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Most manufacturers have heard about the ISO 9000 series of international quality standards and guidelines. But what does becoming ISO-registered really mean, and what can it mean for your business?
The core of the ISO Quality Systems Standards that provide guidance in developing and implementing an effective quality-management system. Not specific to any particular product, these standards apply to manufacturing and service industries alike. The standards, first published in 1987 and revised in 1994, are under revision again and are expected to be ratified by the end of the year.
From a practical standpoint, implementing a quality-management system based on ISO 9000 is a good business decision. For successful organizations, many ISO 9000 requirements are being met through policies and procedures used in day-to-day operations. Implementation provides an opportunity for you to analyze your operations, identify problem areas and improve overall quality and efficiency. It also serves to unite business units in the common quest of customer satisfaction and continuous improvement.
The 2000 Revision: Making a Good Idea Better
As stated earlier, the ISO 9000 standard is in its second revision. This new quality system standard is intended to move companies from implementing procedures, to creating opportunities for continuous improvement. The revision process has focused on achieving a consistency between the two key standards in the new ISO 9000 family.
ISO 9001: Quality Management Systems – Requirements
This provides minimum requirements for the quality management system. It is intended for demonstrating system compliance to customers and for third party certification. It replaces ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994.
ISO 9004: Quality Management Systems – Guidance for Performance Improvement
This provides guidance for improving an organization’s performance by improving its quality management system beyond the minimums given in ISO 9001.
ISO 9001 and ISO 9004 are referred to as the “consistent pair” of quality management system standards because they employ common vocabulary and structure to facilitate their use. For instance, ISO 9001 focuses on making a quality management system more effective while ISO 9004 will make it more efficient. Changing the name of ISO 9001 from “Quality Assurance – Requirements” to “Quality
System – Requirements” means that ISO is adopting a more business-oriented approach.
They are intended to be used together by organizations wishing to develop systems that go beyond the requirements of ISO 9001:1994. The intent has been to create a user-friendly pair of standards applicable to all types of product and all sectors of the economy. Most importantly, each of these standards moves beyond documenting and adhering to processes to instilling continuous improvement as a standard business practice.
A Review of the New Standard
The revised standard is based on eight principles:
§ Customer Focus
§ Leadership
§ Involvement of People
§ Process Approach
§ Systems Approach to Management
§ Continuous Improvement
§ Factual Approach to Decision Making
§ Mutually Beneficial Supplier Relationships
It is structured on five fundamental clauses:
1. Quality Management System Requirements
2. Management Responsibility
3. Resource Management
4. Process Management
5. Measurement, Analysis, and Improvement
The process model in Figure 1 is a conceptual presentation of the quality management system requirements specified in the new standard. The model reflects graphically, the integration of clauses 5,6,7, and 8 in the standard. Since it is a model of the complete quality system process, it is capable of demonstrating both vertical and horizontal process integration in a closed-loop manner.
Figure 1
For a vertical loop example, management defines requirements under Clause 5, Management Responsibility; necessary resources are determined and applied with Clause 6, Resource Management; processes are established and implemented under Process Management, Clause 7, and results are measured, analyzed, and improved through Measurement, Analysis, and Improvement, Clause 8. Management review closes the loop as the cycle returns to Management Responsibility for change authorization and initiation of improvement.
As an example of a major horizontal loop, the model recognizes the fact that customers play a significant role during process input of needs and requirements, the identified product and/or service realization processes are then exercised and customer satisfaction is evaluated at process output. Output data are used to improve the customer inputs, completing the closure of the horizontal process loop.
Continuous Improvement
While ISO 9001:2000 reorganizes the existing standard and adds requirements for customer satisfaction, ISO 9004:2000 provides the blueprint for continuous improvement. Using the longstanding model, Plan – Do – Check - Act, ISO 9004:2000 gives an organization the guidance on how to improve an existing quality management system. Companies must note that ISO 9004:2000 should not be used by registrars and third party auditors as a benchmark for performance. ISO 9004:2000 is rather a recipe for going beyond the basic requirements of ISO 9001:2000.
The new Standard requires that the system compare actual quality performance to objectives defined in the quality policy and quality objectives. While the ISO 9000:1994 standard had elements that required corrective and preventive action, no clear direction was provided on how to implement continuous improvement.
The new standard points out five specific activities that lead a company toward achieving continuous improvement:
- The quality policy must include specific mention of commitment to continuous improvement.
- A quality system must have measurable quality objectives to support the commitment to continuous improvement.
- Management reviews must lead to actions related to improvement of the quality system and products and to assign resources for their implementation.
- Procedures must be in place for collecting and analyzing quality performance data for identifying where improvements can be made.
- Organizations must plan and manage for continuous improvement of the quality system, including the use of quality policy, objectives and quality performance data.
Companies seeking to comply with the new standard will be faced with revising their quality policy to specifically address continuous improvement. Activities will now be measured against quality objectives and the commitment to reach these objectives. Organizations will need to have a system for collecting performance data and have resources available to address deficiencies. Management review will require not only conformance with existing processes, but also with any new requirements. In all, the entire workforce from management on down must seek ways to improve performance measures against the quality objectives.
The Impact of the new Standard on Companies Certified to ISO 9000:1994
The new ISO 9000:2000 Standard will require currently certified organizations to invest additional time and resources to meet the new requirements. Companies with strategic/business planning processes in place to measure customer satisfaction will have a head start. Those that have achieved certification as a means of improving their business processes will also have an edge.
But, for those organizations that have only made a minimal commitment to ISO 9000 and perceive certification merely as a marketing tool or to satisfy a customer, may feel that the new requirements hurt them. This does not change the fact that ISO 9000:2000 offers considerable advantages to them and their customers.
Steps to Conversion
1. Get copies of the Standard and review them. Although ISO 9001 is the key document, since it contains the requirements, ISO 9004 is also central.
2. Set up a core implementation or conversion team. If possible, reconstitute the team you used in your original certification effort. This team will carry the primary responsibility for managing the initiative.
3. Contact your Registrar to discuss options and obtain input. If you decide you don’t have the expertise internally to carry out the transition, seek outside assistance.
4. Conduct a gap analysis to determine how your current system meets the requirements of the new Standard. Annex B of ISO 9001:2000 provides a table that shows the relationship between the new and the old. The gap analysis should not be confined to your quality management system. Consider also your business management system and other business processes that may be candidates for incorporation into ISO 9000:2000. For example, it you survey your customers to obtain their feedback on your products and performance, you have, at least, the initial groundwork for the customer satisfaction process required in the new version.
5. Determine how you should structure your documentation. The simplest way to organize the conversion is to remap your current documentation to the new system without changing the existing numbering or organization. The alternative is to renumber and restructure your current documentation into the new system. This will take more work up front, but in the long run will create a more streamlined system. For companies currently certified to ISO 9000:1994, your Registrar will be the best advisor.
6. Determine whether you have new training needs. You may wish to obtain instruction in setting up a business operating system based on the Plan-Do-Check-Act process, in establishing a continuous improvement system or in designing customer satisfaction processes.
The Bottom Line
By incorporating customer satisfaction and continuous improvement factors, ISO 9000:2000 moves closer to the principles of Total Quality Management than its predecessor. At the same time, it retains the discipline of third-party assessment, certification and surveillance that has made ISO 9000 a good business decision. It is an evolution that raises the expectation level for excellence and offers substantial benefits to organizations, their customers and suppliers. |
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