Sensitization on the University ISO Certified QMS. Christopher A Moturi Deputy Management Representative

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Sensitization on the University ISO Certified QMS Christopher A Moturi Deputy Management Representative University of Nairobi ISO 9001:2008 1 Certified http://www.uonbi.

1 Sensitization on the University ISO Certified QMS Christopher A Moturi Deputy Management Representative University of Nairobi ISO 9001: Certified Content Introduction to ISO 9001 Standard Quality Management Principles ISO Standard: Requirements The University QM Documentation An Overview of the Audit Process 2 1

2 Introduction to ISO 9001 Standards 3 Intro 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 University of Nairobi ISO 9001: Certified 2

3 Quality Management Process Model Continual improvement of the quality management system Management responsibility Customers Resource management Measurement, analysis and improvement Customers Satisfaction Requirements Input Product realization Product Product Output Key Value-adding activities Information flow 5 Spirit of Continual Improvement Act How to improve next time? Plan What to do? How to do? Do Do what was planned Check Did things happen according to plan? Goal: Attaining Higher levels Moving target QMS: Sustaining the gains 6 3

4 Benefits of Implementation of ISO 9001 To operate efficiently To achieve customer satisfaction To improve financial results Satisfy all the stakeholders To secure sustainability 7 Scope of QMS 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 University of Nairobi ISO 9001: Certified 4

5 Quality Management Principles 9 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 10 5

6 ISO: 2015 Standard Requirements See other notes ISO pptx 11 An Overview of the Audit Process 12 6

7 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 Clause 3.1) 13 Other Key Definitions -Auditing Definitions from ISO 19011: Audit Criteria Set of policies, procedures or requirements 3.3 Audit Evidence records, statements of fact or other information, which are 3.4 Audit Findings relevant to the audit results of the evaluation of the criteria and verifiable collected audit evidence against audit criteria 3.5 Audit Conclusions outcome of an audit, provided by the audit team after consideration of the audit objectives and all audit findings 14 7

8 Why do we have to Audit? ISO 9001:2008, clause 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 15 Other Key Definitions -Auditing 3.8 Auditor 3.6 Audit Client organization or person requesting an audit 3.7 Auditee organization being audited person with the competence (3.14) to conduct an audit INVOICE KES

Other Key Definitions -Auditing 3.10 Technical expert 3.9 Audit Team one or more auditors (3.8) conducting an audit (3.1), supported if needed by technical experts (3.

9 Other Key Definitions -Auditing 3.10 Technical expert 3.9 Audit Team one or more auditors (3.8) conducting an audit (3.1), supported if needed by technical experts (3.10) person who provides specific knowledge or expertise to the audit team (3.9) 17 The 3 Dimensions of Auditing Intent Implementation Effectiveness How does the organization intend to implement the QMS and how is this intent documented? Does the implementation of the QMS reflect the intent reflected in the design Is the system operating in an effective manner (i.e., does it meet the parameters established by the intent) 9

10 Principles of Auditing Ethical conduct Fair presentation Due professional care independence Evidence based approach Trust, integrity, confidentiality, discretion Audit findings and conclusions are accurate and truthful Exercise care according to the confidence placed in them by clients 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 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 20 10

11 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 21 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 22 11

12 Pre-audit Meeting A meeting of the audit team to determine Objective/s Scope Criteria Assign responsibilities Resource requirements Audit plan 23 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 24 12

13 Audit Basis ISO 9001:2008 UON/QM (manual) UON/OP (procedures) Any statutory and regulatory requirements? 25 Audit Notification 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 26 13

14 Audit Checklist Available in Q-Pulse Software 27 Four Phases of an Audit Opening meeting Execution of the audit Auditors meeting Closing meeting 28 14

15 Nonconformity Classifications Major nonconformity Minor 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 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 30 15

16 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 31 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 32 16

17 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 33 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 34 17

18 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 35 18

Internal Audit Checklist System & Process Compliance Auditing

Internal Audit Checklist System & Process Compliance Auditing www.iso-9001-checklist.co.uk Internal Audit Checklist Contents Guidance 3 About this Checklist 3 Audit Scoring Criteria 3 Principles of Auditing 4 Audit Methodology 5 Introduction 5 Preparation 7 Documented