ISO 9001 Lead Auditor Course

The following diagrams supplement the ISO 9001 Lead Auditor Course.
Read these diagrams in conjunction with the relevant section (numbers) in
the course.



Figure 1.3
Quality Management

The definition of Quality Management is coordinated activities to direct and control an
organization with regard to quality. The coordinated activities (quality management tools)
identified in the ISO 9000:2000 standard are as depicted in the following diagram:

Quality Management System








To manage




- Policies - Proactive - Reactive - Effectiveness
- Objectives - Preventive - Detective - Efficiency
- Processes - Confidence - Conformity - Capability
- Resources
- Controls




















Conformity
Consistency
Assurance
Processes
ISO 9001
Standard
QMS
Principles
Quality
Management
System
Quality
Improvement
Quality
Control
Quality
Assurance
Quality
Planning
Figure 2.2
A typical documentation structure is depicted in the following
pyramid diagram:

Procedures
(who, what, when, where)
Operational
documentation
(how)
Quality
Records
Quality Manual Policy
4. 2.2
Procedures
4.2. 3, 4.2.4, 8. 2.2,
8.3, 8.5.2, and 8. 5. 3
(plus optional procedures)
Documents needed to plan, operate
and control processes
Evidence of results achieved
& activities performed
(see Control of Records: 4.2.4)
Level 1
Describes company policy relating
to each ISO 9001 requirement
Level 2
Level 3
Level 4
QMS Documentation
TYPICAL HEIRARCHY





















Figure 3.9
RAB/QSA ACCREDITATION PROGRAM
ACCREDITING
AUTHORITY
REGISTRARS
REGISTERED
ORGANIZATIONS
CUSTOMERS
NATIONAL GOVERNMENT/ TRADE ASSOCIATIONS
3
RD
PARTY
AUDITORS
INTERNAL
AUDITORS


RAB
TRAINING
ORGANIZATIONS
INDEPENDENT
AUDITORS
LEAD AUDITOR
TRAINING
TRAINING REGISTRATION
RAB
RAB

Figure 4.1
Managing an audit program

Managing an Audit Program Process Flow

PLAN DO CHECK ACT








- Objectives - Schedule audits - Monitor
- Extent - Evaluate auditors - Review
- Responsibilities - Select teams - Identify need for
- Resources - Direct activities for corrective action
- Procedures - Maintain records - Identify opportunities
to improve

































AUTHORIZE
PROGRAM
IMPLEMENT
MONITOR
and
REVIEW
ESTABLISH
AUDIT
ACTIVITIES
IMPROVE
AUDITOR
COMPETENCE
Figure 4.2.2.3

Internal Audit Planning and Preparation

Departments Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Sales P A A
Management P
Technical P A A
Planning P A
Logistics A P A
Purchasing A P A
Warehouse 1 A A P
Warehouse 2 A P
Process 1 A A P
Process 2 A A P
Calibration A P

Key: P = Audits planned to be conducted once a year
A = Additional audits considering STATUS, IMPORTANCE, and prior AUDITS





























Figure 5.3.2.1
Audit Plan - ABC, Inc.

Auditors: Group 1 - Mr. M. Damon (Team Leader); Mr. R. Moore
Group 2 - Ms. A. Jolie; Mr. R. Anderson

Audit Date: Month / Day(s) / Year

DAY 1 TIME GROUP 1 GROUP 2

08.30-09.00 Opening Meeting Opening Meeting

09.00-09.30 Plant Tour Plant Tour

09.30-10.30 Quality Manual Quality Manual

10.30-12.00 Contract Engineering Warehouse

12.00-12.30 Audit Team Prep Audit Team Prep

12.30-13.00 Lunch Lunch

13.00-14.30 Sales/Customer Support Purchasing

14.30-16.00 Design Engineering Production Scheduling

16.00-18.00 Product Development Manufacturing Engineering

18.00-18.30 Review Review


DAY 2


TIME

GROUP 1

GROUP 2
08.30-10.30 Software Systems Assembly

10.30-12.00 Calibration - Lab Assembly/Test

12.00-12.30 Audit Team Prep Audit Team Prep

12.30-13.00 Lunch Lunch

13.00-14.30 Industrial Engineering Test/Calibration - Mfg

14.30-16.00 Quality Assurance Final Inspection/Packaging

16.00-17.00 Audit Team Meeting Audit Team Meeting

17.00- Closing Meeting Closing Meeting



Figure 5.6.1
Audit Checklist

Area audited: Document Control Procedure DC-05

Look at: Procedure DC-05
Look for: Conformity of procedure to policies and ISO 9001 standard
Control of all document types, including external documents

Look at: Document Approvals
Look for: Approvals by authorized persons prior to document issue
Evidence of approvals, e.g., signature or electronic proof

Look at: Document Changes
Look for: Documents reviewed, updated as necessary, and re-approved
Current revision status identified along with nature of changes

Look at: Document Usage
Look for: Legible and identifiable versions available at points of use
No obsolete documents in use; retained documents identified
























Figure 6.1.4
Collecting and verifying information

Process for collecting information to reaching audit conclusions





Audit evidence





Audit findings





Sources of
information
Evaluate against audit
criteria
Collect by appropriate
sampling and verifying
Reviewing

Audit conclusions