ISO 9001 QUALITY

MANAGEMENT
SYSTEMS
MIKE DUNN
ELIZABETHTOWN COMMUNITY & TECHNICAL COLLEGE
 MODERN QUALITY

INDUSTRIAL BOOM & MASS W.E. DEEMING – “FATHER OF QUALITY”

PRODUCTION
• Introduced statistical concepts and quality theories
• Increased output required a different approach to improve results.
to quality.
• Influenced companies and cultures across the
• Quality inspections introduced. globe.
MODERN QUALITY (CONT’D.)
TQM QMS
TOTAL QUALITY QUALITY
MANAGEMENT MANAGEMENT
SYSTEM
• Everyone plays a role
in quality. • Name coined by British
IT consultant in 1991.
• Use by Japan in
automotive industry. • Set of processes,
procedures, policies,
• Adopted worldwide. instructions, and other
standards.

• Work together to form a

system of operations.
 HISTORY OF ISO 9001 REVISIONS
• Initial release.
1987 • Documentation rules and SOF requirements.

• Certification made available.

1994 • Required documentation for QMS.

• Introduced the Plan Check Do Act process model.

2000 • Documentation requirements reduced significantly.

• Not many changes made from 2000 revision.

• Wording changed for clarity.
2008
• Current revision.
2015 • Promotes risk based thinking and continual improvement.
 ISO 9001:2015 STANDARD
CLAUSES 0-3:
CORE PRINCIPLES CLAUSE 6- PLANNING CLAUSE 8- OPERATIONAL PLANNING
INTRO/DEFINITIONS • Orgs must plan to identify risks AND CONTROL
and find ways to lower the • Know how to control suppliers.
CLAUSE 4-CONTEXT OF ORG impact of those risks. • Know how to handle non-conforming
• Who does the org care about? • Create Objectives outputs.
• What does the org do? • Plan to achieve them. • Know how to communicate..

CLAUSE 5- LEADERSHIP & CLAUSE 7- SUPPORT & CLAUSE 9- PERFORMANCE

COMMITMENT RESOURCE MANAGEMENT EVALUATION
• Who’s responsible for what? • Employee training. • Review data to determine how the QMS is
• Document control. performing (audits, meetings, etc.)

CLAUSE 10- IMPROVEMENT ACTIONS

• Fix your problems for good and improve.