The main changes of ISO 9001:2015 QMS & the new concept of the Standards

1. Quality Management System

2. Table of Contents
 Why ISO 9001:2015
 Benefits of ISO 9001
 Terms & Definitions
 Key Changes of QMS
 New Concept of QMS
 Principles of QMS
 Plan Do Check Act

3. Why ISO 9001:2015
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and

4. Why ISO 9001:2015
b) aims to enhance customer satisfaction through the effective application of the system,
including processes for improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.

5. Why ISO 9001:2015
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any
organization, regardless of its type or size, or the products and services it provides.

6. Benefits of ISO 9001:2015
The new version of the standard brings the user a number of benefits.
• Puts greater emphasis on leadership engagement
• Helps address organizational risks and opportunities in a structured manner
• Uses simplified language and a common structure and terms, which are particularly helpful to
organizations using multiple management systems, such as those for the environment, health &
safety, or business continuity
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organizations

7. Benefits of ISO 9001

8. Terms & Definitions
Quality : Degree to which a set of inherent characteristics of an
object fulfills requirement
Risk : Effect of uncertainty on objectives
Information : Meaning data
Documented Information : Information required to be controlled and maintained by
an organization and the medium on which it is contained
Monitoring : Determining the status of a system, a process or an activity
Measurement : Process to determine a value
Continual Improvement : Recurring activity to enhance performance

9. Terms & Definitions
Corrective Action : Action to eliminate the cause of a nonconformity and to
prevent repetition
Service : Intangible output that is the result of at least one activity
necessarily performed at the interface between the
provider and the customer
Product : The result of a process
Outsource : Make an arrangement where an external organization
performs part of an organization’s function or process
Nonconformity : Non fulfillment of requirement
Conform to : To obey a rule or reach the necessary stated standard

10. Key Changes of QMS
Main Changes
 The Adoption of High Level Structure
 An explicit requirement for Risk-Based thinking to support and improve the
understanding and application of the process approach
 Fewer prescribed requirements
 Less emphasis on documents
 Improve applicability for service
 A requirement to define the boundaries of the QMS
 Increased emphasis on organizational context
 Increase leadership requirements
 Greater emphasis on achieving desired outcomes to improve customer satisfaction

11. Key Changes of QMS
Structure and Terminology
ISO 9001 : 2008 ISO 9001 : 2015
Products Products & Services
Exclusions Not Used
Documentation, Records Documented Information
Work Environment Environment for the operation of process
Purchased Product Externally provided products and services
Supplier External Provider

12. Key Changes of QMS

13. New Concept of QMS
Risk Management
An organization needs to plan and implement actions to
address risks
 Identify the risk
 Assess the impact of risk
 Action to manage the addressed risk
 Risk Reporting & Monitoring

14. New Concept of QMS
Change Management
Change management starts with identifying the change requirement.
 Change in the scope of the QMS
 Policy change
 Product Change (Technology improvement, raw material change, change in customer
requirement etc.)
 Process Change (Quality improvements and Productivity increase)
 Procedure Change (Equipment changes, new equipment, raw material changes etc.)

15. New Concept of QMS
Change Management
 Change in Employees (New positions, new recruitments,
resignations, long leave etc.)
 Change in Management (Mergers, take-overs etc.)
 Changes in Requirements (Customer requirements, code
requirements, legal requirements, QMS requirements
etc.)

16. New Concept of QMS

17. New Concept of QMS
The Role of Top Management
Top management shall demonstrate leadership and commitment with respect to the quality
management system by: (5.1.1)
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality
management system and are compatible with the context and strategic direction of the
organization;

18. New Concept of QMS
The Role of Top Management
c) ensuring the integration of the quality management system requirements into the
organization’s business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the
quality management system requirements;

19. New Concept of QMS
The Role of Top Management
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to
their areas of responsibility.

20. Principles of QMS
This International Standard is based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the principle is important for the
organization, some examples of benefits associated with the principle and examples of typical actions to
improve the organization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.

21. Plan-Do-Check-Act

22. Plan-Do-Check-Act
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to
deliver results in accordance with customers’ requirements and the organization’s policies;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and
services against policies, objectives and requirements and report the results;
— Act: take actions to improve performance, as necessary.

23. Plan-Do-Check-Act