ISO 9001:2008 Quality Management System Training

ISO 9001:2008
Quality Management System

TRAINING
STRUCTURE
 Terminology & Concepts (ISO9000)

 Role of ISO9001, ISO9004 and QMPs
 Review of requirements (Based on QMPs)
TERMINOLOGY & CONCEPTS (ISO 9000)
Quality
degree to which a set of
inherent characteristics
fulfils requirements
Quality Policy
overall intentions and direction
of an organisation related to
quality, as formally expressed
by top management
Quality Objective
something sought,
or aimed for,
related to quality
Continual Improvement
recurring activity
to increase the ability
to fulfil requirements
Continual improvement
Achieve
u al objectives
n tin ent
Plan Co vem
p ro
Act Do Im
Quality
Management Check Moving
System: target
support to Achieve
achieve the objectives
objectives
Correction
Action taken to eliminate a detected nonconformity
Corrective Action(Reactive)
Action taken to eliminate the cause of a detected
nonconformity or other undesirable situation
• Preventive Action(Proactive)
Action take to eliminate the cause of a potential
nonconformity or other potentially undesirable
situation
Procedure
specified way
to carry out
an activity or a process
ISO9001 & ISO9004 (a consistent pair)
ISO9001 : Requirements
ISO9004 : Guidelines for performance

improvements
ISO9001 & ISO9004 (a consistent pair)
ISO9001 : focuses on the effectiveness

of the system in meeting
customer requirements
ISO9004 : guide for moving beyond

ISO9001
(not intended for certification
or contractual purposes)
QUALITY MANAGEMENT PRINCIPLE
comprehensive and fundamental rule or

belief, for leading and operating an
organisation, aimed at continually
improving performance over the long term
by focusing on customers while
addressing the needs of all other
stakeholders
ISO/TC176/WG15
QUALITY MANAGEMENT PRINCIPLES
 Customer-Focused Organisation
 Leadership
 Involvement of People
 Process Approach
 System Approach by Management
 Continual Improvement
 Factual approach to decision making
 Mutually beneficial supplier relationships
Process Approach
PROCEDURE
(Specified way to carry out an activity or
process – may be documented or not)
Input Output
PROCESS
PROCESS
(set
(set of
of interrelated
interrelated oror
Resources interacting
interacting activities)
activities) Product
Monitoring & Measurement Opportunities

(Before, During, and After the Process)
14
Process Approach
The process approach emphasizes the importance
of:
Understanding and meeting requirements

Looking at processes in terms of added value
Obtaining results of process performance
Continual improvement of processes
15
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM
Management
Responsibility
Customer
Measurement,
Customer Resource Analysis and Satisfaction
Management Improvement
Product
Requirements Realisation Produc
Input t Output
Value Adding Activities

Information Flow
4.2 DOCUMENTATION REQUIREMENTS
 Policy & Objectives

 Quality Manual
 Procedures
 Other Documents
 Records
 Control of documents
 Control of Records
5.1 MANAGEMENT COMMITMENT
Provide Evidence of
Commitment to Development &
Improvement of Effectiveness
of QMS
Communicating Importance of Meeting Requirements

Establishing Quality Policy & Objectives
Conducting Management Reviews
Providing Necessary Resources
5.2 CUSTOMER FOCUS
Aim : to enhance customer satisfaction
ensure customer requirements

(needs and expectations as defined
in ISO 9000:2000) are
Determined
and
Fulfilled
5.3 QUALITY POLICY
Appropriate to purpose of organisation

Commitment to comply with requirements
Commitment to continually improve effectiveness
Framework for setting and reviewing quality objectives
Communicated and understood
Reviewed for continuing suitability
5.4 PLANNING
Established at relevant functions and levels

Measurable
Consistent with Policy
(this is the place we have to focus for a system
to be effectively designed and is the greatest
oppurtunity as well as a challenge)
5.5 RESPONSIBILITY, AUTHORITY &
COMMUNICATION
5.5.1 Responsibility and Authority
Responsibilities, Authorities and Interrelation
Defined & Communicated

COMMUNICATION
5.5.2 Management Representative
Processes Established, Implemented & Maintained

Report on Performance
Report on Need for Improvement
Ensuring Awareness of Customer Requirements
COMMUNICATION
5.5.3 Internal Communications
Communication Processes established

including
Effectiveness of QMS
5.6 MANAGEMENT REVIEW
5.6.1 General
5.6.2 : Review Inputs
5.6.3 : Review Out puts

6.0 Resource Management
6.1 : provision of resources

6.2 : Human resources
•Determine necessary competence (competence of
inspectors, operators, trainers, auditors, but what
about managers?)
•Satisfy needs (training or other actions)
•Evaluate effectiveness of actions
•Awareness of relevance/importance of activities
•Records
6.3 : Infrastructure
6.4 : Work Environment
7.1 PLANNING OF PRODUCT
REALISATION
Quality Objectives and Requirements for Products

Processes
Documentation
Resources
Verification/Validation/Monitoring/Inspection/Test
activities
Records
7.2 CUSTOMER RELATED PROCESSES
7.2.1 Determination of requirements related to the

product
•Specified by customer
•Necessary for specified, known, intended use
•Statutory/Regulatory
•Additional
7.2.2 Review of requirements related to the product
7.2.3 Customer Communication

•Product information
•Enquiries, contracts, order handling
•Customer feedback (inc complaints)
7.3 DESIGN AND DEVELOPMENT
7.3.1 Planning
Planning
Design Inputs
Design outputs
Design review
Verification
Control of changes
7.4 PURCHASING
7.4.1 Purchasing Process

