Get Ready, a New ISO 9000 Standard is Coming

By: Larry Powers and Dave Johnson

If you haven’t already heard, a new version of the ISO 9001:1994 standard is coming: ISO 9001:2000 It will be significantly different from and will replace the current ISO 9001:1994 version. It is expected that the new standard will be finalized and published in the fourth quarter of 2000, or in early 2001. Here’s what we know so far about ISO 9001:2000:

• The second change draft version (CD2) has been reviewed and approved.
• There is a drive to harmonize ISO 9000 and ISO 14000.
• Continuous improvement is key.
• Customer Satisfaction is paramount.
• The standard should be seen as a business system, not a manufacturing system.
• There is a new numbering protocol for the standard:

0 – Introduction
1 – Scope
2 – Normative Definitions
3 – Terms and Definitions
4 – Quality Management System Requirements
5 – Management Responsibility
6 – Resource Management
7 – Process Management
8 – Measurement, Analysis and Improvement

• It contains several new requirements but keeps all the current requirements. The prevailing viewpoint on upgrading if you are already ISO 9000:1994 certified is that you will be given a year from official publication of ISO 9000:2000 to update your quality management system.

At this stage, the evaluation of the proposed new requirements should be based on the Second Committee Draft version of ISO 9001:2000. However, it should be undertaken with full awareness that the Final Draft International Standard may differ from the Second Committee Draft and similarly, that the International Standard may differ from the Final Draft International Standard.

The new standard takes the process management approach that is widely used in today’s business world; this orientation is consistent with the Plan-Do-Check-Act  improvement cycle used in the ISO 14000 family of standards. In addition to its business-oriented process approach, ISO 9001:2000 addresses customer satisfaction and continuous improvement, environmental requirements, and the management system elements, all of which give it a wider applicability outside the traditional manufacturing environment.

In light of the new requirements and the introduction of a process management approach, we recommend that organizations strategically identify, plan, and implement the needed supplemental requirements as soon as possible.

Many companies have developed their quality management system (QMS) in conformance with ISO 9000:1994 and have grown comfortable with its the 20-element structure. However the change in approach should not require upheaval in the existing QMS documentation, even though some adjustments will be necessary.

As a first step, we would recommend that a gap analysis be performed to identify any gaps between your present QMS and the new standard and identify any needed improvements. Once the needed revisions have been made, the registrar will assess the updated QMS to the new standard during the next surveillance audit. Ultimately, upgrading your QMS to the new standard represents an opportunity for your company to improve the existing QMS. Furthermore, it will help to eliminate unnecessary documentation and procedures and will encourage product and service improvements.

New Requirements of ISO 9001:2000

The significant changes in ISO 9001’s structure will, at worst, create temporary challenges. Most structural change issues will be resolved by developing guidance tools to help auditors, quality managers and top management to see where existing documents fit into the new clause structure. However, we see five long-term changes that will affect a company’s QMS.  Briefly, these are::

• Terminology Changes: New wording within the standard is the first and most noticeable change. For example, “quality system” is replaced by “quality management system”, “supplier” by “organization”, “subcontractor” by “supplier”, “product:” by “product and/or service, and “supplier’s management with executive responsibility” by “top management”. Even the standard’s title has shrunk from “Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation and Servicing” to “Quality Management Systems – Requirements”. These changes may need to be addressed when updating the Quality Manual, Level 2 procedures, or in training materials.
• Scope Changes:      When ISO 9001:2000 is published, ISO 9002:1994 and ISO 9003:1994 will cease to exist as options for conformance and registration. Instead, companies will register to (or replace their existing registration certificates with) ISO 9001:2000. Any limitations on an organization’s QMS that don’t occur within the organization (i.e., design, or servicing) will be indicated on the certificate. This tailoring allows an organization to restrict the applicability of Clause 7 – Process Management in the new standard. Nevertheless, the new standard reminds users that companies remain responsible for the results of their activities (i.e., products and services they provide to their customers).
• Additional Customer Satisfaction Requirements:  While ISO 9000 always had focused on customer-based product and service specifications, the new standard includes sub-clauses that actually specify customer satisfaction and/or dissatisfaction measurement requirements. Companies will have to evaluate their available resources and consider new information sources for maintaining and improving both their QMS and customer satisfaction levels.
• Formally Requiring Continuous Improvement:  Through its management responsibility, internal quality audits and corrective/preventive action clauses, the current standard infers that an organization should engage in continuous improvement. The new standard defines the need to monitor and measure continuous improvement. ISO 14001 and QS-9000 already require continuous improvement as an auditable element of a management system. The inclusion of this requirement in the new standard will help organizations achieve greater compatibility with these environmental and automotive objectives.  Most importantly, a measurable continuous improvement system will identify areas of cost savings and will justify the organization’s ISO 9000 cost –of quality.
• New Focus on Management Responsibility and Resource Assurance: Although the requirements for management accountability and resource allocation haven’t increased, new wording in the new standard clarifies top management’s responsibility in establishing an effective QMS that leads to continuous improvement and customer satisfaction. While this is not as important a change as some of the others described here, it does emphasize effective process management. The new standard will also help organizations establish total quality management processes similar to the Baldrige Award criteria.

