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© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
PMI, PMP, PMBOK and the PMI Registered Education Provider logo are registered marks of the Project Management Institute, Inc.
“IMPORTANCE OF AUDITING ISO 9001: 2015”
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
At the end of the class, please fill the training feedback form! (Yellow paper in your notebook)
Return the feedback form at the reception!
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Learning Outcomes
At the end of this session, you will able to understand:
About 3FOLD Education Centre
7 Quality Management Principles
Brief on ISO 9001:2015
Purpose of Audit
Types of Audit
Auditing ISO 9001:2015
Clarifications / Questions.
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
7 Quality Management Principles
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
PROCESS APPROACH –CONTINUAL IMPROVEMENTS OF PROCESS
PDCA Cycle
Processes in terms
Of Added Value
DO
Continual improvements
of Processes based on
objective measurements
ACTION
Measure results of process
Performance and effectiveness
- Objective Measurements
CHECK
Understandings &
meeting requirements
PLAN
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
1. Scope 2. Normative references
3. Terms and definitions 4. Context of organization
5. Leadership 6. Planning
7. Support 8. Operation
9. Performance evaluation 10. Improvement
I N T R O D U C T I O N
Standard Overview
8
Date:
ISO
/TC
176/S
C 2
/ N
1282
8
Do Check ActPlan
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
and Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Quality objectives
and planning
9.1 Monitoring,
measurement, analysis and evaluation
10.2 Nonconformity and corrective
action
10.3Continual
improvement
5.3Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.1General
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
CLAUSES BASED ON QUALITY MANAGEMENT PRINCIPLES
CUSTOMER FOCUS- 4,6,9 & 10
LEADERSHIP- 4,5,7 & 10
ENGAGEMENT OF PEOPLE- 4,5,6,7
PROCESS APPROACH- 6,8 & 9
IMPROVEMENT- 6,8,9 & 10
EVIDENCE BASED MANAGEMENT- 7,8,9 & 10
RELATIONSHIP MANAGEMENT- 4,5 & 8
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
➢ To determine conformity to requirements
➢ To determine effectiveness of the system
➢ For improvement of the system
➢ To meet regulatory requirements
➢ To meet contract requirements
➢To gain registration for marketing and customer assurance purposes
Purpose of Management System Audit
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Types of Audits
Third Party Audit
Audit by independent body seeking conformance to a standard such as ISO 9001(certification/ registration
body)
First Party Audit
Undertaken by an organization on its own quality system - to
seek conformance and improvement Self-audit (Client,
auditor and auditees are Internal or company appointed
consultant)
Second Party Audit
Undertaken by an organization on an existing or potential
supplier usually relating to a contract of supply Audit by an
interested body (like a customer, vendor,
subcontractor)
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
The Quality audit is define as “ a systematic & independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives”.
(1) Adequacy audit:- (System or Management audit)
determine the extend to which the documented
information adequately meet the requirements
of standard.
(2) Compliance audit:-
Which seeks to establish the extent to which the
documented system is implemented and
observed by the work force.
Audit - Quality Audit
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Important Terms relating to Documented information
The following terms to be considered
Term Details
Documented information
Information and its support medium and guidelines or evidences
Guideline Document stating recommendations or suggestions
Record Documented information stating results achieved or providing evidence of activities performed
Specification Documented information stating requirements
Documented information
Documented information
Documentation, Manual, documented procedures, record
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Auditing Questions
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Auditing Questions
INPUTS
OUTPUTS
ProcessOperators
PEOPLE
MATERIALS
METHODS
ENVIRONMENT
INFRASTRUCTUREAdmin
Corrective actions Customer FeedbackManagement Supervision
Non-conformance
Records
Monitor
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Important Auditing Elements of ISO 9001:2015309 ISO 9001 REQUIREMENTS
4 Context of organisation (24)4.1 Context (2)4.2 Interested parties(3)4.3 Scope(7)4.4 QMS and processes (12)
5 Leadership (26)5.1 Leadership and commitment(13)5.2 Policy(7)5.3 Responsibilities (6)
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Important Auditing Elements of ISO 9001:2015309 ISO 9001 REQUIREMENTS
6 Planning (27)6.1 Actions to address risks(8)6.2 Quality objectives(14)6.3 Planning of changes (5)7 Support (43)7.1 Resources(17)7.2 Competence(4)7.3 Awareness (4)7.4 Communication(5)7.5 Documented information(13)
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Important Auditing Elements of ISO 9001:2015309 ISO 9001 REQUIREMENTS
8 Operation (128)8.1 Operation control(9)8.2 Requirements(19)8.3 Design and development (36)8.4 External providers (21)8.5 Production service provision(26)8.6 Release of product and services(5)8.7 Non conforming output(12)
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Important Auditing Elements of ISO 9001:2015309 ISO 9001 REQUIREMENTS
9 Performance (43)9.1 Monitoring measurement(16)9.2 Internal audit(10)9.3 Management review (17)
10 Improvement (18)10.1 General(4)10.2 Corrective action(12)10.3 Continual improvement(2)
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Context of organisation
Internal Context
Addressed consideration of Strengths and Weakness that would generate opportunity or risk or Threat to the company
(SWOT)
Organisation Core Values
• Business strategic risk
• Organization capability
• Resources
• Financial capability
• Workplace safety
• Employees
• Services
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Context of organisation
External Context
External factors that may relate to Opportunity or challenges or Threats from the elements analysed
(SWOT)
Elements• Political
• Economic
• Social
• Technological
• Legal
• Environmental
• Competitor
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Auditing Questions
Interested Parties
• Have you identified interested parties?
• Their needs and expectations
• Priority to meet needs and expectation of interested parties
Scope and QMS
• Have you defined scope of QMS?
• Processes involved?
• Their interconnection?
• Risk and opportunity analysis
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Auditing Questions
Man
• Roles and responsibilities?
• Organisational Knowledge
• Competence
• Training need analysis
• Training plan
• Conduction of training
• Training effectiveness analysis, etc
Machines
• Calibration of tools and equipment's
• Maintenance policy
• Breakdown maintenance records
• Preventive maintenance records
• Maintenance log book
• Production planning, etc
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Auditing Questions
Materials
• Approved suppliers/vendors/contractor list
• Procedure for the same
• Performance evaluation
• Re evaluation basis
• Inspection/Quality assurance of supplies, etc
Customer
• Customer requirements analysis
• Validation of product or services
• Customer feedback
• Performance evaluation
• Customer focus
• Customer complaints register, etc
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Auditing Questions
Leaders
• Context
• Policy
• Objectives
• Commitment
• Interested parties
• Resources
Management Appointee, if any.
• Internal audit programmes
• Conduct of audits
• Management Review details
• Non conformities
• Corrective actions, Improvements
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Clarifications
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
Upcoming Training Schedule for QMS
ISO 9001:2015
• Batch Start Date: 9/2/2018
• Batch End Date: 9/3/2018
• Frequency: Every Friday
Product ManagerMr. Dineshdinesh@3foldtraining.com050 – 1036364
© 2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD
END OF THE SESSIONPlease return the feedback form at the reception!
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