ISO/IEC 17025:2001 GLIER - Analytical Laboratories …

1 GLIER - Analytical Laboratories ISO/IEC 17025:2001 Quality System procedures Section 4, 5 Table of Contents Page 1 of 1 Revision 07 Issued: December 2004 Quality System procedures TABLE OF CONTENTS 4 Management requirements 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 5 Technical requirements Personnel Accommodation and environmental conditions Test and calibration methods and method validation Equipment Measurement traceability

2 Sampling Handling of test and calibration items Assuring the quality of test and calibration results Reporting the results GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 1 of 7 Revision 08 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 GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 2 of 7 Revision 08 Issued: Oct.

3 2008 Management Requirements Laboratory Organisation 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. 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 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 Operational Facilities This Quality System covers activities at the GLIER Laboratory s 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. 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. Management Responsibility Technical Operations. Overall responsibility for Technical Operations in the laboratory is assigned to the Laboratory Supervisor within each respective Unit. GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 3 of 7 Revision 08 Issued: Oct.

5 2008 Lab Heads. Are Management representatives for the GLIER Laboratory operations with key function in authorization of management system and management review (review, continual improvements, departures and prevention). See Also 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.

6 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 ) 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 Dr. Ken G Drouillard Lab Head Metals Laboratory Dr. Brian J. Fryer Quality Manager Mr.

7 Jean Claude Barrette Laboratory Supervisor - Organic Laboratory Dr. Nargis Ismail Laboratory Technician - Organic Laboratory Mr. David Wei Qiu Laboratory Supervisor- Metals Laboratory Mr. Jean Claude Barrette GLIER Office Administrator Ms. Mary Lou Scratch Chart A provides an organisational outline for the GLIER Laboratories , University of Windsor. GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 4 of 7 Revision 08 Issued: Oct. 2008 Staff Substitution. Substitution arrangements for key managerial position when practical is as follows Position Substitution Lab Director Lab Heads Head Metals Lab Head Organic Head Organic Head Metals Lab Quality Manager Lab Supervisors Workload. The Laboratory processes approximately 1,500 samples annually. The breakdown by Unit together with assigned staff follows: Unit No.

8 Of Staff No. of Samples Inorganic Chemistry 1 500 Organic Chemistry 2 1,000 Total 3 1,500 GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 5 of 7 Revision 08 Issued: Oct. 2008 GLIER Laboratory Organisational Chart A Vice-President Academic University of WindsorGLIER 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 GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 6 of 7 Revision 08 Issued: Oct. 2008 University of WindsorAcademic OperationsExecutive Assistantto the Vice-PresidentAcademicDirectorGreat Lakes InstituteExecutive Secretaryto the Vice-PresidentAcademicAssociate Vice-PresidentAcademic AffairsAssociate Vice-PresidentResearchSpecial Assistant to the VPA &Director, Faculty Recruitment & RetentionDirector, Division of InstructionalDevelopment and Co-ordinator ofAcademic ComputingUniversity Academic StructureVice-President, AcademicPresident GLIER - Analytical Laboratories ISO/IEC 17025 Quality System procedures Section Laboratory Organisation Page 7 of 7 Revision 08 Issued: Oct.

9 2008 APPENDIX A REVISION HISTORY Revision 0 April 23, 2003 -new issue of revised format Quality manual Revision June 14, 2004 - Organisational chart update - Haffner to Drouillard, use Manager instead of Supervisor terminology Rev. No. Rev. Date Revised by Sections Affected Description Aug. 9, 2004 JC Barrette Appendix A Approval Change to follow add revision table add approval/authorization page 07 Dec. 2004 JC Barrette Org. Chart all text Title 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 08 Oct. 2008 JC Barrette Header Registration clients Keyposition/Chart 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 GLIER - Analytical Laboratories ISO/IEC 17025:2001 Quality System procedures Section Quality System Page 1 of 4 Revision 07 Issued: December 2004 Quality Manual Authorisation and Approval The following section of this Quality Manual has been reviewed and approved for issuance by the commissioned management personnel.

10 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 GLIER - Analytical Laboratories ISO/IEC 17025:2001 Quality System procedures Section Quality System Page 2 of 4 Revision 07 Issued: December 2004 Management Requirements Quality System 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 . 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.