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TABLE OF CONTENTS
4 Management requirements
4.1 Organization
4.2 Quality System
4.3 Document Control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Services to the client
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Corrective action
4.11 Preventative action
4.12 Control of records
4.13 Internal audits
4.14 Management review
5 Technical requirements
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.1 Revision 08
Laboratory Organisation Page 1 of 7 Issued: Oct. 2008
The following section of this Quality Manual has been reviewed and approved for issuance by
the commissioned management personnel. This is a controlled document, and unauthorised
printing or photocopying is prohibited. Copies not showing the original signature are considered
uncontrolled copies, and may not reflect currently issued policy/procedure.
____________________________________________________________________
Laboratory Director Date
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.1 Revision 08
Laboratory Organisation Page 2 of 7 Issued: Oct. 2008
Management Requirements
4.1.1 Registration
GLIER Laboratories were established in 1984 and is owned and registered as a legal
entity of the University of Windsor, Windsor, Ontario, N9B 3P4 Canada.
4.1.2 Accreditation
GLIER Laboratories have been accredited for specific tests since 1998, through the
Standards Council of Canada’s (SCC) Program for the Accreditation of Laboratories
(PALCAN), and their assessment body, the Canadian Association for Environmental
Analytical Laboratories (CAEAL).
Responsibilities
The major focus at the GLIER Laboratories is environmental testing, providing services
for a range of environmental samples. This range includes solid wastes, effluents,
receiving waters, ground waters, soils, sediments, plant, animal and fish tissues (See
Section 5.4 for a complete list of Test Methods).
Clients Served
The GLIER Laboratories provide analytical science services to all interested parties:
government, industry, and private individuals.
Lab Heads. Are Management representatives for the GLIER Laboratory operations
with key function in authorization of management system and management review 4.10
(review, continual improvements, departures and prevention). See Also 4.6.1.3
Quality Manager. Representative for the implementation of the ISO17025 System and
availability of all resources for implementation within the GLIER quality system.
Quality Assurance. Overall responsibility for quality assurance in each laboratory resides
with the respective Laboratory Supervisor. This overall responsibility includes
implementing a system which is understood, accepted and documented and which
incorporates adequate review, audit and internal quality control. This responsibility
includes documenting work instructions for the unit and ensuring adequate training and
supervision for staff. It also includes, where appropriate, validation of test methods and
application of adequate internal quality control.
Job Descriptions. All laboratory job descriptions shall be prepared and approved by the
immediate Supervisor. Copies of all current job descriptions for managerial, professional
and technical staff shall be maintained on file in the Administrative Office.
Key Positions. The staff filling the key positions identified above are:
Position Substitution
Lab Director Lab Heads
Head – Metals Lab Head – Organic
Head – Organic Head – Metals Lab
Quality Manager Lab Supervisors
Vice-President
Academic
University of Windsor
GLIER
Executive Director
GLIER
Administration
ML Scratch
Laboratory Director
BJ Fryer
Quality Manager
JC Barrette
Lab Technician
D. Qiu
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.1 Revision 08
Laboratory Organisation Page 6 of 7 Issued: Oct. 2008
University of Windsor
Academic Operations
President
Vice-President, Academic
Director
Great Lakes Institute
08 Oct. JC Barrette Header List 17025 only. Not 17025:2001, year of doc. revision
2008 4.1.1 Registration GLIER legal entity of University of Windsor
4.1.2 clients Removed consultants from clients served
Keyposition/Chart Remove vacant for Nargis Ismail, Org Lab
4.1.5Resposibility Defined Lab Head and Quality Manager Responsibilities
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.2 Revision 07
Quality System Page 1 of 4 Issued:
December 2004
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.2 Revision 07
Quality System Page 2 of 4 Issued:
December 2004
Management Requirements
4.2.1 Scope
GLIER Laboratories maintain a quality system in accordance to ISO/IEC 17025-2001
guidelines. Policies, systems, programmes, procedures and instructions which
encompass this Quality Assurance programme are documented to ensure the quality of
testing results.
The Quality Manager is responsible for implementing and overseeing the quality system.
The assigned inividual has the authority to use the resources available at GLIER to
enforce the Quality System Procedures.
The quality objective is to ensure that a well structured and documented GLIER Quality
Management System (QMS) is in place, and that this system incorporates adequate
review, audit, and internal quality control. The purpose of the QMS is to ensure the
services and advice offered by GLIER meet the needs of our clients and the requirements
of the accrediting agency. The QMS is a structured management system of principles,
objectives, policies, responsibilities and implementation plans at the organisational and
project-specific levels. It provides the structure within which planning, implementation
and performance assessment may occur.
The organisational system of the QMS regulates activities that support common or
standardised functions. Some examples of the types of controls used in GLIER include:
¾ utilizing SOP’s to ensure data consistency in the measurement process;
¾ auditing operational performance of the laboratory on a routine basis and providing
corrective action if needed;
¾ maintaining complete records of sample receipt, laboratory analysis and data
reporting.
