The ISO 9001 & ISO 14001 Standards and the environment

The ISO 9001 & ISO 14001 Standards 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 more
than 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.

Audit Of Electronic Documents In ISO 9001 Standards

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.

ISO 9001 — a way of managing for conformance

Quality assurance, according to the Standard, is a way of managing that prevents non-conformance and thus “assures quality”. This is what makes ISO 9001 different from other standards: it is a management standard, not a product standard. It goes beyond product standardisation: it is standardising not what is made but how it is made. To use standards to dictate and control how organisations work was to extend the role of standards to new territory. To take such a step we might have firstly established that any such requirements worked — that they resulted in ways of working which improved performance.

Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party.

ISO 9000 (1994) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.”

To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that. Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer.

ISO 9001 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”.

What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9000 will take care of quality? The Standard encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality. However, would being responsible for ISO 9001 lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation?

Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7). The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way.

According to ISO 8402 (quality vocabulary), quality is:

“The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”

Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers. In these ways, ISO 9000 encouraged “planning for quality”.

Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000, start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind

Quality Assurance In ISO 9001 Standards

Quality assurance, according to the ISO 9001 Standard, is a way of managing that prevents non-conformance and thus “assures quality”. This is what makes ISO 9001 Standardsdifferent from other standards: it is a management standard, not a product standard. It goes beyond product standardisation: it is standardising not what is made but how it is made.

To use the ISO 9001 standards to dictate and control how organisations work was to extend the role of standards to new territory. To take such a step we might have firstly established that any such requirements worked — that they resulted in ways of working which improved performance. Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party. ISO 9000 (2008) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.” To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that.

Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer. ISO 9000 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”. What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9001 Standardswill take care of quality?

The ISO 9000 Standards encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality.

However, would being responsible for ISO 9001 standards lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation? Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7).

The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way. According to ISO 8402 (quality vocabulary), quality is: “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.” Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers.

In these ways, ISO 9000 standards encouraged “planning for quality”. Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000 standards , start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind.

ISO 9001 Standard For Quality

The International Organization for Standardization, ISO, is a non-governmental agency that publishes and develops standards for the public and private sectors. From mechanical engineering and technology to agriculture, the ISO 9000 Standards establishes benchmarks and guidelines for quality products and services. ISO 9001 quality standards are a highly regarded and internationally recognized set of standards that are used in businesses, nonprofit groups and government organizations.

Since 1947, the ISO has published more than 17,500 standards. Many of these standards are specific for a product or process. In 1979, the ISO established the quality management and quality assurance committee. This committee established international quality management guidelines. The first guidelines published in 1986 were referred to as ISO 8402. These standards were updated and replaced with the ISO 9000 family of quality management systems standards. The latest round of quality standards fall under the ISO 9001:2008 title.

ISO quality standards include technical requirements, customer service levels, continual improvement requirements and documentation of key systems and processes. Quality is assured through strict process monitoring, checking for defects and routine internal and external reviews. Conformance with the rules and regulations of the ISO standards results in a company being publicly labeled as ISO 9001 certified or ISO 9001 registered.

Companies and organizations that adopt ISO quality standards increase their visibility as a quality-focused company. The public recognition as an ISO 9001 certified company could lead to increased access to contracts, especially for the government and to higher prestige in an industry. For some businesses, ISO 9001 certification is seen as a competitive advantage, while in other industries compliance is a requirement for continued operation.

The ISO claims that implementation of ISO standards increases a company’s return on investment, increases market share and profits and improves operational results. Societal benefits are improved health and safety, corporate compliance with legal requirements and reduced environmental impact.

The ISO quality standards and audits confirm compliance with the processes and business framework for a company to produce quality goods and services. Audits and reviews do not certify the actual products or services provided by a company, only the business methodology and quality systems that are designed to ensure quality. It is also a misconception that the ISO standards for quality only apply to manufacturing and physical goods. The ISO standardsare also applicable to the service industry.

Advantages Of ISO 9001 Standard

Successful firms are good at two things: increasing sales and reducing costs. However, these two things may prove irrelevant if the quality of the product or service is poor. ISO 9001 Standard is concerned with improving the quality of operations which can affect both top and and bottom line growth. Implementation of ISO 9001 Standard affects the entire organization by providing a transition to both a new common language and a new way of thinking about continuous process improvement. Here’s how you can bring the benefits of ISO 9001 Standard to your organization.

1. Obtain management buy-in. The most important step to any quality initiative is to obtain management commitment. This will increase both the visibility and awareness of your efforts.

2. Create an implementation team. This should include a representative from all functional areas of the organization including marketing, finance, planning, production and design. Also be sure to assign a Management Representative. This should be your strongest upper-level advocate for the success of ISO 9001 Standard implementation.

3. Communicate the goals of the program and provide training. This should include employees as well as major suppliers. The communication should be concise, tied to improving the success of current goals and objectives, and in a language in which employees are familiar with.

4. Map out the most critical processes of the current system. Use an organizational flow chart to show how information flows from the placement of an order to delivery. Compare this flowchart with the ISO 9001 system (see Resources for a link to Management Standards) and identify areas for improvement.

5. Create an implementation plan based on opportunities for improvement found in Step 4. The plan should be thorough and specific. Document each change in the process flowchart. If you already have documentation supporting your processes, use it. However, if you identify an area which lacks documentation, this should be viewed as an opportunity. Documentation is the lifeblood of continuous improvement. If you don’t already have one, create a documentation control system which manages the creation, approval, distribution, storage and disposal of documents.

6. Report out on improvements, create metrics to track improvements and repeat the process.ISO 9001 Standard is about continuous process improvements, and the success of the program is a function of both commitment and the achievement of this goal.

ISO 9000 Standards Video Clip