TSWAN LABORATORIES LTD

Lab Quality Manual

ISO/IEC 17025:2017

Revision #01
Effective Date 3/11/2023

1
Tswan Laboratories Ltd 19, St. Paul’s Street, Phase 3, Gwagwalada, Abuja
 REVISION HISTORY
DATE AMMENTMENT APPROVED BY REVISION
VERSION
 Table of Contents

1.0
Scope .................................................................................................................................................... 4

2.0
References ........................................................................................................................................... 4

3.0 Terms and Defi

nitions ......................................................................................................................... 4

4.0 General
Requirements ........................................................................................................................ 4
4.1
Impartiality .............................................................................................................................................
4
4.2 Confi
dentiality ........................................................................................................................................ 5

5.0 Structural
Requirements ..................................................................................................................... 5

6.0 Resource
Requirements ..................................................................................................................... 6
6.1
General ..................................................................................................................................................
6
6.2
Personnel .............................................................................................................................................. 6
6.3 Facilities and Environmental
Conditions ................................................................................................ 7
6.4

Equipment ............................................................................................................................................ .
7
6.5 Measurement
Traceability ..................................................................................................................... 8
6.6 External
Resources ............................................................................................................................... 8

7.0 Process
Requirements ........................................................................................................................ 9
7.1 Review of Requests, Tenders, and
Contracts ....................................................................................... 9

3
Tswan Laboratories Ltd 19, St. Paul’s Street, Phase 3, Gwagwalada, Abuja
7.2 Selection, Verifi cation, and Validation of
Methods ................................................................................. 9
7.3
Sampling ..............................................................................................................................................
10
7.4 Handling of Test
Items ......................................................................................................................... 10
7.5 Technical
Records ............................................................................................................................... 10
7.6 Measurement
Uncertainty ....................................................................................................................11
7.7 Data
Validation .....................................................................................................................................11
7.8 Data
Reporting .....................................................................................................................................11
7.9
Complaints ...........................................................................................................................................
12
7.10 Non-
Conformances ............................................................................................................................. 13
7.11 Control of
Data .................................................................................................................................... 13

8.0 Management
System ......................................................................................................................... 13
8.1
General ................................................................................................................................................
13
8.2 Management System
Documentation ................................................................................................. 13
8.3 Document
Control ................................................................................................................................ 14
8.4 Record
Control .................................................................................................................................... 15
8.5 Risks and
Opportunities ...................................................................................................................... 15
8.6
Improvement ........................................................................................................................................
15
8.7 Corrective
Actions ................................................................................................................................ 16
8.8 Internal
Audits ...................................................................................................................................... 16
8.9 Management
Reviews ......................................................................................................................... 16

Page 3 of 17

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Tswan Laboratories Ltd 19, St. Paul’s Street, Phase 3, Gwagwalada, Abuja
 1.0 Scope

The lab at Tswan Laboratories Ltdx (TSWAN LABORATORIES LTDX) is committed to a policy
of providing exemplary service with respect to performing accurate testing and analysis of
environmental water and wastewater samples. The TSWAN LABORATORIES LTDX lab
provides laboratory testing for the TSWAN LABORATORIES LTDX Certification Body
and any customer requesting lab analysis under the scope of testing.

2.0 References

1. ISO/IEC Standard 17025 General requirements for the competence of testing and calibration
laboratories.

2. ISO Standard 19011 Guidelines for quality and/or environmental management systems
auditing.

3.0 Terms and Definitions

For the purposes of this document, the relevant terms and definitions given in ISO/IEC Guide 99,
ISO/IEC 17000, and ISO/IEC 17025 apply.

4.0 General Requirements

4.1 Impartiality (Procedure for Management of Impartiaity QSP4.2)

4.1.1 The TSWAN LABORATORIES LTDX lab is dedicated to undertaking testing

activities impartially and also eliminating risks to impartiality which arise from its
activities and the activities of its personnel. TSWAN LABORATORIES LTDX has
policies and procedures to avoid involvement in any activities that would diminish
confidence in its competence, impartiality, judgment or operational integrity.
Conflicts of interest cast doubt on the accuracy and validity of results and cannot be
allowed to influence testing activities.

4.1.2 TSWAN LABORATORIES LTDX ensures its senior executives and staff are free
from any commercial, financial and other pressures which might influence the results
of the testing process. The Laboratory management is composed of respectable
professional scientist free from any commercial, financial or other pressures that
might influence decisions and signs Conflict of Interest agreements stating as such.
Confidentiality and Disclosure Agreement QF4.5)

4.1.3 The TSWAN LABORATORIES LTDX lab is responsible for the impartiality of its
activities. TSWAN LABORATORIES LTDX ensures its personnel are free from any
undue internal and external commercial, financial and other pressures and influences
that may adversely affect the quality of their work. Employee salaries and
promotions are not dependent upon the outcome of testing or any related commercial
activity.
 4.1.4 Tswan laboratories ltd routinely identifies risks to impartiality that arise from its
activities and relationships, and the activities and relationships of its personnel. Risks
are identified and evaluated through the following means:
a. Personnel conflict of interest questionnaires at the time of hiring, before undertaking any testing,
and before any job reassignment. (Conflict of Interest Questionnaire QF4.2.3.1)
b. Written assessments of the impartiality of personnel which is reviewed by the Laboratory
management.
c. Annual impartiality reviews.
d. Annual management reviews.

