What is a Quality

Management System?

Quality:
achieving desired results

Management:
establishing policy and objectives and
providing resources to achieve them

System:
set of interrelated or interacting processes
The ISO 9001:2000 QMS 1
 The eight clauses of ISO 9001 : 2000
Product/Services
Realization
Customer
Customer 7.1 Plan Process Satisfaction
Requirements 7.2 Get Requirements
7.3 Design & Develop
7.4 Purchase Inputs
7.5 Provide Service
7.6 Check Measuring Devices
Measurement,
Resource
Analysis and
Management
Improvement
ISO 9001:2000 Model
6.1 Provision 8.1 Plan
6.2 Human Resources Quality Management System 8.2 Measure
6.3 Facilities 8.3 Nonconforming
6.4 Work Environment 4.1 General Requirements 8.4 Analysis
4.2 Documentation Requirements 8.5 Improve

Management Responsibility

5.1 Commitment 5.4 Planning

5.2 Customer Focus 5.5 Administration
5.3 Quality Policy 5.6 Management Review

The ISO 9001:2000 QMS 2

 Representation of a Process
Procedure
( specified way to carry out an activity or a process. –
may be Documented or not)
Effectiveness
( Ability to
achieve desired
Results)

INPUT PROCESS OUTPUT

( Set of interrelated PRODUCT
(Includes or interacting ( Results of a
Resources) activities Process)

Monitoring and Efficiency

Measuring opportunities ( Results achieved
( Before, during and after the process) vs. resources used)

The ISO 9001:2000 QMS 3

 The Eight Clauses of ISO 9001 : 2000
 Clause 0: Introduction
 Clause 0 describes the use of the standard in addressing:
 Customer satisfaction and regulatory requirements
 Defines the “process approach” as a systematic identification
and management of processes and their interaction

 Clause 1: Scope
 Establishes the intent of the standard: to provide product
that meets requirements,
 To address customer satisfaction
 States the rules for permitting exclusion of requirements in
clause 7, where they do not apply because of the nature of
the organization

The ISO 9001:2000 QMS 4

 The Eight Clauses of ISO 9001 : 2000
 Clause 2: Normative Reference

 Identifies ISO 9001:2000 QMS fundamentals and

vocabulary as a standard whose content also applies in
meeting ISO 9001 requirements.
 Clause 3: Terms and Definitions

 Describes the change in the use of the terms organization

and supplier

The ISO 9001:2000 QMS 5

 4. Quality Management System
 4.1 General Requirements
 4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records

Why do it?
To make certain that your QMS provides product
and or services that meet your customer needs and
will continually improve in its ability to do so
consistently in the future.

The ISO 9001:2000 QMS 6

 Clause 4

Quality
Management System

The ISO 9001:2000 QMS 7

 4. Quality Management System
 What is it?
A means to demonstrate, through documented
procedures, that:

 The quality system is in support of a quality manual

that referrers to procedures and instructions.
 A quality plan is in operation.
 The overall system is in effective use.
 The QMS is continually improving.

The ISO 9001:2000 QMS 8

 4. Quality Management System
 What`s new?

 Provision is to be made for continual improvement

 Manual is to include “sequence of interaction” of
processes, and scope of the QMS
 Details and justification for any exclusions are
required

The ISO 9001:2000 QMS 9

 4. Quality Management System
 Outline of a typical Quality Manual:
 Quality Policy
 Organizational Chart
 Quality assurance organization
 Statement of authority and responsibility
 Distribution list of controlled copies
 Quality management system clauses 4 – 8
 Procedures index
 Forms index
 Operating procedures
 Job instructions
 Records, forms, and specifications

The ISO 9001:2000 QMS 10

 4. Quality Management System
 How do I do it?
1. Determine the requirements of the standard, including both
documentation and implementation.
2. Plan the structure of the documentation (Quality Manual)Guidelines
for developing quality manuals:
 An outline that includes:
 Quality policy, organizational chart
 Quality assurance organization
 Statement of authority and responsibility
 Distribution list of controlled documents
 Quality system clause 4-8
 Procedure master list & index
 Work instructions
 Records, forms and specifications

The ISO 9001:2000 QMS 11

 4. Quality Management System
3. Establish existing company practices by using:`
 flowcharts,
 Procedures ( written and unwritten)
 work instructions.
4. Evaluate resources, present and needed
 Personnel, equipment and instrumentation
 Specifications and acceptance standards
 Quality records
5. Establish a quality planning function to meet requirements for
 products,
 projects and
 contracts

The ISO 9001:2000 QMS 12

 4. Quality Management System
6. Implement the quality system. Consider:
 Quality plans,
 Resources/timeframe
 Updating procedures,and instrumentation
 Identifying extreme measurement requirements
 Clarify acceptance standards
 Compatible elements, and
 Quality records instructions and quality records.

The ISO 9001:2000 QMS 13

 4. Quality Management System
7. Provide for control of quality documents
 List all documents where a procedure is required
 Develop a plan for control of all documents, including
review, updating, and re-approval
 Before being issued, verify that documents are adequate,
readable,and easily identified
 Identify the current revision status of all documents
 Ensure accessibility to documents at the work station/job
site
 Establish control over documents that become absolute,
including removal and controlled retention.
 Identify and control documents originating from outside
the organization

The ISO 9001:2000 QMS 14

 4. Quality Management System
 Provide for control of quality records
 Control to demonstrate that requirements are being met
and are effective
 Establish procedures for identification, storage,
retrieval,protection, retention time, and disposal of
records
 Records are to be readable and easily identified
 All documents and data required for the QMS are to be
controlled and readily available to users when needed
 External documents such as standards and customer
drawings are to be identified and controlled.
 Before being issued, all documents and data are to be
reviewed and approved by authorized personnel

The ISO 9001:2000 QMS 15

 4. Quality Management System
 A master list (or equivalent control)is to show current
revision status of all documents and be readily available to
avoid the use of the wrong documents.
 Current documents are to be in use where needed.
 Obsolete documents are to be taken out of circulation
 Obsolete documents retained for legal or other purpose are
to be so identified

The ISO 9001:2000 QMS 16

 4. Quality Management System
 Examples of Quality Documents
 Documents necessary to maintain the QMS
 Procedures for data approval and control
 Master list of documents and data sheets
 Schedule for review of documents and data
 Procedures to control quality records
 index of records
 Retention schedule of records
 Drawings, specifications, test procedures
 Operation sheets quality system procedures
 Quality records, and documents defined as quality
records
 Quality plans, quality manual, operating procedures,
 Work/job instructions
The ISO 9001:2000 QMS 17
 4. Quality Management System
 Examples of Quality Records
 Quality records specified in documentation procedures
 Identification of documents of nature of change
 Records of management review process
 Records of disposition (disposal)
 Inspection reports
 Test data
 Qualification report
 Validation reports
 Audit reports
 Material review reports
 Calibration data

The ISO 9001:2000 QMS 18

 4. Quality Management System

 Pitfalls
 The quality system is not viewed as a process
 Not adequately documented
 Not complete, or only a”paper system”
 Faults in the system, e.g. unauthorized changes to
documents
 Inspection procedure not sufficient
 Subjective element are being used when a specific one
is available
 Records are not readily available

The ISO 9001:2000 QMS 19

 Factors to consider in the Control of Quality Records
 Identification  Designation of individual records
 Collection  Responsibility to record collection
 Indexing  An indexing structure providing an access trail
 Access  Provision for ready access of quality records for
those using them
 Filing  Filing quality records where access is easy, during
the high review part of the records life
 Storage
 Less accessible bulk storage during archival part
of record life
 Records are to demonstrate conformance to
 Maintenance specified requirements and effective quality
system operation. Supplier quality records may
be an element of such data.
 Legibility  Readable under normal operating conditions
 Retention Time  Established, recorded, and administered
 Form of Records  Hard copy, electronic, or other media
The ISO 9001:2000 QMS 20
 Documentation Development
Documentation Tiers (1of4)

Defines Approach &

Responsibilities Quality
Tier 1
Policy Manual
Defines policies &
Defines WHO
WHAT, WHEN Objectives according to 4.2
Operating Procedures
Tier 2
Defines who is responsible for what, where and
Answers HOW When it would apply and why it is being done

Work Instructions
Tier 3
Defines details as to how specific tasks must be performed eg.
Provides a Calibration, testing procedures, manufacturing procedures
Quality Record Forms and Records
Tier 4
Defines and provides evidence of conformity to requirements

The ISO 9001:2000 QMS 21

 Clause 5.
Management
Responsibility

The ISO 9001:2000 QMS 22

 5. Management Responsibility
 5.1 Management Commitment
 5.2 Customer Focus
 5.3 Quality Policy
 5.4 Planning
 5.4.1 Quality measurable Objectives
 5.4.2 Quality Management System Planning
 5.5 Responsibility, Authority and Communication
 5.5.1 Responsibility and Authority
 5.5.2 Management Representative
 5.5.3 Internal Communication
 5.6 Management Review
 5.6.1 General
 5.6.2 Review Input
 5.6.3 Review Output

The ISO 9001:2000 QMS 23

 5. Management Responsibility
 Why do it?
To ensure that top management takes a leading and
visible role in defining, implementing,
administering, and improving the QMS, within the
goal of meeting all customer requirements.

