ISO 9001:2015

QMS LEAD IMPLEMENTER

COURSE
Presented by:
Eman Bukhari
Contents:
■ Quality Management Principles
■ Risk based thinking
■ ISO 9000 Family
■ ISO 9001:2015 Clauses, and guidelines standards
(ISO 19011, ISO 10013, AND ISO 31000)
 QUALITY
MANAGEMENT
PRINCIPLES
Quality Management
Principles
1. Customer Focus
2. Leadership
3. Engagement of people
4. Process approach
5. Continual improvement
6. Evidence Base to decision making
7. Relationship Management
Customer Focus
■ The primary focus of quality management is to meet customer
requirements and to strive to exceed customer expectations.
■ Sustained success is achieved when an organization attracts
and retains the confidence of customers and other interested
parties.
■ Every aspect of customer interaction provides an opportunity
to create more value for the customer.
■ Understanding current and future needs of customers and other
interested parties contributes to sustained success of the
organization.
Mahatma Gandhi

A customer is the most

important visitor on our
Premises. He is not
dependent on us. We are
dependent on him. He is not
an interruption on work, he
is the purpose of it. He is
not an outsider on our
business, but he is a part of
it. We are not doing him a
favour by serving him, he is
doing a favour by giving us
an opportunity to do so.
-
How could I build customer
focus system?
Recognize Direct and indirect customer

Understand needs and expectations of the customer

Link the organization’s objectives to customer needs and expectation

Communicate customer needs and expectations throughout the

organization.

Plan, design, develop, produce, deliver and support goods and services
to meet customer needs and expectations

Measure and monitor customer satisfaction

Determine and take actions on interested parties’ needs and

expectations that can affect customer satisfaction

Actively manage relationships with customers to achieve sustained

 Leadership

Leaders provide:
■ Unity of purpose
■ Direction
■ Internal environment in which people are engaged in achieving
the organization’s quality objectives
■ Creation of unity of purpose and direction and engagement of
people enable an organization to align its strategies, policies,
processes and resources to achieve its objectives.
 Leadership

■ Communicate the organization’s mission, vision, strategy, policies

and processes throughout the organization
■ Create and sustain shared values, fairness and ethical models for
behavior at all levels of the organization.
■ Encourage an organization-wide commitment to quality
■ Ensure that leaders at all levels are positive examples to people in
the organization.
■ Provide people with the required resources, training and authority
to act with accountability.
■ Inspire, encourage and recognize people’s contribution
Engagement of people

■ Competent, empowered and engaged people at all levels

throughout the organization are essential to enhance its
capability to create and deliver value
■ Communicate with people to promote understanding of the
importance of their individual contribution.
■ Promote collaboration throughout the organization.
Engagement of people
■ Facilitate open discussion and sharing of knowledge and
experience
■ Empower people to determine constraints to performance and to
take initiatives without fear.
■ Recognize and acknowledge people’s contribution, learning and
improvement
■ Enable self-evaluation of performance against personal
objectives.
■ Conduct surveys to assess people’s satisfaction, communicate
the results,
■ and take appropriate actions
 Process approach
Process effectiveness:
Controls Extent to which
planned activities are
realized and planned
results achieved

Process
set of
interrelated or Produc
Input Output
interacted t
activities that
transfer input to
outputs
Process efficiency:
Relationship between
result achieved and the
Resources
result used

A desired result is achieved more efficiently when activities and

related resources are managed as a process
Internal / Matter Matter Internal /
Start End
external Information point point Information external
provider energy energy customer

Source of Receiver of
input Activities Outputs
input outputs

Possible controls and check points to monitor and measure performance

P-D-C-A CYCLE
 The methodology known as “Plan-Do-Check-Act” can
be applied to all processes of the QMS

Plan:
Act: establish objectives and
take actions to continually processes necessary to deliver
improve process results in accordance with
performance
P customer requirements and the
organization

A D
Check:
monitor and organization's C Do:
policies measure processes and
product against policies, implement the processes
objectives and requirements for
the product and report the results
 Risk based
thinking is part
of the process
approach!
Process owner is
responsible for planning
and assuring results.

P
 People in process are
executing planed
activities

P D
 Results are checked
before products and
services are delivered
to customer.

P D C
 Customer
internal or
If any nonconformities in products, external
services or process are detected, they are
analyzed and corrective actions are
performed to eliminate nonconformities.

P D C

feedback
A
 We are monitoring customers’ perception
of the degree to which their needs and Customer
expectations have been fulfilled, and
acting upon the results in order to improve
their satisfaction.

Products
and/or
P D C services

feedback
A
feedback Customer
A satisfaction
 Process approach 0.3
First of all customer
requirements, needs Customer
and expectations are
gathered and analyzed. Requirement
feed forward
A s,
needs and
expectations
Products
and/or
P D C services

feedback
A
feedback Customers’
A satisfaction
 Customer
Requirement
Business
plan A s,
needs and
expectations
Products
and/or
P D C services

A
Customers’
Process owner A satisfaction
shall align process
goals to company
goals …
 Customer
Requirement
Business
plan A s,
needs and
expectations
Products
Statutory & and/or
Regulatory P D C services
requirements

A
Customers’
… process owner shall
ensure process to meet
A satisfaction

applicable statutory and

regulatory
Requirements, …
 Customer
Requirement
Business
plan A s,
needs and
expectations
Products
Statutory & and/or
Regulatory P D C services
requirements

Requirements A
of other
Customers’
processes
…
A satisfaction

… and coordinating
his/hers plans to plans of
other processes.
 Measurements of process effectiveness

Customer
Requirement
Business
plan A s,
needs and
expectations
Products
Statutory & and/or
Regulatory P D C services
requirements

Requirements A
of other
Customers’
processes
A satisfaction
 Measurements of process effectiveness
Goals planned Goals achieved

Customer
Measurement of
process efficiency Requirement
Business
plan A s,
needs and
Resources Resources expectations
planned used
Products
Statutory & and/or
Regulatory P D C services
requirements

Requirements A
of other
Customers’
processes
A satisfaction
 Measurements of process effectiveness
Goals planned Goals achieved

Customer
Measurement of
process efficiency Requirement
Business
plan A s,
needs and
Resources Resources expectations
planned used
Products
Statutory & and/or
Regulatory P D C services
requirements
NCR

Requirements A
of other CSI
Customers’
processes
A satisfaction
Improvement
■ Successful organizations have an ongoing focus on improvement
■ Improvement is essential for an organization to maintain current levels
of performance, to react to changes in its internal and external
conditions and to create new opportunities
■ Promote establishment of improvement objectives at all levels of the
organization
■ Educate and train people at all levels on how to apply basic tools and
methodologies to achieve improvement objectives.
■ Ensure people are competent to successfully promote and complete
improvement projects
■ Track, review and audit the planning, implementation, completion and
results of improvement projects.
■ Integrate improvement considerations into the development of new or
modified goods, services and processes.
Evidence-based decision
making
■ Decisions based on the analysis and evaluation
of data and information are more likely to
produce desired results
■ Decision making can be a complex process, and it always involves
some uncertainty.
■ It often involves multiple types and sources of inputs, as well as their
interpretation, which can be subjective.
■ It is important to understand cause-and-effect relationships and
potential unintended consequences.
■ Facts, evidence and data analysis lead to greater objectivity and
confidence in decision making.
Evidence-based decision
making
■ Determine, measure and monitor key indicators to demonstrate
the organization’s performance
■ Analyse and evaluate data and information using suitable
methods.
■ Make decisions and take actions based on evidence, balanced
with experience and intuition
Relationship management
■ For sustained success, an organization manages its
relationships with interested parties, such as suppliers
■ Interested parties influence the performance of an
organization.
■ Sustained success is more likely to be achieved when the
organization manages relationships with all of its
interested parties to optimize their impact on its
performance.
■ Relationship management with its supplier and partner
networks is of particular importance.
RISK BASED
THINKING
?What is risk? What can I do
?What is risk

