Quality Concepts and ISO 9001:2008 QMS Awareness

Sunday, April 12, 2015

Forthcoming ISO 9001:2015 QMS Awareness: Transition Planning for ISO 9001:2015

Forthcoming ISO 9001:2015 QMS Awareness: Transition Planning for ISO 9001:2015: Transition planning guidance document, prepared by the International Accreditation Forum (IAF) in cooperation with ISO/TC 176/SC 2/WG 23, ...

Friday, March 27, 2015

Verification and Validation in QMS

Verification and Validation in QMS

People generally ask difference in verification and validation. These are two terms having the same objective 'confirmation' through the provision of objective evidence. ISO 9000:2005 has defined both terms as under:

Verification: Verification is the conformation through the objective evidence that specified requirements have been fulfilled.

Validation: Validation is the confirmation through the objective evidence that the requirements for a specific intended use or application have been fulfilled.

Verification ensures that the output (or the product) has satisfied the input requirements, the requirements that are specified. Validation ensure that the output (or the product) is capable of fulfilling requirements for the specified application or intended use.

There may be situations where the resulting the output (or the product) during product realization process cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become known only after the product is in use or the service has been delivered. In such situations, validation of processes ensures that the output (or the product) is fit for the intended use. Validation is required where the output (or the product) cannot be verified without damaging or destroying the output (or the product). For example it is difficult to verify the welding output or a product like a gun bullet or a tear-shell.

Verification is done by monitoring and measurement that the output meets input requirements.

Validation of a process requires establishment of certain arrangements, such as defined criteria for review of process, defined criteria for approval of the process, approval of the equipment, approval of qualification of people, use of specific methods, use of specific procedures, requirements for records and re-validation.

Accordingly, we can say that the verification is the confirmation that the right product is produced in accordance with its specifications. And validation is confirmation that the right product is produced that will meet expected results. Verification is the evaluation of whether or not the output (or the product) complies stated requirements. And validation is assurance that the output (or the product) meets the needs what is expected.

Saturday, February 28, 2015

Forthcoming ISO 9001:2015 QMS Awareness: ISO/DIS 9001 - Quality Management Principles

Forthcoming ISO 9001:2015 QMS Awareness: ISO/DIS 9001 - Quality Management Principles: ISO/DIS 9001 - Quality Management Principles Keshav Ram Singhal A quality management principle is a comprehensive and fundamental beli...

Monday, February 16, 2015

Forthcoming ISO 9001:2015 QMS Awareness: Forthcoming ISO 9001:2015 QMS - What Should We Do ...

Forthcoming ISO 9001:2015 QMS Awareness: Forthcoming ISO 9001:2015 QMS - What Should We Do ...: Forthcoming ISO 9001:2015 QMS - What Should We Do Now? Keshav Ram Singhal We know that ISO 9001:2008 QMS standard is undergoing revisi...

Friday, February 13, 2015

Forthcoming ISO 9001:2015 QMS Awareness: ISO/DIS 9001 - LEADERSHIP

Forthcoming ISO 9001:2015 QMS Awareness: ISO/DIS 9001 - LEADERSHIP: ISO/DIS 9001 - LEADERSHIP Keshav Ram Singhal Clause 5 of ISO/DIS 9001 provides requirements related to the leadership. Leaders at all ...

Sunday, January 25, 2015

Forthcoming ISO 9001:2015 QMS Awareness: IATF announces plans to develop a design specifica...

Forthcoming ISO 9001:2015 QMS Awareness: IATF announces plans to develop a design specifica...: The International Automotive Task Force (IATF) has announced that it has set up a working group of IATF member organisations “to develop ...

Tuesday, January 13, 2015

Forthcoming ISO 9001:2015 QMS Awareness: When is ISO 9001:2015 going to become effective?

Forthcoming ISO 9001:2015 QMS Awareness: When is ISO 9001:2015 going to become effective?: ISO 9001:2015 is going to become effective from the date of its publication. ISO 9001:2015 is due to be published by the end of 2015. Howe...