4.1.5 When risks to impartiality are identified, Tswan Laboratories Ltd takes steps to eliminate
or minimize those risks.

4.2 Confidentiality

4.2.1 Tswan laboratories ltd lab and its personnel are legally obligated to keep confidential all
information supplied to it by the client as well as all data, records, and information obtained
during testing activities except for information required or considered to be publicly
available unless authorized by the client. Tswan laboratories ltd shall inform the client in
advance of any information it intends to make publicly available, unless prohibited by law.
Confidentiality is maintained by the use of computer passwords, locks on doors and fi ling
cabinets, padlocked covers on equipment under test as well as observation by Tswan
laboratories ltd personnel.

4.2.2 Where the law or contractual agreements require information to be made public or disclosed to
any other party, the client shall be informed in advance of what information was provided
unless the law prohibits such notification.

4.2.3 Any information about the client which was obtained from any outside source shall be treated
as confidential. The source of such information shall also be considered confidential.

4.2.4 All Tswan laboratories ltd personnel and subcontractors involved in testing activities sign a
Confidentiality and Disclosure Agreement (QF4.5).

5.0 Tswan Laboratories Ltd Structure (Tswan Laboratories Ltd Organizational Chart QF5.1)

5.1 The Tswan Laboratories Ltd lab is a division of Tswan Laboratories Ltd which is a legal entity
registered as a Limited Liability Company to do business in Nigeria.

5.2 The Lab General Manager has overall responsibility for the technical operations, quality
assurance, and the provisions of the resources needed for laboratory operations.

5.3 Tswan Laboratories Ltd Lab scope of testing includes all required testing defined in its scope of
accreditation
5.4 TSWAN LABORATORIES LTDX shall carry out its testing and calibration activities according
to the requirements of ISO/IEC Standard 17025, and to satisfy the needs of the customer.
This management system covers work carried out by TSWAN LABORATORIES LTDX
employees at the TSWAN LABORATORIES LTDX permanent facilities, the TSWAN
LABORATORIES LTDX test site, and field activities.

5.5 TSWAN LABORATORIES LTDX defines the organization and management structure of the
laboratory. The TSWAN LABORATORIES LTDX management system specifies the
responsibility, authority and interrelationships of all personnel and has deputies for key
positions as feasible. (Job Descriptions QF6.1.1.2)
5.6 The TSWAN LABORATORIES LTDX lab has the personnel with the authority and resources
to carry out their duties including implementation, improvement, and identification of
departures from the quality system or from the procedures for performing tests, and to
initiate actions to prevent or minimize such departures. These duties are identified in the
personnel job descriptions.

5.7 The Program Manager is responsible for ensuring all TSWAN LABORATORIES LTDX
personnel are aware of the importance of meeting customer requirements. All staff is
required to read and understand the TSWAN LABORATORIES LTDX Lab Quality Manual
as documented in QF6.1.3. A signed copy of this document is kept in the employee’s
personnel file. A Management Review is performed at least annually and the results of this
review are communicated to the staff by the Program Manager in the next regularly
scheduled staff communication meeting following the Management Review

6.0 Resource Requirements

6.1 General

The TSWAN LABORATORIES LTDX lab is equipped and staff ed with adequate resources
necessary to perform its laboratory activities.
6.2 Personnel (Employee Training Procedure QSP6.1.2)

6.2.1 The TSWAN LABORATORIES LTDX lab shall only use employees who are employed by, or
under contract to TSWAN LABORATORIES LTDX, and have completed the impartiality
and confidentiality requirements of TSWAN LABORATORIES LTDX.

6.2.2 The Lab General Manager will ensure the competence of all employees who operate specific
equipment, perform tests and /or calibration, evaluate results and sign test reports. The
personnel assigned to these tasks must meet the requirements set forth in the appropriate job
descriptions (See QF6.1.1.2).

6.2.3 New employees or employees assigned to a new task will be trained by a qualified employee
for a period of time to be determined by the Lab General Manager. TSWAN
LABORATORIES LTDX has a procedure for training of new employees (See QSP6.1.2).

6.2.4 TSWAN LABORATORIES LTDX maintains Job Descriptions for all positions (See
QF6.1.1.2).
6.2.5 TSWAN LABORATORIES LTDX has a procedure which defines the requirements for the
competencies, training goals, formal authorization, demonstration of capability, and
monitoring of personnel.

6.2.6 TSWAN LABORATORIES LTDX formally authorizes only certain personnel to perform
certain tasks. These tasks include quality system maintenance, method verification, data
validation, and lab analyses. TSWAN LABORATORIES LTDX maintains records of

the qualifications and training of all personnel (See QF6.1.2.1).

6.3 Facilities and Environmental Conditions

6.3.1 Various tests performed in the lab may be affected by environmental conditions. Tests shall
be stopped if the environmental conditions jeopardize the test results (TSWAN
LABORATORIES LTDX Lab Standard Operating Procedures LQSP5.4.1.3 through
LQSP5.4.1.18).

