iso 9001 overview - saiglobal · migration plan for iso 9001:2008 certifications to iso 9001:2008...

ISO 9001 Overview

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What is ISO 9001:2008?

ISO 9001:2008 is an international standard for implementing a quality management system


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Why Use ISO 9001:2008?

ISO 9001:2008 sets out how a company can establish an effective quality management system to meet its

stakeholders’ needs


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IS0 9000:2008

The revision is not a significant modification from ISO 9001:2000

No new requirements have been added

Rather clarifications to the existing ISO 9001:2000 requirements have been made

Clarifications / changes were made to improve consistency with other management system standards such as ISO14001:2004


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Summary of Changes

The current version of ISO 9001 has been around since 2000 and was, at the time of its release, considered to be a “significant”upgrade to the previous versions. It is normal practice for Standards to be reviewed and updated every five years or so and, although not part of the update criteria, usually following a significant upgrade the next set of changes have been of a minor nature.The 2008 version appears to be following this same pattern and the ISO Committee is describing the changes as “minor editorial and clarification changes only”


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Summary of ISO 9001:2008 Amendments

Section 0.1 General: Recognizes that an organization’s quality management system can be influenced by its business environment, and the changes and risks in that environment.Section 0.2 Process Approach: Text added to emphasize the importance of processes being capable of achieving desired outputs.Section 0.3 Relationship with ISO 9004: Standard no longer considered as a “consistent pair” with 9004, which is now intended to extend the benefits and manage for sustainable success. ISO 9004 undergoing revision for 2009 publicationSection 1 Scope– Clause 1.1: Recognizes that “product” also applies to any

intended output resulting from product realization processes.


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Section 7 Product Realization

– Clause 7.2.1: Clarifies what may be included in post delivery activity.

– Clause 7.3.1 Design and Development Planning: Changed to explain that activities may be conducted and recorded separately or any in any combination.

– Clause 7.5.4 Customer Property: Now includes personal data belonging to the customer.

– Clause 7.6 Control of Monitoring and Measuring Equipment:Title has changed from the previous “Devices” to “Equipment, clarification given regarding identification of equipment, and notes have been added about the use and capability of computer software.


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Section 8 Measurement, Analysis and Improvement

– Clause 8.2.1 Customer Satisfaction: Examples of sources of customer satisfaction data are now included.

– Clause 8.3 Control of Nonconforming Product: Reorganization of the present requirement

– Clause 8.5.2 Corrective Action: The organization is required to review the “effectiveness” of the corrective action taken

– Clause 8.5.3 Preventive Action: The organization is required to review the “effectiveness” of the preventive action taken


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ISO and IAF Agreement on a Migration Plan for ISO 9001:2008

Certifications to ISO 9001:2008 will only be issued after publication of ISO 9001:2008 which is expected by the end of 2008.

One year after the publication of ISO 9001:2008, all certifications issued (new and re-certifications) must be to ISO 9001:2008.

Two years after the publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid.


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IS0 9000:2008 Series of Standards

ISO 9000:2005 - Fundamentals and Vocabulary– Provides an introduction to Quality Management Systems

(QMS) and vocabulary

ISO 9001:2008 - Requirements– Specifies requirements for a QMS where capability to provide

product that meets customer and applicable statutory and regulatory requirements needs to be demonstrated

ISO 9004:2009* - Managing for Sustainable Success – A Quality Management Approach

– Provides guidance on achieving long term, sustainable success for an entire organization. Compliments ISO 9001 but no longer a “consistent pair”

* Under development


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8 Quality Management Principles

1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach to management6. Continual improvement7. Factual approach to decision making8. Mutually beneficial supplier relationship


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CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Input Output

Management responsibility

Clause 5

Clause 6 Clause 8

Clause 7

Customers

RequirementsProduct

realization

Customers

Satisfaction

Value adding activitiesInformation flow

Introduction to ISO 9000:2008

Resource Management

Product

Measurement, analysis and Improvement


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ISO 9001:2008 Requirements

Scope– 1.1 General– 1.2 Application

Normative reference

Terms and definition– References ISO 9000– “Product” can mean “service”


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Permissible Exclusions

Can only reduce the scope of requirements related to “Product Realization” (Section 7)

May not exclude any requirement that affects ability to provide product and/or service that meets customer and applicable statutory and regulatory requirements


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4 Quality Management System

To meet the requirements you must:

– Document

– Implement

– Maintain

– Continually improve effectiveness


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4 Quality Management System

4.1 General requirements– Processes, interaction, improvement

4.2 Documentation requirements– General– Quality manual– Control of document– Control of records


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5 Management Responsibility

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning

– Objectives

– Management system


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5 Management Responsibility

5.5 Responsibility, authority and communication– Top management emphasis– Management representative must be a member of the

organization’s management• Includes promotion of customer requirements throughout the

organization– Internal communication

5.6 Management review– Lists of inputs and outputs– Recommendation for improvement– Action items expected– Records


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6 Resource Management

6.1 Provision of resources– To improve processes and enhance customer satisfaction

6.2 Human resources– Determine competence– Provide training or other action– Ensure necessary competence has been achieved

