QSM Associates, Qualit y Management Series, Rev . 3.0, All Auditing & Certification of Auditing & Certification of Quality Management System Quality Management System
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QSM Associates, QualityManagement Series, Rev. 3.0, All
Auditing & Certification of Auditing & Certification of
Quality Management SystemQuality Management System
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Contents
Review of Existing System
ISO 9001 Team Building
Development of System According to ISO 9001:2008
Considerations for Inspection, Maintenance & Refinery
Operations
Implementation of New System
Auditing
Certification
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Review of Existing System
Identify All Processes
Determine Interaction and overall flow
Determine Input & Output of Processeseach process
Map Detail Flow of Each Activity
Analyze Gap Between Existing System &
Requirements
Develop Checklist
based on ISO 9001
Standard
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ISO 9001:2008 Team Building
Determine Organization Chart
Identify Unit Head
Form Steering Committee
Steering Committee Lead by
Senior Management
Identify Clause Related to Each Unit
Identify Assistants
Regular Meetings &
Decision Making
Appoint ManagementRepresentative
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ISO 9001:2008 Team Building
Tips for Team Building
Have a mission statement
Odd number of members
Determine norms and behavior
Requirement for contribution from each member
Make it a point to meet all deadlines
Trust all members
Empowerment to all members
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Develop System According to ISO 9001:2008
Development,
Gap Analysis
Training
Concepts
Training
Auditors
Internal
Audit
Second
Audit
Manual
Procedures
Instructions
Correction
Correction
Management
Review
CERTIFICATION
Yes
No
Re-do
Yes No
Re-do
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Considerations for Inspection, Maintenance &
Refinery Operations
Quality Management System
Determine inputs and outputs
Determine interaction and flow process
Identified relevant industrial standards, codes, regulations, work
instructions, inspection methods, legal and regulatory requirementsetc.
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Considerations for Inspection, Maintenance &
Refinery Operations
Management Responsibility
Determine objectives including those for each relevant functions
Identify who are the customers and how to determine their perception
and needs
Determine what are the key criteria for success like timeliness, good
reports
Determine method for communications like memo, tool box briefing
to promote requirements, results of performance, problems etc.
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Considerations for Inspection, Maintenance &
Refinery Operations
Resource Management
Determine based on industrial problems, new findings, requirements
what type of equipment and new system needs to be in place.
Training in terms of knowledge, skills and attributes of each
individual positions and job functions.
How to verify competence of staff.
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Considerations for Inspection, Maintenance &
Refinery Operations
Product Realization
Planning for operations, inspection and maintenance
Methods of operations and work requirements
Method of inspection, frequency and meaningful recording
Recording and review of variations in inspection results and data.
Verification of subcontractors personnel, skills and knowledge.
Verification of subcontractors products.
Data, precautions, warning signs, hazards and risk in operations,inspection and maintenance.
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Considerations for Inspection, Maintenance &
Refinery Operations
Measurement, Analysis & Improvement
Data to collect, particularly in reporting of incidents, accidents,
breakdown, damages, changing of parts, etc.
Data on all key functions efficiency
Proper and adequate recording of results
Speed and effectiveness of detection and actions taken for non-
compliance.
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Implementation of New System
The following steps should be considered:
Briefing to all staff on the importance of ISO 9001 and its success
Memorandum by Top Management on the importance of ISO 9001
and its success
Checking and reporting on implementation progress by unit head
Review of progress by Top Management every month
Implementation to take place by part and not as whole, and
immediately after each system activity is approved
Feedback system to be created and opinions sought for all
recommended system activities.
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Auditing
Quality Audit
² A systematic and independent examination to determine
whether quality activities and related results comply with
planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
² Audits can be done by trained personnel in an organization, or by
hired or professional auditors
Observation
² A statement of fact made during an audit and substantiated by
objective evidence
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Auditing
Objective Evidence
² Qualitative or quantitative information, records or statements of
fact pertaining to quality of an item or service or to the existing
quality system element, which is based on observation,
measurement or test which can be verified .
Nonconformity
² The non-fulfillment of specified requirements
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Auditing
Two Basic Audits to be Conducted:
The Ad eq uacy Audit
Also known as syst e m or manage me nt audit and is a d e sktop
e xe rcise
De t e rmine s t he e xt e nt of conformance of t he docume nt e d
q uality syst e m to its applicabl e standard.
Me t h od includ e :
R e vi e w t he standard clause by clause and d e t e rmine if t he y are
addre sse d in t he q uality syst e m docume ntation
R e vi e w t he docume ntation and find t he applicabl e clause in t he
standard
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Auditing
A Compliance Audit
To asse ss the e xt en t of impl emen tation & m ai n t en a nce of the
doc u men t e d quality syst em
Basi c s of this audit :
Checking on all defined records
Checking on implementation and understanding
Checking on effectiveness of system
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Auditing
An quality audit consist of the following steps :
Initiating An Audit
Informa tion and performance review
Review of manual and procedures (Adequacy)
Preparing & P lanning the Audit
Prepare audit plan and schedule
Determine resource requirements
Execution of the Audit (Compliance)
Auditing and preparing reports
Concluding the audit
F ollow-up on Corrective Actions
Ensure all nonconformities found are corrected
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Auditing
Non-Conformities found during audit are divided into two
categories :
´Ma jorµNon Conformities
O ther possible terms are ´Hold Pointsµ, ́ Serious Non-
Complianceµ, ́ Category 1µ
A complete break down or absence of a required element
MinorNon-Conformities
Can also be known as ´Category 2µ
An isolated f ailure to comply w ith requirement
A number of minor related non-conformities, may be jud ged b y theLead Assessor to constitute a ma jor non-conformity .
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Certification Process
Initial
Assessment
Bi-Annual
Surveillance
Reassessment
Award of Certificate
Application
Submit
Manual
Preliminary
Assessment