The Quality System Manual is the first level document, which describes the
implementation of the GLIER Quality Management System within the Laboratory. It
specifies the activities required to achieve the quality goals established by GLIER. The
QSM is updated as required and is approved by the respective Laboratory Heads.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.2 Revision 07
Quality System Page 3 of 4 Issued:
December 2004
The Quality System Procedures are the second level documents which outline the detail
of management strategies for carrying out policies and objectives specified in the QSM.
The sections within this document describe, in a systematic manner, the measures which
the laboratory employs to implement the QA program.
These documents describe all the written instructions necessary to utilise Laboratory
testing procedures (i.e. methods) within GLIER and provide a working document where
all details are specified. SOP’s are updated on a regular basis by the Laboratory
Supervisors and approved by the appropriate Laboratory Head. They are kept in a central
area within each analytical laboratory. SOP documents are revised, controlled and
distributed through the Administration Office.
These documents specify the sets of definitive instructions which must be followed,
without exception, by all staff, for those procedures that are standard across the
laboratory or across a series of analytical methods. These include procedures such as
sample receiving, data management, preparation of standards and analyst proficiency
records. Upon revision, the latest version is approved by the appropriate Laboratory
Head and forwarded to each Laboratory Supervisor for use in appropriate Laboratory.
All relevant forms and working documents outlined in the GLIER QMS documentation
are retained in the Quality Assurance office for use by technical personnel charged with
carrying out any related activities.
Records are maintained by the responsible personnel according to the respective SOP
and/or RP, and stored at locations specific to the ordered task. Examples include
logbooks, training records, equipment monitoring.
See (Appendix 4.2.3 – Workload Management) as a guide to records controls for routine
monitoring
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.2 Revision 07
Quality System Page 4 of 4 Issued:
December 2004
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.3 Revision 10
Document Control Page 2 of 8 Issued:
October 2008
Management Requirements
4.3.1 General
Document Control is necessary to ensure that lab personnel have access to current
policies and procedures at all times. Quality documents that are placed under a
controlled distribution include, but are not limited to: the QM, the SOP’s. Related
Procedures, and Forms. Control is maintained by initially distributing the documents to
the staff members who need to be aware of or need to follow the contained information or
procedures.
The Quality Manager ensures that all quality documentation is adequately controlled
using a Document Header with the following information including the first page as
authorization.
A master list of all quality documentation, which identifies all current revisions, is
located at the front of this document, and in the Quality Control Office. Laboratory Head
signatures located on the authorisation sections of each quality document are evidence of
document control. The master list includes the following documentation:
The Quality System Manual is the first level document, which describes the
implementation of the GLIER Quality Management System within the Laboratory.
The Quality System Procedures are the second level documents which outline the detail
of management strategies for carrying out policies and objectives specified in the QSM.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.3 Revision 10
Document Control Page 3 of 8 Issued:
October 2008
These documents describe all the written instructions necessary to utilise Laboratory
testing procedures (i.e. methods) within GLIER and provide a working document where
all details are specified.
Validation Data binder tabulated with data sourced from the QA/QC SOP log files.
Tabulated as per 5.4.5.1 validation parameters.
These documents specify the sets of definitive instructions which must be followed,
without exception, by all staff, for those procedures that are standard across the
laboratory or across a series of analytical methods.
All relevant forms and working documents outlined in the GLIER QMS documentation
are retained for use by technical personnel charged with carrying out any related
activities.
Distribution
Manuals in Circulation
The Quality Manager ensures that all changes or additions to the quality documentation
undergo adequate review and are approved by the respective Laboratory Head.
Obsolete Documentation
Obsolete documentation retained for legal or reference purposes will be maintained in file
and suitably identified by denoting obsolete over the controlled document label.
‘Controlled’ copies will be marked accordingly. Documents in circulation will be
considered ‘uncontrolled’ copies, and require validation of revision number before use.
If the obsolete method is re-instituted as a regular or non-routine test method, it will first
be subjected to documented validation procedures according to ISO/IEC 17025 section
4.3.
4.3.3.2 Revisions
A log of revisions to quality documentation will appear in the revisions section of each
controlled document, and is approved by the respective Laboratory Head for Laboratory
SOP and RP. The Quality Manual and Quality System procedures is approved by the
Laboratory Director.
Amendments may, upon approval, involve expeditiously issuing entire new documents,
issuing replacement pages or dated and initialled changes in ink to the original document.
Revisions will be clearly marked, initialled, and dated by the Laboratory Manager.
Exceptions to the above rules are valid for data collection forms, laboratory logs, and
similar documents which do not require management authorisation.
Storage Method
- the revision&date directory will change as per edits, use most current.
