Saturday, October 15, 2011

ISO/IEC 17025 QUALITY MANUAL


ISO/IEC 17025 QUALITY MANUAL
Revision F
http://www.mobilepowersolutions.com/files/MPS_Quality_Manual.pdf
  Mobile Power Solutions
ISO/IEC 17025 QUALITY MANUAL

TABLE OF CONTENTS
Quality Manual Section
Applicable
ISO/IEC 17025:2005
clause(s)  Page
Quality Policy 4.2.2 3
Introduction  4
Scope and Exemptions 1 4
1  Quality System Management Organization   4.1, 4.2 5, 6
2  Quality System Documentation and Record Control  4.3, 4.13 7, 8
3  Contract Review and Purchasing  4.4, 4.5, 4.6 9
4  Customer Service  4.7, 4.8 10
5  Quality System Monitoring and Measurement  4.9, 4.10, 4.11, 4.12, 4.14,
4.15
10, 11
6  Technical Requirements  
 General  5.1 12
 Testing Personnel  5.2 12
 Accommodation and Environmental Conditions  5.3 12, 13
 Test Methods and Method Validation  5.4 13, 14
 Test Equipment  5.5 14
 Measurement Traceability  5.6 15
 Sampling  5.7 15
 Handling of Test Items  5.8 15
 Test Quality Assurance  5.9 16
 Reporting Test Results  5.10 16, 17 Mobile Power Solutions
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     QUALITY POLICY
Mobile Power Solutions is committed to continual improvement of processes and services to
achieve ongoing customer satisfaction.  It is therefore our policy to:
Consistently provide quality testing services that conform to customer and regulatory
requirements.
Ensure that all personnel are competent and qualified for the tasks they perform, and
that all personnel familiarize themselves with quality system documentation in order to
implement the policies and procedures in their work.
Professionally and effectively perform testing services to produce accurate and precise
results.
Consistently comply with ISO 17025 to ensure quality testing services, and to continually
improve the effectiveness of the Quality Management System.
It is Mobile Power Solutions goal to encourage active participation of all employees in quality
planning and continual improvement efforts to meet all quality, service and cost objectives.
     Mobile Power Solutions
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  INTRODUCTION
Mobile Power Solutions was established in 2003 as a performance and regulatory testing
laboratory for batteries, cells and chargers.  The company recognizes its responsibility as a
provider of quality testing services.  To this end, Mobile Power Solutions has developed and
documented a quality management system to ensure customer satisfaction by complying with
regulatory requirements and improving management of the company.  The quality management
system has been designed to comply with international standards ISO/IEC 17025:2005 (E) and
ISO 9001:2000.
This manual has been prepared to define the quality system, establish responsibilities of the
personnel affected by the system, and to provide general procedures and policy statements 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 process controls are effectively
implemented to assure service quality.
SCOPE AND EXEMPTIONS
The Mobile Power Solutions quality management system applies to the testing of cells, batteries
and chargers by utilizing regulatory test methods and specific customer testing requirements.
ISO 17025 is an international standard containing general requirements for the competence of
testing and calibration laboratories.  Mobile Power Solutions is in business only a testing
laboratory and does not perform calibration services; therefore, the following exemptions apply:
Section 4.3.3.3 Document changes – Mobile Power Solutions’ document control system does
not allow for amendment of documents by hand.
Section 5.4.6.1 Estimation of uncertainty of measurement – applies only to a calibration
laboratory or testing laboratory performing its own calibrations.  Mobile Power Solutions does not
perform any equipment calibration.
Section 5.6.2.1 Calibration – applies only to a calibration laboratory or testing laboratory
performing its own calibrations.  Mobile Power Solutions does not perform any equipment
calibration.
Section 5.7 Sampling - is performed to the applicable regulatory test method or specific
customer requirements.  Mobile Power Solutions does not create sampling plans or procedures.
Section 5.10.4 Calibration certificates - applies only to a calibration laboratory or testing
laboratory performing its own calibrations.  Mobile Power Solutions does not perform any
equipment calibration. Mobile Power Solutions
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1 Quality System Management
Company Organization and Management Responsibility
 Mobile Power Solutions (MPS) is a registered Corporation in the State of Oregon and holds legal
responsibility for its operation.