6.3.2 The environmental conditions which interfere with accurate analysis are documented in the
applicable lab standard operating procedure.

6.3.3 The standard operating procedure (SOP) for each test directs the technician to monitor and
perform testing in the correct environmental conditions for the applicable analyses.

6.3.4 The procedures also specify measures necessary to prevent cross-contamination where and if
applicable. All employees are responsible for housekeeping. Special procedures shall be
prepared when necessary.

6.3.5 The requirements for accommodation of environmental conditions and cross contaminaion are
met regardless of the location. This includes testing conducted at the TSWAN
LABORATORIES LTDX laboratory, the TSWAN LABORATORIES LTDX test site, and
any field activities.

6.4 Equipment (Equipment Operation Procedure LQSP5.4.1.1)

6.4.1 The TSWAN LABORATORIES LTDX lab is furnished with supplies, reference materials,
and equipment required for the correct performance of tests. (Lab Equipment List LQF5.5.1.1)
6.4.2 If equipment goes outside the direct control of the laboratory for any reason, the equipment
shall be re-calibrated to ensure proper function.

6.4.3 TSWAN LABORATORIES LTDX has procedures for the correct handling, storage,
calibration, and preventive maintenance of test equipment. Personnel qualified and
authorized to operate equipment are responsible for its accurate operation.

6.4.4 All measuring equipment shall be verified to conform to the manufacturers specifications prior
to being placed into service at the lab. Equipment is calibrated per the manufacturer’s
instructions and to ensure it complies with the relevant standard specifications.

6.4.5 Equipment purchased for measurement is selected to be capable of achieving measurement

accuracy specified by the method.
6.4.6 All measuring equipment shall be calibrated against a traceable reference material according to
the specified calibration schedule. All equipment calibrations shall be kept current. If there is
doubt concerning the accuracy of piece of equipment, the equipment shall be taken out of
service and re-calibrated.

6.4.7 Calibration intervals are specified on the Lab Equipment List (LQF5.5.1.1). Calibration
intervals are reviewed and adjusted by the QA Officer. The Field Technical Manager is
responsible for the calibration and maintenance of equipment.

6.4.8 Equipment and reference materials are identified with a unique serial number or lot number.
Equipment requiring outside calibration will have a label visibly displayed showing the date,
when last calibrated and the date when calibration is due.
(LQF5.5.1.1)

6.4.9 If equipment is suspected to be defective or providing inaccurate results, the operator will
immediately isolate the equipment and tag it “out of service”. The equipment will remain
out of service until the Field Technical Manager arranges for repair and/or recalibration of
the equipment. (LQSP5.4.1.1

6.4.10 If certain equipment requires intermediate checks to maintain confidence the calibration
status of equipment, LQSP5.5.5.1 shall be followed (Equipment Calibration Records LQF5.5.5).

6.4.11 When equipment calibration or intermediate checks reveal a correction factor in the readings,
these values are implemented and taken into account for data reporting. The allowance for
calibration correction factors does not include lab-fortified blank failures.

6.4.12 Test equipment is safeguarded from adjustments which would invalidate the test results as
defined in LQSP5.4.1.1.

6.4.13 Records are maintained for each piece of equipment which include identification of the
equipment, operator manuals, calibrations, maintenance, and repairs. Up-to-date instructions
on the use and maintenance of equipment is readily available for use by the designated
personnel. Calibration and maintenance records are kept on fi le in the lab office.

6.5 Measurement Traceability (Equipment Calibration Procedure

LQSP5.5.5.1)

6.5.1 All measurements are traceable through an unbroken chain of calibrations or reference
materials. Calibration records and certificates of analysis are maintained according to the
equipment calibration and record control procedures.

6.5.2 The procedure for calibration of equipment is designed and followed to ensure that calibrations
and measurements made by the laboratory are traceable to the International System of Units
(SI). When calibrations cannot be made in SI units, the lab uses certified reference materials
provided by a competent supplier to give a reliable characterization of a material. The lab
only uses calibration labs meeting the requirements of ISO/IEC 17025. The lab shall use
only certified reference materials provided by an approved supplier. Lot numbers of reagents
and chemicals are recorded in the Chemical/Reagent Log (LQF4.6.2.1).
6.5.3 When traceability to the (SI) system is not possible, traceability is made to certifi ed reference
materials provided by an approved and certified provider.

6.6 External Resources

6.6.1 When lab activities are beyond the capability of TSWAN LABORATORIES LTDX,
subcontractors shall be chosen which meet the requirements of the following Standards:
a. Testing and calibration - ISO/IEC 17025
b. Auditing of quality systems - ISO/IEC 17021
c. Certified reference materials - ISO/IEC Guide 34
d. Proficiency testing - ISO/IEC 17043

6.6.2 TSWAN LABORATORIES LTDX has a procedures for approval of subcontractors and the
selection and purchasing of services and supplies it uses that affect the quality of the tests
and calibration of equipment. Purchased materials are not used until they are verified as
complying with specifications defined in the methods for the applicable tests.
(Purchasing Procedure LQSP4.6.1)

