15189 Quality Manual
Order Quality Manual
Quality Policy Statement
3.0 Terms and Definitions
4.0 Management Requirements
4.1 Organization and Management Responsibility
4.2 Management System
4.3 Document Control
4.4 Service Agreements
4.5 Examination by Referral Laboratories
4.6 External Services and Supplies
4.7 Advisory Services
4.8 Resolution of Complaints
4.9 Identification and Control of Nonconformities
4.10 Corrective Action
4.11 Preventive Action
4.12 Continual Improvement
4.13 Control of Records
4.14 Evaluation and Internal Audits
4.15 Management Reviews
5.0 Technical Requirements
5.2 Accommodations and
5.3 Laboratory Equipment, Reagents, and Consumables
5.4 Pre-examination Processes
5.5 Examination Processes
5.6 Ensuring Quality of Examination Results
5.7 Post Examination Processes
5.8 Reporting of Results
5.9 Release of Results
5.10 Laboratory Information Management
Laboratory recognizes its responsibility as provider of quality
services. To this end, XYZ Laboratory has developed and
documented a quality management system to better satisfy the needs of
its customers and to improve management of the organization.
quality system complies with the international standards ISO
manual has been prepared to define the quality system, establish
responsibilities of the personnel affected by the system, and to
provide general procedures for all activities comprising the quality
system. In addition, this manual is utilized for the purpose of
informing our customers of the quality system, and what specific
controls are implemented to assure service quality.
Quality Policy Statement
Laboratory accepts responsibility for the complete satisfaction of its
responsibility through adequate training of our employees, professional
ethical commitment to patient care through quality examinations,
exceeding customer requirements, and maintaining a company culture that
continuous improvement. Our
to deliver error free services on time, every time.
Senior Management and Staff of
XYZ Laboratory also undertake to ensure that all activities are
strict accordance with documented procedures and comply with
requirements of the ISO 15189 Standard.
management team will
periodically review the performance of the management system and our
objectives to ensure their effectiveness, continuing relevance, and
Organization and Management Responsibility
XYZ Laboratory holds legal responsibility for its
operation and is organized to operate in accordance with the
requirements of ISO 15189, whether carrying out work in its permanent
facilities or on location, at customer sites.
XYZ Laboratory is not part of an organization performing
activities other than testing; therefore, there is no potential
conflict of interest amongst its personnel.
organization of XYZ Company is illustrated below in Figure 1.
Documentation of the System
The Quality Manual is the principal document that defines the quality
system at XYZ Laboratory.
Quality System Procedures are documented to establish and maintain
continuity of each activity or function affecting quality.
Quality procedures will be readily available to personnel for
reference and implementation. The quality document structure contains
this Quality Manual, Quality Procedures, Work Instructions, and Quality
Agreement review is an integral part of the quality system at
XYZ Company. All agreements are reviewed and accepted only if
the requirements are clear and understood, and the laboratory has the
capability and capacity to assure full customer expectations.
Records of reviews, including any significant changes, are maintained.
Communications are maintained with the client from request/quote
through commencement of work. This includes informing the client of any
deviation from the agreement.
process for agreement review is further defined in the Service
Agreements Review Procedure.
Identification and Control of Nonconformities
XYZ Company has established and maintains a policy and procedures that
are implemented when there are problems with the management
system, or with pre-examination, examination, and post
activities, and the activities do not conform to its own procedures or
the agreed requirements of the client.
policy and procedures shall ensure that nonconforming work or problems
that do not conform to requirements are identified and managed, to
prevent unintended use or delivery of services. This procedure
ensures that non-conforming work or problems are corrected, where
applicable, and subject to verification after correction to demonstrate
conformity. Where required by the agreement, the proposed rectification
of non-conforming work or problems is reported for concession to the
customer, the end user, regulatory body, or other applicable authority.
Identification of nonconforming work or problems with the quality
system or with testing and activities can occur at various
points within the quality system, and technical operations such as
customer complaints, quality control, instrument calibration, checking
of consumable materials, staff observations or supervision, test
report checking, management reviews, and internal or external
Where the evaluation indicates that the nonconforming work could recur
or that there is doubt about the compliance of XYZ Laboratory
operations with its own policies and procedures, the corrective actions
procedure shall be followed to identify the root cause(s) of the
problem and to eliminate this (these) cause(s).
process for nonconforming work is further defined in the Control
of Nonconforming Product/Work Procedure.
Validation of methods
All standard and non-standard test methods and procedures are validated
to ensure that such methods and procedures are fit for their intended
use and are relevant to the requirements of ISO 15189, as well as, the
The results of such validation are recorded together with the procedure
utilized and any other relevant information. The record states whether
the method or procedure is fit for the intended use.
Uncertainty of Examination Results
XYZ laboratory recognizes that many factors determine the correctness
and reliability of the tests performed by a laboratory. These
factors include contributions from: human factors, accommodation and
environmental conditions, test and calibration methods and method
validation, equipment, measurement traceability, and handling of test
and calibration items.
The extent to which the factors contribute to the total uncertainty of
measurement differs considerably between (types of) tests. XYZ
Laboratory takes into account these factors in developing test and
calibration methods and procedures, in the training and qualification
of personnel, and in the selection and calibration of the equipment it
The Estimation of Estimation of Uncertainty of Measurement
Procedure is applied for estimating uncertainty of
measurement, except when the test methods preclude such rigorous
calculations. In certain cases it is not possible to undertake
metrologically and statistically valid estimations of uncertainty of
measurement. In these cases the laboratory attempts to identify all the
components of uncertainty and make the best possible estimation, and
ensure that the form of reporting does not give an exaggerated
impression of accuracy. Reasonable estimation is based on knowledge of
the performance of the method and on the measurement scope, and makes
use of previous experience and validation data.
degree of rigor needed in an estimation of uncertainty of measurement
depends on factors such as:
Requirements of the test method
Requirements of the client
existence of narrow limits on which decisions on conformance to a
specification are based
where a well-recognized test method specifies limits to the values of
the major sources of uncertainty of measurement and specifies the form
of presentation of calculated results, the laboratory is considered to
have satisfied the estimation uncertainty of measurement by following
the test method and reporting instructions.
The results of each test carried out by the laboratory are
reported accurately, clearly, unambiguously, and objectively, and in
accordance with any specific instructions in the test methods.
results are normally reported in a test report and include all
information requested by the client and necessary for the
interpretation of the test results, and all information
by the method used.
Paragraph numbering in the above sample is for illustration
purposes only. The numbering in the actual product may
ISO 15189 Sample Procedure
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15189 Quality Manual Information