 MPS is a privately held company, not part of any other company or organization.
 MPS is organized to operate in accordance with the requirements of ISO/IEC 17025, whether
carrying out work in its permanent facilities or at off-site locations.  It is the responsibility of all
employees to work in accordance with the quality policies while satisfying the needs of our
clients.
 MPS is not part of an organization performing activities other than testing; therefore, there is no
potential conflict of interest amongst its personnel.
 All MPS employees are responsible to conduct themselves in a manner that does not diminish
the confidence in our competence, impartiality, judgment or operational integrity as viewed by
both MPS employees and our customers.  This responsibility includes activities both in and
outside of normal operations at MPS.
 Assignment of Responsibility:
 
 In the absence of the Quality Manager and/or the Senior Test Engineer, the VP of Operations
or CEO will assume these duties.
 In the absence of the Senior Test Engineer, the Laboratory Supervisor will assume the duties
of the Senior Test Engineer.
 In the absence of the Laboratory Supervisor, the Senior Test Engineer will perform laboratory
supervision.Mobile Power Solutions
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The organizational responsibilities of Mobile Power Solutions personnel are illustrated below:
President and CEO
Chief Technology Officer
Vice President of
Operations
Laboratory Supervisor
Senior Test Engineer
Quality Manager
Responsible for:
Š Customer service
Š Purchasing
Š Test planning
Š Technical training
management
Š Interfacing with the CTO on
test reports and
certifications
Š Quality system document
and record control
Responsible for:
Š Oversight of laboratory testing methods and equipment
selection to meet ISO 17025 requirements
Š Ensuring that testing complies with relevant standards
Š Development and validation of new or modified test
methods
Š Evaluation of test results and data
Responsible for:
Š Developing, implementing, maintaining and improving the ISO
17025 compliant quality management system
Š Promoting quality awareness throughout the organization
Š Managing the corrective and preventive action system
Š Managing the equipment calibration and maintenance programs
Š Managing the internal audit program and conducting management
reviews
Responsible for:
Š Ensuring laboratory compliance with ISO 17025 requirements
Š Providing input to and complying with the testing schedule
Š Monitoring test performance
Š Supervising and training test technicians
Š Providing engineering support on assigned consultation projects
Responsible for:
Š Ensuring laboratory compliance with ISO 17025 requirements
Š Assisting the laboratory manager to meet the testing schedule
Š Supporting operations with regard to maintenance, allocation, and
procurement of test equipment and lab supplies
Š Preparing facilities, fixtures and documentation for customer testing
Š Preparation and oversight of any off-site testing necessary
Š Leading test failure analysis and reporting activities
Š Providing engineering support on assigned consultation projects
Responsible for:
Š Ensuring the effectiveness and integrity of the ISO 17025
compliant quality management system
Š Ensuring a high level of customer satisfaction is
consistently achieved
Š Appointing qualified management personnel to key
positions
Š Marketing and sales including contract negotiationMobile Power Solutions
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 Gifts or favors from suppliers, customers or internal activities that may benefit from “in-spec” test
results are prohibited to avoid any perception of conflict of interest per Client Confidentiality QA-
002.
 Proprietary rights and confidential information for both MPS and its customers are adequately
secured per Client Confidentiality QA-002.
 Job descriptions are maintained for all personnel detailing responsibility, authority, and education
and training requirements per Job Description and Training QA-003.
 The Quality Manager ensures that the integrity of the quality system is maintained when changes
to the system are planned and implemented.
2 Quality System Documentation
The Quality Manual is the governing document that defines the quality system policies and
statements of intent of Mobile Power Solutions and is based on ISO 17025:2005 requirements.
The Quality Procedures and Test Instructions describe who, what, when, where and how
quality management system and testing processes are performed.
Quality Forms related to quality procedures and test instructions are used for data collection.
Quality Records are retained as objective evidence of compliance to the requirements of ISO
17025 and MPS procedures and test instructions per Record Control QA-012.
