The ISO 9000 Standard requires that documents be reviewed.
Previously the implication was that the review was a
check by potential users that the document was fit
for purpose before it was offered for approval. It
could be construed that for a document to receive
approval it must be checked and therefore ‘review
and approval’ in this context are one and the same
and the requirement is in this instance enhanced
rather than relaxed.
A review is another look at something. Therefore
document review is a task that is carried out at any
time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in
connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the
information)
Read more on ISO 9000 Standards at http://www.iso9000-standards.com
Saturday, June 30, 2012
ISO 9001:2008 Standards Check List
1. ISO 9001 General Requirements
Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?
2. General Documentation Requirements Does the quality management system documentation include documented procedures and records required ensuring effective operation and control of its processes?
3. Quality Manual Has a quality manual been established and maintained that includes:
4. Control of Documents Are documents required for the quality management system controlled?
5. Control of Records Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
6. Management Commitment How has top management demonstrated commitment to the development and improvement of the quality management system?
7. Quality Policy Organization has top management ensured that the quality policy:
8. System Planning 1. Quality Objectives a. What are the quality objectives that have been established at relevant functions and levels within the organization?
9. Responsibility, authority and Communication Responsibility, authority and Communication Audit Checklist 1. Responsibility and authority
10. Resource Management Resource Management Audit Checklist 1. Provision of resources
11. Planning of Product/Service Realization Planning of Product/Service Realization Audit Checklist Is planning of the realization processes consistent with the other requirements of the organization’s quality management system?
12. Management Review Management Review Audit Checklist 1. General checklist a) Does the top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? 13. Product review Determination of Requirements Related to the Product (7.2.1)
14. Design and Development Planning and Design and Development Inputs What is the design and development planning methodology described in the design procedure?
15. Design and Development Outputs Audit Are the outputs of the design and/or development process documented in a manner that enables verification against the design and/or development inputs?
16. Design and Development Review Audit Are systematic reviews of design and/or development conducted at suitable stages?
17. Design and/or Development Verification Is design and/or development verification performed to ensure the output meets the design and/or development inputs?
18. Design and/or Development Validation Is design and/or development validation performed to confirm that resulting product is capable of meeting the requirements for the intended use?
19. Control of Design and Development Changes Are design and/or development changes identified, documented, and controlled?
20. Purchasing Process Does the organization control its purchasing processes to ensure purchased product conforms to requirements?
21. Purchasing Information Do purchasing documents contain information describing the product to be purchased?
22. Verification of Purchased Product Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented?
23. Control of Production and Service Are the production and service provision planned and carried out under controlled conditions including:
24. Validation of Processes for Production and Service Provision Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated checklist.
Read more on ISO 9001:2008 Standard at http://www.iso9001store.com
2. General Documentation Requirements Does the quality management system documentation include documented procedures and records required ensuring effective operation and control of its processes?
3. Quality Manual Has a quality manual been established and maintained that includes:
4. Control of Documents Are documents required for the quality management system controlled?
5. Control of Records Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
6. Management Commitment How has top management demonstrated commitment to the development and improvement of the quality management system?
7. Quality Policy Organization has top management ensured that the quality policy:
8. System Planning 1. Quality Objectives a. What are the quality objectives that have been established at relevant functions and levels within the organization?
9. Responsibility, authority and Communication Responsibility, authority and Communication Audit Checklist 1. Responsibility and authority
10. Resource Management Resource Management Audit Checklist 1. Provision of resources
11. Planning of Product/Service Realization Planning of Product/Service Realization Audit Checklist Is planning of the realization processes consistent with the other requirements of the organization’s quality management system?
12. Management Review Management Review Audit Checklist 1. General checklist a) Does the top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? 13. Product review Determination of Requirements Related to the Product (7.2.1)
14. Design and Development Planning and Design and Development Inputs What is the design and development planning methodology described in the design procedure?
15. Design and Development Outputs Audit Are the outputs of the design and/or development process documented in a manner that enables verification against the design and/or development inputs?
16. Design and Development Review Audit Are systematic reviews of design and/or development conducted at suitable stages?
17. Design and/or Development Verification Is design and/or development verification performed to ensure the output meets the design and/or development inputs?
18. Design and/or Development Validation Is design and/or development validation performed to confirm that resulting product is capable of meeting the requirements for the intended use?
19. Control of Design and Development Changes Are design and/or development changes identified, documented, and controlled?
20. Purchasing Process Does the organization control its purchasing processes to ensure purchased product conforms to requirements?
21. Purchasing Information Do purchasing documents contain information describing the product to be purchased?
22. Verification of Purchased Product Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented?
23. Control of Production and Service Are the production and service provision planned and carried out under controlled conditions including:
24. Validation of Processes for Production and Service Provision Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated checklist.
Read more on ISO 9001:2008 Standard at http://www.iso9001store.com
Quality Management System For Business Performance Improvement
The purpose of Quality Management Standard (QMS) is to encourage the application of process approach to manage a company.
A process is an activity that uses resources to change the inputs to outputs. For company to perform effectively, they have to identify and manage the interrelated and interacting processes. The “Process Approach” is the systematic identification and management of the processes applied within a company and particularly the interactions between those processes.
In order to manage a company efficiently, it is important to do it in a systematic and transparent manner.
Success can be achieved by implementing and maintaining a quality management system that is designed to continually improve the performance while addressing the requirements of all interested parties. 8 quality management system principles that can be used by management in order to manage the company towards improved performance are as below:
Customer focus Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
Leadership Leaders establish the purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives. Involvement of people People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the benefit of the organisation.
Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. System approach to management An organisation’s effectiveness and efficiency in achieving its objectives is attributed to the identifying, understanding and managing interrelated processes. Continual improvement Continual improvement of the organisation’s overall performance should be a permanent objective of the organisation.
Factual approach to decision making Effective decisions are based on the analysis of data and information. Mutually beneficial supplier relationships An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
These eight quality management principles form the basis for the quality management system standards within the ISO 9000 family.
Read more on ISO 9000 Standard at http://www.iso9001store.com
information on Quality Management, please go to http://www.iso9001store.com
Success can be achieved by implementing and maintaining a quality management system that is designed to continually improve the performance while addressing the requirements of all interested parties. 8 quality management system principles that can be used by management in order to manage the company towards improved performance are as below:
Customer focus Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
Leadership Leaders establish the purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives. Involvement of people People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the benefit of the organisation.
Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. System approach to management An organisation’s effectiveness and efficiency in achieving its objectives is attributed to the identifying, understanding and managing interrelated processes. Continual improvement Continual improvement of the organisation’s overall performance should be a permanent objective of the organisation.
Factual approach to decision making Effective decisions are based on the analysis of data and information. Mutually beneficial supplier relationships An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
These eight quality management principles form the basis for the quality management system standards within the ISO 9000 family.
Read more on ISO 9000 Standard at http://www.iso9001store.com
information on Quality Management, please go to http://www.iso9001store.com
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