ISO 9001 2008 vs ISO 9001 2000

ISO 9001 2008 and ISO 9001 2000 use the same numbering system to organize the standard. As a result, the new standard looks muchlike the old standard. However, some important clarifications and modifications were made. These changes are summarized below.

Outsourced Processes

The process approach continues to be of central importance to ISO 9001. And since outsourcing has become increasingly commonduring the last few years, the new ISO 9001 standard has expandedits discussion of outsourced processes (see ISO 9001 Part 4.1).

The new standard makes it clear that an outsourced process is still part of your QMS even though it is performed by a party that is external to your organization. The new standard emphasizes the need to ensure that outsourced processes comply with allcustomer and legal requirements. While the responsibility for a process may have been outsourced, your organization is,nevertheless, still responsible for ensuring that it meets all customer, regulatory, and statutory requirements.

While the old standard said that outsourced processes must becontrolled, the new standard goes further by expecting you also to specify the type, nature, and extent of control. ISO 9001 2008 also wants you to think carefully about how you’re going to controloutsourced processes. How you choose to control an outsourcedprocess should be influenced by the potential impact it could have on your products, whether or not process control will be shared with the process supplier, and whether or not adequate controls

can be contractually established using your purchasing process.

Documentation

ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentationincludes not only the records required by the standard but also therecords that your organization needs to have in order to be able toplan, operate, and control its QMS processes. So the new standardhas expanded the definition of documentation to include all QMSprocess records.

Part 4.2.1 makes it clear that a single document may contain severalprocedures or several documents may be used to describe a singleprocedure. While this has always been an option, the new standardmakes this possibility explicit.

ISO 9001 2000 Part 4.2.3 gave the impression that all externaldocuments needed to be identified and controlled. This has now been clarified. The new standard says that you need to identify andcontrol the distribution of only those external documents that youneed in order to be able to plan and operate your QMS. In otherwords, only relevant external QMS documents need to be controlled, not all of them.

Management Representative

ISO 9001 2000, Part 5.5.2, allowed you to appoint any member of management to oversee the organization’s QMS. Since the oldstandard did not explicitly say that the management representativemust be a member of the organization’s own management, outsiderswere sometimes appointed, instead. This loophole has now been closed.

ISO 9001 2008 now makes it clear that the management representativemust be a member of the organization’s own management. Outsidersmay no longer perform this important function.

Competence

While both old and new standards stress the importance ofcompetence, the old standard wasn't very clear about who they were talking about. Not it's pretty clear that all QMS personnel must be competent. ISO 9001 2008, Part 6.2.1, makes it clear that any taskwithin the QMS may directly or indirectly affect the organization'sability or willingness to meet product requirements. Since any QMS task could directly or indirectly influence product quality, the competence of anyone and everyone who carries out any QMS task must be assured.

Infrastructure

For ISO 9001 2000 (Part 6.3) the term infrastructure includes buildings, workspaces, equipment, software, utilities, and supportservices like transportation and communications. ISO 9001 2008 has now added information systems to the previous list of supportservices. Both old and new standards expect you to provide theinfrastructure (including information systems) that your organization needs in order to ensure that product requirements are being met.

Work Environment

According to ISO 9001 2000, Part 6.4, you are expected to manage the work environment that your organization needs in order to be able to ensure that all product requirements are being met. However, it failed to indicate exactly what they were talking about. This problem has now been solved. ISO 9001 2008 says that the term work environment refers to working conditions.These working conditions include physical and environmentalconditions, as well as things like noise, temperature, humidity,lighting, and weather. According to the new standard, all of these conditions need to be managed in order to help ensure that product requirements are being met.

Customer Requirements

According to ISO 9001 2000, Part 7.2.1, you are expected to identifyyour customers’ specific delivery and post delivery requirements.Since some people weren’t sure about what post delivery meant, the new standard has tried to clarify this.

According to ISO 9001 2008, post delivery requirements includethings like warranty provisions, contractual obligations (such asmaintenance), and supplementary services (such as recycling and final disposal).

Design and Development Planning

Both old and new standards expect organizations to plan andperform product design and development review, verification, and validation activities (Part 7.3.1).

