Chapter 10:Quality Management Systems

Jennifer Sadorus

Heather Heller

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

1st Three Requirements

Scope Normative Reference Terms and Definitions

INFORMATION ONLY

Requirements Activity

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

6 – Resource Management

Provision of Resources Human Resources Infrastructure Work Environment

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

Documentation Activity

Form 4 Groups of 3

Documentation

POLICY

PROCEDURE

WORK INSTRUCTIONS

RECORDS OR PROOF

OR PRACTICES

BREAK!

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

Implementation Activity

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

Audit Activity

Form 2 Groups

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