What is ISO 9000 implementation?

• Knowledge portal
• Qualityworld
• Quality FAQs
• Information
• Journal of Quality
• Jobs
• Press
• Links

The 9000 family consists of four standards on quality management and quality assurance (QA).

The family consists of:

• ISO 9000: 2000 Quality management systems - Fundamentals and vocabulary
• ISO 9001: 2000 Quality management system - Requirements
• ISO 9004: 2000 Quality management system - Guidelines for performanceimprovement and
• ISO 19011 Auditing quality and environmental management systems

Application of these standards refers to the process of implementing their collective intent. Implementing both the requirements and using the principles and guidelines contained in this family of standards will help ensure customer satisfaction thus enhancing the ability of the organisation to meet its objectives.

Application is not merely implementing the requirements of the ISO 9001.

The intent of ISO 9001

Although there are many requirements and guidelines, they have a common intent that:

• organisations design and manage their processes effectively to achieve corporate objectives, not that they create functional silos that compete for resources.
• organisations choose the right things to do based on an objective analysis of the environment in which they operate, not slavishly follow procedures that serve no practical purpose
• management create an environment in which people will be motivated, not create bureaucratic systems of documentation that stifle initiative and creativity.

The principle advantage of this family of standards is that it enables a company to benchmark (compare) its system with others. An unknown standard would have no currency in the marketplace.

Which approach should be used

Options

An organisation does not have to use ISO 9000 to establish a quality system but it can use ISO 9001, to obtain international recognition that its quality management system is effective in enabling it to meet customer requirements.

ISO 9001 requires a quality system to be established but does not specify how this should be done. Options include:

• implementing the requirements of ISO 9001, as applicable then seeking certification of the system
• documenting what is done, comparing this with ISO 9001, then pursuing certification of the system
• designing a system that enables the organisation to fulfil business goals using ISO 9000 and ISO 9004 as a guide to the fundamentals and principles of quality management, then seeking certification of the system against ISO 9001.

Responding to requirements

This approach is referred to as the standard-led approach. It produces a description of a 'bolt-on system' because the requirements of ISO 9001 are a set of rules and do not address every aspect of organisational performance. By implementing the requirements, each in isolation, a description of the manner in which the organisation operates is produced that responds to the requirements. This description tends to address only those aspects covered by the requirements and therefore leaves out some vital elements that give the system its essential dynamic qualities. Providing what is described is being implemented, it may provide confidence to customers that the products and services supplied meet their requirements. Such a management system will not address the cultural and behavioural factors or internal efficiency and effectiveness vital for sustaining customer satisfaction and will therefore be impotent. This is the simplest of the three approaches but not the most cost effective.

Document what an organisation does

While there is some sense in simply documenting what the organisation does, it is by no means what the standard requires. ISO 9001:2000 has fewer requirements for documentation because the focus has changed from proving compliance through adherence to procedures to demonstrating that the system is effective through examination of the results achieved.

All organisations have a management system but it may not be formalised or its scope and content may not be complete and understood. Documentation provides proof of what is done but unless the documentation describes the processes employed to achieve the organisation's objectives, it may result in a series of disjointed and irrelevant documents. Unless great care is taken in what is documented, a company can end up with far too many documents describing its operations in far too much detail. Auditors will inevitably find the organisation not doing things it said it did, and vice versa.

Design a quality system

By far the best method is to design a quality management system as a series of interconnected processes needed to enable the organisation to meet its goals. This employs the process and system approach. It encompasses a little of the other two approaches with one fundamental difference. The business objectives are defined first and then the processes for achieving them are developed, resourced and documented as necessary for effective operation and control. In this way a system is built. A system is more than a collection of parts; it consists of the interconnection of related processes that deliver business results and products that generate satisfied customers.

Making the choice

While the first option is by far the simplest, it is not a viable proposition. It may enable an organisation to gain a badge on the wall although it shouldn't if the auditors are at all competent. It also encourages the view that ISO 9000 only exists to put a badge on the wall and has little to do with an organisation's performance or the quality of its products. It maintains a body of people whose sole job is to keep the badge and whose activities add little value but are an avoidable cost. An organisation that was serious about quality would use ISO 9000 as a tool to improve its performance and should choose either of the other two options.