While each of these three activities serves a different purpose, ISO 9001 2008 makes it clear that these three activities can be carried out and recorded separately or in any combination as long as it makes sense for the product and the organization.

Design and Development Outputs

Part 7.3.3 of ISO 9001 2000 wants you to make sure that the design and development process generates information (outputs) that your purchasing, production, and service provision processes need to have.

ISO 9001 2008 now also says that design and development outputs could include information that explains how products can be preserved during production and service provision.

Monitoring and Measuring Equipment

While ISO 9001 2008, Part 7.6, refers to the need to control monitoring and measuring equipment, the old standard talked about controlling devices. Since the term device can refer to almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear. The new ISO 9001 standard

has removed this ambiguity by using the term equipment.

Both the old and the new standard wants you to confirm thatmonitoring and measuring software is capable of doing the job you want it to do. In addition to this requirement, the new standardsuggests (in a note) that configuration management and wellestablished verification methods can be used to ensure the ongoing suitability of monitoring and measuring software. However, this is not a requirement, just a statement that explains how the ongoing suitability of software can be maintained.

Customer Satisfaction

Both old and new standards want you to monitor and measure customer satisfaction (perceptions). A new note to ISO 9001 2008, Part 8.2.1, explains that there are many ways to monitor and measure customer satisfaction. You could usecustomer satisfaction and opinion surveys. And you could collectproduct quality data (post delivery), track warranty claims, examinedealer reports, study customer compliments and criticisms, andanalyze lost business opportunities.

Internal Audit Records

Both old and new standards refer to the need to establish a procedure to define how internal audits should be planned,performed, reported, and recorded (Part 8.2.2). However, the oldstandard did not explicitly state that audit records must actually bemaintained. This oversight has now been corrected. ISO 9001 2008now explicitly says that you must maintain a record of your internalaudit activities and results.

Process Monitoring and Measurement

Both old and new standards expect you to monitor and measure your QMS processes. A new note to ISO 9001 2008,

Part 8.2.3, wants you to consider the impact each process has on the overall effectiveness of your QMS and the impact it has on your ability to meet product requirements (when you’re making decisions about what kinds of process monitoring and measurement methods should be used).

Release of Product

According to ISO 9001 2000, Part 8.2.4, you must make sure that product monitoring and measuring records indicate who was responsible for authorizing the release of products. However, the old standard did not specify who must be on the receiving end.This has now been clarified.

ISO 9001 2008 now makes it clear that products are released fordelivery to customers. Records must now indicate who releasesproducts for delivery to customers.

OTHER ISO 9001 PAGES

ISO 9001 Introduction

Quality Management Principles

ISO 9001 2000 versus ISO 9001 1994

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

ISO 9001 2000 Translated into Plain English

ISO 9001 1994 Translated into Plain English

How to Upgrade to the New Quality Standard

Quality Management Gap Analysis Tool

How to Develop your own Process-based QMS

Detailed Process-based QMS Development Plan

Quality Management Audit Program

The Process Approach

Frequently Asked Questions

ISO 9004 PAGES

Introduction to ISO 9004 2009 Quality Management

Overview of the ISO 9004 2009 Quality Standard

ISO 9004 2009 Translated into Plain English

Home Page Our Libraries A to Z Index Our Customers

How to Order Our Products Our Prices Our Guarantee

PRAXIOM RESEARCH GROUP LIMITED9619 - 100A Street, Edmonton, Alberta, T5K 0V7, Canada

Telephone: 780-461-4514 info@praxiom.com

First published on October 28, 2000. Updated on December 7, 2011.

Disclaimer and Limitation of LiabilityThe publisher and authors have used their best efforts in designing and

  developing this electronic publication. We make no representation or warranties  with respect to accuracy or completeness of the contents of this publication and  specifically disclaim any implied warranties or merchantability or fitness for any

  particular purpose and shall in no event be liable for any loss of profit or any  other commercial damage, including but not limited to special, incidental,

  consequential, or other damages.

