02 ISO 9001 2015 Awareness & Transition

TUV Middle East
Member of TÜV NORD Group
ISO 9001:2015 Awareness Training

Welcome
▪ Introduction
▪ Emergency Preparedness & Response
▪ Facilities – viz Training hall; wash rooms;
prayer hall; refreshments; lunch.
▪ Mobile Phones –“Silent Mode”, No laptops
▪ Respect for Opinion
▪ Understanding the course materials
▪ Course Duration
▪ Timings for breaks:
- Lunch and Prayer
▪ Course structure – Discussions, group
exercises, presentations etc.
2 TUV ME │ QM 001 - ISO 9001:2015 Awareness Training │ REVISION 01│ ISSUE DATE 28.12.2015
Objective and Aim of this course:
What are your objectives in attending this course?
To understand
▪ The concepts & historic evolution of ISO 9001

▪ When ISO 9001 :2015 will be used , discussions on timing related points.
▪ Why ISO 9001:2015 version has been issued?
▪ What’s new? The main changes in ISO 9001:2015.
▪ How to implement ISO 9001:2015 – In a briefly way
Contents:
▪ History of ISO 9001
▪ Why ISO 9001:2015 version has been issued?
▪ The main changes in ISO 9001:2015
▪ Quality management system principles
▪ Risk management vs ISO 9001:2015
▪ Context of the organization
▪ Leadership
▪ Planning for the quality management systems
▪ Support
▪ Operation
▪ Performance evaluation
▪ Improvement
History of ISO 9001
What is new? The main changes in
ISO 9001:2015
1- 8 QMS principles reduced into 7 QMS principles

2- Concept of risk based thinking.
3- High level structure of ISO 9001:2015 (10 clauses).
4- Concept of Interested parties (clause 4.2)
5- Additional commitments for the Top Management , absence of MR(Clause 5.0)
6- More freedom for documentation.(clause 7.5)
7- Greater emphasis on service providers.(clause 8.4)
8- Improvement of customer satisfaction.
7 Quality management principles
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence based decision making
Relationship management
.
Concept of risk based thinking

(Crossing the road vs Risk)
Risk management
▪ Risk definition
Risk
Effect of uncertainty on an expected result
Note 1: An effect is deviation from expected – positive or

negative
Note 2: Uncertainty is the state, even partial, of deficiency of

information related to, understanding or knowledge of, an
event, its consequence, or likelihood
Note 3: Risk is often expressed in terms of a combination of

the consequences of an event and the associated likelihood
occurrence
Risk management
▪ Reason for risk based thinking (as per ISO)
• Improve customer satisfaction and

confidence
• Assure consistency of quality of the
Reason product
• Establish pro-active culture of prevention
and improvement
Risk management framework
identify and treat
risks
risk can be
internal or external
integrate risk
management in to
the culture
risk management
should be an
ongoing process
responsibility
shall be assigned
this is a
preventive
measure
better to define
and document
this is
everyone's
responsibility
Example of risk associated with processes
Purchase process
Risk
Analysi
s Risk evaluation
(Option Respo
Process Risk (R) /
al) How to address risk nsibili Monitoring
Steps opportunity (O)
ty
Unacce
L S Accept
pt
What Who When How
Purchase
1- Planning
of purchase
- Insufficient
supplies (R)
M H
---  1- selecting a different
sources of supplies (as a
manager
back up for any

emergency situation)
2- looking for a new
suppliers regularly
- Overstatement M M 1- Very close

of needs (R) ---  coordination bet.
Purchase and other
- Increasing M M department,…………etc)
purchase  ----
needs based
on customer
req. (O)
L : Likelihood , S: Severity
Key terminology
‘Documented Information’
“retain documented information as evidence of …. “ – Record
“maintain documented information……. “ - documentation other than records
Change from ‘identify’ to ‘determine’

Discover the process results in knowledge
‘any’ - selection and choice
‘consider’ – “necessary to think about but can be rejected”
‘take into account’ – “necessary to think about but cannot rejected”
‘interested party’ and ‘stakeholder’ - synonyms of the same concept
‘ensure’ - the responsibility can be delegated, but not the accountability to make
sure that it is performed.
Key terminology
Context of the organization (as per clause

