Laboratory Accreditation
What is Laboratory Accreditation?
It may be defined as: “A formal recognition that a laboratory is competent to perform specified tests or measurements.”
Accreditation can also be summarized as “Tested once-accepted everywhere.” Accreditation is the one that offers the least duplication of effort, is the most transparent, most widely accepted and is the least discriminatory option. When a laboratory is accredited its capability is defined in a schedule of specific tests and calibrations granted by the accreditation body. This occurs only after the accreditation body is satisfied that the laboratory seeking accreditation has access to all necessary sources to undertake these particular tests correctly and is managed in such a way that it is likely to do this consistently.
The laboratory should be able to convince a team of technical experts that it is properly equipped, has available other necessary resources and that its staff have all appropriate qualifications and skills necessary to perform the tests in question.
The International Laboratory Accreditation Cooperation (ILAC), the International Organization for Standardization (ISO) and the United Nations Industrial Development Organization (UNIDO) prepare laboratory accreditation bodies in developing countries to participate in the ILAC Mutual Recognition Arrangement.
All laboratories are treated equally, irrespective of ownership and it is on the grounds that it provides an open and fair mechanism for the selection of a laboratory to undertake particular projects. ILAC encourages accreditation of laboratories by a local body where it exists. The results produced by an accredited laboratory in one country are accepted by authorities in any other country that is a signatory to the ILAC Arrangement and all accredited laboratories throughout the world are subject to the same strict requirements.
Need for Accreditation:
Laboratory accreditation and recognition of test results is a final determinant as to whether the goods produced by the exporter are acceptable in other countries.
It is a key to providing assurance that certification bodies operating in one country follow the same strict procedures as those in others.
It provides confidence to the buyer or user of services, that is, the product is safe and meets the conditions and standards imposed by the country’s regulatory authorities.
It ensures that results of tests of any type made on a product are reliable and are within acceptable limits.
It minimizes mistakes and reduces the risks of fraudulent behavior.
Conformity assessment is a term used to describe the whole process of accreditation and certification and is the process of determining whether products, processes, systems and people meet specified requirements.
It is important to understand the difference between certification or registration (ISO 9001) and accreditation (ISO/IEC 17025) and not to confuse the two approaches.
Certification:
Means compliance with a standard or specification
Uses management system auditors who are certified by an independent body as meeting internationally agreed criteria
May be general in the scope of recognition
Considers the total business
Accreditation:
Evaluates people, skills and knowledge
Uses assessors who are recognized specialists in their fields
Evaluates the supporting management systems for a specific activity
Involves practical tests as appropriate (proficiency testing and measurement audits)
Essential Prerequisites:
Establishing an accreditation body is not a step to be taken lightly. Firstly, it requires the need to do so. Secondly, it demands some political and governmental support, on an on-going basis if international recognition is a consideration. Thirdly, there are certain requirements even for systems that will never aspire to high levels of technology capability. Nowhere in the world, is accreditation a commercially viable activity unless it has strong support from the government of the home market.
ISO/IEC 17025
ISO 9001 certification signifies Quality Management Systems, but it does not address technical competence. ISO 9001 evaluate the Systems for managing the quality of product or service and ISO/IEC 17025 is a benchmark for Performance.
There are two parts to ISO/IEC 17025 accreditation:
1. Management requirements
2. Technical requirements
1. Management requirements: point 4 of ISO/IEC 17025:2005 (E)
It covers various aspects like:
• Organization
• Management system
• Document control
• Review of request
• Tenders and contracts
• Subcontracting of test and calibrations
• Purchasing services and supplies
• Service to customers
• Control of non-conforming testing and or calibration work
• Improvement
• Corrective action
• Preventive action
• Control of records
• Internal Audits
• Management reviews
2. Technical requirements: point 5 of ISO/IEC 17025:2005 (E)
Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from:
• Human factors
• Accommodation and environmental conditions
• Test and calibration methods and method validations
• Equipment
• Measurement traceability
• Sampling
• The handling of test and calibration items
It may be defined as: “A formal recognition that a laboratory is competent to perform specified tests or measurements.”