Legal Restrictions on the Use of this Page Thank you for visiting this page. You are, of course, welcome to view our

 material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercial, home use. But, you are not legally authorized to print or produce additional copies or to copy and paste

 any of our material onto another web site or to republish it in any way.

Copyright © 2000-2011 by Praxiom Research Group Limited. All Rights Reserved.

ISO 9001 2008 vs ISO 9001 2000

ISO 9001 2008 and ISO 9001 2000 use the same numbering system to organize the standard. As a result, the new standard looks muchlike the old standard. However, some important clarifications and modifications were made. These changes are summarized below.

Outsourced Processes

The process approach continues to be of central importance to ISO 9001. And since outsourcing has become increasingly commonduring the last few years, the new ISO 9001 standard has expandedits discussion of outsourced processes (see ISO 9001 Part 4.1).

The new standard makes it clear that an outsourced process is still part of your QMS even though it is performed by a party that is external to your organization. The new standard emphasizes the need to ensure that outsourced processes comply with allcustomer and legal requirements. While the responsibility for a process may have been outsourced, your organization is,nevertheless, still responsible for ensuring that it meets all customer, regulatory, and statutory requirements.

While the old standard said that outsourced processes must becontrolled, the new standard goes further by expecting you also to specify the type, nature, and extent of control. ISO 9001 2008

also wants you to think carefully about how you’re going to controloutsourced processes. How you choose to control an outsourcedprocess should be influenced by the potential impact it could have on your products, whether or not process control will be shared with the process supplier, and whether or not adequate controls can be contractually established using your purchasing process.

Documentation

ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentationincludes not only the records required by the standard but also therecords that your organization needs to have in order to be able toplan, operate, and control its QMS processes. So the new standardhas expanded the definition of documentation to include all QMSprocess records.

Part 4.2.1 makes it clear that a single document may contain severalprocedures or several documents may be used to describe a singleprocedure. While this has always been an option, the new standardmakes this possibility explicit.

ISO 9001 2000 Part 4.2.3 gave the impression that all externaldocuments needed to be identified and controlled. This has now been clarified. The new standard says that you need to identify andcontrol the distribution of only those external documents that youneed in order to be able to plan and operate your QMS. In otherwords, only relevant external QMS documents need to be controlled, not all of them.

Management Representative

ISO 9001 2000, Part 5.5.2, allowed you to appoint any member of management to oversee the organization’s QMS. Since the oldstandard did not explicitly say that the management representativemust be a member of the organization’s own management, outsiderswere sometimes appointed, instead. This loophole has now been closed.

ISO 9001 2008 now makes it clear that the management representativemust be a member of the organization’s own management. Outsidersmay no longer perform this important function.

Competence

While both old and new standards stress the importance ofcompetence, the old standard wasn't very clear about who they were talking about. Not it's pretty clear that all QMS personnel must be competent. ISO 9001 2008, Part 6.2.1, makes it clear that any taskwithin the QMS may directly or indirectly affect the organization'sability or willingness to meet product requirements. Since any QMS task could directly or indirectly influence product quality, the competence of anyone and everyone who carries out any QMS task must be assured.

Infrastructure

For ISO 9001 2000 (Part 6.3) the term infrastructure includes buildings, workspaces, equipment, software, utilities, and supportservices like transportation and communications. ISO 9001 2008 has now added information systems to the previous list of supportservices. Both old and new standards expect you to provide theinfrastructure (including information systems) that your organization needs in order to ensure that product requirements are being met.

Work Environment

According to ISO 9001 2000, Part 6.4, you are expected to manage the work environment that your organization needs in order to be able to ensure that all product requirements are being met. However, it failed to indicate exactly what they were talking about. This problem has now been solved. ISO 9001 2008 says that the term work environment refers to working conditions.These working conditions include physical and environmentalconditions, as well as things like noise, temperature, humidity,lighting, and weather. According to the new standard, all of these conditions need to be managed in order to help ensure that product requirements are being met.

Customer Requirements

According to ISO 9001 2000, Part 7.2.1, you are expected to identifyyour customers’ specific delivery and post delivery requirements.Since some people weren’t sure about what post delivery meant, the new standard has tried to clarify this.

