Specifications and requirements for Preparation of Laboratory Accreditation - Report Example

Laboratory Quality Systems Specifications and requirements for Preparation of Laboratory Accreditation: A Project report for implementing ISO 17025 By Name: Student number: To: Board of Directors From: Laboratory Quality Manager Date: As per the request by the top most management regarding the subject of obtaining NATA accreditation of ISO 17025 within a duration lasting six months only, certainly the following steps were fully undertaken to achieve the accreditation of the laboratory; 1. Making contact with national agency responsible for the accreditation. An authorized representative will certainly be nominated and his or her name submitted to the accreditation body. This particular nominee is responsible and will act on behalf of the laboratory facility in regard to matters that relate to the accreditation and application. An advisory visit by the National Association of Testing Authorities to the laboratory facility will be undertaken with the objectives of discussing the assessment process and explaining the legal requirement that should be availed for the accreditation of the facility. It is through this advisory visit that we shall obtain a report on key issues to improve. 2. Establishment of a project team (a) The project team will be established will involve personnel from all the departments. The project personnel will consist of the laboratory manager, the quality manager, personnel from the human resources and the finance departments. The project team will accurately study the requirements and the costs to be involved during the process of accreditation and more purposely develop and comprehensive plan to train the facility staff and introduce them to the requirement of accreditation. Also to note is that this project team will assist the accreditation body during their assessment period at the facility. During the first month, the team will meet every week and from the second to sixth month, they will meet once a month. (b) An internal working group consisting of the general manager, the heads of the four departments of the facility, the laboratory manager and the laboratory quality manager. This particular group will meet at every month to discuss all what is entailed the forthcoming accreditation. The working group will also certainly discuss the details of the accreditation program and therefore lay a firm foundation that will lead to a successful accreditation of the laboratory facility. Also very important task for the group will be to compare the currents standards at the facility with those of ISO requirements and hence look for the gaps and the loopholes. The below tables summarizes task plan for the working groups within the period of the six months. Table 1: The articulated Steps towards achieving Laboratory Accreditation NO. Achievement Actions Time frame 1 Nominate authorized representative to (NATA) Apply for Nomination of new authorized representative One day 2 National Accreditation body Advisory visit Coordinate with the National Association of Testing Authorities (NATA) for advisory visit to our laboratory facility to inform us about assessment process and requirements to be met One day 3 Introduce an educative seminar to all staff about accreditation requirements (ISO 17025) Explain the requirements for accreditation and the benefits of accreditation to all staff members One day 4 Hold a training program Avail details recommendations from Working Group (B) and launch a precise schedule for staff training Seven days 5 Staff meeting Updates about progress towards accreditation are availed, discussion of key issues will be undertaken Every two months 6 Avail progress documents to the accreditation body Progress documents will be sent to the accreditation body for reviewing purposes One week 7 Pre-assessments about progress After initial review form the accreditation body, a feedback from them will enable us lay an action plan to achieve the needed requirements. Fourteen (14) days 8 Communicate with accreditation body for the final assessment Arrange a legal agreement with the accreditation body to perform the accreditation exercise in our laboratory facility One day 9 Prepare for the final accreditation assessment Organize and prepare laboratory facility and all the staff members for the final accreditation. One day 10 Final assessment The accreditation body will conduct a final assessment exercise of the laboratory facility. If the body finds that the laboratory conforms to all the documented requirements of the standards (ISO 17025), it shall be recommended for final assessment and the laboratory facility is accredited. Two weeks Table 2: The major Management Requirements Clause Achievement Responsibility Plan Action Time frame 1.1 Document Control Definition and review of all documents General Manager Laboratory Manager Quality Manager Heads of the four departments All facility documents must be identified and reviewed by the authorized personnel before any issuance One month (The second month) 2.1 Corrective Action The Policy and procedures Laboratory Manager Quality Manager Heads of the four departments Corrective action is applicable when certain things go wrong. This is undertaken through the Corrective Action Request (CAR) form. The implementation of such actions is monitored via a Corrective Action Log (CAL) form, Entailing list of determinate actions that that are followed by the laboratory representative One week 3.1 Preventative action Identify and take appropriate action Laboratory Manager Quality Manager Heads of the departments Possible sources of non-conformities are identified and action plan to handle them developed. This is followed by implementation and adherence to action plan which ensures effective actions are achieved. Seven days 4.1 Internal Audits Plan and organize internal audits The laboratory Manager Qualified and well trained human personnel should be selected by the laboratory manager to carry out the audit. Internal audits should be carried out often as dictated by the stipulated schedule and procedure to verify continuing compliance with the requirements of the management system. Two audits are required; One audit will be undertaken after selection the audit personnel and the second audit prior to the end of the sixth month. 