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HOW TO CONDUCT
QMS AUDITS EFFECTIVELYas per ISO 9001:2015 & ISO 19011:2018
PMI, PMP, PMBOK and the PMI Registered Education Provider logo are registered marks of the Project Management Institute, Inc.
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At the end of the Seminar, please fill the training feedback form! (Yellow paper in your notebook)
Return the feedback form at the reception!
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INTRODUCTION
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Objectives
• Basic Terms & Definitions
• Introduction to QMS & Audit
• Purpose & Benefits
• Stages of Audit (PDCA)
• AUDIT PROCESS
Audit Programme
Audit Plan, Audit Checklist
Opening Meeting, Nonconformity Report
Closing Meeting, Audit Report, Closure, Follow Up
• Auditor Competence Development
• Golden Rules of Audit
• Critical Success Factors
• Clarifications / Questions
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7 Quality Principles
QMP 1 – Customer focusQMP 2 – LeadershipQMP 3 – Engagement of peopleQMP 4 – Process approachQMP 5 – ImprovementQMP 6 – Evidence-based decision makingQMP 7 – Relationship management
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Objectives & Benefits of QMS Audit
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Objectives & Benefits
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• Ensure Conformity
• Check Effectiveness of QMS
• Identify the Opportunities for Improvement
• Quality Performance & Culture Enhances
• A system for certification / future learning
• To capitalize opportunities and neutralize threats
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Terms & Definitions
• Audit Organization
• Customer
• Supplier
• Audit
• Audit Types
• Audit Criteria
• Audit Scope
• Competence
• Quality
• QMS
• ISO 9001
• ISO 19011
• Conformity
• Nonconformity
• Compliance
• Observations
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Key Terms & Definitions related to audit :
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• Audit: Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
• Audit Scope: Extent and boundaries of an audit
• Audit Criteria: Set of requirements used as a reference against which objective evidence is compared
• Audit programme: Arrangements for a set of one or more audits planned for a specific time frame and directed towards a specific purpose
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Key Terms & Definitions related to audit:
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• Audit Plan: Description of the activities and arrangements for an audit
• Objective evidence: Data supporting the existence or verity of something
• Risk: Effect of uncertainty on objectives
• Conformity: Fulfillment of a requirement
• Nonconformity: Non-fulfillment of a requirement
• Competence: Ability to apply knowledge and skills to achieve intended results
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Framework - ISO 9001:2015 Annex SL, Appendix 3 The ten clauses
1)Scope 2)Normative references 3)Terms and definitions4)Context of the organization 5)Leadership 6)Planning 7)Support 8)Operation 9)Performance evaluation 10)Improvement
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Linkage to ISO 9001 2015
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Linkage to ISO 9001 2015
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Linkage to ISO 9001 2015
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ISO 19011:2018
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ISO 19011:2018
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ISO 19011:2018
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Stages of Audit
Check lists
Audit Team Briefing
AuditorTraining / Qual
Audit Team
Decision
Training Materials
Roles & Resp.
Preparation
Audit Plan
Opening Meet
Conductance
Auditing
Closing Meet
Individual Reporting
Consolidated Reporting
Communicate the Report
Follow up
Corrective Actions
Follow Up
Input to MRM
Audit
Preliminary
Pre-Audit Post-Audit
Scope & Criteria
Actions & Improvements
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AUDITOR SKILLS & ATTRIBUTES
Attributes• Ethical,
• Open-minded,
• Diplomatic,
• Punctual,
• Professional
• Versatile,
• Tenacious,
• Un-biased
SKILLS• Planning
• Listening
• Observing
• Interview
• Analyzing
• Reporting
• Reviewing
• Judgment
KNOWLEDGE • Process / Function
• Compliance Requirements
• Criteria
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Documented Information
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Audit Check-List
• What is a Checklist
• Contents
• Advantages
Audit Programme
• What is an Audit Programme
• Contents
• Advantages
Audit Plan
• What is an Audit Plan
• Contents
• Advantages
Nonconformity Report
• What is Nonconformity Report
• Contents
• Advantages & Closure
Audit Report
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AUDIT PROGRAMME
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AUDIT PLAN
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Checklist – Purchase Process
SL #
Cla
use
#
Check-Point or Subject of Audit Objective Evidence
Po
siti
ve
Co
nfo
rma
nce
OFI
Ob
serv
atio
n
Min
or
NC
Maj
or
NC
Rem
ark
s
01 8.4.1 Are the approved suppliers listed? √
02 8.4.1Do you have the criteria and records on the selection of
External providers? Check.√
03 8.4.1Do you have the criteria and records on the evaluation
of External providers? Check.√
04 8.4.2Are the controls for the external providers defined and
complied?√
05 8.4.2Scope of externally provided products/services and
extent of control - Are they defined and monitored?√ √
06 8.4.2Product or service verification plan and records are
available adequately?√ √ √
07 8.4.3
P.O or Specs about the product or service including the
requirements on Quality, Quantity, Delivery Time,
Verification, etc. defined and documented?
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Audit Checklist – Clause 9 Performance Evaluation
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QMS Nonconformity Report
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1) Closing Meeting 2) Audit Report3) Correction4) Corrective Action5) Closure 6) Follow UP
After conducting the QMS ……
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Follow Up
Agreed Corrective Action Plans are followed
up by the Auditor, usually in a scheduled
review/next audit
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Auditor Competence Development
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• Auditors shall be competent
• Criteria for competence to be defined
• Competence development programs & Refresher
• Auditing ability is more important
• Avoid “One Man Army” approach
• Auditor independence to be ensured
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Golden Rules of Audit
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• Check for conformity, effectiveness and improvement
• Value addition is important
• Talk less & Listen more
• Be diplomatic as well as Professional
• Communication, Coordination & Follow up shall be effective
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Golden Rules of Audit
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• Identify the improvement areas
• Don’t look for NCs always
• No blame culture
• Don’t run behind the papers
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Critical Success Factors - Leadership
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• Leadership Commitment
• Empowerment for the Audit Team
• Enforcement within organization
• Top Management shall set an example to respect the Audit
• Communication and Support for the audit
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Critical Success Factors – Middle Managers
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• Cooperate with the Audit Plan
• Allow the staff for their respective roles
• No personal issues, only teamwork
• Transparency required
• Don’t exhibit the attitude “My Dept. is better than yours”
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Critical Success Factors : Audit Team
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• Competence development (Cross functional)
• Auditor Vs. Employee role
• Audit beyond a checklist
• Communication, Coordination & Follow up shall be effective
• Focus value addition than completing the task
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Critical Success Factors : Process Owners
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• Transparency during audit
• Corrective Actions – Effective / Timely
• Pro-active feedback till close-out
• Seek value addition rather than saving faces
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Objectives Achieved?
• Basic Terms & Definitions
• Introduction to QMS & Audit
• Purpose & Benefits
• Stages of Audit (PDCA)
• AUDIT PROCESS
Audit Programme
Audit Plan, Audit Checklist
Opening Meeting, Nonconformity Report
Closing Meeting, Audit Report, Closure, Follow Up
• Auditor Competence Development
• Golden Rules of Audit
• Critical Success Factors
• Clarifications / Questions
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Clarification… If any?
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END OF THE SESSIONPlease return the feedback form at the reception!