According to ISO 9001 2008, post delivery requirements includethings like warranty provisions, contractual obligations (such asmaintenance), and supplementary services (such as recycling and final disposal).

Design and Development Planning

Both old and new standards expect organizations to plan andperform product design and development review, verification, and validation activities (Part 7.3.1).

While each of these three activities serves a different purpose, ISO 9001 2008 makes it clear that these three activities can be carried out and recorded separately or in any combination as long as it makes sense for the product and the organization.

Design and Development Outputs

Part 7.3.3 of ISO 9001 2000 wants you to make sure that the design and development process generates information (outputs) that your purchasing, production, and service provision processes need to have.

ISO 9001 2008 now also says that design and development outputs could include information that explains how products can be preserved during production and service provision.

Monitoring and Measuring Equipment

While ISO 9001 2008, Part 7.6, refers to the need to control monitoring and measuring equipment, the old standard talked about controlling devices. Since the term device can refer to

almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear. The new ISO 9001 standard has removed this ambiguity by using the term equipment.

Both the old and the new standard wants you to confirm thatmonitoring and measuring software is capable of doing the job you want it to do. In addition to this requirement, the new standardsuggests (in a note) that configuration management and wellestablished verification methods can be used to ensure the ongoing suitability of monitoring and measuring software. However, this is not a requirement, just a statement that explains how the ongoing suitability of software can be maintained.

Customer Satisfaction

Both old and new standards want you to monitor and measure customer satisfaction (perceptions). A new note to ISO 9001 2008, Part 8.2.1, explains that there are many ways to monitor and measure customer satisfaction. You could usecustomer satisfaction and opinion surveys. And you could collectproduct quality data (post delivery), track warranty claims, examinedealer reports, study customer compliments and criticisms, andanalyze lost business opportunities.

Internal Audit Records

Both old and new standards refer to the need to establish a procedure to define how internal audits should be planned,performed, reported, and recorded (Part 8.2.2). However, the oldstandard did not explicitly state that audit records must actually bemaintained. This oversight has now been corrected. ISO 9001 2008now explicitly says that you must maintain a record of your internalaudit activities and results.

Process Monitoring and Measurement

Both old and new standards expect you to monitor and measure your QMS processes. A new note to ISO 9001 2008, Part 8.2.3, wants you to consider the impact each process has on the overall effectiveness of your QMS and the impact it has on your ability to meet product requirements (when you’re making decisions about what kinds of process monitoring and measurement methods should be used).

Release of Product

According to ISO 9001 2000, Part 8.2.4, you must make sure that product monitoring and measuring records indicate who was responsible for authorizing the release of products. However, the old standard did not specify who must be on the receiving end.This has now been clarified.

ISO 9001 2008 now makes it clear that products are released fordelivery to customers. Records must now indicate who releasesproducts for delivery to customers.

OTHER ISO 9001 PAGES

ISO 9001 Introduction

Quality Management Principles

ISO 9001 2000 versus ISO 9001 1994

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

ISO 9001 2000 Translated into Plain English

ISO 9001 1994 Translated into Plain English

How to Upgrade to the New Quality Standard

Quality Management Gap Analysis Tool

How to Develop your own Process-based QMS

Detailed Process-based QMS Development Plan

Quality Management Audit Program

The Process Approach

Frequently Asked Questions

ISO 9004 PAGES

Introduction to ISO 9004 2009 Quality Management

Overview of the ISO 9004 2009 Quality Standard

ISO 9004 2009 Translated into Plain English

Home Page Our Libraries A to Z Index Our Customers

How to Order Our Products Our Prices Our Guarantee

PRAXIOM RESEARCH GROUP LIMITED9619 - 100A Street, Edmonton, Alberta, T5K 0V7, Canada

Telephone: 780-461-4514 info@praxiom.com

First published on October 28, 2000. Updated on December 7, 2011.

Disclaimer and Limitation of LiabilityThe publisher and authors have used their best efforts in designing and

  developing this electronic publication. We make no representation or warranties  with respect to accuracy or completeness of the contents of this publication and  specifically disclaim any implied warranties or merchantability or fitness for any

  particular purpose and shall in no event be liable for any loss of profit or any  other commercial damage, including but not limited to special, incidental,

  consequential, or other damages.

