Awareness on

Contents

1. Terminology

2. Overview of ISO 9001:2015

3. ISO 9001 structure

4. ISO 9001 Certification

5. Implementation steps
Terminology

QUALITY
 Degree to which a set of inherent characteristics fulfils requirements.

Other
 Fitness
to purpose
 Conformance to specification or requirement.

QUALITY CONTROL
Terminology

Quality management
o Coordinated activities to direct and control
an organization with regard to quality.
Quality management system
o Management system to direct and control
an organization with regard to quality.
7 principles of ISO 9001:2015
SN Principles Approach
1 Principle 1 Should understand current and future
Customer needs, meet customer
Customer Focus requirements Strive to exceed customer
expectations
2 Principle 2 Establish unity of purpose and engage
people in achieving quality objectives
Leadership
3 Principle 3 People at all level are the essence of an
Engagement of organization
People Focus on competency empowered and
engaged people in delivering value.
4 Principle 4 Result is achieved more efficiently when
Process Approach interrelated resources and activities are
managed as a process.
systematically identify and manage the
process employed.
 7 principles of ISO 9001:2015
SN Principles Approach
5 Principle 5 Should be a permanent objective of the
Improvement organization.
To maintain current performance and to
create new opportunities
6 Principle 6 Effective decisions are based no facts,
Evidence Based evidences and analysis of data.
Decision Making
7 Principle 7 An organization and its interested
Relationship parties are interdependent and a
Management
mutually beneficial relationship
enhances the ability of both to optimize
performance
Schematic representation of Process
Benefits of Implementing Quality management System

Internal Benefits

Improved management confidence

Improved awareness of company objectives

Improved communications

Responsibilities and authorities are adequately defined

Improved traceability to root causes of quality

problems
Improved utilization of resources

Fewer rejects, therefore less repeated work and

warranty costs

Errors rectified at the earliest stage, and not repeated

Continual improvements

Increased productivity

Increased profits and company growth

External benefits
Easyaccess to international market through
demonstration of competence and improving
competiveness

Improved customer satisfaction

Consistency in quality of products and services

Customer confidence ( reduces the amount of

inspection)

Improve company image

ABOUT ISO

ISO 9001:2015,Quality management

System- Requirements /Clauses/

1. SCOPE
2. NORMATIVE REFERENCES
3. TERMS AND DEFINITIONS
4.1. understanding the organ and its context
understanding the external context (issues related
to legal, technological, competitive, market,
culture, social and economic environments).
understanding the internal context (issues related
to values, culture, knowledge and performance of
the organ.)
In general:-
 Monitoring
 Evaluation
 Review
 Validation
 verification
4.2. understanding the needs and expectations of interested parties
Customer requirement:-
 Price
 Quality
 Delivery/time/

4.3. determining the scope of the quality management system

 The scope of the organ quality management system shall be
available and maintain as documented information.
4.4. Quality management system and its process
Generally
 Determine the inputs required and out puts expected from these
process.
 Determine the sequence and interaction of these process.

Process:-set of interrelated or interacting activities w/c transform

inputs into out puts.
Process approach:-the systematic identification and management of
the process employed with in an organization basic tools of QMS.
5. Leadership
5.1. leaders commitment
-Top management commitment with respect to QMS by:-
 Accountability /committed/
 QMS establish/quality policy, quality objective/
 Communicated ,under stood and applied
 Ensuring that the integration of the systems requirements
 Process approach, risk based thinking
 Ensuring
 Engaging, directing and supporting
 promoting
- Top management commitment with respect to customer
focus.
5.2. policy
Top management must establish, implement and maintain
Quality policy and also communicating it.

5.3. Organization roles ,responsibilities and

authorities
 Top management must ensure that the responsibilities
and authorities for relevant roles are assigned,
communicated and understood with the Organization.
6. Planning

6. 1. Actions to address risks and opportunities

 When planning for the QMS the organ shall consider:-
External context (issues related to legal, technological, competitive,
market, culture, social and economic environments).
Internal context (issues related to values, culture, knowledge and
performance of the organ.)
Needs and expectations of interested parties
Risk and opportunities .
How to:
 Determine the inputs required and out puts expected from these
process.
 Integrate and implement the actions in to its QMS process.
 Determine the sequence and interaction of these process
 Evaluate the effectiveness of these actions.
6.2. Quality objectives and planning to achieve them
 The organ establish the quality objective at relevant function, levels and process needed
for the QMS.
SMART(Sustainable, Measurable, achievable Reliable, Time bounded)
 When planning how to achieve its Quality objective ,by determine:-
o What will be done
o What resources will be required
-People( Education, training, Experience)
-Infrastructure (building ,utilities)
-Environment(Physical, social, psychological)
o Who will be responsible
o When it will be completed
o How the results will be evaluated

