MEDT 08 :
Module 6:
Laboratory
Policy and Procedure Manual
Management
MODULE 06
POLICY AND PROCEDURE MANUAL
At the end of this module, you are expected to:
1. Give the importance of Policy and Procedure manual
2. Know how to create policy and procedure manual
THE QUALITY MANAGEMENT SYSTEM
Organization Personnel Equipment
Purchasing Process Information
and Inventory Control Management
Documents Occurrence
Assessment
and Record management
Process Customer Facilities and
improvement service Safety
The management of documents and records is one of the 12 essential elements
of the quality system. The management system addresses both use and maintenance of
documents and records. A major goal of keeping documents and records is to find
information whenever it is needed.
DOCUMENTS VS. RECORDS
What is a Document?
Provide written information about policies, processes and procedures.
Characteristics of Documents:
1. Communicate information to those who need it, including laboratory staff, users
and laboratory management personnel
2. Need to be updated or maintained
3. Must be changed when a policy, process or procedure changes
Course Module
MEDT 08 :
Module 6:
Laboratory
Policy and Procedure Manual
Management
4. Establish formats for recording and reporting information using standardized forms
(once the forms are used to record information, they become records)
Examples of Documents:
Quality Manual
Standard Operating Procedures (SOPs)
Job Aids
What is a Record?
Collected information produced by the laboratory in the process of performing and
reporting a laboratory test.
Characteristics of Records:
1. Need to be easily retrieved or accessed
2. Contains information that is permanent, and does not require updating
Examples of Records:
Completed forms
Charts
Sample logs
Patient records
Quality control information
Patient reports
DOCUMENTS
Documents include all the written policies, processes and procedures of the
laboratory.
What is a policy?
o A policy is “a documented statement of overall intentions and direction defined
by those in the organization and endorsed by management”.
o Tell “what to do”, in a broad and general way
o Include a statement of the organizational mission, goals and purpose
o Serve as the framework for the quality system and should always be specified
in the quality manual.
o Policy – A statement or memo that outlines the institution’s position on an
administrative or operational issue.
o Policy Manual – Collections of statements and memos that outline the
position of the institution on a wide range of administrative and operational
issues.
CvSU Quality Policy
We Commit to the highest standards of education, Value our
stakeholders, Strive for continual improvement of our products and
Course Module
MEDT 08 :
Module 6:
Laboratory
Policy and Procedure Manual
Management
services, and Uphold the University’s tenets of Truth, Excellence, and
Service to produce globally competitive and morally upright individuals.
Examples of Policies
University Policy
Administrative Policy
Human Resource Management Policy
Providing Care Policy
Hospital Policy
Information Management Policy
What is a process?
o ISO 9000 defines a process as a “set of interrelated or interacting activities
that transform inputs into outputs”.
o It is the steps involved in carrying out quality policies.
o A process is “how it happens”.
o Processes can generally be represented in a flow chart, with a series of steps
to indicate how events should occur over a period.
What is a procedure?
o It is the specific activities of a process (ISO 9000).
o It is easily described as the performance of a test.
o A procedure tells “how to do it” and shows the step-by-step instructions that
laboratory staff should meticulously follow for each activity.
o The term standard operating procedure (SOP) is often used to indicate these
detailed instructions on how to do it.
o Job aids, or work instructions, are shortened versions of SOPs (either
handwritten or printed) that can be posted at the bench for easy reference on
performing a procedure.
Course Module
MEDT 08 :
Module 6:
Laboratory
Policy and Procedure Manual
Management
Why are documents important?
o Documents are the essential guidelines for all the laboratory operations.
o Quality Manual—This is the overall guiding document for the quality system and
provides the framework for its design and implementation. A laboratory is required
to have a Quality Manual for ISO accreditation
o Standard Operating Procedures (SOP)—SOP contain step-by-step written
instructions for each procedure performed in the laboratory. These instructions
are essential to ensure that all procedures are performed consistently by everyone
in the laboratory.
o Reference materials—Good reference materials are needed in order to find
scientific and clinical information about diseases, laboratory methods, and
procedures.
What makes a good document?
o Written clearly and concisely—it is better to avoid wordy, unnecessary
explanations in the documents
o Written in a user-friendly style—it might be helpful to use a standard outline so the
general structure will be familiar to staff and easily used by new personnel
o Written to be explicit and accurate, reflecting all implemented measures,
responsibilities and programs.
What is a quality manual?
o The quality manual is a document that describes the quality management system
of an organization (ISO 15189)
o Important guide or roadmap, all persons in the laboratory should be instructed on
its use and application.
o When writing a quality manual, it is a good idea to use a steering committee
o The purpose of the quality manual is:
Clearly communicate information
Serve as a framework for meeting quality system requirements
Convey managerial commitment to the quality system
Course Module
MEDT 08 :
Module 6:
Laboratory
Policy and Procedure Manual
Management
Key points in quality manual
There is only one official version
The quality manual is never finished; it is always being improved
It should be read, understood, and accepted by everyone
It should be written in clear; easily understood language
The quality manual should be dated and signed by the management
What is an SOP?
o Standard Operating Procedure (SOPs) – SOPs are also documents, and
contain written step-by-step instructions that laboratory staff should meticulously
follow when performing a procedure.
Written SOPs ensure the following:
Consistency — everyone should perform the tests exactly the same way
so that the same result can be expected from all staff
Accuracy — following written procedures helps laboratory staff produce
more accurate results than relying on memory alone because they will not
forget steps in the process
Quality — consistent (reliable) and accurate results are primary goals of
the laboratory, and could be considered as the definition of quality in the
laboratory
A good SOP should be:
Detailed, clear and concise, so that staff not normally performing the
procedure will be able to do so by following the SOP
Easily understood by new personnel or students in training
Updated on a regular basis
Standardized Format of writing an SOP:
Title — name of test;
Purpose — include information about the test;
Instructions — detailed information for the entire testing process,
including pre-examination, examination and post-examination phases;
Name of the person preparing the SOP;
Signatures of approving officials and dates of approval — it is
necessary to follow the laboratory’s quality policy and regulatory
requirements.
Pre-examination instructions should address sample collection and
transport to the laboratory, and conditions needed for proper sample
handling.
Examination instructions should address the actual step-by-step
laboratory procedures to follow and the quality control procedures needed
to ensure accuracy and reliability.
Post-examination instructions should provide information on reporting the
results, including the unit of measurement to be used, the normal
Course Module
MEDT 08 :
Module 6:
Laboratory
Policy and Procedure Manual
Management
(reference) range, ranges that are life-threatening (sometimes called
“panic values”) and instructions for how to deal with an urgent report.
Reminder (Use of Manufacturer’s Instructions or Product Insert)
The instructions that manufacturers provide in their product inserts
tell how to perform the test, but do not include other important
information that is specific to laboratory policy.
Do not rely solely on manufacturer product inserts for SOPs. Use
information from these inserts but develop SOPs specific to your
laboratory.
Policy and Procedure Manuals
Documents that allow other communication efforts to be brief, referring the person to
a specific manual for further information.
To meet these goals, manuals must be complete, clear in instruction and explanation
and organized to allow easy and timely location of needed information.
They should also be dynamic documents with up-to-date, pertinent, and accurate
information.
References and Supplementary Materials
1. World Health Organization (2011). Laboratory quality management system handbook.
USA: WHO
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