GLIER QSP Managementrequirements

ISO/IEC 17025:2001
Quality System Procedures

Revision 07
Page 1 of 1
Issued:
December 2004
GLIER - Analytical Laboratories
Section 4, 5
Table of Contents
TABLE OF CONTENTS
Management requirements
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
Organization
Quality System
Document Control
Review of requests, tenders and contracts
Subcontracting of tests and calibrations
Purchasing services and supplies
Services to the client
Complaints
Control of nonconforming testing and/or calibration work
Corrective action
Preventative action
Control of records
Internal audits
Management review
Technical requirements
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
Personnel
Accommodation and environmental conditions
Test and calibration methods and method validation
Equipment
Measurement traceability
Sampling
Handling of test and calibration items
Assuring the quality of test and calibration results
Reporting the results
Section 4.1
Laboratory Organisation
4.1
ISO/IEC 17025
Revision 08
Page 1 of 7
Issued: Oct. 2008
Quality Manual Authorisation and Approval
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
Section 4.1
ISO/IEC 17025
Revision 08
Page 2 of 7
Issued: Oct. 2008
Management Requirements
4.1
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 Canadas (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.
4.1.3
Operational Facilities
This Quality System covers activities at the GLIER Laboratorys permanent facility only.
GLIER Laboratories is comprised of two units - the Organic Analytical Unit and the
Metals Analytical Unit. Staff from each unit report to the Laboratory Supervisor whom
reports to the respective Laboratory Head.
4.1.4
Conflict of Interest
GLIER Laboratories operates as an impartial body within the institution of the University
of Windsor, and is free from undue pressures that would affect its independence of
judgement or integrity to its client as set out by the University of Windsor Policy
Conflict of interest or Commitment Policy' November 1999.
4.1.5
Management Responsibility
Technical Operations. Overall responsibility for Technical Operations in the laboratory
is assigned to the Laboratory Supervisor within each respective Unit.
Section 4.1
ISO/IEC 17025
Revision 08
Page 3 of 7
Issued: Oct. 2008
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.
Client Confidentiality. All staff employed by the GLIER Laboratory, University of
Windsor shall be required to sign a confidentiality agreement which includes an
agreement, on the part of the employee, to hold in confidence all confidential information
relating to a client, including proprietary rights. Confidentiality Agreement Forms are
drafted by Legal Counsel at the University of Windsor and are signed by all staff.
Copies of confidentiality agreements shall be maintained on file in the Administrative
Services Section (See Appendix 4.1 )
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:
Lab Head - Organic Laboratory
Lab Head Metals Laboratory
Quality Manager
Laboratory Supervisor - Organic Laboratory
Laboratory Technician - Organic Laboratory
Laboratory Supervisor- Metals Laboratory
GLIER Office Administrator
Dr. Ken G Drouillard

Dr. Brian J. Fryer
Mr. Jean Claude Barrette
Dr. Nargis Ismail
Mr. David Wei Qiu
Mr. Jean Claude Barrette
Ms. Mary Lou Scratch
Chart A provides an organisational outline for the GLIER Laboratories, University of

Windsor.
Section 4.1
ISO/IEC 17025
Revision 08
Page 4 of 7
Issued: Oct. 2008
Staff Substitution.
Substitution arrangements for key managerial position when
practical is as follows
Position
Substitution
Lab Director
Head Metals Lab
Head Organic
Quality Manager
Lab Heads
Head Organic
Head Metals Lab
Lab Supervisors
Workload. The Laboratory processes approximately 1,500 samples annually. The

breakdown by Unit together with assigned staff follows:
Unit
No. of Staff
No. of Samples
Inorganic Chemistry
Organic Chemistry
Total
1
2
3
500
1,000
1,500
Section 4.1
ISO/IEC 17025
Revision 08
Page 5 of 7
Issued: Oct. 2008
GLIER Laboratory Organisational Chart A

Vice-President
Academic
University of Windsor
GLIER
Executive Director
GLIER
Administration
ML Scratch
Laboratory Director
BJ Fryer
Laboratory Head
Organic Lab
KG Drouillard
Laboratory Head
Metals Lab
BJ Fryer
Quality Manager
JC Barrette
Organic Lab Supervisor

Nargis Ismail
Lab Technician
D. Qiu
Metals Lab Supervisor

JC Barrette
ISO/IEC 17025
Revision 08
Page 6 of 7
Issued: Oct. 2008
Section 4.1
University of Windsor
Academic Operations
President
Vice-President, Academic
Executive Assistant
to the Vice-President
Academic
Executive Secretary
to the Vice-President
Academic
Director
Great Lakes Institute
Associate Vice-President
Academic Affairs
Associate Vice-President
Research
Special Assistant to the VPA &

