Quality Manual
Michael Koch
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Why?
 ISO/IEC 17025 states the necessity for
an accredited laboratory to have a
quality system with certain requirements
as well as procedures to keep
documents under control
 The quality manual is the keystone of
the documentation of a quality system.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual
 Contents
 Document Control
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Contents
ISO/IEC 17025 – 4.2.1
 The laboratory shall establish, implement and
maintain a quality system appropriate to the
scope of its activities.
 The laboratory shall document its policies,
systems, programmes, procedures and
instructions to the extent necessary to assure the
quality of the test and/or calibration results.
 The system’s documentation shall be
communicated to, understood by, available to,
and implemented by the appropriate personnel.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Contents
ISO/IEC 17025 – 4.2.2
 The laboratory’s quality system policies
and objectives shall be defined in a
quality manual (however named).
 The overall objectives shall be
documented in quality policy statement.
 The quality policy statement shall be
issued under the authority of the chief
executive.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Contents
ISO/IEC 17025 – 4.2.2 (followed)
 It shall include at least the following:
 the laboratory management’s commitment
to good professional practice and to the
quality of its testing and calibration in
servicing its clients;
 the management’s statement of the
laboratory‘s standard of service;
 the objectives of the quality system;
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Contents
ISO/IEC 17025 – 4.2.2 (followed)
 a requirement that all personnel concerned
with testing and calibration activities within
the laboratory familiarize themselves with
the quality documentation and implement
the policies and procedures in their work;
and
 the laboratory management’s commitment
to compliance with this International
Standard.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Contents
ISO/IEC 17025 – 4.2.3
 The quality manual shall include or
make reference to the supporting
procedures including technical
procedures.
 It shall outline the structure of the
documentation used in the quality
system.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual – Contents
ISO/IEC 17025 – 4.2.4
 The roles and responsibilities of
technical management and the quality
manager, including the responsibility for
ensuring compliance with this
International Standard, shall be defined
in the quality manual.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Policy
 The quality policy is one of the essential
things in a quality system.
 the whole system should only reflect the quality
policy in the daily work and put the policy into
concrete terms
 the policy shall be issued under the authority
of the chief executive
 It is very important to have a clear statement, how
crucial quality is in the work of his/her laboratory
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Policy
 Quality policy is very specific for each
laboratory in the framework of its tasks,
its role in a larger organization and its
relationship to its customers.
 There is no recipe for the formulation
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Presentation of the Laboratory

This chapter should contain:
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Address
Phone, Fax, e-mail
Internet-Website
Ownership
Year of foundation
History
Bank account
Memberships in
associations and
organisations
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
 Statement of
independence from
influences that may
adversely affect the
quality of the work
 Cooperation with
other laboratories
and organizations
 …
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization and Management
 Names of persons responsible for
commercial management
 Names of persons responsible for
technical management
 including a short description of the
qualification of the technical manager and
his deputy
 Organization chart
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization
Chart
Dr. J. Bigboss
Director
Dr. T. Analyst
Technical Manager
D. Ocument
Quality Manager
Dr. T. Oluol
Manager Organic Analysis
Deputy Technical Manager
Dr. T. Itan
Manager Anorganic Analysis
Dr. B. Acter
Manager Microbiology
B. Enzene
M. Anganese
E. Coli
P. Esticide
I. Ron
C. Lostridium
P. Henole
C. Opper
A.L.Cohole
B. Ismut
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manager
 The laboratory must have a quality
manager (and if possible a deputy)
 The name and responsibilities/duties
have to be stated here
 The quality manager must have direct
access to the highest level of
management at which decisions are
made on laboratory policy or resources
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Staff
 number of employees
 names of persons responsible for
subdivisions
 reference, where information for all technical
staff is documented concerning
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relevant authorizations
competence
educational and professional qualifications
training (in the past and plans for the future)
skills
experience
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Allocation of Responsibilities
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For signing contracts
For signing test reports
For acquisition
For procurement
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
List of
Signatures
 For all relevant
staff
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Administration, Access and
Review of the Quality Manual
 All staff must have access to the quality
manual.
 This access must be managed
 All copies must be current versions
 The quality manual must be regularly
reviewed
 All these things are the duties of the
quality manager
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Standard Operation Procedures
 There have to be standard operation
procedures for all relevant procedures
 It is useful to have the SOPs in separate
documents
 The quality manual should contain a list
of available SOPs
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Standard Operation Procedure –
Content - I
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general description of the method
underlying standard
sampling and conservation
range of application
interferences
necessary equipment
chemicals (purity, where to buy)
measurement
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Standard Operation Procedure –
Content - II
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calibration
evaluation
control charts
other quality assurance measures
use of reference materials
presentation of results
limit of detection, limit of determination
responsibilities
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Standard Operation Procedure –
Standardised Methods
 A standard can not cover the laboratory
specific details
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equipment
supplier
trained staff
responsibilities
QA measures
limit of detection, ...
 These details have to be documented
 The extent of the SOP depends on the
qualification of the staff
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Other Guidelines
 If the laboratory has other guidelines,
they should be included or referenced in
the quality manual
 for calibration
 for calculation of detection limits
 for calculation and construction of control
charts
 for ...
