The document provides an overview of ISO 9001:2008 quality management standards. It discusses key aspects of a quality management system including quality assurance, quality control, planning to prevent defects, inspection and measurement techniques, customer satisfaction, and continual improvement. It also covers topics like managing documents and records, handling non-conforming products, internal audits, and defining the scope of registration.

1. ISO 9001:2008
QUALITY
MANAGEMENT
SYSTEM
PRESENTED BY:
Wendy Stein, International Contract
Compliance Auditor

2. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
QUALITY – Degree to which a set of inherent
characteristics fulfils requirements*
– *ANSI/ISO/ASQ Q9000-2008
Level to which the existing quality system satisfies our customer’s
requirements
The ability of a product or service to meet or exceed customer
expectations
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3. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
QUALITY ASSURANCE – The part of Quality Management that focuses
on providing confidence that quality requirements will be fulfilled
QUALITY CONTROL – The part of Quality Management that focuses on
fulfilling quality requirements*
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4. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 PROACTIVE – PLANNING  PROVIDES FOR INSPECTION
& MEASUREMENT
 PREVENTATIVE IN NATURE
WHERE DEFECTS AND/OR  AIMED AT DETECTING
DEFICIENCIES ARE DEFECTS
CONCERNED
 IS A MEASURE OF THE
 PROVIDES FOR SUCCESS OF QUALITY
CUSTOMER SATISFACTION ASSURANCE (QA)
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5. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 Ensure YOUR Work is Accurate
 Verify the Work of Your Co-Workers – ASK SOMEONE TO CHECK
YOUR WORK TOO!
 Do Not Accept Deviations from ESTABLISHED Written Procedures
Without Communication – AND APPROVAL
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6. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
The standards originated in manufacturing process
Now they are employed across several types of
organizations
A quot;productquot;, in ISO vocabulary, can mean a physical
object, OR a service
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7. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
ISO – INTERNATIONAL STANDARDIZATION ORGANIZATION
9001-2008 - The latest revision to the Quality Management System
Standard
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8. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
A SYSTEMATIC approach to QM which emphasizes
the importance of:
Identification of Requirements, Understanding them and Meeting
Our Goals
The Need to Consider Processes in Terms of “IS THIS VALUE
ADDED?”
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9. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
Obtaining the Results of Process Performance & Effectiveness
and Analyzing Your Findings (ROOT CAUSE)
Continual Improvement of Processes Based on Objective
Measurement & Evidence
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10. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
QUALITY MANUAL – Written, Endorsed and Driven by the Management
of SOC Minden that will state how we will achieve our business and quality
goals & objectives.
Quality Management IS NOT SEPARATE FROM General Management –
Quality Management SHOULD be an integral part of our organizations
overall management approach
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11. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
SOC team members are committed to achieving and maintaining Total
Customer Satisfaction by supplying the highest quality services, while
maintaining commitment to our core values.
Our success as an enterprise is a direct reflection of the promises we
keep to our customers and their respect for SOC. We must first keep our
promises to one another and demonstrate mutual respect to fellow team
members, supply partners, and our customers.
We willingly accept the responsibility of leadership to achieve our quality
goals, which will be reached through innovation, education, teamwork,
and the desire for continuous improvement.
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12. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 CONTROL OF DOCUMENTS
 Controlling Documents ensures we utilize only current business
practices and/or customer requirements
 Includes both internally produced and externally obtained
documents
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13. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 CONTROL OF RECORDS
 Ensure Current Forms are Used
 Ensure the SAME Forms is Used
 Completed Forms become Records and are Retained to Provide
Objective Evidence to the Customer – We are in fact doing what
we say we are doing
 Provides for objective evidence to ensure conformance to the
standard
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14. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 CONTROL OF RECORDS
FORM
NUMBER TITLE OWNER
E-1 Letter of Authorization Operations
E-2 Travel Profile Human Resources
E-3 Expense Reimbursement Request Financial Management
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15. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 A Document will change and evolve to reflect our current business
practices
 A Record does not change and is a history of our past business
practices
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16. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 Both can and should be used to perform documented quality and
performance trends
 Compare our data to competitors’’ data and/or quality benchmarks
 Both can be used to solve customer related problems & issues
 Both support status reviews, decision making and long term planning
initiatives
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17. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 CONTROL OF NON-CONFORMING PRODUCT/SERVICE – How do
we react and intervene when our process doesn’t meet our own
requirements or the requirements of the customer
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18. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 INTERNAL AUDITING & SELF ASSESSMENT – Looking into the way
we conduct business from the inside, analyzing our processes to
ensure we are doing things
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19. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 Ask Yourself & Others – “WHAT CAN GO WRONG?”
 Then Write Your Process Plan (PROCEDURES)
Accordingly
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20. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
1. IDENTIFY YOUR PROCESSES
2. INVOLVE ALL OF THE STAKEHOLDERS IN DEVELOPMENT
3. DOCUMENT YOUR PROCESSES
4. LISTEN TO YOUR CUSTOMERS AND IMPLEMENT
CORRECTIVE &/OR PREVENTATIVE MEASURES
ACCORDINGLY
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21. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
INTERMEDIATE RESULT
CAUSE • Error Detection Corrective
Machine
Work • Deviation from Action
or
Procedure Established Implementation
Human Error
Procedures END RESULT
ZERO
DEFECT
MODIFY/CHANGE PROCEDURES ANALYZE ACTION FOR
FOR PREVENTATIVE ACTION EFFECTIVENESS
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22. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 The design is too complex – too many parts (KISS METHOD)
 The design is inadequate – Not enough direction in the written
standards
 The process does not flow logically
 Too much repetition and/or too many adjustments
 Critical mission essential information is left out
 YOU do not know ENOUGH about the process in and of it’s self for a
process you are attempting to document – call in the SME!!
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23. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
 Question the Individuals involved in performing the actual work - then
document the process accordingly
 Keep in mind adjustments may need to be made to ensure compliance
to customer/client requirements – BUT BE FLEXIBLE & CREATIVE in
your problem solving – BUT BE SURE TO INCLUDE ALL OF THE
PLAYERS.
Cause Result
ERROR DEFECT
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24. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
Prevention of
Defects Benchmark Pride, Confidence
Performance and Personal
Customer Standards Satisfaction
Satisfaction
Global Procedural and
Enhanced Customer Recognition Regulatory
Process Confidence Compliance
Reliability
Process Productivity
Reduction in Ownership Process
Wasted Effort Consistency
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25. QUALITY MANAGEMENT SYSTEM ORIENTATION &
AWARENESS (QMS)
WHAT IS THE SCOPE OF REGISTRATION?
• The Scope of Our Registration – Tells Our
Customers Exactly What We are
Good, GREAT at doing
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