Legal Restrictions on the Use of this Page Thank you for visiting this page. You are, of course, welcome to view our

 material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercial, home use. But, you are not

 legally authorized to print or produce additional copies or to copy and paste any of our material onto another web site or to republish it in any way.

Copyright © 2000-2011 by Praxiom Research Group Limited. All Rights Reserved.

ISO 9001 2008 vs ISO 9001 2000

ISO 9001 2008 and ISO 9001 2000 use the same numbering system to organize the standard. As a result, the new standard looks muchlike the old standard. However, some important clarifications and modifications were made. These changes are summarized below.

Outsourced Processes

The process approach continues to be of central importance to ISO 9001. And since outsourcing has become increasingly commonduring the last few years, the new ISO 9001 standard has expandedits discussion of outsourced processes (see ISO 9001 Part 4.1).

The new standard makes it clear that an outsourced process is still part of your QMS even though it is performed by a party that is external to your organization. The new standard emphasizes the need to ensure that outsourced processes comply with allcustomer and legal requirements. While the responsibility for a process may have been outsourced, your organization is,nevertheless, still responsible for ensuring that it meets all customer, regulatory, and statutory requirements.

While the old standard said that outsourced processes must be

controlled, the new standard goes further by expecting you also to specify the type, nature, and extent of control. ISO 9001 2008 also wants you to think carefully about how you’re going to controloutsourced processes. How you choose to control an outsourcedprocess should be influenced by the potential impact it could have on your products, whether or not process control will be shared with the process supplier, and whether or not adequate controls can be contractually established using your purchasing process.

Documentation

ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentationincludes not only the records required by the standard but also therecords that your organization needs to have in order to be able toplan, operate, and control its QMS processes. So the new standardhas expanded the definition of documentation to include all QMSprocess records.

Part 4.2.1 makes it clear that a single document may contain severalprocedures or several documents may be used to describe a singleprocedure. While this has always been an option, the new standardmakes this possibility explicit.

ISO 9001 2000 Part 4.2.3 gave the impression that all externaldocuments needed to be identified and controlled. This has now been clarified. The new standard says that you need to identify andcontrol the distribution of only those external documents that youneed in order to be able to plan and operate your QMS. In otherwords, only relevant external QMS documents need to be controlled, not all of them.

Management Representative

ISO 9001 2000, Part 5.5.2, allowed you to appoint any member of management to oversee the organization’s QMS. Since the oldstandard did not explicitly say that the management representativemust be a member of the organization’s own management, outsiderswere sometimes appointed, instead. This loophole has now been closed.

ISO 9001 2008 now makes it clear that the management representative

must be a member of the organization’s own management. Outsidersmay no longer perform this important function.

Competence

While both old and new standards stress the importance ofcompetence, the old standard wasn't very clear about who they were talking about. Not it's pretty clear that all QMS personnel must be competent. ISO 9001 2008, Part 6.2.1, makes it clear that any taskwithin the QMS may directly or indirectly affect the organization'sability or willingness to meet product requirements. Since any QMS task could directly or indirectly influence product quality, the competence of anyone and everyone who carries out any QMS task must be assured.

Infrastructure

For ISO 9001 2000 (Part 6.3) the term infrastructure includes buildings, workspaces, equipment, software, utilities, and supportservices like transportation and communications. ISO 9001 2008 has now added information systems to the previous list of supportservices. Both old and new standards expect you to provide theinfrastructure (including information systems) that your organization needs in order to ensure that product requirements are being met.

Work Environment

According to ISO 9001 2000, Part 6.4, you are expected to manage the work environment that your organization needs in order to be able to ensure that all product requirements are being met. However, it failed to indicate exactly what they were talking about. This problem has now been solved. ISO 9001 2008 says that the term work environment refers to working conditions.These working conditions include physical and environmentalconditions, as well as things like noise, temperature, humidity,

lighting, and weather. According to the new standard, all of these conditions need to be managed in order to help ensure that product requirements are being met.

