ISO 14001 Requirements: September 2009

Wednesday, September 30, 2009

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.

ISO 9001 and ISO 14001 Information Site

Business benefits of ISO 14000

Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

What is a quality systems registrar

What is a quality systems registrar
A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)
There are some 573 registration bodies in operation worldwide, including52 in the United States.
The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.
To do this, the registrar:a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:— On paper (desktop study).— On site (throughout your facility).b. Registers your quality system, assuming it conforms, to ISO 9000.c. Monitors conformity on an ongoing basis by means of regular reauditsand other methods.All quality system registrars perform these functions, with certainvariations. Registrars differ in two principal ways:a. Accreditation status.b. Scope of accreditation
Reputable ISO 9000 registrars are accredited by international accreditationbodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:a. Registrars must make their services available to all qualified supplierswithout imposing undue financial or other conditions, andmust administer their regulations in a nondiscriminatory manner.b. The registrar’s organization must not engage in activities that mayaffect its impartiality. For example:— It must not provide consulting services “on matters to whichits certificates are related” (i.e., quality systems). This requirementis superseded by the ISO 9000 restriction noted earlier.— It must not directly engage in commerce with firms that it hasassessed and/or registered.— Individuals involved in the registration process must not haveprovided consulting services to registration clients, or any relatedfirms, within the previous two years.— Its employees and agents must not engage in business activitiesthat would cause others to question the firm’s impartiality.— The registrar may not market consultancy and registrationservices together, and may not recommend consulting servicesto clients.— Auditors may not give advice as part of registration audits.— The registrar must provide the accreditation body with documentationof its employees’ qualifications.— The registrar must have appropriate facilities for carrying outits activities.— The registrar must have a quality manual and documentedprocedures. (Curiously, EN 45012 does not require that registrarsregister to ISO 9000!)— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.
Another point of differentiation is scope of accreditation. All registrarsare not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.

Policy and Procedures for Quality Assurance

Quality PolicyThe Institute seeks to ensure that the following standards, guidelines, requirements and procedures are adhered to:· European Standards and Guidelines for Quality Assurance in the European Higher Education Area;· All relevant HETAC Standards and Guidelines;· National Framework of Qualifications Standards;· Policies and Procedures approved by the Institute’s Academic Council;· All other relevant regulatory and professional requirements.The Institute also seeks to ensure that its education provision and services meet the requirements of its students in a learner centered and supportive environment.1.2 CommunicationThis Policy is published on the Institute website and communicated to stakeholders through email alerts. It will be formally published in Institute Yearbook from September 2009.1.3 ImplementationIt is the responsibility of the President, the Registrar, the Academic Council, Heads of School, Heads of Department and Heads of Function to ensure that this policy is implemented.1.4 MeasurementThe policy is measured by internal audits, Programmatic Review and external peer review.1.5 EvaluationEach quality process will be audited for compliance by the Registrar’s Office annually. This audit can include recommendations for minor changes to the process. The audit reports will be placed before the Academic Council.The Academic Council will conduct an evaluation of each process against national and international best practice on a three year cycle. The environmental scanning technique discussed in the Institute’s Self-Study 2009 will support this evaluation.1.6 Continuous ImprovementRecommendations for improvement will be generated through the measures indicated in 1.4 and 1.5 above. The implementation of these recomendations will ensure continuous improvement.1.7 Key Performance Indicators(i) Each of the seven areas identified under the European Standards and Guidelines will be revised on a three year cycle. See 1.8 below.(ii) Best practice will become an embedded feature of the process and external peer review reports will testify that minimum standards are surpassed.
1.8 Goals and Objectives

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment)to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on Interpretations,
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categorie
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.