3.24)
business environment
combination of internal and external factors and
conditions that can have an effect on an
organization's approach to its products , services
and investments and interested parties.
Note 2 : In English this concept is often referred to

by other phrases such as business environment,
organizational environment or ecosystem of an
organization (3.01).
High level Structure of ISO 9001:2015
Structure of ISO 9001:2015 – in PDCA Cycle
4. Context of the organization
4.1 Understanding the organizations and its context
The organization shall determine, review and monitor issues
External Issues Internal Issues
• Legal, • Values
• Technological, • Culture
• Competitive • Knowledge
• Market, • Performance
• Cultural,
• Social
• Economic Environment
Issues can include positive and negative or

conditions for consideration
4.2 Understanding the needs and expectations of interested parties

▪ Determine, monitor and review information about the interested parties and
their requirements
- Owners,
- Customers,
- Competitors,
- Employees,
- Bankers,
- Union,
- Supplier etc.
4.3 Determining the scope of quality management system

SCOPE
Boundaries Applicability
Consider:
- External and internal issues (4.1)

- Requirements of relevant interested parties (4.2)
- Products and services
Documented information shall be available and maintained on :
- Products and services covered

- Exclusion and its justification if any
4.4 Quality management system and its processes
Required inputs and expected outputs
Sequence and interaction

Shall Determine the
Criteria, methods (including monitoring &
processes needed
measurements & related performance indicators) &
and their application
controls
and shall:
Resources need and ensure their availability
To the extent
necessary, shall Responsibilities and authorities
maintain & retain
documented Risk and opportunities – plan and implement actions
information
Evaluate and implement any changes to achieve
intended results
Improve the processes and QMS
5. Leadership
5.1 Leadership and Commitment

engaging, Policy
Accountab directing &
Resource ility and Objectives
s needed supporting
persons
Communication
&
Achieving Implementation
intended
results
Use of process
approach &
risked based
Integration of thinking
QMS to the Define and
business support roles &
Promoting responsibilities
improvement
5. Leadership
5.1.2 Customer Focus

▪ Demonstrate leadership & commitment to ensure
- Customer & Applicable statutory & regulatory requirements are determined,
understood and consistently met
- Risk & Opportunities affecting conformity to products and services are
determined and addressed
- focus on enhancing customer satisfaction
5. Leadership
5.2 Quality Policy
- Top management shall establish, Review and Maintain
Appropriate to the purpose and Available as documented

context of the organization & information
supports its strategic direction
Commitment to satisfy applicable

requirements
Communicated,
understood and applied
within the organization
Commitment to continual
improvement of QMS
Available to relevant
Provide framework for setting interested parties as
quality objectives appropriate
5. Leadership
5.3 Organizational roles, responsibilities and authorities
Top management shall
assign Responsibility,
Communicated and understood

Authority to ensure:
• Conformity to standard
requirements
• Intended output of process
• Reporting top management on:
• Performance of QMS
• Opportunity for
improvement
• Need for change or
innovation
• Promotion of the customer
focus
• Maintain integrity of QMS when
changes are planned or
implemented
6. Planning
6.1 Actions to address risks and opportunities
Determine the risk and opportunities
Needs and expectations of

External and internal issues (4.1) interested parties
(4.2)
Changing Sharing risk

Taking risk
Eliminating the or retaining
Avoiding in order to
the risk likelihood & risk by
risk pursue an
source consequenc informed
opportunity
es decision
6. Planning for the quality management system
6.1 Actions to address risk and opportunities
Risk and opportunities need to be

addressed to
Assurance to
quality Prevent, or reduce, Achieve continual
management undesired effects Improvement
system
Proportionate
actions - Integrate and implement in QMS & Evaluate the effectiveness
Opportunities – Adoption of new practices, launching new products, opening new

markets, addressing new customers,building partnerships, using new technology etc.
6.2 Quality objectives and planning to achieve them
Establish quality objectives at relevant functions, levels and processes and
maintain documented information
Quality objective shall:

Plan how to
- Be consistent with quality policy achieve?
- Be measurable
- Take into account applicable requirements - What will be done?
- Relevant to conformity of products & - What resources required?
services & the enhancement of customer - Who is responsible?
satisfaction - When it will be completed?
- Be monitored - How the results will be
- Be communicated evaluated?
- Be updated as appropriate
6.3 Planning of changes
▪ The organization shall consider:
- Purpose of the change & its

Any changes to potential consequences
quality management
system? - The integrity of QMS
- Availability of resources
- Allocation or reallocation of
responsibilities and authorities
7. Support
7.1 Resources
Determine and provide resources needed for establishment,

implementation, maintenance, continual improvement and consider:
- Capabilities of, and constraints on, existing internal resources
- What need to be obtained from external providers
7.1.2 People 7.1.3 7.1.4 Process 7.1.5 7.1.6