Evaluate, Select, Re-evaluate suppliers
Basis of ability to supply
Define criteria to be employed
Records
7.4.2 Purchasing Information
7.4.3 Verification of Purchased product
7.5 PRODUCTION AND SERVICE
PROVISION
7.5.1 Control of Production and Service Provision
 Controlled Conditions
 Information
 Work Instructions
 Suitable Equipment
 Availability & Use of Monitoring & Measuring Devices
 Implement Monitoring & Measurement Activities
 Release, Delivery & Post Delivery Activities
PROVISION
7.5.2 Validation of Process
“Special Processes”
Criteria for review and approval
Equipment and personnel
Specific methods and procedures
Requirements for records
Revalidation
PROVISION
7.5.3 Identification and Traceability
Where appropriate, identify product
Identify Measurement and Monitoring status
Control and record traceability when required

PROVISION
7.5.4 Customer Property
Exercise care
Identify
Verify
Protect
Safeguard
Report and record problems
PROVISION
7.5.5 Preservation of Product
Identification
Handling
Packaging
Storage
Protection
Products and Component Parts
7.6 CONTROL OF MONITORING &
MEASURING
 Determine measurements to be made

 Select and use suitable equipment
 Where necessary
Calibrate (traceable)
Adjust
Identify (calibration status)
Safeguard from invalidation
Protect
Records
 Validity of previous results
 Includes software
8 MEASUREMENT, ANALYSIS &
IMPROVEMENT
8.1 General
Plan & Implement Processes

Demonstrate Product Conformity
Ensure Conformity of QMS
Continually Improve Effectiveness of

QMS
Statistical Techniques
8.2 MONITORING & MEASUREMENT
8.2.1 Customer Satisfaction
Determine Methods
Monitoring and Use of Information
Customer Perception(interesting?)
Fulfilling Customer Requirements
Proactive not Reactive

8.2.2 Internal Audit

Planned Intervals
Conformity to ISO 9001:2000
Effective Implementation &
Maintenance
Programme (Status & Importance)
Auditor Objectivity
Corrective Actions (no undue delay)
Follow-up Verification
8.2.3 Monitoring & Measurement of Processes
Suitable Methods
Ability of Process
Achieve Planned Results
Correction & Corrective Action, where

appropriate
Release of records
8.2.4 Monitoring & Measurement of Product
Product Characteristics
Planned Arrangements
Appropriate Stages
Verify Requirements Fulfilled
Records
Evidence of Conformity
ID of person authorising release
No release if not successful (except
concession)
8.3 CONTROL OF NONCONFORMING
PRODUCT
Identify & Control (prevent use/delivery)

Documented Procedure
Deal with nonconformity
Eliminate it (rectify/scrap)
Accept it (concession)
Preclude original use (regrade)
Records
Re-verification (where corrected)
Appropriate action if found after delivery
8.4 ANALYSIS OF DATA
Determine, Collect, Analyse Data to

Demonstrate Suitability & Effectiveness of
QMS
Evaluate Improvement Opportunities
Analysis to provide information on

Customer Satisfaction
Product Conformance
Process Characteristics/Trends
Suppliers
8.5 IMPROVEMENT
8.5.1 Continual Improvement
Continually Improve Effectiveness of QMS

through use of
Quality Policy
Quality Objectives
Audit Results
Analysis of Data
Corrective & Preventive Action
Management Review
8.5 IMPROVEMENT
8.5.2 Corrective Action
Eliminate cause of nonconformities to prevent

recurrence
Documented Procedure
Review (inc Customer Complaints)
Determine Cause
Evaluate Need for Action
Take Action
Record Results
Review Action
8.5 IMPROVEMENT
8.5.3 Preventive Action
Eliminate cause of potential nonconformities to

prevent ocurrence
Documented Procedure
Determine Potential Problems & Causes
Evaluate Need for Action
Take Action
Record Results
Review Action

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ISO 9001:2008

Quality Management System

 Terminology & Concepts (ISO9000)

ISO9004 : Guidelines for performance

ISO9001 : focuses on the effectiveness

ISO9004 : guide for moving beyond

comprehensive and fundamental rule or

Monitoring & Measurement Opportunities

Understanding and meeting requirements

Value Adding Activities

 Policy & Objectives

Communicating Importance of Meeting Requirements

Aim : to enhance customer satisfaction

ensure customer requirements

Appropriate to purpose of organisation

Established at relevant functions and levels

5.5.1 Responsibility and Authority

Responsibilities, Authorities and Interrelation

Defined & Communicated

5.5.2 Management Representative

Processes Established, Implemented & Maintained

5.5.3 Internal Communications

Communication Processes established

5.6.2 : Review Inputs

5.6.3 : Review Out puts

6.1 : provision of resources

Quality Objectives and Requirements for Products

7.2.1 Determination of requirements related to the

7.2.2 Review of requirements related to the product

7.2.3 Customer Communication

7.4.1 Purchasing Process

Where appropriate, identify product

Identify Measurement and Monitoring status

Control and record traceability when required

 Determine measurements to be made

Plan & Implement Processes

Ensure Conformity of QMS

Continually Improve Effectiveness of

8.2.1 Customer Satisfaction

Proactive not Reactive

8.2.2 Internal Audit

8.2.3 Monitoring & Measurement of Processes

Correction & Corrective Action, where

8.2.4 Monitoring & Measurement of Product

Identify & Control (prevent use/delivery)

Determine, Collect, Analyse Data to

Analysis to provide information on

8.5.1 Continual Improvement

Continually Improve Effectiveness of QMS

8.5.2 Corrective Action

Eliminate cause of nonconformities to prevent

8.5.3 Preventive Action

Eliminate cause of potential nonconformities to

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