■ Risk is the “effect of uncertainty on objectives” and an

effect is a positive or negative deviation from what is
expected

■ Risk can be defined by two (2) parameters

■ – Severity (impact) • This is the Seriousness of the harm ‫ا‬
■ – Probability • This is the Probability that the harm will
occur
Risk Assesment
Severity

H M L

M L L L

Probability
H M
ILnc M

r eas
H H M
inHg
risk
 QUALITY MANAGEMENT SYSTEMS – RISK
BASED THINKING
In Clause 4: the
organization is
required In Clause 6: the
to determine risks that In Clause 9: the
organization is required
can affect its ability to organization is required
to plan and take action
meet objectives” to consider risks and
to address risks and
opportunities when
opportunities
determining what
needs to be monitored,
In Clause 5: top measured, analyzed
management are In Clause 8: the and
required to commit organization is required evaluated
to to have processes
ensuring Clause 4 is which
followed identify and address In Clause 10: the
risk in its operations organization is required
to improve by
responding to changes
in risk and opportunities
ISO 9000 FAMILY
 ISO 9000 series
ISO 9000
Quality management
systems—Fundamentals
and vocabulary
Essential background for
the proper understanding and
implementation of
ISO 9001
ISO 9001
Quality management
systems—Requirements
Requirements aimed primarily
at giving confidence in the
products and services
an organization provides,
thereby improving
customer satisfaction
ISO 9002
Quality management
systems —
Guidelines for the
application of
ISO 9001:2015
Guideline standard has been
developed to assist users to
apply the quality management
system requirements
of ISO 9001:2015[28] Quality
management systems –
Requirements.
ISO 9001:2015
ISO 9001:2015
■ 4 context of organization
■ 5 Leadership
■ 6 Planning
■ 7 support
■ 8 Operation
■ 9 Performance evaluation
■ 10 Improvement
Activity:
How to link
Process
approach, PDCA
cycle and ISO
9001:2015
clauses???
 CONTEXT OF
ORGANIZATION
Clause 4
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 and its
processes
Understanding the .4.1
organization and its context
■ The organization shall determine external and internal issues
that are relevant to its purpose and that affect its ability to
achieve the intended outcome(s) of its integrated management
system (QMS).
■ The organization should make itself aware of the
“environment” within which it operates both externally and
internally and which factors need to be taken into account when
implementing its QMS.
 Political

Environm
Legal
ent

PESTE
L

Economic Social

Technolog
ical
 Strength Internal

Threats
SWO Weakness
T

external Opportunit
ies
 Understanding the needs .4.2
and expectations of interested
parties
■ The organization shall determine:
■ a) the interested parties that are relevant to
the quality management system; and
■ b) the requirements of these interested
parties.
Determining the scope of the 4.3
quality management system

■ The organization shall determine the boundaries and

applicability of the QMS to establish its scope.
■ When determining this scope, the organization shall
consider
■ a) the external and internal issues referred to in 4.1;
and
■ b) the requirements referred to in 4.2.
■ C) The products and services of the organization
 Interested
context Scope
parties
Define scope of your
?organization
 Quality management 4.4
system and its processes
■ The organization shall establish, implement, maintain and
continually improve the management system, including
the processes needed and their interactions, in accordance
with the requirements of this international standard
■ A)Inputs required and output expected
■ b) the sequence and interaction
■ c) criteria and methods including measurements and
related performance indicators needed to ensure the
effective operation and control of these processes
Quality management 4.4
system and its processes
■ d) ensure the availability of resources needed;
■ e) Responsibilities an authorities
■ f) Risk and opportunities
■ g) monitor, measure and analyze these
■ h) Opportunities for improvement
Define Your QMS and its
process
LEADERSHIP
Clause 5
Clause 5 - Leadership

■ 5.1 Leadership and commitment

■ 5.2 Quality policy
■ 5.3 Organizational roles, responsibilities
and authorities
5.1 Leadership and commitment
5.1.1 general
■ Top management shall demonstrate leadership and commitment
with respect to the QMS by:
■ a) taking accountability of the effectiveness of QMS
■ b) policies and objectives
■ c) ensuring the policy communicated understood & applied
■ d) integration of the QMS into the organization’s processes;
■ e) promoting awareness of the process approach
■ f) resources availability communication
Leadership and commitment 5.1
5.1.1. general
■ h) ensuring that the QMS achieves its intended outcome(s);
■ i) engaging, directing and supporting persons to contribute to
the QMS;
■ j) promoting continual improvement;
■ h) supporting other relevant management roles to demonstrate
their leadership as it applies to their areas of responsibility
Leadership and commitment 5.1
5.1.2. Customer Focus
Leadership shall demonstrated leadership and commitment with respect
to customer focus by ensuring that:
■ a) customer and applicable statutory and regulatory requirement are
determined, understood and consistently met,
■ b) Risks and opportunities effecting conformity are determined and
addressed.
■ c) The focus on enhancing customer satisfaction is maintained
Quality policy 5.2
5.2.1 Developing the quality policy
■ a) is appropriate to the purpose of the organization;
■ b) provides a framework for setting QMS objectives;
■ c) includes a commitment to satisfy applicable requirements; and
■ d) includes a commitment to continual improve the effectiveness of the
QMS.
 Quality policy 5.2

■ 5.2.2 communicating the quality policy

■ The QMS policy shall :
■ 1) be available as documented information;
■ 2) be communicated within the organization ‫ة‬
Define Your organization
Quality Policy
5.3 Organizational roles,
responsibilities and authorities
■ Top management shall ensure that the responsibilities and authorities for
relevant roles are assigned and communicated within the organization.
■ Top management shall assign the responsibility and authority for:
■ a) ensuring that the QMS conforms to the requirements of this
International Standard; and
■ b) reporting on the performance of the QMS to top management.
■ C)Reporting on the performance of the quality management system, on
opportunities for improvement and on the need for change or
innovation, and especially for reporting to top management,
■ d) ensuring the promotion of customer focus throughout the organization
■ e) ensuring the integrity of the QMS is maintained when changes to the
QMS are planned and implemented
PLANNING
Clause 6
 Clause 6 – Planning
■ 6.1 Actions to address risks and
opportunities
■ 6.1.1 Determining risks and
opportunities
■ 6.2 Quality objectives and planning to
achieve them
■ 6.3 Planning of changes
Actions to address risks 6.1
and opportunities
■ 6.1.1 When planning for the quality management system,
the organization shall consider the issues referred to in 4.1
and the requirements referred to in 4.2 and determine the
risks and opportunities that need to be addressed to:
■ a) give assurance that the quality management system can
achieve its intended result(s);
■ b) Enhance desirable effects,
■ c) prevent, or reduce, undesired effects;
■ d) achieve continual improvement
Actions to address risks 6.1
and opportunities
■ 6.1.2 The organization shall plan:
■ a) actions to address these risks and opportunities;
■ b) how to:
■ 1) integrate and implement the actions into its quality management
system processes (see 4.4);
■ 2) evaluate the effectiveness of these actions.
■ Actions taken to address risks and opportunities shall be proportionate to
the potential impact on the conformity of products and services
 Actions to address risks 6.1
and opportunities
■ NOTE : Options to address risks and opportunities
can include: avoiding risk, taking risk in order to
pursue an opportunity, eliminating the risk source,
changing the likelihood or consequences, sharing the
risk, or retaining risk by informed decision.
ISO 31000
RISK MANAGEMENT
Quality objectives and 6.2
:planning to achieve them
■ 6.2.1 The organization shall establish quality objectives at relevant
functions, levels and processes.
■ The quality objectives shall:
■ a) be consistent with the quality policy,
■ b) be measurable;
■ c) take into account applicable requirements;
■ d) be relevant
■ e) be monitored;
■ f) be communicated;‫صل‬V‫لتوا‬VV‫ا‬
■ g) be updated as appropriate. (retain doc info)
Quality objectives and 6.2
:planning to achieve them
■ 6.2.2 When planning how to achieve its quality 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.
S M A R T
We are going to show how
QMS operates on strategic
and operational level using
PDCA approach.
Each management level is
using its’ own PDCA loop.
Both loops are connected
and synchronized by
information exchange.
 Top management
QMS Process owners