Infrastructure Environment Monitoring & Organizational
- Shall provide measuring knowledge
- Shall - Determine the
the persons - Shall resources
determine, necessary
necessary for determine,
provide and - Shall
effective provide and knowledge &
maintain monitoring
implementatio maintain Consider:
environment & measuring
n of its QMS infrastructure a. Internal
necessary for resources are
and operation necessary for sources
effective suitable &
& Control of its effective b. External
operation maintained
processes operation sources
7. Support
7.2 Competence
Determine the necessary competence of person(s)
doing work under its control that affects its
performance of QMS,
Ensure competence based on appropriate

education, training or experience
Where applicable, take action to acquire necessary

competence and evaluate the effectiveness of
action taken
Retain appropriate documented information
7. Support
7.3 Awareness
Persons doing work under the
organization’s control shall be aware of:
Implications of
Their
Relevant Quality not conforming
Quality Policy contribution to
objectives to QMS
QMS
requirements
7.4 Communication
Internal What to communicate
When to communicate
Determine the
communication Whom to communicate
How to communicate
External Who communicates
7. Support
7.5 Documented information
7.5.1 General
▪ The documented information of the organizational QMS shall included:
- Required by this International standard
- Determined by the organization
▪ The extent of the documented information is based on:

- Size of organization & its type of activities, processes, products & Services
- Complexity of the processes and their interaction
- Competence of persons
7. Support
7.5.2 Creating and updating
Creating and updating

documented information shall
ensure
Identification & Format & media Review & approval

description e.g. language, for suitability and
e.g. tittle, date, author, software version, adequacy
or reference number graphics, paper,
electronic
7. Support
7.5.3 Control of documented information

- Documented information shall be controlled to ensure:
- Available and suitable for use, where and when it is needed

- It is adequately protected
(e.g. from loss of confidentiality, improper use or loss of integrity)
- Distribution, access, retrieval and use
- Storage and preservation, including preservation of legibility
Controls
- Control of changes (e.g. version control)
- Retention and disposition
8. Operation
8.1 Operational planning and control
▪ The organization shall plan, implement and control the processes and implement
action for risk and opportunities by:
- Determining requirements for the product and services
- Establishing criteria for processes and acceptance
- Determining the resources
- Implementing control as per the criteria
- Retaining the documented information
* Control planned changes and review the consequences of unintended changes,

taking action to mitigate any adverse effects, as necessary”
Ensure the outsourced processes are controlled
8. Operation
8.2 Requirements for products and services
8.2.1 Customer communication
Information related to products and services
Handling enquiries, contracts or orders, including changes

Communication
with customer Obtaining customer feedback including customer
shall include: complaints
Handling or controlling customer property
Specific requirements for Contingency action when

relevant
8. Operation

8.2.2 Determining the requirements for products and services
- While offering the products and services to the customer, organization
shall ensure:
- Product and service requirements are defined including
- Applicable statutory and regulatory requirements
- Considered necessary by the organization
- Can meet the claims for the products

and services it offers
8. Operation
8.2.3 Review of requirements related to products and services
Requirements specified by customer, delivery, post

delivery
The organization
Requirements not stated by customer, necessary for
shall ensure the specified or intended use
ability to meet the
Requirements specified by the organization
requirements and
conduct review Statutory and regulatory requirements applicable
before Contract or order requirements differing from those

committing to the previously expressed
customer: Retain documented information on results of review, any

new requirements, as applicable
8. Operation
8.3 Design and development of products and services
8.3.1 General
The organization shall establish, implement and maintain a design and development
process that is appropriate to ensure the subsequent provision of products
and services
8. Operation

8.3.2 Design and development planning
- In determining the stages and controls for design and development, the
organization shall consider:
Nature, duration and complexity Internal and external resources needed
Need to control interfaces between

Process stages including review
persons involved
Verification and validation Involvement of customers & users
Level of control expected by customers

Responsibilities and authorities and other relevant interested parties
Documented information needed to demonstrate
8. Operation
8.3.4 Design and

8.3.3 Design and 8.3.5 Design and
development
development inputs controls development outputs
- Essential requirements - Meet input requirements
Results?
- Functional & - Are adequate
performance - Include or reference
- Information derived from Reviews? monitoring & measuring
previous similar & acceptance criteria
- Statutory & regulatory - Fit for intended purpose
- Standards or code of Verification? and their safe
practice - Retain documented
- Potential consequences information
of failure Validation?
8.3.6 Design and development changes

