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ISO
17025 Quality Manual
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Quality Manual
Table of Contents
Introduction
Quality Policy Statement
1.0 Scope
2.0 References
3.0 Terms and Definitions
4.0 Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
4.5 Subcontracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Client
4.8 Complaints
4.9 Control of Nonconforming Testing and/or Calibration Work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews
5.0 Technical Requirements
5.1 Technical Requirements - General
5.2 Personnel
5.3 Accommodations and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling and Transportation of Test and/or Calibration Items
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
INTRODUCTION
XYZ Company recognizes its responsibility as provider of
quality services. To this end, XYZ Company has developed
and documented a quality management system to better satisfy
the needs of its customers and to improve management of the
company. The quality system complies with the
international standards ISO/IEC 17025:2005 and ISO 9001:2008.
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 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.
4.0 Management Requirements
4.1 Organization and Management
4.1.1 XYZ Company holds legal responsibility for its
operation and is organized to operate in accordance with the
requirements of ISO/IEC 17025, whether carrying out work in
its permanent facilities or on location, at customer sites.
4.1.2 XYZ Company is not part of an organization performing
activities other than testing and/or calibration; therefore,
there is no potential conflict of interest amongst its
personnel.
The organization of XYZ Company is illustrated below in
Figure 1.
4.2 Quality System
4.2.1 Documentation of the System
4.2.1.1 The Quality Manual is the principal document that
defines the quality system at XYZ Company.
4.2.1.2 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.
4.3 Quality Policy
4.3.1 XYZ Company Quality Policy:
XYZ Company will provide our employees with adequate
procedures to satisfy standards acceptable to most industrial
entities. We will strive to improve the quality of our
services at reduced cost and to constantly satisfy the
expectations of our customers and relevant agencies.
The Senior Management and Staff of XYZ Company also
undertake to ensure that all activities are conducted in
strict accordance with company documented procedures and
comply with the requirements of the ISO/IEC 17025 Standard.
4.4 Review of Requests, Tenders, and Contracts
4.4.1 Contract/order review is an integral part of the
quality system at XYZ Company. All contracts/orders are
reviewed and accepted only if the requirements are clear and
understood, and the company has the capability and capacity to
assure full customer expectations.
4.4.2 Records of reviews, including any significant
changes, are maintained.
4.4.3 Communications are maintained with the client from
request/quote through commencement of work. This includes
informing the client of any deviation from the contract.
4.4.4 The process for contract review is further defined in
the Contract Review Procedure.
4.9 Control of Nonconforming Testing and/or Calibration
Work
4.9.1 XYZ Company has established and maintains a policy
and procedures that are implemented when any aspect of its
testing and/or calibration work, or the results of this work,
do not conform to its own procedures or the agreed
requirements of the client.
4.9.2 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. 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 contract, 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.
4.9.3 Identification of nonconforming work or problems with
the quality system or with testing and/or calibration
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 and calibration certificate checking, management
reviews, and internal or external audits.
4.9.4 Where the evaluation indicates that the nonconforming
work could recur or that there is doubt about the compliance
of XYZ Company 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).
4.9.5 The process for nonconforming testing and/or
calibration work is further defined in the Control of
Nonconforming Testing or Calibration Work Procedure.
5.0 Technical Requirements
5.1 Technical Requirements - General
5.1.1 XYZ Company recognizes that many factors determine
the correctness and reliability of the tests and/or
calibration performed by a laboratory. These factors include
contributions from: human factors (5.2), accommodation and
environmental conditions (5.3), test and calibration methods
and method validation (5.4), equipment (5.5), measurement
traceability (5.6), and handling of test and calibration items
(5.8).
5.1.2 The extent to which the factors contribute to the
total uncertainty of measurement differs considerably between
(types of) tests and between (types of) calibrations. XYZ
Company 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.
5.2 Personnel
5.2.1 XYZ Company's management ensures the competency of
all who operate specific equipment, who perform tests and/or
calibrations, evaluate results and sign test reports and
calibration certificates. When using staff that is undergoing
training, adequate and appropriate supervision is provided.
Personnel performing specific tasks are qualified on the basis
of appropriate education, training, experience, and/or
demonstrated skills, as required.
5.4.5 Validation of methods
5.4.5.1 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/IEC 17025 Clause 5.4.5 as well as the
client.
5.4.5.2 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.
5.4.6 Uncertainty of Results
5.4.6.1 The uncertainty of calibration results are
calculated and documented in accordance with the requirements
of ISO/IEC 17025 Clause 5.4.6. The Estimation of
Uncertainty of Measurement Procedure is applied to all in
house calibrations/tests OR The uncertainty of
measurement is available on the certificate of analysis or
calibration certificate from a subcontractor.
5.4.6.2 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 (see
section 5.10).
5.10 Reporting the Results
5.10.1 The results of each test, calibration, or series of
tests or calibrations carried out by the laboratory are
reported accurately, clearly, unambiguously, and objectively,
and in accordance with any specific instructions in the test
or calibration methods. The results are normally reported in a
test report or a calibration certificate and include all the
information requested by the client and necessary for the
interpretation of the test or calibration results, and all
information required by the method used. In the case of test
or calibrations performed for internal clients, or in the case
of a written agreement with the client, the results may be
reported in a simplified way and may not require the
formalized calibration certificate, but all data (data that
would be on an actual calibration certificate if one were to
be generated) is readily available and kept permanently on
file
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