The most recent ISO 9001:2015 standard is constructed

around seven quality management principles:

 customer focus
 leadership
 engagement of people
 process approach
 improvement
 evidence-based decision making
 relationship management
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative reference 2. Normative reference
3. Terms and definitions 3. Terms and definitions
4. Quality management system 4. Context of the organisation
5. Management responsibility 5. Leadership
6. Planning 6. Resource management
7. Support
7. Product realisation 8. Operation
8. Measurement, analysis and
improvement 9. Performance evaluation
10. Improvement
THE CORE OF ISO 9001:2015 : RISK-BASED THINKING

Risk-based thinking has a very important place in ISO 9001:2015

You are now strongly encouraged as an organisation to use risk

analysis in order to decide for yourself which challenges you see
in the management of your business processes.

Formal risk analysis, familiar to many organisations via FMEA or

HACCP techniques, is now standard for everyone.
CONTEXT OF THE ORGANISATION IMPORTANT IN ISO 9001:2015
ISO 9001:2015

requires an organisation to construct its quality management

base on the needs and expectations of interested parties and
that you evaluate and deal with internal and external strategic
questions.

You have to show that, as an organisation, you understand

and respond to the expectations of all the parties concerned.
LEADERSHIP AND COMMITMENT IN ISO 9001:2015

ISO 9001:2008 requires Management Representative

ISO 9001:2015 does not mention this aspect any more

because it emphasis on leadership and management commitment

It requires greater involvement by top managers and business

leaders in controlling the quality management system
DOCUMENTED INFORMATION

ISO 9001:2015 no longer requires obligatory documented

procedures or a quality manual.

This is now referred to as ‘documented information’ in practically

all clauses of ISO 9001:2015.

The definition states that it concerns ‘information that the

organisation has to control and maintain’.
DIFFERENT TERMINOLOGY IN ISO 9001:2008 AND ISO 9001:2015

 ISO 9001:2008 ISO 9001:2015

 Products Products and services

 Documentation, quality manual, Documented information

documented procedures,
records,instructions
 Work environment Environment for the operation of
processes

 Monitoring and measuring Monitoring and measuring resources

equipment

 Purchased product Externally provided products and

services

 Supplier External provider

4.4 Quality Management System and its process
4.4.1 QMS :

 establish
 implement
 maintain
 continually improve

Process :

 what is needed

 their interaction
5.1.2 Customer Focus
Ensuring :

a. customer and applicable statutory & regulatory requirements are:

-determine
-understood
-consistently met

b. enhance customer satisfaction

c. maintain focus on enhancing customer satisfaction

5.2 Policy
5.2.1 Establishing the quality policy

a. appropriate

b. provide framework

c.commitment

d.continual iimprovement
5.3 Organizational roles,responsibilities and auuthorities
Assign the responsibilities and authorities :

a. confirm to the standard

b. deliver the intended outputs

c.reporting on the performance

d.promotion of customer focus throughout the organization

e.maintain integrity
6. Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning to consider the needs and requirements
of internal and external parties

a. to give assurance

b. enhance desirable effects

c. prevent or reduce undesired effects

d.achieve improvement
Opportunities :

-adoption of neew practices

-launching new products

-opening new markets

-addressing new customers

-building new partners

-using new technologies

6.2 QUALITY OBJECTIVES & PLANNING TO ACHIEVE THEM
6.2.1 Established at relevant function

The quality objectives shall :

a. be consistent with quality policy

b. be measurable
c. take into account applicable requirements
d. be relevant to enhance customer satisfaction
e. be monitored
f. be communicated
g. be updated
6.3 Planning of changes
Carried out in a planned manner and to consider:
a. the purpose of the changes

b. the integrity of tthe QMS

c. the availability of resources

d. the allocation or reallocation of responsibilitiess & authorities

7. Support
7.1 Resources

7.1.1 General
To consider:

a. capabilities/constraint on existing resources

b. what need to be obtained from external providers

7.1.2 People
To provide the persons necessary for effective implementation

7.1.3 Infrastructure
Infrastructure include :

a. building & associate uttilities

b. equipment including hardware and software
c. transportation resources
d. information & communication technology
7.1.4 Environment for operation of processes
To provide necessary environment

a. social (e.g non-discriminatory, calm, non-confrontational)

b. psychological (e.g stress-reducing, burnout prevention

emotionallly protective)

c. physical (e.g temperature,heat, humidity, light, airflow, hygiene, noise)

