan-Do-Check-Act cycle. The EMS is an evolving process and is consistently modified to accommodate new information, changing circumstances and changes in organization priorities.

The critical components of each of the four elements are:

Planning, includes identifying environmental aspects and establishing goals [Plan];

Implementing, includes training and operational controls [Do];

Checking, includes monitoring and corrective action [Check]; and

Reviewing, includes progress reviews and acting to make needed changes to the EMS [Act].

There are a variety of reasons that an organization may develop and implement an EMS. The reasons are many and varied and often depend upon the type of organization. A business with international offices has different reasons than a public agency to develop and implement an EMS. Table 1 provides a list of the most common of these reasons.

Some disadvantages to developing and implementing an EMS relate to the costs associated with development of the program and include:

An investment of internal resources, including staff/employee time;

Costs for training of personnel;

Costs associated with hiring consulting assistance, if needed; and

Costs for technical resources to analyze environmental impacts and improvement options, if needed.

Critical factors that assure the success of any management system include:

Commitment from senior management;

Designated staff including a Core team to act as a cheerleader and a representative trained in the program;

Involvement of all employees in the covered fenceline;

Dedicated resources;

A link to the overall strategic planning of the organization;

Sufficient time to develop and implement the program;

Proper follow through on the checking and acting components; and

A willingness to make the cultural shift required for the program to succeed.

The ISO 14001 guidance lists 17 elements, shown in Table 2, as the foundation of an EMS.

Several documents and publications cover the various elements of an EMS in detail. One of these is the US EPA publication “Achieving Environmental Excellence: An Environmental Management Systems (EMS) Handbook for Wastewater Utilities,”

The requirement of §4.3.1 of ISO 14001 is to establish and maintain procedures 1) for identifying the environmental aspects of the organization’s activities, products, and services that it can control and those that it can influence and 2) for determining which of those aspects have or can have a significant impact on the environment. Understanding the requirement of this element of ISO 14001 is central to understanding the concept of an environmental management system.

A single manufacturing facility has potentially hundreds of environmental aspects. How far must it go in identifying its environmental aspects to satisfy the terms of the requirement? ISO 14001 specifies that the organization is to identify those aspects that it can control and those that it can influence and that it must also take into account planned or new developments and new or modified activities, products, and services. These stipulations in the requirements, without actually drawing boundaries on how far the organization must go in identifying environmental aspects, at least establish some categories of aspect that must be considered. Beyond this principle, each organization must identify its aspects comprehensively enough so as to not fail to identify a significant aspect or a legal requirement. An objection to comprehensive identification of aspects is that the organization may become so immersed in aspects identification that it loses sight of the end objective of the procedure, which is to determine significance.

“Significant impact” is not a stand-alone term in §4.3.1. It is accompanied by the phrase “impact on the environment” and “environment” is a defined term. Significant aspects, then, are those environmental aspects that have or can have significant impacts on air, water, land, natural resources, flora, fauna, and humans. The organization determines, using its own criteria, what magnitude of impact on these seven environmental receptors constitutes a significant impact. Whether an aspect is regulated is not intended to be a factor in determining significance.

Proper execution of the environmental aspects procedure is important, in part, because it lifts environmental management out of the regulatory compliance mode and into the mode of systematically consequences for the environment, irrespective of regulation. The organization that rigorously applies the environmental aspects procedure discovers many opportunities to improve environmental performance that regulation does not address, including:· Use of energy

· Consumption of materials

· Environmental impacts of employee activities

· Environmental impacts of products and by-products post-manufacture, including distribution, use, reuse, and disposal

· Environmental impacts of services

· Unregulated waste streams such as carbon dioxide

identifying environmental aspects and impacts and considering their

DOE Policy on ISO 14001

An early approach on ISO 14001 was to require DOE contractors to develop an ISO 14000-like EMS through a DOE-wide Order. Some contractors did not like the implication of the draft Order would ‘require’ a ‘voluntary’ standard. Although some viewed the draft Order as broad and flexible, the Order was never finalized. Likewise, largely due to a change of administration, DOE was not able to establish a formal Policy regarding ISO 14001.

The current approach within DOE is to encourage voluntary implementation of an environmental management system as an integrated component of the contractually-required Integrated Safety Management System (62 FR 34841).4 Further, DOE encourages implementation of an environmental management system where it makes good business sense for the individual site. The voluntary approach is supported by the White House Office of Science and Technology Policy,5 and the integrated approach has been recognized as acceptable by EPA.6 DOE is also actively involved with the standard both at DOE sites and through an Interagency Working Group on ISO 14000. In addition, many DOE contractors are implementing ISO 14001 where it makes business sense for their individual site. Implementation is seen in a variety of ways from full third-party certification to implementation of various aspects of the standard.

