Quality
Management
System
An Overview of ISO 9001:2015
What is ISO?
ISO stands for International Organization for Standardization
The word ISO came from the Greek work “ isos” which means EQUAL
What is ISO 9001?
ISO 9001 helps organizations to implement Quality Management System.
Implemented by more than a million organizations in around 175 countries.
Quality refers to all those features of a product (or service) which are required by the customer.
Quality management means what the organization does to enhance customer satisfaction,
and achieve continual improvement of its performance.
Management system means what the organization does to manage its processes, or activities
in order that its products or services meet the organization’s objectives, such as satisfying the
customer's quality requirements and complying to regulations
Timeline ISO 9001:2015?
1980
2000
Technical Committe Formed
First Major Revision
1987
First Edition 2008
Second Minor Revision
1994 2015
First Minor Revision Second Major Revision
Processes, not Products
ISO 9001 concern the way an organization goes about its work.
It is not product standards.
It is not service standards.
It is process standards.
They can be used by product manufacturers and service providers.
Processes affect final products or services.
ISO 9001 gives the requirements for what the organization must do to manage processes
affecting quality of its products and services.
Benefits of ISO 9001:2015
Improve Credibility or Image
Common language for dealing with customers and suppliers worldwide in B2B
Satisfying customers and other stakeholders
Build Continual Development Culture
Increase of Employer Engagement
Standards for ISO 9001
There are 10 Clauses / Standards in iso 9001
First 3 Clauses are Introductory.
The ramaining 7 are known as Auditable Clauses.
Clause 4
- Context of the Organization
Internal and External Issues
Needs and Expectations of Interested Parties
Scope of the Organization
Clause 5
- Leadership
Accountability of the Top Management
Quality Policy
Clause 6
- Planning
Addressing Risks and Opportunities
Quality Objectives
Changes of Planning
Clause 7
- Support
All resources will be working as a Support for QMS implementation
Competency
Awareness
Communication
Documented Information
Clause 8
- Operation
Planning and Control
Determining Requirements by customer communication (Review, change etc)
Design and Developement
Control of externally provided products or services
Product or service Provision (Control of provision, identification, property belonging
to customers or external providers, preservation, post delivery activities)
Release of Products
Control of Non-conforming outputs
Clause 9
- Performance Evaluation
Monitoring, measurement, analysis and evaluation (Customer Satisfaction
Perspect)
Internal Audit
Management Review Meeting
Clause 10
- Continual Improvement
Non-Conformity
Corrective Action Plan (CAP)
Continual Improvement
Thank You