- Shall identify, review & control changes, retain documented information
8. Operation
8.4 Control of externally provided processes, products and services
8.4.1 General
Apply control
Incorporation based on ability
into products
and services
Criteria for
Control externally evaluation
provided
Provided directly
processes, Selection
to customer
products or
service when,
Monitoring
Providing
process or part
of process Re-evaluation
Retain documented information

8. Operation
8.4 Control of externally provided processes, products and services
8.4.2 Type and extent of control 8.4.3 Information for external

providers
- Ensure processes remain within
in the control of QMS Communicate to external providers
- Define controls to apply to the for:
resulting output - Processes, products & services to
Take into consideration be provided
- Approval of products, services,
- Potential impact of this external
methods, processes, equipments
provided processes, products
and release of products
and services
- Competence of personnel
- Effectiveness of controls applied
- Interaction with organization QMS
by external provider
- Control & monitoring of performance
- Verification activities
Establish and implement
verification or other activities Ensure adequacy of requirements
8. Operation
8.5 Production and service provision

8.5.1 Control of production and service provision
- Shall implement production and service provision under controlled conditions:
- Controlled condition shall include, as applicable:
Documented information – product & Appointment of competent persons

service characteristics or activities including any required qualification
Availability and use of suitable Validation & periodic revalidation of

monitoring & measuring resources process
Implementation of monitoring & Implementation of actions to prevent

measuring activities human error
Use of Suitable infrastructure & Release, delivery and post delivery

process environment activities
8. Operation
8.5.2 - Suitable means to identify outputs

Identification
- Status of outputs with respect to monitoring & measurement
and
traceability - Control the unique identification & retain documented information
8.5.3 - Shall exercise care – under control or being used

Property
- Identify, verify, protect & safeguard
belonging to
customers
- Report in case of incorrectly used, lost, damage, unsuitable for use
or external
providers - Include material, components, tools, customer premises etc.
- Ensure preservation of outputs during production & service

8..5.4
Preservation
- Identification, handling, packaging, storage, transmission etc.
8. Operation
- Statutory & Regulatory requirements
8.5.5 Post - Potential undesired consequences associated

delivery
- Nature, use and intended lifetime
activities –
the - Customer requirements
organization
shall - Customer feedback
consider:
- Include warranty provisions, maintenance,& supplementary
services as recycling or final disposal
- Review & control changes

8..5.6
Control of
- Retain documented information – results of review of changes,
changes
personnel authorizing the change and any necessary actions
8. Operation
8.6 Release of products and services
- Shall implement the planned arrangements at appropriate stages
- Approved by a relevant authority and, as applicable, by the customer
- Retain evidence of conformity with the

Retain documented
information on the acceptance criteria
release of products
and services and shall - Traceability to the person(s) authorizing release
include: for delivery to the customer.
8. Operation
8.7 Control of nonconforming outputs
Identify and control to prevent their unintended use or delivery
Take appropriate action – during or after service provision, after delivery of product
How to deal?
Correction Retain documented information that:

Segregation, containment, return or - Describes nonconformity
suspension - Describes the action taken
- Describes any concessions
Informing to the customer
obtained
Obtain acceptance under concession - Authority deciding the action
Conformity to the requirements shall be verified after correction
9. Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
What needs to be monitored and measured?
The methods to ensure valid results

The organization
shall determine:
When to perform?
When the results are analysed & evaluated?
Evaluate performance & effectiveness of QMS
Retain appropriate documented information
9.1.2 Customer satisfaction

▪ The organization shall monitor
Determine methods
- Customer perceptions of the degree to which for obtaining,
monitoring and
their needs & expectations have been fulfilled reviewing this
information
Monitoring of Customer perceptions can include: customer surveys,

customer feedback on delivered product or services, meeting with customers,
market-share analysis, compliments, warranty claims and dealer reports
9.1.3 Analysis and evaluation
Conformity of products and services

The organization
shall analyse and The degree of customer satisfaction
evaluate appropriate
data and information Performance & effectiveness of QMS
arising from
monitoring and If planning has been implemented effectively
measurement.
Effectiveness of actions taken to address risks and
opportunities
The results of
analysis shall be The performance of external providers
used to evaluate:
The need for improvements
Methods to analyse data can include statistical techniques
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned interval to ensure
quality management system
a) confirms to:
Organization’s own requirements & Requirements of the standard
b) is effectively implemented and maintained
9.2.2 The organization shall plan, establish and maintain audit programme and
shall take into consideration of:
- Frequency?
- Importance of processes concerned
- Methods?
- Changes affecting the organization
- Responsibilities?
- Results of previous audits - Planning requirements?
- Reporting?
9.2 Internal audit
Define audit criteria and scope for each audit
The Select auditors and ensure objectivity and impartiality

