7. Continual Improvement of the S
Quality Management System a C
C t
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Management
responsibility i u
s
R
e
s s
Resource f
t
q
management
Measurement,
a t
u analysis
o
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improvement c o
t
m
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m
i
m
e
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n o e
t
n r
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Product
(and/or service) Output
Input Product
Realization
Model of a process – based quality management system
8. INPUT OUTPUT
Organization
CUSTOMER CUSTOMER
Continual Improvement of the
Quality Management System
Management
responsibility Customers
Customers Measurement
Resource Analysis and
management Satisfaction
improvement
Output
Input Product
Requirements Product
Realization
CUSTOMER ORIENTED PROCESS
21. Process owner exist
Suggested questions about the owner:
• Who is it?
• How do you know they are the owner?
• Does the owner know they are the owner?
• Have they been given authority and responsibility for the process?
Is a process owner required by ISO/TS 16949:2002?
No, but responsibility and authority is
Critical Elements of All Processes
22. Process is defined
Suggested questions about process definition:
• Where is it defined?
• How is it defined?
• Who defined it?
Is a process definition required by ISO/TS 16949:2002?
Review 4.1 General requirements
Critical Elements of All Processes
23. Process is documented
Suggested questions about process documentation:
• Does it need to be documented?
• Where is it documented?
• How is it documented?
Is a process documentation required by ISO/TS 16949:2002?
Review 4.2 Documentation Requirements
Critical Elements of All Processes
24. Linkage of process established
Suggested questions about linkages:
• What are the inputs/outputs?
• Where do the inputs come from?
• Where do the outputs go?
• How many difference inputs/outputs are there?
• Who is the supplier(s) of the inputs?
• Who is the customer of those outputs?
• What other processes are linked to the inputs/outputs?
Are linkages being established required by ISO/TS 16949:2002?
Read 4.1 and 0.2
Critical Elements of All Processes
25. Process is monitored
Suggested questions about process monitoring:
• What is monitored?
• How often?
• How is it reported?
• Who gets the information?
• What do they do with it?
• Is it what they want?
• Who else might want to know?
• Is there continual improvement?
•Are they part of Management Review?
Is a process monitoring required by ISO/TS 16949:2002?
Read 5.6.1, 4.1d), 7.4.3.2, 7.6
Critical Elements of All Processes
26. Records are maintained
Suggested questions about records:
• What are the records?
• Why these records?
• Where are they maintained?
• For how long?
• Should there be other records?
• Who needs these records?
• Does anyone ever review them?
Is maintenance of records required by ISO/TS 16949:2002?
Read 4.2.4,7.6.2 and other clauses.
Critical Elements of All Processes
Editor's Notes
More companies are recognizing the positive impact of implementing a good quality management system. The rise in numbers of companies that have implemented a QMS system that conforms to ISO9001:2000 show that there is continued interest in the positive aspects of the recognition.
Our approach to the development of a QMS has come from a long background, specifically since the end of WWII. The drive has been two fold: (1) to come to a common understanding of the understanding of what quality is and (2) the need to demonstrate our capability to provide goods and services that meet our customers requirements.
Clause 5.0 “Management responsibility” identifies all of the requirements expected of management to support and maintain this quality management system. While the content might seem rather simple, the implications are considerable.
“ If you fail to plan, you can plan to fail”. Planning for all the activities in ISO9001:2000 is absolutely essential in the development of a management system. This clause, 6.0 Resource Management, gives us an idea of the resources we have to establish to establish and maintain our QMS. The focus is on human resources, infrastructure, facilities, and the work environment. Additionally, while not specifically mentioned, the financial resources of the organization should also be taken into account to ensure long-term capability to sustain the companies activities.
“ If you fail to plan, you can plan to fail”. Planning for all the activities in ISO9001:2000 is absolutely essential in the development of a management system. This clause, 6.0 Resource Management, gives us an idea of the resources we have to establish to establish and maintain our QMS. The focus is on human resources, infrastructure, facilities, and the work environment. Additionally, while not specifically mentioned, the financial resources of the organization should also be taken into account to ensure long-term capability to sustain the companies activities.
Clause 7.0, Product (or service) Realization is one of the biggest most complicated clauses of the requirement. This is the only clause where an “exception” can be taken. You may not “design” or have “monitoring and measurement” devices.. All other clauses (4.0, 5.0, 6.0, and 8.0 are all mandatory and cannot have any portion excluded from the requirement.
In the previous version of ISO9001 (1994), there was not a lot of emphasis on the process of collecting and evaluating data. Here we have a mandatory requirement for the organization to collect, by various means, data that will be used to improve processes. This clause also has requirements for four (4) mandatory procedures: (1) Control of non-conforming product, (2) Internal Auditing, (3) Corrective Action and (4) Preventative Action.
ISO9004 is a good guideline document for process improvement. If necessary it could be used as a “one-semester” college course in Quality Management. It should be used in conjunction with ISO9001 as an approach to add improvement tools to the existing Quality System.
The activities necessary for an ISO9001:2000 system is to (1) document what you do and (2) do what you document and (3) continuously improve all of your operations.
The activities necessary for an ISO9001:2000 system is to (1) document what you do and (2) do what you document and (3) continuously improve all of your operations.
The activities necessary for an ISO9001:2000 system is to (1) document what you do and (2) do what you document and (3) continuously improve all of your operations.
The activities necessary for an ISO9001:2000 system is to (1) document what you do and (2) do what you document and (3) continuously improve all of your operations.
Documentation is important in a QMS. The original ISO9001 standard was quite prescriptive, in that it “prescribed” what documents (procedures) you had to create. The new version of ISO9001:2000 is more “descriptive” in that it “describes” what you need to do, and allows you the option on how you wish to control the process. You may not always need a “procedure” to control a process with a check-list or some other reference document will work.
Documentation is important in a QMS. The original ISO9001 standard was quite prescriptive, in that it “prescribed” what documents (procedures) you had to create. The new version of ISO9001:2000 is more “descriptive” in that it “describes” what you need to do, and allows you the option on how you wish to control the process. You may not always need a “procedure” to control a process with a check-list or some other reference document will work.
Quality Management Principles are a set of Management tools to help them with the management of the process. While you won’t be audited against these principles, you will most likely be asked how you use these tools in the management of your system.
Quality Management Principles are a set of Management tools to help them with the management of the process. While you won’t be audited against these principles, you will most likely be asked how you use these tools in the management of your system.
Quality Management Principles are a set of Management tools to help them with the management of the process. While you won’t be audited against these principles, you will most likely be asked how you use these tools in the management of your system.
Quality Management Principles are a set of Management tools to help them with the management of the process. While you won’t be audited against these principles, you will most likely be asked how you use these tools in the management of your system.
Quality Management Principles are a set of Management tools to help them with the management of the process. While you won’t be audited against these principles, you will most likely be asked how you use these tools in the management of your system.
Quality Management Principles are a set of Management tools to help them with the management of the process. While you won’t be audited against these principles, you will most likely be asked how you use these tools in the management of your system.
