Quality Management System Training Programme

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The key takeaways are that the document discusses Quality Management Systems, their purpose and implementation based on ISO 9001 standards.

The purpose of a Quality Management System is to take advantage of best practices recommended in ISO 9001:2015 for quality management in order to develop and implement meaningful, simple and effective processes for improving customer satisfaction.

The main sections covered in ISO 9001 are context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.

Quality Management System

Training Programme
Improvement Management
Consultants Pvt. Ltd. (IMCPL)
• Dr. Sanjay Rajpal, founder MD, has 27 years
of rich industry experience as
implementer, auditor and trainer for
BE/M.Tech./MBA/Ph.D.
Tutor/ Auditor for QMS, management systems
EMS, OH&S, ISMS, TL-
QMS, TS16949, FSMS – Worked at Engineers India Limited (EIL) in
and other ISO/ construction division, Hitachi, electronics
CMMI/NABH systems
CQE-ASQ/ SSBB components manufacturing as well as Bureau
Veritas Certification (BVC) for systems training
and auditing
– More than 500 training, consulting and auditing
assignments completed with the purpose of
organizational development using international
systems
Quality Management System (QMS)
Purpose
To take advantage of best practices
recommended in ISO 9001:2015 for quality
management in order to develop and
implement meaningful, simple and effective
processes for improving customer satisfaction.
The scope includes improving the quality of
decisions and support for defect-free, timely
and within budget completion of project
activities.
Quality Management System

Quality

Management System
ISO 9001 Evolution

ISO 9001 ISO 9002 ISO 9003

• 1987 • 1987 • 1987


• 1994 • 1994 • 1994
• 2000 • Withdrawn • Withdrawn
• 2008
• 2015
QMS Management System (4)

Organization
and its context Support
(4) (7) &
Operation
(8) Customer
Satisfaction
Plan Do

Results of
the QMS
Customers Planning
Leadership (5)
Performance policy
(6) evaluation (9)
requirements implemen
tation

Act Check
Quality of
Needs and Improvement products
(10)
expectations of and
relevant interested services
parties (4)
Process Approach
4 Context of the Organization
4.1 Understanding the organization and its
context
4.2 Understanding the needs and expectations
of interested parties
4.3 Determining the scope of the quality
management system
4.4 Quality management system and its
processes
5 Leadership

5.1 Leadership and commitment


5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Developing the Quality Policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and
authorities
6 Planning
6.1 Actions to address the risk and
opportunities
6.2 Quality Objectives and planning to achieve
them
6.3 Planning of Changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for operation of processes
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.2 Measurement Traceability
7.1.6 Organizational Knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
7.5.1 General
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
Operations

Requirements

Design

External
Providers

NC products?
Production
8 Operation
8.1 Operation Planning and Control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to the products and
services
8.2.3 Review of the requirements related to the products and services
8.2.4 Changes to the requirements related to the products and services
8.3 Design and Development of Products and Services
8.3.1 General
8.3.2 Design & Development Planning
8.3.3 Design & Development Inputs
8.3.4 Design & Development Controls
8.3.5 Design & Development Outputs
8.3.6 Design & Development Changes
8 Operation
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and Extent of Control
8.4.3 Information for external providers
8.5 Production & service provision
8.5.1 Control of production & service provision
8.5.2 Identification & traceability
8.5.3 Property belonging to customers and external providers
8.5.4 Preservation
8.5.5 Post Delivery Activities
8.5.6 Control of Changes
8.6 Release of Products and Services
8.3 Control of nonconforming outputs
9 Performance Evaluation
9.1. Monitoring, measurement, analysis and
evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and Evaluation
9.2 Internal Audit
9.3 Management Review
9.3.1 General
9.3.2 Management Review Inputs
9.3.3 Management Review Outputs
10 Improvement
10.1 General
10.2 Non Conformity and Corrective Actions
10.3 Continual improvement
QMS Implementation/Audit
• QMS implementation team formation having representative
all departments lead by ISO coordinator
• Documentation review and development for each department
– Policies
– Procedures
– Templates
• Implementation support
– Reviews
– Audits
– Improvements
• Coordination with certifying body
• Coordination/ participation during audits
• Coordination for surveillance audit I and II
Improvement Approach

Understanding of processes
Analysis of problems and causes
Current
Ideal Recommendation and implementation
Critical thinking
Experience Sustain
Project management
Creativity skills (PDCA)
Documentation
Statistics Communication
Auditing/ reviewing
Organizational Training
behaviour Problems
Influencing identification
Human behaviour Determination Risks identification
100% ownership Opportunities
identification
When ISO 9001 works...when don’t?
Quality Management
Can? Will?
Principles
• Customer Focus
• Leadership
• Engagement of People
• Process Approach
• Improvement
• Evidence based approach
• Relationship
Management
Questions?
Thank you !

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