ISO 9001 & ISO 14001 Standards

International standardization began in the electrotechnical field when the International Electrotechnical Commission (IEC) was established in 1906. The International Federation of the National Standardizing Associations (ISA) was then set up in 1926 to create standards in the field of mechanical engineering.International standardization began in the electrotechnical field when the International Electrotechnical Commission (IEC) was established in 1906. The International Federation of the National Standardizing Associations (ISA) was then set up in 1926 to create standards in the field of mechanical engineering.

Four years after ISA was dissolved in 1942, delegates from 25 countries decided to create a new international organization, ISO, “to facilitate the international coordination and unification of industrial standards.”  Since its creation, ISO has experienced three major turning points. For its first 40 years, ISO followed its initial mission, focusing on technical standards for specific products or technologies such as screws, sizing systems for clothing and shoes, and laser technology.  The organization’s first turning point came in the 1980s when ISO delved into the development of “process” standards, specifically the ISO 9000 Quality Management System standards. The creation of generic management standards that could cover almost any industry sector was a notable departure from the product/industry/technology-specific nature of previous ISO standards. The ISO 9000 series became ISO’s most widely known and successful (measured by sales) standards ever, with more than half a million organizations adopting them globally.

ISO’s evolution continued with another turning point a decade later. In 1993, with the creation of ISO/TC 207 to develop the ISO 14000 Environmental Management standards, ISO took its most notable step into the public policy arena, extending its influence beyond industry and their customers, and into issues of general public interest.

Six decades after its creation, ISO has grown into the world’s largest and most widely recognized standards development organization. ISO’s influence is exercised not solely through its size and popularity, but also because of the status of its outputs as the world’s “trade-legal” standards as recognized by the World Trade Organization (WTO).  Once nationalized, these international standards can become market requirements (even for companies without foreign operations), for instance, as part of government procurement criteria, as has happened in the case of the ISO 9000 and ISO 14000 series standards.

There is, therefore, little doubt that any new ISO standards in the social or environmental field can and will have a sizable influence on businesses, governments, and civil society around the world.

Currently, a total of 148 countries participate in the ISO confederation, either as a member body (97 countries, with active participation and voting rights), as a correspondent member (36 countries, without voting rights but full information access), or as a subscriber member (15 countries, with reduced membership fee and limited access to the information).

Why is ISO 9001:2008 Certification Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9001:2008 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO 9001 certification:

• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share

ISO 9000 AND THE CONSTRUCTION INDUSTRY
A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aA formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aformal quality management system at a construction firm, there has to be direct demands from their customers, whose requirement for quality is essential for doing business.

Most of the construction organizations will not enter into the cost and allocation of resources to implement a quality management system unless they will be compensated. There is a general movement towards making implementation of a quality management system a contractual requirement. Small to medium sized organizations can always argue that they ‘operate to a quality system’ although this is not formalized. However, since the existence of such ‘informal’ quality systems aredifficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standards that are applicable to all organizations irrespective of size or nature of business.

ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization to develop a quality management system that meets the requirements specified by ISO 9001:2000, which arerecognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably the most prolific of all formal standards. This could be due to the worldwide applicability standardization andflexibility with which the standards are associated, even though there are some experts that still question the standards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

ISO 14001 Standards Audit
ISO 14001 sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.Certification means that a qualified body (an accredited certifier) has inspected the EMS system that has been put in place and has made a formal declaration that the system is consistent with the requirements of ISO 14001.The standard allows for self-certification, a declaration by an enterprise that it conforms to ISO 14001. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptanceof national certification that may make it particularly difficult for companies in some countries to achieve credible certification at a reasonable cost. For firms concerned about having certification that carries real credibility, the costs of bringing in international auditors are typically quite high, partly because the number of internationally recognized firms of certifiers is limited at present.2The issue of accreditation of certifiers is becoming increasingly important as the demand increases.Countries that have adopted ISO 14001 as a national standard can accredit qualified companies as certifiers, and this will satisfy national legal or contractual requirements. However, the fundamental purpose of ISO is to achieve consistency internationally. If certificates from certain countries or agencies are not fully accepted or are regarded as second class, the goal will not have been achieved. It is probable that the international marketplace will eventually put areal commercial value on high-quality certificates, but this level of sophistication and discrimination has not yet been achieved. It is essential to the ultimate success of the whole system that there be a mechanism to ensure that certification in any one country has credibility and acceptability elsewhere.The ISO has outlined procedures for accreditation and certification (Guides 61 and 62), and a formal body, QSAR, has been established to operationalize the process. At the same time, a number of established national accreditation bodiesheavily involved in ISO have set up the informal International Accreditation Forum (IAF) to examine mechanisms for achieving international reciprocity through multilateral agreements (MLAs). However, these systems are in the earlystages, and many enterprises continue to use the established international certifiers, even at additional cost, because of lack of confidence in the acceptability of local certifiers.Given the variability in the design of individual EMS and the substantial costs of the ISO 14000 certification process, there is a growing tendency for large companies that are implementing EMS approaches to pause before taking thislast step. After implementing an EMS and confirming that the enterprise is broadly in conformance with ISO 14001, it is becoming routine to carry out a gap analysis to determine exactly what further actions would be required to achievecertification and to examine the benefits and costs of bringing in third-party certifiers.
ISO 14001 Standards Certification

ISO 14001 Standards sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.

Certification means that a qualified body (an accredited certifier) has inspected the EMS system that has been put in place and has made a formal declaration that the system is consistent with the requirements of ISO 14001 Standards.

The standard allows for self-certification, a declaration by an enterprise that it conforms to ISO 14001 Standards. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptance of national certification that may make it particularly difficult for companies in some countries to achieve credible certification at a reasonable cost. For firms concerned about having certification that carries real credibility, the costs of bringing in international auditors are typically quite high, partly because the number of internationally recognized firms of certifiers is limited at present.

The issue of accreditation of certifiers is becoming increasingly important as the demand increases.

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
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

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 categories:

-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.

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA).  This PDCA concept is applied at the Quality Management System and the process levels.

2.  Convert the question to requirement  raised by  QMR or the QMS Committee which derived from theISO 9001 standards.  In this case, several questions can lead to one single requirement.

3.  To edit those questions to suit the process that is to be audited.  For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise.  There is no better way to do that than by developing the audit questions with them.

How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA).  This PDCA concept is applied at the Quality Management System and the process levels.

2.  Convert the question to requirement  raised by  QMR or the QMS Committee which derived from theISO 9001 standards.  In this case, several questions can lead to one single requirement.

3.  To edit those questions to suit the process that is to be audited.  For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise.  There is no better way to do that than by developing the audit questions with them.

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 ofISO 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
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

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 categories:

-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.

ISO 9001 Standards DVD

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The Introduction to ISO 9001:2008 DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.