Quality Manual
Policies and statements of intent for
meeting applicable Standard requirements
ISO 17025
Requirements for competence of testing and calibration labs
Quality Records provide evidence of
compliance
1
2
3
4
QS and Testing Procedures
Who, what, when, where and how QMS
processes and tests are performed
Quality Forms
Determine what data is collected
for a process
Quality Manual
Policies and statements of intent for
meeting applicable Standard requirements
ISO 17025
Requirements for competence of testing and calibration labs
Quality Records provide evidence of
compliance
1
2
3
4
QS and Testing Procedures
Who, what, when, where and how QMS
processes and tests are performed
Quality Forms
Determine what data is collected
for a processMobile Power Solutions
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Document Control
 The Quality Manual and all documented procedures are readily available at the point of use
and controlled per Document Creation and Control QA-001.
 The document control procedure ensures documents are approved for adequacy, uniquely
identified (including revision status), periodically reviewed and updated, legible and protected
from damage.
 Approvers perform document reviews and approvals based on pertinent information available
to them by virtue of their position in the company.
 Documents of external origin are identified and controlled.
 Obsolete or down rev documents are not available for use in testing and are segregated from
current revisions if they are retained for any purpose.
Document Changes
 Document changes are controlled per Document Creation and Control QA-001.  A description
of the change is recorded in the revision history.
 Document changes are reviewed by the same functions that performed the original review
and approval unless specifically designated otherwise.
Quality Record Control
Record Control QA-012 defines the means needed to identify, collect, index, access, file,
store, maintain and dispose of quality and technical records.
 Records are legible, stored in a suitable environment to prevent damage or deterioration and
are readily retrievable.  Records may be in hard copy or electronic format.  Electronic data is
protected, backed up, stored and access controlled per Computer Network and Security
Maintenance QA-013.
 All records are held securely and in confidence.
 MPS retains records of original observations, derived data and sufficient information to
establish an audit trail.
 Observations, data and calculations are recorded at the time they are made and are
identifiable to the specific task. Mobile Power Solutions
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3 Contract Review and Purchasing
 Contract review is a primary function and an integral part of the quality system at Mobile Power
Solutions.  All contracts/orders are reviewed and accepted only if the requirements are clearly
understood, and the company has the capability and capacity to fulfill customer expectations.
Reference Contract Review QA-005.
 Communication is maintained with the client from the time a request for quote is processed
through commencement of work.  This includes informing the client of any deviation from the
contract and obtaining approval prior to beginning testing.
 If a contract needs to be amended after work has commenced, the same contract review
process is repeated.  Any amendments are communicated to affected personnel and the
customer.
Subcontracting Testing Services
 It is not the policy of MPS to routinely subcontract testing.  However, should it become
necessary to subcontract work due to unforeseen circumstances, the following will apply:
• The contract review process applies to any work that is subcontracted out.
• The subcontractor will be an approved supplier per Supplier Approval and Review
Process QA-007.
• MPS informs clients in writing of the arrangement to subcontract, and if appropriate,
obtains customer approval to subcontract.
• MPS is responsible for the subcontractor’s work, except when the customer or a
regulatory authority specifies the subcontractor.
 MPS occasionally utilizes off-site testing facilities.  In these instances, tests are performed by
MPS personnel.  If the off-site testing facility’s equipment is used, the test setup and
calibration are verified for compliance to ISO 17025.
 Calibration of MPS test and measuring equipment is subcontracted to an ISO 17025
accredited calibration laboratory.
 Purchasing Services and Supplies
 The MPS purchasing department maintains approved suppliers for the purchase of supplies
and services that have a direct affect on the quality product and testing performed. Reference
Purchasing Services and Supplies QA-006 and Supplier Approval Process QA-007.
 Purchased services, supplies and consumable materials directly affecting testing quality are
not used until an incoming inspection is performed to ensure compliance with specified
requirements per Purchasing Services and Supplies QA-006.    Mobile Power Solutions
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4 Customer Service
 MPS does everything possible to assure that customers receive the best possible service while
maintaining the utmost in confidentiality when required.  Customer service may include but is not
limited to the following:
 Affording customers access to the laboratory to witness testing when requested.
 Preparing, packaging and dispatching test items and reports as required by our customers for
verification purposes.
 Advising, guiding and communicating with our customer on technical matters, providing
opinions and interpretations for testing performed or to be performed.
 Communicating to our customers any major deviations in testing being performed.
