A Glance about the ISO 9001:2000 & 9004:2000 PA2 TQM Class by erwin s.

ISO 9001:2000

ISO 9001:2000

ISO9001:2000 & 9004:2000 Both of them are the member of the ISO9000 standards, a family of standards for quality management systems (QMS) ISO9000 procedures consist of: a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement

Both of them are the member of the ISO9000 standards, a family of standards for quality management systems (QMS)

ISO9000 procedures consist of:

a set of procedures that cover all key processes in the business;

monitoring processes to ensure they are effective;

keeping adequate records;

checking output for defects, with appropriate and corrective action where necessary;

regularly reviewing individual processes and the quality system itself for effectiveness; and

facilitating continual improvement

ISO9001 Milestones ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document, not used for certification purposes, but important reference document to understand terms and vocabulary related to quality management systems. In the year 2005, revised ISO 9000:2005 standard has been published, so it is now advised to refer to ISO 9000:2005. ISO 9001:2000 Quality management systems – Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints. ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation

ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document, not used for certification purposes, but important reference document to understand terms and vocabulary related to quality management systems. In the year 2005, revised ISO 9000:2005 standard has been published, so it is now advised to refer to ISO 9000:2005.

ISO 9001:2000 Quality management systems – Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.

ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation

What is ISO 9001? ISO9001 applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.

ISO9001 applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.

What’s before ISO9001:2000? ISO 9001 2000 has replaced the old ISO 9001 1994 standard. In addition, the old ISO 9002 1994 and ISO 9003 1994 quality standards have been discontinued. They are now obsolete! If you're now ISO 9001 1994 certified, you're going to have to update your quality management system in order to meet the new ISO 9001 2000 requirements. And if you're now ISO 9002 or ISO 9003 certified, you're going to have to become ISO 9001 2000 certified !

ISO 9001 2000 has replaced the old ISO 9001 1994 standard. In addition, the old ISO 9002 1994 and ISO 9003 1994 quality standards have been discontinued. They are now obsolete!

If you're now ISO 9001 1994 certified, you're going to have to update your quality management system in order to meet the new ISO 9001 2000 requirements. And if you're now ISO 9002 or ISO 9003 certified, you're going to have to become ISO 9001 2000 certified !

ISO9001:1994 vs ISO9001:2000 New Standard In the past, ISO had three standards: ISO 9001:1994 , ISO 9002:1994 , and ISO 9003:1994 . Now there's only one standard: ISO 9001:2000 ! ISO 9002 and ISO 9003 have been dropped. So, if you are currently ISO 9002:1994 or ISO 9003:1994 certified, you will now need to become ISO 9001:2000 certified. And if you're now ISO 9001 certified, you're going to have to update your quality system in order to meet the new ISO 9001:2000 requirements.

New Standard

In the past, ISO had three standards: ISO 9001:1994 , ISO 9002:1994 , and ISO 9003:1994 . Now there's only one standard: ISO 9001:2000 ! ISO 9002 and ISO 9003 have been dropped. So, if you are currently ISO 9002:1994 or ISO 9003:1994 certified, you will now need to become ISO 9001:2000 certified. And if you're now ISO 9001 certified, you're going to have to update your quality system in order to meet the new ISO 9001:2000 requirements.

ISO9001:1994 vs ISO9001:2000 (contd) New Structure When you compare ISO 9001:1994 and ISO 9001:2000 you’ll notice that ISO has abandoned the 20-clause structure of the old standard. Instead of 20 sections, the new standard now has 5 sections. ISO reorganized the ISO 9001 standard in order to create a more logical structure, and in order to make it more compatible with the ISO 14001 environmental management standard. While this reorganization is largely a cosmetic change, it could have some rather profound implications if you’ve organized your current quality manual around the old 20-part structure.

New Structure

When you compare ISO 9001:1994 and ISO 9001:2000 you’ll notice that ISO has abandoned the 20-clause structure of the old standard. Instead of 20 sections, the new standard now has 5 sections. ISO reorganized the ISO 9001 standard in order to create a more logical structure, and in order to make it more compatible with the ISO 14001 environmental management standard. While this reorganization is largely a cosmetic change, it could have some rather profound implications if you’ve organized your current quality manual around the old 20-part structure.

ISO9001:1994 vs ISO9001:2000 (contd) New Emphasis In general, the new standard is more customer-oriented than the old standard. While the old standard was also oriented towards meeting customer requirements and achieving customer satisfaction, the new standard addresses this in much greater detail. In addition, it expects you to communicate with customers and to measure and monitor customer satisfaction.The new standard also emphasizes the need to make improvements. While the old standard did implicitly expect organizations to make improvements, the new standard makes this explicit. Specifically, ISO 9001 now wants you to evaluate the effectiveness and suitability of your quality management system, and to identify and implement systemic improvements.

New Emphasis

In general, the new standard is more customer-oriented than the old standard. While the old standard was also oriented towards meeting customer requirements and achieving customer satisfaction, the new standard addresses this in much greater detail. In addition, it expects you to communicate with customers and to measure and monitor customer satisfaction.The new standard also emphasizes the need to make improvements. While the old standard did implicitly expect organizations to make improvements, the new standard makes this explicit. Specifically, ISO 9001 now wants you to evaluate the effectiveness and suitability of your quality management system, and to identify and implement systemic improvements.