7.1.5 Monitoring and measuring resources
7.1.5.1 General
The ressources provided :

a. are suitable for the specific type of monitoring & measurement

b. are maintained to ensure their continuing fitness for their purpose

7.1.5.2 Measurement traceability
Measuring equipment shall be :

a. calibrated or verified or both

b. identified to determine their status

c. safeguarded from adjustments, damage or deterioration

7.1.6 Organizational knowledge
To consider current knowledge and determine how to acquire additional
knowledge

a. internal sources (e.g intelectual property,knowledge gained from experience

lession learned from failures etc)

b. external sources (e.g standards, academia, conferences, from customers)

7.2 Competence
a. Determine necessary competency

b. competenccy base on education, training or experience

c. take action to acquire competencey

d. retain appropriate documented information as evidence

7.3 Awareness
Person doing the job shall be aware of :

a. the quality policy

b. relevant quality objectives

c. constribution to the effectiveness of the QMS

d. the implications of not conforming

7.4 Communication
Shall determine the internal and external communication including:

a. on what it will communicate

b. when to communicate

c. with whom to communicate

d. how to communicate

e. who communicates
7.5 Documented information
Shall include :
a. documented information required by the standard

b. documented information necessary for effectiveness

8. OPERATION
8.1 Operational planning and control

a. determin the requirement for the products and services

b. establishing criteria for :

i. the processes
ii. the acceptance of products and services

c. determine the resources needed to achieve conformity

d. implementing control of the processes

e. determining , maintaining and retaining documented information
to the extend necessary :

i. to have confidence that the processes have been carrried out as

planned

ii. to demonstrate the conformity of products and services to their

requirrements

The output of this planning shall be suitable for the ooperation

Control planned changes and review the consequences

Ensure that outsourced processes are controlled

8.4 Control of externally provided processes, product and services

8.4.1 General

The organization shall determine the controls to be applied to externally

provided processes , products and services conform to the requirements:

a. products and services are provided directly to the customers on behalf of the
organization

b. a process, or part of the process is provided as a result of decision made by

the organization
8.5 Production and service provision
Controlled conditions shall include:

a. the availability of documented informationn that defines:

i. the characteristic
ii. the result to be achieved

b. the availability and use of suitable monitoring and measuring ressources

c. the implementation of monitoring at various stages

d. the use of suitable infrastructure and environment for he operation of processes

e. the appointment of competent persons

f. the validation and periodic revalidation

g. the implementation of actions to prevent human error

h. the implementation of release, delivery and post-delivery

activities
8.7 Control of nonconforming outputs

8.7.1 Nonconforming outputs are identified and controlled

to prevent their unintended use or delivery

Actions to be taken:

a. correction

b. segregation, containment, return or suspension of provision

of products and services
c. informing the customer

d. obtaining authorization for acceptance under consession

Conformity to the requirements shall be

verified when nonconforming outputs are corrected
9. Performance evaluation

9.1 Monitoring , measurement, analysis and evaluation

9.1.1 General

The organization shall determine:

a. what needs to be monitored and measured

b. the methods for monitoring, measurement, analysis and

evaluation needed to ensure valid results
c. when the monitoring and measuring shall be performed

d. when the results from montoring and measurement shall be analysed

andd evaluated

The organizaation shall evaluate the performance and effectiveness

of the quality management system

The organization shall retain appropriate documented information as evidence

of the result
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned
intervals to provide information on whether the quality
management system:

a. conforms to :

i. the organization's own rrequirements for its qms

ii. the requirements of this standard

b. is effectively implemented and maintained

9.3 Management review
9.3.1 General

Top management shall review the organization's qms at

planned intervals to ensure its :

i. continuing suitability
ii. adequacy
iii. effectiveness
iv. allignment wth the strategic direction of the organization
10. Improvement
10.1 General

The organization shall determine and select opportunities

for improvement and implement any necessary actions to
meet customer reequirements and enhance customer
satisfaction:

a. improving products and services to meet requirements and

future needs and expectation

b. correcting, preventing or reducing undesired effects

c. improving the performance and effectiveness
of the qms

i. correction
ii. corrective action
iii. continual iimprovement
iv. brreakthrough change
v. innovation
vi. re-organization
10.3 Continual improvement
The organizaation shall continually improve the:

i. suitability
ii. adequacy
iii. effectiveness of the qms

The organization shall consider:

i. results of analysis and evaluation

ii. the output from management review

to determine if there are needs or opportunities that shall be addressed as

part of continual iimprovement