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Sensitization on the University ISO Certified QMS
University of Nairobi ISO 9001:2008 1 Certified http://www.uonbi.ac.ke
Christopher A Moturi
Deputy Management Representative
Content
• Introduction to ISO 9001 Standard
• Quality Management Principles
• ISO Standard: Requirements
• The University QM Documentation
• An Overview of the Audit Process
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Introduction to ISO 9001 Standards
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• ISO standards are revised on a regular cycle
• University Certified - July 2008
• Re-certifications – April 2011, April 2014
• New version ISO9001: 2015 issued Sep 2015
• University has started transition to ISO9001: 2015
Intro
University of Nairobi ISO 9001:2008 4 Certified http://www.uonbi.ac.ke
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Quality Management Process Model
Value-adding activities Information flow
Key
Output
Continual improvement of
the quality management system
Customers
Satisfaction
Customers
Requirements
Resource management Measurement,
analysis and improvement
Management
responsibility
Input
Product Product Product
realization
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Spirit of Continual Improvement
Goal: Attaining
Higher levels
Moving target
QMS: Sustaining
the gains
Plan What to do?
How to do?
Do Do what was
planned
Check Did things happen
according to plan?
Act How to improve
next time?
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Benefits of Implementation of ISO 9001
• To operate efficiently
• To achieve customer satisfaction
• To improve financial results
• Satisfy all the stakeholders
• To secure sustainability
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The scope of the University QMS covers all educational services offered to customers:
Teaching & Learning
Research & Extension
Consultancy
Community Services
Support Services: This also includes related functions and services such as farm produce, detergents, mortuary services, mineral water, publishing, laboratory, clinical, workshop services that are an integral part of its educational services
Scope of QMS
University of Nairobi ISO 9001:2008 8 Certified http://www.uonbi.ac.ke
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Quality Management Principles
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The Principles
The seven quality management principles:
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-based Decision Making
7. Relationship Management
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ISO: 2015 Standard Requirements …See other notes ISO 9001 2015.pptx
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An Overview of the Audit Process
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Definitions: Internal Audit
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
(ISO 19011 Clause 3.1)
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Other Key Definitions -Auditing
Audit Criteria Audit Evidence
Audit Findings
Audit Conclusions
Set of policies, procedures or requirements
records, statements of fact or other information, which are relevant to the audit criteria and verifiable results of the evaluation of the
collected audit evidence against audit criteria
outcome of an audit, provided by the audit team after consideration of the audit objectives and all audit findings
3.5
3.2
3.4
3.3
Definitions from ISO 19011:2002
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Why do we have to Audit?
ISO 9001:2008, clause 8.2.2 –conducted to determine whether or not the management system:
Conforms to the planned arrangement for each management system
Is effective in meeting the organizations policy and objectives
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Other Key Definitions -Auditing
person with the competence (3.14) to conduct an audit
INVOICE
KES--
3.8 Auditor
Auditee
Audit Client
3.7
3.6
organization being audited
organization or person requesting an audit
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Other Key Definitions -Auditing
one or more auditors (3.8) conducting an audit (3.1), supported if needed by technical experts (3.10)
3.9 Audit Team
person who provides specific knowledge or expertise to the audit team (3.9)
3.10 Technical expert
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The 3 Dimensions of Auditing
Intent How does the organization intend to implement the QMS and how is this intent documented?
