ISO 9001 Awareness

© Operational Excellence Consulting. All rights reserved.
Copyrights of all the pictures used in this presentation are held by their respective owners.
ISO 9001 Awareness

4© Operational Excellence Consulting. All rights reserved.
Outline
• Overview of ISO 9000
• ISO 9001
Process Approach
The Requirements (Clauses)
Audit Approach
• Handling the Audit Session
Copyrights of all the pictures used in this presentation are held by their respective owners.
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What is ISO 9000?
• International consensus on good management practice
• Looks for repeatability and meeting customer
requirements
• Distilled into standard requirements
• Covers any organization – whatever the size, industry or
culture

ISO 9000 Series
• ISO 9000
Quality Management Systems: Fundamentals and Vocabulary
• ISO 9001
Quality Management Systems: Requirements
• ISO 9004
Quality Management Systems:
Guidelines for performance improvements
Focus of this
presentation

Why is a Quality Management System
Important?
• Customer satisfaction
• Cost of poor performance
• Repeat business
• Increased profitability
• Increased effectiveness
• Consistency

Process Approach

Process Model
Process
Control
Input and
input specifications
Process
Activities
and Sub-Processes
Output and
output specifications
Resources Roles
Process
Owner
Process
Goal
Quality Parameters
and Key Performance
Indicators
Process
Enablers

Basic Objective
• Organization must be able to demonstrate:
Awareness of customer requirements
Customer satisfaction
Improvement
Prevention
Consistently meet customer requirements

5 Key Clauses of ISO 9001
Value-adding activities
Information flow
Management
Responsibility
Resource
Management
Measurement,
analysis,
improvement
Product
Realization
Input Output
Product/
service
Continual improvement of the
Quality Management System
CustomerRequirements
CustomerSatisfaction
(4) “System” Clause
(6) Asset Clause
(5) Leadership Clause
(7) Delivery Clause
(8) Closed-Loop
Clause

Managing Processes
• Identify required process outputs
• Define process objectives in line with corporate
objectives
• Determine necessary inputs and controls
people, facilities, work environment
• Monitor to ensure achievement
• Know what is good progress at interim stages
• Establish escalation channels for adverse trends
• Process ownership

Documentation Requirements 2
• Control of Documents and Records

Chapter 5 – Management Responsibility
• Management commitment
• Customer focus
• Quality policy
• Quality management system planning
Quality objectives
QMS planning
• Responsibility, authority & communication
Internal communication
Management representative
• Management Review

Chapter 6 – Resource Management
• Provision of resources
• Human resources
Competence, awareness
and training
• Infrastructure
• Work environmentThis document is a partial preview. Full document download can be found on Flevy:

Chapter 7 – Product Realization 2
• Production and service
provision
Operations control, validation of
processes, identification and
traceability, customer property,
preservation of product
• Control of monitoring and
measuring devices

Chapter 8 – Measurement, Analysis &
Improvement 2
• People
Resource Availability
Competence, Awareness & Training
Infrastructure & Work Environment
• Process
Quality Trends and Models (e.g. Six Sigma, CMMI)
Better, Cheaper, Faster (e.g. re-useable components)
Process Management
Process Improvement (e.g. defect rate, cost of poor quality)
• Technology
Availability of Tools
Application of Tools

What Are Audits Used For?
• Looking at the overall process
• Auditing conformity
• Auditing effectiveness
• Approving Suppliers / Subcontractors
• Assessing for Certification
• Investigating problems
• Way of improving

Audit Focus
Effectiveness of QMS
in achieving the organization’s
objectives and
in providing products that conform
to customer requirements

Document Review
• Can be done in advance
of actual site visit
• Purpose
To ensure that, in theory,
the Documented Quality
System (DQS)
meets the requirements of
ISO 9001
or other standards

Assessment Findings
Positive Aspects
Areas of Improvement
Minor Nonconformity
Major Nonconformity

Handling the Audit Session

Rights of Auditor 1
• Can change areas/projects to be audited
• Can add in more projects to be audited if they
wish to verify something
• May start the audit session earlier, or extend the
session, if necessary. Auditees should avoid
scheduling other meetings before or after the
scheduled times.

Auditee’s Conduct
• Polite
• Professional
• Positive / Receptive
• Sincere
• Commitment
• Formal but not overly serious

Interacting with Auditors – Don’ts
for Auditees
• Assume auditors are familiar with
your organization’s QMS
• Challenge auditors
• Show more competence in ISO 9001
• Argue internally
• Express unfairness
• Ask for solution
• Fix non-conformities on the spot

End of Presentation
To view the full list of training presentations,
please visit us at:
Operational Excellence Consulting
http://www.oeconsulting.com.sg

ISO 9001:2008 Clauses
1.0 Scope
2.0 Normative Reference
3.0 Terms and Definitions
4.0 Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Document Control
4.2.4 Control of Records
5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus

ISO 9001:2008 Clauses (Continued)
7.0 Product Realization (Continued)
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Output
7.3.4 Design and Development review
7.3.5 Design and Development verification
7.3.6 Design and Development validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of purchased Product

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