The challenges of business in the new millennium have most companies searching for the keys to success. Within this context, ISO 9000 has emerged as one of the hottest, and perhaps more controversial, management topics. With 15 years of experience, it appears the “jury is still out” on the value of the ISO 9000 Standards.
ISO 9000 a make work project? Fodder for Dilbert cartoons?
Is ISO 9000 simply “Document what you do, do what you say”?
ISO 9000 an opportunity to improve the organization through meaningful change?
A published “ISO 9000 Survey” would have us believe that, in reality, it is all three. The survey identified the stunning fact that:
One point is clear, the value derived from ISO 9000 is a choice, illustrated by the fact that 50% of the companies chose to take advantage of the opportunity and 50% did not.
The International Organization for Standardization comprises the Standards Bodies of over 100 countries worldwide. The ISO 9000 standards are the most widely accepted quality standards in the world. They have emerged as the internationally accepted measure of quality management and assurance practices. The ISO 9000 standards outline the general elements a quality system must address – not how they must be addressed. Therefore the standards provide the company with a “tool” for process and quality system improvement. As with the use of any tool, it is critical to understand the objectives or requirements for its use.
ISO 9000 can:
The differences begin at a strategic level; in the willingness to utilize the opportunity and ensure that the ISO 9000 implementation process addresses the critical business issues. If the process does not significantly impact issues of relevance to the strategic, customer and shareholder goals it is of little value to the company.
Key decisions made at a strategic level determine the approach required at an operational level. Broad based participation and clear prioritization are critical steps to building organizational capability and process improvement.
Quality Control Standards
A frequent question that arises near the beginning of an ISO 9000 implementation is, “Tell me exactly what I have to do?”. This is especially true of companies familiar with other industry standards.
Quality control standards typically focus on product and outline specific methods and/or procedures to employ. The scope of the standard is specifically defined ensuring that the application is uniform. The ISO 9000 Standards vary significantly from this model. The standards focus on process not product. They define a minimum set of requirements outlining what needs to be addressed; a basic framework to achieve quality.
The more comprehensive approaches such as Total Quality Management (TQM), Total Quality Control (TQC) or Continuous Quality Improvement are more difficult to define. They are quality centered approaches to business based on principles advocating a clear shared organizational vision, customer satisfaction (internal and external), member involvement, systems alignment and fact based decision making. Though not always explicitly stated, the ISO 9000 standards share many of the same principles. Whereas quality awards such as the Malcolm Baldrige Award or the Deming Prize focus on excellence, the ISO 9000 standards define a minimum level.
In this way the ISO standards attract criticism from both camps. On the one hand it is too vague for those used to very defined standards, yet not comprehensive enough as the standards outline minimum requirements. However, herein also lies its versatility and universal applicability.
Developing and maintaining an understanding of the present and future needs of the customer.
A clear, shared vision or organizational purpose. Leaders articulate a direction and maintain an environment that allows others to adopt it as their own.
Involvement of people:
Motivation of people is critical to the organization’s success. Compliance is the absence of resistance whereas commitment engages both physical and mental capabilities.
All activities within the organization are the result of systematic steps; and therefore can be understood and improved.
System approach to management:
Understanding the interrelation of processes allows the management of the parts for the benefit of the whole.
Continual improvement is critical to the long-term competitiveness and therefore viability of the organization.
Factual approach to decision making:
Accurate and reliable information is required to ensure that performance meets objectives and decisions are based on sound indicators.
Mutually beneficial supplier relationships:
Similar to the interrelation of processes inside the organization, a mutually beneficial relationship is necessary for the long-term success of both entities.
The ISO 9000 standards define proven elements of an effective quality system. Though not always explicitly stated, the standard is based on the same guiding principles as quality management. As stated previously, understanding these principles and the intent behind each quality element is, in the long run, the fastest route to implementing the standards. This base of understanding will allow a deeper interpretation of the standard. Therefore, allowing for greater customization, the ability to justifiably depart from the “typical” methods of addressing the standard.