6.3. planning of change

When the organ determines the need for changes to the quality management
system , the change shall be carried out in planned manner.
-The propose of changes
-The integrity of the Qms
-The availability of resource
 o
B7. 2 Competence

A7.1 Resources C7. 3 Awareness

E D7. 4 Communication
7.1 Resources
The organization shall determine and provide the resources
needed for the establishment, implementation, maintenance
and continual improvement of the QMS.
-People (determine and provide)
-Infrastructure (determine, provide and maintain)
-Environment for the operation of process
(Human and Physical factors)
-Monitoring and measuring resources
-Measurement traceability
-Organizational Knowledge(determine and maintain)
It is knowledge specific to the organization; it is generally
gained by experience
It may be internal or external sources.
7. 2 Competence
The organization shall
-Determine the necessary competence of persons
-Ensure persons are competent(Education, training
and Experience)
-Take actions to acquire the necessary competence
 provision of training
Mentoring
Re-assignment
Hiring or contracting of competent persons
-Retain appropriate Documented Information as
Evidence.
7. 3 Awareness
The organization shall ensure the persons doing
work are aware of:
a) The quality policy
b) Relevant quality objectives
c) Their contribution to the effectiveness of the
QMS
d) The implication of not conforming to the QMS
7. 4 Communication
The organization shall determine the internal and
external communications relevant to QMS:

a) On what it will communicate

b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who to communicate
7. 5 Communication
The organization shall determine the internal and
external communications relevant to QMS:

a) On what it will communicate

b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who to communicate
QMS:
a) DI required by the standard
b) DI determined by the organization as
being necessary for the eff. of system
When creating and updating ensure:
a) Identification and description
b) Format and media
c) Review and approval for suitability and
adequacy
DI shall controlled:
a) Available and suitable for use
Where and when it is needed
b) Adequately protected
Loss of confidentiality, improper use
For control of DI the org shall
address :
a) Distribution, access, retrieval and
use
b) storage and preservation
c) Control of changes
d) Retention and disposition
A
9.1 Monitoring, measurem
ent, analysis and evaluatio
n

B
9.2 Internal A
udit

C
9.3 Managem
ent Review
9.1 Monitoring, measurement, analysis and evaluation

Determine:
what needs to be monitored and measured
methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results
when the monitoring and measuring shall be
performed
when the results from monitoring and measurement
shall be analyzed and evaluated.
Retain appropriate documented information.
Evaluate the quality performance and the effectiveness of
the QMS
9.2 Internal Audit

The organization shall conduct internal audit at planned

intervals to provide information on whether the QMS:

a) conforms to:
I. The organization’s own requirements for its
QMS
II. The requirements of ISO 9001:2015 QMS
b) Is effectively implanted and maintained
9.3 Management Review

9.3.1 General
Top management shall review the org.’s QMS, at
planned intervals to ensure its continuing
suitability,
adequacy,
effectiveness
and alignment with the strategic direction of the
org.
9.3 Management Review

9.3.2 Management Review Inputs

Top management review shall be planned and carried out
taking into considerations:
a) the status of actions from previous Mgt. review
b) changes in internal and external issues that are
relevant to the QMS
c) Information's on the performance and effectiveness
of QMS
d) The adequacy of resources
e) The effectiveness of actions taken to address risks
and opportunities
f) Opportunities for improvements
 9.3 Management Review

9.3.3 Management review outputs

The outputs of the mgt review shall include decisions and
actions related to:
a) Opportunities for improvement
b) Any need for changes to the QMS
c) Resource needs
-people
-Information
-Environment

Shall retain documented information as evidence of the results

of the Mgt. Review
Benefits of Implementing Quality management System

Internal Benefits

Improved management confidence

Improved awareness of company objectives

Improved communications

Responsibilities and authorities are adequately defined

Improved traceability to root causes of quality problems

Improved utilization of resources

Fewer rejects, therefore less repeated work and warranty

costs

Errors rectified at the earliest stage, and not repeated

Continual improvements

Increased productivity

Increased profits and company growth

 External benefits
Easyaccess to international market through
demonstration of competence and improving
competiveness