The Lab General Manager collects records which provide evidence for confidence in the
subcontractors’ work. Records may include proficiency testing reports, inter-laboratory comparisons,
certificates, and quality system audit reports. (Subcontractor Competence Procedure QSP6.2.2.)
6.6.3 TSWAN LABORATORIES LTDX takes full responsibility for the activities of its
subcontractors except in the case where the client or regulatory agency specifies which
subcontractor is to be used. TSWAN LABORATORIES LTDX follows a procedure to
ensure that sub-contractors and suppliers are qualified to perform their work assignments and
that their activities are monitored. TSWAN LABORATORIES LTDX also:
a. Maintains a list of qualified subcontractors and a record of their compliance with appropriate
International Standards. (Qualified Subcontractors QF6.2.2.4.1)

b. Maintains records of approved suppliers. (Approved Suppliers LQF4.6.4.1)

c. Follows the procedures for non-conformances related to subcontractors and suppliers.
d. Asks its clients to provide their consent before any work is allowed to be subcontracted.
(Subcontractor Authorization Request QF6.2.2.4.2)
e. May require sub-contractors to read any quality system documents applicable to their work
activities.
f. Requires all subcontractors to sign legally binding confidentiality agreements and declare any
situations within their organization which may cause conflicts of interest.
(Confidentiality Agreement QF6.2.2.3)

7.0 Process Requirements

7.1 Review of Requests, Tenders and Contracts

 7.1.1 TSWAN LABORATORIES LTDX has a procedure for the Review of Requests, Tenders
and Contracts (See LQSP4.4.1).

7.1.2 The TSWAN LABORATORIES LTDX labs uses internationally recognized and current
testing methods.

7.1.3 Test results requiring a statement of conformity to a standard or regulation shall identify the
reference, the criteria, and the calculation method if applicable. TSWAN LABORATORIES
LTDX does not issue calibration certificates.

7.1.4 The TSWAN LABORATORIES LTDX lab requires legally binding contracts for
certification related testing activities. All other testing may be completed in the form of
request. TSWAN LABORATORIES LTDX shall decline to undertake the testing if there
is a lack of competence or capability for any of the required activities.

7.1.5 Deviations from the agreement and non-conformities affecting the accuracy of reported
testing results shall be reported to the client as soon as apparent. Any deviations requested
by the customer shall be documented. Requested deviations which are unethical shall not
be considered or accepted.

7.1.6 Amendments to the contract or request may require additional review including revision to the
evaluation plan, re-assignment of personnel or resources, and distribution of additional
documents and information.

7.1.7 TSWAN LABORATORIES LTDX affords clients cooperation to clarify the client’s request
and to monitor the lab’s performance in relation to the work performed, provided that the
laboratory ensures confidentiality of other clients. Clients are welcome to visit TSWAN
LABORATORIES LTDX as long as a minimum of 48 hours’ notice is provided. The
Program Manager shall maintain a minimum of weekly communication with clients when
the time frame of applicable tests merits it.

7.1.8 Records of pertinent discussions, reviews, requests, tenders and contracts shall be retained per
the record control procedure. Verbal requests shall be confirmed in writing.

7.2 Selection, Verification and Validation of Methods

7.2.1 Selection, and Verification of Methods (Demonstration of Capability Procedure

LQSP5.2.1)

7.2.1.1 The TSWAN LABORATORIES LTDX lab uses appropriate methods and procedures for
all tests and calibrations within its scope. Methods published in “Standard Methods are
used. TSWAN LABORATORIES LTDX has rewritten the methods as Lab Standard
Operating Procedures (SOP) to facilitate ease of use by TSWAN LABORATORIES
LTDX personnel.

7.2.1.2 All reference materials required by authorized personnel are available to them. Personnel
are assigned their own copy of procedures for their use. All documents are kept current and
tracked through document control procedures.
7.2.1.3 Revised methods are updated annually. Revised methods are not adopted into the TSWAN
LABORATORIES LTDX Lab Quality System until review and approval.

7.2.1.4 All methods are appropriate for the applicable measurement parameter and concentration.
The laboratory uses test methods which meet the needs of the client and which are
appropriate for the tests it undertakes. The laboratory uses the latest valid edition of any
applicable standard.

7.2.1.5 Methods selected by the TSWAN LABORATORIES LTDX lab are verified before adoption
into use at TSWAN LABORATORIES LTDX. Standard Operating Procedures (SOP)
specifically for use by TSWAN LABORATORIES LTDX personnel shall be written for
each method. Revised methods are re-verified. Lab personnel shall complete an Initial
Demonstrations of Capability (DOC) following successful training for each applicable lab
analysis prior to initial data reporting. Ongoing Demonstrations of Capability (DOC) shall be
performed annually. Lab personnel shall also participate in semi-annual proficiency testing
from an outside authorized proficiency test provider for all analytes and methods that they
are authorized to perform.

7.2.1.6 The TSWAN LABORATORIES LTDX lab does not develop methods. The TSWAN
LABORATORIES LTDX lab does not use non-standard methods.

7.2.1.7 Any deviations from verified methods shall be documented and reported by the technician,
justified and authorized by the Lab Manager, and be acceptable by the customer.

7.2.2 Validation of Methods

The TSWAN LABORATORIES LTDX lab does not use non-standard methods, develop methods
or use standard methods outside their intended scope.

