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QUALITY MANAGEMENT SYSTEM STANDARD

ISO 9000 FAMILY

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by

ISO, the International Organization for Standardization and is administered by

accreditation and certification bodies. The rules are updated, as the requirements motivate changes

over time.

Some of the requirements in ISO 9000:2008(which is one of the standards in ISO 9000 family)

include:

a set of procedures that cover all key processes in the business;

• monitoring processes to ensure they are effective;

• keeping adequate records;• checking output for defects, with appropriate and

corrective action where necessary;• regularly reviewing individual processes and the

quality system itself for effectiveness; and• facilitating continual improvement

9001:2008

• The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.

9000:2008

• Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.

• You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints

9000:2008• When developing new products, you need to

plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.

• You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits)

9000:2008

• You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem seeking and keep records to use as a tool to improve the system

Analysis of QMS of firm XYZ a) determines the processes needed for the quality

management system and their application throughout (XYZ),

b) determines the sequence and interaction of these processes,

c) determines criteria and methods needed to ensure that both the operation and control of these processes are effective,

d) ensures the availability of resources and information necessary to support the operation and monitoring of these processes,

e) monitors, measures where applicable and analyzes these processes, and

f) implements actions necessary to achieve planned results and continual improvement of these processes.

Elements of Quality Management

System

Documentation

• Quality policy

• Quality objectives

• Procedures required to ensure the effective planning ,operation and control of its processes

Management responsibility

• Top management is committed to the development and implementation of the quality management system and continually improves its effectiveness by:

• a) communicating the importance of meeting customer as well as statutory and regulatory requirements,

• b) establishing a quality policy,• c) establishing quality objectives, • d) conducting management reviews, and • e) ensuring the availability of resources

Responsibility, Aunthority & Communication

• Ensure that processes needed for quality management system are established, implemented and maintained

• Report to the TM on the perfomance of the quality management system and any need for the improvement , and

• Promote awareness of customer requirements throughout the organisation.

Management Review

• Results of audits

• Customer feedback

• Process of perfomance and product conformity

• Status of preventive and corrective actions

• Follow up actions from previous management reviews

• Recommendations for improvement

Resource management

• implement maintain the QMS & improve its effectiveness

• Enhance customer satisfaction by meeting their requirements

• Provision of resources • Human resources •  Infrastructure • Work environment

 Product realization

• Planning of product realization

• Customer- related processes

• Purchasing

• Production and service provision

• Control of monitoring and measuring equipment

Measurement, analysis and improvement

• Monitoring and measurement

• Internal Audits

• Control of nonconforming product

• Continual improvement

Procedure for certification

• Application and its processing

• Process of certification for the grant of license (Adequacy audit, Preliminary visit, Assessment fee, Assessment(opening meeting-conduct of assessment-closing meeting and report)

• Contditions

• Renewal

Advantages

• Create a more efficient, effective operation• Increase customer satisfaction and retention• Reduce audits• Enhance marketing• Improve employee motivation, awareness, and

morale• Promote international trade• Increases profit• Reduce waste and increases productivity.

PROBLEMS

• A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration.

• ISO 9001 is not in any way an indication that products produced using its certified systems are any good.

• Softer approach to flaws indicated in the system

Presented by

• Gaurav Singh Chouhan

• Gauravsingh_2k5@hotmail.com