Post on 21-Dec-2015
What’s ISO?
International Organization for Standardization
Provide international standards for products and servicesFacilitates worldwide exchange of goods and
services
What We Need to Know
1. Basics of ISO2. Benefits3. Requirements4. Documentation Procedures5. How to Implement ISO6. How to do an Internal Audit7. How to Register
Getting to Know ISO
Found in 1946 – Geneva, Switzerland 90 Member Countries ANSI – USA Representative ISO Technical Committee (TC) 176
Developed the International Standards for Quality in 1987
ISO 9000, 9001 & 9004
Benefits of ISO Registration
Global competitiveness Maintain or increase market shares Secondary benefits for the supplier
Decrease in scrap, rework and nonconformities at final inspection
Increase in product reliability Improved time to market, on-time delivery and
throughput Decrease in the cost of poor quality measured but
external forces
Requirements
Scope Normative References Terms and Definitions Quality Management System (QMS) Management Responsibilities Resource Management Product or Service Realization Measurement, Analysis and Improvement
The Other 5 Requirements
5 - MANAGEMENT
4 - QMS COUNTINUAL
7 - PRODUCT
6 - RESOURCE8 - MEASUREMENT,
ANALYSIS
INPUT OUTPUT
CUSTOMER
RESPONSIBILITY
IMPROVEMENT
REALIZATION
MANAGEMENT AND IMPROVEMENT
REQUIREMENTS PRODUCT
SATISFACTION
MODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM
4 – Quality Management System (QMS)
Identify the process Determine the process sequence Set methods for effective operation and control of
process Ensure availability of resources and information for the
process Monitor, measure and analyze the process Continually improve the process Document
Quality policies, manuals, procedures… Set controls for documents and maintain records of conformance
5 – Management Responsibility
Commitment Customer Focus Quality Policy Planning – Quality Objectives and QMS Define Responsibilities, Authorities and
Communication Review
7 – Product Realization
Plan Customer Related Design and Develop Purchasing Production and Service Provision Control of Monitoring and Measuring
Devices
8 – Measure, Analyze and Improve
Monitor and Measure Control of Nonconforming Product Analysis of Data Improvement
Implementation
Top Management Commitment Appoint the Management Representative Awareness Appoint an Implementation Team Training Time Schedule Select Element Owners Review the Present System Write the Documentation Install the New System Internal Audit Management Review Pre-Assessment Registration
Internal Audits
Objectives Does actual performance conform to documented
QMS? Initiate corrective action to deficiencies Follow up on noncompliance items from previous
audits Provide continued improvement through feedback Encourage possible improvements by thinking about
the system
How To Do An Internal Audit
Auditor Trained in auditing principles and procedures Objective, honest and impartial Good communicator, listener and observer
Techniques Examination of documents Observation of activities Interviews
Procedure Pre-Audit Meeting
Timetables, what is being audited, review requirements Audit
Determine how well the system has been implemented and maintained Closing Meeting
Present a summary including nonconformities, corrective action and decide on follow-up
Two Ways to be ISO Certified
2-Party SystemCustomer audits the supplier’s quality system
3-Party SystemRegistrar audits and certifies a supplier’s
quality system
Registration
Select a RegistrarQualifications and experienceCertificate recognitionRegistration processTime and cost constraintsAuditor qualifications
Registration Process
Application for Registration Document Review Pre-Assessment Assessment Registration Follow-up Surveillance
What We Now Know
1. Basics of ISO2. Benefits3. Requirements4. Documentation Procedures5. How to Implement ISO6. How to do an Internal Audit7. How to Register
Resources
ISO Homepage http://www.iso.org/iso/home.htm
ISO 9001 Auditing Practices Group:
Non Conformity handout www.iso.org/tc176/iso9001auditingpracticesgroup
Common Sense Consulting:
Process Assessment and Audit Worksheet http://www.schnauber.com/free-stuff.html
National Food Service Management Institute:
United States Department of Agriculture http://sop.nfsmi.org/HACCPBasedSOPs.php