quality manual
TRANSCRIPT
Quality Manual
Feras Mfarrej – ASU 2014
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.
Quality Manual
Contents
Document Control
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.
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.
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;
Quality Manual – Contents
ISO/IEC 17025 – 4.2.2
(followed)◦ a requirement that all personnel
concerned with testing and calibration activities within the laboratory familiarizethemselves with the quality documentation and implement the policies and procedures in their work; and
◦ the laboratory management’s commitmentto compliance with this International Standard.
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.
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.
Quality Policy
The quality policy is one of the essentialthings 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
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
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:
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
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
Quality Manager
The laboratory must have a quality manager (and if possible a deputy)
The name and responsibilities/dutieshave to be stated here
The quality manager must have directaccess to the highest level of management at which decisions are made on laboratory policy or resources
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
Allocation of Responsibilities
For signing contracts For signing test reports For acquisition For procurement
List of Signatures
For all relevant staff
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
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
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
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
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
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 ...
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
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
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)
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
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
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
Interlaboratory Tests
Participation in interlaboratory test should be a matter of course for each laboratory in its testing field
Planning Results Corrective actions
Complaints
Policy and procedure for the handling of complaints◦ from clients
◦ from other parties
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.
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
Document Approval and Issue
ISO/IEC 17025 – 4.3.2.1All 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.
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)
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.
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
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
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).
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.
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.
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.
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
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
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
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:
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.
THANKS
Feras Mfarrej – ASU 2014