- all files feed from: LimsSTD:\AnaLabsAdm\LabManual\\
Quality Manual:
\\Quality Manual\ Revision&Date \ GLIER Laboratory Quality Manual…doc
Related Procedures:
\\Rel.Prod.\Metals\ Revision&Date \ relprod…wpd
\\Rel.Prod.\Organic\ Revision&Date \ rp…wpd
The new document is saved/stored in a newly created folder named with a higher revision
number. The previous file remains in its respective revision folder. The revision
history/record contains all necessary descriptions of changes for reference. The
document is reissued, as outlined in section 4.3.3.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.3 Revision 10
Document Control Page 6 of 8 Issued:
October 2008
All text formatting (as outlined above) will be removed upon formal reissue of document,
and final changes included in the revision record located at the front of each controlled
document.
To ensure data management procedures that incorporate adequate procedures for the
security, recording, calculation, validation, authorization, transmittal, storage and
disposal of all test data and related records.
The Laboratory Supervisor is responsible to retain all technical records pertaining to the
execution of data analysis. This includes, but is not limited to, sample submission,
original observations, calibration records, sample process and analysis, data generation,
test performance, report generation and client feedback.
All records may be disposed of after a period of five (5) years or as necessary,
unless otherwise specified by legal or contractual obligations.
Each respective Laboratory Head is responsible for disposal of any records kept.
This task is done manually in Windows explorer by the drag an drop method.
Refer to the equipment binder under computers and Appendix 8.1 for procedure.
Log books and clipboards (log worksheets) for Internal Quality Control are all
returned to a home Equipment binder. It contains sections such as balances,
temperature, water, computers.
Each Laboratory has one dedicated computer workstation that must be secure-
password protected and have data storage back-up.
- Windows operated computers must be password protected on boot up
and have a time out password prompt as well (screensaver). User specific
accounts for privileged access to specific folders should also be activated
as necessary.
See Equipment Binder under Computer Maintenance for set-up details.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.3 Revision 10
Document Control Page 8 of 8 Issued:
October 2008
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.4 Revision 07
Review of Requests, Tenders Page 2 of 6 Issued:
and Contracts December 2004
i) Purpose
This procedure defines the authority, responsibilities, and system for review of requests,
tenders and contracts that lead to a contract for services by GLIER Laboratories.
ii) Scope
Prior to accepting to perform any services for our clients, the following conditions will be
met:
iii) Definitions
The request, tender and contract review procedure will be conducted by the Laboratory
Head of each respective laboratory, and the process will remain consistent for both
internal and external customers.
Formal written contract proposals are reviewed and authorised by the both the GLIER
Director and University of Windsor Associate Vice-president of Research.
The GLIER Administrator is responsible for coordinating and maintaining all financial
records pertaining to execution of the contract grant account with the University of
Windsor's Financial Services department.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.4 Revision 07
Review of Requests, Tenders Page 3 of 6 Issued:
and Contracts December 2004
Management Requirements
This procedure defines the authority, responsibilities, and system for review of requests,
tenders and contracts that lead to a contract for services by GLIER Laboratories.
i) Client and Laboratory Head agree on the terms and conditions regarding a
requested contract of service by the GLIER Laboratories. The Lab
Manager initiates the inter university verification process by completing a
UofW Research Contract form
ii) Upon Director authorisation, the research contract form and client
contract are submitted for approval to the office of Research Services. One
copy is retained by the GLIER Administrator in central files;
iii) Office of Research Services sends the authorised form and client contract
to Financial services to open a Grant account;
¾ Agreements regarding testing time line and sample disposal, storage or return
shall be made.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.4 Revision 07
Review of Requests, Tenders Page 4 of 6 Issued:
and Contracts December 2004
¾ The laboratory has the required technical and managerial capability and resources
to meet the customer's requirements.
The request, tender and contract review procedure will be conducted by the Laboratory
Head of each respective laboratory, and the process will remain consistent for both
internal and external customers. The review will be conducted in a practical and efficient
manner, incorporate financial, legal, and scheduling objectives of both the customer and
laboratory.
The Laboratory Supervisor will use routine methods that are approved by the Laboratory
Head, selected from the approved and authorised Standard Operating Procedure (SOP) of
the GLIER Quality Manual. The routine methods used are based on the latest edition of
published international, national and regional standards which enlist a validated SOP
quality assurance/quality control procedure.
The Laboratory Supervisor is responsible for ensuring that the laboratory is physically
capable of performing the analysis, will select the most appropriate method, and ensure
the required analytical personnel with the necessary skills and expertise to perform the
analysis are available.
A contract may be defined either as a written document or verbal agreement held between
the customer and Laboratory Head which outlines the intent to procure services.
All correspondence with the client regarding the contract agreement will be recorded and
maintained in the clients contract file.
Any reviews done by the Lab Heads having technical relevance must be communicated
to the Lab Supervisor of the respective lab.