 What is it?
An orderly documentation of top managements
responsibilities in establishing, reviewing, and
providing resources to support the companies quality
system.

The ISO 9001:2000 QMS 24

 5. Management Responsibility
 What`s new?

 Greater emphasis on top management commitment

 Increased attention to effective internal
communication ensuring that objectives are
“SMART”.
 Improved concerns for customer needs and
expectations
 Grater commitment to meeting requirements and
continuous improvement

The ISO 9001:2000 QMS 25

 5. Management Responsibility (1of8)
 How do I do it?
1. Ensure managements commitment ( sub-clause 5.1)
 Communicate importance of meeting customer
and legal requirements
 Establish a quality policy and quality objectives
 Conduct management reviews
 Provide all necessary resources
2. Focus on the customer (sub clause 5.2)
 Demonstrate that customer and regulatory needs
are defined, transatlantic into requirements, and
are being met.

The ISO 9001:2000 QMS 26

 5. Management Responsibility (2of8)
3. Establish a quality policy (sub-clause 5.3):

 Assign responsibility to an individual or team to develop the

quality policy. It should include:
 The organizations quality objectives
 Management commitment to meet requirements and to
continually improve
 Relevance to organizational goals
 Expectations and needs of customers

 Ask for input from across the organization to ensure

ownership of the quality policy

The ISO 9001:2000 QMS 27

 5. Management Responsibility (3of8)
 Develop “SMART” comprehensive objectives
 Verify that the quality policy is communicated to and
understood by everyone affected by it. You can help ensure
that the policy is understood, implemented, and maintained at
all levels by:
 Conducting orientation session for new employees

 Display copies of the quality policy

 Holding departmental meeting/discussion

 Reinforcing and follow up on the ideas of the policy

 Verifying that awareness and understanding are uniform

 Periodically evaluate the quality policy for suitability

The ISO 9001:2000 QMS 28

 5. Management Responsibility (4of8)
4. Create quality objectives and system plans (sub-clause 5.3)
 Establish quality objectives throughout the
organization
 Ensure that all objectives are “SMART” and can be
measured
 Commit to continual improvement
 Plan to meet product quality requirements
 Plan actions to meet and document objectives
 Identify needed systems
 Document permitted exclusions
 Provide for resources
 Ensure that changes take place in a controlled manner.

The ISO 9001:2000 QMS 29

 5. Management Responsibility (5of8)
5. Demonstrate that your QMS is well administered (sub-
clause 5.5)
 Define areas of responsibility and authority
 Use organizational charts, as necessary
 Provide job descriptions for those whose work affect
quality
 Communicate these relationships to everyone
affected

The ISO 9001:2000 QMS 30

 5. Management Responsibility (6of8)
 Appoint management representative who:

 Ensures that the QMS is established and implemented

 Reports on the performance of the QMS
 Ensures that customers needs are well known
 Interfaces with outside parties on quality issues
 Provide for internal communication.
 Demonstrate that the provisions of the QMS and its
effectiveness are communicated to all levels and functions.

The ISO 9001:2000 QMS 31

 5. Management Responsibility (7of8)
6. Provide for management review of the QMS (sub-clause
5.6)
 Ensure suitability and effectiveness in meeting policy
and objectives
 Determine if QMS modifications, such as policy and
objectives, are needed
 Review current performance and look for improvement
opportunities by:
 Assessing audit results
 Reviewing customer feed back
 Observing performance of the process and
nonconformance of the product

The ISO 9001:2000 QMS 32

 5. Management Responsibility (8of8)
 Assessing preventive and corrective actions
 Relieving follow-up actions following previous reviews
 Considering ways to improve the QMS

 Identifying actions to:

 Improve the QMS

 Improve the product/service

 Provide resources

 Maintain records of reviews

The ISO 9001:2000 QMS 33

 5. Management Responsibility

 Examples of Quality records:

 Corrective action taken

 Evidence of conformance of operation of the QMS
 Dissemination of quality policy, for understanding,
implementation and maintenance
 Management review of records of results
 Quality records specified in documentation procedures
 Results of document and data reviews
 Distribution lists

The ISO 9001:2000 QMS 34

 5. Management Responsibility
 Record of resource requirements and in-house
verification activities
 Documents necessary to maintain the QMS:

 Quality plans,
 Operating procedures,
 Work/job instructions
 Procedures to control documents
 Management review procedures
 Inspection procedures and instructions
The ISO 9001:2000 QMS 35
 5. Management Responsibility

 Management Review

 No management review system exists

 Corrective action on internal audit results has not been
carried out.

The ISO 9001:2000 QMS 36

 5. Management Responsibility
4. Create quality objectives and system plans (sub-clause
5.4)

 Ensure that all objectives are “SMART”

 Commit to continual improvement of both product and
QMS
 Plan to meet product quality requirements
 Plan actions to meet and document objectives
 Identify needed systems
 Document permitted exclusions
 Provide for resources
 Ensure that changes take place in a controlled manner.

The ISO 9001:2000 QMS 37

 5. Management Responsibility
 Guidance in preparing the Quality Policy

 Make it easy to understand

 Make it challenging yet achievable
 Relate objectives to performance (including quality goals), fitness
for use, safety, and reliability
 Consider cost to minimize losses
 Establish quality objectives at appropriate levels of management
 Determine and provide the necessary training
 Control all activities that affect quality
 Provide sufficient resources to achieve the objectives
 Emphasize prevention and continuous improvement
 Indicate the method to be used and the criteria to be met

The ISO 9001:2000 QMS 38

 5. Management Responsibility
 Examples of Quality Documents
 Clear assignment of individual responsibility, lines of authority, and
interrelationship of all personnel whose work affect quality
 Quality plans, Operating procedures, Work/job instructions
 Procedures to control documents
 Management review procedures
 Inspection procedures and instructions
 Examples of Quality records:
 Corrective action taken
 Evidence of conformance of operation of the QMS
 Management review of records of results
 Quality records specified in documentation procedures
 Results of document and data reviews
 Distribution lists

The ISO 9001:2000 QMS 39

 5. Management Responsibility
 Pitfalls
 Managers have no written statement of their

responsibilities, authority, and accountability

 There is a lack of quality plans for a specific product

 A policy statement exists, but not understood

 No real control system exists.

 Work/job instructions are not at the place of work

 Changes are not made to all issues of documents

 Management representative has inadequate defined

responsibilities and authorities

 No management review system exists

 Corrective action on internal audit results has not

been carried out.