Customer Requirements

According to ISO 9001 2000, Part 7.2.1, you are expected to identifyyour customers’ specific delivery and post delivery requirements.Since some people weren’t sure about what post delivery meant, the new standard has tried to clarify this.

According to ISO 9001 2008, post delivery requirements includethings like warranty provisions, contractual obligations (such asmaintenance), and supplementary services (such as recycling and final disposal).

Design and Development Planning

Both old and new standards expect organizations to plan andperform product design and development review, verification, and validation activities (Part 7.3.1).

While each of these three activities serves a different purpose, ISO 9001 2008 makes it clear that these three activities can be carried out and recorded separately or in any combination as long as it makes sense for the product and the organization.

Design and Development Outputs

Part 7.3.3 of ISO 9001 2000 wants you to make sure that the design and development process generates information (outputs) that your purchasing, production, and service provision processes need to have.

ISO 9001 2008 now also says that design and development outputs could include information that explains how products can be preserved during production and service provision.

Monitoring and Measuring Equipment

While ISO 9001 2008, Part 7.6, refers to the need to control monitoring and measuring equipment, the old standard talked about controlling devices. Since the term device can refer to almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear. The new ISO 9001 standard has removed this ambiguity by using the term equipment.

Both the old and the new standard wants you to confirm thatmonitoring and measuring software is capable of doing the job you want it to do. In addition to this requirement, the new standardsuggests (in a note) that configuration management and wellestablished verification methods can be used to ensure the ongoing suitability of monitoring and measuring software. However, this is not a requirement, just a statement that explains how the ongoing suitability of software can be maintained.

Customer Satisfaction

Both old and new standards want you to monitor and measure customer satisfaction (perceptions). A new note to ISO 9001 2008, Part 8.2.1, explains that there are many ways to monitor and measure customer satisfaction. You could usecustomer satisfaction and opinion surveys. And you could collectproduct quality data (post delivery), track warranty claims, examinedealer reports, study customer compliments and criticisms, andanalyze lost business opportunities.

Internal Audit Records

Both old and new standards refer to the need to establish a procedure to define how internal audits should be planned,performed, reported, and recorded (Part 8.2.2). However, the oldstandard did not explicitly state that audit records must actually bemaintained. This oversight has now been corrected. ISO 9001 2008now explicitly says that you must maintain a record of your internal

audit activities and results.

Process Monitoring and Measurement

Both old and new standards expect you to monitor and measure your QMS processes. A new note to ISO 9001 2008, Part 8.2.3, wants you to consider the impact each process has on the overall effectiveness of your QMS and the impact it has on your ability to meet product requirements (when you’re making decisions about what kinds of process monitoring and measurement methods should be used).

Release of Product

According to ISO 9001 2000, Part 8.2.4, you must make sure that product monitoring and measuring records indicate who was responsible for authorizing the release of products. However, the old standard did not specify who must be on the receiving end.This has now been clarified.

ISO 9001 2008 now makes it clear that products are released fordelivery to customers. Records must now indicate who releasesproducts for delivery to customers.

OTHER ISO 9001 PAGES

ISO 9001 Introduction

Quality Management Principles

ISO 9001 2000 versus ISO 9001 1994

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

ISO 9001 2000 Translated into Plain English

ISO 9001 1994 Translated into Plain English

How to Upgrade to the New Quality Standard

Quality Management Gap Analysis Tool

How to Develop your own Process-based QMS

Detailed Process-based QMS Development Plan

Quality Management Audit Program

The Process Approach

Frequently Asked Questions

ISO 9004 PAGES

Introduction to ISO 9004 2009 Quality Management

Overview of the ISO 9004 2009 Quality Standard

ISO 9004 2009 Translated into Plain English

Home Page Our Libraries A to Z Index Our Customers

How to Order Our Products Our Prices Our Guarantee

PRAXIOM RESEARCH GROUP LIMITED9619 - 100A Street, Edmonton, Alberta, T5K 0V7, Canada

Telephone: 780-461-4514 info@praxiom.com

First published on October 28, 2000. Updated on December 7, 2011.

