1. finance
2. accounting and auditing

CENTRE FOR CLINICAL DIAGNOSTICS
Quality Manual
Effective Date: 27 May, 2013
Author (QA Manager)
Amendment History
Version
Date
Facility Director
Author/s
Amendment details
1
11/2/2013
H Kramer
First version
2
27/5/2013
H Kramer
Section 4 updated to include Conflict of
Interest reference.
NB. The Quality Manual framework is ISO 17025 (R&D). Additional information from ISO 15189 has been
included and is referenced at the beginning of each section.
1. INTRODUCTION & DESCRIPTION
ISO 15189 (2009), 4.1, 5.1
The University of Queensland Centre for Clinical Research (UQCCR) mission is to improve
health through excellence in research, clinical partnerships, mentorship and service. Within
the UQCCR, the Centre for Clinical Diagnostics (CCD) has been established to manage and
conduct research into oncology and reproductive medicine and the development and
optimisation of in vitro diagnostic medical devices to support diagnosis and treatment. CCD
receives samples from the UQCCR clinic operating on Level 3 of the UQCCR Building and
also from referring practitioners collaborating with the CCD research program.
The CCD is located on Level 7 of the UQCCR at the Herston campus of The University of
Queensland (UQ). It is fully owned by UQ. All resources, staffing and funding are provided
by UQ.
Senior management ensures that responsibilities are defined, documented and communicated
within the organization and ensures the independence and authority necessary to perform
these tasks. An appointed member of management has responsibility and authority that
includes quality management system (QMS) oversight, reporting QMS performance to senior
management and ensuring the awareness of regulatory and customer requirements throughout
the organization.
CCD management provides the resources needed to maintain the effectiveness of the QMS
and to meet regulatory and customer requirements.
Review NLT: May 2014
Page 1 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
Appendix 1 contains an organizational chart for CCD. Appendix 2 contains a list of the
Position Descriptions for key roles within the Facility.
2. QUALITY POLICY
ISO 15189 (2009), 4.2.3
The UQCCR quality policy forms the core of our quality system. We:
 improve health through excellence in biomarker measurement and IVD development
 comply with all expectations encompassed within the ISO standards 17025 (R&D)
and 15189.
 apply the quality policy through a quality management system (QMS). The QMS
provides a documented formalised framework encompassing all actions and
procedures conducted within CCD and the Level 3 Clinic.
 enhance customer satisfaction through a process of continual improvement and
regulatory compliance while ensuring optimal care of our clients, support of our staff
and confidentiality of records
 ensure that all personnel are trained in the QMS and are competent in all relevant
procedures
 are proficient in all testing services offered while promoting a high standard of
excellence in support of clinicians, clients and other professionals
3. MANAGEMENT REVIEW
ISO 15189, 4.15
Laboratory management reviews the suitability and effectiveness of the quality management
system (QMS), including all services and procedures. The results of the review are
documented, including goals and action plans, and staff informed. This review occurs at least
annually, and more frequently during establishment of the QMS. Laboratory management
follows up the findings and ensures actions are taken within an appropriate timeframe. The
review also includes information on new or revised regulatory requirements.
SOP 014
Management Review
4. STAFF, EDUCATION & TRAINING
ISO 15189 (2009), 5.1
Facility management has:
• Personnel policies (UQ) and job descriptions available for all staff
• Staff professional records, including training
• Appropriate oversight of operations
• Appropriate training and education programs, including safety and confidentiality
The UQ ‘Policy and Procedures Library’ provides comprehensive coverage for all aspects of
CCD’s operations. Particular attention is drawn to the policy ‘Conflict of Interest within
Responsible Conduct of Research’ (section 4.20.02a of the ‘Policy and Procedures Library’).
Review NLT: May 2014
Page 2 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
The suitability of education and experience of all personnel employed in any capacity within
the CCD and Clinic is confirmed during the employment process. UQCCR maintains a focus
on the relevancy and currency of all staff education, training and conduct. Training and
education is appropriate to ensure continuous improvement in our services. All staff receive
appropriate training in the Quality Management System.
UQCCR recognises the benefits of learning to staff, clients and our services.
SOP 001
SOP 002
Personnel and Training
UQ Policies
5. QUALITY ASSURANCE (QA)
ISO 15189 (2009), 4.2, 4.9
QA provides ongoing assurance that the Facility is operating in compliance with the
accreditation requirements. It supports and controls a framework of Standard Operating
Procedures (SOP) and documents and provides independent oversight of the operations of the
Facility.
SOP 003
SOP 004
SOP 009
SOP 010
SOP 011
SOP 012
SOP 013
Control of documents
Control of records
Subcontracting of tests and calibrations
Purchasing services and supplies
Feedback, including complaints
Nonconformances, including corrective and preventive actions
Audits
These documents are complemented by a comprehensive series of technical procedures
prepared by staff, with compliance maintained by QA.