The ISO 9001:2000 QMS 40

 5. Management Responsibility
 Management Representative

 The management representative has inadequate defined

responsibilities and authorities
 The MR is not implementing his/her defined responsibilities
and authorities

 Management Review

 No review system exists

 Corrective action on internal audits has not been carried out

The ISO 9001:2000 QMS 41

 5. Management Responsibility
 Quality Policy
 A policy statement exists,
 A policy statement is written, but not understood or
implemented at all levels, particularly at the shop floor
level
 Objectives are not clearly defined
 No real control system exists.
 No person has been assigned responsibility
 There is no disciplined recall system for obsolete or
modified documents
 Work/job instructions are not at the place of work

The ISO 9001:2000 QMS 42

 Clause 6.
Resource
Management

The ISO 9001:2000 QMS 43

 6. Resource Management

 6.1 Provision of Resources

 6.2 Human Resources

 6.2.1 General
 6.2.2 Competence, Awareness and Training

 6.3 Infrastructure

 6.4 Work Environment

The ISO 9001:2000 QMS 44

 6. Resource Management
 Why do it?
 To make certain that adequate physical, financial and
human resources are available to meet all requirements
of the QMS.
 What is it?
 A process to identify, provide for, and manage all
required resources.
 What`s new?
 Confirming the effectiveness of training
 Provide timely resources for implementation of QMS
and enhancing customer satisfaction.
 Maintain human resource records

The ISO 9001:2000 QMS 45

 6. Resource Management (1 of 3 )

 How do I do it?
 Provision of Resources (sub-clause 6.1)
1. Identify resource requirements.
 Provide resources and assign trained personnel for:
 Establishing and improving the QMS
 Work performance
 Verification activities
 Satisfying customers needs
2. Human resource (sub-clause 6.2)
 Identify training needs
 List all job functions
 Establish training requirements for each function
 Include the requirements in job descriptions

The ISO 9001:2000 QMS 46

 6. Resource Management ( 2 of 3 )

3. Provide training based on:

 Quality plan elements
 Process knowledge requirements, methods, equipment
 Product knowledge requirements, specification
 Cross training
 Extent trainees knowledge and skills
 Other requirements: internal customers, delivery
4. Establish a record personnel qualifications in individual personnel files
to include:
 All required training completed (date, duration and grade)
 Education, (initial, additional) & previous experience
 Physical characteristics and limitations
 Medical records
 Cross training and other Special training
 Awards, rewards and promotions.

The ISO 9001:2000 QMS 47

 6.2 Human Resource (3of3)
5. Develop and document a training plan to include:

 Required training
 Optional additional training
 Qualifications of trainers
 Periodic evaluation of effectiveness and competence

The ISO 9001:2000 QMS 48

 A Quality Hire
Employing The KESAA Factors

Basic Skill Demonstration

Level Testing
Specific Skills S
Skill Match

K = Knowledge Ap = Aptitude
E = Experience Ap , At At = Attitude
K,E
Task Fit
Company Fit

Work History Interviewing

Education Screening
References
The ISO 9001:2000 QMS 49
 Training Systems Model

•Mandate Need Support

•Expressed Need
•Needs Analysis Outputs
•Enhanced K,S
Management •Improved:
•Performance
Design •Attitude
•Instruction
•Evaluation Training
•Delivery Delivery
•Administration Outcomes
Procedures •Customer Service
•Facilities •Productivity
Evaluation
•Media •Profit/Payoff
•Instructor- Facilitator •Quality
•Participants KESAA The ISO 9001:2000 QMS 50
 6.3 & 6.4 Infrastructure & Work Environment

6. Define, as applicable, necessary physical resources.

 Equipment,
 Infrastructure,
 Facilities
 Work environment,
 Visual Management – 5S
 Services (transportation, communication).

The ISO 9001:2000 QMS 51

 6. Resource Management

 Examples of Quality Documents

 Quality system training needs
 Training procedures and modules
 List of qualified trainers, by skill

 Examples of Quality Records

 Personnel skills, education, experience, and training
 Training plans for operators
 Required training certification

The ISO 9001:2000 QMS 52

 6. Resource Management
 Pitfalls
 There is a lack of sufficient resources

 Lack of trained personnel. ( the organization lays

down required training, but does not follow its own

rules.)
 There are no relationships / interfaces, particularly

with feed back from installation and servicing

 No records exists or records are inadequate

 There is alack of appropriate education, training or

experience
 Training needs are not assessed

 Training is not objectively evaluated.

The ISO 9001:2000 QMS 53

 Stepping up to the World-Class Status
Acclaimed
World-Class
Organization
Recognized for
World-Class
Processes

BNQP-Qualified
Organization

ISO 9004
Enhanced QMS

ISO 9001
Registered QMS

Nonintegrated
Quality Control
Procedures The ISO 9001:2000 QMS 54
 Clause 7:

Product Realization

The ISO 9001:2000 QMS 55

 7. Product Realization
 7.1 Planning of product realization
 7.2 Customer- related processes
 7.2.1 Determination of requirements related to the
product
 7.2.2 Review of requirements related to the product
 7.3 Design and development
 7.3.1 Design and development planning
 7.3.2 Design and development Input
 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 ( cont…

The ISO 9001:2000 QMS 56

 7. Product Realization
 7.4 Purchasing
 7.4.1 Purchasing Process
 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
 7.5.2 Validation for processes for production and service
provision
 7.5.3 Identification and tracebility
 7.5.4 Customer property
 7.5.5 Preservation of product
 7.6 Control of monitoring and measuring devices

The ISO 9001:2000 QMS 57

 7. Product Realization
 7.1 Planning of Production Realization
 Why do it?
 To make certain that you have plans for all

realization processes (production, installation, and

servicing) to be executed under controlled
conditions to ensure that quality objectives are met.
 What is it?
 Evidence of planning for the realization of your
production, installation and servicing processes, as
appropriate:
 Objectives are met
 The steps to produce /deliver the product or services
are identified and planned (cont…

The ISO 9001:2000 QMS 58

 7.1 Planning of Production Realization
 Equipment is suitable and operated under controlled
conditions
 Need for documented instructions is identified, for activities
affecting quality
 A suitable working environment is ensured
 Processes are monitored and approved
 Workmanship and acceptance criteria are established
 Plans for verification and validation of activities are
prepared!!!!
 Necessary records are determined.
 What`s new?
 Activities are to be verified and validated ( sub-clause 7.1

c)
 Determining of quality objectives

The ISO 9001:2000 QMS 59

 7.1 Planning of Production Realization
 How do I do it?
1. Base process control on the quality plan
2. Identify critical control points
3. Define factors affecting control of key processes
(production, installation, and services)
 Equipment, work environment, and hazardous
material control
4. Identify the following product requirements:
 Specification, and workmanship standards
 Regulatory standards and codes
 Acceptance criteria

The ISO 9001:2000 QMS 60

 7.1 Planning of Production Realization

5. Review existing monitoring techniques

6. Develop control and approval procedures
7. Develop work/job instructions
8. Develop control equipment maintenance procedures
9. Identify special procedure
10. Develop verification procedures
11. Develop validation procedures
12. Establish appropriate record system to provide confidence
in conformity

The ISO 9001:2000 QMS 61

 7.1 Planning of Production Realization
 Examples of Quality Documents
 Quality plan
 Procedures for:
 product control

 monitoring

 change approval

 maintenance

 Reference standards and codes ( health, safety, environment)

 Work/job instructions
 Product standards, representative samples
 Examples of Quality Records
 Records to show conformity, process change approval
 Process monitoring results and process maintenance

The ISO 9001:2000 QMS 62

 7.1 Planning of Production Realization
 Pitfalls

 There is a lack of demons ratable planning for control

of personnel, machinery, materials, methods of work,
environment, etc.
 No objectives have been set for product or projects
 Inadequate planning for validation and verification!!!
 Inadequate written work instructions/procedures
where their absence could affect quality

The ISO 9001:2000 QMS 63

 7.2 Customer Related Processes
 Why do it?
 To make certain that you will be able to meet your

customers needs before accepting an order.

 What is it?
 Documentation that you understand customers needs and are
sure that all requirements are adequate defined, and that
requirements that differ from those in the contract are
resolved.
 You are to be following a procedure for reviewing requests
for quotations, contracts, or accepted orders.

The ISO 9001:2000 QMS 64

 7.2 Customer Related Processes
 How do I do that?
1. Document the customers requirements
2. Identify pre-contract practices
3. Establish contract or order review procedures
4. Verify the capability to meet requirements
5. Internalize customer requirements and resolve any
differences
6. Maintain control of customer purchase orders that are
written under one contract.
7. Develop a plan for deployment

The ISO 9001:2000 QMS 65

 7.2 Customer Related Processes
8. Establish customer purchase order review procedures
9. Obtain customer agreements
10. Revise/improve procedures
11. Evaluate revisions

Examples of Quality Documents

 Changes of product requirements
 Procedures for reviewing contracts and purchase orders
 Product and service specifications
 Contract or acceptance order

The ISO 9001:2000 QMS 66

 7.2 Customer Related Processes
 Examples of Quality Records
 evidence of ability to meet contract requirements
 Proof of contract and purchase order review
 Results of product reviews and follow-up actions
 Pitfalls
 No contract procedures exist
 Procedures are incomplete or misunderstood
 Records are inadequate, lack of customer involvement
 There is no documented procedure for handling verbal orders
 Inadequate feedback of customer experience

The ISO 9001:2000 QMS 67

 7.2 Customer Related Processes
 Contract Review Process. Process steps include:
 Give all affected parties the opportunity to review the contract
 Use a checklist to verify all contract elements are included
 Provide a way to make changes in the contract
 Reach agreement
 Discuss the result of the contract review
 Discus the quality plan draft.
 What to consider in a contract:
 Reference to product specifications
 Delivery information
 Responsibilities for:
 Nonconforming products and product quality verification
 A service provider list that might contain: performance criteria
and costs.
The ISO 9001:2000 QMS 68
 7.3 Design and Development
 Why do it?
 To make certain that the product you produce meets

all specified design requirements set by the

customer, regulatory agencies, and statutory law.