Wednesday, September 16, 2009

ISO 14001 And The Environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

ISO 9001 – Compatibility with other management systems

ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

Saturday, September 12, 2009

Quality Planning

Whenever the term “product” is used within the ISO 9001 standard, it refers to both tangible goods and intangible services. The ISO 9001 standard is meant to be generic which means that it is suitable for all kinds of organization, whether commercial or otherwise. The purpose of the quality management system model that is being propagated by the standard is the fulfillment of customer requeirements and expectations in order to induce high levels of customer satisfaction. An unsatisfied customer is essentially a customer whose requirements or needs, and expectations of the level of services being granted upon him/her have not been met. We are all customers because we buy products all the time. So we know what it means to be a dissatisfied customer. The common reaction is to never to go back to that seller and look for other alternatives. A successful organization is one which understands what it takes to meet customer requirements in order to satisfy their needs and expectations. A specific process is thus necessary to resolve any customer complaint or dispute. This process should be geared towards satisfying the customer’s needs and expectations. The parameters of this process should be referenced from the terms of the sale and purchase. This is why it is necessary to review the customer’s requirements before committing to the sales contract. It is necessary that the customer understands what he/she is paying for and it is equally necessary for the organization to understand what it is supposed to deliver. When your organization has these processes in place, then the only thing to do next is to continually measure the effectiveness and subsequently take actions to continually improve the whole process.
For more information, please visit http://www.iso9001-standard.us

ISO 14001 And The Environment

Friday, September 4, 2009

Establishing a ISO 9001 records procedure

Establishing a ISO 9001 records procedure
The standard requires records to remain legible, readily identifiable and retrievable and that a procedure defines the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records have a life cycle. They are generated during
which time they acquire an identity and are then assigned for storage for a prescribed period.

During use and storage they need to be protected from inadvertent or malicious destruction and as they may be required to support current activities or investigations, they need to be brought out of storage quickly. When their usefulness has lapsed, a decision is made as to whether to
retain them further or to destroy them.

Readily retrievable means that records can be obtained on demand within a reasonable period (hours not days or weeks) Readily identifiable means that the identity can be discerned at a glance.

Although the requirement implies a single procedure, several may be necessary because there are several unconnected tasks to perform. A procedure cannot in fact ensure a result. It may prescribe a course of action which if followed may lead to the correct result, but it is the process that ensures the result not the procedure.

The revised requirement omits several aspects covered in clause 4.16 of the 1994 version.
Collection of records is now addressed by Analysis of data (clause 8.4)
Indexing of records is a specific form of identification and is therefore already addressed
Access is now addressed by the requirement for record retrieval
Filing is a specific form of storage and is therefore already addressed

You may only need one procedure which covers all the requirements but this is not always practical. The provisions you make for specific records should be included in the documentation for controlling the activity being recorded. For example, provisions for inspection records should be included in the inspection procedures; provisions for design review records should be included in the design review procedure. Within such procedures you should provide the forms (or content requirement for the records), the identification, collection/submission provisions, the indexing and filing provisions. It may be more practical to cover the storage, disposal and retention provisions in separate procedures because they may not be type-dependent. Where each department retains their own records, these provisions may vary and therefore warrant
separate procedures.

Unlike prescriptive documents, records may contain handwritten elements and therefore it is important that the handwriting is legible. If this becomes a problem, you either improve discipline or consider electronic data capture.

Records also become soiled in a workshop environment so may need to be protected to remain legible. With electronically captured data, legibility is often not a problem. However, photographs and other scanned images may not transfer as well as the original and lose detail so care has to be taken in selecting appropriate equipment for this task.

Whatever the records, they should carry some identification in order that you can determine what they are, what kind of information they record and what they relate to. A simple way of doing this is to give each record a reference number and a name or title in a prominent location on the record.

1994 –2000 Differences

Previously the standard covered retrieval in four ways. It required:

(a) that quality records be made available for evaluation by the customer or his representative for an agreed period, where agreed contractually. Records can take various forms – reports containing narrative, computer data, and forms containing data in boxes, graphs, tables, lists and many others.

Where forms are used to collect data, they should carry a form number and name as their identification. When completed they should carry a serial number to give each a separate identity. Records should also be traceable to the product or service they represent and this can be achieved either within the reference number or separately, provided that the chance of mistaken identity is eliminated. The standard does not require records to be identifiable
to the product involved but unless you do make such provision you will not be able to access the pertinent records or demonstrate conformance to specified requirements.

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Wednesday, September 30, 2009

Wednesday, September 16, 2009

Saturday, September 12, 2009

Friday, September 4, 2009