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The paper "Specifications and requirements for Preparation of Laboratory Accreditation" is a perfect example of a report on management. As per the request by the topmost 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…
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Extract of sample "Specifications and requirements for Preparation of Laboratory Accreditation"
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
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