QA conducts a routine program of internal audits to ensure ongoing compliance.
6. DOCUMENT CONTROL
ISO 15189 (2009), 4.3
Documents are in electronic format, digitally signed and 21 CFR 11 compliant. They are
stored in an Electronic Laboratory Notebook maintained on a secure server with restricted
access. In some circumstances, paper copies of QMS documents are used. Printed copies of
quality system documents are issued from the ELN and have an identical format to electronic
documents. All documents that form part of the CCD quality system are uniquely identified
and subject to control and are detailed in a master list, including version and issue date.
Documents are defined as including policies, procedures, instructions, forms, text books,
international standards, reference intervals and software. The document system structure
includes general policies as defined by The University of Queensland, Standard Operating
Procedures covering processes and administrative topics and Work Instructions/Assay
Protocols for all technical operations.
Review NLT: May 2014
Page 3 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
Documents are reviewed and approved by authorised personnel and are subject to scheduled
review. All changes in current practice are reviewed and approved prior to issuing. Only
currently authorised versions of documents are available for use.
Superceded/expired ‘Master’ documents are identified as such and retained in the electronic
or paper archive, whichever is applicable, for a period as defined in the relevant SOP.
The document control procedures are defined within the relevant QMS documents.
SOP 003
Control of Documents
7. RECORDS, MAINTENANCE & ARCHIVING
ISO 15189 (2009), 4.3
All records are uniquely identified and are stored in a manner such that they are readily
retrievable. Records may be stored in secure, audited offsite storage.
Records are attributable, legible, contemporaneous (recorded as observed), original and
accurate. A suitable environment is provided to prevent damage, loss, deterioration or
unauthorised access. The retention period for records is defined in the relevant SOP.
Records include the following: request forms, results, reports, instrument printouts,
laboratory worksheets/books, electronic records, calibration data, QC data (internal and
external), audit reports, training records and maintenance records. The CCD Facility has
SOPs for the handling, archiving and retention of records.
SOP 004
SOP 006
SOP 007
Control of Records
Records and Sample Retention
Electronic Laboratory Notebook
8. ACCOMMODATION & ENVIRONMENT
ISO 15189 (2009), 5.2
The facility and resources are fit for intended use and are maintained in a functional capacity
that does not compromise result quality or delivery. The comfort and safety of staff and
clients are optimised and clients are protected from recognised hazards.
The laboratory environment:
• Is suitable for the designated procedures
• Does not adversely affect the result outcome
• Is monitored and controlled and the environmental conditions recorded
• Has effective separation between incompatible activities and measures to prevent
cross-contamination
• Has appropriate measures to prevent unauthorised access
• Has relevant storage space and conditions to ensure sample, consumables and records
integrity
Review NLT: May 2014
Page 4 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
• Is well maintained and clean with provision for disposal according to local regulations
• Has established maintenance activities when the absence of such activities could
affect product quality
WI 0059
WI 0060
Comet Dataloggers Setup
Comet Datalogger Alarms
9. EQUIPMENT, SERVICES, PRODUCTION & SUPPLIES
ISO 15189 (2009), 4.5, 4.6, 4.7, 5.3; 5.8
The CCD Facility has all the equipment required to conduct the services offered in a high
quality reliable manner. In those cases where the Facility needs to use equipment outside its
permanent control, laboratory management ensures that the requirements of this International
Standard are met.
The CCD Facility has procedures for the handling of test and calibration items. These items
have unique permanent identifiers and are traceable, where applicable, to national primary
standards. Periodic calibration by NATA certified providers is documented.
Equipment:
• Is installed/commissioned through a compliant, documented and approved Installation
Qualification/Operational Qualification (IQ/OQ) process unless determined otherwise
through a documented risk assessment process
• Is uniquely identified
• Is demonstrated fit for purpose
• Is included in a documented maintenance and/or calibration program, where
appropriate, with all outcomes recorded in facility records.
• Is operated by authorised personnel only
• Is provided with a Work Instruction for use, maintenance and calibration
• including:
• Is validated by the manufacturer where appropriate
• Maintains the integrity of data
• Utilises electronic audit trails where appropriate
• Uses unique user names and passwords
The CCD Facility has defined its policies and procedures for the selection and use of
purchased external services, equipment and consumable supplies. Equipment and supplies
should not be used until they have been verified as complying with the quality standards
defined by the facility. Suppliers of critical goods are assessed and records of these
evaluations approved and maintained.
A list of approved suppliers and records of goods received is maintained within the quality
management system.
Review NLT: May 2014
Page 5 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
The facility has an effective documented procedure for evaluating and selecting referral
laboratories and consultants. These arrangements are reviewed periodically.
