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In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in. Standardizing Quality Systems The ISO, or International Organization for Standardization, was established in 1947 to develop international [...]
Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and [...]
Planning of Product Realization Plan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the: Quality objectives and product requirements Need for processes, documents, and resources Verification, validation, monitoring, [...]
For organizations that are in the process of implementing a QMS, and wish to meet the requirements ofISO 9001:2008, the following comments may be useful. For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes: – Identifying the processes necessary for the [...]
It is important that records are not destroyed before their useful life is over. There are several factors to consider when determining the retention time for records. The duration of the contract – some records are only of value whilst the contract is in force. The life of the product – access to the records [...]
Develop Quality Management System Documentation In ISO 9001 Standards Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9001 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do [...]
The ISO 9001 Standards requires that a documented procedure be established to define the controls needed. This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented. Although the ISO 9001 standards implies that a single procedure is required, should you choose to produce several [...]
The ISO 9001 Standards requires that documents be approved for adequacy prior to issue. Approval prior to issue means that designated authorities have agreed the document before being made available for use. Whilst the term ade- quacy is a little vague it should be taken as meaning that the document is judged as fit for the [...]
ISO 9001:2008 include these checklists as follows: 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 [...]