The new ISO· 9000 - Revitalising TQM

The ISO was established in 1947 to promote standardisation of products. “Isos”, a Greek word, means, “equal”. ISO standards aim at equality in product standards. Subsequently ISO got involved in standardising management systems. The first such effort was to standardise quality systems. A technical committee TC 176 was established to prepare a draft international standard (DIS) that was later validated as the ISO 9000 series in 1987. The development of this series benefited immensely from BS 7570 (British Standard). The ISO 9000 series has been revised twice since then. Once in 1994 and then in December 2000. The ISO 9000 standards are recognised across more than 160 countries as the base for setting up a quality management system (QMS). Providing assurance to customers is the focus of these standards.

QMS
Every organisation needs to identify and satisfy customer expectations to remain in business and make profits. Product quality is one such expectation of the customer. A high level of service could be another such expectation.

Eight principles of ISO 9000: 2000

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

Once these customer expectations are identified, appropriate policy, plan, processes, and procedures are required to achieve these expectations.

A QMS is a collection of resources that ensures that an organisation meets its customers’ requirements for product / service quality. These resources comprise capital, people, processes, and procedures. Several interpretations of a QMS exist. Some authors consider vision, mission, policy, objectives and review mechanisms also as a part of QMS.

The QMS provides a means to the management of the organisation to:

• Plan and achieve delivery of products that conform to or exceed customers’ expectations.
• Plan and provide everyone involved with the tools, techniques, training, and instruction necessary to fulfill their tasks efficiently and effectively.

A QMS can be based on the ISO 9000 series of standards. The ISO 9000 standards define the requirements of quality assurance systems. They outline generic and fundamental business practices for management of quality in an organisation.

ISO 900 I: 1000
The 1994 version of ISO 9000 series had three quality assurance management system standards in ISO 9001, ISO 9002, and ISO 9003. ISO 9001 addressed organisations manage the entire spiral of activities from design, development, installation, and servicing. ISO 9002 was applicable for organisations without a designing process. ISO 9003 addressed organisation that wanted responsibility of only the final inspection stage. The ISO 9001: 2000 standard replaces all these previous standards and applies a single standard to all organisations.

The ISO 9001: 2000 standard encourages the organisation to adopt a process approach to quality management, continual improvement, and customer satisfaction. The process approach suggests all work is accomplished as part of a process, and that a QMS is most effective when developed as a family of interrelated processes. The eight quality management principles are embedded in the process approach.

Rationale for revision
The ISO 9000 series of quality system standard has been accepted internationally as an approval of adequate management systems to assure consistent quality of product and/or service delivery. The acceptance is across industries. Then why revise?

The basic reason for this revision lies in the paradigm for continual improvement. If managing quality is all about planning, control and improvement then shouldn’t the internationally acceptable standard be subject to improvement. In the ten years that the ISO 9000 was in use, preceding the revision committee being setup, the limitations of the standard were mercilessly exposed. The more commonly discussed limitations were:

• Customer neglected - the standard did not seek customer input in a proactive manner. Efforts to understand customer requirements were limited to contract review.
• Inadequate management commitment - the standard itself did not seek, and hence did not receive adequate top management commitment.
• Company-wide involvement not achieved - the standard, internationally failed to encourage teamwork.
• Silo-approach glorified contrary to accepted quality management principles of crossfunctional processes, the standard glorified departmentalisation, though indirectly.
• Inadequate attention to suppliers - The standard failed to highlight supplier management issues effectively.
• Improvement approach neglected - the improvement paradigm was conspicuously absent.
• Documentation worshipped - although unfortunate, the standard and its implementation had. become synonymous with over-documentation.

The new version addresses these limitations.

Another key reason for this revision lies in the fact that the earlier version had outlived its utility. It was designed as a bare minimum quality standard. We need to carry the quality management revolution to higher levels of maturity.

A key limitation of the earlier version was the absence of financial guidelines. The new version also ignores this aspect of business. This makes practical sense. Financial systems all over the world are advanced due the obvious implications involved. Performance on these systems and guidelines is also routinely and meticulously audited.

The revision considers previous experience with QMS standards (1987 and 1994 editions) and emerging insights into generic management systems. A closer alignment of QMS with the needs of organisation is expected.

Other reasons for the year 2000 revisions of the standards include emphasising the need to monitor customer satisfaction, meeting the need for more user-friendly documents, assuring consistency between QMS requirements and guidelines, and promoting the use of generic quality management principles by organisations.

The revised ISO 9000 standards will give users the opportunity to add value to their activities and to improve their performance continually by focusing on the major processes within the organisation.