7.3 Sampling

7.3.1 The TSWAN LABORATORIES LTDX lab has sampling procedures for all on-site sampling
activities. Composite sampling programs are tailored specifically for individual flow
patterns. All sampling locations are labeled.

7.3.2 Detailed instructions for collecting samples on-site at TSWAN LABORATORIES LTDX are
contained in the sampling procedures. A sampling plan shall be developed for sampling
conducted by TSWAN LABORATORIES LTDX personnel at locations off -site.

7.3.3 Relevant sampling data is recorded on the Chain of Custody (LQF5.8.1) or the Field Report
(QF7.4.5). Any deviations from the sampling procedures or programs are documented on the
Chain of Custody (LQF5.8.1) and noted in the Test Report. Deviations from the sampling
procedures requested by the customer are reviewed, recorded in the customer’s file and
communicated to the appropriate personnel.

7.4 Handling of Test Items (Test Item Handling Procedure LQSP5.8.1.1)

7.4.1 TSWAN LABORATORIES LTDX has a procedure for the transportation, receipt, handling,
protection, storage, retention, disposal and/or return of test items.

7.4.2 TSWAN LABORATORIES LTDX has a system for identifying test items.

7.4.3 Upon receipt of test items, abnormalities are recorded on the Chain of Custody. When there is
doubt as to the suitability of the item for testing, the Lab General Manager shall consult the
client for further instructions. Deviations from acceptable conditions are included in the
report.

7.4.4 The laboratory has the proper accommodations for preservation, storage, handling, and
preparation of test items as required by the methods. Storage conditions are monitored and
recorded.

7.5 Technical Records

7.5.1 TSWAN LABORATORIES LTDX has a procedure for the execution and retention of
technical records and bench sheets to facilitate identification of factors affecting uncertainty
of test results and to enable the test to be repeated as close as possible to the original. Dates
and personnel conducting the test activity is recorded for all testing. Original measurements,
data, and calculations shall be recorded at the time they are made.
7.5.2 Correction and alterations of data are required to be initialed and dated. Original records are
kept with the revised records.

7.6 Measurement Uncertainty (Procedure to Estimate Uncertainty LQSP5.4.6.1)

7.6.1 TSWAN LABORATORIES LTDX uses procedures to estimate the uncertainty of

measurement for the equipment calibrations and testing measurements it performs. Method
Detection Level determinations shall be conducted for all applicable test methods and all lab
analysts prior to initial data reporting. Subsequent MDL determinations are required once
yearly for each applicable analysis that the lab performs.

7.6.2 Calibrations of equipment are evaluated for measurement uncertainty and documented in the
calibration record.

7.6.3 All uncertainty components are taken into account using appropriate methods of analysis. If
uncertainty cannot be calculated, an estimation is provided.

7.7 Assuring the Validity of Results (Reference Standard Calibration ProcedureLQSP5.6.3.1)

7.7.1 TSWAN LABORATORIES LTDX has quality control procedures to ensure the validity of the
tests performed by lab personnel. Results of quality control testing are tracked. These quality
control functions are contained in the various individual Lab Procedures where applicable.

7.7.2 Semi-annually, all lab analysts shall analyze proficiency tests for all authorized test methods.
The lab utilizes a second source calibration standard for internal proficiency purposes. The
analyst must achieve a recovery within the specified range defined in the lab SOP or take
corrective action if results are outside of the acceptance range.

7.7.3 Data from quality control testing is used to improve analysis techniques and identify non-
conformances. The criteria for quality control testing is set by the proficiency testing
provider or included in the applicable lab SOP.

7.8 Data Reporting

7.8.1 General

7.8.1.1 All test data is reviewed and test reports are authorized and signed by the Lab General
Manager and/ or the Program Manager.

7.8.1.2 Test reports include all of the results requested by the customer. Copies of every test report
are kept on fi le. Test reports can be issued electronically or hard copy.

7.8.1.3 Test results and data may be reported in the form of a lab report, a final evaluation report, or
a data spreadsheet. The form of the report shall be suitable for the type of testing and fulfill
the customer’s needs. The format of Test Reports is such as to accommodate ease of
interpretation.

7.8.2 Minimum Requirements for Test Reports

7.8.2.1 TSWAN LABORATORIES LTDX lab test reports are clear, complete, and include certain
basic information. This includes:
a. The name and address of the lab and location of testing
b. The name and contact information of the customer.
c. Identification of the persons performing the tests and authorizing the report
d. A title, page numbers, and a unique test report number on every page.
e. Dates for collection, receipt, analysis, and the report.
f. The results, units of measurement, and any deviations.

7.8.2.2 The TSWAN LABORATORIES LTDX lab is responsible for sampling conducted by the lab
and data produced by the lab and its authorized subcontractors. Testing results from
subcontractors are clearly identified as such on the Test Report. Data and sampling provided
by the customer is clearly marked as such. The TSWAN LABORATORIES LTDX lab is not
responsible for data and sampling conducted by the customer. Test results relate only to the
items identifi ed as tested in the report.

7.8.3 Specific Requirements for Test Reports

7.8.3.1 When applicable, certain other information is included in the test reports. This may include
environmental conditions, measurement uncertainty parameters, and opinions or
interpretations.

