Quality Manual Sample
Quality Manual Sample
Quality Manual Sample
0 Scope
2.0 The lab at North American Testing (NAT) is committed to a policy of providing exemplary service
with respect to performing accurate testing and analysis of environmental water and wastewater
samples. The NAT lab provides laboratory testing for the NAT Certification Body and any customer
requesting lab analysis under the scope of testing. The lab conforms to ISO/IEC Standard 17025 and
TNI 2016 Laboratory Standard.
उ तर अमे रक पर ण (एनएट ) क योगशाला पयावरणीय जल और अप!श"ट जल के नमून$ के सट क
पर ण और &व'लेषण के संबध
ं म, अनक
ु रणीय सेवा दान करने क नी/त के !लए /तब0 है। NAT लैब NAT
स4ट5फकेशन बॉडी के !लए योगशाला पर ण और पर ण के दायरे म, योगशाला &व'लेषण का अनरु ोध
करने वाले 5कसी भी :ाहक को दान करता है। योगशाला आईएसओ / आईईसी मानक 17025 और
ट एनआई 2016 योगशाला मानक के अनE
ु प है।
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. Standard Methods for the Examination of Water and Wastewater (23rd edition).
7. NSF/ANSI Standard 350 Onsite Residential and Commercial Water Reuse Treatment Systems
8. TNI 2016 Laboratory Standard Volume 1: Management and Technical Requirements for Laboratories
Performing Environmental Analysis.
9. New York State Regulations Title 10, Subpart 55-2 - Approval of Laboratories Performing
Environmental Analysis
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.
4.1 Impartiality
4.1.1 The NAT 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. NAT 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.
एनएट लैब /न"प Eप से पर ण ग/त&वFधय$ को करने के !लए सम&पत है और /न"प ता के !लए जोGखम$ को
भी समाIत करता है जो इसक ग/त&वFधय$ और इसके क!मय$ क ग/त&वFधय$ से उ पKन होता है। एनएट क
ऐसी नी/तयां और 5Mयाएं हN जो 5कसी भी ग/त&वFधय$ म, शा!मल होने से बचती हN, जो इसक मता, /न"प ता,
/नणय या प रचालन अखंडता म, आ म&व'वास को कम करती हN। प रणाम$ क सट कता और वैधता पर Pयाज के
4.1.2 NAT 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 Board of Directors is composed
of respectable area business people free from any commercial, financial or other pressures that might
influence decisions and sign Conflict of Interest agreements stating as such. Rev031119 Page 4 of 17 Lab
Quality Manual (Confidentiality and Disclosure Agreement QF4.5)
NAT यह सु/नि'चत करता है 5क उसके व र"ठ अFधकार और कमचार 5कसी भी Sयावसा/यक, &व तीय और अKय
दबाव$ से मुTत हN जो पर ण 5Mया के प रणाम$ को भा&वत कर सकते हN। /नदे शक मंडल 5कसी भी वाGणिUयक,
&व तीय या अKय दबाव$ से मुTत सVमानजनक ेW के Sयवसायी लोग$ से बना है, जो /नणय$ को भा&वत कर
सकते हN और इस तरह के बताते हुए 4हत$ के समझौत$ पर हZता र कर सकते हN। Rev031119 Page 4 of 17
लैब गण
ु व ता मैनअ
ु ल (गोपनीयता और कट करण समझौता QF4.5)
4.1.3 The NAT lab is responsible for the impartiality of its activities. NAT 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.
एनएट लैब अपनी ग/त&वFधय$ क /न"प ता के !लए िजVमेदार है। NAT अपने क!मय$ को 5कसी भी आंत रक
गण
ु व ता पर /तकूल भाव डाल सकते हN। कमचार के वेतन और पदोKन/त पर ण या 5कसी भी संबFं धत
4.1.4 NAT 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 Board of Directors. c. Annual
impartiality reviews. d. Annual management reviews.
NAT /नय!मत Eप से /न"प ता के !लए जोGखम$ क पहचान करता है जो इसक ग/त&वFधय$ और संबध
ं $ और
समय Pयाज 'नावल के का!मक संघष। (Pयाज 'नावल QF4.2.3.1 का संघष) b। /नदे शक मंडल cवारा समी ा
क गई क!मय$ क /न"प ता का !लGखत आकलन। सी। वा&षक /न"प ता समी ा। घ। वा&षक बंधन समी ा।
4.1.5 When risks to impartiality are identified, NAT takes steps to eliminate or minimize those risks.
जब /न"प ता के जोGखम क पहचान क जाती है, तो NAT उन जोGखम$ को ख म करने या कम करने के !लए
4.2 Confidentiality
4.2.1
The NAT 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. NAT 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 NAT 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 NAT personnel and subcontractors involved in testing activities sign a Confidentiality and
Disclosure Agreement (QF4.5).