 What is it?

 Procedures to control, verify and validate product

design and supporting software.
 A design control process in operation that has adequate
resources and assigned responsibilities.

The ISO 9001:2000 QMS 69

 7.3 Design and Development
 How do I do it?
1. Document all customer requirements and any other
pertinent requirements ( input) (sub-clause 7.3.2)
2. Establish a plan for design control and assign
responsibilities
3. Assign qualified staff and provide adequate resources
4. Obtain input from all cross-functional activities to
establish interfaces (7.3.1)
5. Document the control procedures, with milestones
required by the standard

The ISO 9001:2000 QMS 70

 7.3 Design and Development
6. Design output (7.3.3) to:
 Meet input requirements
 Contain reference data
 Meet regulatory and statutory laws
 Consider safety
 Review documentation before release
7. Provide output verification as planned (7.3.5) through:
 Alternative calculations
 Comparison with proven design
 Qualification tests
 Review of documents before release (7.3.4)

The ISO 9001:2000 QMS 71

 7.3 Design and Development

8. Validate the design ( 7.3.6)

 Ensure that design verification is successful
 Confirm that the final product/service meets user needs
 Assess the need for multiple validations

9. Develop change control procedures ( 7.3.7 )

 Identification,
 Documentation,
 Review &
 Approval

The ISO 9001:2000 QMS 72

 7.3 Design and Development

 Examples of Quality Documents

 Documentation f procedures, responsibilities, and
resources for design and development.
 See: 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, and 7.3.7

 Examples of Quality Records

 Group interface communication
 Input approval, Output verification, Review and follow-
up
 Verification results
 Validation results and follow-up
 Change approval

The ISO 9001:2000 QMS 73

 7.3 Design and Development
 Pitfalls
 Design responsibilities/authorities/interfaces are not

specified in writing, or not followed

 Drawings are not under control

 Lack of real design review

 A system exist but not being used

 The tolerances that are specified are impossible to achieve

 Quality standards too high or too low

 Prototype are to subjected to critical examination

 Gauges and test equipment on experimental work are not

calibrated
 Sampling systems are faulty or not agreed to by the

customer

The ISO 9001:2000 QMS 74

Process Design Control

The ISO 9001:2000 QMS 75

 7.3 Design and Development
 Stages in the Design Control Process
1. Design Planning
2. Design Input
3. Design Output
4. Design Review
5. Design Verification
6. Design Validation, and
7. Design Change.

 The difference between design verification and validation:

 verification compares design output to input; it is the
“organizations point of view”.
 validation ensures that the product meets user needs and
requirements; it is the “customers point of view”.
The ISO 9001:2000 QMS 76
 Verification vs. Validation

 The difference between verification and validation:

 Verification compares design output;

 it is the organizations point of view.

 Validation ensures that the product/service meets

user needs and requirements:
 It is the customers point of view.

The ISO 9001:2000 QMS 77

 Stages in the Design Control Process

1. Design  Procedures for each activity established

Planning  Responsibility identified
 Resources adequate; qualified resources
 Interfaces between groups defined
 Communication between groups
established
 Plans updated as design evolves

The ISO 9001:2000 QMS 78

 Stages in the Design Control Process

2. Design  Design requirements identified including:

Input  Acceptance criteria
 Requirements of regulatory

bodies
 Proper functioning

 Safety characteristics

 Adequacy reviewed
 Incomplete, ambiguous, or conflicting
requirements resolved

The ISO 9001:2000 QMS 79

 Stages in the Design Control Process

3. Design  Technical documented to be used from

Output production through servicing (drawings,
specifications, instructions, and
procedures that are crucial to safe
functioning of the product, including
operation, storage, handling,
maintaining, and disposal.
 Output documents to be reviewed before
release of product

The ISO 9001:2000 QMS 80

 Stages in the Design Control Process

4. Design  Scheduled reviews of development status

with all participating groups
Review
 Record of reviews maintained.
 A plan to verify that outputs meets input.
5. Design  Techniques may include:
Verification  Alternate calculations
 Comparison to other designs

 Tests and demonstrations

 Document review

•The difference between verification and validation:

Verification compares design output to input; it is the
organization’s point of view.
The ISO 9001:2000 QMS 81
Stages in the Design Control Process

6. Design  A plan to validate that user needs and

Validation requirements are met.
 Follows successful verification
 Includes defined operating conditions
 Normally done on final product
 May have different validations for
specific intended uses

•The difference between verification and validation:

Validation ensures that the product meets user needs and
Requirements; it is the customer’s point of view
The ISO 9001:2000 QMS 82
Stages in the Design Control Processes

Stage Elements

7. Design  A plan to control design changes before

Change implementation:
 Identify
 Document

 Review

 Approve

The ISO 9001:2000 QMS 83

 Process
Monitoring
and
Validation

The ISO 9001:2000 QMS 84

 Process Control

Human Work Infra-

resources environment structure

Customer Satisfaction
Inputs Process Planned
(product realization or other)
resultsM&M
OUTPUTS

Planning M&M
(methods) processes Monitoring and measurement
Of output:
Purpose of process Control: To obtain confidence in actual
To consistently achieve planned results. Output.
The ISO 9001:2000 QMS 85
 Design and development Acceptance
User
needs

Design
Review
Input

Design
Process

Verification Design
Output
Validation Product

The ISO 9001:2000 QMS 86

Verification and Validation
VERIFICATION VALIDATION

Confirmation through the provision of objective evidence, that

specified the requirements

requirements for specific indented
use of application

have been fulfilled

In design and development,

Concerns the process of examining
the result of an activity a product

to determine conformity with

T the stated requirements user needs
for that activity

The ISO 9001:2000 QMS 87

7.3.5 & 7.3.6 Verification and Validation
VERIFICATION VALIDATION

Confirmation through the provision of objective evidence, that

specified the requirements for specific

requirements indented use or application

have been fulfilled

In design and development,

Concerns the process of examining

the result of an activity a product

to determine conformity with

the stated requirements user needs
for that activity

The ISO 9001:2000 QMS 88

 Validation of Processes
(for special processes)

Human Work Infra-

resources environment structure

Process
Inputs (product realization or other) Planned
M&M
Results
OUTPUTS

Planning M&M
(methods) processes Monitoring and measurement
Purpose of validated process: Of output:
To consistently achieve planned results To obtain confidence in actual
and provide confidence in actual output. Output.
The ISO 9001:2000 QMS 89
 7.5.2 Validation of Process

Human Work Infra-

Resources Environment structure

Customer &
Regulatory Req.
Planned
Results
Inputs Processes M&M
Product/Service Realization
Outputs

Monitoring and
Planning M & M of Measurement of
(methods) Processes Output:
to obtain
Purpose of Process Control: Confidence in
To consistently achieve planned results Actual output
and provide confidence in actual output
The ISO 9001:2000 QMS 90
Process Validation Decision
Diagram
Is process
output fully
verifiable?

Is required
verification
Redesign cost
affective?
product or options
process

Verify
Validate
process
Process
output

The ISO 9001:2000 QMS 91

 The Deming Chain Reaction

Return on
With each improvement, processes Investment
& systems run better & better.
Productivity increases as waste Provide Jobs &
goes down. Customers get better more Jobs
Products, which ultimately
Increases market share leading Stay in Business
to better return on investment.
Increase Market

Decrease Prices

Improve Productivity

Decrease Costs

Improve Quality

The ISO 9001:2000 QMS 92

7.4 Purchasing

The ISO 9001:2000 QMS 93

 7.4 Purchasing
 7.4.1 Purchasing Process
 7.4.2 Purchasing Information
 7.4.3 Verification of Purchased Product

 Why do it?
 To make certain the product received from your
suppliers meets your requirements.
 You in turn, incorporate this product into your
production process to make the product that meets
your customers requirements.
 “product” includes hardware, software, and processed
materials.