7.8.3.2 Details of sampling activities are included in the test reports. See section 7.8.5.

7.8.4 Calibration Certif cates

The TSWAN LABORATORIES LTDX Lab does not generate Calibration Certifi cates.

7.8.5 Sampling Reports

When TSWAN LABORATORIES LTDX collects the samples, detailed information is also
included in the test reports. This includes the location of sampling, a reference to the
sampling plan, the sampling method, and environmental conditions.

7.8.6 Statements of Conformity

The TSWAN LABORATORIES LTDX Lab reports only the data and does not issue statements of
conformity.

7.8.7 Opinions and Interpretations

7.8.7.1 The Lab General Manager is the only person authorized to express or report opinions or
interpretation regarding lab activities, analysis methods, or the data. The laboratory shall
document the basis upon which the opinions and interpretations have been made.

7.8.7.2 Opinions and interpretations shall be clearly marked as such in the report.
16
7.8.7.3 Opinions and interpretations provided verbally are documented.

7.8.8 Amendments to Reports

7.8.8.1 Amended test reports include identifi cation of which information was changed and the
reason for the change. Amended reports shall meet all of the requirements of section 7.8 for
test reports.

7.8.8.2 Material amendments to a Test Report after issue shall be made only in the form of a further
document, or data transfer, which includes the statement: “Amendment to Test Report #
XXX-TSWAN LABORATORIES LTDXX”.

7.8.8.3 When it is necessary to issue a completely new test report, it is uniquely identified and
contains a reference to the original that it replaces.

7.9 Complaints (Complaint Procedure QSP7.13)

7.9.1 TSWAN LABORATORIES LTDX has a procedure for the resolution of complaints received
from clients or other parties.

7.9.2 The TSWAN LABORATORIES LTDX complaint procedure is available upon request to
anyone. If the complaint is misdirected, TSWAN LABORATORIES LTDX will direct the
complainant to the appropriate contact.

7.9.3 Records are maintained of all complaints, investigations and corrective actions taken by the
laboratory. Complaints are logged and tracked.

7.9.4 TSWAN LABORATORIES LTDX is responsible for the investigation and resolution of all
submitted complaints.

7.9.5 TSWAN LABORATORIES LTDX acknowledge receipt of all complaints and provides regular
updates on the status of the investigation.

7.9.6 The investigation, communication, and decision resolving the complaint shall be made by
persons not involved in activities related to the complaint.

7.9.7 The outcome of complaint investigations are communicated to the complainant.

7.10 Non-Conformances Non-Conformance and Corrective Actions Procedure (QSP8.7)

7.10.1 TSWAN LABORATORIES LTDX has a procedure for the handling of non-conformances.

7.10.2 Records are maintained of all on-conformances, investigations, root causes, and corrective
actions taken by the laboratory. Non-conformances are logged and tracked.

7.10.3 Where an evaluation of the non-conformance indicates the non-conformance could recur or
there is doubt about the lab’s compliance with its own policies and procedures, the Non-
Conformance and Corrective Actions Procedure should be promptly followed.
7.11 Control of Data

7.11.1 TSWAN LABORATORIES LTDX collects, stores, or has access to all information required
to perform it’s functions.

7.11.2 Any TSWAN LABORATORIES LTDX lab automated equipment used for the acquisition of
data shall utilize the equipment manufacturer’s software designed for the particular
application. TSWAN LABORATORIES LTDX uses computer software suitable for the
processing, recording, reporting, storage and retrieval of test data. TSWAN
LABORATORIES LTDX has a procedure for data protection (See QSP8.4). Computers are
maintained to ensure proper functioning in a climate-controlled environment.

7.11.3 Data and information stored at TSWAN LABORATORIES LTDX is password protected or
locked and stored in appropriate environmental conditions. Paper copies are backed up
electronically. Electronic copies are backed up and stored off -site.

7.11.4 TSWAN LABORATORIES LTDX manages, stores and maintains its own data.

7.11.5 All reference materials required by authorized personnel to perform their duties are available
to them. Personnel are assigned their own copy of procedures for their use.

7.11.6 All data transfers and calculations are checked and verified by a secondary person.

8.0 Quality Management System

8.1 General

This document, plus other documents described herein, defi nes the quality system supporting the
testing activities at the TSWAN LABORATORIES LTDX lab. This quality system manages
all testing work performed at the TSWAN LABORATORIES LTDX lab as well as all fi eld
activities. It also governs reports and assures objectivity of the information contained in the
reports.

8.2 Management System Documentation

8.2.1 The TSWAN LABORATORIES LTDX lab has defined and documented policies and
objectives for quality in accordance with ISO/IEC 17025 and TNI 2016 Laboratory Standard
by establishing this Quality Manual and every other document in the Quality Management
System. The Program Manager ensures that these policies are acknowledged, implemented,
and maintained at all levels of the operations. The Program Manager also ensures that all
employees are made aware of the relevance and importance of their activities and how they
contribute to the achievement of quality objectives. All employees shall read the Lab
Quality Manual and are required to acknowledge their strict adherence to following the
procedures and instructions contained in the Lab Quality Manual. All employees are
encouraged to report any improprieties by management to either the Certification
Committee, the Lab management SON , or any other regulatory authority. (Obligations of
Employees QF6.1.3)

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8.2.2 The Quality Management System includes policies and procedures which ensure competent
and accurate testing. The TSWAN LABORATORIES LTDX lab also has procedures to
ensure the impartiality of its personnel and activities.

