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ISO 13485 Standard Management Responsibility Requirements - Plannig Quality Objectives. The top management shall determine the quality objective not only in order to look good on the quality manual or at the external audit. Well planned quality objectives (and achieving them) would generate a happy top management at the next management's review.
ISO 9001
| ISO 13485
| The top management shall determine appropriate quality objective that would ensure competence to the products' requirements and shall ensure that the objective are determine to the appropriate and relevant functions throughout the organization.
| The top management shall determine appropriate quality objective that would ensure competence to the products' requirements and shall ensure that the objective are determine to the appropriate and relevant functions throughout the organization.
| Quality objective shall be documented.
| Quality objective shall be documented.
| Quality objective must be measurable and consist with the quality policy.
| Quality objective must be measurable and consist with the quality policy.
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Actually there are no additional requirements regarding this chapter. But I would like to add a few words. I am very sensitive when it comes to quality objectives. Please bear with me.The main idea of the quality objective is determining measurable objective that will maintain the quality management system's effectiveness. In other words, the organization is required to determine objectives, that by fulfilling them, the quality management system would achieve improvement (haven't we said that before? we could swear…).
The purpose of quality objective is to relate the quality policy to the implementation of the quality management system. You joined up a meaningful, powerful and impressive quality policy. The real proof for implementing the policy is to set appropriate objectives.
In general, the purpose of the objective is maintaining improvement. But not less important, the purpose is to compete with regulatory requirements. The ISO 9001 Standard applies to customer's requirements, but if you are reading this article, so probably the ISO 13485 Standard is more relevant to you. Regulatory requirements. That is the name of the game. ISO 13485 Standard Management Responsibility Requirements - Plannig Quality Management system ISO 9001
| ISO 13485
| While planning the quality management system, the top management shall ensure the next issues:
| While planning the quality management system, the top management shall ensure the next issues:
| The quality management system is planned according to the main requirements of this international standard.
| The quality management system is planned according to the main requirements of this international standard.
| Any changes occurred throughout the organization shall ensure that the quality management system fulfill still the requirements of this international standard.
| Any changes occurred throughout the organization shall ensure that the quality management system fulfill still the requirements of this international standard.
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The make the story short and simple, when planning a quality management system the next components are to be considered: - Planning the processes combining the quality management system and the relations between them. The purpose is to plan the methods with which the organization shall realize the product.
- Ensuring authorities and responsibilities regarding the processes defined.
- Planning of resources required for maintaining an effective quality management system.
- Planning appropriate criteria for maintaining the effectiveness of the quality management system. The planning shall include the methods to measure and control these criteria.
- Planning the required documentation. The planning shall include procedures (quality and processes), work instructions and records.
When planning (and constructing) your quality management system, you must take into account how changes are to be implanted and controlled. And because we are dealing here with the ISO 13485 Standard, changes are to be expected throughout regulatory and statutory requirements, but also organizational changes or addition of function or roles throughout the organization. View the next article about the ISO 13485 Management responsibility - Responsibility and Authority |