Plan: establish the objectives of the

system and its processes, and the
resources needed to deliver results
P in accordance with customers'
requirements and the organization's
policies;

A
 Top management
QMS Process owners

P Do: implement what

was planned;

A
 Top management
QMS Process owners

P Check: monitor and (where applicable)

measure processes and the resulting
products and services against policies,
objectives and requirements and report
the results;

A
 Top management
QMS Process owners

Act: take actions to improve

performance, as necessary.
D

A
 Top management
QMS Process owners
5.2
Quality policy
8.1
Target values
P 6.1 and 6.2
Business plan with
quality objectives 8.1
Action plan
6.1
Actions Quality plan
FMEA,
SWOT
D
Top management shall
establish, implement
and maintain a quality
C policy and establish quality
objectives at relevant
functions, levels and
processes needed for the
A quality management
system.
 Top management
QMS Process owners
5.2
Quality policy
8.1
Target values
P 6.1 and 6.2
Business plan with
quality objectives 8.1
Action plan
6.1
Actions Quality plan
FMEA,
SWOT
D
The organization
shall plan actions to
address these risks
C and opportunities.

A
 Top management
QMS Process owners
5.2
Quality policy
8.1
Target values
P 6.1 and 6.2
Business plan with
quality objectives 8.1
Action plan
6.1
Actions Quality plan
Managing organization
FMEA,
according to Quality policy SWOT
D and objectives 8.2 to 8.5
Operations as planned
The organization shall
plan, implement and
control the processes
C needed to meet
the requirements for the
provision of products
A and services
 Top management
QMS Process owners
5.2
Quality policy
8.1
Target values
P 6.1 and 6.2
The organization shall implement
Business plan
planned arrangements, at with 8.1
appropriate quality objectives
stages, to verify Corrective 10.2
actions
Action plan
that the product and service 6.1
Actions Quality plan
requirements have been met and 9.1.3
Managing organization
control nonconforming output. Analyzing FMEA,
according to Quality policy SWOT
data
D and objectives
8.7
8.2 to 8.5
Operations as planned
Control of
nonconformities
8.6
Check Nonconformance
C 9.2
Check

Internal audits

A Customers
 Top management
QMS Process owners
5.2
Quality policy
8.1
Target values
P 6.1 and 6.2
Business plan with
8.1
quality objectives Corrective 10.2
actions
Action plan
6.1
Top management shall 6.1
Actions Quality plan
review the organization's 9.1.3
Managing organization
Analyzing FMEA,
according to QualityQMS,
policyat planned SWOT
data
D and objectives Intervals.
8.7
8.2 to 8.5
Operations as planned
Control of
nonconformities
8.6
Check Nonconformance
C 9.2
Check

9.3 Internal audits

Management review
A 9.3.3 Analyzing results and action
9.1.2
Customers
taking
 Top management
QMS Process owners
5.2
Quality policy
8.1
Target values
P 6.1 and 6.2
Business plan with
8.1
quality objectives Corrective 10.2
actions
Action plan
6.1
Actions Quality plan
9.1.3
Managing organization
Analyzing FMEA,
according to Quality policy SWOT
data
D and objectives
8.7
8.2 to 8.5
Operations as planned
Control of
nonconformities
8.6
Check Nonconformance
C 9.2
Check

9.3 Internal audits

Management review
A 9.3.3 Analyzing results and action
9.1.2
Customers
taking
Practical
Company Top management Process owners Project manager and experts
owners

example
Corrective &
Quality policy preventive
actions

Business plan with C

quality objectives A

PLAN
NOT
OK Targets
Analysis
App of NC
rova
l
OK Approved Process plan Action plan
business plan

Work according to Work according to

DO

Work according to
plan plan plan

Non
conformance
Checking
CHECK

Checking Checking
Quarterly monthly
Prototype production
(vendor)
Audit
report Auditing Non
conformance
C A
Checking

Analyzing results Monthly

Customer
Annual
report Quarterly Non
Annual management review conformance
ACT

Checking

Customer satisfaction
Analysis of customer feedback
perception of quality
 Planning of changes 6.3
■ Where the organization determines the need for change to the quality
management system (see 4.4).
■ The change shall be out in a planned systematic manner
■ The organization shall consider:
■ a) the purpose of the change and any of its potential consequences;
■ b) the integrity of the quality management system;
■ c) the availability of resources;
■ d) the allocation or reallocation of responsibilities and authorities.
‫طبق التخطيط للتغيير‬
SUPPORT
Clause 7
:Clause 7 support

■ 7.1. Resource
■ 7.2 Competence
■ 7.3 Awareness
■ 7.4 Communication
■ 7.5 Documented information
 Clause 7– Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
:Resources .7.1
■ 7.1.1 General: The organization shall determine and provide the
resources needed for the establishment, implementation,
maintenance and continual improvement of the quality
management system
■ 7.1.2 People: To ensure that the organization can consistently
meet customer and applicable statutory and regulatory
requirements, the organization shall provide the persons
necessary for the effective operation of the quality management
system, including the processes needed.
Resource .7.1

■ 7.1.3 Infrastructure: The organization shall determine, provide

and maintain the infrastructure for the operation of its processes
to achieve conformity of products and services.
■ 7.1.4 Environment for the operation of processes: The
organization shall determine, provide and maintain the
environment necessary for the operation of its processes and to
achieve conformity of products and services.
Resource .7.1
■ 7.1.5 Monitoring and measuring resources:
■ 7.1.5.1. General: The organization shall determine and provide the
resources needed to ensure valid and reliable results when monitoring or
measuring is used to verify the conformity of products and services to
requirements.
■ 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,
measurement equipment shall be:
■ Calibrated or verified, or both at specified intervals, or prior to use
against measurement standards traceable to international or national
measurement standards; when no such standards exit, the basis for
calibration or vierification shall be retained as documented information,
■ Identified in order to determine their status,
■ safegaurded
Organizational 7.1.6
: knowledge
■ The organization shall determine the knowledge necessary for
the operation of its processes and to achieve conformity of
products and services.
■ This knowledge shall be maintained, and made available to the
extent necessary.
■ When addressing changing needs and trends, the organization
shall consider its current knowledge and determine how to
acquire or access the necessary additional knowledge.
Organizational 7.1.6
: knowledge
■ NOTE 1 : Organizational knowledge can include information such as
intellectual property and lessons learned.
■ NOTE 2: To obtain the knowledge required, the organization can
consider:
a) internal sources (e.g. learning from failures and successful projects,
capturing undocumented knowledge and experience of topical
experts within the organization);
b) b)external sources (e.g. standards, academia, conferences, gathering
knowledge with customers or providers).
Competence .7.2
■ The organization shall:
■ a) determine the necessary competence of person(s) doing work under
its control that affects its quality performance;
■ B) ensure that these persons are competent on the basis of appropriate
education, training, or experience;
■ c) where applicable, take actions to acquire the necessary competence,
and evaluate the effectiveness of the actions taken;
■ d) retain appropriate documented information as evidence of
competence
■ NOTE : Applicable actions can include, for example, the provision of
training to, the mentoring of, or the reassignment of currently employed
persons; or the hiring or contracting of competent persons.
Awareness .7.3
■ Persons doing work under the organization's control shall be aware of:
■ a) the quality policy;
■ b) relevant quality objectives;
■ c) their contribution to the effectiveness of the quality management
system, including the benefits of improved quality performance;
■ d) the implications of not conforming with the quality management
system requirements
TRAINING
Communication .7.4

■ The organization shall determine the internal and external

communications relevant to the quality management system
including:
■ a) on what it will communicate;
■ b) when to communicate;
■ c) with whom to communicate;
■ d) how to communicate.
■ E) who communicate.
Documented information 7.5