6.3 Infrastructure– Buildings, workspace, utilities– Process equipment– Support services (IT systems)

6.4 Work environment– Manage conditions of environment to achieve product

requirement conformance


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7 Product Realization

7.1 Planning of product realization– Include product objectives, relevant processes and resource,

appropriate test and validation7.2 Customer related processes

– Customer requirement - stated and implied– Statutory and regulatory– Product requirements and changes– Organization ability– Communication with customers

7.3 Design and development– Planning, inputs, outputs, systematic reviews, verification

and validation, control of changes


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7.4 Purchasing– Supplier evaluation and selection– Relevant purchasing information– Verification of purchased product

7.5 Production and service provision– Controlled conditions including product characteristics, work

instructions, suitable equipment, measuring devices, and system

– Release, delivery and post delivery activities– Validation of processes when no other method– Identification and traceability of product and it’s status – Care of customer property– Preservation of product

• Includes constituent parts


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7.6 Control of monitoring and measuring devices– Calibrated where necessary– Adjusted and readjusted– Identifies status– Safeguarded from invalid adjustment– Protected from damage or deterioration


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8 Measurement, Analysis, and Improvement

8.1 General– Plan and implement– Measurement and monitoring processes

• To demonstrate product conformity, system conformity and continually improve the QMS

8.2 Monitoring and measurement– Customer satisfaction

• Perception of fulfillment– Internal planned audit, etc.

• Auditors independent of their own work– Processes

• Demonstrate achievement of planned results– Product

• Monitor and measure characteristics• Conformity with acceptance criteria• Waiver / concession from customer


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8 Measurement, Analysis, and Improvement

8.3 Control of nonconforming product– Elimination, concession, preclude intended use

8.4 Analysis of data– Customer satisfaction– Product and process requirements and trends– Suppliers

8.5 Improvement– Continually improve effectiveness

of the system– Corrective action– Preventive action


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Next Steps – Implementing a Quality Management System conforming to ISO 9001:2008

Phase I: Assess present status of management system

Phase II: Plan the implementation / transition

Phase III: Implement plan

Phase IV: Assess and review

Phase V: Consolidate and improve

Phase VI: External assessment


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Next Steps

Implementation Transition Assess existing Business System

• Review: • Scope

I.D. Affected Process Owners and Implementation Team

• Existing documentation • Assessment system • Management review

Prepare and coach teams • Corrective and Preventive Action Systems

• Senior management focus • Performance since registration

for compliance gaps

Phase I: Assess Current Status of the Management System


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Next Steps

Implementation Transition Develop: Project Plan

Develop: Overall transition plan

Documentation plan Training plan Communication plan Process mapping plan Calibration plan Assessment plan Management review plan

Plan for those topics needing attention as a result of the review

Documentation (especially if existing system is not process focused)

Transition Measurement and Improvement plan

Registrar selection plan

Plan to implement processes to fulfill any system gaps

Phase II: Plan the Implementation/Transition


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Next Steps

Implementation Transition Maintain project plan Provide training identified Process map the business processes

Gather metrics data I.D. improvement issues Publish improvement

Map processes is not already

Measure processes Train assessors to assess for business effectiveness

Gather metrics data I.D. improvement issues Publish improvement

Phase III: Implement the Plan


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Next Steps

Assess Review Use internal assessment to verify compliance and I.D. business effectiveness issues

Use internal assessment to verify compliance and I.D. business effectiveness issues

Share information to gain improvement momentum

Share information to gain improvement momentum

Start management reviews

Continue management reviews (revised)

Phase IV: Assess and Review


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Next Steps

Implementation Transition $ Improvement issues (process mapping, assessments, customer satisfaction)

$ Improvement issues (process mapping, assessments, customer satisfaction)

Change the processes Change the processes

Publish gains and success

Publish gains and success

Close gaps with compliance

Close gaps with compliance

Phase V: Consolidate and Improve


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Next Steps

Implementation Transition Optional pre-assessment On going surveillance

(increase scope) Registration assessment Upgrading the existing

registration Business focus Business focus

Phase VI: External Assessment


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Summary

ISO 9001:2008 continues the emphasis on business process effectiveness to ensure customer satisfactionTop management have greater accountability and ownership for the Quality Management SystemThe organization is required to measure business performance against objectivesProperly implemented, it will help the organization to:

– Be more competitive– Improve cycle times– Reduce costs– Improve morale


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SAI Global’s Training and Business Solutions provides a full range of consulting, public and in-house training in international standards, regulatory requirements, and process improvement techniques which maximizes performance and profitability for your company

Contact us or visit our website for ways in which we can help support your organization’s ISO 9001:2008 implementation or transition or other business process improvement activities

SAI GLOBAL Training and Improvement Solutions


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SAI Global

Training and Improvement Solutions2 Summit Place

Independence, Ohio 44131

Call: 1-800-374-3818

Email: [email protected]

Web: www.saiglobal.com/training

iso 9001 overview - saiglobal · migration plan for iso 9001:2008 certifications to iso 9001:2008...

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