How the epidemic through laboratories accreditation?

Every businessman desires that he should be able to export maximum and that whatever he exports be readily acceptable to clients in the world market without any hassle. This is possible only if he exports quality products which have been tested by a reliable laboratory in his own country.

But the question remains as to how can we be sure that the results provided by a certain lab are really authentic? It is this requirement of authenticity that forces us to approach a lab that is accredited according to the requirements of international standard, ISO 17025.

For exporters, it is a big headache whether the product their clients are exporting comes up to the requirements of the international standard. Exporters might have also obtained valid certificate for the same, yet the importer would not necessarily have confidence that the laboratories' certificates obtained will be accepted. For his own satisfaction, he may require the product to be tested again. This creates difficulty, delay, and leads to wasteful extra costs.

The overseas importer on his part would be safe from all troubles at his end if he trusts the test certificates issued in the exporter's country which is the only sensible way left for both the parties if they use the services of accredited laboratories.

A National Accreditation Council (NAC) in any country ensures whether the laboratory is competent to undertake the tests; the equipment used was fit for the purpose; the testing methods were appropriate; the staff fulfilled the required standard of competence; appropriate records were kept; and much, much more!

ISO 17025 is an international standard that spells out general requirements for the competence of testing and calibration laboratories, which are 25 in number: 15 pertain to management, while 10 belong to technical side. The standard contains all such requirements that testing and calibration laboratories have to meet. This would be necessary if the laboratories wish to demonstrate that they operate a quality system, are technically competent and are able to generate technically valid results. Any laboratory that fulfils these requirements and confirmed by the NAC after due assessment, would be declared as an accredited laboratory.

It may be mentioned that before opting for accreditation, it would be worthwhile if a Gap Analysis of the lab is carried out. It's a one or two days' exercise that apprises the management of the lab as to where the lab stands at present and where it should be as far as international standard was concerned. The person conducting the Gap Analysis gets a fair idea as to how much efforts would be required to bring the lab up to an acceptable level so as to comply with the 25 requirements of ISO 17025.

Now, let's discuss these 25 requirements:

A. Management Requirements

1. Organization 2. Management system 3. Document control 4. Review of requests, tenders and contracts 5. Subcontracting of tests and calibrations 6. Purchasing services and supplies 7. Service to the customer 8. Complaints 9. Control of non-conforming testing and/or calibration work 10. Improvement 11. Corrective action 12. Preventive action 13. Control of records 14. Internal audits 15. Management reviews.

B. Technical Requirements

1. General 2. Personnel 3. Accommodation and environmental conditions 4. Test & calibration methods and method validation 5. Equipment 6. Measurement traceability 7. Sampling 8. Handling of test and calibration items 9. Assuring the quality of test & calibration results 10. Reporting the results.

The success of the accreditation program mainly depends on how successfully it is implemented and that depends upon the seriousness of the management i.e. how much committed the top management is! The whole process takes a period of six months. All the 25 requirements are addressed during this period, laying emphasis on the following main steps:

Main Steps

o An Introductory Lecture. To create awareness about laboratory accreditation among the lab staff, an introductory lecture is delivered and a brief description of all the clauses is given.

o Preparation of Quality System Documentation (QSD). The Quality Manual, Quality Procedures (both management and technical), work instructions and forms are to be prepared.

o Control of Non-conforming Testing and Calibration Work. The lab personnel are apprised as to which all actions would be necessary when a non-conforming test and calibration work is detected. The responsibility for the management of this non-conforming work would be designated.

o Corrective Action. Corrective action becomes necessary when anything wrong has happened. This is done through a Corrective Action Request (CAR) form. The implementation of such actions is followed through a Corrective Action Log (CAL) form which contains a list of these actions in an abbreviated form for reminding the management rep of the lab to follow the progress regarding such actions.

o Preventive Action. As opposed to the Corrective Action, Preventive Action is taken to preclude the possibility of any thing going wrong.

o Internal Audits. It's a proven fact that internal audits act as a lubricant for the quality management system of a lab. The more a lab is subjected to internal audits, the more its systems become stable. For conducting internal audits, a group of suitably selected personnel of the lab, say four to six in number, may be trained as internal auditors. The conduct of internal audits would be a planned activity and has to be taken seriously.

o Management reviews. Through Management Reviews, we control the entire process of quality management throughout the lab. The management review meetings must be attended by the head of the organization or the lab.

o Accommodation and Environmental Conditions. It means that accommodation and environmental conditions of the lab in which tests and calibrations are conducted should be appropriate.

o Methods. Appropriate methods would be used by the lab, preferably those methods which have been published in international, regional or national standards. Latest, valid edition of the standard would be used. The lab shall validate methods where necessary.

o Equipment. The equipment shall be operated by authorized personnel and would be calibrated before being placed into service. The test and calibration equipment shall be safeguarded from adjustments.

o Reporting the Results. The results shall be reported in a test report or calibration certificate and they will be reported accurately, clearly and unambiguously in accordance with the instructions in the test or calibration methods.

o Review of documents by Accreditation Body. Once a lab confirms that it is ready for accreditation to ISO 17025, it approaches one of the accreditation bodies for its assessment. The accreditation body asks for the documents of this lab for carrying out an independent check.

o Pre-assessment. The documents are checked by the accreditation body and sent back to the laboratory after check. The points / observations made by the accreditation body are resolved and accreditation body is informed by the lab. Then, the laboratory requests the accreditation body to conduct a final assessment of the lab.

o Final Assessment. The accreditation body conducts a final assessment of the lab. If the body finds that the lab conforms to all the 25 requirements of the standard (ISO 17025), it is recommended for final assessment and the lab is accredited.

Comparison with ISO 9001:2000 A question generally comes to the mind of the people: If a laboratory want to get accreditation as per ISO 17025, will it also have to get ISO 9001:2000 certification? The reply is a big NO! ISO 9001:2000 covers only management requirements whereas ISO 17025 covers both management as well as technical requirements. Hence, if a lab is ISO 17025, it needn't be certified to ISO 9001:2000 as management requirements are included in ISO 17025.

Benefits
By implementing ISO 17025, following benefits would accrue:-

o The processes of the lab would be qualified.

o The staff working in the lab would be properly trained and competent.

o An organised internal audit program will eliminate all the bugs in the working of the laboratory.

o The lab would be using validated methods.

o The responsibilities and authorities of the personnel in the lab will be clearly allocated.

o As proper sampling would be in vogue, there would be no need of resorting to repeated sampling which will save time, money and efforts.

o As all systems would be streamlined, customer complaints will be reduced and efficiency will increase.

o By carrying out proficiency testing, the clients will have more confidence in the results of the lab.

Conclusion. Accreditation of the laboratories is an inescapable requirement these days. It is a must for the authenticity of their results. By using the services of an accredited lab, there would be no need for a client to test the item again in his own country. If a lab is accredited, it means that it would be using calibrated equipment; its methods would be validated and the quality of tests and calibrations would be maintained. The results would be accurately reported and would be authentic. Regular annual assessments would keep the lab on track and its efficiency would be maintained. Last but not the least: the lab would join the elite group of the accredited laboratories of the world!

About the Author: Mr. Azfar A Khan is a consultant who prepares laboratories for accreditation according to the requirements of international standard ISO 17025. He also conducts Gap Analyses of the laboratories. Besides laboratories, he also provides consultancy for Quality Management System ISO 9001:2000. He has written numerous articles on Quality and provided consultancy to various organizations, companies, factories, educational institutions, laboratories, etc. He is an IRCA (England) certified auditor. E-mail: azfar44@hotmail.com [http://www.qualitywaysinternational.com]