Major changes in ISO 9001 :2000 clauses (in brackets)
- Communicate with customers (7.2.3)
- Identify customer requirements (5.2, 7.2.1)
- Meet customer requirements (5.2)
- Monitor and measure customer satisfaction (8.2.1)
- Meet regulatory requirements (5.1)
- Meet statutory requirements (5.1)
- Support internal communication (5.5.3)
- Provide quality infrastructure (6.3)
- Provide a quality work environment (6.4)
- Evaluate the effectiveness of training (6.2.2)
- Monitor and measure processes (8.2.3)
- Evaluate the suitability of quality management system (8.4)
- Evaluate the effectiveness of quality management system (8.4)
- Identify quality management system improvements (5.1, 8.4)
- Improve quality management system (5.1,8.5)

Major changes
The main changes that have been introduced in the consistent pair (with ISO 14001: 1996) of quality management system standards are:

• A new process-oriented' structure and a more logical sequence of the contents
• A continual improvement process as an important step to enhance the QMS
• Increased emphasis on the role of top management, which includes its commitment to the development and improvement of the quality management system, consideration of legal and regulatory requirements, and establishment of measurable objectives at relevant functions and levels
• The concept of “permissible exclusions” to the standard has been introduced to cope with the wide spectrum of organisations and activities
• A requirement for the organization to monitor information on customer satisfaction and/or dissatisfaction as a measure of system performance
• Significant reduction in the amount of required documentation
• Terminology changes/improvements for easier interpretation
• Increased compatibility with the environmental management system standard
• Specific reference to quality management principles
• Consideration of the benefits and needs of all interested parties
• Addition of the concept of organizational self-assessment as a driver for improvement (ISO 9004).

The revision explicitly defines product as hardware, software, services, and processed materials. The standards had over the years, erroneously, created an impression that excluded service from product. The revision has also redefined supplier as the organizations that supply products and services to the organisation seeking certification.

New version and related documents
The ISO 9000: 1994 family of quality standards contained over twenty-seven standards and documents. This was a concern for users. The year 2000 QMS standards will consist of four primary standards: ISO 9000, ISO 9001, ISO 9004 and ISO 19011.

This poses an obvious question. What happens to the other standards? They will be withdrawn, transferred to other technical committees, or replaced by technical reports, technical specifications or brochures. ISO 10012, Quality Assurance for Measuring Equipment, will remain as an international standard.

ISO 8402 that addressed terms and vocabulary relevant to the ISO 9000 series has been withdrawn. The content with substantial improvement will be included in the ISO 9000:2000 (Quality Management Systems: Fundamentals and Vocabulary) standard. The quality management concepts in ISO 9000-1 have also been integrated into the ISO 9000:2000 standard.

Transition
If your organisation already has an ISO 9001/2/3 certification, you have some reason to worry. Popular perception suggests that up gradation may need more effort than what you invested in initial certification. This concern will be more severe on organisations that went for ISO 9000 certification to satisfy a market requirement only. Typically, such organizations are unable to focus on implementation issues once the certification is complete.

Whatever be the case, some basic steps will need to be followed for transition. These include:

• Senior management awareness: Expose the senior management to ISO 9001: 2000 through a training session lasting at least a day. Seek their commitment to the process.
• Baseline assessment: Conduct an assessment of your current policy, plan, processes, and procedures and map it against the requirements of the ISO 9001: 2000. This will help you identify areas where no change, minor change, or major change is required.
• Action plan: Prepare a schedule of activities to be performed. Use of project management tools is recommended. Take special care to address all resources at this stage.
• Process analysis: To implement the process approach across your organisation you will need to invest time and effort in identifying and analysing processes. Use of process mapping is highly recommended.
• Documentation: Modify or prepare documentation as per the findings of the baseline assessment.
• Implementation: Implement the proposed changes. This stage will require all the patience you have.
• Auditor training: Train internal auditors thorough a course that includes practical training.
• Audit, review, and improvement: Probably the most important stage in the entire transition process. Conduct several rounds of internal audits and subsequent management reviews. If possible, convince auditees to also conduct self audits. Record and track improvements.

Registration
All organizations will be registered / certified to ISO 9001:2000. Suppliers / users not responsible for design activities have to clearly define and describe this in scope of registration / certification. The organisation is not obliged to include within the scope of its certification all the products that it provides. However, for those products that are included in the certification scope, all applicable requirements of ISO 9001 :2000 must be addressed.

Exclusions are limited to Section 7 (“Product Realisation”), and requirements can only be excluded if it can be justified that they do not affect the organisation’s ability to provide products that meets customer and applicable legal/regulatory requirements.

Accredited certifications to the 1994 editions will remain valid for up to 14 December 2001. However, organisations should consider transition to ISO 9001 :2000 certifications as soon as possible.

Clauses of ISO 9001: 2000

• Scope
• Normative reference
• Terms and definitions
• Quality management system
• Management responsibility
• Resource management
• Product realisation
• Measurement, analysis and improvement

Conclusion
Implementing the ISO 9001: 2000 will need more skills, knowledge, and attitude than what was required for ISO 9001: 1994. Now that the wish for less documentation is granted, many management representatives will face the tough task of creating a system that works. Focus on customer satisfaction and continual improvement will need a high level of maturity. All this is likely to result in superior organisational results. A lot is promised. Let time play the judge.