ISO 9001 Standard - ISO 9001 Standards

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Introduction to ISO 9001 Standard Certification

Introduction to ISO 9001 Standard Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000?. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

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Why Is ISO 9000 Important?

Why Is ISO 9000 Important?

ISO 9000 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9000 is important because of its international orientation. Currently, ISO 9000 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.
ISO is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important.

ISO 14001 Standards

ISO 14001 is in fact a series of international standards on environmental management. It provides a framework for the development of an environmental management system[/url] and the supporting audit programme.
The ISO 14001 series emerged primarily as a result of the Uruguay round of the GATT negotiations and the Rio Summit on the Environment held in 1992. While GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio Summit generated a commitment to protection of the environment across the world.

After the rapid acceptance of ISO 9000, and the increase of environmental standards around the world, the International Standards Organisation (ISO) assessed the need for international environmental management standards. They formed the Strategic Advisory Group on the Environment (SAGE) in 1991, to consider whether such standards could serve to:

Promote a common approach to environmental management similar to quality management;
Enhance organizations ability to attain and measure improvements in environmental performance; and
Facilitate trade and remove trade barriers.
In 1992, SAGEs recommendations created a new committee, TC 207, for international environmental management standards. This committee and its sub-committees included representatives from industry, standards organizations, government and environmental organizations from many countries. What developed was a series of ISO14001 standards designed to cover:

-environmental management systems
-environmental auditing
-environmental performance evaluation
-environmental labelling
-life-cycle assessment
-environmental aspects in product standards

ISO 14001 was first published as a standard in 1996 and it specifies the actual requirements for an environmental management system. It applies to those environmental aspects over which an organization has control and where it can be expected to have an influence.

ISO 14001 is often seen as the corner-stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System and is the only ISO 14000 standard against which it is currently possible to be certified by an external certification body. However, it does not in itself state specific environmental performance criteria.

iso 14001

Migration to ISO 9001:2008

The International Accreditation Forum (IAF) and the International Organization for
Standardization (ISO) have agreed on an implementation plan to ensure a smooth transition of
accredited certification to ISO 9001:2008, the latest version of the world’s most widely used
standard for quality management systems (QMS). The details of the plan are given in the joint
communiqué by the two organizations which appears below.
Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that it
is maintained at the state of the art and a decision taken to confirm, withdraw or revise the
document.
ISO 9001:2008, which is due to be published before the end of the year, will replace the year
2000 version of the standard which is implemented by both business and public sector
organizations in 170 countries. Although certification is not a requirement of the standard, the
QMS of about one million organizations have been audited and certified by independent
certification bodies (also known in some countries as registration bodies) to ISO 9001:2000.
ISO 9001 certification is frequently used in both private and public sectors to increase
confidence in the products and services provided by certified organizations, between partners
in business-to-business relations, in the selection of suppliers in supply chains and in the right
to tender for procurement contracts.
ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing and
certification. These services are performed independently of ISO by certification bodies. ISO
does not control such bodies, but does develop voluntary International Standards to
encourage good practice in their activities on a worldwide basis. For example, ISO/IEC
17021:2006 specifies the requirements for bodies providing auditing and certification of
management systems.
Certification bodies that wish to provide further confidence in their services may apply to be
“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC
17011:2004 specifies the requirements for carrying out such accreditation. IAF is an
international association whose membership includes the national accreditation bodies of 49
economies.
ISO technical committee ISO/TC 176, Quality management and quality assurance, which is
responsible for the ISO 9000 family of standards, is preparing a number of support documents
explaining what the differences are between ISO 9001:2008 and the year 2000 version, why
and what they mean for users. Once approved, these documents will be posted on the ISO
Web site – probably in October 2008.

