This is the first of the series of posts regarding the ISO 17025 and accreditation. ISO 17025 specifies the management and technical requirement to be met by testing and calibration laboratories. Accreditation of the laboratories is usually performed by national accreditation bodies which usually has Mutual Recognition Agreements between other national bodies. The accreditation will have the credibility only if the operation of the accreditation body (national body) complies with ISO 17011 and applies the ISO 17025 rigorously on laboratories. The credibility of the laboratory depends on the quality management system which is implemented through the quality manual of the laboratory. It is ironic that the credibility is not dependent on the state of the art instruments or the analyst with years of years of education and training but on the quality system of the laboratory and the quality assurance manager who implements the system. However in most of the laboratories the quality assurance manger is not a qualified personnel and frequently is a mid level manager or the senor-level analyst who performs the quality assurance job as part of his duties. In some instances, these jobs may be contracted out. These situations create the inconsistencies in the policy due to the lack of formalized procedure and differences in writing style. Developing quality manual that is appropriate for the laboratory and its implementation is necessary for achieving the quality. Quality leads to accreditation and accreditation did not lead to quality.
If it is not written down, it does not exist.
Manual
The policy or procedure manual documents what need to be done, how it should done and act as reference for the implementation of the policy or procedure.
The lack of documentation leads to inconsistencies in the operation of the laboratory leading to the degradation of quality. Documented policies and procedure creates uniformity in the implementation of tasks. It helps in the reproduction of experimental results regardless of the accuracy, facility or analyst.
There should be a process to create, modify or rescind the policy so that the policies meet the quality assurance needs of the organization. This avoids creating a policy in a whimsical manner as a knee-jerk reaction. The policies should go through development, approval, review and implementation process. It is approved, communicated and documented. The instructions given by supervision does not constitute as a policy but as an order or directive.
In God we trust, everything else is documented.
Types of Manual
The manuals in the laboratories are broadly classified into two general types, namely operation manuals and technical manuals, both of which plays an equal role in the quality of the laboratory.
Operational Manuals
These manuals are applicable to the whole of the laboratory operations from administration to technical examinations and to all personnels. Administrative, quality assurance, health & safety and sample control are some types of operation manuals.
Technical Manuals
The technical manuals are used in the analytical section of the laboratory for the specific requirements in the testing of samples. Every section the laboratory can have its own technical methods manual for different samples, instruments and analytical methods. The technical manuals are unique to every laboratory, however certain aspects like training, analytical procedures, quality assurance, documentation, inventories, etc., are common to every laboratory.
Components of a Manual
Policy, procedure, supporting documents, static documents, and forms are the usual components of the manual.
Policy
Policy can be defined as the guiding principle that governs the decisions made on behalf of the organization. Policies do not address the implementation unless it is a component. Policies are mainly intended to ensure reproducibility. Policy is a precision tool which enables that everything performs in unison.
Policies are “Thou shall….” statements.
The policies should not be a rephrasing of accreditation criteria to satisfy the accreditation requirement but should be drafted after understanding the rationale behind the requirement and should be practical to implement.
Procedure
The procedures provides the instructions as how the laboratory will implement the policy. Standardized procedures followed by the personnel will ensure reproducibility and accuracy. The procedures should be specific so that it could be followed without any ambiguity.
Supporting and Static Documents
These are the essential documents that are relied by the laboratory for the day to day operations but the documents are not in the direct control of the laboratory. These are documents like regulatory agency requirements, legal status, etc. These non controlled documents did not require approval through the laboratory’s document control procedure but are subject to the same document control procedure.
Forms
Forms and worksheets are the standardized documents that are used to record and manage information related to various process and activities within a quality management system that can be reviewed by both technical and administrative reviewer. The Forms are official laboratory documents and subject to document control requirements. The use of laboratory letterhead or logos on personal forms and worksheets should be addressed in the quality policy.
Manual – creation and approval
The person responsible for the creation and maintenance of the manual must be defined in the document control policy. The director of the laboratory or quality assurance manager is responsible for the approval of the manual. The drafting, in most cases, are assigned to other personnel or contracted out to non employees in certain cases. In all these instances, the documents were reviewed and approved by the laboratory’s approving authority.