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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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