ISO 9001:2008
Quality Management System
The ISO 9001:2008 standard is one of the most
widely known standards, implemented by over
850,000 organizations in 163 countries.
The ISO 9001 standard has become an international
reference for quality management requirements in
Business-to-business relationships.
ISO 9001 helps organizations of any type and size
with quality management including:
Fulfilling customers quality requirements
Following applicable regulatory requirements
Enhancing customer satisfaction
Achieving continual performance improvement in
Pursuit of these objectives.
The standard has earned a worldwide reputation
known as the generic quality management system
standard, which can be applied to any organization,
large or small, whatever its business, product or
Service.
Management system refers to the organizations
structure for managing its processes or business
Activities. This structure transforms input of resources
into a product or service that meets the organizations
business objectives, satisfies the customers quality
Requirements and complies with regulations.
ISO 9001 provides a framework of requirements for
management to address customer focus, process the
management approach, and pursue continual
Performance improvement.
info@globalstandards.com.pk
www.globalstandards.com.pk
THE BENEFITS:
Achieve consistency of product quality and
compliance with legal requirements.
Formalize Good Working Practices.
Assure satisfaction and added value to customers.
Reduce costs for quality products & services.
Be internationally recognized as a well-managed
organization and business.
To increase the promotion of product and services
through marketing.
Workers know what to do and how.
Better management control.
Attract new customers and markets.
Increase credibility, customers, and profit.
The ISO 9001 standard is based on the management
Principles as shown below.
Principle 1 - Customer focus
Principle 2 - Leadership
Principle 3 - Involvement of people
Principle 4 - Process approach
Principle 5 - System approach to management
Principle 6 - Continual improvement
Principle 7 - Factual approach to decision making
Principle 8 - Mutually beneficial supplier relationships
Global Standards is the firm for the consultancy of quality
management system and has privilege for the effective
implementation for long term.
Global Standards professional consultants work for clients
to ensure the management systems are effectively
established, implemented, maintained, and continually
improved to meet customers growing expectations and legal
Statutory requirements for the organization.
ISO 9001:2015
Quality Management System-DIS

ISO 9001:2008 ISO 9001:2015 CD Amendments

0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative references 2. Normative
references
3. Terms and definitions 3. Terms and
definitions
4. Quality Management 4. Context of the
System organization
4.1 General 4.1 Understanding
Requirements the organization and
its context
4.2 Documentation
Requirements
4.2.1 General
4.2.2 Quality Manual - Quality Manual not required
4.2.3 Control of 7.5 Documented Records and Documents are now "Documented Information"
Documents Information
4.2.4 Control of Records 7.5 Documented Records and Documents are now "Documented Information"
Information
5. Management 5. Leadership
Responsibility
5.1 Management
Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning 6. Planning
5.4.1 Quality Objectives
5.4.2 Quality
Management System
Planning
5.5 Responsibility,
Authority, and
Communication
5.5.1 Responsibility and
Authority
5.5.2 Management MR not required
Representative
5.5.3 Internal
Communications
5.6 Management 9.3 Management
Review Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6. Resource 7. Support
Management
6.1 Provision of 7.1 Resources
Resources
6.2 Human Resources 7.2 Competence
6.2.1 General
6.2.2 Competence,
Training, and
Awareness
6.3 Infrastructure
6.4 Work Environment
7. Product Realization 8. Operation
7.1 Planning of Product
Realization
7.2 Customer-Related
Processes
7.2.1 Determination of
Requirements Related
to the Product
7.2.2 Review of
Requirements Related
to the Product
7.2.3 Customer
Communication
7.3 Design and
Development
7.3.1 Design and
Development Planning
7.3.2 Design and
Development Inputs
7.3.3 Design and
Development Outputs
7.3.4 Design and
Development Review
7.3.5 Design and
Development
Verification
7.3.6 Design and
Development Validation
7.3.7 Control of Design
and Development
Changes
7.4 Purchasing
7.4.1 Purchasing
Process
7.4.2 Purchasing
Information
7.4.3 Verification of
Purchased Product
7.5 Production and
Service Provision
7.5.1 Control of
Production and Service
Provision
7.5.2 Validation of
Processes for
Production and Service
Provision
7.5.3 Identification and 8.6.2 Identification
Traceability and traceability
7.5.4 Customer
Property
7.5.5 Preservation of 8.6.4 Preservation
Product of goods and
services
7.6 Control of
Monitoring and
Measuring Equipment
8. Measurement, 9. Performance
Analysis, and evaluation
Improvement
8.1 General
8.2 Monitoring and
Measurement
8.2.1 Customer
Satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and
Measurement of
Processes
8.2.4 Monitoring and
Measurement of Product
8.3 Control of
Nonconforming Product
8.4 Analysis of Data
8.5 Improvement 10. Improvement
8.5.1 Continual 10.2 Improvement Continual deleted
Improvement
8.5.2 Corrective Action 10.1 Nonconformity
and corrective
action
8.5.3 Preventive Action - No requirement related to Preventive Action (Risk
Management replacement)