Director, Faculty Recruitment & Retention
Director, Division of Instructional

Development and Co-ordinator of
Academic Computing
University Academic Structure
Section 4.1
APPENDIX A
ISO/IEC 17025
Revision 08
Page 7 of 7
Issued: Oct. 2008
REVISION HISTORY
Revision 0
April 23, 2003
H.Hagen
-new issue of revised format Quality manual
Revision 1.1 June 14, 2004
H.Hagen
- Organisational chart update - Haffner to Drouillard, use Manager instead of Supervisor
terminology
Rev.
Rev.
Revised
Sections
No.
Date
by
Affected
06
Aug. 9,
2004
JC Barrette
07
Dec.
2004
JC Barrette
08
Oct.
2008
JC Barrette
Description
4.1
Appendix A
Approval
4.1 Org. Chart
all text
4.1.5
Title page
Change rev.no. to follow Q.M.2003

add revision table
add approval/authorization page
Title terminology, re-organized similar to2003
Change terminology of Lab Manager back to Supervisor
Staff Substitution added similar to 2003
Approval by Lab Director
Header
4.1.1 Registration
4.1.2 clients
Keyposition/Chart
4.1.5Resposibility
List 17025 only. Not 17025:2001, year of doc. revision

GLIER legal entity of University of Windsor
Removed consultants from clients served
Remove vacant for Nargis Ismail, Org Lab
Defined Lab Head and Quality Manager Responsibilities
Auth.
Section 4.2
Quality System
4.2
ISO/IEC 17025:2001
Revision 07
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
Section 4.2
Quality System
ISO/IEC 17025:2001
Revision 07
Page 2 of 4
Issued:
December 2004
4.2
Quality System
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.
4.2.2
Quality Objective
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:
utilizing SOPs to ensure data consistency in the measurement process;
auditing operational performance of the laboratory on a routine basis and providing
corrective action if needed;
maintaining complete records of sample receipt, laboratory analysis and data
reporting.
4.2.3
Quality Documentation
Quality Policy and Quality System Manual (QSM)
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.
Section 4.2
Quality System
ISO/IEC 17025:2001
Revision 07
Page 3 of 4
Issued:
December 2004
Quality System Procedures (QSP)

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.
Standard Operating Procedures (SOPs)
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. SOPs 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.
Related Procedures (RP)
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.
Forms and Records
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
Section 4.2
Quality System
APPENDIX A
ISO/IEC 17025:2001
Revision 07
Page 4 of 4
Issued:
December 2004
REVISION HISTORY
Rev.
Rev.
Revised
Sections
No.
Date
by
Affected
06
Aug. 9,
2004
JC Barrette
07
Dec. 8,
04
JC
4.2
Appendix A
Approval
4.2.1
Title Page
Description

add revision table
Scope statement expanded to responsibility to Quality
Manager
Lab Director Approval
Auth.
ISO/IEC 17025
Section 4.3
Document Control
4.3
Page 1 of 8
Revision 10
Issued:
October 2008

policy/procedure.
______________________________________________________________________
Laboratory Director
Date
ISO/IEC 17025
Section 4.3
Document Control
Page 2 of 8
Revision 10
Issued:
October 2008
4.3
Document Control
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 SOPs. 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.
4.3.2
identified by subject, date of issue, revision number and page numbering

with total pages;
reviewed for accuracy;
approved by authorised person;
available when required;
replaced when obsolete.
Document Approval and Issue
4.3.2.1 Master List.

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:
Quality Policy and Quality System Manual (QSM)
The Quality System Manual is the first level document, which describes the
implementation of the GLIER Quality Management System within the Laboratory.
Quality System Procedures (QSP)
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.
Section 4.3
Document Control
ISO/IEC 17025
Revision 10
Issued:
October 2008
Page 3 of 8
1) Standard Operating Procedures (SOPs)

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.
2) SOP Validation data
Validation Data binder tabulated with data sourced from the QA/QC SOP log files.
Tabulated as per 5.4.5.1 validation parameters.
Related Procedures (RP)
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.
Forms and Records
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.
4.3.2.2 Availability and Review
Distribution
A distribution list of all quality documentation is maintained in the Quality Control
Office, and the Quality Manager ensures that all persons identified on the distribution list
receive updated documents and return all obsolete documents. Distribution list will be as
follows:
Manuals in Circulation
Complete manual: Home copy (1 copy) - Quality Control Office
Partial manuals: Standard Operating Procedures (6 Copies)
S.O.P.
Organic Lab
Sample Preparation Lab
Related Prod.
SOP-Validation Data Sample Preparation Lab
Metals Lab
Instrument Lab
Data Management Lab
Section 4.3
Document Control
ISO/IEC 17025
Page 4 of 8
Revision 10
Issued:
October 2008
Review and Approval

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
Documentation Changes
4.3.3.1 Changes or Additions

