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Introduction
The Purpose of this Presentation is to
Provide an Overview of ISO 9001 and
What It Means to Everyone at Gunderlin
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ISO 9001
The Ultimate Goal of ISO 9001 is to Provide
CONSISTENT PROCESSES
Documented Systems Provide For
Consistency
RESPONSIBILITIES Defined
Periodic Internal & External Audits Ensure
Systems Are Working
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ISO 9001 Origin & Scope Of Application
International Organization for Standardization
TC 176 - Meets in Geneva, Switzerland
• TC = Technical Committee
Europe Wide
• Must Be Registered to Sell In Europe
Japan is Accepting
US Military Switching From MIL-Q-9858A
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ISO 9001 Sections
Section 4 - Quality Management System
Section 5 - Management Responsibility
Section 6 - Resource Management
Section 7 - Product Realization
Section 8 - Measurement, Analysis and
Improvement
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Responsibility
Quality In Hands
Of 'Operator' or
Artesian
Quality In Hands
Of Management
Industrialisation
1970's
Circle (or Cycle) Of Responsibility
1800's 1960's
1990's
1930's
Statistics
&
Data Analysis
Information Age
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Documentation Organization
Tier 1
Tier (Level) 2
Tier (Level) 3
Tier (Level) 4
Tier (Level) 5
Systems
Manual
Policies and General
Operating Procedures
Inter-Departmental Procedures
Product and Process Documents
Forms and Tags
Objective Evidence Records
Ad Hoc (Temporary) Documents
(including any associated records)
Defines Approach
Through Policies
(We will... or We do…)
Defines Who, What and When Things
Happen
(These describe Tier 3 Sub-Systems)
Answers How Things Happen - The
Individual Steps
(These describe Tier 4 Documents (Records)
The Results of Tier 3
Systems/Procedures - Evidence of
Occurrence such as Inspection and
Test Results
These Are Typically
Investigative Documents
and Records
Situation Specific
Procedure Specific
Department and/or
Location Specific
Applies to the Entire Company
Major Systems - Typically Apply to
the Entire Company
The 'Standard' Document Pyramid
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Documentation
Organization Charts
Procedures
• Flow Charts
• Process Sheets
• Process Routers
• Work Instructions
Forms
Tags
Prints
Specifications
SPC Data
Inspection & Test Results
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Myths vs. Truths
ISO 9001 Is NOT An Effort To CHANGE
The Way You Do Things Now!
Documentation Is Meant To Be Easily
Changed!
The Less Documentation, The Better.
Think On The Job (OTJ) training.
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Basic Rules
Your Job & Documentation
• SAY What You Do
Documentation
• DO What You Say You Do
Actions
If It’s Not WRITTEN Down, It DIDN’T
Happen
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Real Life
What ISO 9001 Means To You
You MUST:
• Know Your Job Duties
• Know What Training Your Job Requires
• Be Able To Tell About How You Were Trained
• Know What Documentation Involves YOU!
• Know How To Find Out What The ‘Latest’ Version Is
• Know What The Documentation Says
• Know How The Documentation Applies To YOU!
• Know What The INTENT of the Documentation
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Quality Policy
You MUST Know What
The Gunderlin Quality Policy Is
And
You WILL Be Asked What The Quality
Policy Means To YOU!
You do NOT have to memorize it word for
word!
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Things To Be Alert For
Container / Job Labeling
Documents - Watch for “Headers”
• Title
• Date
• Originating Department or Group
