Quality Management System

according to the International Standard

ISO9001:2015
ADEL YOUNIS
Quality & BD Consultant
PHD in TQM

 9001:2015

:
: 9000
:
:
:
:
: ISO 9001 : 2015

What Does ISO Mean?

International Organization for Standardization



23 1947
25 1947 149 2004
1951

13 ,000 2000
391 ,000 .

ISO 9000

1987 1994
15 2000

( / )

2009

2015

 9000

9001:1987
9001:1994
9001:2000
9001:2008

9001:2015

 9001:2015

2015

2017

2017

2018

 !!

.





.
.

INSPECTION


.
QUALITY CONTROL

.
QUALITY ASSURANCE

.
TOTAL QUALITY MANAGEMENT


.


Quality Management System

) ( Quality objectives
.

.
ISO 9001:2015
ISO
9001:2015

.
-

.

.
()1
.
( )2
.


.
""
. ""
""
.
" "..... "
"...

.
-
-:

.
- .

.
_
.

:


.


9001
.
.

.
.

25

 9001

:
,
/
/

:
,
/

ISO 9001:2008 Model

Continual Improvement of
the Quality Management System

8. Measurement
Analysis and
Improvement

6. Resource
Management

System
7. Product
Realization

Product

CUSTOMERS

Requirements

Quality Management

Satisfaction

CUSTOMERS

5.Management
Responsibility

 PDCA
4

7.8

10

 ISO 9001 : 2015

ISO 14001



ISO 9001 : 2015

4. Context of the
organization

Understanding the
context of the
organization

5. leadership

Leadership &
commitment

Quality policy
Understanding needs
and expectations

6 planning for QMS

7 support

8 operations

Actions to address
risk and opportunities

Resources

Planning & control

Competence

Determination of
products & services
requirements

Quality objectives

9 performance &
evaluation

Monitoring,
measurement,
analysis & evaluation

Internal audit

10 improvement

General

NC & corrective
actions

Awareness
Scope of QMS

Roles, responsibilities
& authorities

Planning of changes
Communication

Documented
information

QMS

PLAN

Design &
development of
products & services

Control of externally
provided products &
services

Product & service

provision

Release of product &

service

ISO 9001 : 2015

Structure

Control of NC
products or services

DO

Management review

CHECK

Continual
improvement

ACT

 )(ISO9001:2015

:1
-:
, .
,
.

-2 :

2- Normative Reference:

ISO 9000 - 2005 .

-3 :

3- Terms and Definition:

- 9001:2015

 .4

4.1
4.2
4.3 /
4.4

Clause 5 : Leadership

5.1 Leadership & Commitment

5.2 Policy
5.3 organizational roles, responsibilities & authorities

5.1 leadership & commitment

5.1.1 General:
Accountability for effectiveness of QMS
Establishing quality policy & Objectives, compatible with context & strategy of the
organization
Integration of QMS to BMS
Promoting both of process approach & RBT
Ensuring availability of resources needed by QMS
Communicating the importance of the effective QMS, and being conforming with it
Ensuring the achievement of the intended QMS objectives
Engaging, directing, supporting persons to contribute to the effectiveness of the
QMS
Promoting improvement
Supporting other relevant management roles to demonstrate leadership

5.1.2 customer focus

Top management shall ensure that:
Customer & statutory and regulatory requirements are determined,
understood, and consistently met.
Risks and opportunities that can affect conformity of products and
services , or may enhance the customer satisfaction are determined.
Maintaining the focus on customer satisfaction

5.2 policy
5.2.1: developing the Quality Policy
Quality policy shall be established and maintained by the Top
management so that:a) Appropriate to the purpose and context of the organization,
supporting its strategic directions
b) Setting quality objectives with framework
c) Committed to satisfy applicable requirements
d) Committed to continual improvement of QMS

5.2 policy continue

5.2.2 communicating Quality Policy:
Q.P shall:
a) Available and maintained as documented information
b) Communicated, understood, and applied within the organization
c) Available to relevant interested parties.

5.3 organizational roles, responsibilities, and authorities

Top management shall ensure that the responsibility and authority for
relevant roles are assigned, communicated and understood within the
organization, and ensuring that:a) QMS conforms to requirements of this international standard
b) Processes are delivering its intended outputs
c) Reporting to top management QMS performance and any
opportunity for improvement
d) Promotion of the customer focus through the organization
e) Ensuring integrity of the QMS, when planning or implementing any
changes in it.

