Chapter 9 - Quality Systems

1
Chapter 9 - Quality Systems

• Team 2 Cindy Guthrie, Amy Randolph
• and Robin Tomer

2
ISO 9000 Series of Standards

• ISO 9000 Series of Standards
• International Organization for Standardization
  (ISO) formed in 1946 in Geneva, Switzerland
• International standards of quality used by more
  than 60 countries
• ISO 9000, 9001, 9002, 9003 and 9004
• Purpose of a quality system?

3
Implementation

• Senior management commitment
• Appoint management rep
• Awareness
• Appoint imp. team
• Training
• Time schedule
• Select element owners

• Review present system
• Write the documents
• Install the new system
• Internal audit
• Management review
• Preassessment
• Registration

4
Documentation

• Policy - Why, What will be done
• Procedure -Who, When, Where
• Work instructions - How
• Records - Evidence
• Document development
• 4 tiers of documentation?

5
ISO/QS 9000 Elements

• Management Responsibility
• The Quality System
• Contract Review
• Design Control
• Document Data Control
• Purchasing
• Control of Customer Supplied Product
• Product Identification Traceability
• Process Control
• Inspection Testing

• Control of Inspection, Measuring Test Equipment
• Inspection Test Status
• Control of Nonconforming product
• Corrective Preventive Action
• Handling, Storage, Packaging, Preservation
  Delivery
• Control of Quality Records
• Internal Quality Audits
• Training
• Servicing
• Statistical Techniques

Exercise
6
Writing the documents

• Keep simple and concise - same format
• Should include quality policy and statement and
  distribution list
• All 20 elements should be included - just state
  if not applicable
• Include forms, contracts, etc..

7
Internal Audits

• Done after policies, procedures and work
  instructions developed and implemented
• Internal audit is the system used to make sure
  systems is being followed and expected results
  obtained
• Objectives of internal audit?

8
Registration

• Assessment of a quality system by a third party,
  a registrar. 2 Parts
• Selecting a registrar
• Registrar Accreditation Board (RAB)
• Registration process
• Six basic steps

9
Conclusion/Discussion

• Benefits of implementing a quality system?