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What is ISO 9000 / ISO 9001:2000?
ISO 9000 is an international standard adopted in 1987 by the International
Organization for Standardization (ISO) setting specific criteria for documenting
and establishing a quality management system and was recently updated via ISO
9001:2000. ISO 9000 / ISO 9001:2000 not only shows that a company has documented
its quality management principles and procedures, it also shows that the company
operates according to them. A certificate is good for three years and requires
a yearly assessment.
WHY WAS THE ISO 9001:1994 STANDARD REVISED?
ISO requires all standards to be periodically revised to satisfy the needs
of the global community. The new revisions take into account previous experience
with quality management systems standards and emerging insights into management
systems in general.
WHAT ARE THE CHANGES TO ISO 9001-2000?
STRUCTURE
The revision of the ISO quality management standards includes a significant
change to the structure of ISO 9001 and ISO 9004, which, while retaining the
essence of the original requirements, will reposition the 20 elements of the
current ISO 9001-1994 and the guidelines of ISO 9004-1-1994 into five sections:
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What were the twenty elements of ISO 9000?
1. Management Responsibility
2. The Quality System
3. Contract Review
4. Design Control
5. Document and Data Control
6. Purchasing
7. Control of Customer Supplied Product
8. Product Identification and Traceability
9. Process Control
10. Inspection and Testing
11. Control of Inspection, Measuring and Test Equipment
12. Inspection and Test Status
13. Control of Nonconforming Product
14. Corrective Action
15. Handling, Storage, Package and Delivery
16. Control of Quality Records
17. Internal Quality Audits
18. Training
19. Servicing
20. Statistical Techniques
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What are the five sections
of the new ISO 9001:2000 ?1. Quality Management System
2. Management Responsibility
3. Resource Management
4. Product/Service Realization
5. Measurement, Analysis and Improvement
ISO 9000:2000 Sections
(click for graphical presentation of the ISO 9001:2000 sequence and interaction
of the clauses (processes) to meet Customer Requirements to ensure Customer
Satisfaction and Continuous Improvement.)
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SEQUENCE
There is a more logical sequence of requirements and guidelines due to
the process orientation of the new standards ISO 9001:2000 is based on a
process approach. The ISO 9000:1994 standard was based on 20 elements.
These 20 elements have now been reduced to 5 sections. These sections
contain all 20 elements but blend them together into a structure that
promotes the process approach.
An audit to the ISO 9001:2000 standard will change from an element audit
to a process audit. In a process audit the focus is on processes,
continuously improving processes within the organization and satisfying
the customer. The auditor should evaluate the organizations performance
against its customer requirements.
TOP MANAGEMENT
More emphasis has been placed on the role of top management, which
includes its commitment to the development and improvement of the
quality management system, with a customer focus, consideration of
statutory and regulatory requirements, and establishment of measurable
objectives at relevant functions and levels.
CONTINUAL IMPROVEMENT
An enhanced requirement for "continual improvement" has been introduced
into ISO 9001, defining a complete cycle to improve the effectiveness of
the quality management system.
APPLICATION
The concept of exclusions to the requirements of ISO 9001-2000 has been
introduced as a way to cope with the wide spectrum of organizations and
activities that will be using the new standard. This concept is
addressed in clause 1.2 "Application" of ISO 9001-2000.
CUSTOMER SATISFACTION
Another new item that has been introduced into ISO 9001-2000 is the
requirement for the organization to monitor information on customer
satisfaction as a measure of system performance.
RESOURCES
Attention has been placed on top management to provide and make
available the necessary resources. Requirements now include evaluation
of the effectiveness of training, provision of relevant information,
internal and external communication, facility needs, and human and
physical factors of the work environment.
DOCUMENTATION
The number of requirements for documented procedures has been reduced in
ISO 9001-2000, and the emphasis placed on the organization demonstrating
effective operation.
HOW DOES TRANSITION OCCUR?
Although implementation does not require restructuring or renumbering of
your quality manual, procedures and other documents to align with ISO
9001-2000, the new requirements have to be addressed. An understanding
of the process management model should also be developed and specific
training conducted for management, internal auditors and staff.
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Why is ISO 9000 / ISO 9001:2000 Registration So
Important?
First of all it provides a system for managers and organizations to
achieve excellence and opens the door for American manufacturers and/or
service organizations seeking a larger role in both international trade
and with other American organizations. Many organizations require their
suppliers to be certified or at a minimum to be working toward
registration on ISO 9000 / ISO 9001:2000 to do business.
Consider the facts (source MORI/SGS-ICS) that with ISO registration:
• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share.
What Next?
Contact us today and
we will help you start the process towards improved productivity,
reduced waste and the prestige of ISO registration.
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