Disclaimer and Limitation of LiabilityThe publisher and authors have used their best efforts in designing and

  developing this electronic publication. We make no representation or warranties  with respect to accuracy or completeness of the contents of this publication and  specifically disclaim any implied warranties or merchantability or fitness for any

  particular purpose and shall in no event be liable for any loss of profit or any

  other commercial damage, including but not limited to special, incidental,  consequential, or other damages.

Legal Restrictions on the Use of this Page Thank you for visiting this page. You are, of course, welcome to view our

 material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercial, home use. But, you are not legally authorized to print or produce additional copies or to copy and paste

 any of our material onto another web site or to republish it in any way.

Copyright © 2000-2011 by Praxiom Research Group Limited. All Rights Reserved.

ISO 9001 2008 vs ISO 9001 2000

ISO 9001 2008 and ISO 9001 2000 use the same numbering system to organize the standard. As a result, the new standard looks muchlike the old standard. However, some important clarifications and modifications were made. These changes are summarized below.

Outsourced Processes

The process approach continues to be of central importance to ISO 9001. And since outsourcing has become increasingly commonduring the last few years, the new ISO 9001 standard has expandedits discussion of outsourced processes (see ISO 9001 Part 4.1).

The new standard makes it clear that an outsourced process is still part of your QMS even though it is performed by a party that is external to your organization. The new standard emphasizes

the need to ensure that outsourced processes comply with allcustomer and legal requirements. While the responsibility for a process may have been outsourced, your organization is,nevertheless, still responsible for ensuring that it meets all customer, regulatory, and statutory requirements.

While the old standard said that outsourced processes must becontrolled, the new standard goes further by expecting you also to specify the type, nature, and extent of control. ISO 9001 2008 also wants you to think carefully about how you’re going to controloutsourced processes. How you choose to control an outsourcedprocess should be influenced by the potential impact it could have on your products, whether or not process control will be shared with the process supplier, and whether or not adequate controls can be contractually established using your purchasing process.

Documentation

ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentationincludes not only the records required by the standard but also therecords that your organization needs to have in order to be able toplan, operate, and control its QMS processes. So the new standardhas expanded the definition of documentation to include all QMSprocess records.

Part 4.2.1 makes it clear that a single document may contain severalprocedures or several documents may be used to describe a singleprocedure. While this has always been an option, the new standardmakes this possibility explicit.

ISO 9001 2000 Part 4.2.3 gave the impression that all externaldocuments needed to be identified and controlled. This has now been clarified. The new standard says that you need to identify andcontrol the distribution of only those external documents that youneed in order to be able to plan and operate your QMS. In otherwords, only relevant external QMS documents need to be controlled, not all of them.

Management Representative

ISO 9001 2000, Part 5.5.2, allowed you to appoint any member

of management to oversee the organization’s QMS. Since the oldstandard did not explicitly say that the management representativemust be a member of the organization’s own management, outsiderswere sometimes appointed, instead. This loophole has now been closed.

ISO 9001 2008 now makes it clear that the management representativemust be a member of the organization’s own management. Outsidersmay no longer perform this important function.

Competence

While both old and new standards stress the importance ofcompetence, the old standard wasn't very clear about who they were talking about. Not it's pretty clear that all QMS personnel must be competent. ISO 9001 2008, Part 6.2.1, makes it clear that any taskwithin the QMS may directly or indirectly affect the organization'sability or willingness to meet product requirements. Since any QMS task could directly or indirectly influence product quality, the competence of anyone and everyone who carries out any QMS task must be assured.

Infrastructure

For ISO 9001 2000 (Part 6.3) the term infrastructure includes buildings, workspaces, equipment, software, utilities, and supportservices like transportation and communications. ISO 9001 2008 has now added information systems to the previous list of supportservices. Both old and new standards expect you to provide theinfrastructure (including information systems) that your organization needs in order to ensure that product requirements are being met.

