2. 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.
4. 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.
5. 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.
6. 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;
7. 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.
8. 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.
9. 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.
10. 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
11. 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
12. Presentation of the
Laboratory
◦ Address
◦ Phone, Fax, e-mail
◦ Internet-Website
◦ Ownership
◦ Year of foundation
◦ History
◦ Bank account
◦ Memberships in
associations and
organisations
Statement of independence
from influences that may
adversely affect the quality
of the work
Cooperation with other
laboratories and
organizations
…
This chapter should contain:
13. 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
14. Organization Chart
D. Ocument
Quality Manager
A.L.Cohole
P. Henole
P. Esticide
B. Enzene
Dr. T. Oluol
Manager Organic Analysis
Deputy Technical Manager
B. Ismut
C. Opper
I. Ron
M. Anganese
Dr. T. Itan
Manager Anorganic Analysis
C. Lostridium
E. Coli
Dr. B. Acter
Manager Microbiology
Dr. T. Analyst
Technical Manager
Dr. J. Bigboss
Director
15. 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
16. Staff
number of employees
names of persons responsible for
subdivisions
reference, where information for all technical
staff is documented concerning
◦ relevant authorizations
◦ competence
◦ educational and professional qualifications
◦ training (in the past and plans for the future)
◦ skills
◦ experience
19. 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
20. 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
21. Standard Operation Procedure
–
Content - I
general description of the method
underlying standard
sampling and conservation
range of application
interferences
necessary equipment
chemicals (purity, where to buy)
measurement
22. Standard Operation Procedure
–
Content - II calibration
evaluation
control charts
other quality assurance measures
use of reference materials
presentation of results
limit of detection, limit of determination
responsibilities
23. Standard Operation Procedure –
Standardised Methods
A standard can not cover the laboratory
specific details
◦ 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
24. 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 ...
25. 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
26. 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
27. 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)
28. 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
29. 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
30. 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
31. Interlaboratory Tests
Participation in interlaboratory test
should be a matter of course for each
laboratory in its testing field
Planning
Results
Corrective actions
32. Complaints
Policy and procedure for the handling
of complaints
◦ from clients
◦ from other parties
33. 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
◦ regulations,
◦ standards,
◦ other normative documents,
◦ test and/or calibration methods, as well as
◦ drawings,
◦ software,
◦ specifications,
◦ instructions and
◦ manuals.
34. 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
soil
analysis
No 132 rev. 3.1
35. 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.
36. 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)
37. 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.
38. 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
39. 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
40. 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
◦ 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).
41. 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.
42. 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.
43. 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 re-
issued as soon as practicable.
44. 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
45. 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
46. Header of the Quality Manual
On each page of each chapter:
◦ 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
47. Example – Top and Bottom of a
Quality Manual Page
Quality Manual
Quality Policy
chapter: 1
revision: 1
page 1 of 3
author: checked: approved: date of issue:
48. 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.