6 planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 planning changes

Clause 6.1 will be demonstrated in a separate lecture.

6.2 Quality objectives & planning to achieve them.

6.2.1 organization shall establish quality objectives at relevant functions, levels and
processes needed for the QMS. So that:
a) Be consistent with quality policy
b) Measurable
c) Take into account applicable requirements
d) Relevant to conformity of product and service and enhance customer satisfaction
e) Monitored
f) Communicated
g) Updated as appropriate

6.2 Quality objectives & planning to achieve them. 2

6.2.2 when planning how to achieve objectives, the organization shall
determine:
a) What will be done
b) What resources will be required
c) Who will be responsible
d) When it will be completed
e) How the results will be evaluated

6.3 planning of changes

Any changes in the QMS shall be conducted in a planned manner, and
the organization shall consider:
a) Purpose of the change and their potential consequences
b) Integrity of the QMS
c) Availability of resources
d) Allocation, or reallocation of responsibilities and authorities

7. Support
7.1 resources
7.2 competence
7.3 awareness
7.4 communication
7.5 documented information

Clause 7.5 will be demonstrated in a separate lecture.

7.1 resources
7.1.1 general
7.1.2 people
7.1.3 infrastructure
7.1.4 environment for the operation of the process
7.1.5 monitoring and measuring resources
- 7.1.5.1 general
- 7.1.5.2 measurement traceability
7.1.6 organizational knowledge

7.1.1 General
For the purpose of establishment, maintenance, and continual
improvement of the QMS, the organization shall both determine and
provide the needed resources by considering:
a) Capabilities of and constrains on, existing internal resources
b) What needs to be obtained from external providers

7.1.2 People
For the purpose of effectively implementing QMS, the organization shall
provide necessary persons for the operation & control of operations

This will be more clearly demonstrated afterwords

7.1.3 infrastructure
The organization shall determine, provide and maintain the
infrastructure necessary for the operation of its processes, in order to
achieve conformity of products and services, this may include:
a) Building and associate utilities
b) Equipment including HW / SW
c) Transportation resources
d) IT and communication technology

7.1.4 environment for operation of processes

The organization shall determine, provide and maintain the necessary
environment for the operation of its processes, to achieve conformity of
products and services, it may be a combination of both human and
physical factors, such as:
a) Social non-discriminatory / calm / non-confrontational)
b) Psychologically stress reducing / burnout prevention / emotionally
protective.
c) Physical temperature, heat, humidity, light , air flow, hygiene
,noise

7.1.5 Monitoring and measurement resources

7.1.5.1 General
In case that product or service provided by the organization should be
verified for conformity, the organization shall determine, provide the
needed resources to ensure validity and reliability of results, these
resources should:
a) Suitable for the specific type of monitoring and measurement
activities being undertaken
b) Maintained to ensure continuing fitness for purpose
Appropriate documented information should be maintained as an
evidence.

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by
the organization to be an essential part of providing confidence in the
validity of measurement results, measuring equipment shall be:
a) Calibrated or verified or both, at specific intervals, or prior to use.
b) Identified in order to determine their status
c) Safeguarded from adjustment, damage or deterioration that would
invalidate the calibration status and subsequent measurement
results.

7.1.6 organizational knowledge

The organization shall determine the knowledge necessary for the
operation of its processes, it should be maintained and made available
to the extent necessary.
When addressing any change needs and trends, the organization shall
consider it current knowledge and determine how to acquire or access
any necessary additional knowledge and required updates.
internal sources of knowledge : IPs, in house references, failure case
studies, successful projects, results or improvement in processes,
products, services
External sources of knowledge : standards, academia , conferences,
from customer or external providers.

