Among other things, all relevant requirements for QM systems are described in ISO 9001:2015. This standard is used by organizations that want to have confirmed that they can permanently provide their products and/or services and that these products meet customer requirements and the associated legal and regulatory requirements. By applying the various requirements and efficiently implementing a QM system and their processes, organizations aim to increase customer satisfaction. With the revision of ISO 9001:2015, the High Level Structure (HLS) was introduced. This structure standardizes the structure of the other management system standards. Thus, the HLS creates the best conditions for the implementation of an integrated management system and in the implementation of further standards, such as in the areas of environment (ISO 14001), occupational health and safety (ISO 45001), energy (ISO 50001), information security (ISO 27001) or compliance (ISO 19600). The uniform structure of HLS is described in the following graphic.
Figure 1 Structure of the management system
The numbers in brackets refer to the sections of the standards. Source DIN EN ISO 9001:2015
Quality management in the automotive industry
The quality management system standard in the automotive industry, IATF 16949:2016, was also adapted to the High Level Structure following its revision by the International Automotive Task Force (IATF), which is made up of representatives of automotive manufacturers and automotive associations. In IATF 16949, reference is made at various points to the contents of ISO 9001. This means that the IATF standard is regarded as a supplement and can only be used in conjunction with ISO 9001 for audits and certifications. In addition to the requirements of both standards, legal, regulatory and other customer requirements and, above all, customer-specific requirements (CSR’s) must also be taken into account and integrated into the QM system.
IATF 16949 requires the implementation of new or newly formulated requirements in addition to 23 supplementary processes, specification documents and evidence that must be documented. These include the consideration of product safety relevant aspects in the organization, the treatment of risks and opportunities in the risk-based approach, the integration of CSR’s, the assurance of competence within the organization (especially 1st and 2nd party auditors), the processing and documentation of required work packages in product and production process development, the identification, consideration and labeling of special characteristics, consideration of extended specifications in supplier selection, continuous development and monitoring of supplier QM system, tracking, implementation and validation of product and process changes, control, rework and repair of non-conforming results, implementation of an audit program to track system, process and product audits, consideration of other inputs for management review or implementation of a warranty management system included Defective Parts Analysis Process.
The implementation of a QM system according to IATF 16949 has, among other things, the following advantages:
- Visible seal of quality through an effective management system
- Assurance and achievement of a high quality level
- Treatment and reduction of risks throughout the organization
- Consolidation of structural and process organization
- Continuous improvement of system, process and product quality
- Improving opportunities in supplier selection
- Building trust with customers
- Increase in customer satisfaction
- Reduction of system audits by each OEM
- Liability minimization through IATF implementation (state of technology)
- Reduction of internal and external costs
- Error prevention and reduction of scatter and waste in the supply chain
- Reliability within the value chain
The procedure for implementing, further developing or updating a QM system is divided into three steps and shown in Figure 2:
During the project implementation, the IQZ can support you, for example, with documentation proposals for the creation or revision of the entire relevant QM documentation, program an interface of role description and competence matrix with Excel tools or ensure the standard-compliant monitoring, risk assessment and implementation (incl. labeling and traceability) of changes with our change request tool (“IQZ-Change-Request-Tool”), etc.