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 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 and occupational health and safety

Adopting ISO 9001 might lead to improvements in occupational health and safety in a variety of ways. In the process of formally documenting procedures, for example, managers can identify and eliminate hazardous practices and add safety precautions. Moreover, by fostering more focused attention to detail,ISO 9001 adoption can reveal new “win-win” opportunities to improve quality or efficiency and occupational health and safety that were previously obscured by indirect and distributed costs and benefits.

Additionally, processes that provide warning signals and prompt corrective action can forestall serious accidents. Finally, routine auditing and corrective action procedures required by ISO 9001 to address management system failures encourage root-cause analysis that can identify problematic work practices that might otherwise precipitate not only quality failures, but occupational health and safety concerns.

Departments charged with managing quality sometimes also manage health and safety, and companies are increasingly implementing integrated management systems that incorporate all these considerations. Occupational health and safety can be improved by applying the tools of continuous improvement associated with ISO 9001 certification. Employees who know how to identify root causes of quality problems, for example, also have the skills to identify root causes of safety problems.

The high rates of repetition and increased monitoring implicit in the emphasis of ISO 9001 on routinization and standardization of tasks can increase stress and repetitive motion injuries, potentially worsening the safety records of plants with quality program. Moreover, to the extent that the higher equipment utilization associated with ISO 9001 adoption translates into reduced employee downtime, employee fatigue, a major cause of injuries, might be expected to increase. Additionally, new quality management procedures implemented in association with ISO 9001 that add inspection tasks to work processes optimized for production can occasion poor ergonomic conditions that leave employees susceptible to injuries.

Process Approach In ISO 9001 Standards

The ISO 9001 International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

Six Sigma Vs ISO 9000

The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two, it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodologies in tackling the issues.

Six Sigma – A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In doing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption of processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understanding. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided internally. This enables the “belts” to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation make the picture clearer and help the “belts” to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond standardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful events and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activities with the vision of the leader of the company. The approach is “how to” rather than “what to” deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and quality systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, based on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and document control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within your company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business activity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify.

Introduction To ISO 14001 Standards

An environmental policy should reflect the vision, intentions, philosophy, values, and beliefs of the organization with respect to the environment. Top management should put a great deal of thought and imagination into developing and crafting the policy, since it will become the code of conduct by which the organization lives and operates. The policy should be practical and inspirational, providing a framework and a compass for business and technical decisions and actions, and at the same time motivate and encourage all personnel in the organization to achieve excellence in environmental performance.

The ISO 14001 Standard specifies several requirements for the development, content, intent, and implementation of an environmental policy:

1. Top management is responsible and accountable for defining the organization’s environmental policy. They must, as a minimum, carefully review, approve, and commit to abiding by an environmental policy that has been developed for their consideration.

2. The policy must completely cover the organization’s (i.e., facility’s) range of operations, including where appropriate, raw material acquisition, transportation, packaging, and shipping of product,as well as all on-site operations that may impact the environment.

3. The policy must contain three core commitments that are ISO 14001 absolute requirements:

(i) A commitment to continual improvement of the EMS and environmental performance.
(ii) A commitment to the prevention of pollution (i.e., this means taking all reasonable steps to eliminate, or at least minimize, pollution).
(iii) A commitment to comply with relevant environmental legislation and regulations, and with other requirements to which the organization subscribes. This means the organization commits to meet local, regional, and national legislated environmental standards.

4. The policy must give direction and a framework for progress through new environmental objectives and targets that will be set during the course of implementing and maintaining the EMS.

5. The policy must be documented, and it must be implemented through the day-to-day functioning of the EMS.

6. The policy must be maintained, meaning kept up to date and relevant to current operations and conditions.

7. The policy must be communicated to all employees. This implies active, intentional efforts by the organization, led by top management, to ensure all employees know about, understand, and apply the principles, ideas, and commitments in the policy.

8. The policy must be made available to the public, i.e., it must be accessible to all members of the public who wish to see it.

In addition to the essential requirements for an environmental policy, other considerations that may be incorporated into the policy include:

Principles of sustainable development, resource renewal, and preservation • of biological diversity

A commitment to use the most effective pollution abatement technology and • equipment, consistent with economic viability of the business (i.e., BEAT – Best Economically Achievable Technology)

Use of environmental performance indicators to quantitatively monitor • progress

Life cycle thinking – consideration of ‘cradle to grave’ impacts of a • product, which would require the organization to assess cumulative environmental impacts from all stages, from design of the product; acquisition of raw materials; processing to finished product; packaging; shipment; end-use; and ultimate re-use, recycle, or disposal.

For all components of this element of the Standard to be brought to fruition, it is essential that there is clear allocation of responsibilities for developing, approving, communicating, disseminating, implementing, maintaining, and when necessary, revising the environmental policy.

Although environmental policy is the first element of ISO 14001, it may be prudent for an organization to defer finalization of the wording of their policy until work has been done to identify the scope of environmental impacts from the operation, and other planning and preliminary preparation for the EMS has been done. This will help to ensure the policy is authentic and appropriate for the organization’s purpose.

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Quality In ISO 9001 Standards

The Eight Dimensions of Quality

1. Performance

2. Reliability

3. Durability

4. Serviceability

5. Aesthetics

6. Features

7. Perceived Quality

8. Conformance to Standards

Terminology

Every product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:

1. Physical: length, weight, voltage, viscosity

2. Sensory: taste, appearance, color

3. Time Orientation: reliablility, durability, serviceablity.

Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

The Eight Dimensions of Quality1. Performance2. Reliability3. Durability4. Serviceability5. Aesthetics6. Features7. Perceived Quality8. Conformance to StandardsTerminologyEvery product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:1. Physical: length, weight, voltage, viscosity2. Sensory: taste, appearance, color3. Time Orientation: reliablility, durability, serviceablity.Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

Effects of ISO 9001 Implementation

Overall we can say that a company sought certification primarily to meet internal needs rather than as a response to external market forces. However the first action to be certified seems as a proactive response, we could not see a clear effort in the company to evaluate the actual results of this process.

Despite all, it has been stated that the certification has enabled them to achieve higher quality, productivity thus product reliability and increase in customer satisfaction. From the aspect of cost dimension it was declared that ISO 9001 implementations had moderately positive impacts on cost reductions by the increase in productivity and decreases in spoilage, rework and scrap. A factor affecting the occurrence of previous impacts is careful selection of the appropriate supplier.

Overall the most important impact of certification was stated to be the improvements in the brand image of the company from the viewpoint of their customers. This will also be very advantageous in the retention of existing customers and attraction of new ones. As a result of the synergy between the stated improvements company achieved a significant competitive advantage compared to competitors that are not certified.

Company has neither any application nor any action regarding TQM and quality costs.