ISO 9001 : 2015

QMS Requirements- FDIS

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ISO 9001:2015 Timeline

2013

2014

2015

May 2013 CD
(Committee
Draft)

February 2014 DIS

(Draft International
Standard)

February 2015 FDIS

(Final Draft International
Standard)

September 2015
Published IS
(International Standard)

+ Transition period
for certification

 ISO 9001 : 2015

ISO 9001:
Sustainable development



PDCA
(Context) (scope)
(its processes)
(interested parties)

"document" and "records" "documented information".

"Control of externally provided products and services"

4

 ISO 9001 : 2015

"4.1 Understanding the organization and its context"

"4.2 Understanding the needs and expectations of interested parties."
QMS
4.4.2 Process Approach

(Risks and Opportunities) 6.1.

(Changes)
( 6)

7.1 , 7.2, 7.3 7.4
Corrective action Continual improvement
(Prevent)
5

Starting point

Sources of Inputs

PREDECESSO
R PROCESSES
e.g. at providers
(internal or
external) at
customers, at
other relevant
interested
parties

Inputs

End point

Activities

MATTER,
ENERGY,
INFORMATIO
N, e.g. in the
form of
materials,
resources,
requirements

Outputs

Receivers of
Outputs

MATTER,
ENERGY,
INFORMATIO
N, e.g. in the
form of
product,
service,
decision

SUBSEQUENT
PROCESSES
e.g. at
customers
(internal or
external), at
customers, at
other relevant
interested
parties

Possible controls and

check points to
monitor and measure
performance

Schematic representation of the elements of a single process

Quality Management System (4)

Support &
Operation
(7,8)

Organization
And its context
(4)

Do

Plan

Customer
requirements

Planning
(6)

Performance
evaluation
(9)

Leadership
(5)

Act
Needs and
expectations of
relevant
interested
Parties (4)

Customer
satisfaction

Check

Results of
The QMS

Product and
services

Improvement
(10)

Representation of the structure of this International Standard in the PDCA cycle

 ISO 9001 : 2015

1. Scope
2. Normative references
3. Terms and conditions: Organization, Interested party, Requirement, Management system,
Top management, Objective, Risk, Documented information
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
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6. Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes

 ISO 9001 : 2015

7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8. Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and services provision
8.7 Release of products and services
8.8 Control of nonconforming outsputs
9

 ISO 9001 : 2015

9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual Improvement

10

Clause 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
4.4.1. General
4.4.2. Process Approach

Cultural

External
Environment

Suppliers

Internal
Environment
Customers

Government

Financial

Owners

Growth Factors

Social

Society

Demographic

Political

4.1 Understanding-Organization-Context

22

4.2 Understanding Needs and Expectations

Corporate
Policies
Customers
Employees and
Auditors
External Auditors,
Business Partners
Shareholders

23

100% On-Time Delivery

Customer Need and

Expectation (5.2)

100% of shipments received by

Customer Focus

Process
Maintenance

% Downtime

customer on scheduled day

Goal and Objectives (5.4)

% On-Time (on day required)

Result Measurable (5.4)

Process

Process

Shipment

Training

Shipment

Setup Jobs

Accuracy

Filled

Key Processes (4.1)

Process
Measurables (8.2.3)
37

Clause 5. Leadership

5.1 Leadership & Commitment

5.2 Quality Policy

5.3 Organizational Roles,

Responsibilities & Authorities

5. Leadership

Clause 6. Planning
6.1 Actions to address risks &
opportunities

6.2 Quality objectives & planning

To achieve them

6.3 Planning of changes

6. Planning

46

6 Planning

Identify
The Risks

Analyze &
Prioritize

Plan
Actions to
address

Take Action

Check
Effectiveness

Learn &
Improve

47

Clause 7. Support
Competence

7.2

Resources

7.1

7.3

Awareness

7. Support

Documented
Information

7.5

7.4

Communication

Clause 8. Operation
8.1 Operational Planning & Control
8.2 Determination of Market needs & interactions with customers
8.3 Operational Planning process
8.4 Control of external Provision of Goods & Services
8.5 Development of Goods & Services
8.6 Production of goods and provision of services
8.7 Release of goods and services
8.8 Nonconforming goods & services

Clause 9. Performance evaluation

9.1.

Monitoring, measurement , analysis and

evaluation
9.1.1.General, 9.1.2.customer satisfaction, 9.1.3.
Analysis & evaluation of data

9.2.

Internal Audit

9.3.

Management Review

Clause 10. Improvement

10.1 Nonconformity and

Corrective Action

10.2 Improvement