ISO 14001 – Specifications With Guidance for Use

ISO 14001 – Specifications with Guidance For Use

Given the number of international participants involved in the process of developing the ISO 14001 Specifications, it is amazingly brief, consisting of five pages. This includes a Scope, Definitions, and EMS requirements.

The heart of the specification is in the EMS Requirements, the principles of which are summarized below:

Principle #1 – Commitment and Policy Top management must make a commitment to the program.

Principle #2 – Planning To be successful, the program must be organized. This includes an organizational structure, open communications, both internal and external, and a mechanism for identifying issues.

Principle #3 Implementation Program must be undertaken, including training, writing process descriptions, and establishing prevention programs.

Principle #4 Measurement and Evaluation Create a mechanism for assessing performance and progress toward goals.Principle #5 Review and Improvement? ISO 14004, Section 4, Environmental Management System (EMS)

Reference: ISO 14004, Section 4, Environmental Management System (EMS) Principles and Elements.

ISO 14001 – Certification/Registration

ISO 14001 – Certification/Registration

Similar to the organized approach to problem solving contained in ISO 9000

and ISO 14000, an organized approach is necessary to achieve certification. Although the written requirements contained in ISO 14001 are straightforward and brief, the level of effort required to conform with the requirements should not be underestimated.

If an environmental review of the facility‘s operations has not been conducted, it is important to retain a qualified consultant to conduct the review. which should focus on the requirements of ISO 14000 versus programs currently in use. This activity is known as a Gap Analysis.?E After the Gap Analysis is completed, the environmental status of the operation should be known and the level of effort necessary to develop the ISO 14000 program understood.

It can easily take six months to a year to develop a program that meets EMS requirements. Staff should develop the EMS program as they will ultimately be required to manage it. If staff is inadequate to develop the program, a consultant can be retained to provide guidance to staff as the program is being developed.

But, retaining a consultant will not resolve the problem of long term program maintenance. The ultimate goal of developing the EMS is to obtain certification/registration. Aside from the internal benefits offered by the ISO 14000 series of standards, external benefits may be derived through the certification/registration process. The certification/registration process only applies to ISO 14001, and this is the only standard to which the audit process applies. For the purposes of certification/registration, all other ISO 14000 standards are considered guidance. Certification can either be by a self declaration?Eor by an independent registrar.

Obviously the use of an independent registrar would give more credibility to those looking at an organization from outside.

Registrars have individual preferences about how the requirements should be administered. A registrar should be selected early in the process to help ensure that the program being developed is consistent with the registrars preferences. When the program is fully prepared and implemented, the registrar will be notified and a formal program audit undertaken. This audit will not result in a denial of ISO 14000 certification, but it may result in either approval or a list of deficiencies that must be corrected before certification.

ESTABLISHING THE INITIAL STATE OF THE QMS For SME

Establishing The Initial State of The ISO 9001 QMS For SME

The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.

According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and

other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.

However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality of the ISO 9001 QMS . Throughout this paper, existence is equated with the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results.

A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:

1. Complete Death: No documentation, no functioning.

This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product.

Relatively few companies will find themselves in this situation.

2. Informally Alive: No documentation, some level of functioning.

Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” [2]. SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.

3. Formally Death: Some level of documentation, no functioning.

SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.

4. Formally Alive: Some level of documentation, some level of functioning.

Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. This situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.

The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008

The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008

Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.

Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004 require your attention for compliance with ISO 9001:2008.

Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:
- Develop an environmental policy statement appropriate for your company
- Integrate processes for identifying environmental aspects and impacts
- Identify environmental objectives, set related targets, and establish programs for achieving results
- Integrate environmental responsibilities and authorities into a management system
- Outline an environmental awareness and training program
- Establish environmental metrics and indicators for monitoring performance
- Integrate requirements on non-conformance and corrective and preventive actions into your existing system
- Understand the purpose and scope of the environmental management review
- Integrate document control requirements of ISO 14001:2004 into your current system
- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS

Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.

Optimize understanding and retention with the Plexus Learning Model
- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.
- Hands-on insights. Lecturing is minimized so learning is maximized.
- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.

Demonstrating conformity with ISO 9001:2008

emonstrating 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.

The ISO 9001 Quality Manual

The ISO 9001 standards requires companies to write an ISO 9000 quality manual that defines how each requirement of the rather broad ISO 9001:2008 standard is applied at the company. In a sense, the ISO 9000 quality manual is a company specific version of the standard.
While writing the quality manual represents a big hurdle for most companies, the ISO 9001:2008 standard requires further details in form of ISO 9000 quality procedures, a quality policy and quality objectives. Most companies make the mistake of creating various different documents to meet these requirements; however, this usually is the beginning of a cumbersome and bureaucratic ISO 9000 quality system.Tip: Combine the different documentation requirements (i.e., quality manual, procedures, corporate policy and objectives) as much as possible into one comprehensive manual. This reduces repetition and bureaucracy, and it saves time implementing the quality system.

Quality Standards ISO 9001:2008

Quality Standard were developed to assist companies control quality and maintain a high standard of customer satisfaction. Quality has become a lot more than that, quality standards can assist your company with good management practices, reduce risk and increase profit margins.
A good quality system should not be written just to satisfy the accreditation process, but should be written with the company’s business practices in mind and to enhance procedures and policies to ensure sound operation.
The principles of the ISO Quality System can be applied to every company, regardless of its size, type or industry. Having a good quality system in place will ensure that your products, services are of the highest standards, your customers are happy and the future of your organisation is heading in the right direction.
What is ISO?ISO is the International Organization for Standardization, based in Switzerland it was established in 1947 to develop common international standards. It has members from over 140 countries worldwide, comprising of .
ISO published its first standards in 1987 and revised in 1994. ISO 9000 refers to the set of quality management standards. The 1994 standards are known as ISO9001. A new set of standards were released in November 2001, these are known as ISO 9001:2000. The transition from an existing ISO 9001 standard to a ISO 2000 standard can be achieved relatively easily. If you are starting a new Quality Management System, it would be best to use the new ISO 2000 standards.
What is the difference between ISO 9000 and ISO 14000?ISO 9000 is primarily concerned with quality management. In plain English this means anything that affects a product or service required by a customer and what that organisation does to ensure that a certain standard of quality is achieved and maintained.
ISO 14000 is primarily concerned with the environment. In plain English, what an organisation does to manage the impact of its activities on the environment.