Top Management of any organization has a tremendous influence on the success of that organization. This is a self evident, and a simple fact. It would follow therefore, that the success of a project for an ISO Certification (certification of a Quality Management System QMS to ISO 9001) would depend on how top management leads this project. The good news is that ISO 9001 provides simple rules which define the roles and responsibilities for top management. These rules ensure that not only is ISO certification achieved; the organization will also have a formal mechanism for success in whatever it chooses to do. You will find that the rules make powerful sense, and once organized, does contribute to overall organizational success.
Section #5 (ISO 9001:2008:5) is the second section dealing with requirements that need to be met for compliance to ISO 9001:2008. It is the first section that defines activities and actions that people in an organization need to take within the Quality Management System (QMS) that is set up per requirements in section 4 of ISO 9001.
Top Management is ultimately responsible for the effectiveness of the Quality Management System (QMS), and is expected to ensure that the following actions are taken to provide and demonstrate leadership of the system. Customer must be King, and the entire system needs to have that focus.
There needs to be a clear and concise statement of Policy that ensures that employees do what is needed to execute the purpose of the organization, continually improve the effectiveness of the Quality Management System (QMS), and provides a framework for establishing Quality Objectives that when achieved, will ensure compliance with the Quality Policy. This policy must be understood by all employees, and must be kept up to date.
The Quality Management System (QMS) must be planned in such a manner that it will do the job of achieving the purpose of the organization. For example, if the organization manufactures and sells ball point pens, the business processes in the QMS must define how customer and other requirements are collected, the pens designed, how the raw materials and components will be purchased, and used in manufacturing processes that will produce the pens. There must also be processes for measuring and monitoring, and ensuring that all equipment is capable to do what is required. All employees must be competent to do the job that is required of them. Finally, there must be processes to contain any accidents, problems, and protocols to prevent significant problems in the future.
Top management must designate a management representative who will ensure that all of the above actions are planned and executed as needed. The following is a good overall summary of the actions must be done:
Section #5 (ISO 9001:2008:5) is the second section dealing with requirements that need to be met for compliance to ISO 9001:2008. It is the first section that defines activities and actions that people in an organization need to take within the Quality Management System (QMS) that is set up per requirements in section 4 of ISO 9001.
Top Management is ultimately responsible for the effectiveness of the Quality Management System (QMS), and is expected to ensure that the following actions are taken to provide and demonstrate leadership of the system. Customer must be King, and the entire system needs to have that focus.
There needs to be a clear and concise statement of Policy that ensures that employees do what is needed to execute the purpose of the organization, continually improve the effectiveness of the Quality Management System (QMS), and provides a framework for establishing Quality Objectives that when achieved, will ensure compliance with the Quality Policy. This policy must be understood by all employees, and must be kept up to date.
The Quality Management System (QMS) must be planned in such a manner that it will do the job of achieving the purpose of the organization. For example, if the organization manufactures and sells ball point pens, the business processes in the QMS must define how customer and other requirements are collected, the pens designed, how the raw materials and components will be purchased, and used in manufacturing processes that will produce the pens. There must also be processes for measuring and monitoring, and ensuring that all equipment is capable to do what is required. All employees must be competent to do the job that is required of them. Finally, there must be processes to contain any accidents, problems, and protocols to prevent significant problems in the future.
Top management must designate a management representative who will ensure that all of the above actions are planned and executed as needed. The following is a good overall summary of the actions must be done:
1) Show A Commitment To The Customer
2) Establish A Quality Policy
3) Establish, Monitor And Update Quality objectives
4) Assign Resources
5) Assign Responsibility And Authority
6) Conduct Periodic Management Reviews
2) Establish A Quality Policy
3) Establish, Monitor And Update Quality objectives
4) Assign Resources
5) Assign Responsibility And Authority
6) Conduct Periodic Management Reviews
Top Management will also face the challenge of pulling together the information from their quality management system (QMS) and using that information effectively for management review and planning activities as well as for the purposes of continual improvement.
In general, registered organizations communicate about their processes and the effectiveness of their quality management system at a management level but don't carry this activity to other levels and functions throughout the organization. Communication has always been an issue for organizations, and the requirements in the revised standard may lead organizations to develop a more methodical approach in conveying information.
When making changes, it's also not unusual for organizations to forge ahead without considering how changes affect the overall system. Although many organizations review how changes such as the addition of new equipment or new technologies or a reduction of workforce may affect their organization, many lack a formal approach for handling this issue while ensuring that the integrity of the quality management system is maintained.
In general, registered organizations communicate about their processes and the effectiveness of their quality management system at a management level but don't carry this activity to other levels and functions throughout the organization. Communication has always been an issue for organizations, and the requirements in the revised standard may lead organizations to develop a more methodical approach in conveying information.
When making changes, it's also not unusual for organizations to forge ahead without considering how changes affect the overall system. Although many organizations review how changes such as the addition of new equipment or new technologies or a reduction of workforce may affect their organization, many lack a formal approach for handling this issue while ensuring that the integrity of the quality management system is maintained.
How can the Quality Institute of America help?
The Quality Institute of America (QIA) has helped organizations of all types achieve and maintain certification of their Quality Management Systems (QMS) since 1994 over two continents and for several hundred entities. It does so by:
• Providing Training, Consulting, Auditing in ISO 9001 and related standards, such as TS 19649, AS9100, API, ISO 14001, and OHSAS 18001.
• Providing a Quality Management Software (QISS) that automates the act of designing, implementing, and operating these systems through an integrated set of modules for:
Organization Structure
* Document Control
* Records Control
* Nonconformance Control
* Supplier Management
* Corrective Actions
* Preventive Actions
* Calibration
* Maintenance
* Training
* Audits
* Management Review
* Laboratory Management
* Inspection & Test.MANAGEMENT RESPONSIBILITY AND ISO CLAUSE 5
• Providing Training, Consulting, Auditing in ISO 9001 and related standards, such as TS 19649, AS9100, API, ISO 14001, and OHSAS 18001.
• Providing a Quality Management Software (QISS) that automates the act of designing, implementing, and operating these systems through an integrated set of modules for:
Organization Structure
* Document Control
* Records Control
* Nonconformance Control
* Supplier Management
* Corrective Actions
* Preventive Actions
* Calibration
* Maintenance
* Training
* Audits
* Management Review
* Laboratory Management
* Inspection & Test.MANAGEMENT RESPONSIBILITY AND ISO CLAUSE 5
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