7.1 Planning of Product Realisation The organisation shall plan and develop the processes needed for service realisation. This includes the need to establish processes, documents, and provide resources specific to the service; required verification, validation, monitoring, inspection and test activities specific to the service, and also the records needed to provide evidence that the realisation processes and resulting service meet the requirements.
7.2 Customer Related Processes The organisation shall determine customer requirements, statutory and regulatory requirements and any additional requirements determined by the organisation, and review these requirements. Records resulting from the review and actions arising should be maintained. This clause focuses mainly on the service provided, but can cover additional factors such as regulatory or legal requirements, and unspecified customer expectations.
7.3 Design & Development> The organisation shall plan and control the design and development of its service. This requires determining the design and development stages, the review, verification and validation of each stage, and the responsibilities and authorities for design and development. This clause requires you to have controls for the design processes and to establish a disciplined approach to the design process. The design process should include inputs, outputs, review, verification and validation. Design and development changes also need to be identified and records maintained.
7.4 Purchasing The organisation shall ensure that purchased product conforms to specified purchase requirements. The organisation shall evaluate and select suppliers based on their ability to supply product in accordance with these requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of results of evaluation shall be maintained. The organisation shall also establish and implement the inspection or other activities necessary (verification) for ensuring that purchased product meets specified requirements.
7.5.1 Control of production & service provision This clause describes the various types of controls that you might need to have in place for the delivery of service. These include the availability of information that describes the service, the availability of work instructions, the use of suitable equipment, the availability of monitoring and measuring devices and the implementation of monitoring and measurement.
7.5.2 Validation of processes for production and service provision ITD do not have any processes where the resulting outputs cannot be verified by subsequent monitoring and measuring, therefore this clause is excluded
7.5.3 Identification & Traceability Where appropriate, the organisation shall identify the product/service by suitable means. Where traceability is a requirement, the organisation shall control and record the unique identification of the product / service. Identification is knowing what the product or service resulting from a particular process is. Where you need to identify a product/service, the methods used and the records to be kept need to be defined. Traceability is knowing where a product/service came from.
7.5.4 Customer Property The organisation shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product/service.
7.5.5 Preservation of Product The organisation shall preserve the conformity of the product/service during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection.
7.6 Control of monitoring & measuring devices This means having confidence in the equipment used to check your work. This clause applies to organisations where monitoring devices and measuring equipment are used to verify that what you are providing meets your customer requirements. Monitoring implies observation and supervision activities. Measurement considers the determination of a quantity, magnitude or dimension. Where necessary to ensure valid results, measuring equipment shall be calibrated, adjusted, safeguarded and protected from damage and deterioration.
8.1 Measurement Analysis & Improvement This clause covers the wider monitoring, measurement, analysis and improvement of the quality management system. The organisation shall plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of the product/service, to ensure conformity of the QMS and to continually improve the effectiveness of the QMS. This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
8.2.1 Customer Satisfaction The organisation shall monitor information relating to customer perception as to whether they have met customer requirements. The methods for obtaining and using this information shall be determined. Monitoring of customer satisfaction should be performed on an ongoing basis, as customers’ perceptions of performance change over time. The results of the customer satisfaction monitoring should be addressed in the management review and continual improvement activities, to identify and implement those changes which will improve the relationship with customers. Note: Satisfaction is not the opposite of dissatisfaction. Satisfaction can produce a neutral response whereas dissatisfaction can produce a strong negative response!
8.2.2 Internal Audit The organisation shall conduct internal audits at planned intervals to determine whether the QMS conforms to the standard and to the QMS requirements established by the organisation, and is effectively implemented and maintained. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. Management must ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results.
8.2.3 Monitoring & Measurement of Processes The organisation shall apply suitable methods for monitoring and measuring the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective action shall be taken, as appropriate, to ensure conformity of the service.
8.2.4 Monitoring & Measurement of Product There is considerable overlap between this clause and the previous one. In many cases the same monitoring or measurement procedures will be adequate for the purposes of monitoring or measuring both processes and products / services.