- ISO 9001 is the generic standard that applies to any business. However there are sector specific standards i.e. TS 16949 for the automotive sector and AS9100 for the defence and aerospace sector. The ISO requirements form the base requirements of both these latter standards. As base line management system requirements ISO 9001 consists of the following:
1.Document control and requirements, control of records
2.Management responsibility – policy, communication, customer focus, leadership, QMS review, planning, responsibility and authority etc.
3.Resource management – provision of resources, human resources, competence, training and awareness, infrastructure, plant, facilities and equipment, work environment, safety.
4.Product realisation and process control – planning, acceptance criteria, confidentiality, change control, determination of customer requirement and review, customer communication, design and development, inputs and outputs, design for manufacture, special characteristics, design review, design and development validation and verification, prototypes, product approval process, control of design changes.
5.Purchasing control – supplier management and development, customer approved sources, purchasing information, verification of purchased product, incoming product quality, supplier monitoring.
6.Product and service provision – control of production including: control plans, work instructions, verification of job set-ups, preventative maintenance, management of production tooling, scheduling, data capture, validation of processes for production, identification and traceability, customer property, preservation of product – storage and inventory.
7.Control of measuring devices including: MSA, calibration records, laboratory requirements
8.Measurement, analysis and improvement: statistical tools application and concepts, internal audit, process audit, product audit, audit planning and auditor qualification. Monitoring and measurement of processes and products.
9.Control of non-conforming product
10.Data analysis
11.Continual Improvement including: problem solving, error-proofing, corrective action effectiveness, non-conforming parts analysis
12.Preventative action
ISO 9001: 2008
Top management shall:
“provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness”
“ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction”
TS 16949:2009 also includes:
“review the product realization processes and the support processes to assure their effectiveness and efficiency”