■ 7.5.1 General :The organization's quality management system shall include

■ a) documented information required by this International Standard;
■ b) documented information determined by the organization as being
necessary for the effectiveness of the quality management system.
■ NOTE :The extent of documented information for a quality management
system can differ from one organization to another due to:
■ the size of organization and its type of activities, processes, products and
services;
■ the complexity of processes and their interactions
■ the competence of persons
Documented information 7.5

7.5.2 Creating and updating: When creating and updating

documented information the organization shall ensure appropriate:
■ a) identification and description (e.g. a title, date, author, or
reference number);
■ b) format (e.g. language, software version, graphics) and media
(e.g. paper, electronic);
■ c) review and approval for suitability and adequacy
Control of documented 7.5.3
:Information
■ 7.5.3.1 Documented information required by the quality
management system and by this International Standard shall be
controlled to ensure:
■ a) it is available and suitable for use, where and when it is needed;
■ b) it is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity
■ 7.5.3.2 For the control of documented information, the
organization shall address the following activities, as applicable:
■ a) distribution, access, retrieval and use;
■ b) storage and preservation, including preservation of legibility;
■ c) control of changes (e.g. version control);
■ d) retention and disposition.
:Documented Information

■ Documented information of external origin determined by the

organization to be necessary for the planning and operation of
the quality management system shall be identified as
appropriate, and controlled.
■ NOTE: Access can imply a decision regarding the permission to
view the documented information only, or the permission and
authority to view and change the documented information.
DOCUMENTATIO
N
‫اكتب ما ستفعل افعل ما كتبت اثبت ذلك طور عملك‬

‫■ مبدأ التوثيق‬
 ‫ماهو التوثيق ‪ /‬الوثيقة ‪..‬؟‬
‫■ التوثيق‪ :‬حفظ المعلومة في وسط ما‬
‫■ الوسط قد يكون ورقي او الكتروني او صورة او‬
‫بطاقة‬
‫■ نظام ادارة الجودة يمكن توثيقه بشكل ورقي او‬
‫برنامج حاسوب‬
‫■ ما المقصود بالوثيقة‪:‬‬
‫■ الوثيقة معلومات محفوظة في وسط ما‬
 ‫اهداف التوثيق‬

‫■ من متطلبات نظام ادارة الجودة ‪ISO 9001:2015‬‬

‫■ التوثيق ضمان لقيام العاملين بالمهام المطلوبة وفق ما‬
‫تم توثيقه‬
‫■ ‪ .1‬تنفيذ الخطة‬
‫■ ‪ .2‬مطابقة المنتج ‪ /‬الخدمة‬
‫■ مرجع للتدقيق امام الجهة المانحة‬
 ‫فوائد التوثيق‬
‫■ وصف نظام إدارة ا‪V‬لجودة للمؤسسة‪.‬‬
‫العاملين على فهم أدوارهم مما يزي ٌد شعورهم بأهميةٌ وهدف عملهم‪.‬‬
‫ٌ‬ ‫■ مساعدة‬
‫ٌ‬
‫العاملين و اإلدارة‪.‬‬ ‫■ يسٌاعد عل‪V‬ى الفهم المتبادل ٌ‬
‫بين‬
‫كيف ي ٌمكن أن تنجز األمور لتحقي ٌ‬
‫ق المتطلبات المحددة‪.‬‬ ‫ٌ‬ ‫■ يحٌدد‬
‫العاملين ‪ /‬الموظفين الجدد و إعادة تدريب الموظفٌين‬
‫ٌ‬ ‫■ يقٌدم قاعدة لتدريبٌ‬
‫ٌ‬
‫الحاليين‬
‫ٌ‬
‫للتحسين المستمر‬ ‫■ يقٌدم قاعدة‬
‫■ يظٌهر لألطراف المهتمة مقدرات المؤسسة‬
‫■ قٌدم قاعدة لتدقي ٌ‬
‫ق نظام إدارة الجودة‬
‫■ قٌدم قاعدة لتقيي ٌم األفعال و المالئمة المستمرة لنظام إدارة الجودة‬
‫هرم وثائق الجودة‬
‫سيا‬
‫سة‬
‫الج‬
‫ودة‬
‫دليل الجودة‬

‫اجراءات الجودة‬

‫اجراءات العمل‬

‫تعليمات العمل‬

‫النماذج وا السجالت والمرفقات والمواصفات‬

 ‫سياسة الجودة‬

‫■ سياسة الجودة ‪ :‬هو مجمل نوا يا ٌ و توجهات الشركة‬

‫المتعلقة بالجودة و التي تٌم التعبي ٌر عنها رسميا ٌ‬
‫بواسطة اإلدارة العليا للشركة‪.‬‬
‫■ يجٌب أن تكون سياسة الجودة واضحة ومنسجمة مع‬
‫السياسة لعامة للشركة‪ ،‬و يجٌب أن تقدم إطار عمل‬
‫لوضع أهداف الجودة‬
 ‫دليل الجودة‬
‫■ دليل الجودة ‪ :‬هو وثيقة تصف نظام إدارة الجودة بمؤسسة ما‪.‬‬
‫■ يمكن أن يمتد دليل الجودة و يتٌسع بالتفاصي ٌل حسب حجم و‬
‫درجة تعقيد المؤسسة ‪.‬‬
‫■ يجب أن يشتمل دليل الجودة على ‪:‬‬
‫■ مجال نظام إدارة الجودة‪ ،‬بما ف ذلك تفاصيل أي استبعاد‬
‫ومبرراته‪.‬‬
‫■ اإلجراءات الموثقة التي تم وضعها ف نظام إدارة الجودة‪.‬‬
‫■ وصفا ً للتداخل بين عمليات نظام إدارة الجودة‬
‫ما الفرق بين االجراء واالجراء الموثق‬

‫■ االجراء ‪ :‬وصف محدد لتنفيذ نشاط أو عملية‪.‬‬

‫■ االجراء الموثق ‪ :‬هو إجراء تم إنشاؤه وتوثيقه‬
‫وتطبيقه والمحافظة عليه‬
 ‫اجراءات الجودة‬

‫■ اجراءات الجودة‪ :‬وهي االجراءات الموثقة التي تم‬

‫ادخالها للشركة بعد تبنيها لنظام ادار‪V‬ة الجودة مثل دليل‬
‫الجودة – التدقيق الداخلي – مرادعة االدارة‬
‫■ اجراءات الممارسات التصنيعية الجيدة‪ :‬وهي‬
‫اجراءات الموثقة التي تم داخالها للشر‪V‬كة بعد تبنيها‬
‫لنظام الممارسات التصنيعية الجيدة ‪GMP‬‬
 ‫اجراءات العمل‬

‫■ اجراءات العمل‪ :‬هي االجراءات المتبعة والموجودة‬

‫اساسا في الشركة اال انها لم تكن موثقة وتم توثيقها‬
‫بعد تبني نظام ادارة الجودة االيز‪V‬و ‪9001:2015‬‬
‫وتصف اداء العملية بشكل عام دون الدخول الى‬
‫تفاصيل كل عمل‬
‫■ مثل اجراء المبيعات – المشتريات ‪ -‬الصيانة‬
 ‫تعليمات العمل‬

‫■ تعليم[ات العمل‪ :‬وصف موثق ألداء عمل معين‬

‫بشكل كامل وتفصيلي‬
‫■ تتبع تعليمات العمل الجراء العمل‬
‫■ مثال‪ :‬اجراء الصيانة‪ :‬يتبع له تعليمة عمل‬
‫صيانة المكيفات‬
 ‫كيف نفرق بين االجراء وتعليمة العمل‬

‫■ يصف االجراء الموثق بشكل عام األنشطة‬

‫المتعلقة بالوظائف المختلفة بينما تصف‬
‫تعليمة العمل المهام الواجب تنفيذها في احد‬
‫هذه الوظائف‬
 ‫النماذج والسجالت‬

