QMS The International Organization for Standards (ISO) was founded in 1946 in Geneva, Switzerland. Its mandate is to promote the development of international standards to facilitate the exchange of goods & services worldwide. ISO is composed of 90+ countries, and US representative is American National Standards institute (ANSI)
QMS ISO technical committee published international standards in the year 1987. The standards are adopted in almost all countries
Benefits of ISO registration There are various reasons for implementing a quality that conforms to an ISO standard. The primary reason is that customers demand for compliance to a quality system. Other reasons are needed improvement in processes or systems and desire for global deployment of product & services
Significant improvement needed Internal quality is measured by %of scrap, rework & nonconformance at final inspection. Production reliability as measured by the number of breakdowns/month, time dedicated to emergencies and % of downtime/shift. External quality is measured by the customers of acceptance
ISO 9000 series of standards It is generic in scope. By design, the series can be tailored to fit any organization’s needs, whether it is large or small, a manufacturer or a service organization. It can be applied to construction, engineering, health care, legal and other professional services as well as the manufacturing of any form.
ISO The three standards of the series are described briefly below, ISO 9000:2000, QMS – Fundamentals & Vocabulary: Establishes a starting point for understanding the standards and defines the fundamental terms and definition used in the ISO 9000 Family
ISO ISO 9001:2000, QMS – Requirement: ISO 9001, ISO 9002 and ISO 9003 in the old standards were integrated in ISO 9001:2000. The ISO 9000:2000 standard is used to assess a firm’s ability to meet customer and applicable regulatory requirement and thereby address customer satisfaction.
ISO ISO 9004:2000, Quality management systems– guidelines for performance improvements:The standard provides guidance for continual improvement of a firm’s quality management system to benefit all parties through sustained customer satisfaction.
ISO ISO 9000 system is designed as a simple system that could be used by any industry, but specific industry have been developed quality systems and currently three quality systems are:
AS9100 This systems is introduced for aerospace industry officially by the Society of Automotive Engineers in May 1997. This development was an attempt to unify the requirement of NASA, DOD, and FAA. In march 2001, the International Aerospace Quality Group (IAQG) aligned with ISO9001:2000.
ISO/TL 16949 This standard is entitled Quality Systems Automotive Suppliers-Particular Requirements for the application of ISO 9001. It harmonizes the supplier quality requirements of US auto makers and approved by Asian automakers.
TL 9000 It will consolidate the various quality system requirements within telecommunications industry, it has 5layers and they are ISO 9000 requirements TL 9000 requirements(hardware, software & services) TL 9000 measurements
ISO 9001 Requirements The standard has 8 clauses and they are Scope Normative references Definition Quality management systems Management responsibility Resource management Product/service realization Measurement analysis & Improvement This is for the information only Requirements that organizations must meet
ISO 9001 Scope: The purpose of the standard is for the organization to demonstrate its ability to provide a product that meet customer & regulatory requirements and achieves customer satisfaction. Normative reference: QMS that provides concepts & definitions. Terms & Conditions: Every parameters are explained.
ISO 9001 Quality Management System (QMS) 4.1 General requirement 4.2 Documentation 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records
ISO 6 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment
ISO 7 Product realization 7.1 Planning of product 7.2 Customer related process 7.3 Design & Development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring & measuring devices
ISO 8 Measurement, Analysis & Improvement 8.1 General 8.2 Monitoring & measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement
Implementation Top management commitment Appoint the management representative Awareness Appoint an Implementation Training Time schedule Select Element owners Review the present System Write the documents Install the new system Internal Audit Management review Pre assessment Registration
Documentation Policy Procedure Work instructions Records Document development
Assignment Time: to be submitted by 16th Sept’11 Write briefly about Internal Auditing? Explain the procedure of Registration of Quality system? Elaborate the ISO14000 complete series? List the benefits of EMS?