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Introduction to ISO 9001:2000

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Outline

• ISO 9000 is the most successful standard in ISO history and is accepted world-wide

Over 500,000 registrations world-wide with registrants in over 150 countries from all continents

• Being applied in a wide variety of organizations

• Over 40 “sectors” or industry classifications - led by: electrical/optical equipment, metal products,

construction, machinery, wholesale/retail trade

- but growing in acceptance by many others, including: engineering, information technology, health/social work, utilities, transportation, public administration, education, other services.

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ISO 9000:2000 is based on Eight ISO 9000:2000 is based on Eight Quality Management PrinciplesQuality Management Principles

• 1-Customer Focus• 2-Leadership• 3-Involvement of People• 4-Process Approach• 5-System Approach• 6-Continual Improvement• 7-Factual Approach to Decision Making• 8-Mutually Beneficial Supplier

Relationships

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1- Customer Focus1- Customer Focus

• Organizations depend on their customers and therefore should:

understand current and future customer needs,

meet customer requirements, and

strive to exceed customer expectations.

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2- LeadershipLeadership

• Leaders should:

establish unity of purpose and direction of the organization, and

create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

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3- Involvement of People3- Involvement of People

• People at all levels are the essence of an organization, and

their full involvement enables their abilities to be used for the organization’s benefit.

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4- Process Approach4- Process Approach• Organizations need to do more than

simply monitor process outputs, (typically through inspection activities)

they must also control all process inputs, (people, facilities/equipment, material and methods)

Process Approach(contd)Process Approach(contd) and, they must establish appropriate

controls over the transformation activities (if desired results are to be achieved consistently and efficiently)

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What is a Process?

Activity that transforms input into output

ActivityInput Output

Resources:PeopleFacilities/EquipmentMaterialMethods

Results:ProductsServicesPerformance

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How is a Process Managed?

ActivityInput Output

Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

Monitor & Measure the Processmake sure the inputs are right, the transformation

activities consistently work, and the desired results are achieved, then - improve the process as needed

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How is a Process Measured?

ActivityInput Output

Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

EfficientNo Waste

EffectiveDesired Results Achieved

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5-System Approach5-System Approach

• Organizations must understand a system is a set of interrelated processes, and

the output of one process is the input to one or more subsequent processes, so ...

It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective

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6-Continual Improvement6-Continual Improvement

• Continual improvement of the organization’s overall performance should be a permanent objective:

Improvement must be a planned activity if the

organization desires to improve overall performance and capabilities.

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Plan Do

Act Check

QMS

Results

Baseline Performance

Improvement Objective

Improve Process

through PDCA Cycle

Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed

to Achieve and Sustain Desired Results

The QMS must be used for continuous improvement ...

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7- Factual Approach to7- Factual Approach toDecision MakingDecision Making

• Effective decisions are:

based on the analysis of data and information.

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8- Mutually Beneficial8- Mutually BeneficialSupplier RelationshipsSupplier Relationships

• An organization and its suppliers are truly inter-dependent, and

a mutually beneficial relationship enhances the ability of both to create value.

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Role of ISO 9000:2000

• Defines quality managementprinciplesterms and definitionsfundamentals:

- systems approach- process approach- continual improvement

• ISO 9000:2000 is a “normative reference” (i.e. part of the requirements)

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Role of ISO 9001:2000

• Specifies quality system requirements:

for achieving customer satisfaction applicable to entire enterprise

note: “permissible exclusions” (likedesign) are limited to

requirementswithin Clause 7 - Product

Realization,and your registrar must verify theyare not part of your business

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Role of ISO 9004:2000

• Provides guidelines for performance improvement, based on

quality management principles and approaches defined in ISO 9000, and

continual improvement of the quality management system itself

note: however, ISO 9004 is NOT intended as aguideline for implementing or assessingimplementation of ISO 9001 requirements

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ISO 9001 and ISO 9004are the “Consistent Pair”

comprised of the following 8 clauses:1. Scope

2. Normative references (part of the requirements)

3. Terms and definitions

4. Quality management system

5. Management responsibility

6. Resource management

7. Product (and/or service) realization

8. Measurement, analysis & improvement

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Continual Improvement of theQuality Management System

The Process-Based QualityManagement System

ManagementResponsibility

ProductRealization

ResourceManagement

MeasurementAnalysis &

Improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Product

Input Output

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ISO 9001:2000 implements the PDCA improvement cycle• Plan

Clause 5. Management responsibility - everything flows from Management who define the requirements for the system

Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system

• DoClause 7. Product (and/or service)

realization - the necessary process are established and carried out

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ISO 9001:2000 implements the PDCA improvement cycle• Check

Clause 8. Measurement, analysis and improvement - processes and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported

• ActClause 8. Measurement, analysis and

improvement - acting upon data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process (Clause 5.6)

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Clause 4 - Quality management system

• 4.1 General requirements - New: must define processes to be managed (including out-sourced processes - which typically include design, training, calibration, heat treat, etc.); determine the sequence and interaction of these processes; determine the criteria and methods needed to ensure these processes are effective; and take actions to improve these processes

• 4.2 Documentation requirements - New: documentation requirements less prescriptive; however, at a minimum must include a quality manual and the following six documented procedures: Control of Documents (Clause 4.2.3), Control of Quality Records (Clause 4.2.4), Internal Audits (Clause 8.2.2), Control of Nonconforming Product (Clause 8.3), Corrective Action (Clause 8.5.2), and Preventive Action (Clause 8.5.3).

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Clause 5 - Management responsibility

• 5.1 Management commitment - New: top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness

• 5.2 Customer focus - New: customer requirements (identified per Clause 7.2.1) must be met with the aim of enhancing customer satisfaction (a “perception” that must be measured per Clause 8.2.1)

• 5.3 Quality policy - New: quality policy must include commitment to meeting requirements and continual improvement of the effectiveness of the QMS, provide a framework for establishing/reviewing measurable quality objectives; and, quality policy must be periodically reviewed for continuing suitability

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Clause 5 - Management responsibility

• 5.4 Planning - New: establish measurable quality objectives at relevant functions and levels in the organization needed to meet product requirements (identified per Clause 7.1 a); and identify and plan quality system processes (identified per Clause 4.1)

• 5.5 Responsibility, authority and communication - New: management representative must promote awareness of customer requirements throughout the organization; internal communications regarding the effectiveness of the quality system must be established

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Clause 5 - Management responsibility

• 5.6 Management review - New: evaluate the need for changes to the quality system (including policy and objectives) by reviewing specified inputs (improvement opportunities) and reporting specified outputs (related management actions and resource needs)

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Clause 6 - Resource management

• 6.1 Provision of resources - New: determine and provide resources needed to implement and improve the QMS and address customer satisfaction

• 6.2 Human resources - New: determine needed competencies, evaluate effectiveness of actions taken to satisfy competency needs; and ensure employees are aware of the importance of their activities and how they contribute to achieving quality objectives

• 6.3 Infrastructure and 6.4 Work Environment - New: determine and manage the infrastructure (buildings, workspace, utilities, equipment and support services), as well as the work environment needed to achieve product conformance

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Clause 7 - Product realization

• 7.1 Planning of product realization - New: determine measurable quality objectives for contracts, projects and products

• 7.2 Customer-related processes - New: define the processes for communicating with the customer with regards to product information; inquiries, contracts or order handling, and customer feedback, including complaints

• 7.3 Design and development resources - New: design output to include appropriate information for purchasing, production and for service provision

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Clause 7 - Product realization

• 7.4 Purchasing - New: establish criteria for supplier evaluation and selection, and periodic re-evaluation

• 7.5 Production and service provision - New: Nothing, essentially the same as requirements contained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 of ISO 9001:1994

• 7.6 Control of measuring and monitoring devices - New: validate software used to verify product

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Clause 8 - Measurement, analysis and improvement

• 8.1 General - New: plan and implement monitoring, measurement, analysis and improvement processes

• 8.2 Monitoring and measurement - New: must measure and monitor customer satisfaction (note: customer satisfaction is any information relating to the customer’s “perception” of the organization’s ability to meet customer requirements); internal auditors must now be objective and impartial (vice “independent); and processes used to manage the quality system must be measured/monitored to the degree necessary to demonstrate they achieved planned results

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Clause 8 - Measurement, analysis and improvement

• 8.3 Control of nonconforming product - New: Nothing, essentially the same as requirements contained in Clause 4.13 of ISO 9001:1994)

• 8.4 Analysis of data - New: analyze data to determine quality system effectiveness and to provide information on customer satisfaction, supplier performance, product conformance, and process/product characteristics and trends used to identify opportunities for preventive action

• 8.5 Improvement - New: must improve effectiveness of the quality management system (note: accomplish through the use of quality policy, objectives, audit results, analysis of data, corrective/preventive actions, and management review)

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ISO 9000:2000 standards released December 2000

• The final International Standard (IS) was released 15 December 2000 and is available now

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Thank you