‫■ النموذج ‪ :‬هو وثيقة تستخدم لتسجيل البيانات المطلوبة لنظام‬

‫إدارة الجودة ‪.‬‬
‫■ السجل ‪ :‬وثيقة تعط النتائج المنجزة أو توفر دالئل للنشاطات‬
‫المنجزة‬

‫■ العالقة بين النموذج والسجل‪:‬‬

‫■ يصبح النموذج سجال بعد تسجيل البيانات عليه‬
‫تحتوي الوثائق على ‪..‬‬

‫■ ‪ .1‬الغالف الوثائق يحدد فيه‪:‬‬

‫■ اسم الشركة‬
‫■ عنوان الوثيقة ورقمها‬
‫■ معد ومراجع ومعتمد ومدقق الوثيقة‬
‫■ رقم وتاريخ اإلصدار الخاص بها‪-‬‬
‫■ رقم النسخة‬
‫■ عدد الصفحات‪.‬‬
‫تحتوي الوثائق على ‪..‬‬
‫■ الوثائق على النقاط التالية‪:‬‬
‫■ الغاية‪.‬‬
‫■ مجال التطبيق‪.‬‬
‫■ المرجع المعياري والقانوني‪.‬‬
‫■ المصطلحات والتعاريف‪.‬‬
‫■ المسؤوليات‪.‬‬
‫■ خطوات التنفيذ‪.‬‬
‫■ النماذج‪.‬‬
‫إن ُو ِج ْ‬
‫ـدت‬ ‫■ المرفقات ْ‬
‫ماذا يجب ان تحتوي تعليمة العمل‬

‫■ الغالف يحدد فيه‪:‬‬

‫■ اسم الشركة‬
‫■ عنوان تعليمة العمل ورقمها‬
‫■ معد ومراجع ومعتمد ومدقق‬
‫■ رقم وتاريخ اإلصدار الخاص بها‪-‬‬
‫■ رقم النسخة‬
‫■ عدد الصفحات‪.‬‬
‫ماذا يجب ان تحتوي تعليمة العمل‬

‫■ الوثائق على النقاط التالية‪:‬‬

‫■ المسؤوليات‪.‬‬
‫■ خطوات التنفيذ‪.‬‬
‫■ النماذج‪.‬‬
 ‫الخطوات االساسية لتوثيق نظام الجودة‬

‫■ وضع فهرس نظام ادارة الجودة والذي يحتوي على كافة االجراءات وتعليمات العمل التي‬
‫سيتضمنها النظام‬
‫■ انشاء وتوثيق سياسة الجودة ودليل الجودة‬
‫■ انشاء وتوثيق اجراءات الجودة واجراءات العمل‬
‫■ انشاء وتوثيق تعليمات العمل‬
‫■ مراجعة واعتماد التعليمات التي تم توثيقها من قبل المعنيين باالعداد والمراجعة واالعتماد‬
‫■ تصوير النظام وتوزيع النسخ الالزمة على اماكن االستخدام‬
‫■ تفعيل النظام من خالل تدريب العاملين على رأس العمل والتأكد من فهمهم لإلجراءات‬
‫وتعليمات العمل‪.‬‬
‫ممارسات التوثيق الجيدة‬
 ‫ماهي ممارسات التوثيق الجيد‬

‫هو أن تكون موجز‪V‬ة و مقروءة ومتقنة مع إمكانية تتبع‬

‫السجالت‬

‫هذه العبارات البسيطة تشتمل على كل متطلبات‬

‫إجراءات او ممارسات التوثيق الجيد‬
‫هو أن تكون موجزة و مقروءة ومتقنة مع إمكانية‬
‫تتبع السجالت‬

‫بساطة العبارة وصعوبة المهمة‬

 ‫هو أن تكون موجزة و مقروءة ومتقنة مع‬
‫إمكانية تتبع السجالت‬

‫• يجب على الوثيقة ان‬ ‫• يجب ان تكون‬ ‫• يجب ان تكون‬ ‫• امكانية تتبع اي‬
‫تسرد المضمون‬ ‫الوثيقة قابلة للقراءة‬ ‫الوثيقة خالية من‬ ‫جانب من جوانب‬
‫بأكمله وان تكون‬ ‫من قبل العمالء‬ ‫االخطاء‬ ‫الوثيقة‬
‫مفهومة لدى الجميع‬ ‫الداخليين‬ ‫• مثال من الذي قام‬
‫والخارجيين‬ ‫بادخال البيانات؟‬
‫أين؟ لماذا؟‬
‫امكانية‬
‫موجزة‬ ‫مقروءة‬ ‫متقنة‬ ‫تتبع‬
‫السجالت‬
‫كيف نجعل المهمة سهلة؟‬
‫دعونا نبحث ماذا يعني ان تكون موجزة؟‬

‫■ هل وثائقنا موحدة ؟‬
‫■ هل الوثائق سهلة اإلستخدام للجميع؟‬
‫■ هل توجد لدينا بعض المستندات بها أخطاء مستمرة؟‬
‫■ هل وثائقنا تسرد المضمون كامال ‪ ،‬بداية‪ ،‬وسط ونهاية لكل‬
‫فرد ؟‬
‫دعونا نبحث ماذا يعني ان تكون مقروءة؟‬

‫■ بأبسط األشكال‪ V‬مقروءة تعني ‪:‬‬

‫■ هل كل شخص يستطيع قراءة ماهو مكتوب؟‬

‫■ ذلك بغض النظر عن من الذي سيقرأ ؟ أين ؟ما هو الموضوع الذي ستتم قراءته ؟‬
 ‫دعونا نبحث ماذا يعني ان تكون متقنة؟‬

‫■ يجب تسجيل البيانات في أقرب وقت ممكن‪ ،‬و يجب أال تكون‬
‫مزورة‪.‬‬

‫■ بكل بساطة الأحد يملك مجال يحدد لنفسه متى وكيف تمت‬
‫صياغة العملية لتصيد على األخطاء ‪.‬‬
 ‫دعونا نبحث ماذا يعني امكانية تتبع‬
‫السجالت؟‬
‫■ أن يستطيع كل شخص فهم من الذي قام بتسجيل البيانات ؟ لماذا ؟‬
‫■ ماهي البيانات المسجلة ؟ متى تم تسجيل البيانات؟‬
‫■ ‪ -‬هل تم توقيع كل شخص على ماقام بتسجيله ؟‬
‫■ ‪ -‬هل لدينا تعليمة عمل موحدة ؟‬
‫■ ‪ -‬هل نستطيع فهم مانسجله؟‬
‫■ ‪ -‬هل نستطيع تحديد ماهو مسجل؟‬
‫التوثيق الموحد هو المفتاح‬
 ‫انت مسؤول عن توقيعك‬

‫■ التوقيع او التوقيع االلكتروني‬

‫■ فإنه ال يجوز أبدا أن يحال أو يكشف إلى أى شخص آخر‪.‬‬
‫■ غير مسموح لك إطالقا إستخدام التوقيع اإللكتروني ألي‬
‫شخص آخر‪.‬‬
‫■ أنت مسئول عن جميع المعلومات المسجلة قبل التوقيع‪.‬‬
‫■ يجب مراجعة جميع المعلومات قبل التوقيع عليها للتأكد من‬
‫عدم وجود أي أخطاء من قبل األشخاص‪.‬‬
 ‫ماذا افعل ان وجدت اخطاء؟‬

‫■ يجب ان تصحيح األخطاء من قبل الشخص الذي قام بعملها‪.‬‬

‫■ أو‬
‫■ إذا لم يكن الشخص موجود فتصحح بواسطة مديره‬
‫■ أو‬
‫■ إذا لم يكن الشخص موجود فتصحح بواسطة ثان أعلى عضو‬
‫في اإلدارة‪.‬‬
‫■ ‪ .............‬وهكذا إلى آخره‬
 ‫كيف يتم تصحيح الخطأ؟‬

