Purchasing Services and Supplies - Section 4, 5 Table of Contents Page 1 of 1 TABLE OF CONTENTS

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 sub- contractors 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.

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ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies

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Revision 07 Issued: December 2004

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.

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ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies Page 4 of 6 Revision 07 Issued: December 2004 4.6.3 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.

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ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies Page 5 of 6 Revision 07 Issued: December 2004 4.6.4 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.

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Purchasing Services and Supplies

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APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.6 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8, 04 JC All text 4.6.2 4.6.2 4.6.3.1.2 4.6.1.3 proc. 4.6.3.1.1 purc. 4.6.3.1.2 prod. 4.6.3.1.2 prod. Title page

Change terminology of Lab Manager back to Supervisor Lab Supervisor inspects goods, not technician

Delete reference to SOP

Lab Head define approval of critical purchases Lab Head has final approval

Lab Head approval on critical eq’m specs Lab Head replaces Lab Manager Reference to questionnaire

Add H.Hagen draft of questionnaire to appendix Lab Director approval

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Revision 07 Issued: December 2004

4.7 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.

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Revision 07 Issued: December 2004 Management Requirements 4.7 Service to Client 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

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.

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Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.7 Appendix A Approval Scope

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page collaborator/client definition

07 Dec. 9,

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ISO/IEC 17025:2001 Quality System Procedures Section 4.8

Customer Complaints Page 1 of 3

Revision 07 Issued: December 2004

4.8 Quality Manual Authorisation and Approval

policy/procedure.

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Revision 07 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.

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).

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ISO/IEC 17025:2001 Quality System Procedures Section 4.8

Customer Complaints Page 3 of 3

Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.8 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8, 04 JC 4.8.2 all text 4.8.3 complaints Title page

Add non-technical issues are addressed by Lab Heads Change terminology of Lab Manager ot Supervisor Responsibility to Job Title for record keeping Lab Director approval

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ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 1 of 5 Revision 08 Issued: October 2008

4.9 Quality Manual Authorisation and Approval

policy/procedure.

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ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 2 of 5 Revision 08 Issued: October 2008 Management Requirements

4.9 Control of Non-conforming Testing

In document Section 4, 5 Table of Contents Page 1 of 1 TABLE OF CONTENTS (Page 32-44)