Fourth Quarter 2000 is Just Around the Corner

We recommend using the time until publication of ISO 9001:2000 to ensure that your QMS is in conformance with ISO 9000 and that it aims for measurable customer satisfaction and continuous improvement.  If basic SPC and customer service training are not sufficient to meet this requirement, one of the best solutions is to get help from a professional with proven experience in implementing a systematic approach.  If you are going to consider the assistance of an ISO 9000 consultant to revise your QMS, be sure to use a well-rounded one with professional training experience in both continuous improvement skills and customer satisfaction systems because the two should go hand-in-hand.  Finding the right professional may not be easy, but a few do exist.  The cost justification will be realized in continuous improvement cost savings, increased customer satisfaction, and a reeducation in the business disruption that is typical with a novice consultant. .     

What the Registrars are Saying

The changes in ISO 9001:2000 will require evidence of management commitment to quality objectives. Those objectives must be agreed upon by senior managers as a strategic direction for their business. This change is quite fundamental, involving not so much a change to the existing system, but rather a re-evaluation of the purpose of the system. Not only will this require that an organization think about their system, the certification bodies must also consider the basis of their assessment methodology.

Although it is probable that ISO 9001:2000 will be issued late in the year 2000, many organizations will seek early self-compliance to the new standard. However, the new focus on commitment to improvement will take time to generate evidence of its implementation.

The process of assessing compliance will have to change. It will be necessary to establish whether the QMS is relevant to, and supportive of, the improvement objectives set by the client.

• Justification for objective setting in terms of needs and expectations of interested parties
• Relevance of the defined management system to the achievement of the objectives
• Progress through improvements to the system in the achievement of milestones towards those objectives
• Effective use of the system in feeding back information used in the improvement cycle

Transition to the New Standard

The transition period from the current version of the standard to the new version should be defined by the registrar and the client, recognizing the assessment cycle for the organization and the rules to be announced by the Accreditation Bodies. It is anticipated at this stage that this co-existence period may be a minimum of one (1) year and a maximum of two (2) years.

If you are already certified to ISO 9001, ISO 9002, or ISO 9003 we recommend that a company contact its certification body to discuss the timeframe for recertification or upgrade of of its certification.

To facilitate a smooth transition, we have identified the following key areas as important:

• Determine the QMS updates needed for compliance with the new version of the standard
• Ensure management focus on the structure of the new version and the management role
• Establish (or update current) procedures required by the new version of the standard, and implement these procedures
• Ensure general staff awareness to encourage total involvement and understanding.
• Focus Internal Auditor training on the relationship between the two versions and the new requirements
• Conduct an Internal Audit to the new requirements prior to the surveillance audit to ISO 9000:2000 requirements
• Conduct training on a systematic approach to Continuous Improvement and Customer Satisfaction that is compliant with ISO 9000:2000 requirements.

Most Frequently Asked Questions

Does my organization have to change its current quality management system?

It is not intended that you should have to change the structure of your system; however, the revised standard will include some new requirements and you should consider addressing them in your system at an appropriate opportunity.

Not all documentation will need to be revised. If the quality management system is successfully implemented, satisfies the needs and objectives of the organization, and reflects the way the organization works, there should be no need to rewrite your documentation. It is likely, however, that some adjustments will have to be made to address specific new requirements such as measurement of customer satisfaction and/or dissatisfaction and to update the cross-reference of the quality system documentation to ISO 9000:2000.

Will the year 2000 revision affect our organization’s current quality system registration/certification?

Yes. The transition strategy adopted by your organization to meet the requirements of the new standard should include an appropriate timing for upgrading the registration/certification.

The process of upgrading registration/certification should be a smooth transition process that is incorporated into the applicable Registration or Certification Body’s regular audit routine. We would adivse a company to contact its Registration/Certification Body to negotiate a suitable transition timeframe.

What should we do now?

We recommend that your organization familiarize itself with the changes in the new standard, analyze them, then consider how the changes will affect the organization’s current quality system and related activities/processes. Some consulting companies can provide overview training describing the transition.

Our organization is applying for ISO 9000 certification/registration in early 2000. What should we do?

The organization should gear its quality management system to the requirements of the current standard, with the added aspects of the major component changes that are included in the new standard (i.e., Customer Satisfaction, Continuous Improvement, and Process Monitoring).  It would be wise to prepare your system for registration to ISO 9000:1994 and relatively compliant with the second change draft of the new revision (ISO/CD2 9001:2000).

What does our organization need to do if it is registered/certified to ISO 9002, or 9003?

Once the ISO 9001:2000 is published, ISO 9002 and ISO 9003 will become obsolete.

You will be able to assess the requirements of ISO 9001:2000 by reducing the scope of the standard as it applies to the specifics of your business.

Can organizations remain certified/registered to the 1994 version of the ISO 9001, 9002, and/or 9003?

We anticipate that your registration/certification will remain valid for a period of time after the revised standard is adopted and that there will be a transition period before quality management systems will have to conform to the year 2000 edition.

What is the focus of the ISO 9001:2000?

• A new process-oriented structure and a more logical sequence to the contents
• A continual improvement process as an important step to enhance the quality management system
• The measurement of customer satisfaction to provide key information for improvement
• Increased attention to resources such as communication and work environment
• Terminology changes
• Increased compatibility with the environmental management system standard

How will a small organization be able to adapt the requirements of the standard? What flexibility will be allowed?

The requirements of the revised ISO 9001 will be applicable to small, medium, and large organizations alike. The standard provides some guidance on reducing the scope of the standard for specific processes that are not performed by the organization. It will, however, be up to the individual organization, in consensus with the certification body, to determine the complexity of the system needed to demonstrate its capability to meet customer requirements for its products and/or services.

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