8.2.3 The Lab General Manager report to the Management of the Lab and is appointed to oversee
the proper implementation of the quality system in the lab. The Lab General manager is the
leader for testing activities, and therefore has authority to direct the activities of lab
personnel on a day-to-day basis and has significant influence in employment, assignment,
disciplinary actions, and termination. TSWAN LABORATORIES LTDX is committed to
the improvement and proper implementation of the entire Quality Management System. The
Quality Management System is regularly reviewed for proper implementation and for areas
of improvement during:
a. Management reviews (8.5)
b. Annual internal audits (8.6)
c. Corrective actions (8.7)
d. Monthly preventive actions meetings (8.8)
Records of these actions provide evidence that the quality system is being followed and improved
upon.

8.2.4 This Lab Quality Manual is considered the master document governing the TSWAN
LABORATORIES LTDX lab. The Lab Quality Manual outlines the general principles and
policies of the TSWAN LABORATORIES LTDX lab in regards to the requirements set
forth in ISO/IEC 17025 Standard. The specific details of testing activities and
responsibilities are included in the Lab Quality System Procedures. All quality system
procedures (LQSP) are referenced in this document and all quality forms (LQF) are
referenced in those quality system procedures. The entire quality system is linked as a
network and all quality system documents can be found through this Lab Quality Manual.

8.2.5 All personnel are provided access to the Quality Management System through this Quality
Manual and are required to read the Quality Manual soon after hiring. The Program Manager
identifies the documents which are distributed to the appropriate personnel for them to
properly fulfill their duties and notifies all employees when any changes to the Quality
Manual have been made.

8.3 Document Control (Document Control Procedure QSP8.3)

8.3.1 TSWAN LABORATORIES LTDX has a procedure for the control of documents
which are generated internally and form a part of the TSWAN LABORATORIES
LTDX quality system. TSWAN LABORATORIES LTDX maintains current
versions of external documents. Original paper copies of approved versions of
quality system documents are contained in the Quality Management System master
binder. Electronic versions of quality system documents are contained in the Quality
Management System folder on the TSWAN LABORATORIES LTDX computer
system. The Program Manager has responsibility for document control. No other
employees are authorized to alter documents or the directory in which they are kept.
 8.3.2 TSWAN LABORATORIES LTDX document control ensures that:
a. Only current versions of approved documents are circulated for use.
b. All documents are reviewed at least annually and updated as needed.
c. All TSWAN LABORATORIES LTDX quality system documents have a document control
number and a revision number.
d. Personnel are assigned their own copy of documents for their use and document distribution is
tracked. (Documents Issued Log (QF7.4.3)
e. Documents which have become degraded or illegible are replaced.
f. The distribution of external documents is also controlled.

g. Obsolete documents are retrieved, archived or destroyed, and replaced with approved versions.

8.4 Record Control (Record Control Procedure QSP8.4)

8.4.1 TSWAN LABORATORIES LTDX has a procedure for the control of general records
including identification, collection, indexing, access, fi ling, storage, maintenance
and disposal of records. These records include reports from internal audits,
management reviews and corrective and preventive actions. All records shall be
legible and stored in a safe manner. TSWAN LABORATORIES LTDX follows all
legal requirements (state and federal) regarding the control of documents. Records
generated and stored at TSWAN LABORATORIES LTDX are maintained so as to
protect confidential information. In the event that TSWAN LABORATORIES
LTDX is purchased, all records are the property of the new owners. In the event that
TSWAN LABORATORIES LTDX goes out of business or becomes bankrupt, the
Program Manager is obligated to become the custodian of records and will maintain
the records according to all document/record control procedures.

8.4.2 All records are stored in a secure fi le cabinet, in case of paper copy, and/or on the
TSWAN LABORATORIES LTDX computer system, in case of electronic
documents. Both the fi le cabinet and the area on the server have restricted access. A
cyclic backup of electronic fi les is carried out weekly and the backup copies are
maintained in a diff erent building for increased data safety, e.g. to prevent damage
by fi re. Long-term archiving and retrieval is the responsibility of the Program
Manager.
Types of records include:
a. Records which are generated directly from individual testing activities. These type of records
shall be identified by the TSWAN LABORATORIES LTDX project code or the product name
and are retained for the previous and the current evaluation cycle.
b. Records which are generated internally by TSWAN LABORATORIES LTDX for
administrative reasons and fulfillment of the requirements of ISO/IEC 17025. These type of
records are identified by the document control number and are retained for 7 years.

8.5 Risks and Opportunities

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 8.5.1 TSWAN LABORATORIES LTDX is dedicated to undertaking activities impartially
and also eliminating risks to impartiality which arise from its activities and the
activities of its personnel. Conflicts of interest cast doubt on the accuracy and
validity of results and cannot be allowed to influence testing activities. TSWAN
LABORATORIES LTDX maintains the integrity of data and ensures the ethical
conduct of its personnel. TSWAN LABORATORIES LTDX conducts annual data
integrity and ethics training for all employees and ensures its personnel are aware of
the relevance of their activities and how they contribute to the achievement of the
objectives of the TSWAN LABORATORIES LTDX management system. See
Management Requirements Procedure (LQSP4.1.5.2).