Changes or additions to the quality documentation may be initiated by anyone on written
application to the Quality Manager and/or Laboratory Head or as a result of corrective
action, but they must follow the approval process, including a management review and
authorisation, before changes can be formally instituted and a revision issued.
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.
4.3.3.3 Hand-written Amendments
Hand-written amendments to quality documents may be conducted on controlled quality
documents only, dated and initialled by the lab supervisor. Changes to quality
documentation must comply to regulations set out in section 4.3.3.2 before formal
approval and reissue.
Section 4.3
Document Control
ISO/IEC 17025
Page 5 of 8
Revision 10
Issued:
October 2008
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.
4.3.3.4 Electronic Document Control
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 Manualdoc
Quality System Procedures:
\\Q.Sys.Prod\Appendix\Revision&Date \ appendicesdoc
\\Q.Sys.Prod\Section 4\ Revision&Date \ QSP 4.1doc
\\Q.Sys.Prod\Section 5\ Revision&Date \ QSP 5.2doc
Standard Operating Procedures:
\\SOP\Metals\ Revision&Date \ 01-001wpd
\\SOP\Organic\ Revision&Date \ SOPORGwpd
Related Procedures:
\\Rel.Prod.\Metals\ Revision&Date \ relprodwpd
\\Rel.Prod.\Organic\ Revision&Date \ rpwpd
SOP Validation Data
\\SOPValidationData\Revision&Date \metals&organic.doc
Reference 4.12.2.1.4 for Back up of records.

Changes to Electronic Documentation
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
Section 4.3
Document Control
Page 6 of 8
Revision 10
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.
Departures from Quality Documentation
Departures from policies, procedures or methodologies documented in the Quality
Manual, Standard Operating Procedures and Related Procedures may be permitted under
exceptional circumstances. All departures must receive prior written approval from the
appropriate authority.
4.3.4
Data Management
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.
4.3.4.1 Corrections to Original Test Data

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 initialed 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, i.e. cross out, bold, highlight., as available by program.
ISO/IEC 17025
Section 4.3
Document Control
Page 7 of 8
Revision 10
Issued:
October 2008
4.3.4.2 Storage and Disposal of Records

It shall be the responsibility of the respective Laboratory Supervisor to ensure that
records identified in this Manual and under their responsibility are easily
retrievable and stored in a secure manner.
As soon as such records no longer serve a useful purpose within an individual
section they remain in the custody of the respective Laboratory Supervisor, stored
in records storage.
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.
4.3.4.3 Maintenance of Computer Files

The laboratories central computer (LIMS ST - running windows 2000) is backed
up weekly onto an external drive source. The external drive source is supplied by
the University under the Novell network (having its own back-up).
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.
4.3.4.4 Maintenance of Equipment log books and binders.
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.
4.3.4.5 Computer Data Protection and Confidentiality
Each Laboratory has one dedicated computer workstation that must be securepassword 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
Section 4.3
Document Control
APPENDIX A
Page 8 of 8
Revision 10
Issued:
October 2008
REVISION HISTORY
Revision 5.1 April 23, 2003

H.Hagen
H.Hagen
- addition of Appendix A: Revision History section
- updates to Storage Hard drive information
Rev.
Rev.
Revised
Sections
No.
Date
by
Affected
Description
Aug. 9,
2004
Aug. 9,
2004
JC Barrette
4.3.3.4
edit file storage location and reference back-up records
JC Barrette
07
Dec. 8,
04
JC
08
Nov 2,
06
JC Barrette
4.3
Appendix A
Approval
Hagen Rev. No.s
4.3.3.3 elec. Doc.
4.3.3.1 changes
4.3.3.2
Title page
4.3.4 Data
Management
change rev.no. to follow Q.M.2003

add revision table
Change listed version 0, 1.1 to 5.1, 5.2
Actual practices listed
Quality manager responsible for document changes
Clarify approval of QM, QSP by Lab Director
2003 QM format change, copy over missed
edited 4.3.4 for QSP 2006
09
Oct 18,
07
JC Barrette
4.3.2.1&
4.3.2.2Master List
4.3.3.3 Handwritten amendts.
10
Oct.
2008
JC Barrette
Header
4.3.1
06
add SOP Validation Binder

yes to controlled documents by lab
Supervisor with date and initial
Remove year in 17025:2005

Headers, Page numbering and page total
Auth.
Section 4.4
Review of Requests, Tenders
and Contracts
4.4
ISO/IEC 17025:2001
Revision 07
Page 1 of 6
Issued:
December 2004

policy/procedure.
______________________________________________________________________
Laboratory Director
Date
Section 4.4
and Contracts
i)
ISO/IEC 17025:2001
Revision 07
Page 2 of 6
Issued:
December 2004
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:
All customer requirements will be adequately understood, documented and agreed
upon:
The laboratory has all necessary resources available to carry out the agreed
requirements;
The test method chosen is accepted by the client to be technically sufficient to
meet their requirements
iii)
Definitions
Contract: A contract may be defined either as a written document or verbal agreement
held between the client, Laboratory Head and University of Windsor which outlines the
intent to procure services.
iii)
Authorities and Responsibilities

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.
Section 4.4
and Contracts
ISO/IEC 17025:2001
Revision 07
Page 3 of 6
Issued:
December 2004
4.4
4.4.1
Review of Requests, Tenders and Contracts