Accreditation can also be summarized as “Tested once-accepted everywhere.” Accreditation is the one that offers the least duplication of effort, is the most transparent, most widely accepted and is the least discriminatory option. When a laboratory is accredited its capability is defined in a schedule of specific tests and calibrations granted by the accreditation body. This occurs only after the accreditation body is satisfied that the laboratory seeking accreditation has access to all necessary sources to undertake these particular tests correctly and is managed in such a way that it is likely to do this consistently.
The laboratory should be able to convince a team of technical experts that it is properly equipped, has available other necessary resources and that its staff have all appropriate qualifications and skills necessary to perform the tests in question.
The International Laboratory Accreditation Cooperation (ILAC), the International Organization for Standardization (ISO) and the United Nations Industrial Development Organization (UNIDO) prepare laboratory accreditation bodies in developing countries to participate in the ILAC Mutual Recognition Arrangement.
All laboratories are treated equally, irrespective of ownership and it is on the grounds that it provides an open and fair mechanism for the selection of a laboratory to undertake particular projects. ILAC encourages accreditation of laboratories by a local body where it exists. The results produced by an accredited laboratory in one country are accepted by authorities in any other country that is a signatory to the ILAC Arrangement and all accredited laboratories throughout the world are subject to the same strict requirements.
Need for Accreditation:
Laboratory accreditation and recognition of test results is a final determinant as to whether the goods produced by the exporter are acceptable in other countries.
It is a key to providing assurance that certification bodies operating in one country follow the same strict procedures as those in others.
It provides confidence to the buyer or user of services, that is, the product is safe and meets the conditions and standards imposed by the country’s regulatory authorities.
It ensures that results of tests of any type made on a product are reliable and are within acceptable limits.
It minimizes mistakes and reduces the risks of fraudulent behavior.
Conformity assessment is a term used to describe the whole process of accreditation and certification and is the process of determining whether products, processes, systems and people meet specified requirements.
It is important to understand the difference between certification or registration (ISO 9001) and accreditation (ISO/IEC 17025) and not to confuse the two approaches.
Certification:
Means compliance with a standard or specification
Uses management system auditors who are certified by an independent body as meeting internationally agreed criteria
May be general in the scope of recognition
Considers the total business
Accreditation:
Evaluates people, skills and knowledge
Uses assessors who are recognized specialists in their fields
Evaluates the supporting management systems for a specific activity
Involves practical tests as appropriate (proficiency testing and measurement audits)
Essential Prerequisites:
Establishing an accreditation body is not a step to be taken lightly. Firstly, it requires the need to do so. Secondly, it demands some political and governmental support, on an on-going basis if international recognition is a consideration. Thirdly, there are certain requirements even for systems that will never aspire to high levels of technology capability. Nowhere in the world, is accreditation a commercially viable activity unless it has strong support from the government of the home market.
ISO/IEC 17025
ISO 9001 certification signifies Quality Management Systems, but it does not address technical competence. ISO 9001 evaluate the Systems for managing the quality of product or service and ISO/IEC 17025 is a benchmark for Performance.
There are two parts to ISO/IEC 17025 accreditation:
1. Management requirements
2. Technical requirements
1. Management requirements: point 4 of ISO/IEC 17025:2005 (E)
It covers various aspects like:
• Organization
• Management system
• Document control
• Review of request
• Tenders and contracts
• Subcontracting of test and calibrations
• Purchasing services and supplies
• Service to customers
• Control of non-conforming testing and or calibration work
• Improvement
• Corrective action
• Preventive action
• Control of records
• Internal Audits
• Management reviews
2. Technical requirements: point 5 of ISO/IEC 17025:2005 (E)
Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from:
• Human factors
• Accommodation and environmental conditions
• Test and calibration methods and method validations
• Equipment
• Measurement traceability
• Sampling
• The handling of test and calibration items
posted by sureshbhagtani at 7:54 AM
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