ISO 9000 Overview

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ISO 9000 Overview
2
The Purpose of this Overview

• What is ISO 9000?
• What will it require from YOU, as a (Company)
  Employee?

3
Things You Should Know

• Corporate Objective
• How do you know how to do your job?
• What do you do if you find a defect?
• Are there written instructions for your job?

4
What is ISO?

• International Organization for Standardization

5
Development of Quality Standards

• Prior to WWII, Quality Standards were driven by
  the Military
• Britain used the BS Standards
• United States used the MIL Standards

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Development of Quality Standards

• Europe- Government Driven BS-5750, EN 29000
• USA- Quality Driven Fords Q1 GMs
  Targets for Excellence

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ISO 9000 Quality Management Standard

• Adopted 1987 current version is 1994
• Practical collection of well recognized and
  universal business practices
• Applies to any type of facility
• Emphasizes the system a facility uses to assure
  quality

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ISO 9000 Quality Management Standard

• ISO 9000
• ISO 9001
• ISO 9002
• ISO 9003
• ISO 9004

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Elements of ISO 9002

• 4.1 Management Responsibility
• 4.2 Quality System
• 4.3 Contract Review
• 4.4 Design Control
• 4.5 Document and Data Control
• 4.6 Purchasing
• 4.7 Control of Customer Supplied Product

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Elements of ISO 9002

• 4.8 Product Identification and Traceability
• 4.9 Process Control
• 4.10 Inspection and Testing
• 4.11 Control of Inspection,Measuring, and Test
  Equipment
• 4.12 Inspection and Test Status
• 4.13 Control of Nonconforming Product
  

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Elements of ISO 9002

• 4.14 Corrective and Preventive Action
• 4.15 Handling, Storage, Packaging,
  Preservation, and Delivery
• 4.16 Control of Quality Records
• 4.17 Internal Quality Audits
• 4.18 Training
• 4.19 Servicing
• 4.20 Statistical Techniques

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3 Major Requirements for ISO 9000 Certification

• A standard system for documenting
  quality practices (i.e. a Quality Manual)
• A system to track that the quality practices are
  in place and effective (Audits)
• A third party (Registrar), whose function is to
  audit, certify and maintain certifications
  of organizations

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Types of ISO 9000 Audits

• Gap Analysis
• Self Certification Audit
• Registration Audit

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Self Certification Audit

• Perform Gap Analysis
• Action Plan Developed from Gap Analysis
• Action Plan Implemented
• Perform Internal Audit
• Corrective Action
• Perform Self Certification Audit

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Registration Audit

• Select Registrar
• Registrar performs Gap Analysis
• Action Plan developed from Gap Analysis
• Action Plan implemented
• Perform Internal Audit
• Corrective Action
• Registrar performs Registration Audit
• Registration complete or corrective action

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Audit Results

• Observation Statement of fact made during a
  quality audit and substantiated through
  objective evidence
• Conforming Meets the intent of the standard
• Nonconforming Non-fulfillment of a
  specified requirement

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Types of Nonconformities

• Major Nonconformity Absence of a
  required procedure or the total breakdown of a
  procedure
• Minor Nonconformity Single observed lapse in a
  procedure

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Registration Cycle

• Registration is valid for three years
• Surveillance Audits (Maintenance
  Audits) Mini Audit covers only a
  portion of the Registration
  Audit Required to be conducted
  at a minimum, annually

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Your Role During the Audit

• Know the Quality Policy- To produce the highest
  quality widget sold in North America
• When asked Who is responsible for Quality? the
  answer is- Everyone
• If asked How do you know how to do your job?
  the answer is- Through Training

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Know the Plants Management Representative(s)!

• They are the key contact for the ISO 9000
  program they are responsible for your plants
  Quality Manual they will notify your Area
  Manager of upcoming audits.

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Management Representatives

• Typically, each major area will have a
  representative

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ISO 9000Documentation Structure
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ISO 9000 is not ISO 14000

• Both standards written by the same
  organization ISO 9000 Quality Management
  Standard ISO 14000 Environmental
  Management Standard

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ISO 9000 Quick Definition

• Document what you do
• (Quality Manual)
• Do what you Document
  (Audits)
• Prove it!
• (Records)