Changes to a clients contract are admissible under specific instruction, notification, and
authorisation from the client. In the event changes are anticipated for any of the outlined
procedures relating to a contract agreement, the client will be notified by the Lab Heads
or as delegated. Such notification will be in writing of such changes if they are deemed
to affect the normal execution of their contract provisions.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.4 Revision 07
Review of Requests, Tenders Page 6 of 6 Issued:
and Contracts December 2004
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.5 Revision 08
Subcontracting of Tests Page 2 of 4 Issued:
October 2008
i) Purpose
ii) Scope
In order to execute client requests for services not offered by GLIER Laboratories, this
section outlines the requirements that will be met to ensure the competence of the
subcontractor to complete any required test(s) that may impact the quality of results.
iii) Definitions
Terms of the subcontractor agreement are authorised by the Laboratory Head, with
intended to reflect the client requirements.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.5 Revision 08
Subcontracting of Tests Page 3 of 4 Issued:
October 2008
GLIER Laboratories may, from time to time, enter into agreements with other
laboratories to conduct analytical work on behalf of clients. As per the discretion of the
Laboratory Head, testing work may be completed by the subcontracting laboratory. The
Laboratory Head is responsible for securing a competent subcontractor. A minimum
competency must be shown via conformance to ISO 17025 requirements.
Proof of competency will be required from each subcontracted service, and may take the
form of conformance to international standards of service, work history and/or
completion of a supplier/contractor competence survey.
The ideal situation when subcontracting is to hire another CAEAL accredited laboratory.
However, if that is not possible, the subcontractor could be required to participate in
interlab comparisons for the suite of parameters involved. If this is not available,
incorporate another laboratory to split or share samples in order to cross check work of
the laboratory performing the analytical work. If knowledge of certain Reference
Material is available, results of analysis could be supplied in support of the Reference
Material. Also, samples of known composition could be analysed by the subcontracting
laboratory to verify results.
The respective Laboratory Heads shall obtain prior permission from the client in writing
to sub-contract any portion of the client's testing to another party. These arrangements
are made on a project-specific basis, and agreements are confirmed in writing before any
action is taken.
Any amendments to original must be signed by Lab Head to supersede.
All original subcontractor reports are submitted in writing or electronically and kept by
the respective Laboratory.
A Quality Assurance Plan must accompany the agreement, and be approved by the
respective Laboratory Head. The purpose of this Plan is to ensure that results obtained by
the sub-contracting laboratory will demonstrate the quality of its analytical work.
08 Oct. JC Barrette Header List 17025 only. Not 17025:2001, year of doc. revision
2008 4.5.1 Minimum competency required as 17025 accreditation
4.5.2 Subcontractor reports are submitted in writing or elec.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.6 Revision 07
Purchasing Services and Page 1 of 6 Issued:
Supplies December 2004
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.6 Revision 07
Purchasing Services and Page 2 of 6 Issued:
Supplies December 2004
Management Requirements
4.6.1.1 Purpose
To ensure all equipment, supplies and services are functioning properly and/or meet
required specifications, and define the authority, responsibilities, and system for the
purchase of quality critical equipment, materials and services for use in GLI Laboratories.
4.6.1.2 Scope
This procedure applies to all analytical and quality critical equipment, materials and
services used by GLI Laboratories to carry out analysis of testing as outlined in SCC
accredited methodologies .
4.6.1.3 Procurement
The respective Laboratory Supervisors shall be responsible for preparing specifications
for all purchased services, equipment and supplies used in the conduct of laboratory
testing. Supplies will include test organisms, reagents, glassware, spare parts etc.
Services will include sub-contracted testing, as well as equipment servicing.
The Laboratory Head has final approval of request from the Lab Supervisor via purchase
requisitions or tenders.
The individual(s) approving the specifications shall also be responsible for (i) issuing
related tenders or requests for proposal; (ii) evaluating related bids and proposals; and
(iii) either approving related purchase orders or contracts, or seeking approval by the
designated spending authority.
The respective Laboratory Supervisor shall maintain a file that identifies all purchased
goods by:
• purchase order number;
• description, including grade/batch number, species/lot number, model/serial
number, etc.;
• vendor name;
• date of receipt;
• ID of person checking order;
• disposition of order and reason for acceptance or rejection;
• assigned inventory number, if applicable.
Prior to acceptance all purchased goods shall be checked by (i) verifying appropriate
correspondence between the purchase order and packing slip; and (ii) verifying, when
applicable, conformance to any prescribed specifications. Such checking shall normally
be carried out by the individual(s) initiating the purchase order.