Request, Tender and Contract Review Procedure
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.
4.4.2
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;
iv)
Confirmation of Grant account is received by the GLIER Administrator,

which is appended to the central file contract;
v)
Upon completion of required contract services, the GLIER Administrator

notifies Financial services to invoice client for services rendered, and a
copy of the requested invoice is appended to the contract in central files;
vi)
Confirmation of payment is received by the GLIER Administrator

internally, and contract is closed.
Terms of Agreements
This procedure shall ensure that:
All requirements including methodology used will be adequately defined,
documented and understood by the customer.
Agreements regarding testing time line and sample disposal, storage or return
shall be made.
Section 4.4
and Contracts
ISO/IEC 17025:2001
Revision 07
Page 4 of 6
Issued:
December 2004
The laboratory has the required technical and managerial capability and resources
to meet the customer's requirements.
The appropriate method and/or calibration is agreed upon by customer prior to
start of analysis.
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.
4.4.3
Records of Reviews
Reviews and amendments to contracts will be carried out by Laboratory Heads as
necessary, and changes recorded in management meeting minutes.
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.
4.4.4
Subcontracting Review
Reviews and amendments relating to subcontracted work will be carried out by
Laboratory Heads as necessary, and a record maintained in management meeting
minutes.
Section 4.4
and Contracts
4.4.5
ISO/IEC 17025:2001
Revision 07
Page 5 of 6
Issued:
December 2004
Client Notification
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
Revision 07
Page 6 of 6
Issued:
December 2004
Section 4.4
and Contracts
APPENDIX A
REVISION HISTORY
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4.4
Appendix A
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Section 4.5
Subcontracting of Tests
4.5
ISO/IEC 17025
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______________________________________________________________________
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Date
Section 4.5
i)
ISO/IEC 17025
Revision 08
Page 2 of 4
Issued:
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Purpose
This procedure outlines the system used by GLIER Laboratories to implement
subcontracting of analytical services, and applies to all contracted services which may
impact the quality of results reported to the customer.
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
Sub-Contractor: Vendor/Supplier of analytical services required to complete the
requirements of a contract agreement.
iii)
Authorities and Responsibilities

Terms of the subcontractor agreement are authorised by the Laboratory Head, with
intended to reflect the client requirements.
Section 4.5
4.5.1
ISO/IEC 17025
Revision 08
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October 2008
Subcontractor Competence
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.
4.5.2
Client Notification
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.
4.5.3
Responsibility to Client
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.
4.5.4
Sub-Contractor Register
The Laboratory Manager shall maintain a record of all sub-contractors and a record of
the evidence of compliance with CAN-P-4D for those sub-contractors providing service
for GLIER Laboratory accredited methodologies only.
Through the use of various GLIER management appointed assessment methods,

subcontracting laboratory(s) have been able to demonstrate the quality of its analytical
work. A list of currently appointed subcontractors appears in Appendix 4.5.4.
ISO/IEC 17025
Revision 08
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Section 4.5
APPENDIX A
REVISION HISTORY
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4.5
Appendix A
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Section 4.6
Purchasing Services and
Supplies
4.6
ISO/IEC 17025:2001
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Section 4.6
Supplies
ISO/IEC 17025:2001
Revision 07
Page 2 of 6
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December 2004
4.6
Purchasing Services and Supplies
4.6.1
Equipment, Service and Supply Procurement
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 results of such assessments shall be communicated to the Laboratory Supervisor.
The Laboratory Supervisor shall maintain a list of all approved suppliers, including subcontractors from whom the laboratory obtains goods or services.
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 maintains an appropriate inventory for ongoing
consumables.
Section 4.6
Supplies
ISO/IEC 17025:2001
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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.
4.6.1.4 Sole Source Procurement (University of Windsor Financial Services Policy)
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.
4.6.2
Inspection and Verification

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.
.
Section 4.6
Supplies
4.6.3
ISO/IEC 17025:2001
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Purchasing Documents
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 Purchase of Critical Equipment, Services and Supplies

