(Quality Management Systems and Measurement systems analysis) a. List five reaso
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(Quality Management Systems and Measurement systems analysis) a. List five reasons why a company may wish to have their Quality Management Q3 System accredited to an international standard such as ISO 9001: 2008. 5 marks) b. List and briefly describes the contents of ISO 9001: 2008 clause 7. (8 marks) Apart from ISO 9001, name and briefly describe the purpose of the two other standards in the ISO 9000 series. c. 6 marks) d. Describe using a diagram the difference between accuracy and precision. 6 marks)Explanation / Answer
Improve Company and Product Quality
Describe, Understand, and Communicate Your Company Processes
Improve Efficiency, Reduce Waste, and Save Money
Develop a Professional Culture and Better Employee Morale
2. List and breifly describe the contents of ISO 9001:2008
1. Scope - This International Standard specifies requirements for a quality management system where an organisation
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements,
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
5. Management responsibility - Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and e) ensuring the availability of resources.
6. Resource management - The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
7. Product realisation - In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
8. Measurement, analysis and improvement - The organization shall plan and implement the monitoring, analysis and improvement processes needed
a) to demonstrate conformity to product requirements.
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
3. Purpose of other standars in ISO 9000 series
a) ISO 9000:2000 refers to the ISO 9000 update released in the year 2000.
The Technical Committee responsible for the ISO 9000 family developed specifications for the ISO 9000:2000 revisions, leading to a significant advancement of the standards and reflecting contemporary concepts of quality management.
The ISO 9000:2000 revision had five goals:
b) ISO 9000:2015 :
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Relationship management
4. Difference between accuracy and precision
Definition of Accuracy :
There are two common definitions of the term accuracy. In math, science, and engineering, accuracy refers to how close a measurement is to the true value.
The ISO (International Organization for Standardization) applies a more rigid definition, where accuracy refers to a measurement with both true and consistent results. The ISO definition means an accurate measurement has no systematic error and no random error. Essentially, the ISO advises the term accurate be used when a measurement is both accurate and precise.
Definition of Precision :
Precision is how consistent results are when measurements are repeated.
Precise values differ from each other because of random error, which is a form of observational error.
Precision can be broken down into two components:
Repeatability: The variation observed when the same operator measures the same part repeatedly with the same device.
Reproducibility: The variation observed when different operators measure the same part using the same device.
Example: Let’s talk potato chips! Suppose you’re a snack foods manufacturer producing 12 oz. bags of potato chips. You test the weight of the bags using a scale that measures the bags precisely (in other words, there is little variation in the measurements), but not accurately – measuring 13.2 oz., 13.33 oz., and 13.13 oz. for three samples.
Or maybe the scale is accurate, measuring the three samples at 12.02 oz., 11.74 oz., and 12.43 oz., but not precise. In this case, the measurements have a larger variance, but the average of the measurements is very close to the target value of 12 oz.
Or maybe your measurements are all over the place, with samples measuring at 11.64 oz., 12.35 oz., and 13.04 oz., in which case your scale may be neither accurate nor precise.
1. Scope - This International Standard specifies requirements for a quality management system where an organisation
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements,
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
2. Normative reference 3. Terms and definitions 4. Quality management system - The organization shall: a) determine the processes needed for the quality management system and their application throughout the organization, b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,5. Management responsibility - Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and e) ensuring the availability of resources.
6. Resource management - The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
7. Product realisation - In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
8. Measurement, analysis and improvement - The organization shall plan and implement the monitoring, analysis and improvement processes needed
a) to demonstrate conformity to product requirements.
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
3. Purpose of other standars in ISO 9000 series
a) ISO 9000:2000 refers to the ISO 9000 update released in the year 2000.
The Technical Committee responsible for the ISO 9000 family developed specifications for the ISO 9000:2000 revisions, leading to a significant advancement of the standards and reflecting contemporary concepts of quality management.
The ISO 9000:2000 revision had five goals:
- Meet stakeholder needs
- Be usable by all sizes of organizations
- Be usable by all sectors
- Be simple and clearly understood
- Connect quality management system to business processes
b) ISO 9000:2015 :
1. Customer focus
- Understand the needs of existing and future customers
- Align organizational objectives with customer needs and expectations
- Meet customer requirements
- Measure customer satisfaction
2. Leadership
- Establish a vision and direction for the organization
- Set challenging goals
- Model organizational values
- Establish trust
3. Engagement of people
- Ensure that people’s abilities are used and valued
- Make people accountable
- Enable participation in continual improvement
- Evaluate individual performance
4. Process approach
- Manage activities as processes
- Measure the capability of activities
- Identify linkages between activities
- Prioritize improvement opportunities
5. Relationship management
- Identify and select suppliers to manage costs, optimize resources, and create value
- Establish relationships considering both the short and long term
- Share expertise, resources, information, and plans with partners
- Collaborate on improvement and development activities
4. Difference between accuracy and precision
Definition of Accuracy :
There are two common definitions of the term accuracy. In math, science, and engineering, accuracy refers to how close a measurement is to the true value.
The ISO (International Organization for Standardization) applies a more rigid definition, where accuracy refers to a measurement with both true and consistent results. The ISO definition means an accurate measurement has no systematic error and no random error. Essentially, the ISO advises the term accurate be used when a measurement is both accurate and precise.
Definition of Precision :
Precision is how consistent results are when measurements are repeated.
Precise values differ from each other because of random error, which is a form of observational error.
Precision can be broken down into two components:
Repeatability: The variation observed when the same operator measures the same part repeatedly with the same device.
Reproducibility: The variation observed when different operators measure the same part using the same device.
Example: Let’s talk potato chips! Suppose you’re a snack foods manufacturer producing 12 oz. bags of potato chips. You test the weight of the bags using a scale that measures the bags precisely (in other words, there is little variation in the measurements), but not accurately – measuring 13.2 oz., 13.33 oz., and 13.13 oz. for three samples.
Or maybe the scale is accurate, measuring the three samples at 12.02 oz., 11.74 oz., and 12.43 oz., but not precise. In this case, the measurements have a larger variance, but the average of the measurements is very close to the target value of 12 oz.
Or maybe your measurements are all over the place, with samples measuring at 11.64 oz., 12.35 oz., and 13.04 oz., in which case your scale may be neither accurate nor precise.
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