Management’s role in change of any form is critical. Without direction, resources and guidance, the inertia required to overcome the status quo is unlikely. Management commitment provides the required profile and ensures that the quality system activities guide the business process. The quality system is integrated as opposed to added on.
Objectives (and methods to achieve objectives) are defined for each process. Quality does not happen by accident. A focus on “upstream” activities is the most efficient and cost effective method of meeting objectives.
Monitoring Process and Performance:
“Management by fact.” “If it is not measured it is not done.” Accurate and reliable information is required to ensure that performance meets objectives and decisions are based on sound indicators.
A focus on assessment and the action required to continually improve performance against objectives. A systematic and continuous review of objectives against the requirements for competitiveness.
The system, and resulting activity, is documented to the extent required to verify compliance and effectiveness. This facilitates the planning, monitoring and assessment process by providing confidence through generating objective evidence.
Continuous quality system improvement requires constant monitoring of the key processes and their supporting infrastructure. This mechanism must be formalized if it is to become an integrated part of the company’s business process. Staying aligned with changing customer requirements is the cornerstone of continued company competitiveness.
Quality Systems Inc. has expertise in the implementation of effective quality
systems and quality improvement projects within both large and small organizations.
A specific focus of the firm has been “start up or restart” situations.
These situations require a greater emphasis on defining quality system requirements,
training client personnel and integrating a quality focus into the existing
The experience and proven methodology of Integrated Quality Systems will ensure that your quality improvement efforts are effective and continuous.
ISO services include:
Integrated Quality Systems Inc. will undertake a detailed assessment of the existing quality system documentation and compare it with the intent of the ISO standards. This assessment will also identify the implementation status of the existing quality system elements.
Integrated Quality Systems Inc. will identify those areas that are:
A cost effective approach will incorporate as much of the existing quality system as possible.
IQ Systems will work with organizations to define a comprehensive implementation plan. The plan will establish and coordinate the project activities and will assist the Project Leader in managing the project including progress reporting, and internal/external resource allocation.
Design and Development
The previous stages will identify the requirements of, and gaps associated with, the quality system. Once these “design criteria” are defined, a structured methodology is deployed and integrated into the business process.
Based on the framework of ISO 9000, the consultants will work with project teams to identify and resolve detailed process gaps. IQ Systems will assist in the detailed documentation of the quality system. Proven project management controls will be utilized to ensure timely completion.
Implementation of ISO 9000 requires that all employees, within their respective spheres of responsibility, understand their duties and the quality system requirements. In order to harness the knowledge of key personnel, training sessions covering ISO 9000 principles, quality elements and implementation should be conducted. Integrated Quality Systems Inc. can develop customized training sessions for specific delivery to key project teams. Previous interaction with company personnel will ensure that the session is completely company specific and therefore delivers the maximum benefit for the investment in time.
Internal Quality Audit Program
Integrated Quality Systems Inc. can assist in developing an independent internal audit program.
Quality Auditor Training
Integrated Quality Systems Inc. will provide a customized Internal Quality Auditor training session. This is a one-day course that gives designated auditors an understanding of their role and skill requirements.
Quality Auditor Coaching
Internal Quality Auditing is a discipline that combines theoretical knowledge and practical skills. An auditor must have a good working knowledge of the ISO 9000 standards and audit techniques. This must be complimented by certain personal attributes and the inquiry skills to confirm quality system compliance and effectiveness.
The practical aspects of auditing are developed with audit experience. The time required for this development are significantly reduced with the assistance of an experienced auditor acting as a coach.
The auditor candidates will work directly with an experienced Certified Quality Auditor to develop and refine:
· Audit organization skills.
· Audit approach.
· Inquiry skills.
· Audit reporting.
Prior to an on-site audit by the chosen registrar, Integrated Quality Systems Inc. will perform a full quality system assessment confirming registration readiness. This will ensure the required level of preparedness to successfully complete the registration audit.
Experience and proven success
Implementation focused on Return on Investment
Complete turnkey services
Quality Management Philosophy