The ISO 9001:2000 QMS 94

 7.4 Purchasing
 What is it?
 A means to demonstrate effective operation of
procedures for the purchasing process, which would
include, as appropriate:
 Supplier evaluation
 Purchasing data
 verification of purchased product at supplier side
 Verification of purchased product at organizations site.
 Reminder: those who provide services ( e.g. freight
carriers, outside calibration services) are suppliers, as
well.

The ISO 9001:2000 QMS 95

 7.4 Purchasing
 How do I do it?
1. Evaluate existing purchasing specifications and requirements and
update the procedure if necessary
 Review the process for developing and approving specifications
 Update the procedures, if necessary
2. Begin upgrading specification as required
3. Prepare, review and approve purchasing documents
4. Establish criteria for determining supplier acceptability
 Evaluate and select suppliers based on their ability to meet
requirements, including:
 Product requirements (What is the supplier’s product
quality history?)
 Delivery dependability & quality system capability via
audit/ISO 9001

The ISO 9001:2000 QMS 96

 7.4 Purchasing
5. Develop a supplier classification system
 Start with a list of acceptable suppliers
 Define the extent of control to be exercised over suppliers
based on:
 Type of product
 Impact on final product quality
 Results of previous quality audits
 Previously demonstrated quality capability
 A qualified supplier list should include providers of:
 Raw material
 Tooling & equipment
 Business service, such as consultants and registrars
(auditors)

The ISO 9001:2000 QMS 97

 7.4 Purchasing
6. Establish a record system
 Keep records on:
 Suppliers quality capability
 Established procedures for communicating
requiremmnents and performance with suppliers
 Results of periodic supplier review
 Purchased contracts and supporting data
 review and approval of purchasing data
7. Develop the plan
 Develop a schedule
 Coordinate with receiving inspection
 Assign responsibility for administration

The ISO 9001:2000 QMS 98

 7.4 Purchasing
8. Review/improve procedures
9. Evaluate revisions.
 Examples of Quality Documents
 Purchasing information 7.4.2
 Purchasing process procedures
 Product specifications
 List of acceptable suppliers
 Examples of Quality records
 Results of purchasing evaluation
 Suppler selection, assessment
 Established procedures for communicating requirements
and performance with supplier
 purchase contracts and supporting data
 Review and approval of purchasing data
The ISO 9001:2000 QMS 99
 7.4 Purchasing
 Pitfalls
 Lack of control or no evidence of control of suppliers
 No records of acceptable suppliers
 Violated the rule “ we only buy from approved
suppliers”
 Insufficient data on purchasing documents
 Did not inform suppliers of the QMS requirements
when formalizing contracts
 Not following your own systems, e.g. a telephone order
has no written confirmation

The ISO 9001:2000 QMS 100

 Typical Content of Purchase Orders

1. Quantity
2. Identification and description of the product/service
3. Cost information
4. Billing instructions
5. Shipping instructions
6. Packing instructions
7. Requirements for approval of product, process, or
personnel
8. Requirements for product/service verification and release
to the supplier

The ISO 9001:2000 QMS 101

 Purchase Order

Bill to: #4 Ship to: # 5

------------------------ --------------------------
-------------------------- --------------------------

Quantity #1 Part #-#2 Description #2 Cost/Unit #3 Total Cost #3

Additional Comments: # 6,7&8__________________________________________

__________________________________________

The ISO 9001:2000 QMS 102

 7.5 Production and Service Provision
 7.5.1 Control of production and service provision

 7.5.2 Validation of processes for production and

service provision

 7.5.3 Identification and tracebility

 7.5.4 Customer property

 7.5.5 Preservation of Product

The ISO 9001:2000 QMS 103

 7.5.1 Control of Production and Service Provision

 Why do it?
 To make certain that processes are carried out under controlled
conditions.

 What is it?
 Clause 7.5 calls for controlled conditions during production and
service, including:
 Information describing necessary product characteristics
 Work instructions, where needed
 Use and maintenance of equipment
 Suitable monitoring and measuring devisees
 Monitoring activities
 Processes for release, delivery, and activities after delivery

The ISO 9001:2000 QMS 104

 7.5.1 Control of Production and Service Provision

 How do I do it?
1. Identify customer service requirements
2. Document the service requirements
 Establish procedures
 Perform the service
 Report and verify that the requirements are met.
3. Revise, review and improve procedures
4. Evaluate revisions
 Typical Elements of Servicing
 Control of service manuals
 Supply of service parts ,

The ISO 9001:2000 QMS 105

 7.5.1 Control of Production and Service Provision

 Corrective action
 Quality auditing of activities
 Management of review of audit findings
 Service records
 Examples of Quality Documents
 Servicing requirements
 Servicing procedures and manuals
 Service personnel training requirements
 Measurement equipment and calibration procedures

The ISO 9001:2000 QMS 106

 7.5.1 Control of Production and Service Provision

 Examples of Quality Records

 Personnel training results and certificates

 Measurement equipment and calibration results

 Corrective action

 Service records

 Process validation, as required,see 7.5.2

The ISO 9001:2000 QMS 107

 7.5.1 Control of Production and Service Provision

 Pitfalls

 Lack of liaison between the service department and the

main company

 No procedures

 Procedures are incomplete

 Field measurement equipment is inadequate compared

to equipment used in the factory

The ISO 9001:2000 QMS 108

 7.5.2 Validation of Processes for Production and Service Provision

 Why do it?
 Processes are to be validated in situations where it may
not be possible to verify quality by checking later.

 What is it?
 A plan to provide assurance that process control are
sufficient to ensure meeting all customer requirements

The ISO 9001:2000 QMS 109

 7.5.2 Validation of Processes for Production and Service Provision

 How do I do it?
1. Identify all process factors 9 potential variables) that may affect
the capability of the product or service to meet customer
requirements
2. Ensure that all equipment requirements are identifies and that
equipment and facilities meet these requirements
3. Verify that requirements for operation and administration of
each production element have been verified
4. Confirm that adequate training is available for all personnel
5. Verify that documented procedures are adequate for all
production requirements
6. Ensure adequate record keeping to demonstrate that procedures
are being followed
7. Provide for process revalidation when there is a significant
change in product or production method

The ISO 9001:2000 QMS 110

 7.5.2 Validation of Processes for Production and Service Provision

 Examples of Quality Documents

 Listing of potential variable factors affecting the process

 Materials

 Operation

 Environment

 Utilities

 Training criteria required for qualified personnel

 Examples of Quality Records

 Records of continuous monitoring and control of critical
process characteristics
 Evidence of analysis of process, equipment, and personnel
records

The ISO 9001:2000 QMS 111

 7.5.2 Validation of Processes for Production and Service Provision

 Pitfalls
 Overlooking factors that are essential to meeting customer
requirements
 Lack of demonstrable planning for control of personnel,
equipment, material, methods of work
 No objectives have been set for product or project
 Inadequate planning for validation and verification
 Inadequate written work instruction/procedures where their
absence could affect quality.

The ISO 9001:2000 QMS 112

 7.5.3 Identification and Tracebility
 Why do it?
 To make certain that your product is properly identified at
all stages of production, and to avoid errors that can cause
scrap and rework
 What is it?
 A provision for identifying incoming materials, in-process
product, and finished product.
 Where required, it is a record that tracks the history, usage,
and location of product.
 Identification: the ability to separate two or more materials
or products
 Tracebility: the ability to separate material or product by
individual unit, batch, lot, or run.

The ISO 9001:2000 QMS 113

 7.5.3 Identification and Tracebility
 How do I do it?
1. Establish customer and or regulatory requirements
2. Document existing tracebility practices, including:
 From your supplier
 In your plant (develop flowchart)
 To your customer
 At / after installation
3. Revise/improve tracebility procedures
4. Consider types of tracebility/identification:
 Unit identification (serial Number)
 Lot identification
 Product date code

The ISO 9001:2000 QMS 114

 7.5.3 Identification and Tracebility
5. Consider methods of identification:
 Paper versus electronic
 Labeling
 Bar codes
6. Determine the following about the records to be kept:
 Availability,
 retention times, and
 Responsibility
 Examples of Quality Documents
 Procedures for product and lot identification at all
stages, such as:
• Receiving activities, production, final product
acceptance, warehouse distribution
 Product lists
The ISO 9001:2000 QMS 115
 7.5.3 Identification and Tracebility

 Examples of Quality Records

 Material batches, lots, or units at all stages, such as:
 Receiving, production, final product acceptance,

warehousing and distribution.

