Purpose To determine that customer requirements, including the requirements for delivery and post-delivery activities are understood and recorded. Any requirements, not stated but are necessary for the specified or intended use, statutory, legal or regulatory requirements and any others considered necessary shall be determined and noted where appropriate. NOTE Post-delivery activities include, for example, act…
Purpose [enter-your-company-name-here] has established procedures to review the requirements related to product or service prior to supply. These procedures ensure that product or service and customer requirements are defined, contract or order requirements differing from those previously expressed are resolved and the organisation has the ability to meet the defined requirements. Procedure [enter-your-compan…
Purpose To determine effective arrangements for communicating with customers in relation to product information, enquiries, contracts or orders, customer feedback and complaints. Procedure (This document lists some generic responses. Your specific internal response should be framed around these or detailed accordingly) [enter-your-company-name-here] has established and implemented procedu…
Purpose Unless the organisation has claimed an exemption to this clause, it is required to plan and control the design and development of product. During the design and development planning, the organisation shall determine; the stages of design and development the necessary and appropriate review, verification and validation processes for each stage the res…
Purpose This procedure asserts that, during the design and development phase, the inputs to the design are reviewed in order to assure that they are in conformance with the requirements for the end design. The review process is documented in accordance with the procedure 4.2.4 – Control of records Procedure During and following the design and development phase, [enter-your-company-name-here] conducts assessments to ensure that the inputs will ens…
Purpose This procedure asserts that, during the design and development phase, the outputs shall be in a form that is capable of verification against the design and development inputs. 7.3.2 Design and development inputs. Procedure The design and development outputs shall; correlate with the input requirements that were set for the design and development phase. be in a form that provides ap…
Purpose To demonstrate the procedure for review of the design and development process in order to verify that the results will meet requirements and to identify any potential or actual problems and propose necessary actions. Procedure The regular review process shall be carried out by top management. The timing and frequency of the reviews shall be determined at the start of the project and varied as necessary. Participants in…
Overview The Key Business Area named Quality ISO9001:2008 and its sub-sections are designed to reflect the order and format of the requirements of the ISO9001:2008 Quality Management System Standard (QMS). Whilst these documents will enable your organisation to complete much of the documentation for accreditation to the standard, there is more that must be done. What to do now It is necessary to review and edit these documents to…