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  ISO 9000 Year 2000 Revision

Why the revision?

The International Organization for Standardization (ISO) will publish a revision of ISO 9000 Quality Assurance Standard by the 4th quarter of 2000.   The revision has been brought about not only by ISO's five-year review plan, but market demand.  According to a survey conducted by ISO,  over 80% of the respondents stated that there was a need to revise the existing version (1994). The directions of the revision are as follow:

1. Use simple definitions for easier reading and application;
2. Strengthen the requirements for effectiveness, continual improvement and prevention of non-conformances;
3. Facilitate the organizations to perform self-assessment;
4. Allow greater compatibility with the ISO 14001 Environmental Management System Standard. The common elements of both standards can be implemented in an integrated fashion, thereby minimizing unnecessary duplication and conflicts. Such compatibility will also enable an ISO 9000 certified organization to merge ISO 14001 elements into its existing system when it decides to implement ISO 14001;
5. Adopt  the Plan-Do-Check-Act cycle, thus changing the standard from a manufacturing-based model into a process-based one. It will then become more applicable to organizations of different industries and different sizes, and can cater better to the implementation of total quality management. 

What has been changed?

RE-ORGANIZING THE ISO 9000 SERIES

Comparing with the existing version, the Year 2000 version will regroup the ISO 9000 series into 4 modules:

1. ISO 9000 Concept and vocabulary for a Quality Management System
   This will replace the existing ISO 8402 standard. There will be a number of changes in the supply chain terminology:
   "Subcontractor" -> "Supplier" -> "Purchaser" will be changed to
   "Supplier" -> "Organization" -> "Customer"
   
2. ISO 9001 Requirements of a Quality Management System
   The existing versions of ISO 9002 and ISO 9003 will be cancelled. In other words, ISO 9001 will become the only auditable standard, with "permissible exclusions" allowed to some requirements under the following conditions:
   -  the related processes are not performed by the organization, and
   -  these requirements do not affect the organization's ability to provide product/services that meets customer and applicable regulatory requirements.
   
3. ISO 9004 Quality Management System (QMS) Guidance for Performance Improvement
   This is a reference document for guiding the organization towards total quality management, but it is not an implementation guideline for ISO 9001. The major points of ISO 9004 are as follow:
   -   it is based on the 8 Principles of Quality Management; implementing these principles are supposed to eventually benefitting the customers and the interested parties of the organization;
   -   it provides guidance for process management;
   -   it emphasizes the need to evaluate the improvement made by the organization, and facilitates the organization to perform self-assessment.
    
4. ISO 19011 Guidance for Auditing Quality and Environmental Management Systems

RE-STRUCTURING THE REQUIREMENTS OF ISO 9001 STANDARD

The existing 20 requirements will be restructured into four major categories (with 23 sub-elements):

1. Management Responsibility
2. Resources Management
3. Product or Service Realization
4. Measurement, Analysis and Improvement

This new structure is based on the process flow of an organization, clearly depicting the P-D-C-A (Plan-Do-Check-Act) cycle.

1. Management Responsibility
   To realize the commitment to continual improvement, management needs to define the quality policy and objectives, implement quality planning and establish the requirements of its quality management system.  
    
2. Resource Management 
   In order to establish, implement and improve the quality management system, it is necessary to establish the use of trained, qualified and competent staff and provide the necessary resources, including information, facilities and work environment.
    
3. Product Realization (including service)
   It is necessary to establish and implement the processes required to provide the customers with their required products/services, including the identification of customer needs, expectations and requirements, communication the customers, management of customer property, design and development, purchasing, production or servicing, control of non-conforming products and after-sales service etc. 
   
   In this category, the customer plays a very significant role - the input to the above processes comes from the needs, expectations and requirements of the customers; the output from the processes (i.e. products and services) is to satisfy the customers' requirements; the level of customer satisfaction will be measured and the outcomes will be used to re-define the needs, expectations and requirements of the customers, thereby improving the quality of the input. 
     