 Pitfalls
 Components, materials, or products are unmarked
 Batches are stacked on top of each other, when batch
identification is required
 A stage of operation is missing, when tracebility is
necessary

The ISO 9001:2000 QMS 116

 7.5.4 Customer Property
 Why do it?

 To make certain the property you receive from your

customers will be incorporated into your product and
ultimately meet all of your customers requirements.

 What is it?
 Procedures for verification, storage, and maintenance of
customer-supplied property. The requirement to provide
acceptable product is implied.

The ISO 9001:2000 QMS 117

 7.5.4 Customer Property
 How do I do it?

1. Determine the existence of customer-supplied property

(including test equipment)
2. Establish practice for :
 verification,

 storage &

 maintenance

3. Revise/improve your procedures

4. Evaluate revisions.

The ISO 9001:2000 QMS 118

 7.5.4 Customer Property
 Examples of Quality Documents
 Procedures for verification process, storage process,and
maintenance process
 Procedures for controlling nonconformances

 Examples of Quality Records

 Receipts and verification results
 Rejected product (lost, damaged, unusable)
 Product inventory record
 Reports to customers

 Pitfalls
 Items are damaged or badly stored
 Customer-supplied property is not adequately identified.
The ISO 9001:2000 QMS 119
 7.5.5 Preservation of Product
 Why do it?
 To make certain that your procedures for identification, handling,
storage, packaging, preservation, protection, and delivery of
product are adequate, and to protect the integrity of product at all
stages.
 What is it?
 Adequate procedures at all stages, such as:
 Incoming material, in-process product,finished product
 Conditions during delivery as specified by the customer
 Prevention of damage or deterioration
 Secure storage and appropriate receipts and dispatch methods
 Packaging, packing, and marking process
 Protection of product after inspection and test during storage and
during delivery to destination.

The ISO 9001:2000 QMS 120

 7.5.5 Preservation of Product
 How do I do it?
1. Identify the critical points in the process
2. Review available information, e.g. damage rates, shelf life.
3. Generate documentation for:
 Packaging designs, unique customer packaging
requirements.
 In-process handling procedures, warehouse procedures
 Inventory/ stock management procedures
 Transportation techniques/carrier selection
 Storage, preservation, protection, and segregation methods
 Environmental impact
4. Revise and improve procedures
5. Evaluate revisions.
The ISO 9001:2000 QMS 121
 7.5.5 Preservation of Product

 Examples of Quality Documents

 Handling procedures,
 Storage procedures, including receipt and dispatch
authorization
 Preservation and packaging requirements
 Delivery requirements
 Packaging, labels, and shipping containers formats

 Examples of Quality Records

 Verification of storage condition

 Storage dates, expiration dates, and delivery dates as

needed
 Verification results on method of delivery

The ISO 9001:2000 QMS 122

 7.5.5 Preservation of Product

 Pitfalls
 Procedures are inadequate,
 Materials are:
 Damaged/corroded

 Over-age

 Unprotected

 Unidentified

 Nonconforming

 Lack of security;free access to a large inventory

 Product damaged in delivery to customer.

The ISO 9001:2000 QMS 123

 Typical Elements of Preservation of Product
 Identification  Examples of product, packaging, and master
carton marking, as required or needed
 Serial number
 Date code
 Regulatory marking requirements
 Linkage to test and inspection records
 Traceability see 7.5.3

 Protect the product using containers, pallets, or

 Handling work platforms
 Install and maintain conveyors and other
automated transfer systems for product protection
 Train operators in awareness of product
protection
 Operate lift trucks, loaders and other vehicles in a
safe manner to minimize damage

The ISO 9001:2000 QMS 124

 Typical Elements of Preservation of Product
 Packaging  Develop unit pack and master packs to
provide appropriate protection while in
organization’s plant and during shipping.
 Storage
 Provide adequate space and facilities
 Ensure cleanliness
 Maintain an appropriate temperature and
humidity
 Provide appropriate security and access
to storage areas
 Provide for appropriate identification
marking and traceability

The ISO 9001:2000 QMS 125

 Typical Elements of Preservation of Product
 Protection  Control the temperature and humidity
 Segregate product where necessary.

 Delivery  Provide for proper protection after

release, until organization is no longer
responsible for distribution handling,
per contract.
 Consider the delivery method
 Control the temperature and humidity
 Provide security during delivery

The ISO 9001:2000 QMS 126

 7.6 Control of Monitoring and Measuring Devices

 Why do it?
 To make certain that inspection, measuring, and test
equipment is capable of consistently providing specified
measurement requirements, so that proper decisions can be
made for control and acceptance of product.

 What is it?
 Process to ensure that equipment is properly calibrated and
will remain so.
 Also, it is the assurance that measurement uncertainty is
known and consistent with required measurement capability

The ISO 9001:2000 QMS 127

 7.6 Control of Monitoring and Measuring Devices

 How do I do it?
1. Identify all inspection and test equipment
 Measurements to be made
 Accuracy required
2. List equipment and software available to conduct
inspections/tests (fixed and portable)
 Laboratory equipment, inspection and test
equipment
 Production machinery, jigs, fixtures, templates
 Test software

The ISO 9001:2000 QMS 128

 7.6 Control of Monitoring and Measuring Devices
3. Identify recognized calibration requirements and verification
procedures for each piece of equipment
 Fixed and portable equipment
 Required measurement capability
 Know measurement uncertainty
 Calibration schedules
4. Review and flowchart existing procedures and
documentation for:
 Measurements to be made,
 Calibration procedures, measurement uncertainty
 Identification of calibration status on equipment
 work environment control, out-of-calibration action
 Handling and storage, rechecking intervals, and
 Safeguarding against unauthorized adjustments

The ISO 9001:2000 QMS 129

 7.6 Control of Monitoring and Measuring Devices
5. Revise/improve procedures
6. Consider hard copy versus electronic records
7. Evaluate revisions.
 Examples of Quality Documents
 Required measurements and their accuracy
 Listing of all measurement, inspection, and test equipment
affecting quality,
 Verification and calibration schedule
 Basic for calibration ( national standard)
 Calibration process,
 Software verification process
 Corrective action procedure
 Verification and calibration schedule

The ISO 9001:2000 QMS 130

 7.6 Control of Monitoring and Measuring Devices

 Examples of Quality Records

 Calibration and verification results

The ISO 9001:2000 QMS 131

 7.6 Control of Monitoring and Measuring Devices

 Pitfalls
 There is no real control system

 No one is responsible for operating the system

 Equipment that should be in the system is not in the

system (particular in research and development areas)

 Equipment is not identified

 There is no tracebility to the national or international

standard
 When equipment is found out of calibration, no

assessment is made on the impact on previous results

 Not ensuring that adjustable equipment is not altered

to invalidate calibration.

The ISO 9001:2000 QMS 132

 8. Measurement, Analysis and Improvement

 8.1 General
 8.2 Monitoring and measurement
 8.2.1 Customer satisfaction
 8.2.2 Internal audit
 8.2.3 Monitoring and measurement of processes
 8.2.4 Mentoring and measurement of product
 8.3 Control of nonconforming products
 8.4 Analysis of data
 8.5 Improvement
 8.5.1 Continual Improvement
 8.5.2 Corrective Action
 8.5.3 Preventive Action

The ISO 9001:2000 QMS 133

 Clause 8
Measurement, Analysis
and
Improvement

The ISO 9001:2000 QMS 134

 8.1 General

 Why do it?
 To make certain that monitoring and measurement
activities needed to ensure conformity and accomplish
improvement are defined, planned, and implemented.
 What is it?
 Demonstration that a plan for measuring, analyzing,
and continuously improving procedures and product or
service exists and is in operation. This includes making
use of statistical techniques where applicable.
 What`s new?
 The purpose of monitoring and measurement activities
now includes achieving improvement

The ISO 9001:2000 QMS 135

 8.1 General
 How do I do it?
 Define , plan,and implement the elements listed in the
remaining portions of Clause 8. These included:
 Monitoring and measurement of :
 Customer satisfaction

 QMS internal audit

 Processes

 Product

 Control of nonconformity
 Analysis of data
 Corrective action
 Preventive action

The ISO 9001:2000 QMS 136

 8.2 Monitoring and Measurement

 8.2.1 Customer Satisfaction

 8.2.2 Internal Audit
 8.2.3 Monitoring and Measurement of Process
 8.2.4 Monitoring and Measurement of Product

 8.2.1 Customer Satisfaction

 Why do it?
 To make certain that the total of all efforts to meet

customer requirements actually results in satisfied

customers.
 What is it?
 An active plan to search out and put to use

information that reflects the degree of satisfaction

being experienced by your customers.

