Accreditation to ISO means that effective management controls are in place that are clearly defined in writing. These controls include the management of authority, responsibility and the ability to take corrective action to resolve problems. The ability exists to demonstrate that planning and review of equipment and personnel skills are adequate and maintained to a standard which ensures that contract requirements are met and preventive actions are made before manufacturing begins.
1. Work Instructions
These include all operating procedures, product formulations, physical test specifications and quality assurance procedures.
2. Corrective Action
Records will be kept of all corrective action taken and state when and where a problem has occurred. The reason for a failure is analysed, determined and recorded to ensure future consistency of compliance.
Records are kept to demonstrate that systems are working effectively and are available for inspection at all times.
4. Change Controls
All procedural changes are controlled to ensure that the latest reference document is available and used at all times.
It can be demonstrated that controls of inspection, measuring and test equipment are not only suitable for purpose but are regularly calibrated to ensure consistency.
6. Manufacturing Control
Manufacturing is carried out under controlled conditions. Production control systems are in place which identify equipment at all stages and provide a means of recording compliance/non-compliance. A mechanism is in place to pinpoint training requirements in special skills, retraining needs and a review of inspection standards at all stages of manufacturing. Established controls at each stage of production mean that the end product meets both the supplier's and the end customer's quality standards.
7. Raw Material Procurement Control
There are controls in place for the purchasing of raw materials. Chosen suppliers are issued with the precise product specifications and goods-in inspection means that only those raw materials which conform to an agreed specification are used.
8. Inspection And Testing
All finished products will be tested and inspected prior to delivery to the customer to ensure that they meet agreed specifications. When products are reworked they are always re-inspected and re-tested to ensure compliance.
9. Inspection Status
Controls are in place to ensure that records of quality checks have been carried out and that it can be distinguished between inspected and non-inspected material.
10. Sampling Procedures
A control system exists for the preparation of samples and sampling procedures are in place to ensure that the sample taken for inspection is representative of a complete batch of material.
11. Control of Non-conformance Procedures
Non-conforming material is identified and segregated from conforming material. A Material Review Committee will make a decision whether to scrap or rework the material in order to bring it within compliance.
12. Handling And Storage
All products and raw materials will be controlled throughout the manufacturing process. They will be stored in conditions which will protect them from deterioration and damage and they will be handled correctly. They will be correctly identified using the appropriate labelling in compliance with SHE legislation and delivered to the customer in a satisfactory condition. The company will, at all times, provide access and facilities to visiting Quality Assurance representatives.
All personnel whose work affects quality will have the appropriate training. A record of their training will be kept and will be regularly reviewed and updated as required.
All systems will be reviewed and evaluated frequently by the implementation of regular internal audits. The purpose of these audits is not only to ensure that the company remains in compliance with the set procedures but to strive for continual improvement in efficiency.