 Communicating to customers any delays that may result in the customer not receiving their
testing in a timely manner.
 Notifying customers of any event that casts doubt onto the validity of results supplied to them.
 Performing periodic customer surveys.
 Customer Complaints
Complaints, both verbal and written, are documented in accordance with Customer Complaint
QA-008, which addresses the methods for documenting, investigating and resolving complaints to
the customer’s satisfaction.
5 Quality System Monitoring and Measurement
 Control of Nonconforming Testing
 In the event that a nonconformance is identified with regard to any aspect of testing, or the
results of the work do not conform to the agreed upon requirements of the customer, the
nonconformance is contained and corrective action is initiated per Control of Non-Conforming
Testing QA-009.
 In the unlikely event that the test results are found to be erroneous after the test report has
been communicated to the customer, MPS will determine the impact on the test results and
take the necessary action to provide accurate results.
 Continual Improvement
MPS is committed to continually improving the quality management system for process
improvement.  Continual improvement is accomplished through management team’s actions by:
 Reviewing and updating the Quality Policy.
 Reviewing internal and external audit results for improvement opportunities.
 Analyzing quality data and customer survey results and using this data to set new quality
objectives or modify existing ones. Mobile Power Solutions
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 Ensuring corrective and preventive actions are implemented and effective.
 Performing periodic management reviews to evaluate the system per Management Review
QA-021.
 Corrective Action
Corrective and Preventive Action QA-010 describes the methods for taking action when
nonconformities have been identified.
 Root cause analysis is performed and action taken to eliminate the cause and prevent
recurrence.
 Corrective action is selected to eliminate the root cause of the nonconformity and for
effectiveness to prevent recurrence.
 Corrective actions are monitored and evaluated for effectiveness.
 Where the identification of nonconformance raises doubt on MPS’ compliance with its own
policies, procedures, or with ISO 17025, additional internal audits are performed to determine
if gaps exist.  If gaps are identified, corrective action is taken to bring the system back into
compliance.
 Preventive Action
 Preventive action is a pro-active process to identify process and quality system improvement
opportunities.  Once an improvement opportunity has been identified, an action plan is
developed for implementation per Corrective and Preventive Action QA-010.
 Preventive action implementation is monitored to verify that the needed improvements have
been realized and are effective.
 Internal Audits
 Periodic audits of MPS operations are performed in accordance with Internal Quality Auditing
QA-014.
 If audit findings cast doubt on the effectiveness of the operations of the correctness or validity
of the MPS test results, MPS takes timely corrective action, and notifies customers in writing if
investigations show that the test results may have been affected.
 Management Review
 Management Review meetings for all MPS functions are periodically held to assess the
effectiveness and continuing stability of the Quality System to satisfy the requirements of
ISO/IEC 17025 and MPS Quality Policy and Objectives.  Detailed rules for scheduling, Mobile Power Solutions
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conducting and the recording of management reviews are specified in Management Review
QA-021.
 Minutes of the meeting of Management Review are recorded and include a plan for
implementing actions defined during the review.
6 Technical Requirements
Mobile Power Solutions acknowledges that many factors determine the accuracy and precision of
the tests performed by a laboratory.  These factors include contributions from:
human factors
accommodation and environmental conditions
test methods and method validation
equipment
measurement traceability
sampling
handling of test items
 Testing Personnel
 Mobile Power Solution’s management ensures the competency of all who operate specific
equipment, perform tests, evaluate results and sign test reports.  Adequate supervision is
provided for staff undergoing training.  Personnel performing specific tasks are qualified on
the basis of appropriate education, training, experience, and/or demonstrated skills, as
required.   Reference Job Description and Training QA-003.
 All personnel utilized within the laboratory are employed by or under contract to MPS.  Where
outside personnel are utilized that are not under contract or employed by MPS, the MPS Test
Engineer is responsible to ensure these personnel are supervised, competent, and that they
work in accordance with the MPS quality system.
 MPS maintains current job descriptions per Job Description and Training QA-003 for all
managerial, technical, and key support personnel involved in testing.  Responsibilities are
defined for the following:
• Planning and performing tests.
• Evaluation of test results.
• Reporting opinions and interpretations.