The ISO 9001:2000 QMS 137

 8.2.1 Customer Satisfaction

 How do I do it?
1. Refer to sub-clause 7.2 customer-related processes and
sub-clause 7.2.3 customer communication

2. Establish a procedure for compiling, analyzing, and acting

upon information contained in customer feedback data,
reflecting the level of customer satisfaction (sub-clause
8.4)

3. Incorporate customer satisfaction measures into continual

improvement efforts (sub-clause 8.5)

The ISO 9001:2000 QMS 138

 8.2.1 Customer Satisfaction
4. Constantly look for additional sources of information
reflecting the perception of customer satisfaction,
appropriate to your type of business.
 This may include: service calls, product return, repair
part usage, changes in market share, and downtime
affecting customers.
5. Consider practicality of conducting customer satisfaction
survey,using interviews with customers and consumers.
6. Where your product is used by your customers as a
component of their product, consider working with your
immediate customers to develop feedback from later
production or distribution stages

The ISO 9001:2000 QMS 139

 8.2.1 Customer Satisfaction
 Examples of Quality Documents
 Procedures for retrieving, analyzing, and acting on customer
complaint data
 Procedures for conducting surveys of customer
satisfaction/dissatisfaction
 Examples of Quality Records
 Rate of customer returns and complaints for quality reasons
 Record of action taken in response to problems identified
through customer satisfaction data.

 Pitfalls
 There is no procedure for obtaining and acting upon
customer complaints/returns
 Available data reflecting customer satisfaction is overlooked.

The ISO 9001:2000 QMS 140

 8.2.2 Internal Audit
 Why do it?
 To ensure quality activities meet requirements and
demonstrate the effectiveness of your QMS. This strives to
ensure the capability of all elements of quality practice.
 What is it?
 A plan and procedures for conducting internal audits of your
QMS.
 Schedule audit according to status and importance of

activity
 Carry out audits using independent personnel

 Document audit results and any follow-up

 Communicate audit results to appropriate personnel,

including management
 Initiate corrective action

 Verify and record effectiveness of the corrective action

taken. The ISO 9001:2000 QMS 141

 8.2.2 Internal Audit
 How do I do it?
 Refer to ISO 190011 (Guidelines for environmental and
quality auditing)
1. Identify the activities to be audited
2. Establish the qualifications of audit personnel, including:
 Training,experience, skills, availability& independence
3. Develop (or update) audit procedures to include:
 Planning,
 responsibilities,
 requirements,
 records and
 report of results

The ISO 9001:2000 QMS 142

 8.2.2 Internal Audit

4. Conduct an initial (trial) audit

 Evaluate the adequacy of procedures
 Determine the effectiveness of the procedures
 Verify compliance
 Determine the suitability of the working environment

5. Establish a permanent quality audit program

 Examples of Quality Document

 Internal audit schedule
 Procedures for conducting and internal audit
 List of qualified auditors

The ISO 9001:2000 QMS 143

 8.2.2 Internal Audit
 Examples of Quality Records
 Results of internal audits

 Records of management audit review

 Records of corrective action taken

 Pitfalls
 No system exists

 There is no corrective action on findings

 Auditors used are not adequately trained

 No independent person is present to conduct the

audit
 Documents and records are incomplete

The ISO 9001:2000 QMS 144

 Establishing an Internal Quality Audit Process

1. Develop an overall audit plan

2. Assign audit personnel
3. Schedule audits on the basis of importance and
status
4. Review the effectiveness of any previous
corrective action
5. Conduct the audit
6. Submit the audit report to management
7. Management to review noncompliance's
8. Management to take corrective action on
noncompliance's

The ISO 9001:2000 QMS 145

 8.2.3 Monitoring and Measurement of Processes

 Why do it?

 To make certain that processes conform to all

requirements at each production stage, to identify
nonconforming processes at the earliest possible stage,
and to facilitate corrective action and continual
improvement.

 What is it?

 Demonstrate that process-monitoring and process

control procedures are in operation to ensure that
product meets indented purpose

The ISO 9001:2000 QMS 146

 8.2.3 Monitoring and Measurement of Processes
 How do I do it?
1. Evaluate the measuring and monitoring needs of each
stage in the realization process.
2. Consider alternative monitoring and measurement
methods appropriate for each stage. Refer to resource
material on improving work processes, flowcharting,
process control, and process capability
3. Put into use the selected appropriate monitoring and
measurement procedures. Provide for adequate
administration, training, and documentation
4. Continually improve practices
5. Evaluate revisions.

The ISO 9001:2000 QMS 147

 8.2.3 Monitoring and Measurement of Processes
 Examples of Quality Document
 Process for determining a need for statistical techniques
 Listing of applications of statistical techniques

 Examples of Quality Records

 Results of statistical techniques that are applied

 Pitfalls
 Not using statistical techniques when they are necessary
 Ineffective use of statistical methods
 Ineffective use of sampling systems
 Over-control where not called for.

The ISO 9001:2000 QMS 148

 Typical Applications for Statistical Methods
 Process control & Process-capability studies
 Determination of quality levels in sampling plans
 Data analysis, performance assessment, and non-conformity
analysis
 Process improvement safety evaluation & risk analysis
 Trend identification,
 Cause-effect relationship identification
 Analysis of variance and regression analysis, to provide
quantitative process model
 Test of significance, for decision making

The ISO 9001:2000 QMS 149

 8.2.4 Monitoring and Measurement of Products
 Why do it?
 To make certain that product conforms to requirements at
each production stage, to identify nonconforming product at
the earliest possible stage, and to facilitate corrective action
and continual improvement.

 What is it?
 Demonstration that inspection and test procedures are in
operation to ensure that product conforms to specified
requirements. These may include:
 Incoming product
 Procedures for inspections and verification

 Holding or controlling until verified

 The amount that you do depends upon the level of

supplier control
The ISO 9001:2000 QMS 150
 8.2.4 Monitoring and Measurement of Products
 In-process product
 Procedures for identifying and inspection product

 Positive control until tests are completed

 Finished product
 Procedures to ensure that inspections and tests are

completed
 Product conforms to requirements

 Product is not released until tests are completed

The ISO 9001:2000 QMS 151

 8.2.4 Monitoring and Measurement of Products

 How do I do it?
1. Establish a separate plan or procedure for each of the
following that apply:
 Receiving inspection and testing
 In-process inspection and testing
 Final inspection and testing
2. Determine the policy, e.g. “do not use until verified”
3. Identify categories of the product that are affected
4. List all quality characteristics that are subject to
inspection and test
5. Ensure that the procedures for identifying specified
requirements are available

The ISO 9001:2000 QMS 152

 8.2.4 Monitoring and Measurement of Products
6. Provide for complete and current procedures at the
point of inspection/test

7. Provide for positive product identification/recall for

urgent release

8. Release product only when successful tests/records are

complete

9. Revise/improve procedures

10. Evaluate revision

The ISO 9001:2000 QMS 153

 8.2.4 Monitoring and Measurement of Products

 Examples of Quality Documents

 Procedures for test and inspection criteria for:
 Receiving testing and inspection

 In-process inspection and testing

 Final inspection and testing

 Examples of Quality Records

 Test results of inspection and testing
 Incoming,

 in-process, and

 final

 Responsible authority for release noted

The ISO 9001:2000 QMS 154

 8.2.4 Monitoring and Measurement of Products

 Pitfalls
 Lack of control at receiving, e.g. material that requires
testing/inspection goes directly to inventory
 Material that is released to production is not identified, nor
under complete control
 Specified inspections or tests are not carried out
 Records of inspection/tests are missing
 Final inspection or test is bypassed, or company product
release procedures are bypassed
 Reworked product is not fully reinspected.

The ISO 9001:2000 QMS 155

 8.3 Control of Nonconforming Product
 Why do it?
 To make certain that you do not use or unintentionally install
nonconforming product

 What is it?
 Procedures in operation that will help you:
 Identify nonconforming products
 Evaluate degree and extent of nonconformance
 Segregate product physically, where practical, or through clear
identification
 Define who is responsible for authorizing disposition
 Dispose of nonconforming product according to the quality plan or
procedures. Authorize disposition according to:
 Rework to meet specification

 Repair to make fit for use but not as designed

 Acceptance for use, with or without repair

 Notify concerned parties.