‫■ أربعة خطوات بسيطة‬

‫■ ‪-‬رسم خط واحد حول الخطأ‬
‫■ ‪ -‬إجعل التصحيح بجانب الخطأ‬
‫■ ‪ -‬ضع توضيح عن الخطأ‪.‬‬
‫■ ‪ -‬ضع تاريخ وتوقيع تصحيح الخطأ والتوقيع‪.‬‬
‫ماذا سأفعل إذا كنت أحتاج لمساحة أكب[ر‬

‫■ مالعمل إذا لم تكن هنالك مساحة للتصحيح والتوضيح أو‬

‫التوقيع والتاريخ؟‬

‫■ ضع عالمة نجمة (*) قرب الخطأ وضع عالمة (*) في نفس‬

‫الورقة حيث توجد مساحة للكتابة ‪ ،‬ومن ثم ضع معلوماتك ف‬
‫هذا المكان‬
‫على سبيل المثال‪:‬‬

‫■ خطأ ف إسم علي ‪.....‬عال*‬

‫■ التصحيح‬
‫■ علي*‬
‫■ التوقيع ‪:‬‬
‫■ ‪24/11/2016‬‬
‫المعلومة الموثقة ايزو‬
‫‪9001:2015‬‬
 ‫المعلومة الموثقة‬
‫■ المعلومة الموثقة‪ :‬هي المعلومة المطلوب ضبطها‬
‫والمحافظة عليها في الوسط الموجودة فيه من قبل‬
‫المؤسسة‪.‬‬
‫■ المعلومة الموثقة في نظام ادارة الجودة تكون مرتبطة بـ‪:‬‬
‫‪ .1‬نظام ادارة الجودة‬
‫‪ .2‬نظام العمليات التي لها عالقة بالمؤسسة‬
‫‪ .3‬دليل على تحقيق النتائج والخطط‬
‫‪ .4‬دليل على مطابقة الخدمة والمنتج‬
‫المعلومةات الموثقة الملزمة من المواصفة ايزو‬
‫‪9001:2015‬‬
‫المجال‬ ‫■‬
‫سياسة الجودة‬ ‫■‬
‫اهداف الجودة‬ ‫■‬
‫معيار تقييم واختيار الموردين‬ ‫■‬
‫سجالت المعايرة‬ ‫■‬
‫سجالت التدريب والكفاءة والمهارات ومؤهالت‬ ‫■‬
‫سجالت مراجعة متطلبات المنتج‬ ‫■‬
‫خصائص المنتج‬ ‫■‬
‫سجالت ضبط التغيير في العمليات التشغيلية‬ ‫■‬
‫سجالت مطابقة المنتج مع المعيار‬ ‫■‬
‫سجالت المخرجات الغير مطابقة‬ ‫■‬
‫سجالت نتائج المراقبة والمتابعة‬ ‫■‬
‫سجالت برنامج التدقيق الداخلي‬ ‫■‬
‫سجالت نتائج التدقيق الداخلي‬ ‫■‬
‫سجالت نتائج مراجعة االدارة‬ ‫■‬
‫سجالت نتائج االفعال التصحيحية‬ ‫■‬
‫المعلومات الغير ملزمة من المواصفة ايزو ‪9001:2015‬‬
‫لكن ضرورية للتطبيق‬

‫■ اجراء تحديد السياق المؤسسي والجهات المهتمة‬

‫■ اجراء تعريف المخاطر والفرص‪V‬‬
‫■ اجراء الكفاءة والتدريب والوعي‬
‫■ اجراء صيانة وقياس االجهزة‬
‫■ اجراء ضبط الوثائق والسجالت‬
‫■ اجراء المبيعات‬
‫■ اجراء تخطيط وضبط عمليات التشغيل‬
‫■ اجراء المخازن‬
‫■ اجراء ادارة عدم المطابقة واالفعال التصحيحية‬
‫■ اجراء قياس رضا الزبون‬
‫■ اجراء التدقيق الداخلي‬
‫■ اجراء مراجعة االدارة‬
OPERATION
Clause 8
Clause 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 service provision
■ 8.5 Production and service provision
■ 8.5.1 Control of production and service provision
■ 8.5.2 Identification and traceability
■ 8.5.3 Property belonging to customers or external providers
■ 8.5.4 Preservation
■ 8.5.5 Post-delivery activities
■ 8.5.6 Control of changes
■ 8.6 Release of products and services
■ 8.7 Control of nonconforming outputs
Operational planning and 8.1
control
■ The organization shall plan, implement and control the processes,
(4.4), needed to meet requirements for the provision of products and
services and to implement the actions determined in 6.1, by::
■ a) determining requirements for the product and services;
■ b) establishing criteria for
■ 1. the processes
■ 2. and for the acceptance of products and services;
■ c) determining the resources needed to achieve conformity to product
and service requirements;
Operational planning and 8.1
control
■ d) implementing control of the processes in accordance with the
criteria;
■ e) determining and keeping documented information to the
extent necessary
■ 1. to have confidence that the processes have been carried out as
planned;
■ 2. and to demonstrate conformity of products and services to
requirements.
■ Note: Keeping implied both the maintaining and retaining of
documented information.
Operational planning and 8.1
control
■ The output of this shall be suitable for the organization's
operations.
■ The organization shall control planned changes and review the
consequences of unintended changes, taking action to mitigate
any adverse effects, as necessary.
■ The organization shall ensure that outsourced processes are
controlled in accordance with 8.4.
‫طبق مفهوم ضبط والتخطيط على العمليات في‬
‫مؤسستك‬
 Determination of requirements for products and 8.2
services
:8.2.1 Customer communication
■ communication with customer shall include:
■ a) providing information relating to products and services;
■ b) handling enquiries, contracts or order handling, including changes;
■ c) obtaining customer views and perceptions, including customer
complaints;
■ d) handling or treatment of customer property, if applicable;
■ e) establishing specific requirements for contingency actions, when
relevant.
Determination of requirements 8.2.2
for products and services
■ The organization shall ensure that:
■ a) the requirements for the product and service are defined,
including:
■ 1. any applicable statutory and regulatory requirements,
■ 2. Those considered necessary by the organization;
■ b) the organization can meet the claims for the products and
services it offers
‫الضبط والتخطيط للعمليات‬ ‫الموارد‬

‫نوع الضبط‬

‫متطلبات المنتج‬
‫المعيار او المواصفة‬
‫نوع العملية‬

‫نتائج التواصل مع الزبون‬

‫تحديد متطلبات المنتج‬
‫المتطلبات التشريعية‬
‫والقانونية‬
Review of requirements 8.2.3
:related to products and services
■ 8.2.3.1. The organization shall ensure that it has the ability to
meet the requirements for products and services to be offered to
customers.
■ The organization shall conduct a review before committing to
supply products and services to a customer to include:
■ a) requirements specified by the customer, including the
requirements for delivery and post-delivery activities;
■ b) requirements not stated by the customer, but necessary for the
customers' specified or intended use, when known;
 8.2.3 Review of requirements
related to products and services:
■ c) additional statutory and regulatory requirements applicable to the
products and services;
■ d) contract or order requirements differing from those previously
expressed.
■ The organization shall ensure contract or order requirements differing
from those previously defined are resolved.
■ The customer’s requirements shall be confirmed by the organization
acceptance, when the customer does not provide a documented statement
of their requirements.
Review of requirements 8.2.3
:related to products and services
■ Note: In some situations, such as internet sales, a formal review
is impractical for each order. Instead, the review can cover
relevant product information, such as catalogues or advertising
material
■ 8.2.3.2 The organization shall retain documented information for
the results of the review, any new requirement or changed
Changes to requirements 8.2.4
for products and services
■ The organization shall ensure that relevant documented
information is amended and that relevant personnel are made
aware of the changed requirements, when requirements for
products and services are changed
 Changes to
requirements for
Review of products and
requirements services