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.
Critical Supplier: Vendor/supplier of products or services deemed quality critical to the
laboratory's ability to report quality analytical results to its customers.
The Lab Head is responsible approving specifications on critical equipment.
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.
Purchase requisitions/orders clearly specify technical requirements of the equipment.
materials and/or service being ordered.
Formal evaluation of suppliers is carried out via a questionnaire. See Appendix 4.6.3.1
Section 4.6
Supplies
4.6.4
ISO/IEC 17025:2001
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Supplier Approval
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.
An approved suppliers list is maintained in Appendix 4.6.
Section 4.6
Supplies
APPENDIX A
ISO/IEC 17025:2001
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Appendix A
Approval
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4.6.2
4.6.2
4.6.3.1.2
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4.6.3.1.1 purc.
4.6.3.1.2 prod.
4.6.3.1.2 prod.
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Section 4.7
Service to Client
4.7
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Section 4.7
Service to Client
ISO/IEC 17025:2001
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4.7
4.7.1
Service to Client
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
This procedure applies to all analytical services offered by GLIER Laboratories.
GLIER laboratories engage primarily in not for profit research projects with partner
groups and researchers within the public and private sector. In such capacity,
collaborative projects with our clients contribute to the advancement of science through
publications in peer reviewed journals, and thus are not based on the more traditional
market strategies of service-oriented laboratories.
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.
Confidentiality agreements maintained between GLIER Laboratories and its customers
will supersede specific client requests for admittance to facility or documentation when
deemed ethically inappropriate. This responsibility remains the decision of the
Laboratory Head, and shall be considered prior to approving customer requests for
visitation of said facility.
All attempts to ensure good customer relations, including advice, guidance in technical
matters, and interpretations of results, will be maintained.
Section 4.7
Service to Client
APPENDIX A
ISO/IEC 17025:2001
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4.7
Appendix A
Approval
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Section 4.8
Customer Complaints
4.8
ISO/IEC 17025:2001
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Section 4.8
Customer Complaints
ISO/IEC 17025:2001
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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.
4.8.2
Customer Complaints
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.
All non-technical complaints are addressed by the Lab Heads.
4.8.3
Complaints Records
The Laboratory Supervisor and/or Quality Manager as applicable maintains a record of
all complaints and the corrective actions taken. (see file, customer complaints/client
feedback).
Section 4.8
Customer Complaints
APPENDIX A
ISO/IEC 17025:2001
Revision 07
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December 2004
REVISION HISTORY
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Appendix A
Approval
4.8.2
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Section 4.9
Control of Non-conforming
Testing
4.9
ISO/IEC 17025
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Date
Section 4.9
Testing
ISO/IEC 17025
Revision 08
Page 2 of 5
Issued:
October 2008
4.9
Control of Non-conforming Testing
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.
A non-conformance is a deviation from an established protocol or plan, such as:
failure of resources (i.e. personnel, equipment, facilities, work instructions) to
meet performance requirements or other specified requirements;
failure of personnel to comply with documented work instructions or operational
procedures;
failure of test data to meet required standards due to:
failure (or suspected failure) to meet all conditions necessary to ensure the
integrity and representatives of the sample, i.e. sample history deficiencies
exist;
failure (or suspected failure) to comply with the test method SOP's;
failure (or suspected failure) in method performance as demonstrated by
results provided by quality control samples;
inherent property of a sample that compromises the testing, e.g. as verified
by the method of standard additions;
Relevant evidence provided by data validation e.g. as a result of comparison with
expected values, ranges or relationships.
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.
Section 4.9
Testing
4.9.3
ISO/IEC 17025
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Page 3 of 5
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October 2008
Non-Conforming Test Data

Test data will be considered to be nonconforming, if any of the following conditions
exist:
failure (or suspected failure) to meet all conditions necessary to
ensure the integrity and representativeness of the sample, i.e. sample history
deficiencies exist;
failure (or suspected failure) to comply with the test method or supporting work
instructions;
failure (or suspected failure) in method performance as demonstrated by results
provided by quality control samples; inherent property of sample that
compromises the testing, e.g. as verified by the method of standard additions;
relevant evidence provided by data validation, e.g. as a result of comparison
with expected values, ranges or relationships.
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 nonconformance 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.
Section 4.9
Testing
4.9.4
ISO/IEC 17025
Revision 08
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October 2008
Procedure for Remedial Action of Non-conformance

The Laboratory Supervisor ultimately assumes responsibility for ensuring any nonconformance 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 nonconformance is initiated. As soon as the non-conformance has been identified, the
following procedure is conducted:
The instrument will be identified as out of service. Any other instrument or
piece of equipment that may have be adversely affected by the nonconformity, or
is subject to similar fault, will also be evaluated in the same manner.
The reporting of any future results generated by the instrumentation will be
withheld until the root cause and net analytical effect can be determined.
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 nonconformance are notified in writing, and individual concerns and the significance
of potential deviations are determined.
As soon as remedial action is taken, the Laboratory Supervisor authorises the
instrument to be placed back into service. If the instrument cannot be returned to
service immediately, and an acceptable backup method exists, results may be
generated using the backup method.
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.
Section 4.9
Testing
APPENDIX A
REVISION HISTORY
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4.9
Appendix A
Approval
All text
4.9.3
4.9.4
08
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4.9.3
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Section 4.10
Corrective Action
4.10
ISO/IEC 17025:2001
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Section 4.10
Corrective Action
ISO/IEC 17025:2001
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4.10
Corrective Action
4.10.1 General
4.10.1.1 Purpose
This procedure outlines a system for identification and correction of existing quality nonconformities 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 Action: A corrective action is a measure taken to rectify conditions that
compromise the quality of a product or system, or in response to a customer complaint,
and where possible, to preclude its recurrence. It usually identifies a response to an
existing problem.
4.10.2 Cause Analysis
Corrective actions are often carried out in response to a non-conformance (Section 4.9)
and may include;
an investigation of potential causes of nonconformity, and an analysis of

possible contributing factors to determine the root cause.
Potential causes can be assessed from various sources of information,

including client feedback, sample specifications/condition, methods and
procedures, training requirements for staff, or equipment calibrations.
4.10.3 Selection and Implementation of Corrective Actions

