Writing a quality manual


A quality manual is intended to represent the entire operation of a testing/calibration laboratory. It should contain all the details, in brief, of its legal identity, structure, scope, policies, management responsibilities, technical requirements, etc. In other words, all the requirements of ISO/IEC 17025 (or ISO 15189) should be either addressed or cross-referenced to other documents, or briefly described, to show that each is complied with in the management system.

Usually a three or four level documentation system is adopted, the quality manual being the apex document, and system procedures, standard operating procedures or work instructions and system forms being the other documents.

1. Quality manual general contents.
2. How to write a quality manual?.
1. Quality Manual general contents

General information for writing a quality manual.

a.Before starting the preparation of a quality manual it is necessary to study thoroughly the latest version of ISO/IEC 17025 or ISO 15189, as applicable.
b. Concentrate on, contemplate and comprehend each clause. Understand what the standard requires for your operation .
c. c. Those involved in performing the activities should also be involved in preparing the document.
d. For clarity, it is advisable to format the manual in the same sequence as the clauses of ISO/IEC 17025 or ISO 15189, as applicable.
e. Ensure all the clauses and sub-clauses of ISO/IEC 17025 (or ISO 15189) are addressed in the quality manual, or cross-referenced to other documents in the management system where the issues of the relevant clauses are addressed.
f. The essential parts of Quality Manual are

i

Title page

ii

Table of contents

iii

An authorization from the chief executive to nominated persons or designated positions of responsibility for implementing the requirements

iv

Copy distribution list

v

Amendment record

vi

Implementation / Compliance statements addressing every clause / sub clause of ISO-17025" to "ISO/IEC 17025 or ISO 15189

vii

Header / footer on each page with the details of : name of organization, document number, title of chapter, issue number and date effective, page number and total no of pages in that chapter, and optional signature / names of the persons preparing and approving policy or other documents covered in the management system.

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2. Guidance on writing a Quality Manual

There are a number of sources available to assist in the preparation of a laboratory quality manual. The following sections of this web-site provide some sample text that might assist some laboratories.

However, it is essential that a quality manual and its supporting documentation in a laboratory's management system are written for the use of the laboratory and its staff - not just to satisfy an accreditation body

Accordingly, it is essential that the manual reflects the actual policies and practices of the laboratory and is not a set of words prepared to satisfy other parties.

This also applies if some of the examples provided in this website or in other sources are used; the laboratory should ensure that its manual and supporting documentation are tailored to its own needs and actual practices.

Relevant Links

For a model quality manual click on :

 

1. http://www.iasonline.org/PDF/Forms/ct-qualitymanual.pdf

2. http://www.fda.gov/ora/science_ref/lm/vol1/default.htm

Labs can also purchase a quality manual template from AOAC by using following link:

http://www.aoac.org

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