If an organisation believes it already does all the right things, it should go for option two: identify and document its processes, taking care not to over-document and not forgetting to address any new requirements.

If an organisation is uncertain as to whether it does all the right things, it should take option three. Standards should be used as guides, not slaves. A system should be designed which is right for the business before consulting the standard to see which bits have been overlooked.

How should a quality management system be developed?

Two conditions apply:

1. Starting from square one designing a system for a new organisation
2. Setting out the changes needed to bring an existing QMS in line with or better than the best.

The former is not usual as most organisations/businesses are modelled on something that exists so we will consider the second condition. The development or redevelopment of a quality management system must be instigated and fully supported by top management. ISO 9000 - Fundamentals gives guidance on the process and systems approach needed.

The process approach to management is one in which activities are designed to achieve objectives. Where activities convert inputs into outputs of added value. Where the sequence of activities utilize resources to produce results regardless of the function that performs them and whether the resources are internal or external to the organisation. It is an approach in which there is a focus on results and outcomes. Where the factors affecting these results and outcomes are identified and the process designed to prevent failure and secure success. This contrasts with the procedural approach where the focus is on tasks and following rules, where who does what is important, where one follows procedures regardless of whether the results add value for the organisation.

The systems approach to management is one in which all the processes within the organisation are designed to work together to achieve the organisation's goals. It is where the processes are linked together to form a chain that converts stakeholder needs into satisfied stakeholders. It is an approach where the interfaces and interaction between processes is managed in order to balance the needs of all interested parties. This contrasts with the functional approach to management where the focus is on achieving departmental objectives, where managers compete for resources, where work is accomplished through departmental procedures and where there is intense internal competition and rivalry.

A typical activities and related clauses of ISO 9001 for developing an effective system is as follows:

• establish the organisation's purpose or mission (clause 5.3)
• identify the guiding principles, policies or values that will motivate the organisation to accomplish its mission (clauses 5.1, 5.3 & 6.4)
• identify the factors critical to success (clause 4.1c & 5.4.2)
• from the critical success factors define the strategic objectives and measures of success(clause 5.4.2)
• identify and define the key stages in the processes and that will achieve these objectives (clause 4.1)
• identify the skills and competences required for each process stage to be executed as planned (clause 6.2.2)
• define the objectives and measures of success for each process (clauses 4.1c, 5.4.2, 7.1 & 8.2.3)
• identify the specific outputs and how they will be measured (clauses 8.2.3 & 8.2.4)
• define the information, activities and resources required to deliver the required outputs for each process stage (clauses 4.1b, 4.1d, 6.1, 6.3 & 6.4)
• identify the measuring and monitoring methods for verifying the outputs, ensuring the integrity of measurement and confirming objectives have been achieved (clauses 4.1e, 7.6, 8.2)
• identify the methods for improving performance (clauses 4.1f, 5.6 & 8.5)
• identify the methods for validating the process objectives (clauses 8.4, 5.6

At each stage the quality management principles explained in ISO 9000 can be used the test the soundness and integrity of the system.

The physical, financial and human resources are essential to the success of the enterprise and should be selected for their capability, sufficiency and competence to achieve the required objectives.

Monitoring and measurement activities including audits are needed to verify that the objectives are being achieved and to identify opportunities for improvement. They should be an integral part of each process.

ISO 9004 can be used to identify improvement opportunities while ISO 19011 provides a view of how an auditor will look at the systems in place thus helping to prepare for assessment. The standard also provides guidance on conducting internal audits which is an essential tool in process management.

Although ISO 9001 permits exclusions, this is only for the purposes of assessment. There should be no process, function or activity within the organisation that is excluded from the management system except for those people engaged to perform work that has no bearing on the organisation's performance - of which there are likely to be none!

Top management should create an environment in which staff are motivated to achieve the organisation's objectives. Managers should be trained in process management and all staff should understand and be able to apply the principles of variation so that effort is focused on matters that improve performance.

Consultants in quality management systems can be a useful aid for obtaining registration and in the development of the QMS as they provide an outside view, have no departmental axe to grind and have experience of quality management systems of many companies. Beware of the consultant that brings a readymade system/quality manual for it can only describe a typical system and will not have been based on a true assessment of your organisations particular needs. Remember the documentation is but a description of how your organisation functions - it is not the system.