Improved customer satisfaction

Consistency in quality of products and services

Customer confidence ( reduces the amount of

inspection)

Improve company image

 STEPS FOR EFFECTIVE
IMPLEMENTATION OF QMS

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Step 1: Top management commitment
Top management has to agree:
 

• the need for implementing the QMS;

• to lead the project;
• practices will have to change;
• to provide resources;
• to give the project top priority; and
• it will do what it says.
 Steps for effective implementation of QMS

Step 1: Top management commitment

Top management commitment is evident by:
 
• Doing what you say you will do;
• Not accepting sub-standard work;
• Not walking by problems;
• Honoring plans and documents;
• Listening to workforce;
• Establishing effective ways of communication;

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የግል ግቦችና ዓላማዎችን ለጋራ መርህና እሴት፣ ለጋር
የሩቅ ግብና ርእይ ተገዝተውና ተናበው
 Steps for effective implementation of QMS

Step 2: Assigning management representative

•Co-ordinate and work with other management

functions;
•Conduct quality audit and report on the
performance of the quality system
•Co-ordinate quality improvement programs;
•Plan and initiate management reviews;
•Initiate corrective and preventive actions.

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 Steps for effective implementation of QMS

Step 3: Creating a task force/implementation team

 The task force should include people from key

functional areas and of manageable size

 The responsibilities of the task force include:

 
• Prepare quality management system implementation plan in their areas
of responsibilities;

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 Steps for effective implementation of QMS

Step 3: Creating a task force/implementation team

• Co-ordinate the creation of QMS documents and their
implementation;
• Co-ordinate the revision of the existing QMS documents;
• Distribute the QMS documents to the locations where they are
needed for implementation;
• Give information, training and guidance to the employees on the
documented QMS system; and
• Initiate appropriate corrective actions.

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Steps for effective implementation of QMS

Step 4: Training the task force

 Train the task force on:

• Basic concepts of quality management system,
• Quality management system requirements,
• Quality management system documentation,
• Process mapping,
• Implementation, and
• Internal quality audit

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 Steps for effective implementation of QMS

Step 5: Conducting gap-analysis

 Compare the current management practices to the requirements of ISO

9001:2008 QMS to identify the gaps.

 Identify which requirements of clause 7 of the standard may not be

applicable to your processes to be considered for exclusion.

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 Steps for effective implementation of QMS

Step 6: Defining map of processes

 Determine the processes that make up the quality management system,

including,
• product realization,
• resource provision,
• management, and
• monitoring and measurement processes
 determine their sequence and interaction

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 Steps for effective implementation of QMS

Step 7: Develop QMS implementation plan

 Based on your business processes and the findings of the gap analysis,
develop detail implementation plan, including,
•who does what,
•the time frame, and
•the needed material resources.

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 Steps for effective implementation of QMS

Step 8: Quality management system documentation

 
 The QMS documentation should address all the
documentation requirements of the standard
(Clause 4.2.1)

 State:
·  Who is responsible for performing and checking
activities,
 ·  What happens, i.e. how the activity is
performed,
·     Where the activity takes place, and
·     When it will happen.

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 Steps for effective implementation of QMS

Step 8: Quality management system documentation

 

 Your Quality Manual should provide a road map to your QMS

 It should include:
• The scope of the QMS,
• The documented procedures established for the
QMS, or reference to them, and
• A description of the interaction between the
processes of the QMS.

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 Steps for effective implementation of QMS

Step 9: Put the QMS into operation  

 
 To put the quality management system into
operation:

• Everybody needs to have access to the

documentation that relates to their activities

• Everybody needs to be trained to understand

how to use the documents and keep the
QMS up‑to‑date

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Steps for effective implementation of QMS

Step 10: Conduct internal quality audit

 
 Conduct the audit to assess the status and
effectiveness of the implemented quality
management system

Step 11: Conduct management review

 
 Conduct management review to ensure the
suitability and continuity of the quality
management system

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 Steps for effective implementation of QMS

Step 12: Implement corrective actions

 
 Take the corrective action to eliminate the
identified nonconformities and introduce
improvements.
 The activity includes, 
·   Identifying the root causes of the non-
conformities,
·        Plan date of realization,
·        Take the corrective action, and
· Monitor the effectiveness of the corrective
actions taken.

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 THE END

QUALITY IS NEVER ACHIEVED BY ACCIDENT…

MANAGE IT!

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