Selection and use of theISO 9000 family of standards

2013-2014

By : Amine FATIH

ISO is the International Organization for Standardization.

Membership of 158* national standards institutes.

ISO develops voluntary technical standards.

Support the efficient, safer and cleaner products and services.

ISO’s portfolio is more than 17 800 standards.

Quality management and assurance :

ISO/TC 176 is responsible for the ISO 9000 family of standards.

National delegations of 81 countries participate in its work.

21 countries as an observer.

ISO/TC 176, Quality management and assurance :

Provides the fundamentals and the vocabulary. The stage for understanding the basic elements

of quality management. Introduces users to the eight Quality

Management Principles. Use the process approach to achieve continual

improvement,(Figure A).

ISO 9000 :

Figure A The ISO 9000 process approach

ISO 9000 :

To establish a quality management system. Can be certified by an external body.

ISO 9001:

Five sections in the standard need to be considered : Overall requirements for the quality

management system and documentation. Management responsibility, focus, policy,

planning and objectives. Resource management and allocation. Product realization and process

management. Measurement, monitoring, analysis and

improvement.

ISO 9001:

Extend the benefits obtained from ISO 9001 to all parties that are interested in or affected by the operations.

Interested parties include the employees, owners, suppliers, partners and society in general.

Gives guidance on a wider range of objectives of a quality management system.

Managing for the long-term success of an organization.

ISO 9004 :

Recommended for systematic and continual improvement and performance.

Not intended for certification or contractual purposes.

ISO 9004 :

Compatible. can be used separately or in combination.

ISO 9001 and ISO 9004 :

Auditing of quality management systems. Auditing of environmental management systems. Provides guidance on the audit programmes. Conduct of internal or external audits. Information on auditor competence. Provides an overview of the audit programme. Ensure that an implemented QMS* meets the

requirements specified in ISO 9001.

*QMS (Quality Management System)

ISO 19011 :

Implementing and maintaining ISO 9001 :For a successful implementation of the QMS, these seven steps are recommended.

Fully engage of top management : Define why you want to implement ISO 9001. Define the mission, vision, and values in the

organization. Define the organization’s stakeholders :

customers, suppliers, stockholders, employees, society, etc.

Define the quality policy. Define and align organizational objectives and

related product/ service quality objectives.

Identify key processes and the interactions needed to meet quality objectives.

Processes :

Implement and manage the QMS and its processes (using process management techniques)

Process management techniques :

Identify ISO 9001 requirements. Map these requirements with the implemented

QMS, where applicable. Make a gap analysis : identify the fulfilled

requirements. Include in the QMS processes the activities,

procedures and controls needed.

Build the ISO 9001-based QMS :

Implement the system, train company staff and verify effective operation of the processes.

Training :

Focus on customer satisfaction. Monitor and measure the operation of the

QMS. Strive for continual improvement. Consider implementing business excellence

models in the company operations.

Manage the QMS :

Seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity.

Certification :

The accompanying diagram depicts the relationships of the standards in the ISO 9000 family and where they may be applied when implementing the quality management system,(Figure B).

Process model :

Figure BQuality Management Principles.

Process model :

A metal parts fabricating company recognized the need to demonstrate their capability to produce consistent quality product. They first used ISO 9000 to develop a plan to create an acceptable QMS. Next, they prepared the quality manual and quality system procedures as required by ISO 9001, excluding the requirements covering product design and development because their products are made to designs prepared by their customers. They implemented the QMS described in their manual and procedures and ensured the system functioned as planned. Later, in order to bid on the supply of parts to a major automotive company, they upgraded their quality system to meet the automotive sector specific requirements of ISO/TS 16949.

Examples of using the ISO 9000 family of standards :

A welfare agency decided to improve the quality of the services it provided to clients. It adopted ISO 9004 as the basis for implementing its system and planning for improvements. The agency recognized that ISO 9000 provided very useful additional guidance in terminology and understanding and applying QMS concepts to their system. They mapped the resulting system processes to requirements in ISO 9001. They planned to seek certification to ISO 9001 to gain recognition and credibility from clients and supporters.

Examples of using the ISO 9000 family of standards :

Improvements of the organization and the internal communication.

Effective internal auditing and management review of system performance.

Maintaining the benefits and continual improvement :

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