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Introduction to Quality management
degree to which a
set of inherent
characteristics
fulfils
requirements
Introduction to Quality management
What is Quality
Introduction to Quality management
?
Differences in quality
Grade
Category or rank given to
different requirements for
an object having the
same functional use
What is a
a quality management ?
Introduction to Quality management
Organisation improvement
Assurance of meeting
Customer requirement
Assurance of conformance to
Legal requirement
Supplier development
Benefits of QMS
Increased
Improved internal profitability
transfer of know how
Reduced
quality costs
Enhanced customer
satisfaction and loyalty
Increased
competitiveness
Benefits of QMS
ISO 9001
Marketing edge
Why QMS is necessary..?
TS 16949 Automobile
Sector TL 9000 Telecom
requirements EN 9100
Aeronautical
ISO Manufacturing
Market access 9001 Services
Introduction to Quality management
9001:2015
From ISO 9000:2005
Customer focus
Customer focus
Leadership
Leadership
Involvement of people
Engagement of people
Process approach
Process approach
System approach to management
Improvement
Continual improvement
Evidence-based Decision making
Factual approach to decision making
Relationship Management
Mutual beneficial supplier relationships
1.Customer focus
J
customers
J JJJ
Return on
investment
Business
Continuity
Responsible
Behaviorr
Pe
Personal
Development
Leaders provide:
u Unity of purpose
u Direction
u Engagement,
Their full involvement and engagement enables using their abilities to the
benefit of the organisation
4.Process approach
PROCESS
EFFECTIVENESS
Extent to which planned
CONTROLS activities are realised and
planned results achieved
PROCESS
set of interrelated or
INPUT interacting activities OUTPUT PRODUCT
which transforms
inputs into outputs
PROCESS EFFICIENCY
Relationship between the
RESOURCES result achieved and the
resources used
Determining, R R
understanding and I
managing interacting I Process O I Process
O
and interrelated A B
R R
processes as a I
I
system contributes to C C
the organisations I Process Process O
effectiveness and C O I D
efficiency in achieving
I
its objectives
C C
I = INPUT
O = OUTPUT
R = RESOURCES
C = CONTROLS
5.Improvement
The methodology known as Plan-Do-Check-Act can be applied to all processes of the QMS
AGENDA
VIDEO
ISO 9001:2015 Presentation
Standard Clauses
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative Reference 2. Normative Reference
3. Terms and Definitions 3. Terms and Definitions
4. Quality Management Systems 4. Context of the Organization
5. Management Responsibility 5. Leadership
6. Resource Management 6. Planning for the Q M S
7. Product Realization 7. Support
8. Measurement, Analysis & 8. Operation
Improvement 9. Performance Evaluation
10. Improvement
ISO 9001:2015 format design per ISO Joint Technical Coordination Groups
Requirements, as per ISO Guide 83. ISO 9001 and 14001 now revised.
Terminology Changes
ISO 9001:2008 ISO 9001:2015
Products Products and Services
Exclusions Not Used (refer Clause A.5)
Management Rep Not Used
Documentation, Quality Manual, Documented Information (Q-
Procedures, Records Manual, Specific Procedures not
identified)
Work Environment Environment for the operation of
processes
Monitoring and Measuring Monitoring and measuring
Equipment resources
Purchased Product Externally provided products and
services
Supplier External Provider
(Not Used) Interested Party
Preventive Action Not Used
ISO 9001:2015 Presentation
6. Planning the Q M S
Quality Objectives: shall establish quality objectives
at relevant functions, levels, processes; be
monitored; maintain documented information
Actions to address risks and opportunities
Integrate/implement Actions into Q M S
Evaluate the effectiveness of these Actions (PDCA)
Risk Based Thinking, Risk Assessment:
Notation (from the standard): Options to address risks and
opportunities can include: avoiding risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or
consequences, sharing the risk, or retaining risk by informed decision.
7. Support
Resources, People (Competence, Training), Infrastructure,
Monitoring and Measuring activities basically unchanged
Communication/Awareness now in this section (from
Management Responsibility Section)
Documentation: now Documented Information
Documented Information:
8. Operation
(The current Product Realization section)
Products and Services
Design process remains, but sections on
Verification and Validation removed
Section has few Impactful changes: same
overall flow remains: Customer Requirements
> Design > Externally Provided Products and
Services (Purchasing) > Production/Service
Controls > ID Traceability > Preservation >
Non-Conformances IDd and Controlled
ISO 9001:2015 Presentation
9. Performance Evaluation
Performance Evaluation:
The Organization shall determine what
needs to be monitored/measured
Includes
Customer Satisfaction Information
Process Performance
External Provider Performance
Internal Audits
Management Review, including
checking the QMS for alignment with
the strategic direction of the
organization this is NEW!!
ISO 9001:2015 Presentation
10. Improvement
- Determine and Select Opportunities for Improvement
- Examples of Improvement can include Correction,
Corrective Action, Continual Improvement, Breakthrough
Change, Innovation, and Re-organization.
- Corrective Action is in this section
- Retain Documented Information as evidence results of
Corrective Action
Stated Assess
Objectives Risk
Company Objectives
Department Objectives
Individual Objectives
ISO 9001:2015 Presentation
Service - Improve service metrics year over year Inventory Accuracy > 99%
Direct Labor
< 1.30% of sales
Productivity - Increase the facility productivity rate Increase Productivity Index by 5% over 2015
RISK MATRIX
S
E
R
I
O
U
S
N
E
S
S
Jay Stahan
January 12, 2016 PROBABILITY
ISO 9001:2015 Presentation
Risk Based Approach: Tools
Risk Register Ranking Matrix
Probability
Seriousness
ISO 9001:2015 Presentation
Hi-level
Process
Flow
Chart
Assess
Risks
ISO 9001:2015 Presentation