Implementation Does the implementation of the QMS reflect the intent reflected in the design
Effectiveness Is the system operating in an effective manner (i.e., does it meet the parameters established by the intent)
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Principles of Auditing Ethical conduct Trust, integrity, confidentiality, discretion
Fair presentation Audit findings and conclusions are accurate and truthful
Due professional care
Exercise care according to the confidence placed in them by clients
independence Auditors are independent of the activities being audited and are free from bias or conflict of interest
Conclusions will be objective and based only on audit evidence
Evidence based approach
Audit evidence is based on samples of information
Conclusions are verifiable
Lead Auditor
• responsible for all phases of the audit
• have management capabilities & experience
• have authority to make final decisions regarding the conduct of the audit and audit observations
• co-ordinate the audit team and be able to represent the team & control the discussions
• be able to resolve conflicts within the audit team
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Auditors
They have a responsibility to:
• Adhere to procedures and plan the audit
• Collect and analyze relevant and sufficient evidence to permit drawing of conclusions
• have accurate knowledge of and be able to interpret and apply the underlying standards correctly (e.g. clause 7.1 on product realization)
• Remain within the scope & report stumbling blocks
• Make appropriate recommendations
• Be able to answer questions satisfactorily
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Audit Scheduling
The MR plans the audits
• The schedule must be comprehensive to ensure that each activity is examined at least once in a year.(freq dependent on Status of activity & importance of activity)
• In drawing an Audit Schedule, the audit area might be college, school, department t etc
• Selects auditors to ensure impartiality and objectivity
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Pre-audit Meeting
A meeting of the audit team to determine
• Objective/s
• Scope
• Criteria
• Assign responsibilities
• Resource requirements
• Audit plan
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Establish Audit Purpose/Objectives
Audit should be based on documented objectives as established within the overall objectives of the audit programme.
For IQA mainly are:
• Determination of the extent of conformity of QMS to audit criteria
• Evaluation of effectiveness of QMS in meeting requirements
• Identification of areas of improvement
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Audit Basis
• ISO 9001:2008
• UON/QM (manual)
• UON/OP (procedures)
• Any statutory and regulatory requirements?
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A standard format need to be used to contain as a minimum:-
1. Audit area/auditee
2. Audit purpose
3. Audit Scope
4. Audit basis
5. Date of audit
6. Audit team
7. Audit plan (timetable)
8. Resource requirements;-Guide, meeting room, special equipment, tools, etc
Audit Notification
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Audit Checklist
• Available in Q-Pulse Software
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Four Phases of an Audit
• Opening meeting
• Execution of the audit
• Auditors’ meeting
• Closing meeting
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Nonconformity Classifications
Major nonconformity
The absence of, or total systemic breakdown of a management system element specified in the standard or the QMS; any nonconformities where the effect is judged to be seriously detrimental to the organization; and any serious noncompliance to statutory/regulatory requirement
Minor nonconformity
A single system failure or lapse in conformance with a procedure relating to the standard or QMS
Raising Non Conformities
Nonconformities should be:
• Recorded along with supporting evidence
• Reviewed with the auditee to ensure auditee understands and acknowledges findings: • Auditor should resolve any diverging opinions
• Unresolved issues should be recorded
• classifying nonconformities, consider the seriousness: Major Non conformity
Minor Non conformity
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Raising Corrective Action
• On consultation with the auditor perhaps, and certainly those with people in the area where the nonconformity was found, the best corrective action can be decided
• The auditee has to get to the root cause of the problem if it is going to be corrected forever
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Evaluating Corrective Actions
The auditors must evaluate the proposed corrective action before acceptance;
Definitions
Corrections: action taken to eliminate detected non conformity
Corrective actions: action taken to eliminate the source of detected non conformity
Preventive actions: action taken to eliminate the source of a potential non conformity
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Preparing the Audit Report • A standard proforma for the reporting of audit is usually
used
• Audit report should provide a complete accurate, concise and clear record of audit (audit objectives, scope, findings and conclusions)
• It is, therefore, important that the audit report gives a balanced picture of the whole audit (positive and negative findings) and not merely the nonconformities found
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Preparing the Audit Report
The audit report should include:
• Audit objectives and scope
• Identification of client, audit team leader and members
• Dates of audit
• Audit criteria
• Audit findings
Summary of the non-conformities
Positive findings noted
Observations/Opportunities for improvement
Examples of outstanding performance/improvement since last audit
• Audit conclusions
• Attachments (including copies of CARs)
• The audit report including any non-conformity report / corrective action notices are issued to the auditee & Management representative
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Conducting Audit Follow-up
• The conclusions of the audit may indicate the need for corrective, preventive or improvement actions as applicable
• The auditee should undertake these actions within agreed timeframe
• The completion and effectiveness of corrective action should be verified by the auditor either onsite or through subsequent audits
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