Work Environment

According to ISO 9001 2000, Part 6.4, you are expected to manage the work environment that your organization needs

in order to be able to ensure that all product requirements are being met. However, it failed to indicate exactly what they were talking about. This problem has now been solved. ISO 9001 2008 says that the term work environment refers to working conditions.These working conditions include physical and environmentalconditions, as well as things like noise, temperature, humidity,lighting, and weather. According to the new standard, all of these conditions need to be managed in order to help ensure that product requirements are being met.

Customer Requirements

According to ISO 9001 2000, Part 7.2.1, you are expected to identifyyour customers’ specific delivery and post delivery requirements.Since some people weren’t sure about what post delivery meant, the new standard has tried to clarify this.

According to ISO 9001 2008, post delivery requirements includethings like warranty provisions, contractual obligations (such asmaintenance), and supplementary services (such as recycling and final disposal).

Design and Development Planning

Both old and new standards expect organizations to plan andperform product design and development review, verification, and validation activities (Part 7.3.1).

While each of these three activities serves a different purpose, ISO 9001 2008 makes it clear that these three activities can be carried out and recorded separately or in any combination as long as it makes sense for the product and the organization.

Design and Development Outputs

Part 7.3.3 of ISO 9001 2000 wants you to make sure that the design and development process generates information (outputs) that your purchasing, production, and service

provision processes need to have.

ISO 9001 2008 now also says that design and development outputs could include information that explains how products can be preserved during production and service provision.

Monitoring and Measuring Equipment

While ISO 9001 2008, Part 7.6, refers to the need to control monitoring and measuring equipment, the old standard talked about controlling devices. Since the term device can refer to almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear. The new ISO 9001 standard has removed this ambiguity by using the term equipment.

Both the old and the new standard wants you to confirm thatmonitoring and measuring software is capable of doing the job you want it to do. In addition to this requirement, the new standardsuggests (in a note) that configuration management and wellestablished verification methods can be used to ensure the ongoing suitability of monitoring and measuring software. However, this is not a requirement, just a statement that explains how the ongoing suitability of software can be maintained.

Customer Satisfaction

Both old and new standards want you to monitor and measure customer satisfaction (perceptions). A new note to ISO 9001 2008, Part 8.2.1, explains that there are many ways to monitor and measure customer satisfaction. You could usecustomer satisfaction and opinion surveys. And you could collectproduct quality data (post delivery), track warranty claims, examinedealer reports, study customer compliments and criticisms, andanalyze lost business opportunities.

Internal Audit Records

Both old and new standards refer to the need to establish a procedure to define how internal audits should be planned,performed, reported, and recorded (Part 8.2.2). However, the oldstandard did not explicitly state that audit records must actually bemaintained. This oversight has now been corrected. ISO 9001 2008now explicitly says that you must maintain a record of your internalaudit activities and results.

Process Monitoring and Measurement

Both old and new standards expect you to monitor and measure your QMS processes. A new note to ISO 9001 2008, Part 8.2.3, wants you to consider the impact each process has on the overall effectiveness of your QMS and the impact it has on your ability to meet product requirements (when you’re making decisions about what kinds of process monitoring and measurement methods should be used).

Release of Product

According to ISO 9001 2000, Part 8.2.4, you must make sure that product monitoring and measuring records indicate who was responsible for authorizing the release of products. However, the old standard did not specify who must be on the receiving end.This has now been clarified.

ISO 9001 2008 now makes it clear that products are released fordelivery to customers. Records must now indicate who releasesproducts for delivery to customers.

OTHER ISO 9001 PAGES

ISO 9001 Introduction

Quality Management Principles

ISO 9001 2000 versus ISO 9001 1994

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

ISO 9001 2000 Translated into Plain English

ISO 9001 1994 Translated into Plain English

How to Upgrade to the New Quality Standard

Quality Management Gap Analysis Tool

How to Develop your own Process-based QMS

Detailed Process-based QMS Development Plan

Quality Management Audit Program

The Process Approach

Frequently Asked Questions

ISO 9004 PAGES

Introduction to ISO 9004 2009 Quality Management

Overview of the ISO 9004 2009 Quality Standard

ISO 9004 2009 Translated into Plain English

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First published on October 28, 2000. Updated on December 7, 2011.

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