7.2 competence
The organization shall:
a) Determine the necessary competence of person(s) doing work
under its control that affects the performance & effectiveness of
QMS.
b) Competence are based on appropriate education, training and
experience
c) Documented information are maintained as an evidence

7.3 awareness
Organization shall ensure that persons working under its control are
aware of:
a) Quality policy
b) Relevant quality objectives
c) Their contribution in the effectiveness of the QMS, including benefits
of improved performance
d) The implications of not conforming with the QMS requirements

7.4 Communication
Internal and external communication relevant to the QMS should be
determined by the organization, this may include:
a) On what it will communicate
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who to communicate

8 Operation
8.1 Operations planning and control
8.2 Requirements for products and services
8.3 Design and developments of products and services
8.4 Control of externally provided processes products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of non conforming outputs

8.1 Operational planning and control

The organization shall plan, implement and control processes needed by the QMS, to
meet the requirements of the provision of products and services by:
a) Determining requirements of products and services
b) Establishing criteria for both of processes, and acceptance of products and services
c) Determining the resources needed to achieve conformity the product and service
requirements
d) Implement control of the processes in accordance with the criteria
e) Determine and keeping maintain retain documented information to the extent
necessary for :
1. Having confidence that the processes have been carried out as planned
2. Demonstrating conformity of the products and services to their requirements

8.2 requirements for products and services

8.2.1 customer communication
8.2.2 determining the requirements of products and services
8.2.3 review of requirements related to products and services
8.2.4 changes to requirements to products and services.

8.2.1 Customer communication

It shall include:
a) Providing information related to products and services
b) Handling enquiries, contracts or orders, including changes
c) Obtaining customer feedback relating to products and services,
including customer complaints
d) Handling or controlling customer property
e) Establishing specific requirements for contingency actions when
relevant.

8.2.2 determine requirements related to products and services

The organization shall ensure that:
a) The requirements for products and services are defined, including
any applicable statutory and regulatory requirements, and any
requirements related to the organization.
b) It can meet the claims of the products and services it offers.

8.2.3 review of requirements related to products and services

8.2.3.1 the organization shall conduct a review of its ability to provide the
offered products and services to the customer, to include:a) Requirements specified by the customer, but necessary for the specified or
intended use
b) Requirements specified by the organization
c) Statutory and regulatory requirements applicable to the products and
services
d) Contract or order requirements differing from those previously expressed.
8.2.3.2 the organization shall retain documented information as applicable for:
a) Results if the review
b) Any new requirements for the products and services

8.2.4 changes to requirements for products and services

The organization shall ensure that relevant documented information is
amended, and that relevant persons are made aware of the changed
requirements, when the requirements for products and services are
changed.

8.3 Design and development of products and sevices

8.3.1 General
8.3.2 design and development planning
8.3.3 design and development inputs
8.3.4 design and development controls
8.3.5 design and development outputs
8.3.6 design and development changes

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.

8.3.2 design and development planning

The organization shall consider:
a) The nature, duration and complexity of the design and development activities
b) The required process stages, including applicable design and development
reviews
c) Required validation and verification activities
d) Responsibilities and authorities involved in the activities
e) Internal and external resources needed
f) The need to control interface between persons involved in the design and
development processes
g) The involvement of customers and users.
h) The requirements for subsequent provision of products and services
i) The level of control expected for design and development process by customers
and other relevant interested parties.
j) The documented information needed to demonstrate that design and development
requirements have been met.

8.3.3 design and development inputs

The organization shall determine the requirements essential for the
specific types of products and services to be designed and developed
through considering:
a) Functional and performance requirements
b) Information derived from previous similar design and development
activities
c) Statutory and regulatory requirements
d) Standard and code of practice applied by the organization
e) Potential consequences of failure due to the nature of the product
and service

8.3.4 Design and development controls

The organization shall apply control to design and development
processes to ensure that:
a) The results to be achieved are defined
b) Reviews are conducted to evaluate the ability of the results of
design and development to meet requirements
c) Verification activities are conducted
d) Validation activities are conducted
e) Problem determining during the reviews of verification and validation

8.3.5 Design and development outputs

The outputs of D & D shall :
a) Meet the input requirements
b) Are adequate for the subsequent processes for the provision of
products and services
c) Include measuring requirements as appropriate, and acceptance
criteria.
d) Specify the characteristics of products and services that are
essential for its intended use.
Documented information shall ne retained on the above outputs

8.3.6 Design and development changes

All changes made during or subsequent to the design and development
of the product and service, shall be identified, reviewed and controlled,
to insure that there is no adverse impact on conformity to requirements,
documented information shall be retained on:
a) D & D changes
b) Results of review if these changes
c) Authority of this change
d) Action taken to prevent adverse impact.