The History Establishment Of ISO 14001 Environmental Management System

Environmental management began in earnest around 1970 as a direct result of environmental catastrophes and governmental reaction to those catastrophes. In many countries, environmental regulations that focus on control of environmentally damaging emissions to air, discharges to water, and disposal of hazardous wastes were instituted in an effort to prevent future environmental catastrophes and to limit toxic releases to the environment. Regulations, however, too often had the effect of placing a ceiling on environmental performance. Many industrial organizations, reacting negatively to governmental environmental regulations that
they view as being based on bad science, adding unnecessary costs, or making them uncompetitive in international markets, have restricted their environmental management efforts to complying with regulations and nothing morIn response, global institutions, recognizing the interconnected problems of persistent environmental degradation, growing economic divisions, and associated poverty and hunger, developed programs to begin to bring economic and social goals into balance with ecological and natural resource preservation. In 1992, the Global Environmental Summit, convened in Rio de Janeiro by the United Nations, brought representatives of 178 nations together to endorse Agenda 21: The Program of Action for Sustainable Development. Agenda 21 details the actions that are necessary on the part of organizations of all kinds if sustainability is to be achieved and collapse of economic, environmental, and social systems is to be avoided.
A second global summit, the World Summit on Sustainable Development (WSSD), was held in Johannesburg in Summer 2002. In tabulating the results since the Rio summit, the WSSD determined that all environmental trends had experienced further degradation and that the only sustainability gains to be reported were progress against infectious diseases, the global literacy rate, and the greater inclusion of women in society’s activities. The significance of Rio is that it marks the time when much of the world realized that we cannot continue on the same path we have been on. The significance of Johannesburg is the realization that, in spite of enormous effort on the part of many institutions, humankind is losing the battle for sustainability.
ISO 14001 is the EMS Specification developed by the international Organization for Standardization (ISO) of Geneva, Switzerland as a part of the ISO 14000 series of environmental management documents. It was issued as both an International and American National Standard in September 1996. The Second Edition of ISO 14001, ISO 14001:2004, was issued as an International Standard on November 15, 2004 and subsequently as an American National Standard.
ISO 14001 establishes a framework for the conduct of environmental management by requiring the organization to define an Environmental Policy and establish sixteen management procedures that support the policy. Many of the ISO 14001 procedures already exist in some form within organizations and only require modification to meet the requirements of ISO 14001. Other procedures have to be added in their entirety. All of the ISO 14001 procedures represent best management practices as defined by a consensus of the representatives of more than 50 national standards bodies and Non-Governmental Organizations (NGOs) who participated in the development of ISO 14001:1996 from early 1993 through July 1, 1995 and in
the development of the Second Edition from early 2002 until mid-2004.

Records required by ISO 9001:2008

Clause Record required
5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action

Demonstrating conformity with ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines  “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4

Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Organizations preparing to implement a QMS For ISO 9001

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.
For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:
- Identifying the processes necessary for the effective implementation of the quality management system
- understanding the interactions between these processes.
- documenting the processes to the extent necessary to assure their effective operation and control. (It may be
appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)
These processes include the management, resource, product realization and measurement processes that are relevant
to the effective operation of the QMS.
Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.

What is a “document” In ISO 9001 Standard?

The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;
a) Communication of Information as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.
b) Evidence of conformity provision of evidence that what was planned, has actually been done.
c) Knowledge sharing to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.
A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:
paper
magnetic
electronic or optical computer disc
photograph
master sample

ISO 9001 Standards Requirements – Design and Development

Design and Development Planning
Plan and control the product design and development. This planning must determine the:
Stages of design and development
Appropriate review, verification, and validation activities for each stage
Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Design and Development Inputs
Determine product requirement inputs and maintain records. The inputs must include:
Functional and performance requirements
Applicable statutory and regulatory requirements
Applicable information derived from similar designs
Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Design and Development Outputs
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
Meet design and development input requirements
Provide information for purchasing, production, and service
Contain or reference product acceptance criteria
Define essential characteristics for safe and proper use
Be approved before their release

Design and Development Review
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
Evaluate the ability of the results to meet requirements
Identify problems and propose any necessary actions
The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

Design and Development Verification
Perform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.

Design and Development Validation
Perform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.

Control of Design and Development Changes
Identify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.