In the case of purchasing goods and/or services from a sole supplier, Purchasing Services
requires a written explanation by the requisitioner which explains in detail why the goods
and/or services can only be provided by the supplier mentioned in the purchase
requisition. The explanation will be kept on file with the Purchase Order for auditor's
review. In order to meet the requirements as a sole source provider , the goods and/or
services should meet the following:
• to ensure compatibility with an existing product
• to protect copyrights or patents
• for the maintenance or repair of specialised equipment that must be carried out by
the manufacturer or its representatives
• if, for specific research or scientific reasons, the product is only available from
one source. In this case, the requisitioner accepts personal responsibility that no
other product and/or service can meet the specifications required for his/her
research or scientific needs.
Laboratory Supervisors verify items for ensuring purchased materials that affect the
quality of testing are properly inspected/tested to ensure the materials comply with
standard specifications as outlined in the pertaining test method.
.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.6 Revision 07
Purchasing Services and Page 4 of 6 Issued:
Supplies December 2004
Purchasing documents are issued and maintained by the University of Windsor Financial
Department. These documents contain all relevant information to facilitate the
identification and communication of required product specifications to the supplier.
The Laboratory Supervisor issuing the purchase request is charged with ensuring the
proper specifications are identified on the requisition document.
4.6.3.1.1 Definitions
Quality Critical Equipment: Equipment, materials or services that have been determined
to potentially affect the quality of results reported to GLIER Laboratory customer agents.
This definition also includes the purchase of calibration services deemed necessary to
implement SOP, as well as QA/QC guidelines.
4.6.3.1.2 Procedure
Specifications for quality critical laboratory equipment, materials, and services are
defined and approved by the Lab Heads. Vendor approval is based on the Laboratory
Managers recommendations, past performance, reputation, questionnaires, and/or
published methodologies.
Current/additional suppliers may only be used after formal evaluation, which requires
notification of required certificates by suppliers to distribute critical equipment as
outlined in ISO/IEC 17025 and the affected SOP/QA/QC documentation.
Formal evaluation of suppliers is carried out via a questionnaire. See Appendix 4.6.3.1
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.6 Revision 07
Purchasing Services and Page 5 of 6 Issued:
Supplies December 2004
The individual(s) approving the specifications for goods and services shall, where
appropriate, carry out an assessment of suppliers, which may include, but not be limited
to, recommendations, past performance, questionnaires and/or published methodologies.
Approved suppliers shall (i) provide goods and services that are of adequate quality to
sustain confidence in the laboratory's tests; or (ii) in the case of sub-contracted testing,
provide services that meet standards of competence equivalent to those in place at the
GLIER Laboratories, University of Windsor.
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.7 Revision 07
Service to Client Page 2 of 3 Issued:
December 2004
Management Requirements
4.7.1 Purpose
This procedure defines the authority, responsibilities, and system used to ensure the value
of the services offered to clients of GLIER Laboratories .
4.7.2 Scope
4.7.3 Procedure
GLIER Laboratory services and associated personnel will maintain a strict level of
confidentiality for all information pertinent to its clients. Any information pertaining to
laboratory services, including final results, will only be released directly to the customer,
or a designated customer representative.
When not deemed to affect the confidentiality of laboratory clients, GLIER laboratories
will afford the client reasonable access to areas of the laboratory for the purpose of
reviewing procedures and the witnessing of analysis performed for the client.
All attempts to ensure good customer relations, including advice, guidance in technical
matters, and interpretations of results, will be maintained.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.7 Revision 07
Service to Client Page 3 of 3 Issued:
December 2004
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.8 Revision 07
Customer Complaints Page 2 of 3 Issued:
December 2004
Management Requirements
4.8 Complaints
4.8.1 Purpose
This procedure defines the authority, responsibilities, and quality system used to ensure
that all customer complaints are received, documented, assessed and responded to in a
timely basis.
All technical complaints originating from clients, or other external sources, are directed
to the respective Laboratory Supervisor. Where situations (ie: previously issued test
reports) warrant follow-up activities, a corrective action report form is initiated.
An acceptable resolution may include any combination of retest, third party testing, credit
or refund as approved by the respective Laboratory Heads. Before a resolution is
announced, the Laboratory Supervisor determines that the resolution or the action meets
with the client's satisfaction, and obtains authorisation from the Laboratory Head.
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.9 Revision 08
Control of Non-conforming Page 2 of 5 Issued:
Testing October 2008
Management Requirements
4.9.1 Purpose
This procedure defines the authority, responsibilities, and quality system used to ensure
that all customer complaints are received, documented, assessed and responded to in a
timely basis
4.9.2 Definitions
A non-conformance is any analytical result, which may be outside acceptable error due to
the use of an incorrectly calibrated instrument or an instrument found to be out of range
of acceptable deviation during a quality assurance test. In other words, a system that is
not compliant to its normal operating specifications outside of regular maintenance.