8.5.2 TSWAN LABORATORIES LTDX routinely identifies risks to impartiality that arise
from its activities and relationships, and the activities and relationships of its
personnel. Risks are identified and evaluated through the following means:
a. Personnel conflict of interest questionnaires at the time of hiring, before undertaking any testing,
and before any job reassignment. (Conflict of Interest Questionnaire QF4.2.3.1)
b. Written assessments of the impartiality of personnel which is reviewed by the Lab management.
c. Annual impartiality reviews.
d. Annual management reviews.

8.5.3 When risks to impartiality are identified, TSWAN LABORATORIES LTDX takes steps to
eliminate or minimize those risks. Actions are equal in magnitude to the risk. Possible
actions are included in QSP4.2.

8.6 Improvement (Preventive Actions Procedure QSP8.8)

8.6.1 TSWAN LABORATORIES LTDX strives to improve the effectiveness of its management
system through the use of its quality system, audit results, customer feedback, management
reviews, corrective actions and preventive actions. Suggestions for improvements to the
quality system and sources of potential non-conformances are received and discussed during
the monthly staff meeting. Once a potential source of non-conformances has been identified,
preventive actions are taken which follow the same process used for nonconformance’s
including identification, documentation, and re-evaluation for effectiveness. TSWAN
LABORATORIES LTDX has a procedure to identify and reduce or eliminate sources of
potential non-conformances.

8.6.2 Preventive actions are implemented to address the reason for the potential non-conformance
and shall be equal in magnitude to the effect the potential non-conformance may cause.
TSWAN LABORATORIES LTDX solicits feedback from its customers. This questionnaire
is distributed to the customer upon project completion. (Customer Survey LQF4.7.1)
8.7 Corrective Actions (Non-Conformance and Corrective Actions Procedure QSP8.7)

8.7.1 TSWAN LABORATORIES LTDX has a procedure to identify, document, and analyze quality
system non-conformances and implementing corrective action when non-conforming work
or departures from the procedures and policies in the management system or technical
 operations have been identified. Corrective actions are taken to eliminate or reduce the cause
of the non-conformance which may include revising procedures and forms, additional
personnel training, or any other effective action. TSWAN LABORATORIES LTDX has a
policy for

8.7.2 Corrective actions are implemented to address the reason for the non-conformity and shall be
equal in magnitude to the effect the non-conformance has caused in the test, results, or
report. Management evaluates the significance of the non-conformity and may immediately
stop the affected work.

8.7.3 All quality system non-conformances and corrective actions are tracked and documented. The
causes of all quality system non-conformities are identified through a documented root cause
analysis and the corrective action shall be designed to reform the reason for which the non-
conformance occurred. Corrective actions shall be implemented in a timely manner and the
projected dates of completion defined. All corrective actions are re-evaluated at a later date
for effectiveness. Where appropriate, TSWAN LABORATORIES LTDX will perform
additional monitoring to ensure compliance with the quality system.

8.8 Internal Audits (Internal Audit Procedure QSP8.6)

8.8.1 TSWAN LABORATORIES LTDX has a procedure for the conduct of internal audits. The
Program Manager is responsible for arranging or conducting internal audits annually.
Internal audits are performed annually within a 12-month time frame. The projected date for
the next internal audit is scheduled during the current internal audit. If the Lab management
determines that habitual and/or unsatisfactory compliance with the quality management
system is occurring, the management may increase the frequency of internal audits as a
function of the management review.

8.8.2 Internal audits of the laboratory follow the Checklist for the Competence of Testing
Laboratories in accordance with ISO 17025. The person(s) conducting the audit shall be
knowledgeable and experienced concerning the Standards and documents related to the
TSWAN LABORATORIES LTDX Quality Management System. Auditors cannot audit
their own work. Non-conformances and opportunities for improvement are identified and
addressed through the nonconformance and corrective actions procedure. All TSWAN
LABORATORIES LTDX personnel are informed of the results of internal audits.

8.9 Management Review (Management Review Procedure QSP8.5)

8.9.1 The TSWAN LABORATORIES LTDX Lab management conducts a complete review of the
TSWAN LABORATORIES LTDX Quality Management System and activities on an annual
basis. This review ensures that the quality system is adequate for the fulfillment of testing
activities under ISO/IEC 17025 Standard. The review also ensures the effectiveness of the
quality system for satisfying the requirements of the TSWAN LABORATORIES LTDX lab
quality policies and objectives.

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8.9.2 The Program Manager provides the Lab management with a current copy of the Lab Quality
Manual and all necessary information related to the activities of TSWAN LABORATORIES LTDX
from the previous year, including: a. The results of all audits.
b. Feedback from clients, including complaints and appeals.

c. Feedback from impartiality reviews.

d. Personnel issues and employee training.
e. The status of all preventive and corrective actions.
f. The status of objectives and actions from previous management meetings.
g. Any changes that could affect the quality management system.

8.9.3 The Lab management reviews the information and decides what changes should be made to
improve both the Lab and the implementation of the Quality Management System.