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Why and Why not ISO/IEC 17025

The ISO/IEC 17025: 2005 standard was developed as a special purpose standard for laboratories to specify the general requirements for their technical competence. While the standard is generic, it also recognizes that for accreditation purposes, (i.e. for independent recognition of a laboratory’s competence to perform specific tests, or calibrations) the standard may require development of guidelines to explain its use in specific areas of testing or measurement.

ISO/IEC 17025 -2005 has two major components, namely management requirements and technical requirements. The management requirements are written in language relevant to laboratory operation but were developed to meet the systems requirements of ISO 9001-1994 and ISO 9002-1994.

WHY ISO / IEC 17025? : –

  • Improved quality
  • Improved efficiency, productivity and effectiveness
  • Improved level of motivation, co-operation, workmanship and quality awareness
  • Improved communication and quality information and greater quality awareness
  • Greater control of processes and activities throughout organisation.
  • An onward journey of improvement is possible on an on-going basis
  • Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping.
  • Provide guideline for doing testing and measurement in detail.
  • Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc
  • Establish the best system for the product storage and handling.
  • Helps in dealing with issues of implementing the OSHA (Occupational, Safety, Health Assessment) laboratory standards as well as THE ACCREDITATION MEMBER BODY accreditation.
  • Provide guidance for emergency response of laboratory for fire, radiation, chemical spillage, biological spill, and personal injury as well as reduce accidents.
  • Helps in making complete training manual with details of all test procedures and it helps in training any new staff as well as consistency of Quality of testing is maintained in spite of high staff turnover

WHY NOT ISO / IEC 17025?

  1. Do not want to spend money.
  2. Monopoly supplier.
  3. Do not want to export.
  4. Customers do not care.
  5. Unlimited resources.
  6. Do not believe in involving people.
  7. Do not want to train employees.
  8. Enjoy fire fighting and quick fixes.
  9. Believe – Quality does not pay.
  10. Do not want to commit anything on paper.
  11. Expect miracles to overcome challenge.
  12. Have other sources of income and don’t want to grow.

ISO / IEC 17025: 2005 DOCUMENTATION: –

The total documentation for a comprehensive management system under ISO / IEC 17025 can be represented by the four-tier system in a pyramid shown in the figure – 1.

ISO 17025 4 Tire Documentation

ISO/IEC 17025 4-Tire Documentation Structure

  1. ISO 17025 Quality Manual:- It states the Quality Policy and describes the macro level Management     system including details for how the standard requirements shall be fulfilled in the company.
  2. Quality Procedures: – It is normally called as middle management hand book and describes     department activity for a system approach to supply consistent Quality Product. They are     considered to be the core of the system documentation and confidential documents. They     describe how the tasks and functions of the various departments should be performed to meet     the requirements of the ISO / IEC 17025: 2005 standard and the Quality Policy of the     company.
  3. Work Instructions / Operating Procedure: – These documents are required for the Testing     and or calibration purpose otherwise affects Quality of testing and or calibration
  4. Quality Records, Forms:- Forms, records etc. are supporting documents used by the     company to record information for different procedures followed.

The global objectives of the implementation of ISO / IEC 17025 : 2005  are: –

  • To establish Quality in testing and reliability
  • To prevent risk
  • To detect deviations
  • To correct errors
  • To improve efficiency
  • To ensure data quality and integrity.

ISO 17025 consultant provides information about iso 17025 standard implementation and requirements. In the iso 17025 certification basic requirements is iso 17025 manual, iso quality procedure, SOP and quality system implementation.

Read more about Chracterisation Of Environmental Effects – Aspects

 

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What is Calibration and Requirements of Instruments Calibration

What is Calibration

The process of measurements needs control. In fact calibration itself can be regarded as a process to establish control on instruments and get confidence.

The set of operations which establish, under specified conditions, the relationships between values indicated by a measuring instrument or system or values represented by a material measure or reference material; & the corresponding values of a quantity realised by a reference standard is called calibration.

Calibration involves checking the operational integrity of a test or measuring equipment or of a measurement standard of unverified accuracy in order to detect, correlate, report or eliminate (by adjustment) any deviation in accuracy, capability or from any other required performance. Calibration can be carried out for three possible purposes.

  1. Determining whether or not a particular instrument or standard is within some established tolerance in respect of its deviation from a reference standard.
  2. Reporting of deviations in measurements from nominal values.
  3. Repairing / adjusting the instrument or standard to bring it back within tolerance.

For a majority of equipment, the instrument calibration result is then compared with process / product requirements; if found beyond specification, corrective repair and / or adjustment and re calibration is performed. If not found beyond specification, compensation or adjustment is optional.

The instruments calibration for fixed value type instruments like reference standards, the attribute value and calibration system measurement uncertainty is determined and reported in a calibration certificate. In all cases, a calibration report is given which states the present position of the instrument with reference to its required performance specifications. In cases where it is not possible to correct the instrument by adjustment, the reading as given in the calibration report should be used and necessary corrections to the readings obtained during a measurement should be made so as to get the correct value of the quantity being measured.

For example, the calibration of a digital voltmeter may be examined. The digital voltmeter is connected to a calibrator whose accuracy is higher than the accuracy of the voltmeter. This calibrator would have been calibrated against a reference standard and the calibration would be valid at the time of calibration of the voltmeter. A voltage is fed to voltmeter from the calibrator. If the voltmeter reads correctly, it is in calibration and does not require any adjustment. If the reading of the voltmeter is outside the calibration specifications or tolerance limits, the voltmeter requires to be adjusted to indicate the correct value. Where the voltmeter does not read correctly but is within the specification limits, the voltmeter may be optionally adjusted. The calibration report giving the readings of the voltmeter.

Requirement of Instruments Calibration

“Measurement is the first step that leads to control and eventually for improvement – If you can’t measure something, you can’t understand it. If you can’t understand it, you can’t control it. If you can’t control it, you can’t improve it.”

Process converts Inputs to Output:

Inputs:

  • Invested Capital
  • Raw Material
  • Human Resources
  • Energy

Output is a product

Why Calibration is required

  • Controlling the process, relation between inputs & output can be controlled
  • To control the process, we need to know the status of the process
  • Measurement gives information regarding status
  • Control of a process can never be better than the measurements made in the process
  • The more accurate the data obtained from the process, with more accuracy the process can be controlled

National Center for Quality Calibration – NCQC is a leading name in field of instrument calibration services in India. NCQC offers services for themal instrument calibration, ph meter calibration, conductivity meter calibration, mass, weights and balance calibration. NCQC is iso/iec 17025 NABL approved calibration services india providing NABL certificate for thermal, mechanical and electro-thechnical instruments.

 

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