It is the policy of GLIER Laboratories to initiate immediate action(s) to control or correct
a non-conformance identified to affect the quality procedure. The Laboratory Manager
assumes responsibility for investigating the problem and determination of the root cause,
as well as assigning responsibility for the implementation of a corrective action
procedure.
The corrective action processes are maintained under document control procedures using
Corrective Action Reports (Appendix 4.10), and required changes are implemented by the
Section 4.10
Corrective Action
ISO/IEC 17025:2001
Revision 07
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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;
determining and initiating a preventative action to eliminate or control the

problem or prevent its re-occurrence.
implementation of the necessary corrective action and assessment of its

effectiveness.
Applying controls to prevent re-occurrence.
Implementing and documenting changes resulting from the corrective action,

as well as documenting its effectiveness.
4.10.4 Monitoring of Corrective Actions

In the case of an internal method audit, proficiency testing, or any other corrective action,
the following procedures are followed:
An audit report is submitted from the Laboratory Head to the appropriate

Laboratory Supervisor;
A final decision is taken by management regarding the remedial action and a

written reply is submitted from the responsible Laboratory Supervisor to
the Laboratory Head within 15 days.
4.10.5 Additional Actions

The necessity of initiating additional, follow-up, audits, in cases where a serious,
persistent issue has not been solved using the above procedures may occur.
Responsibility for initiating additional audits rests with the Laboratory Supervisor.
Section 4.10
Corrective Action
APPENDIX A
REVISION HISTORY
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Appendix A
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Section 4.11
Preventative Action
4.11
ISO/IEC 17025:2001
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Section 4.11
Preventative Action
ISO/IEC 17025:2001
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4.11
Preventative Action, Continual Improvement
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
Preventative Action: A preventative action refers to the identification of needed
improvements and the prevention of potential non-conformities in quality and technical
operations.
4.11.2 Primary Objective
The primary objective of a preventative action is to prevent potential problems related to
quality, reduction of errors, and quality enhancement.
Preventative action plans can be identified from various resources, including:
Customer feedback
Internal/quality/management review audits
Technical meetings
Staff brainstorming
Quality Control Charts-Predicting control chart trends
- Refer to CAEAL document T27 for additional information. Copy also
contained with Internal Audit File.
Management meeting agenda of GLIER Laboratories representatives include discussions
concerning Preventative Action objectives. It is the intention of GLIER Laboratories to
develop long-term strategies that focus on Preventative Action training and incorporation
into regular Quality Assurance activities.
4.11.3 Procedure
Document any new ideas (or based on preventative resources as listed above) via C.A.R.
forms Appendix 4.9.
Section 4.11
Preventative Action
APPENDIX A
ISO/IEC 17025:2001
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Appendix A
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Section 4.12
Control of Records
4.12
ISO/IEC 17025
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Section 4.12
Control of Records
ISO/IEC 17025
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4.12
Control of Records
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
4.12.2.1.1
Records Maintenance
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.
Key Laboratory Quality Records
Sample Logbook
Customer Request for Tender and Contracts
Customer Complaints
Test Results
Calibration Checks
Compliance Certificates
Traceability of Standards
Non-Conformance Reports
Records of Management Review
Internal Quality Audit Reports
Approved Sub-Contractor files
Section 4.12
Control of Records
ISO/IEC 17025
Revision 08
Page 3 of 8
Issued:
October 2008
4.12.2.1.2
Management Review
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
Manager who shall be responsible for preparing a report detailing the results of the
review.
4.12.2.1.3
Storage, Disposal, Access and Integrity of Records
Storage
It shall be the responsibility of the respective Laboratory Supervisor to ensure that
records identified in this Manual and under their responsibility are easily retrievable and
stored in a secure manner.
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;
Section 4.12
Control of Records
ISO/IEC 17025
Revision 08
Page 4 of 8
Issued:
October 2008
Under no circumstances, except as dictated by a Court of Law, shall records be removed

from the laboratory. Requirements for ensuring client confidentiality shall be observed
when making records available.
Records Integrity
Records are maintained in a secure and suitable environment outside the laboratories in
office space adjacent to the labs.
Maintenance of Equipment log books and binders.
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.
4.12.2.1.4
Protection, Backup and Access of Electronic Records
Maintenance of Computer Files

1) Metals Lab:
The laboratories central computer (LIMS ST - running windows 2000) is backed up
weekly onto an external drive source. The external drive source is supplied by the
University under the Novell network (having its own back-up).
This task is done manually in Windows explorer by the drag an drop method. Refer to
the equipment binder under computers for procedure.
Procedure: External Back-Up (LimsST to Novell)
1.
2.
3.
Ensure PC is booted up into Microsoft and Novell network.