5.1 Test and Calibration Methods and Methods Validation Accurate tests and the calibration results Laboratory Manager Quality Manager Heads of the four departments Certified methods will be used as reference methods during testing in the laboratory It will be very important when environmental conditions are stabilized since they affect the accuracy of results. In the laboratory only ISO certified methods shall be employed during course of work It is demanded that the laboratory shall have data to prove that it can attain level of performance dictated by each standard specification of the method used in the laboratory. Laboratory own developed methods are required to be of high level of validation and they should meet the accuracy demand of a client. They should also be documented. In every method of validation and calibration, it is important to determine accuracy and limit of detection. Also very important is to check the accuracies of the machines daily before releasing any results after the practical sessions. Two months 6.1 Organization Define the organizational structure. Reduce undue pressure and maintain operational integrity General Manager Laboratory Manager Quality Manager The responsibilities and duties of both the staff and the managed should be well defined The top management of the laboratory facility should ensure warm and favorable working conditions for all the staff so as realize quality work in right time. One week 7.1 Quality Improvement Continually improve the effectiveness in management system General Manager Laboratory Manager Quality Manager Department heads All other staff members The facility should have a quality policy that is seconded by quality objectives Analysis of the audit results should be periodically undertaken where the data will be analyzed to gauge performance and quality of services Corrective and preventive actions should be keenly recognized and undertaken to realize better quality within the facility Within the first month Table 3: The Technical Requirements Clause Achievement Responsibility Action plan Time frame 8.1 Personnel Definition of duties and responsibilities Definition of the required skills Staff Training program Laboratory Manager Quality Manager Heads of the four departments For each job, the required skills and experience should be defined well The staff at the laboratory facility should be trained on their duties and responsibilities and the need to produce high quality work Two weeks 9.1 Accommodation and Environmental Conditions Precise monitoring and control of the environmental conditions General Manager Laboratory Manager Heads of the four departments Quality Manager Temperature, humidity, electromagnetic interference amongst other environmental conditions should be monitored and controlled since they affect the quality of results. Only authorized personnel should be allowed to access the testing sections of the laboratory Three months 10.1 Equipments Establishment of calibration procedures Definition of the equipments How to improve, adjust and maintain the equipments Laboratory Manager Quality Manager Heads of the four departments Documentation of the equipments alongside their operating software’s Before use of any equipment, it is wise to prepare and calibrate it. The calibration program should be consistent with all the necessary facts and documented. One week 11.1 Measurement Traceability Identification of the traceability’s of measurement Heads of the four departments All measurement should be traced to the ISO 17025. Calibration of all the equipments should be done using SI units One month 12.1 Sampling Sampling procedures should be developed and improved Laboratory Manager Quality Manager Heads of the four departments A sound sampling plan should be performed with sampling details and procedures being documented. Identified samples should be precisely transported and stored in safe conditions. One week 13.1 Handling Tests and Calibration Items Maintenance of integrity of the items Laboratory Manager Quality Manager Heads of the four departments All items in the laboratory should be identified, tested and calibrated. All procedures reading a sample’s transportation, receipt, protection handling, disposal or retention should be documented. Two weeks 14.1 Assurance of the Quality of the Test and Calibration Results Quality of the results Laboratory Manager Quality Manager Heads of the four departments The laboratory facility should be regularly monitored to realize validated results at all times. The frequency of validation tests should be well planned justified in terms of procedures and documented according to ISO standards. Every month 15.1 Final Reporting of the Results Certificates of calibration and Test reports Quality Manager Laboratory Manager Heads of the four departments All results must be reported in a test report or a certificate of calibration accurately in accordance to the instructions of the type of the test or rather the calibration method. Everyday Prepared by: Name: ______________________________________ Date: _____________ Reviewed by: General Manager: ______________________________________ Date: _____________ References ISO/IEC Guide 58:1993, Calibration and Testing Accreditation Systems. General Requirements for Operation and Recognition ISO 9001:2000, Quality Management Systems -Requirements Australian Standard, General Requirements for Competence of Testing and Calibration Laboratories, 2nd Edition, 2005 Read More