Purpose To identify the procedure used to verify that the design and development outputs have met the design and development input requirements. Procedure Reviews to verify that the design and development outputs have met the design and development input requirements are carried out by top management. The timing and frequency of the reviews may be determined by the Quality Manager or person in charge of the design project, at…
The organisation chart is used to demonstrate in graphic form, the structure or relationship of each role in the organisation. You should identify and clearly indicate a management representative as being the Quality Manager. Depending upon the size and nature of the organisation, this manager may or may not have other managerial responsibilities. You may wish to insert a screen shot of your organisation chart, as shown in the TKO main screen, but be careful not to inse…
Purpose The international standard, ISO9001-2008, specifies the requirements for the Quality Management System (QMS) where the organisation needs to demonstrate that it is able to meet its customer’s requirements together with any statutory and regulatory obligations. The QMS is designed to develop customer satisfaction through its application, the processes for continual improvement and assurance of conformance with the requirements of the customer and any applicable…
Purpose To identify the procedure used to validate that the design and development outputs have met or are capable of meeting the customer’s requirements. Procedure At the completion of the design and development phase, the outputs are reviewed to validate that they have met the design and development input requirements and the product meets the requirements of the customer. Wherever practical, this process is carried out prio…
Purpose The requirements of the international standard ISO9001-2008 are generic in order that they may be applied to all organisations, irrespective of their nature, size or product provided. Consequently, where the requirements of the standard are not applicable to the organisation and cannot therefore be applied, they may be considered for exclusion. Claims of conformity with the international standard ISO9001-2008, may only be made when all exclusio…
Purpose To identify the procedure used to control the change process for design and development. Procedure Any changes to the design of a product may be identified and proposed by: [enter-your-company-name-here] The Customer The Design Consultants engaged in the design and development process Representatives of any external parties who have jurisdiction over the design…
Purpose To establish the current status of documents in the Quality Management System, the international standard ISO9001-2008 states; The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management syst…
Purpose To ensure that purchased product conforms to the requirements of the organisation, particularly where the supplied product is integrated into customer products and services. Procedure All purchases, except for cases where the purchased product has no effect upon the subsequent product realisation or service delivery, shall be made from a supplier listed on the Preferred Supplier Listing and are subject to the following procedure….
Purpose For the purposes of interpretation, the terms and definitions given in ISO 9000 apply to the international standard ISO9001-2008. Wherever the term “product” is used, it may also mean “service”. Terms and definitions Where the term “ organisation ” is used in this quality manual, it refers to [enter-your-company-name-here] “ Supplier ” and “Vendor” are synonymous and refer to the…
Purpose To demonstrate the procedure for purchasing product, especially where the product has an effect upon the subsequent product realisation. Procedure Before commencement of the purchasing process, a suitably qualified person shall verify that the specified purchase is adequate and that all specifications and other information conforms with the requirements for product realisation. [enter-your-…