ISO9001:1994 vs ISO9001:2000 (contd) New Definitions In the past, organizations that wished to be certified were referred to as suppliers because they supplied products and services to customers. Since many people were confused by this usage, ISO has decided to use the word organization instead. Now the ISO standards focus on the organization , not the supplier . The term supplier now refers to the organization’s supplier. The new redefined term supplier replaces the old term subcontractor (which has now been dropped). While this may sound a bit confusing, this new usage simply reflects the way these words are normally used.While you’re probably familiar with the previous concepts, you may not have heard of the next one. ISO now uses the phrase product realization .

New Definitions

In the past, organizations that wished to be certified were referred to as suppliers because they supplied products and services to customers. Since many people were confused by this usage, ISO has decided to use the word organization instead. Now the ISO standards focus on the organization , not the supplier . The term supplier now refers to the organization’s supplier. The new redefined term supplier replaces the old term subcontractor (which has now been dropped). While this may sound a bit confusing, this new usage simply reflects the way these words are normally used.While you’re probably familiar with the previous concepts, you may not have heard of the next one. ISO now uses the phrase product realization .

ISO9001:1994 vs ISO9001:2000 (contd) While this is a rather abstract concept, it is now central to ISO’s approach. In fact, ISO devotes an entire section to this new concept (Section 7). So what does it mean? In order to grasp what it means you need to recognize that a product starts out as an idea. The idea is realized or actualized by following a set of product realization processes. Product realization refers to the interconnected processes that are used to bring products into being. In brief, when you start out with an idea and end up with a product, you’ve gone through the process of product realization.

While this is a rather abstract concept, it is now central to ISO’s approach. In fact, ISO devotes an entire section to this new concept (Section 7). So what does it mean? In order to grasp what it means you need to recognize that a product starts out as an idea. The idea is realized or actualized by following a set of product realization processes. Product realization refers to the interconnected processes that are used to bring products into being. In brief, when you start out with an idea and end up with a product, you’ve gone through the process of product realization.

ISO9001:1994 vs ISO9001:2000 (contd) New Requirements The new ISO 9001:2000 standard introduces some new requirements and modifies some old ones. These requirements are summarized below. For more detail, please see the associated ISO 9001:2000 clauses (in brackets). Communicate with customers (7.2.3). Identify customer requirements (5.2, 7.2.1). Meet customer requirements (5.2). Monitor and measure customer satisfaction (8.2.1). Meet regulatory requirements (5.1). Meet statutory requirements (5.1).

New Requirements

The new ISO 9001:2000 standard introduces some new requirements and modifies some old ones. These requirements are summarized below. For more detail, please see the associated ISO 9001:2000 clauses (in brackets).

Communicate with customers (7.2.3).

Identify customer requirements (5.2, 7.2.1).

Meet customer requirements (5.2).

Monitor and measure customer satisfaction (8.2.1).

Meet regulatory requirements (5.1).

Meet statutory requirements (5.1).

ISO9001:1994 vs ISO9001:2000 (contd) Support internal communication (5.5.3). Provide quality infrastructure (6.3). Provide a quality work environment (6.4). Evaluate the effectiveness of training (6.2.2). Monitor and measure processes (8.2.3). Evaluate the suitability of quality management system (8.4). Evaluate the effectiveness of quality management system (8.4). Identify quality management system improvements (5.1, 8.4). Improve quality management system (5.1, 8.5).

Support internal communication (5.5.3).

Provide quality infrastructure (6.3).

Provide a quality work environment (6.4).

Evaluate the effectiveness of training (6.2.2).

Monitor and measure processes (8.2.3).

Evaluate the suitability of quality management system (8.4).

Evaluate the effectiveness of quality management system (8.4).

Identify quality management system improvements (5.1, 8.4).

Improve quality management system (5.1, 8.5).

ISO9001:1994 vs ISO9001:2000 (contd) New Flexibility Under the new ISO 9001:2000 standard, you may ignore or exclude some requirements . Requirements that may be ignored under special circumstances are known as exclusions . According to ISO, you may ignore or exclude any of the requirements found in Section 7 Product realization as long as you meet certain conditions.You may exclude a Section 7 requirement if you cannot apply it. More precisely, you may exclude or ignore a requirement if: You cannot apply it because of the nature of your organization, or You cannot apply it because of the nature of your products or services

New Flexibility

Under the new ISO 9001:2000 standard, you may ignore or exclude some requirements . Requirements that may be ignored under special circumstances are known as exclusions . According to ISO, you may ignore or exclude any of the requirements found in Section 7 Product realization as long as you meet certain conditions.You may exclude a Section 7 requirement if you cannot apply it. More precisely, you may exclude or ignore a requirement if:

You cannot apply it because of the nature of your organization, or

You cannot apply it because of the nature of your products or services

ISO9001:1994 vs ISO9001:2000 (contd) However, you may not exclude or ignore Section 7 requirements if doing so will compromise your ability or willingness to meet the requirements set by customers and regulators. We believe that this permissible exclusion clause is a very important improvement. We think it’s important because it makes implementation more flexible and conformance less rigid. Because of this significant innovation, you’re more likely to end up with a quality management system that not only complies with ISO’s standards but also meets your organization’s unique needs.This new, more flexible, approach is further demonstrated in another way. When you study the new ISO 9001 standard, you’ll notice that it is less prescriptive than the old standard. In general, the new standard tells you what to do not how to do it. This is particularly evident when you look at how many times procedures are required. When you compare the old and the new standard, you’ll notice that procedures are much less often required by the new standard. This more flexible approach gives you more freedom to decide how you’re going to meet the requirements. In general, this should make it easier for you to develop a more suitable and effective quality management system.

However, you may not exclude or ignore Section 7 requirements if doing so will compromise your ability or willingness to meet the requirements set by customers and regulators.

We believe that this permissible exclusion clause is a very important improvement. We think it’s important because it makes implementation more flexible and conformance less rigid. Because of this significant innovation, you’re more likely to end up with a quality management system that not only complies with ISO’s standards but also meets your organization’s unique needs.This new, more flexible, approach is further demonstrated in another way. When you study the new ISO 9001 standard, you’ll notice that it is less prescriptive than the old standard. In general, the new standard tells you what to do not how to do it. This is particularly evident when you look at how many times procedures are required. When you compare the old and the new standard, you’ll notice that procedures are much less often required by the new standard. This more flexible approach gives you more freedom to decide how you’re going to meet the requirements. In general, this should make it easier for you to develop a more suitable and effective quality management system.

ISO9001:1994 vs ISO9001:2000 (contd) New Approach In order to understand ISO 9001:2000 at a deeper level, you need to recognize that ISO uses a process approach to quality management. While the process approach is not new, the increased emphasis ISO now gives to it is new. It is now central to the way ISO thinks about quality management systems. According to this approach, a quality management system can be thought of as a single large process that uses many inputs to generate many outputs . This large process is, in turn, made up of many smaller processes. Each of these processes uses inputs from other processes to generate outputs which, in turn, are used by still other processes.

New Approach

In order to understand ISO 9001:2000 at a deeper level, you need to recognize that ISO uses a process approach to quality management. While the process approach is not new, the increased emphasis ISO now gives to it is new. It is now central to the way ISO thinks about quality management systems. According to this approach, a quality management system can be thought of as a single large process that uses many inputs to generate many outputs . This large process is, in turn, made up of many smaller processes. Each of these processes uses inputs from other processes to generate outputs which, in turn, are used by still other processes.

The 2000 version ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

ISO 9004:2000

ISO 9004:2000

What is ISO9004:2000 ISO 9004: 2000 Quality management systems – Guidelines for performance improvements , QMS, Guidelines for performance improvement. The aim of this standard is the improvement of the performance of an organization and the satisfaction of customers and other interested parties.

ISO 9004: 2000 Quality management systems – Guidelines for performance improvements , QMS, Guidelines for performance improvement. The aim of this standard is the improvement of the performance of an organization and the satisfaction of customers and other interested parties.

ISO9004:2000 (contd.) ISO 9004:2000 provides information that will be helpful in going beyond ISO 9001:2000 to improve the efficiency of your operation. It is recommended that you obtain data from various sources, both internal and external, to assess the merit of your quality system goals. This information can also be used to improve process function.

ISO 9004:2000 provides information that will be helpful in going beyond ISO 9001:2000 to improve the efficiency of your operation. It is recommended that you obtain data from various sources, both internal and external, to assess the merit of your quality system goals. This information can also be used to improve process function.

ISO9004:2000 (contd.) ISO 9004 as the Quality Management System Guidance standard is intended to adopt a broader view of quality management in pursuit of operational improvement and benefits to interested or involved parties in your business activities. This may include your employees, owners, suppliers and the society in general.

ISO 9004 as the Quality Management System Guidance standard is intended to adopt a broader view of quality management in pursuit of operational improvement and benefits to interested or involved parties in your business activities. This may include your employees, owners, suppliers and the society in general.

ISO9001:2000 vs ISO9004:2000? or otherwise… ISO 9001:2000 and ISO 9004:2000 are harmonized in structure and terminology to assist you in going back and forth from one to the other. Both standards apply a process approach. The ISO 9004:2000 manual consists of guidance and recommendations, which are not intended for certification, regulatory or contractual use, or as a guide to the implementation of ISO 9001

ISO 9001:2000 and ISO 9004:2000 are harmonized in structure and terminology to assist you in going back and forth from one to the other. Both standards apply a process approach.

The ISO 9004:2000 manual consists of guidance and recommendations, which are not intended for certification, regulatory or contractual use, or as a guide to the implementation of ISO 9001

ISO9001:2000 & ISO9004:2000 they are similar at focusing to: Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to decision making Mutually beneficial supplier relationships

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to decision making

Mutually beneficial supplier relationships

Thank You

Thank You