Novell Client:
- cntr + alt + delete
- username: barretb
- password: calculation
Windows Workstation:
- Name: Administrator
- From: Metals Lab
- Password: 5str5ll9t1
Open Windows Explorer
Scroll to Novell back-up location
Description
Location
Novell: J:/barretb on'Gamma\GLIER\Users'
\\Iris-TJA
Instrument PC, ICP-OES
\\Jcoff
Office PC, JC
Section 4.12
Control of Records
4.
5.
ISO/IEC 17025
Revision 08
Page 5 of 8
Issued:
October 2008
\\NSTVR1
Data PC, LIMS server
\\SQL database (L2K GLIER)
Data PC, LIMS server(linked ST.)
\\LIMS ST
Data PC, LIMS ST
\\Metals LIMS St
\\Organic LIMS St
Copy each of the Five directories listed above from the location described one at a
time through the Microsoft network and paste onto the Novell drive.
Override the last date stored directory.
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.
2) Organic Lab: Back up methods
1. GC-MSD onto CD disks
2. Data processing PC onto external hard drive
4.12.3 Technical Records
4.12.3.1 Original Observations
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.
4.12.3.2 Calibration Records
Calibration records shall include sufficient information to facilitate the duplication of that
calibration under the same environmental conditions, should the need arise.
4.12.3.3 Staff Records
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.
4.12.3.4 Test Reports
Copies of test reports are maintained by each respective Laboratory Supervisor. The
format of test reports are outlined in Section 5.10.
Section 4.12
Control of Records
ISO/IEC 17025
Revision 08
Page 6 of 8
Issued:
October 2008
4.12.3.5 Recording of Original Test Data

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.
The following information shall accompany the test data:
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.
Absent Test Data
Test data may be absent if any of the following conditions exist:
damaged sample;
insufficient sample;
sample history deficiency;
laboratory accident.
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.
Section 4.12
Control of Records
ISO/IEC 17025
Revision 08
Page 7 of 8
Issued:
October 2008
4.12.3.6 Corrections of Original Records

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.
4.12.3.7 Corrections to Electronic Data
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.
Changes to electronic copies of quality documentation are reissued under procedures as
outlined in section 4.3.3. as indicated by document revision record. Previous versions are
stored via different revision numbers and therefore are not lost.
The Quality Manager must approve Quality documentation changes.
ISO/IEC 17025
Revision 08
Page 8 of 8
Issued:
October 2008
Section 4.12
Control of Records
APPENDIX A
REVISION HISTORY
Revision 0
March 25, 2003
H.Hagen
H.Hagen
- Change Manager to Supervisor terminology
Rev.
Rev.
Revised
Sections
No.
Date
by
Affected
06
Aug. 9,
2004
JC Barrette
07
Dec. 8,
04
JC
08
October
2008
JC Barrette
4.12
Appendix A
Approvals
Title page
All text
4.12.3.5
4.12.3.7
4.12.2.1.3
Header
4.12.2.1.3
4.12.2.1.4
4.12.3.5
4.12.3.5
Description

add revision table
Lab Manager terminology back to Supervisor
Pencil not allowed
Add responsibility of changes and edit for actual
Record storage if requested by client
Records integrity, storage within office space out of lab
Computer file maintenance; Separate Metals and
Organic Lab Methods
Recording of data: Add original test data is available
for repetition under original method conditions.
Remove statement LIMS planning stages
Auth.
Section 4.13
Internal Audits
4.13
ISO/IEC 17025
Revision 08
Page 1 of 6
Issued:
October 2008

policy/procedure.
______________________________________________________________________
Laboratory Director
Date
Section 4.13
Internal Audits
ISO/IEC 17025
Revision 08
Page 2 of 6
Issued:
October 2008
4.13
Internal Audits
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.
This program is in place to determine whether:
i) policies, procedures and work instructions are implemented effectively as documented;
and,
ii) resources, policies and procedures are suitable to achieve the quality objectives.
The Internal Audit system includes the following key elements:
Internal Audit Key Elements
Equipment/Cal
Facilities
Staff Training
Documents Control
Data Management
Workload Management
Logs and actions

Procurement
Method Validation
Internal Quality Control
Work instruction
Sample Reception
Management Review
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.
4.13.1.3 Auditor Qualification

4.13.1.3.1
Administration of Audit Activities
Section 4.13
Internal Audits
ISO/IEC 17025
Revision 08
Page 3 of 6
Issued:
October 2008
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.
4.13.1.3.2
Auditor Training and Records
Auditors will have appropriate training by an external accredited organisation. Auditors

will include proven methods for implementing an ISO 9000 quality system, as well as
required standards outlined in ISO 17025.
Training records qualified staff are maintained by the Quality Manager in the Quality
Control Office.
4.13.2 Auditing Procedures
4.13.2.1 Quality System Audit Plan
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.
Section 4.13
Internal Audits
ISO/IEC 17025
Revision 08
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.
4.13.2.2 Performance Testing
The Quality Manager operates a performance audit program, which incorporates
participation in proficiency testing and is supplemented by provision of check samples
prepared by a qualified independent source, external to the laboratory. Both organic and
inorganic sections will participate in the Performance Audit Program.
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.
4.13.2.3 Client Notification
It is the intention of GLIER Laboratories to ensure the maintenance of quality analytical
performance. If testing results are deemed by the Auditing personnel to have been
compromised in any manner that may affect the quality of reported results, the respective
client(s) or their representative(s) in ownership of the testing agreement shall be notified
in writing, details of the non-conformance articulated, and mutually acceptable remedial
actions agreed upon.
Records of communications with the client(s) will be maintained with the respective noconformance file. The client will be notified upon satisfactory completion of nonconformance to communicate resulting actions, and ensure client satisfaction.
Section 4.13
Internal Audits
ISO/IEC 17025
Revision 08
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).
Section 4.13
Internal Audits
APPENDIX A
REVISION HISTORY
Rev.
Rev.
Revised
Sections
No.
Date
by
Affected
06
Aug. 9,
2004
JC Barrette
07
Dec. 8,
04
JC
08
October
2008
JC Barrette
ISO/IEC 17025
Revision 08
Page 6 of 6
Issued:
October 2008
Description
4.13
Appendix A
Approval
Title page
All text
I.Audit Prod.
(App 4.13A)
I.Audit Schedule
(App 4.13B)