ISO (International Organization for Standardization) and the IAF (International Accreditation
Forum) have agreed an implementation plan to ensure a smooth migration of accredited
certification to ISO 9001:2008, after consultation with international groupings representing
quality system or auditor certification bodies, and industry users of ISO 9001 certification
services.
ISO 9001:2008 does not contain any new requirements
They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008
only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight
years of experience of implementing the standard world wide with about one million
certificates issued in 170 countries to date. It also introduces changes intended to improve
consistency with ISO14001:2004
The agreed implementation plan in relation to accredited certification is therefore the
following:
Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO
9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued
after official publication of ISO 9001:2008 (which should take place before the end of 2008)
and after a routine surveillance or recertification audit against ISO 9001:2008.
Validity of certifications to ISO 9001:2000
One year after publication of ISO 9001:2008 all accredited certifications issued (new
certifications or recertifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued
to ISO 9001:2000 shall not be valid.

Nonconformity, Corrective Action and Preventive Action in ISO 14001 EMS

The intent of §4.5.3 is that the organization put in place procedures for 1) identifying actual and potential nonconformities to EMS requirements, 2) taking appropriate corrective or preventive action, and 3) reviewing the effectiveness of corrective or preventive actions taken.
The nonconformity requirement of ISO 14001:1996 was a passive requirement in that it was only triggered when a nonconformity came to the attention of the organization through one of the other EMS procedures, such as the EMS audit or management review. ISO 14001:2004, however, requires that the organization establish and maintain procedures to identify actual or potential nonconformities, determine their causes, take action to avoid recurrence or occurrence, record results, and review effectiveness of corrective or preventive actions.

How the organization goes about identifying actual or potential nonconformities is up to it to determine. From the standpoint of registration auditors, it would seem that they would want to see a specific procedure requiring members of the organization to conduct some kind of periodic checklist driven, walk-through inspection for nonconformities. In addition, the procedure should allow for submission of nonconformities by any member of the organization. Actual nonconformities are usually fairly evident and relatively easy to investigate because there is a tangible occurrence with which to deal. The organization should also want to evaluate minor instances of nonconformity that, while not significant in and of themselves, if they occurred under different circumstances, could lead to a significant deviation from the EMS. Such “near misses” could be identified by the occurrence of a sudden, unexpected event, a failure to achieve an objective or target, or a deviation from the Environmental Policy.
Potential nonconformities are more difficult to identify and correct. Here, application of Failure Mode and Effects Analysis would be appropriate for organizations having that capability.

When investigating nonconformities, organizations should focus on identifying underlying root causes, not just the immediate manifestation of the problem. If a chemical storage drum leaks, the organization should take action, first, to mitigate the damage and, then, to determine why the leak occurred; e.g., improper or negligent handling, mechanical failure, or lack of a leak detection system. Corrective or preventive actions should then focus on eliminating the cause through training, communication of procedures, use of leak-resistant drums, or installation of a leak detection system.

Other ISO 14001 sections, principally Emergency Preparedness and Response, Internal Audit, and Management Review, are tools that the organization implements in order to help identify instances of actual or potential nonconformity. The underlying principle of these sections is that the identification of nonconformities should be made by the organization through diligent application of these tools, not from the occurrence of an environmental event, a customer or community complaint, or investigation by a regulatory authority. While §4.5.3 does not specifically mention disciplinary action, in many cases disciplinary action or the threat of disciplinary action is appropriate to prevention of future nonconformities. Many organizations have written codes of conduct that give employees notice that deviations from the codes will not be tolerated and that prescribed penalties can result for infractions. These codes can be expanded to include penalties for deviations from the EMS. If so, penalties should be commensurate with the violation itself and should acknowledge the nature of the environmental damage, the degree of negligence, prior conduct, and the forthrightness of the employee being disciplined. Any such code and its remedies should be administered fairly and consistently and should have as its objective correction and prevention of EMS nonconformities, not punishment of employees.
Finally, identification, investigation, and correction of nonconformities leads to the need to revise documented procedures.

Evaluation Of Compliance Of ISO 14001 EMS

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.

Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.