If any of these causes is due to circumstances outside the control of GLIER, then it is
termed a deficiency. Deficiencies are handled through the use of a Sample
Submission/Reception form, at the sample receiving area. The client is contacted and the
problem resolved before the samples are processed.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.9 Revision 08
Control of Non-conforming Page 3 of 5 Issued:
Testing October 2008
Non-conformance logs are initiated using the Non-Conformance Report (form 4.9)
located in the appendix binder. Each Laboratory Supervisor shall ensure that records of
non-conformances and the actions taken are kept. If applicable, in the case of a non-
conformance applies to both labs the Quality Manager ensures that the record is kept and
actions are followed up. It is also the responsibility of the Quality Manager to have the
CAR reviewed at year end during QA and or management review.
Manual flags are assigned to nonconforming test results. They shall exist at the
following steps in the data management process:
° sample reception;
° sample analysis;
° data validation.
The provision shall exist for each assigned flag to be accompanied by an explanatory
comment. Prior to reporting nonconforming or suspected nonconforming data, the
Laboratory Supervisor shall advise the client and seek further instructions.
If for any reason it is suspected that nonconforming data may have been reported, i.e., as
a result of audit findings, proficiency testing, client feedback or any other circumstance,
the Laboratory Supervisor shall immediately notify any client whose data may have been
affected. After conferring with the client work may be recalled and followed by a
superseded report as necessary.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.9 Revision 08
Control of Non-conforming Page 4 of 5 Issued:
Testing October 2008
The Laboratory Supervisor ultimately assumes responsibility for ensuring any non-
conformance identified in the laboratory is identified and corrected. The Quality
Manager is responsible for ensuring all necessary resources are made available to the
laboratories for the maintenance of the Quality System.
The Lab Supervisor authorizes a resume work (start up) when non-conformance is
corrected.
If an instrument or piece of testing equipment is found to be out of calibration, and is
deemed to possibly impact the quality of the data reported to the customer, an
investigation into the root cause and evaluation of the significance of the non-
conformance is initiated. As soon as the non-conformance has been identified, the
following procedure is conducted:
° Any further work on the instrument will be halted until the extent and
significance of the non-conformance is determined. A decision on the
acceptability of the results produced since the last calibration will be made to
determine if non-conforming results may have been generated and reported
between calibrations.
° If the possibility exists, client(s) whose data have been affected by the non-
conformance are notified in writing, and individual concerns and the significance
of potential deviations are determined.
° After the instrument has been returned to service, its performance shall be
monitored regularly to ensure corrective action taken was effective. If doubt
exists concerning the ability of the instrument to continue to produce reliable
results, the Laboratory Supervisor will devise a long-term strategy for the repair,
replacement, or acceptance of an alternative method.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.9 Revision 08
Control of Non-conforming Page 5 of 5 Issued:
Testing October 2008
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.10 Revision 07
Corrective Action Page 2 of 4 Issued:
December 2004
Management Requirements
4.10.1 General
4.10.1.1 Purpose
This procedure outlines a system for identification and correction of existing quality non-
conformities within the operations of GLIER Laboratories. Outlines for specific
programs and procedures are addressed, with the objective of monitoring these corrective
actions to achieve prevention of any recurrences.
4.10.1.2 Definition
Corrective actions are often carried out in response to a non-conformance (Section 4.9)
and may include;
The corrective action processes are maintained under document control procedures using
Corrective Action Reports (Appendix 4.10), and required changes are implemented by the
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.10 Revision 07
Corrective Action Page 3 of 4 Issued:
December 2004
Laboratory Supervisor with assistance from the Quality Manager and/or Laboratory
Heads as required.
Specific procedures are defined in Section 4.9, the laboratory standard operating
procedures and work instructions, and may include;
In the case of an internal method audit, proficiency testing, or any other corrective action,
the following procedures are followed:
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.11 Revision 08
Preventative Action Page 2 of 3 Issued:
August 2006
Management Requirements
4.11.1 Purpose
This procedure outlines a system for identification and prevention of potential quality
non-conformities within the operations of GLIER Laboratories. Outlines for specific
programs and procedures are addressed, with the objective of monitoring these
preventative actions to achieve prevention of any recurrences.
4.11.1.1 Definition
4.11.3 Procedure
Document any new ideas (or based on preventative resources as listed above) via C.A.R.
forms Appendix 4.9.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.11 Revision 08
Preventative Action Page 3 of 3 Issued:
August 2006
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.12 Revision 08
Control of Records Page 2 of 8 Issued:
October 2008
Management Requirements
4.12.1 General
4.12.1.1 Purpose
To define the type, responsibility and retention time for quality records maintained to
confirm the achievement of the required level of quality outlined in this Quality
Management system.
4.12.1.2 Scope
Management is responsible for incorporating adequate procedures for the recording,
collection, indexing, authorisation, maintenance, storage and disposal of all quality and
technical records
4.12.2 Procedures
Quality documentation is maintained in accordance to procedures set out both this section
and in Sect. 4.3.1.
The Quality Manager and Lab Supervisor is responsible for the control of quality records,
including filing, storage, maintenance, and disposition of said records.