add revision table
Lab Manager terminology back to Supervisor
Deleted from text, moved to Appendix and returned to
2003 version
Copy from 2003 Quality Manual ,Appendix
Header
4.13.2.2

Remove reference to appendix that does not exist
Auth.
Section 4.14
Management Reviews
4.14
ISO/IEC 17025:2001
Revision 07
Page 1 of 4
Issued:
December 2004

policy/procedure.
______________________________________________________________________
Laboratory Director
Date
Section 4.14
Management Reviews
ISO/IEC 17025:2001
Revision 07
Page 2 of 4
Issued:
December 2004
4.14
Management Review
4.14.1 General
4.14.1.1 Purpose
To define management's responsibility to ensuring continued quality in areas of resource
allocation for management system review.
4.14.1.2 Scope
The quality management review process and subsequent report shall include at least the
following sections:
Introduction, statement of meeting objectives

Review of minutes and actions from previous review
Suitability of policies and procedures
Reports from managerial and Managery personnel
Review of recent internal audits
Corrective and preventative actions
Review of recent assessments by external bodies
Results of recent inter-laboratory proficiency testing
Assessment of workload
Assessment of client feedback
Corrective actions to any client complaints
All other relevant factors regarding quality management
Implementation of continual improvement
4.14.2 Review Procedures

4.14.2.1 Quality Management System Review
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
Section 4.14
Management Reviews
ISO/IEC 17025:2001
Revision 07
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.
Section 4.14
Management Reviews
APPENDIX A
ISO/IEC 17025:2001
Revision 07
Page 4 of 4
Issued:
December 2004
REVISION HISTORY
Rev.
Rev.
Revised
Sections
No.
Date
by
Affected
06
Aug. 9,
2004
JC Barrette
07
Dec. 9,
04
JC
4.14
Appendix A
Approval
Title page
Description

add revision table
Auth.

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ISO/IEC 17025:2001

Quality System Procedures

GLIER - Analytical Laboratories

Quality System Procedures

GLIER - Analytical Laboratories

Quality Manual Authorisation and Approval

GLIER - Analytical Laboratories

GLIER - Analytical Laboratories

Dr. Ken G Drouillard

Chart A provides an organisational outline for the GLIER Laboratories, University of

GLIER - Analytical Laboratories

Workload. The Laboratory processes approximately 1,500 samples annually. The

GLIER - Analytical Laboratories

GLIER Laboratory Organisational Chart A

Organic Lab Supervisor

Metals Lab Supervisor

GLIER - Analytical Laboratories

Special Assistant to the VPA &

Director, Division of Instructional

University Academic Structure

GLIER - Analytical Laboratories

Change rev.no. to follow Q.M.2003

List 17025 only. Not 17025:2001, year of doc. revision

GLIER - Analytical Laboratories

Quality Manual Authorisation and Approval

GLIER - Analytical Laboratories

GLIER - Analytical Laboratories

Quality System Procedures (QSP)

GLIER - Analytical Laboratories

Change rev.no. to follow Q.M.2003

GLIER - Analytical Laboratories

Quality Manual Authorisation and Approval

GLIER - Analytical Laboratories

identified by subject, date of issue, revision number and page numbering

Document Approval and Issue

4.3.2.1 Master List.

GLIER - Analytical Laboratories

1) Standard Operating Procedures (SOPs)

GLIER - Analytical Laboratories

Review and Approval

4.3.3.1 Changes or Additions

GLIER - Analytical Laboratories

Reference 4.12.2.1.4 for Back up of records.

GLIER - Analytical Laboratories

4.3.4.1 Corrections to Original Test Data

GLIER - Analytical Laboratories

4.3.4.2 Storage and Disposal of Records

4.3.4.3 Maintenance of Computer Files

GLIER - Analytical Laboratories

Revision 5.1 April 23, 2003

edit file storage location and reference back-up records

change rev.no. to follow Q.M.2003

add SOP Validation Binder

Remove year in 17025:2005

GLIER - Analytical Laboratories

Quality Manual Authorisation and Approval

GLIER - Analytical Laboratories

Authorities and Responsibilities

GLIER - Analytical Laboratories

Review of Requests, Tenders and Contracts

Upon Director authorisation, the research contract form and client

Confirmation of Grant account is received by the GLIER Administrator,

Upon completion of required contract services, the GLIER Administrator