4. Measurement, Analysis and Improvement
   Apart from calibrating the measuring, testing and inspection equipment, it is also necessary to measure the performance of the system, which includes the level of customer satisfaction, the results of internal/external audits, as well as the performance of the product/service.  The results have to be analyzed, so that corrective, preventive and improvement actions can be implemented; the outcomes also have to be fed back to Management Responsibility, so as to initiate continual improvement and re-define the organization's quality objectives and plans.
     

KEY CHANGES

1. Responsibility of Top Management
   There will be more emphasis on top management to get involved in the establishment, maintenance and improvement of the quality management system, which includes defining quality policy and measurable quality objectives (relevant to different functions and levels), quality planning, reviewing system effectiveness, identifying opportunities for continual improvement, providing sufficient resources, strengthening internal communication to ensure all employees are aware of the importance of satisfying customer needs and expectations.  In addition, when organizational change is implemented, the continuity of the quality management system also needs to be maintained.
     
2. Identification of Customer Needs, Expectations and Requirements
   To enhance customer confidence, the organization must determine overall customer needs and expectations (including applicable regulatory requirements), and convert them into quality system requirements.
    
3. Communication with Customers
   To ensure the customer requirements are met, the organization needs to establish formal arrangements to communiate with the customers about:
   • product/service information
   • enquiry and placing of orders (including changes)
   • complaints and response of the organization about non-conforming product/service
   • other feedback from the customers regarding the product/service.
     
4. Measurement of Customer Satisfaction
   The organization needs to establish the procedure and methodology for measuring customer satisfaction, define the standard to be achieved, as well as to review the nature and frequency of measurement.  When the standard is not met,  improvement actions need to be implemented, and results have to be evaluated and fed back to top management as the basis for realizing continual improvement. 
   
5. Resource Management
   Regarding the staff who will affect product/service quality, the organizations needs not only to provide adequate training, but also to review the effectiveness of training, and ensure that the staff is competent and achieves improvement in performance.   Furthermore, the organization also ha to identify, set up and maintain all the information, facilities (including work space, hardware and software facilities, as well as supporting services),and work environment (including staff health and safety, work methods and ergonomics).
   
6. Continuous Improvement
   The organization needs to set up procedure for the continual improvement of the quality management system, which covers:
   -  A quality policy that includes a commitment to continual improvement;
   -  Quality objectives that are consistent with continual improvement;
   -  Management Review to take into account of continual improvement of the quality management system, customer feedback, changing organizational circumstances, so as to re-define policy and objectives;
   -  Internal audits to identify potential opportunities for continual improvement;
   -  Analysis of operational processes, customer satisfaction level and product/service non-conformance with a view to improvement.

For those organizations that have been certified:

Given that the 20 requirements of ISO 9001 will be re-organized into 4 major categories, does this mean our existing documentation structure must be entirely changed?

• Despite the re-organization of standard requirements, the revised standard does not require the organization to re-structure its existing doumentation structure. In other words, the organization can keep its existing documentation structure, and needs only to add or modify the documentataion according to the new or revised requirements. The organization should focus on analyzing and understanding the new concepts and requirements brought about by the new standard, and deriving the necessary quality activities to fulfill them.

How much time do we have for making the transition?

• According to the agreement reached between ISO and IAF (International Accreditation Forum), the certificates issued against the 1994 version of the standard will remain valid for 3 years after the publication of the ISO 9000 Year 2000 version. Within this period, the certification body can continue to audit an organization according to the 1994 version, but the organization needs to have successfully made the transition to the Year 2000 version before the certificate expires.
• In other words, organizations (especially those with certificates expiring in 2001 and 2002) are strongly advised to start reviewing their existing systems for any necessary changes and start implementation as soon as possible.
• During surveillance audits, the organization should discuss with its certification body about the changes to be made in the system. If the organization is ready, it can arrange with the certification body to audit the organization according to the Final Draft International Standard (FDIS); once the standard is formally released, the organization can apply for a change of certificate to one that is issued against the Year 2000 version.  

For those organizations that are in the process / plan to set up the system:

These organizations should set up a quality system based on the requirements of the 2000 version. 

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Updated on 2007/01/25.