organization
shall Ensure results are reported to relevant management
Take correction and corrective actions without undue delay
9.3 Management review
Conduct at planned interval & Consider; The output shall include decision
- Status of actions from previous review and action related to;
- Changes in external and internal issue
- Opportunities for
- Information on the performance & improvement
effectiveness of the QMS including trends in:
- customer satisfaction & feedback - Any need for changes to
- Extent which quality objectives met QMS, including resource
- Process performance & conformity of needs
product and service provision
- nonconformities and corrective actions
- monitoring and measurement results
- audit results
- performance of external providers
- adequacy of resources
- Effectiveness of action taken to address risk
and opportunities
- Opportunities for improvement
10. Improvement
10.1 General
Determine and select opportunities for improvement & implement

necessary actions to meet customer requirements and enhance
customer satisfaction, by improving
Correcting, Performance &

Products and Preventing or effectiveness of
services reducing QMS
Improvement can include:

- Correction , Correction action
- Continual improvement
- Breakthrough Change
- Innovation
- Re-organization
10. Improvement
10.2 Nonconformity and corrective action
React to Action to control and correct

Nonconformity
nonconformity Deal with consequences
Evaluate the need Review the nonconformity

for action to
eliminate the
Determine the causes of nonconformity
cause(s) of the
nonconformity, in Determining if similar nonconformities exist, or could
order that it does potentially occur
not recur or occur
elsewhere by; Implement any action needed
- Review the effectiveness of any corrective action taken
- update risks and opportunities determined during planning, if necessary
- Make changes to the QMS, if necessary

10. Improvement
10.2 Nonconformity and corrective action
Corrective actions shall be appropriate to the effects of nonconformity
The organization shall retain documented information of:

- The nature of nonconformity and any subsequent action taken.
- The results of any corrective action.
10. Improvement
10.3 Continual improvement
Suitability
Continually improve Adequacy
Effectiveness of QMS
Results of analysis and evaluation To determine if there are needs or

opportunities shall be addressed as a
Outputs of management review part of continual improvement
Thanks
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TUV Middle East

Member of TÜV NORD Group

ISO 9001:2015 Awareness Training

What are your objectives in attending this course?

▪ The concepts & historic evolution of ISO 9001

1- 8 QMS principles reduced into 7 QMS principles

Evidence based decision making

Concept of risk based thinking

Note 1: An effect is deviation from expected – positive or

Note 2: Uncertainty is the state, even partial, of deficiency of

Note 3: Risk is often expressed in terms of a combination of

• Improve customer satisfaction and

back up for any

- Overstatement M M 1- Very close

“maintain documented information……. “ - documentation other than records

Change from ‘identify’ to ‘determine’

‘any’ - selection and choice

‘consider’ – “necessary to think about but can be rejected”

‘take into account’ – “necessary to think about but cannot rejected”

‘interested party’ and ‘stakeholder’ - synonyms of the same concept

Context of the organization (as per clause

Note 2 : In English this concept is often referred to

4.1 Understanding the organizations and its context

The organization shall determine, review and monitor issues

External Issues Internal Issues

Issues can include positive and negative or

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of quality management system

- External and internal issues (4.1)

Documented information shall be available and maintained on :

- Products and services covered

4.4 Quality management system and its processes

Required inputs and expected outputs

Sequence and interaction

5.1 Leadership and Commitment

5.1.2 Customer Focus

Appropriate to the purpose and Available as documented

Commitment to satisfy applicable

Communicated and understood

6.1 Actions to address risks and opportunities

Determine the risk and opportunities

Needs and expectations of

Changing Sharing risk

6.1 Actions to address risk and opportunities

Risk and opportunities need to be

Opportunities – Adoption of new practices, launching new products, opening new

Quality objective shall:

6.3 Planning of changes

▪ The organization shall consider:

- Purpose of the change & its

Determine and provide resources needed for establishment,

7.1.2 People 7.1.3 7.1.4 Process 7.1.5 7.1.6

Ensure competence based on appropriate

Where applicable, take action to acquire necessary

Retain appropriate documented information

Internal What to communicate

7.5 Documented information

▪ The extent of the documented information is based on:

Creating and updating

Identification & Format & media Review & approval

7.5.3 Control of documented information

- Available and suitable for use, where and when it is needed

8.1 Operational planning and control

02 ISO 9001 2015 Awareness & Transition

02 ISO 9001 2015 Awareness & Transition