Determination
requirement of
products and
services

Customer
communication
DESIGN AND 8.3
DEVELOPMENT
OF PRODUCTS
AND SERVICES
Design and development of 8.3
products and services
■ 8.3.1 General
■ 8.3.2 Design and development planning
■ 8.3.3 Design and development inputs
■ 8.3.4 Design and development control
■ 8.3.5 Design and development output
■ 8.3.6 Design and development changes
Design and development of 8.3
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.
Design and development 8.3.2
planning
■ In determining the stages and controls for design and
development, 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) the required design and development verification and
validation;
■ d) the responsibilities and authorities involved in the design and
development process;
Design and development 8.3.2
planning
■ e) the internal and external resources needs for D&D
■ f) the need to control interfaces between individuals and parties
involved in the design and development process;
■ g) the need for involvement of customer and user;
■ h) the requirements for subsequent provision of products and
services;
■ i) the level of control expected for the design and development
process by customers and other relevant interested parties.
■ J) the necessary documented information to confirm that D&D
requirements have been met.
Design and development 8.3.3
Inputs
■ The organization shall determine the requirements essential for the specific type of
products and services being designed and developed, including:
■ a) functional and performance requirements;
■ b) information derived from previous similar design
■ c) statutory and regulatory requirements;
■ d) standards or codes of practice that the organization has committed to implement;
■ e) potential consequences of failure due to the nature of the products and services.
■ Inputs shall be adequate for design and development purposes, complete, and
unambiguous.
■ Conflicts among inputs shall be resolved.
■ The organization shall retain documented information of the design and
development inputs
Design and development 8.3.4
:controls
■ The organization shall apply control to the design and development
process to ensure that:
■ a) the results to be achieved are clearly defined;
■ b) reviews are conducted as planned;
■ c) verification activities are conducted to ensure that the design and
development outputs have met the input requirements;
■ d) validation activities are conducted to ensure that the resulting
products and services are capable of meeting the requirements for the
specified application or intended use.
■ e) any necessary actions are taken on problems determined during the
reviews, or verification and validation activities;
■ f) documented information of these activities isretained
Design and development 8.3.5
:outputs
■ The organization shall ensure that design and development outputs:
■ a) meet the input requirements for design and development;
■ b) are adequate for the subsequent processes for the provision of
products and services;
■ c) include of reference monitoring and measuring requirements, as
appropriate and acceptance criteria;
■ d) specify the characteristics of the products and services that ate
essential for their intended purpose and their safe and proper provision
■ The organization shall retain the documented information resulting
from the design and development process
Design and development 8.3.6
:changes
■ The organization shall identify ,review and control changes made to
design during or subsequent to the design and development of products
and services to ensure that no adverse impact on conformity to
requirements.
■ Documented information on
■ a) design and development changes
■ b) The results of reviews
■ c) The authorization of the changes
■ d) The actions taken to prevent adverse impacts shall be retained
CONTROL OF 8.4
EXTERNALLY
PROVIDED
PRODUCTS AND
SERVICES
Control of externally 8.4
provided products and services
■ 8.4.1 General: The organization shall ensure that externally provided
processes, products, and services conform to specified requirements.
■ The organization shall determine the controls to be applied to
externally provided processes, products and services when:
■ a) products and services are provided by external providers for
incorporation into the organization‘s own products and services;
■ b) products and services are provided directly to the customer(s) by
external providers on behalf of the organization
■ c) a process or part of a process is provided by an external provider as
a result of a decision by the organization to outsource a process or
function.
Control of externally 8.4
provided products and services
■ The organization shall determine and apply criteria for the
evaluation, selection, monitoring of performance and re-
evaluation of external providers based on their ability to provide
processes or products and services in accordance with specified
requirements.
■ Retain documented information of these activities and necessary
actions arising form the evaluations.
Type and extent of control of 8.4.2
:external provision
■ The organization shall:
■ a) ensure that externally provided processes remain within the control
of its QMS
■ b) define both the controls that it intends to apply to and external
provider and those it intends to apply to the resulting output:
■ c) take into consideration
■ 1. the potential impact of the externally provided processes, products
and services on the organization's ability to consistently meet customer
and applicable statutory and regulatory requirements;
■ 2. The effectiveness of the controls applied by the external providers
■ D)Determine the verification or other activities necessary to ensure the
externally provided processes, products and services meet
requirements
Information for external 8.4.3
:providers
■ The organization shall ensure the adequacy of specified requirements
prior to their communication to the external provider.
■ The organization shall communicate to external providers its
requirements:
■ a) the processes, products and services to be provided
■ b) approval of:
■ 1. products and services,
■ 2. methods, processes or equipment;
■ 3. The release of product and services
■ c) competence of personnel, including qualification
Information for external 8.4.3
:providers
■ d) their interactions with the organization's quality management
system;
■ e) the control and monitoring of the external provider's
performance to be applied by the organization;
■ f) verification activities that the organization, or its customer,
intends to perform at the external provider's premises.
 ‫الملخص‪:‬‬
‫• نوع المورد‬
‫• معيار االختيار‬
‫اختيار‬

‫• معيار ا‪V‬لضبط‬
‫• متابعة االداء‬
‫ضبط‬
‫• معيار ا‪V‬لتقييم‬
‫• فعالية ال‪V‬ضبط‬
‫تقييم‬ ‫• مطابقته للمتطلبات‬
‫اذكر انواع الموردين الخارجيين ونوع‬
‫الضبط المقترح‬
‫اقترح صيغة للعقود لمورد الخارجي‬
 ‫نوع المور‪V‬د‬
‫الموافقة على ‪ :‬المنتج او الخدمة ‪ /‬طريقة العمل او االجهزة ‪ /‬تسريح‬
‫المنتج او الخدمة‬

‫كفاءة الشخص المسؤول‬

‫التداخالت مع نظام ادارة الجودة‬

‫الضبط‬

‫التقييم‬
PRODUCTION 8.5
AND SERVICE
PROVISION
Control of production and 8.5.1
:service provision
■ The organization shall implement production and service provision
under controlled conditions.
■ Controlled conditions shall include, as applicable:
■ a) the availability of documented information that defines
■ 1. the characteristics of the products to be produced and services to be
provided or activities to be performed
■ 2. and the results to be achieved
■ b) the availability and use of suitable monitoring and measuring
resources;
■ c) monitoring and measurement activities at appropriate stages to
verify that criteria for control of processes and process outputs, and
acceptance criteria for products and services, have been met.
Control of production and 8.5.1
service provision
■ d) the use, of suitable infrastructure and process environment;
■ e) the appointment of competent persons, including any required
qualification;
■ f) the validation, and periodic revalidation, of the ability to achieve
planned results of any process for production and service provision
where the resulting output cannot be verified by subsequent monitoring
or Measurement;
■ g) the implementation of actions to prevent human error;
■ h) the implementation of release, delivery and post delivery activities.
Identification and 8.5.2
:traceability
■ organization shall use suitable means to identify process outputs when
it is necessary to ensure conformity of products and services,
■ The organization shall identify the status of process outputs with
respect to monitoring and measurement requirements throughout
production and service provision.
■ Where traceability is a requirement, the organization shall control the
unique identification of the process outputs, and retain any documented
information necessary to maintain traceability.
Property belonging to 8.5.3
:customers or external providers
■ The organization shall exercise care with property belonging to the
customer or external providers while it is under the organization's
control or being used by the organization.
■ The organization shall identify, verify, protect and safeguard the
customer's or external provider's property provided for use or
incorporation into the products and services.
■ When property of the customer or external provider is incorrectly used,
lost, damaged or otherwise found to be unsuitable for use, the
organization shall report this to the customer or external provider.
■ NOTE: Customer property can include material, components, tools and
equipment, customer premises, intellectual property and personal data.
:Preservation 8.5.4

