ISO 9001:2008

An Overview of the International Quality Management Standard

Isocert Solutions.com

PURPOSE OF THIS SEMINAR

OTo introduce the ISO 9001:2008 standardOTo discuss the implications on an

OrganizationOTo discuss a strategy for implementation

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What does ISO mean?O It is commonly believed that it is an acronym

for International Standards Organization. O This is false

O ISO is the Greek word for equalO The aim of ISO is to equalize the basic structure and

vocabulary of businesses worldwide.O With todays global sourcing of materials and components

it is critical for producers of products and services to be “speaking the same language”

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ISO 9001:2008

First Introduction toachieve confidence fortwo-party contracts

Phase I Revision toprovide compliance for third-party registration

Phase II Revision toattain qualityimprovement and customer value

1987

1994

2000

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History of ISO 9001 Focus

ISO 9001:2008O Current Revision was published in

November 2008O Contains no new requirements to the

previous 2000 versionO It is called an amendment because it only

adds clarifications to the prior revisionO It does however, change the name from

Quality Management Standard to Business Standard

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ISO 9001:2008 (con’t)

O Focus is on conformity and demonstration of customer satisfaction

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The 8 Quality Principles ISO 9001:2008 uses the 8 Quality

Principles as the fundamental foundation for a Business Management System:

1: Customer focus2: Management 3: Involvement of people4: Process approach

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Continued next page

The 8 Quality Principles (con’t)

5: Systems approach to management6: Continual improvement7: Factual approach to decision making8: Mutually beneficial supplier

relationships

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ISO 9001:2008 The Business standard emphasizes: defining requirements verifying achievement of requirements measuring customer satisfaction having objectives for all relevant functions analysis of process data related to business

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Continued next page

ISO 9001:2008 (con’t)

determining the effectiveness of training the continuous improvement cycle management’s role in monitoring quality

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A Process ApproachO ISO 9001:2008 uses a process approach

OA process is any activity that converts inputs to outputs

OAlmost all activities and operations involved in making a product or providing a service are processes

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Process Approach (con’t)

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Requirements

Managementresponsibility

Measurement ,analysis,

improvement

Resourcemanagement

Product(and/or service)

realization

Customer

Customer

Satisfaction

BUSINESS MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT

Input Output Product/ Service

Business Management SystemsTo implement a business management

system the organization must:O Determine the needs and expectations of

customerO Establish quality policy and business objectivesO Define necessary processes and responsibilitiesO Establish the measures for process effectivenessO Determine current effectiveness of processesO Search for process improvement opportunitiesO Prioritize improvements for optimum results

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Business Management SystemsO Plan strategies, processes and resourcesO Implement the planO Monitor the effects of the improvementsO Assess the results against expected outcomesO Review activities to identify follow-up actions

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Benefits of a Business Management System

Some of the benefits of an effective business management system are:

O It creates confidence in processes and products

O Provides a basis for continual improvementO Leads to customer satisfaction and mutual

success

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Business System Documentation

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Extent of DocumentationRange and details of a company's

documentation depend upon:O Size and type of organizationO complexity of products and processesO customer and regulatory requirementsO industry standards and codesO education, experience, and training of personnelO workforce stabilityO past quality problems

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ISO 9001:2008O Comprised of the following 8 clauses:

1. Scope 2. Normative references (part of the

requirements)3. Terms and definitions4. Quality management system

5. Management responsibility6. Resource management7. Product (and/or service) realization8. Measurement, analysis & improvement

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PDCA improvement cycleO Plan

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

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

O Do

Product (and/or service) realization - the necessary processes are established and carried out

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PDCA improvement cycleO Check

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

O ActMeasurement, 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

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Business Management SystemO General requirements - Must define processes

to be managed (including out-sourced processes - which can include design, training, calibration, maintenance, 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

O Documentation requirements - Documentation requirements less prescriptive; however, at a minimum must include a quality manual and the six required subjects to be documented

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Documentation RequirementsThe following 6 subjects (at a minimum) are

required to be included in documented procedures:

O Document Control O Control of RecordsO Internal AuditsO Control of Nonconforming ProductO Corrective ActionO Preventive Action

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Management ResponsibilityO Management commitment - top

management must:O Demonstrate commitment to development

and implementation of their business system and continually improve its effectiveness

O Customer focus - customer requirements must be met with the aim of enhancing customer satisfaction, including “perception” and must be measured and reported

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Management ResponsibilityO Management commitment - top

management must:O Quality policy - establish a quality policy that:

O includes commitment to meeting requirements and continual improvement of the effectiveness of the business management system

O provides a framework for establishing/reviewing measurable business objectives; and, quality policy must be periodically reviewed for continuing suitability

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Management ResponsibilityO Planning - establish measurable business

objectives at relevant functions and levels in the organization needed to meet product requirements and identify and plan business system processes

O Responsibility, authority and communication - management representative must promote awareness of customer requirements throughout the organization; internal communications regarding the effectiveness of the business system must be established

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Management ResponsibilityO Management review - a review of the entire

business management system, presented to top management on a regular basis. Including evaluating the need for changes to the business management 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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Resource ManagementO Provision of resources - determine and provide

resources needed to implement and improve the BMS, meet the requirements (customer, statutory and regulatory) and address customer satisfaction

O Human resources - 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 business objectives

O Infrastructure and Work Environment - 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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Product RealizationO Planning of product realization - determine

measurable business and quality objectives for contracts, projects and products

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

O Design and development resources - design output to show validation of requirements and to include appropriate information for purchasing, production and for service provision

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Product RealizationO Purchasing - use of only approved suppliers,

establish criteria for supplier evaluation and selection, and periodic re-evaluation. Validation of all purchased materials and products

O Production and service provision - all production and service operations are carried out under controlled conditions, including adequate instructions available at the work center

O Control of measuring and monitoring devices - all devices used to measure product must be calibrated including validation of software used to verify product requirements

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Measurement, analysis and improvement

O General - plan and implement monitoring, measurement, analysis and improvement of processes

O Monitoring and measurement - 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 be objective and impartial. Processes used to manage the business management system must be measured/monitored to the degree necessary to demonstrate they achieved planned results

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Measurement, analysis and improvement

O Control of nonconforming product - NO nonconforming product can be unintentionally incorporated into end product

O Analysis of data -analyze data to determine the business 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

O Improvement - must improve effectiveness of the business management system (note: accomplished through the use of quality policy, objectives, audit results, analysis of data, corrective and preventive actions, and management review)

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What does this mean to you?O Developing a Business Management System

designed to comply with ISO provides every member of your organization with the opportunities and tools to make your company more successful.

O This allows for growth and an enhanced work environment, with this comes ownership on every level and enhanced morale

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The last wordO ISO 9001:2008 describes

what is required for a successful company in todays environment.O What is does not do is

tell you HOW to do itO Creativity, innovation

and teamwork in a Business Management Systems is essential

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CERTIFICATE OF COMPLETION

AWARDED TO

[NAME]

For Introduction to Quality Management System Standard ISO 9001:2008

Awarded this ___ day of __________, 20__

Presenter Name and Title

O For more information visit our website Isocertsolutions.com

O We are a full service provider of products and services to support Quality Assurance in any industry.

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