8.4 Control of externally provided processes, products and

services
8.4.1 General
8.4.2 type and extent of control
8.4.3 information for external providers

8.4.1 General
All externally provided processes, products and services shall conform
to requirements, all needed controls shall be applied when:
a) All externally products and services provided from external origin
will be incorporated with the organizations products and services.
b) Products and services from external origin will be provided directly
to the customer on behalf of the organization
c) A process of part of it is provided by an external provider as a result
of a decision by the organization
All external providers shall be subjected to a criteria for evaluation,
selection, monitoring of performance, and even reevaluation, with
reference to requirements, documented information shall be maintained.

8.4.2 type and extent of control

All externally provided processes products and services shall be
ensured that they have adversely affect the organizations ability to
consistently deliver its products, services to the customers, ,through:
a) All externally provided processes is under the control of its QMS
b) Define both the controls that it intends to apply to an external
provider.
c) Take into consideration :
1) The potential impact of externally provided processes, products, and
services on meeting customer, regulatory and statutory
requirements
2) The effectiveness of the control applied on the external providers
d) Determine validation, or whatsoever necessary to ensure that
externally provided P,P and S are meeting requirements

8.4.3 information for external providers

The organization shall ensure the adequacy of requirements prior to
communicating with the external providers, all organizations
requirements communicated to the external providers are for:
a) P, P and S to be provided
b) The approvals of P, S, and methods, processes and equipment.
And the release of the P, S.
c) Competence including any required qualification of persons
d) Interaction with the organization
e) Control of performance applied by the organization to the external
providers
f) Validation or verification intended to be done by the organization or
the customer in the premises of the external providers.

8.5 production & service provision

8.5.1 control of production and service provision
8.5.2 identification and traceability
8.5.3 customers or external providers properties
8.5.4 preservation
8.5.5 post-delivery activities
8.5.6 control of changes

8.5.1 control of production and service provision

Control applied on production and service provision shall include as
applicable:
a) Availability of documented information that defines 1- characteristics
of products and services, or activities to provide them, 2- results
achieved
b) The availability of using monitoring and measuring resources
c) Implementation of monitoring and measuring activities to ensure
that the outputs, and its acceptance criteria have been met
d) The use if suitable infrastructure and environment for the operation
processes
e) The appointment of competent persons, this may include required
qualifications

8.5.1 continue
f) In case the resulting output can not be verified by subsequent
monitoring or measurement, the validation , and periodic validation of
the ability to achieve planned results of product as service provision
shall be applied.
g) Implementation of actions to prevent human error.
h) Implementation of release delivery and pot-delivery activities.

8.5.2 identification and traceability

To ensure conformity of products and services, suitable identification
of outputs shall be used.
These identification shall include the status of the outputs with
respect to monitoring and measurement requirements
Unique identification of outputs shall be applied when traceability is a
requirement, and documented information shall be retained to the
extent necessary to enable traceability.

8.5.3 property belonging to customer or external provider

All external belongings to customers or providers shall be identified,
verified, and safely guarded.
If the external belongings lost, damaged or otherwise found to be
unsuitable for use, this should be reported to the property owner, and
documented information shall be retained describing what has occurred.
External belongings may include material, components, tools and
equipment, premises, IPs and personal data.

8.5.4 preservation
The organization shall preserve identify, handle, contamination control,
packaging, storage, transmission or transportation and protection of
final output during production and service provision.

8.5.5 post-delivery activities

Post delivery activities may include actions under warranty provisions,
contractual obligations like maintenance, supplementary services,
recycling or final disposal shall
a) Meet statutory and regulatory requirements
b) Potential undesired consequences associated with products and
services
c) Nature, use and intended lifetime of the product and service
d) Customer requirements
e) Customer feedback

8.5.6 control of changes

To ensure continuing the conformity with the provided products and
services, the organization shall review and control changes of products
and service provision.
Documented information shall be retained, describing the review of the
changes, authorized persons for this change, and necessary actions
arising from the review.

8.6 release of products and services

Planned arrangements at appropriate stages shall be implemented by
the organization to verify that the products and services requirements
have been met.
Release of products and services shall not be proceeded unless all the
arrangements are satisfactorily completed
Documented information shall be retained , this shall include:
a) Evidence of conformity with acceptance criteria
b) Traceability to persons authorizing the release.

8.7 control of nonconforming outputs

8.7.1 non conforming outputs shall be handled in one or more of the
following products:
a) Corrected
b) Segregated, containment, return or suspension of provision
c) Informed to customer
d) Accepted under concession
8.7.2 documented information shall be retained that:
a) Describe the NC
b) describe the action taken
c) Describe any concession obtained
d) Describe the authority deciding the action in respect to NC.

9 performance evaluation
9.1 monitoring, measurement analysis and evaluation
9.2 internal audit
9.3 management review

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 of monitoring, measurement, analysis and evaluation
c) When to perform monitoring and measurements
d) When to analyze results of monitoring and measurements
QMS shall be monitored and performance wise evaluated.
Documented information about this analysis should be retained as
evidence.

9.1.2 customer satisfaction

Customer satisfaction shall be monitored perception of the degree of
meeting their needs and expectations
Methods for obtaining customer feedback shall be determined, and how
to be monitored and evaluated.
This may include customer survey, customer feedback, meetings with
customers, market share analysis, compliments, warranty claims and
dealer reports.

9.1.3 analysis and evaluation

Data and information arising from monitoring and evaluation shall be
analyzed, and results shall be used to evaluate:
a) Conformity
b) Degree of customer satisfaction
c) Performance and effectiveness of the QMS
d) Effectiveness of implementing planning
e) Effectiveness of actions taken to address risks and opportunities
f) Performance of external providers
g) Need for improvement of QMS
Statistical techniques may be one of the analysis methods

9.2 internal audit

9.2.1 internal audits shall be conducted in planned intervals to provide
information on whether the QMS:
a) Conforms to both of 1- organizations own requirements of the QMS,
and 2- requirements of the international standard.
b) Effectively implemented and maintained.
9.2.2 the organization shall
a) Conduct a full internal audit program
b) Define audit criteria
c) Select qualified auditors
d) Report audit results
e) Take appropriate corrective actions
f) Retain documented information for audit m and audit results

9.3 Management Review

9.3.1 general
9.3.2 Mgt. Re. inputs
9.3.3 Mgt. Re. outputs

9.3.1 General
QMS shall be reviewed by the Top.M at planned
intervals, to ensure that its suitable, adequate, effective
and aligned with strategic directions

9.3.2 inputs
a) Status of actions from previous management review
b) Changes in external and internal issues that are relevant to QMS
c) Information on the performance and effectiveness of the QMS including trends in:
1- customer satisfaction, and FB from interested parties
2- extent to which quality objectives have been met
3- process performance and conformity of products and services
4- NC and corrective actions
5- monitoring and measurement results
6- audit results
7- performance of external providers
d) Adequacy of resources
e) Effectiveness of actions taken to address risks and opportunities
f) Opportunities for improvement

9.3.3 outputs
a) Opportunities for improvements
b) Any need for change in the QMS
c) Resource needs.
Documented information shall be retained as evidence.

10 improvement
10.1 general
10.2 NC and corrective action
10.3 continual improvement

10.1 General
For the purpose of enhancing customer satisfaction, the organization
shall determine and select opportunities for improvements.
This shall include:
a) Improve products and services to meet requirements, and address
future needs and expectations
b) Correcting, preventing or reducing undesired effects
c) Improving the performance and effectiveness of the QMS
Improvement can include correction, corrective actions, continual
improvement breakthrough change, innovation and re-organization.

10.2 NC and corrective action

10.2.1in case of arising any NC, the organization shall:
a) React to NC, and as applicable 1) take action to control and correct
it, 2) deal with the consequences.
b) Evaluate the need for action to eliminate the cause if NC to prevent
reoccurrence by:
1) Reviewing and analyzing NCs
2) Determining causes of NCs
3) Determine if similar NCs are exist, or could potential occur
c) Implement any action needed
d) Review the effectiveness of any corrective action taken
e) Update risks and opportunities determined during planning
f) Make changes to QMS

10.2.2
Documented information shall be retained as evidence of :
a) The nature of the NCs and any subsequent actions taken
b) Results of any corrective action.

10.3 continual improvement

The organization shall continually improve the suitability, adequacy and
effectiveness of the QMS.

The organization shall consider the results of analysis and evaluation

and the outputs from the management review, to determine if there are
needs for opportunities that shall be addressed as part of continual
improvement.

Thanks for time

Adel Younis