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reference Materials
 The laboratory should keep a list of
reference materials used
 This list has to be in the quality manual
 or a note where the RM‘s are listed
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Accommodation and
Environmental Conditions
 ISO/IEC 17025 contains requirements
for accommodation and environmental
conditions
 Their fulfilment must be described in the
quality manual
 Description of the rooms
 Floor plan
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Equipment
 There must be records on each item of
equipment and its software significant to
tests and/or calibration performed
 Usually on separate documents
 List of all records
 (Guideline, what has to be recorded)
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Defect and Incorrect Working
Test Equipment
 Equipment that has been shown to be
defective or outside specified limits
must be taken out of service
 There must be regulations in the quality
manual
 how the equipment has to be labeled
 what must be arranged
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Internal Audits
 Internal Audits can show that the
operation of the laboratory is in
compliance with its quality system and
with ISO/IEC 17025
 Schedule
 Prescribed procedure
 Schedule and procedure must be
documented in the quality manual
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Management Review
 A management review can show the
continuing suitability and effectiveness
of the quality system and of the testing
activities
 Schedule
 Prescribed procedure
 Schedule and procedure must be
documented in the quality manual
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Interlaboratory Tests
 Participation in interlaboratory test
should be a matter of course for each
laboratory in its testing field
 Planning
 Results
 Corrective actions
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Complaints
 Policy and procedure for the handling of
complaints
 from clients
 from other parties
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Control - General
ISO/IEC 17025 – 4.3.1
 The laboratory shall establish and maintain
procedures to control all documents that form
part of its quality system (internally generated or
from external sources), such as
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regulations,
standards,
other normative documents,
test and/or calibration methods, as well as
drawings,
software,
specifications,
instructions and
manuals.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Control System
 Every document must be clearly
identified in the control system
 together with its revision status
 this can be done e.g. by a numbering
system that includes the revision (e.g.
SOP-SA-132-3.1)
standard
operation
procedure
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
soil
analysis
No 132
rev. 3.1
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Approval and Issue
ISO/IEC 17025 – 4.3.2.1
 All documents issued to personnel in the
laboratory as part of the quality system shall
be reviewed and approved for use by
authorized personnel prior to issue.
 A master list or an equivalent document
control procedure identifying the current
revision status and distribution of documents
in the quality system shall be established and
be readily available to preclude the use of
invalid and/or obsolete documents.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Master List
 There can be e.g. a master list of all
valid documents together with their
revision status in the quality manual (or
in a separate document)
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Approval and Issue
ISO/IEC 17025 – 4.3.2.2
 The procedure(s) adopted shall ensure that:
 authorized editions of appropriate documents are
available at all locations where operations essential to
effective functioning of the laboratory are performed;
 documents are periodically reviewed and, where
necessary, revised to ensure that continuing suitability
and compliance with applicable requirements;
 invalid or obsolete documents are promptly removed
from all points of issue or use, or otherwise assured
against unintended use;
 obsolete documents retained for either legal or
knowledge preservation purposes are suitably marked.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Availability
 Authorized copies of the quality manual
should be available
 in the quality manager‘s office
 in the laboratory manager‘s office
 in the laboratory for all staff
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Obsolete Documents
 have to be removed immediately
 it must be assured, that they are
removed in all authorized copies
 obsolete documents must be marked
 but they have to be retained for
 legal purposes
 knowledge preservation
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Approval and Issue
ISO/IEC 17025 – 4.3.2.3
 Quality system documents generated by the
laboratory shall be uniquely identified.
 Such identification shall include
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the date of issue and/or
revision identification,
page numbering,
the total number of pages or a mark to signify the
end of the document, and
 the issuing authority(ies).
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Changes
ISO/IEC 17025 – 4.3.3.1
 Changes to documents shall be reviewed and
approved by the same function that
performed the original review unless
specifically designated otherwise.
 The designated personnel shall have access
to pertinent background information upon
which to base their review and approval.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Changes
ISO/IEC 17025 – 4.3.3.2
 Where practicable, the altered or new
text shall be identified in the document
or the appropriate attachments.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Changes
ISO/IEC 17025 – 4.3.3.3
 If the laboratory’s documentation control
system allows for the amendment of
documents by hand pending the re-issue of
the documents, the procedures and
authorities for such amendments shall be
defined.
 Amendments shall be clearly marked,
initialled and dated.
 A revised document shall be formally reissued as soon as practicable.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Changes
ISO/IEC 17025 – 4.3.3.4
 Procedures shall be established to
describe how changes in documents
maintained in computerized systems
are made and controlled
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Header of the Quality Manual
 at least on the first page of each
chapter:
 identification of the laboratory
 a statement that this is a part of the quality
manual
 number of the chapter
 title of the chapter
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Header of the Quality Manual
 on each page of each chapter:
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date of issue
revision number
name of author
eventually name of person, who checked the
content
 approval notice
 page number
 total number of pages of the chapter
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Example – Top and Bottom of a
Quality Manual Page
Quality Manual
Quality Policy
author:
checked:
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
approved:
chapter: 1
revision: 1
page 1 of 3
date of issue:
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Structure of the Quality Manual
 It is up to the author of the quality
manual to decide about the detailed
structure of “his” quality manual.
 But it is extremely useful to separate it
in chapters, which can be revised
separately without revising and
renumbering the whole manual.
Koch, M.: Quality Manual
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching