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PART - I
DEFINITIONS
(ISO 9001:2008)
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DEFINITIONS
QUALITY:
Degree to which a set of inherent/inborn/natural
characteristics fulfills requirements
CUSTOMER SATISFACTION:
Customers perception of the degree to which the
customers requirements have been fulfilled
QUALITY MANAGEMENT SYSTEM:
Management system to direct and control an
organization with regard to quality
QUALITY POLICY:
Overall intentions and direction of an organization
related to quality as formally expressed by top
management
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DEFINITIONS (cont.)
QUALITY OBJECTIVE:
Something sought, or aimed for, related to quality
QUALITY MANAGEMENT:
Coordinated activities to direct and control an
organization with regard to quality
QUALITY CONTROL:
Part of quality management focused on fulfilling quality
requirements
QUALITY ASSURANCE:
Part of quality management focused on providing confidence
that quality requirements will be fulfilled
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DEFINITIONS (cont.)
CONTINUAL IMPROVEMENT:
Recurring activity to increase the ability to fulfill
requirements
EFFECTIVENESS:
Extent to which planned activities are realized and planned
results achieved
EFFECIENCY:
Relationship between result achieved and the resources
used
ORGANIZATION:
Group of people and facilities with an arrangement of
responsibilities, authorities and relationships
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DEFINITIONS (cont.)
ORGANIZATIONAL STRUCTURE:
Arrangement of responsibilities, authorities and
relationships between people
INFRASTRUCTURE:
Set of facilities, equipment and services needed for the
operation of an organization
WORK ENVIRONMENT:
Set of conditions under which work is performed
PROCESS:
Set of interrelated or interacting activities which
transforms inputs into outputs
PRODUCT:
Result Of A Process
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Audit Definition
Types of Audit
Phases of Audit
DEFINITION OF AUDIT:
A systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to
determine the extent to which agreed criteria are
fulfilled.
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PHASES OF AN AUDIT
Planning
Preparation
Performance
Reporting and Follow-up
(These apply to FPA,SPA and TPA)
Remember!
Proper Planning and Preparation Prevent Poor Performance
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Frequency/ Timing
Responsibility
Criteria
Scope
Duration
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Audit Planning
Day - 1
0900 - 1100
Production: QA Manager
1100 - 1300
1300 - 1400
Lunch Break
1400 - 1600
QA
1600 - 1700
Maintenance: Production
Manager
:Production Manager
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Documents, records
Physical evidence
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QUESTIONING TECHNIQUE
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QUESTIONING TECHNIQUE
Avoid Leading Questions such as:
I see that once your job is completed you file the record in
the depository, am I right?
This will only get a yes, no or nodded response.
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DO
be prepared
be punctual
insist on the person being questioned answer for
themselves
as little talking as possible
avoid misunderstanding
keep questions clear and to the point
be polite and calm
give compliments
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REMEMBER!
If there is no specified requirement, there can be no
noncompliance. What an auditor thinks should be done is
not a specified requirement.
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MINOR NC
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MINOR NC
Raised when a deficiency (or deficiencies) has been identified in a
procedure or work instruction or in the operation of the
organizations QMS, but which are less harsh than warrants a Major
NC.
The following action(s) shall be taken after a nonconformity is
identified:
Must be corrected and verified and closeout within
defined interval
The classification of NCs is based upon good judgement, expertise
and experience of the auditor.
However, The classification of noncompliance is not necessary for
Internal Audits
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READING
COMMUNICATION
INTERVIEWING
LISTENING
FIRST QUESTION
USE OF CHECKLIST
TAKE NOTES
SPOT CHECK DOCUMENTS
RECORDS SAMPLES
OBSERVATION
BODY LANGUAGE
QUESTIONING
SELECTING SAMPLE YOURSELF
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