Quality records are retained in the Quality control office, and are maintained in both
hardcopy and electronic form. Copies of non-process related documents are available for
duplication. Process related documents are maintained by the technical staff at the
specific workstation to facilitate supply on demand and prevent work interruption.
The following table includes some examples of documents maintained under this system.
Storage
As soon as such records no longer serve a useful purpose within an individual section
they remain in the custody of the Quality Manager, stored in records storage.
Disposal
All records may be disposed of after a period of five (5) years or as necessary, unless
otherwise specified by contractual obligations and/or by special request by client. Each
respective Laboratory Head is responsible for disposal of any records kept.
Access
Unless access to specific records is specified by contract or mandated by audit, all client
or other requests for access to records must be directed to the Laboratory Supervisor.
Access to a client's own specific records will not be unreasonably denied. Requests by a
third party must be accompanied by written consent from the client.
Records that may be made available on request to the Laboratory Supervisor shall be
limited to:
• staff curriculum vitae;
• records of analyst proficiency;
• equipment maintenance logs;
• reagent preparation logs;
• records of non-conformance;
• data validation records;
• original test data;
• logs or records relating to primary measurement, i.e. weight, volume,
temperature;
• logs or records relating to water quality i.e. reagent water, dilution water;
• performance audit or quality audit results;
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.12 Revision 08
Control of Records Page 4 of 8 Issued:
October 2008
Records Integrity
Records are maintained in a secure and suitable environment outside the laboratories in
office space adjacent to the labs.
Log books and clipboards (log worksheets) for Internal Quality Control are all returned to
a home Equipment binder. It contains sections such as balances, temperature, water,
computers.
This task is done manually in Windows explorer by the drag an drop method. Refer to
the equipment binder under computers for procedure.
Notes: - Windows 2000 automatic back-up program has been investigated , see Data
Management Log book Nov2002
- Novell requires the drag and drop method therefore the automatic was not
used.
The Laboratory Supervisor will ensure that original observations, including recording of
all relevant testing information, are maintained in a permanent form that facilitates
reproduction of the test if required.
Calibration records shall include sufficient information to facilitate the duplication of that
calibration under the same environmental conditions, should the need arise.
Personnel records for all staff shall be maintained on file in the Administrative Services
Section. These records shall include (i) employee curriculum vitae (ii) record of relevant
training courses and (iii) confidentiality agreement signed by the employee.
Copies of test reports are maintained by each respective Laboratory Supervisor. The
format of test reports are outlined in Section 5.10.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.12 Revision 08
Control of Records Page 6 of 8 Issued:
October 2008
All original test data, including QC data, shall be recorded in a permanent form, e.g.
notebook, worksheet, instrument printout or magnetic media, using a permanent
recording medium at the time observations are made. Under no circumstances is a pencil
allowed as a recording media.
• name of analyst;
• sample ID;
• test method ID;
• date of test;
• test organism lot number, where applicable;
• equipment ID, where applicable.
Currently, data are manually entered into computers on a spreadsheet program (Quattro
Pro) and moved to respective files to sort control and assurance data. Clients are
provided with a hard copy of data results and upon request, a magnetic disk copy.
All associated data with respect to a result is available for repetition under the original
method conditions should identification of any suspect factors affection uncertainty be
required.
Flags assigned manually to absent test data shall exist at the following steps in the data
management process: Sample reception and sample analysis. The provision shall exist
for each assigned flag to be accompanied by an explanatory comment.
Absent data due to conditions other than a laboratory accident shall be confirmed at the
time of sample reception (see Section 5.4.1). If a laboratory accident occurs the
respective Laboratory Manager shall, prior to reporting absent or forming data, advise the
client and seek further instructions.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.12 Revision 08
Control of Records Page 7 of 8 Issued:
October 2008
It is GLIER Laboratory policy to ensure mistakes to test data made during recording are
not erased, made illegible, or deleted in any way that may render the recorded entry
insubmissable as a legal document.
At the time of data recording, situations were corrections to mistakes in original test data
may be required. Mistakes are crossed out and initialled by the recording technician, and
subsequent corrections entered alongside the original data. The use of correction
mediums (‘White Out') is prohibited from use in any recording documents.
In the case of electronic records, the data (cell on spreadsheet) must be highlighted using
special a function (i.e. cross out, bold, highlight) as available by program. The Lab
Supervisor must approve a change.
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.13 Revision 08
Internal Audits Page 2 of 6 Issued:
October 2008
Management Requirements
4.13.1 General
4.13.1.1 Purpose
To define the planning and implementation of internal quality audits to verify whether the
quality activities and analytical results comply with approved procedures and to gauge
the effectiveness and areas requiring improvement of the quality system.
4.13.1.2 Scope
Internal quality audits will cover all elements of the quality system. The Quality
Manager together with each Laboratory Supervisor operates a quality audit program by
carrying out systematic examinations on an annual basis, e.g. through observation,
interviews and examination of records/documentation.