SOP 005
SOP 008
SOP 010
Calibration and Maintenance
Computerised Systems
Purchasing Services and Supplies
10. ANALYSIS/EXAMINATION PROCEDURES
ISO 15189 (2009), 5.5
Analysis procedures are fit for purpose and, where developed in-house, are appropriately
validated (e.g. Evaluation of Precision Performance of Quantitative Measurement Methods
Approved Guideline, EP5-A2, Volume 24, number 25, Clinical and Laboratory Standards
Institute), reviewed and approved. The extent of the validation is determined through a
documented risk assessment process.
It is preferred that procedures selected from external sources are sourced from
established/authoritative textbooks, peer-reviewed journals or official guidelines. The level of
validation is justified and documented.
Manufacturer’s kits have been fully validated by the manufacturer and will be used following
verification that results generated by the CCD Facility are comparable with the
manufacturer’s expectation. Verification will consist of accuracy and precision testing.
There are approved Work Instruction readily available for each procedure. Electronic or
hardcopy manuals are acceptable and may, in certain circumstances, obviate the need for a
more comprehensive Work Instruction.
Biological reference intervals should be established and approved for relevant procedures and
should be periodically reviewed for appropriateness.
A review of procedures takes place on a periodic basis, usually annually, and the outcome
documented and approved by the Facility Manager or delegate.
SOP 016
Performance Evaluation of Quantitative Methods
11. SAFETY
ISO 15189 (2009), 5.2
The CCD Facility is a safe laboratory environment, in compliance with good practice and all
relevant Government regulations and UQ OH&S policies. Safety training, in accordance with
UQ procedures, is undertaken by all personnel and is documented in the quality management
system (QMS).
Samples received for analysis are handled in a manner that ensures safety for the client and
personnel.
Review NLT: May 2014
Page 6 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
Equipment is maintained in a safe operating condition and all dangerous materials are stored
and discarded in compliance with UQ policy.
Facility waste management procedures for biological non-biological materials are in
compliance with UQ policy.
SOP 002
UQ Policies
12. RESEARCH & DEVELOPMENT
Research and development (R&D) activities in the CCD Facility are conducted in compliance
with:
• ISO 17025 (R&D), ‘General requirements for the competence of testing and
calibration laboratories’ and/or
• ISO 15189 – ‘Medical Laboratories – Particular requirements for quality and
competence.’
13. SAMPLE COLLECTION & HANDLING
ISO 15189 (2009), 5.4
Primary samples are received from two sources:
• UQCCR Clinic Level 3
• External referring clinicians/laboratories
CCD sample transport, receipt, storage, sampling and handling procedures are defined with
Work Instructions. Risk assessments for all relevant tasks have been prepared and approved
and are acknowledged by staff in relevant records.
Specimens received from referring clinicians and laboratories remain in the control of their
management systems until received at CCD. Samples may only be handled by CCD
personnel who have been trained in the CCD quality management system.
WI 0040
WI 0061
Sample Receipt, Tracking, Storage, Retention and Disposal
FreezerPro Sample Management Software
14. QUALITY CONTROL
ISO 15189 (2009), 5.6
The CCD quality control (QC) system consists of internal QC and external proficiency
testing, where the latter is applicable. All QC data forms part of the QMS controlled
document system and is retained for predetermined periods. Tests selected for internal QC
and external proficiency testing should be relevant to the routine testing in the CCD facility
and should, if possible, mimic the matrix of true patient samples. Facility management
regularly monitors the outcome of all QC testing and, in collaboration with technical staff,
uses the outcomes to contribute to continuous improvement of testing procedures, including
sample handling. Trend data is maintained so that deviations can be detected early,
documented and acted upon. Records of actions are maintained.
Review NLT: May 2014
Page 7 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
Where an appropriate formal interlaboratory proficiency program is unavailable, CCD will
assess and implement, where feasible, an internal measure to provide assurance of the
ongoing reliability of the test/procedure. This may include exchange of samples with other
laboratories.
CCD will determine the uncertainty of measurement, where feasible, using a NATA defined
method. This measurement will aid in the identification of key uncertainty components and in
the improvement of the robustness of procedures.
SOP 015
Measurement Uncertainty
15. LABORATORY DATA
ISO 15189 (2009), 4.13
The majority of CCD data are in electronic format either in the Electronic Laboratory
Notebook (ELN) which is located on a secure UQCCR server or downloaded from
instrumentation. ELN Notebook data are reviewed and approved electronically by CCD
personnel whose Position Description contains this responsibility.
Where laboratory raw data are downloaded from an instrument to the server, all data transfer,
storage, backup and recovery complies with 21 CFR 11, Electronic Records and Signatures.
Documentation of 21 CFR 11 compliance is retained within the QMS. This validation need
only occur when the system is established or when there is an approved software/server
upgrade. There are written procedures for all actions associated with data handling.