The ISO 9001:2000 QMS 156

 8.3 Control of Nonconforming Product
 How do I do it?
1. Review and document your procedures for:
 Identification, documentation, control, segregation and
prevention of inadvertent use/installation
2. Document the procedures for disposition (disposal),
notification, and classification
3. Assign authority for disposition approval
4. Document the procedures for reinspection of repair or
rework
5. Document the concession reporting and handling
procedures
6. Revise and approve your procedures
7. Evaluate revisions.

The ISO 9001:2000 QMS 157

 8.3 Control of Nonconforming Product

 Examples of Quality Documents

 Nonconformity control activities
 Statement of responsibility for review and authority for
disposition of nonconforming products
 Procedure for control of nonconforming product
 Statement in contract on authority for acceptance by waiver
concession or repair

 Examples of Quality Records

 Results of investigation and disposition of nonconformance
 Reinspection of reworked or repaired product
 Notification of concerned parties
 Agreement of acceptance of waiver concessions

The ISO 9001:2000 QMS 158

 8.3 Control of Nonconforming Product

 Pitfalls

 Nonconforming material/product is not identified, or is

being held in a nonspecified area
 There is no defined responsibility for review and disposition
of rework
 There is no specified rework requirement
 Repair or rework is not reinspected.

The ISO 9001:2000 QMS 159

 8.4 Analysis of Data
 Why do it?

 To ensure your QMS is effective, and having identified

places in your process where the collection and analysis
of data is necessary to ensure quality.

 What is it?

 A process for identifying the need for collecting the

data required for establishing, controlling, and
verifying process capability and product quality.
Where the need is established, you are to maintain and
document procedures for data collection and analysis

The ISO 9001:2000 QMS 160

 8.4 Analysis of Data
 How do I do it?

1. Identify existing applications and procedures

2. Review status, correctness, and effectiveness of data
collection and analysis applications such as in:
 Establishing process capability
 Identifying potential problems
 Verifying product characteristics
3. Examine the quality plan for additional applications
4. Provide for additional applications
5. Evaluate the effectiveness and value of new applications.

The ISO 9001:2000 QMS 161

 8.4 Analysis of Data
 Examples of Quality Documents
 Process for determining a need for data collection and analysis

application
 Listing of application

 Examples of Quality Records

 Results of statistical techniques that are applied

 Data on the QMS

 Pitfalls
 Not analyzing data when necessary

 Ineffective use of analytical methods

 Note: the analysis of data shall provide information relating to:

 Customer satisfaction, conformity to product requirements

 Characteristics and trends of processes and products including

opportunities for preventive action, and

 Suppliers.

The ISO 9001:2000 QMS 162

 4. Analysis of Data
 Typical Applications of Data Collection and Analysis
 Market analysis & product design
 Dependability specification, longevity, and durability
prediction
 Process-control and process-capability studies
 Determination of quality levels in sampling plans
 Data analysis, performance assessment, and nonconformity
analysis
 Process improvement
 Safety evaluation and risk analysis
 Trend identification
 Cause-effect relationship identification

The ISO 9001:2000 QMS 163

 8.5 Improvement
 8.5.1 Continual Improvement
 8.5.2 Corrective Action
 8.5.3 Preventive Action
 Why do it?
 To make certain that there is an active plan for continual

improvement in your QMS.

 What is it?
 A constant search for ways to improve the QMS.

Investigation and elimination of causes of nonconforming

product, at any point in the process, distribution, and
installation
 It is the procedures in use to prevent occurrence of

nonconforming product in the first place.

The ISO 9001:2000 QMS 164

 8.5 Improvement
 How do I do it?
1. Separately identify procedures for corrective action
(actual nonconformities) versus preventive action
( potential nonconformities)
2. Carry out corrective action (see problem solving
techniques)
 Assign responsibility to an individual or team
 Review the number of significance of complaints
and returns. Evaluate their importance.
 Prepare a flowchart of the present system ( see
flow charting a process)
 Evaluate the effectiveness of present practices

The ISO 9001:2000 QMS 165

 8.5 Improvement

 Provide resources:
 Expertise,
 Records, instruction procedures,
 and defective product for analysis
 Revise/improve procedures to:
 Investigate the cause of nonconformities
 Analyze all processes
 Determine a final “fix” e.g.action plan
 Initiate action to prevent recurrence
 Apply new control methods
 Make permanent changes
 Evaluate revised procedures.

The ISO 9001:2000 QMS 166

 8.5 Improvement
3. Carry out preventive action. (See problem solving)
 Assign responsibility to an individual or team
 Review existing preventive action activities
 Prepare a flowchart of the present system
 Evaluate the effectiveness of present practices
 Identify appropriate sources of information:
 Reports of purchased material’s quality
 Processes, waiver concessions
 audit reports, customer complaints and
 service reports

The ISO 9001:2000 QMS 167

 8.5 Improvement
 Identify activities in which preventive action activities can be
established or enhanced examples
 product design,

 product development and

 process control

 Make use of preventive action tools such as Failure Mode and

Effect analysis
 Modify and continuously improve procedures to:
 Identify potential nonconformities

 Initiate action to prevent occurrence

 Apply new controls

The ISO 9001:2000 QMS 168

 8.5 Improvement

 Report preventive actions that are taken

 Evaluate revised procedures
 Follow-up on the effectiveness of the action taken
 Submit actions for management review

 Examples of Quality Document

 Customer complaint handling procedures
 Corrective action procedures (8.5.2)
 Preventive action procedures (8.5.3)

The ISO 9001:2000 QMS 169

 8.5 Improvement

 Examples of Quality Records

 Records of nonconformances meriting assignment to the

corrective action process
 Customer complaints
 Record of action taken on customer complaints
 Corrective action results (sub-clause 8.5.2)
 Preventive action results ( sub-clause 8.5.3)

The ISO 9001:2000 QMS 170

 8.5 Improvement

 Pitfalls

 A corrective action plan exists on paper, but is not being

followed
 No person has been assigned responsibility for
corrective/preventive action
 No formal preventive action plan exists
 There is an emphasis on “troubleshooting rather than
prevention and continual improvement
 The capability to prevent recurrence of product failures is
inadequate.

The ISO 9001:2000 QMS 171

 The Baldrige Criteria for Performance Excellence

Organizational Profile:
Environment, Relationship, and Challenges

2 5
Strategic Human Resource
Planning Focus
1 7
Leadership Business
Results
3 6
Customer & Process
Market Focus Management

4
Information and Analysis
The ISO 9001:2000 QMS 172
The three-Phase approach to Organizational Success

Strategic Planning

a balanced scorecard

Continuous
Self- Improvement Improving
Assessment Performance
value-based
Baldrige cost management
criteria

The ISO 9001:2000 QMS 173

Improving

Work

Process

The ISO 9001:2000 QMS 174

 Improving Work Processes (1of5)
 From time to time your work process may have to be
improved. This may occur, if you:
 Are not meeting your customer needs and requirements
 Have not satisfied the requirements of the regulatory or
surveillance audits, or
 Just want to be better
 To help you do this, use:
 Problem-Solving/Process-improvement Model
 a systematic approach to focus on a problem.
identify root cause (s) and develop and
implement solutions and action plans

The ISO 9001:2000 QMS 175

 Improving Work Processes (2of5)
 Flowcharting a Process
 A graphic tool for documenting and
understanding the flow or sequence of
events in your work process
 Process Control
 The use of data as feedback on how a
process is performing

The ISO 9001:2000 QMS 176

 Improving Work Processes (3of5)

 Collecting, organizing, and reporting data and information

 In problem solving/process improvement, controlled

documentation, and record keeping, you will need to
understand some basic points on controlling data and how
best to present the data graphically

 Gap Analysis
 Identifying missing process elements or undocumented

procedures

The ISO 9001:2000 QMS 177

 Process Improvement Model (4of5)
• PLAN

1. Select the problem/process that will be addressed first

(or next0 and describe the improvement opportunity
2. Describe the current process surrounding the
improvement opportunity
3. Describe all the possible causes of the problems and
agree on the rot cause(s)
4. Develop an effective and workable solution and action
plan, including target dates for improvement

The ISO 9001:2000 QMS 178

 Process Improvement Model (5of5)
 DO

5. Implement the solution or process change.

 Check
6. Review and evaluate the result of the change

 ACT

7. Reflect and act on learning

The ISO 9001:2000 QMS 179

The ISO 9001:2000 QMS 180