5.1 The NAT lab is a division of North American Testing which is a legal entity registered as a Limited
Liability Company to do business in the state of Ohio.
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 The NAT lab scope of testing includes all required testing defined in NSF/ANSI Standards 40, 46, 245,
350, and the following analytes: CBOD5/BOD5 (Carbonaceous / Biochemical Oxygen Demand) TSS (Total
Suspended Solids) pH Alkalinity Temperature Dissolved Oxygen Turbidity Chlorine Rev031119 Page 5 of
17 Lab Quality Manual Fecal Coliforms E. Coli TKN-N (Total Kjeldahl Nitrogen) NH3-N (Ammonia
Nitrogen) NO2-N (Nitrite Nitrogen) NO3-N (Nitrate Nitrogen) PO4-P (ortho-Phosphate) Total Phosphorus
5.4 NAT shall carry out its testing and calibration activities according to the requirements of ISO/IEC
Standard 17025, the TNI 2016 Laboratory Standard, and to satisfy the needs of the customer. This
management system covers work carried out by NAT employees at the NAT permanent facilities, the
NAT test site, and field activities.
5.5 NAT defines the organization and management structure of the laboratory. The NAT 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 NAT 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 NAT personnel are aware of the importance of
meeting customer requirements. All staff is required to read and understand the NAT Lab Quality
Manual as documented in QF6.1.3. A signed copy of this document is kept in the employee’s personnel
fi le. 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
6.1 General
The NAT lab is equipped and staffed with adequate resources necessary to perform its laboratory
activities.
6.2.1 The NAT lab shall only use employees who are employed by, or under contract to NAT, and have
completed the impartiality and confidentiality requirements of NAT.
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. NAT has a procedure for training of new
employees (See QSP6.1.2).
6.2.4 NAT maintains Job Descriptions for all positions (See QF6.1.1.2).
6.2.5 NAT has a procedure which defines the requirements for the competencies, training goals, formal
authorization, demonstration of capability, and monitoring of personnel.
6.2.6 NAT formally authorizes only certain personnel to perform certain tasks. These tasks include
quality system maintenance, method verification, data validation, and lab analyses. NAT maintains
records of Rev031119 Page 6 of 17 Lab Quality Manual the qualifications and training of all personnel
(See QF6.1.2.1).
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 (NAT 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 contamination are
met regardless of the location. This includes testing conducted at the NAT laboratory, the NAT test site,
and any field activities.
6.4.1 The NAT 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 NAT 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.
6.4.6 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 in the calibration
status of the Rev031119 Page 7 of 17 Lab Quality Manual 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.
6.5.1 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 certified reference
materials provided by an approved and certified provider.
6.6.1 When lab activities are beyond the capability of NAT, 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 NAT 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 NAT 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. NAT follows a procedure to
ensure that sub-contractors and suppliers are qualified to perform their work assignments and that their
activities are monitored. NAT 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) Rev031119
Page 8 of 17 Lab Quality Manual 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)
7.1.1 NAT has a procedure for the Review of Requests, Tenders and Contracts (See LQSP4.4.1).
7.1.2 The NAT labs uses nationally 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. NAT does not issue calibration
certificates.
7.1.4 The NAT lab requires legally binding contracts for certification related testing activities. All other
testing may be completed in the form of request. NAT 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 NAT 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 NAT 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 merit 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.
7.2.1.1 The NAT lab uses appropriate methods and procedures for all tests and calibrations within its
scope. Methods published in “Standard Methods For The Examination of Water And Wastewater (23rd
Edition)” are used. NAT has rewritten the methods as Lab Standard Operating Procedures (SOP) to
facilitate ease of use by NAT 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 NAT Lab
Quality System until review and approval. Rev031119 Page 9 of 17 Lab Quality Manual Page 10 of 17
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 NAT lab are verified before adoption into use at NAT. Standard
Operating Procedures (SOP) specifically for use by NAT 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 NAT lab does not develop methods. The NAT 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.
The NAT lab does not use non-standard methods, develop methods or use standard methods outside
their intended scope.
7.3 Sampling
7.3.1 The NAT lab has sampling procedures for all on-site sampling activities. Composite sampling
programs are tailored specifically for individual fl ow patterns. All sampling locations are labeled.
7.3.2 Detailed instructions for collecting samples on-site at NAT are contained in the sampling
procedures. A sampling plan shall be developed for sampling conducted by NAT 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 fi le and communicated to the appropriate
personnel.