• Method modification and development and validation of new methods.
The procedure also defines:
• Qualifications and training programs.
• Expertise and experience required.
• Managerial duties.  Mobile Power Solutions
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    Accommodation and environmental conditions
 Environmental controls for the test laboratory are appropriate for the test(s) being performed.
A temperature-controlled environment is maintained as required by those tests being
performed.  Environmental conditions that can affect test results are listed in the technical
procedures and documented.  Human factors relating to light, ventilation and space are
considered with respect to performing required tasks safely and effectively.  For each area
that requires a controlled environment, MPS documents the conditions that might affect the
test.
 Environmental factors that may adversely affect test measurements are controlled to the
degree necessary so as not to invalidate test results or increase the measuring uncertainty.
Tests are stopped when the environmental conditions jeopardize the results of the tests.
 A calibrated temperature-monitoring device is available and operating whenever testing
necessitating temperature is being performed.  The Laboratory room temperature is recorded
and maintained on file.
 Effective separation of test environments is maintained in work areas for safety and quality
purposes.
 Access to the laboratory is limited to authorized personnel and approved visitors.  Visitors are
supervised at all times.
 It is the policy of MPS to maintain all areas in a clean and orderly manner.
    Test methods and method validation
 All instructions, standards, manuals and reference data relevant to the work of the laboratory
are part of the document control system.
 Current test methods are controlled and stored in a specific location on the MPS intranet.  
 Testing instructions are provided by the customer or written by MPS and approved by the
customer for each test performed.  Any deviations from test instructions must be accepted by
the customer and recorded.
 Where the customer does not specify a testing method, the Test Engineer will select a
published national or international standard.  Methods that have not been established as a
standard are fully documented, statistically validated and agreed to by the involved parties.
 When MPS must develop a procedure for performing a test, a test plan is developed.  The
test plan must identify how the test will progress from start to finish.  Whatever testing plan is
used, it must be documented.  If the customer requests a test method that is not optimal,
MPS will inform the client that the method is not optimal (i.e. inappropriate or out of date).  Mobile Power Solutions
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 Estimation of Measurement Uncertainty
• The extent to which the factors contribute to the total uncertainty of measurement differs
considerably between types of tests.  Mobile Power Solutions takes into account these
factors in developing test methods and procedures, and in the selection and calibration of
the equipment it uses.
• When estimating measurement uncertainty, the requirements and tolerances stated in the
applicable test procedure, as well as customer requirements, are reviewed to determine
any potential measurement uncertainty. If any critical measurement uncertainty exists it
will be included in the analysis of the test results and stated in the test report. Reference
Estimating Measurement Uncertainty QA-023.
 Control of Data
• Calculations and data transfer are subject to checks by someone other than the person
performing the work, prior to reporting the data to the customer.
• MPS utilizes computers and automated equipment for the capture, processing,
manipulation, recording, reporting, storage and retrieval of test data.
• MPS maintains supporting evidence that the software is suitably validated as being
adequate for use (commercial off the shelf software not subject to this requirement).
Procedures are established to ensure integrity and confidentiality of data entry and data
collection, data storage, and data transmission.  Reference Computer Network and
Security Maintenance QA-013.
Test Equipment
 MPS laboratory is furnished with all items of sampling, measurement and test equipment
required to correctly perform all testing specified.
 To assure that equipment used for testing complies with specification requirements and are
capable of achieving the accuracy required for each test performed, the following procedures,
and the systems associated with them, have been instituted to assure compliance with
specifications relevant to the tests concerned:
• Equipment Control and Maintenance QA-016.
• Calibration Program QA-017.
 Only authorized personnel are permitted to operate laboratory equipment.  Relevant manuals
provided by the manufacturer of the equipment are controlled and are made readily available
for use by personnel.  Instructions on the use and maintenance of all equipment are kept up
to date and are readily available. Mobile Power Solutions
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 Gages, measuring and test equipment are uniquely identified and labeled to identify the
calibration status.  Intermediate checks are performed in house per the Calibration Program
QA-017.
 Calibration records for measurement test and operational equipment and its software are
maintained per the respective procedures:  Calibration Program QA-017 and Equipment
Control and Maintenance QA-016.
