Harmonization of quality system standards and guidelines-ISO 9001:2000, EN 45001 and ISO/IEC 17025 to facilitate CE marking

The paper describes how the changing scenario of global market and duplication of efforts for implementing, auditing, reviewing and improving separate quality standards call for one integrated quality system that addresses the consolidated requirements of quality management system incorporating international standard on technical competency. Keeping the benefits of the harmonization in mind, three quality standards, namely ISO 9001, ISO 9002 and ISO 9003 of 1994 have been merged into a single quality standards called quality management system-ISO 9001: 2000 with several valuable improvements. This paper discusses further the need for harmonization of quality system standards and guidelines-ISO 9001:2000, EN 45001 and ISO/IEC 17025 for efficient and effective functioning of a test laboratory. This paper also describes how harmonization of quality, system standards and guidelines facilitates elevating the confidence level of the Indian manufacturers on affixing CE marking on their products for exporting them in European Union (EU).