7.4.1 NAT has a procedure for the transportation, receipt, handling, protection, storage, retention,
disposal and/or return of 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.
7.5.1 NAT 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. Rev031119 Lab Quality Manual
7.5.2 Correction and alterations of data are required to be initialed and dated. Original records are kept
with the revised records.
7.6.1 NAT 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 Procedure LQSP5.6.3.1)
7.7.1 NAT 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.
7.8.1 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
customers 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 NAT 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. Rev031119 Page 11 of 17 Lab
Quality Manual Page 12 of 17
7.8.2.2 The NAT 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 NAT lab is not
responsible for data and sampling conducted by the customer. Test results relate only to the items
identified as tested in the report.
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.
When NAT 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.
The NAT Lab reports only the data and does not issue statements of conformity.
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.
7.8.8.1 Amended test reports include identification 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-XXXXXX”.
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.
7.9.1 NAT has a procedure for the resolution of complaints received from clients or other parties.
7.9.2 The NAT complaint procedure is available upon request to anyone. If the complaint is misdirected,
NAT 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. Rev031119 Lab Quality Manual
7.9.4 NAT is responsible for the investigation and resolution of all submitted complaints.
7.9.5 NAT 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.
7.10.3 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.
7.11.1 NAT collects, stores, or has access to all information required to perform it’s functions.
7.11.2 Any NAT lab automated equipment used for the acquisition of data shall utilize the equipment
manufacturer’s software designed for the particular application. NAT uses computer software suitable
for the processing, recording, reporting, storage and retrieval of test data. NAT 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 NAT 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.
7.11.5 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.
8.1 General
This document, plus other documents described herein, defines the quality system supporting the
testing activities at the NAT lab. This quality system manages all testing work performed at the NAT lab
as well as all fi eld activities. It also governs reports and assures objectivity of the information contained
in the reports.
8.2.1 The NAT 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 Rev031119 Page 13 of 17 Lab Quality Manual Page 14 of 17 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 Board of Directors, ANSI, or any other regulatory authority. (Obligations of Employees
QF6.1.3)
8.2.2 The Quality Management System includes policies and procedures which ensure competent and
accurate testing. The NAT lab also has procedures to ensure the impartiality of its personnel and
activities.
8.2.3 The Lab General Manager report to the Board of Directors 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. NAT 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 NAT lab. The Lab
Quality Manual outlines the general principles and policies of the NAT lab in regards to the requirements
set forth in ISO/IEC 17025 and TNI 2016 Laboratory 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.
8.3.1 NAT has a procedure for the control of documents which are generated internally and form a part
of the NAT quality system. NAT 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 NAT 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 NAT 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 NAT
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. Rev031119 Lab Quality Manual g. Obsolete
documents are retrieved, archived or destroyed, and replaced with approved versions.
8.4.2 All records are stored in a secure fi le cabinet, in case of paper copy, and/or on the NAT 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 different 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 NAT
project code or the product name and are retained for the previous and the current evaluation cycle. b.
Records which are generated internally by NAT 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.
8.5.1 NAT 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. NAT maintains the
integrity of data and ensures the ethical conduct of its personnel. NAT 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 NAT management
system. See Management Requirements Procedure (LQSP4.1.5.2).
8.5.2 NAT 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 Board of Directors. c. Annual
impartiality reviews. d. Annual management reviews.
8.5.3 When risks to impartiality are identified, NAT takes steps to eliminate or minimize those risks.
Actions are equal in magnitude to the risk. Possible actions are included in QSP4.2.
8.6.1 NAT 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
nonRev031119 Page 15 of 17 Lab Quality Manual Page 16 of 17 conformances including identification,
documentation, and re-evaluation for effectiveness. NAT 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. NAT solicits
feedback from its customers. This questionnaire is distributed to the customer upon project completion.
(Customer Survey LQF4.7.1)
8.7.1 NAT 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. NAT 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, NAT will perform additional monitoring to ensure compliance with the quality system.
8.8.1 NAT 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 Board of Directors determines that habitual and/or unsatisfactory compliance with
the quality management system is occurring, the Board 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 NAT Quality Management System. Auditors
cannot audit their own work. Non-conformances and opportunities for improvement are identified and
addressed through the non conformance and corrective actions procedure. All NAT personnel are
informed of the results of internal audits.
8.9.2 The Program Manager provides the Board of Directors with a current copy of the Lab Quality
Manual and all necessary information related to the activities of NAT from the previous year, including:
a. The results of all audits. b. Feedback from clients, including complaints and appeals. Rev031119 Lab
Quality Manual 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 Board of Directors reviews the information and decides what changes should be made to
improve both the Lab and the implementation of the Quality Management System.