Results of audits will be forwarded by the Auditor to the respective Laboratory Supervisor.
Original transcripts are maintained in document control by the Quality Manager.
GLIER Laboratories will ensure that, where resources permit, auditors will be deemed
independent of the activity being audited. these activities are deemed the responsibility
of the Quality Manager. In situations where personnel resources are limited, audit
activities will be conducted by each Laboratory Supervisor on the other laboratory system,
i.e. Metals Supervisor is authorised to audit the Organic Laboratory activities, and visa
versa.
Training records qualified staff are maintained by the Quality Manager in the Quality
Control Office.
All procedures cited in the Quality Manual, together with those described in SOP's and
Related Procedures, will be subject to internally-initiated audit. Other items can be
specified and implemented by the Auditing personnel.
The CAEAL Rating Guide CAN-P-1510D, or any other suitable check list, may be used
when conducting an internal audit. The steps to be followed in conducting a quality audit
are:
• notify relevant individuals regarding details of the audit schedule;
• hold pre-audit meeting and verify arrangements;
• conduct audit;
• hold post audit meeting and convey documented findings;
• develop appropriate corrective action schedule if necessary
• ensure follow up activities verify the implementation and
effectiveness of the corrective action(s) taken
The audit conclusions and any subsequent corrective action(s) shall be documented and
filed by the Quality Manager with the assistance of Laboratory Managers. Corrective
Action forms are used for each identified non-conformance. Summary results shall be
communicated by the Quality Manager to the respective Laboratory Heads during
Management Review meetings, unless actions require immediate implementation of
upper management authority.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.13 Revision 08
Internal Audits Page 4 of 6 Issued:
October 2008
The Quality Manager will identify the auditors and the areas to be audited. Scheduled
audits, in addition to any scheduled CAEAL or other accreditation audits, will occur, at
least. In addition, unscheduled audits may be initiated by the Quality Manager any time.
Such audits may respond to performance audit results, client feedback or any other
circumstance challenging either the quality of the laboratory's' tests or compliance with
the provisions of this Quality System.
The Quality Manager, in co-operation with the respective Laboratory Heads, ensures that
any actions identified in this way are completed according to the specified time frame.
If a performance audit provides results which challenge test method performance, the
Quality Manager may, after appropriate investigation, initiate either corrective action or a
quality audit.
The results of performance audits and any subsequent actions shall be documented and
filed by the Quality Manager. Copies of relevant (summary) information shall be
circulated by the Quality Manager to the respective Laboratory Supervisor.
Findings are defined as those noncompliant practices which require corrective action.
Comments are considered advice and do not require a corrective action response. It is the
responsibility of each respective Laboratory Manager to verify implementation of the
corrective actions.
Records of communications with the client(s) will be maintained with the respective no-
conformance file. The client will be notified upon satisfactory completion of non-
conformance to communicate resulting actions, and ensure client satisfaction.
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.13 Revision 08
Internal Audits Page 5 of 6 Issued:
October 2008
Flowchart
The following flowchart outlines the basic concepts for auditing procedures followed by
GLIER Laboratories (Reprinted from ANSI/ISO/ASQ Q9000-2000).
ISO/IEC 17025
GLIER - Analytical Laboratories Quality System Procedures
Section 4.13 Revision 08
Internal Audits Page 6 of 6 Issued:
October 2008
The following section of this Quality Manual has been reviewed and approved for
issuance by the commissioned management personnel. This is a controlled document,
and unauthorised printing or photocopying is prohibited. Copies not showing the original
signature are considered uncontrolled copies, and may not reflect currently issued
policy/procedure.
______________________________________________________________________
Laboratory Director Date
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.14 Revision 07
Management Reviews Page 2 of 4 Issued:
December 2004
Management Requirements
4.14.1 General
4.14.1.1 Purpose
4.14.1.2 Scope
The quality management review process and subsequent report shall include at least the
following sections:
Laboratory Heads and the Quality Manager meet, at least annually, to evaluate the quality
system, to ensure its continuing suitability and effectiveness, and to introduce any
necessary improvements. Management Review schedule is outlined in Appendix 4.14.
All relevant records relating to a quality audit, performance audit, client feedback and
internal performance check shall be available for the quality system review. The results
of the review and any actions taken shall be documented and filed by the Quality
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.14 Revision 07
Management Reviews Page 3 of 4 Issued:
December 2004
Manager who shall be responsible for preparing a report detailing the results of the
review.
The Quality Manager, in cooperation with the Laboratory Heads, ensures that any actions
are discharged according to the agreed time frame.
ISO/IEC 17025:2001
GLIER - Analytical Laboratories Quality System Procedures
Section 4.14 Revision 07
Management Reviews Page 4 of 4 Issued:
December 2004