Paper records are used where no electronic means of data recording/capture is available. In
these circumstances, a unique identifier (e.g. project code), date and name are added to the
paper, the document scanned to the UQCCR server and then imported into the ELN to the
appropriate folder.
All computer systems are protected from unauthorised access and any data modification are
traceable, attributable and justified.
CCD does not operate a Laboratory Information Management System (LIMS).
SOP 007
Electronic Laboratory Notebook
16. REPORTING OF RESULTS
ISO 15189 (2009), 5.8
The Facility Manager and approved delegate(s) are responsible for the report format and
approval. Reports must be legible with no mistakes and be reported to people authorised to
receive the information. Each report must have a unique identifier and a copy of the report
forms the raw data record for the purposes of record retention.
17. REMEDIAL ACTIONS & COMPLAINTS
ISO 15189 (2009), 4.8, 4.9, 4.10, 4.11, 4.12
Review NLT: May 2014
Page 8 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
Nonconformances occur when outcomes do not conform to the QMS requirements. CCD has
a formal process for handling nonconformances. As soon as one is detected, the procedure or
action should be halted and immediately investigated and reports withheld as necessary.
The response to this situation consists of two levels: the corrective action to rectify the
immediate situation and the preventive action to identify and implement improvements to
reduce or eliminate the risk of a recurrence of the event. Personnel responsible for the
resolution of the problem are designated and all actions documented. Implemented
improvements are verified and monitored by management to confirm that the desired
outcome has been achieved. A periodic review of corrective and preventive actions is
conducted to monitor trends in and causes of nonconformances. This review, accompanied by
a systematic review of operational procedures, assists in identifying further actions that will
contribute to continual improvement.
The laboratory has a policy and procedure for the resolution of complaints. Records of the
complaint and the consequent action are maintained.
SOP 011
SOP 012
Feedback, including Complaints
Nonconformances
18. COMMUNICATION
ISO 15189 (2009), 4.1.6
Forming a proactive relationship with staff, clients, clinicians and suppliers produces more
sustainable outcomes. Communication within CCD is supported by the following:
• Research seminars
• Training (internal and external)
• Mentoring
• Team meetings
• Reports
• Newsletters
• Email
Communication is essential to ensuring the effectiveness of the quality management system
(QMS). Engagement of staff, understanding the gap in their knowledge of the QMS and
targeting communication and education to address this maximises the integration of the QMS
into the routine work, its acceptance and the rate of improvement.
SOP 001
Personnel and Training
19. INTERNAL AUDITS
ISO 15189 (2009), 4.14
Internal audits are conducted on a regular basis to ensure compliance with the QMS
requirements. The main elements of the QMS are subject to audit once every twelve months.
The audits are formally planned and conducted by the independent quality assurance staff.
Personnel must not audit their own activities. Deficiencies or opportunities for improvement
Review NLT: May 2014
Page 9 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
are documented and appropriate corrective and preventive actions implemented. Internal
audit reports are submitted to management for review.
SOP 013
Internal Audits
20. ETHICS
ISO 15189 (2009), Appendix C
The patient’s welfare and interest always take precedence. They are treated fairly and without
discrimination. Information collected from the patient should be sufficient to enable proper
identification with the patient aware of the information collected and its purpose.
Unnecessary personal information is not to be collected.
All procedures carried out on the patient require consent. In the case of clinical trials, there
should be full compliance with the National Statement on Ethical Conduct in Human
Research (2009).
Confidentiality of patient data is very important. The laboratory ensures results are
communicated appropriately and that reasonable safeguards are taken to prevent unauthorized
access to records.
Review NLT: May 2014
Page 10 of 12
Quality Manual v2
CENTRE FOR CLINICAL DIAGNOSTICS
APPENDIX 1: CCD Organisational Chart
UQCCR Director
UQCCR Deputy Director
CCD Quality
Manager
UQCCR Business
Manager
CCD Facility Manager
Facility Technical Staff *
Research Staff
Clinic Supervisor
Facility Support Staff #
Research Students
* Research Officers, Research Assistants
#Laboratory Coordinators, Level 2 staff
Review NLT: May 2014
Page 11 of 12
Quality Manual v2
Clinic Level 3
CENTRE FOR CLINICAL DIAGNOSTICS
APPENDIX 2: Key Positions
Position Descriptions for the following key positions are maintained in the CCD quality
management system:
•
•
•
•
•
•
•
•
•
•
UQCCR Director
UQCCR Deputy Director
CCD Facility Manager
Postdoctoral Research Scholar
Senior Research Officer
Research Officer
Senior Research Assistant
Research Assistant
Laboratory Coordinator
CCD Quality Manager
Review NLT: May 2014
Page 12 of 12
Quality Manual v2