 Measuring Equipment is handled safely, transported, stored, used and maintained per
Equipment Control and Maintenance QA-016 to ensure proper functioning and to prevent
contamination and deterioration.
 Equipment that has been damaged, overloaded, shown by verification or otherwise found to
be producing suspect or defective results is identified as such and removed from service.
Defective equipment activities are evaluated for any affect the equipment may have had on
previously reported test results.  Appropriate action is taken in accordance with Test
Reporting QA-018 and Calibration Program QA-017.
 If test and/or measurement equipment have adjustment points that when tampered with can
affect calibration, then tamperproof seals are placed over all adjustment points.  If these seals
show signs of tampering, it will invalidate the calibration and the equipment must be calibrated
again before it can be used for client’s work.
Measurement Traceability
 All measuring and test equipment having an effect on the accuracy or validity of tests are
calibrated and traceable to national or international standards per the Calibration Program
QA-017.
Sampling
 MPS meets the sample size requirements as specified in UN, UL or IEC standards for testing.
 Where client requires deviations, additions, or exclusions from the documented sample size,
these deviations are recorded in detail with the appropriate sampling data and included in all
documents containing test and/or calibration results and are communicated to the appropriate
personnel.
Handling of test items
 The transportation, receipt, handling, storage, retention and/or disposal of all test items are
defined in Handling of Test Items QA-019.
 Unique and permanent identification of test items is maintained throughout the life of the test.
 Any abnormalities of departures from normal or specified conditions as described in the
methods are recorded.  When there is doubt as to the suitability of an item for test, or when Mobile Power Solutions
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an item does not conform to the description provided, MPS consults with the client for further
instructions before proceeding.
 Where test items need to be stored or maintained under specific environmental conditions,
the conditions are monitored, maintained and recorded.
Test Quality Assurance
 MPS participates in proficiency testing to ensure accuracy and precision of its testing
activities. Reference Proficiency Testing Plan QA-022.
 In addition to periodic audits, testing quality assurance is an ongoing process.  Test quality is
monitored and results are included in the Management Review process.
Reporting Test Results
 Material test results are reported accurately, clearly, unambiguously and objectively in
accordance with Test Reporting QA-018.
 If testing is subcontracted, the subcontractor will provide hard copy or electronic test reports
to MPS.  When MPS test reports include testing performed by subcontractors, the
subcontractor lab results are clearly identified.
 Test Reports contain the following information (at a minimum):
• Title (Test Report or Certificate of Compliance with a given standard)
• Name and address of the testing laboratory and location(s) where testing occurred
• Unique identification of the test report by number, and on each page an identification in
order to ensure that the page is recognized as part of the report, and a clear marking to
mark the end of the test report
• The name and address of the client
• Identification of the test method used
• Description of, condition of, and identification #’s of the items tested
• The date of receipt of the test items where this is critical to the validity, and the date(s) of
performance of the test
• Reference to the sampling plan and procedures used by MPS where relevant
• The test results and appropriate units of measurement
• The name(s), function(s) and signature(s) or equivalent identification of person(s)
authorizing the test report
• Where relevant, a statement to the effect that the test results relate only to the items
tested Mobile Power Solutions
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 Interpretation of test results
Testing interpretation includes the following:
• Deviations from, additions to, or exclusions from the test methods and information on
specific test conditions, such as environmental conditions
• Where relevant, a statement a compliance/non-compliance with requirements and/or
specifications
• Where necessary, a statement of the estimated uncertainty of measurement
• Where appropriate and needed, opinions and interpretations
• Additional information which may be required by specific methods, clients or groups of
clients
Test results containing the results of sampling include the following, where necessary for the
interpretation of test results:
• The date of sampling
• Unambiguous identification of the product sampled
• The location of the sampling, including any diagrams, sketches or photos
• A reference to the sampling plan and procedures used
• Details of any environmental conditions during sampling that may affect the interpretation
of the results
• Any standard or other specification for the sampling method or procedure, and deviations,
additions to or exclusions from the specification concerned
 Opinions and Interpretations
When opinions and interpretations are included, MPS documents the basis upon which the
opinions and interpretations have been made.  Opinions and interpretations are clearly
marked as such. Mobile Power Solutions
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