■ The organization shall ensure preservation of process outputs during

production and service provision, to the extent necessary to maintain
conformity to requirements.
■ NOTE: Preservation can include identification, handling, packaging,
storage, transmission or transportation, and protection.
:Post-delivery activities 8.5.5
■ As applicable, the organization shall meet requirements for post-
delivery activities associated with the products and services.
■ In determining the extent of post-delivery activities that are
required, the organization shall consider:
■ a) statutory and regulatory requirements.
■ b) the risks associated with the products and services;
■ c) the nature, use and intended lifetime of the products and services;
■ d) customer requirements
■ e) customer feedback;
■ NOTE: Post-delivery activities can include actions under warranty
provisions, contractual obligations such as maintenance services,
and supplementary services such as recycling or final disposal
:Control of changes 8.5.6

■ The organization shall review and control unplanned changes

essential for production or service provision to the extent
necessary to ensure continuing conformity with specified
requirements.
■ The organization shall retain documented information describing
the results of the review of changes, the personnel authorizing
the change, and any necessary actions.
Release of products and 8.6
services
■ The organization shall implement the planned arrangements at
appropriate stages to verify that product and service requirements
have been met.
■ Evidence of conformity with the acceptance criteria shall be retained.
■ The release of products and services to the customer shall not proceed
until the planned arrangements for verification of conformity have
been satisfactorily completed, unless other wise approved by a
relevant authority and, as applicable, by the customer.
■ Documented information shall include
■ a) Evidence of conformity with the acceptance criteria
■ b) traceability to the person(s) authorizing the release
Control of nonconforming process 8.7
outputs, products and services

■ The organization shall ensure process outputs, products and

services that do not conform to requirements are identified and
controlled to prevent their unintended use or delivery.
■ The organization shall take appropriate corrective action based
on the nature of the nonconformity and its impact on the
conformity of products and services.
■ This applies also to nonconforming products and services
detected after delivery of the products or during the provision of
the service.
Control of nonconforming process 8.7
outputs, products and services

■ the organization shall deal with nonconforming process outputs,

products and services in one or more of the following ways:
■ a) correction;
■ b) segregation, containment, return or suspension of provision of
products and services;
■ c) informing the customer;
■ d) obtaining authorization for acceptance under concession.
■ Conformity to the requirements shall be verified when
nonconforming outputs are corrected
‫التخلص من عدم‬ ‫• االصالح اتخاذ االفعال التي تجعل المنتج مطابق جزئيا‬
‫• اعادة تصنيع اتخاذ االفعال لجعل المنتج مطابق للمواصفات‬
‫المطابقة‬ ‫• اعادة معالجة تحويل المنتج الى منتج اخر مطابق للمواصفات‬

‫التصريح بالقبول‬ ‫• هنا المنتج ما يزال غير مطابق للمواصفات لكن يوجد زبون غير ممانع‬
‫بالتعامل مع المنتج وقبوله وهنا االمتياز يمنح من المؤسسة للزبون‬
‫تحت االمتياز‬ ‫المعني‬
‫• االمتياز يتضمن ‪ :‬مستوى الجودة ‪ /‬كمية المنتج ‪ /‬الصالحية‬
‫(الموافقة)‬ ‫بالتصريح ‪ /‬التاريخ والزمن‬

‫• ‪ :Scrapping‬ا‪VV‬لتخلصمنا‪VV‬لمنتج‬
‫منع االستخدام‬ ‫• اعادة تدوير تحويل المنتج لجهة اخرى تعمل على اعادة تدوير المنتج الى‬
‫اشياء مفيدة‬
‫االصلي‬ ‫• اعادة تصنيف بمعنى ان المنتج االصلي غير مطابق لكن يمكن تصنيفه‬
‫ضمن اصناف اخرى مطابقة للمتطلبات‬
Control of nonconforming process 8.7
outputs, products and services

■ The organization shall retain documented information that

■ Describes the nonconformity
■ describes of actions taken
■ Describes any concessions obtained;
■ identification of person or authority that made the decision
regarding dealing with the nonconformity
PERFORMANCE
EVALUATION
CLAUSE 9
Performance evaluation 9

■ 9.1 Monitoring Measurement Analysis and Evaluation

■ 9.2 Internal Audit
■ 9.3 Management Review
General .9.1.1

■ The organization shall determine:

■ a) what needs to be monitored and measured;
■ b) the methods for monitoring, measurement, analysis and evaluation,
as applicable, to ensure valid results;
■ c) when the monitoring and measuring shall be performed;
■ d) when the results from monitoring and measurement shall be
analyzed and evaluated.
■ the organization shall retain appropriate documented information as
evidence of the results.
■ The organization shall evaluate the performance and the
■ effectiveness of the QMS
customer satisfaction .9.1.2

■ Monitoring customer perception

■ Obtain information relating to customer views and opinions
■ Information related to customer views can include customer
satisfaction or opinion surveys, customer data on delivered
products or services quality, market share analysis, compliments,
warranty claims and dealer reports
9.1.3 Analysis and evaluation
■ The organization shall analyze and evaluate appropriate data and
information arising from monitoring and measurement.
■ The result of analysis shall be used to evaluate:
A. Conformity of products and services to requirements
B. Customer satisfaction
C. Conformity and effectiveness of QMS
D. Planning has been successfully implemented
E. Processes performance
F. Performance of external provider(s)
G. Determine the need or opportunities for improvement of QMS
INTERNAL 9.2
AUDIT
Internal Audit 9.2
■ 9.2.1 The organization shall conduct internal audits at planned
intervals to provide information on whether the QMS:
■ a) conforms to:
■ 1. the organization’s own requirements for its QMS;
■ 2. the requirements of this International standard;
■ b) is effectively implemented and maintained
 Internal Audit 9.2
■ 9.2.2 The organization shall:
■ a) plan, establish, implement and maintain an audit programme(s),
including the frequency, methods, responsibilities, planning requirements
and reporting. The audit programme(s) shall take into consideration the
importance of the processes concerned and the results of previous audits;
■ b) define the audit criteria and scope for each audit;
■ c) select auditors and conduct audits to ensure objectivity and the
impartiality of the audit process;
■ d) ensure that the results of the audits are reported to relevant
management; and
■ e) retain documented information as evidence of the implementation of the
audit programme and the audit results.
ISO 19001
 9.3
MANAGEMENT
REVIEW
Management review 9.3
■ 9.3.1 MRM at planned intervals taking into consideration:
■ a. Status of previous action
■ B. Changes in external and internal issues related ot QMS including
its strategic direction,
■ Information on QMS including:
■ Nonconformities and corrective actions
■ Monitoring and measurement results, Audit results
■ Customer Satisfaction, Issues concerning external providers and
other relevant interested parties
■ Resources required, processes performance and products conformity
Management review 9.3

■ 9.3.2 Outputs:
■ improvement of the effectiveness of the management system;
■ improvement related to interested party requirements;
■ resource needs to enable improvement to the management
system and its processes
 .10
IMPROVEMENT
Improvement .10

■ 10.1 Nonconformity and corrective actions

■ 10.2 Continual Improvement
Nonconformity and 10.1
corrective actions
■ The organization shall determine and select opportunities for
improvement and implement necessary action to meet customer
requirements and enhance customer satisfaction.
■ This shall include, as appropriate:
■ Improving processes to prevent nonconformities
■ Improving products and services
■ Improving QMS
 Nonconformity and 10.2
corrective action
■ 10.2.1. When a nonconformity occurs, the organization shall:
■ a) react to the nonconformity, and as applicable;
1. take action to control and correct it; and
2. deal with the consequences.
■ b) evaluate the need for action to eliminate the causes of the nonconformity, in
order that it does not recur or occur elsewhere, by:
1. reviewing the nonconformity;
2. determining the causes of the nonconformity; and
3. determining if similar nonconformities exist, or could potentially occur
■ c) implement any action needed;
■ d) review the effectiveness of any corrective actions taken
■ e) make changes to the IMS, if necessary
■ Corrective action shall be appropriate to the effect of nonconformities encountered.
Continual improvement 10.3

■ The organization shall continually improve the suitability,

adequacy and effectiveness of the management system.