ISO
15189 Quality Manual
Order Quality Manual
Table
of Contents
Introduction
Quality Policy Statement
1.0 General
2.0 References
3.0 Terms and Definitions
4.0 General Requirements 4.1 Impartiality 4.2 Confidentiality 4.3 Requirements Regarding Patients
5.0 Structural and Governanace Requirements 5.1 Legal Entity 5.2 Laboratory Director 5.3 Laboratory Activities 5.4 Structure and Authority 5.5 Objectives and Policies 5.6 Risk Management
6.0 Resource Requirements
6.1 General 6.2 Personnel 6.3 Facilities and Environmental Conditions 6.4 Equipment 6.5 Equipment Calibration and Metrological Traceability 6.6 Reagents and Consumables 6.7 Service Agreements 6.8 Externally Provided Products and Services
7.0 Process Requirements 7.1 General 7.2 Pre-examination Processes 7.3 Examination Processes 7.4 Post-examination Processes 7.5 Identification and Control of Nonconforming Product/Work 7.6 Control of Data and Information Management 7.7 Complaints 7.8 Continuity and Emergency Preparedness Planning
8.0 Management System Requirements 8.1 General Requirements and Options 8.2 Management System Documentation 8.3 Control of Management System Documents 8.4 Control of Records 8.5 Actions to Address Risks and Opportunities for Improvement 8.6 Continual Improvement 8.7 Nonconformities and Corrective Actions 8.8 Evaluations 8.9 Management Reviews
INTRODUCTION
XYZ
Laboratory recognizes its responsibility as provider of quality
services. To this end, XYZ Laboratory has developed and
documented a management system to better satisfy the needs of
its customers and to improve patienet care and management of the laboratory.
The
management system complies with the international standard ISO
15189:2022.
This
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 management
system. In addition, this manual is utilized for the purpose of
informing our customers of the management system, and what specific
controls are implemented to assure service quality.
Quality Policy Statement
XYZ
Laboratory accepts responsibility for the complete satisfaction of its
customers and patients. We
exercise this
responsibility through adequate training of our employees, professional
and
ethical commitment to patient care through quality examinations,
meeting and
exceeding customer requirements, and maintaining a company culture that
fosters
continuous improvement. Our
objective is
to deliver error free services on time, every time.
The
Senior Management and Staff of
XYZ Laboratory also undertake to ensure that all activities are
conducted in
strict accordance with documented procedures and comply with
the
requirements of the ISO 15189 Standard.
The
management team will
periodically review the performance of the management system and our
quality
objectives to ensure their effectiveness, continuing relevance, and
suitability.
General Requirements
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 examinations and testing; therefore, there is no potential
conflict of interest amongst its personnel.
The
organization of XYZ Laboratory is illustrated below in Figure 1.
Management System
The Quality Manual is the principal document that defines the management
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
Records.
Service Agreements
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.
The
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
examination
activities, and the activities do not conform to its own procedures or
the agreed requirements of the client.
The
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
audits.
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).
The
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
client.
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
uses.
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.
The
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
· The
existence of narrow limits on which decisions on conformance to a
specification are based
In cases
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.
Reporting Results
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.
The
results are normally reported in a test report and include all
the
information requested by the client and necessary for the
interpretation of the test results, and all information
required
by the method used.
Note:
Paragraph order numbering in the above sample is for illustration
purposes only. The order and numbering in the actual product may
differ.
ISO 15189 Sample Procedure
Order Quality Manual
ISO
15189 Quality Manual Information
|