Boost your ISO 9001 Quality System with IATF 16949
The first black belt level of a martial art is called sho dan, which means "first step" rather than "expert" or "master." The ISO 9001:2015 is similarly a necessary first step on the path to organizational excellence, but it is only that; a first step. The automotive industry's IATF 16949:2016 consists of ISO 9001 plus additional requirements that, while not required for ISO 9001 certification, cover highly useful and desirable features that ISO 9001 mentions only by implication, if at all.
ISO 9001 still focuses predominantly on quality, although clause 6.1 regarding actions to address risks and opportunities directs attention to the other six Toyota production system wastes by implication at the very least. IATF 16949 makes this focus far more explicit while adding additional clauses that enhance significantly the ability of the quality management system to ensure quality. Deployment of these clauses in an ISO 9001 system will therefore enhance the system's ability to deliver tangible and measurable financial results through avoidance of poor quality, reduction of other forms of waste (muda), employee empowerment, and customer satisfaction. This webinar will identify the relevant clauses of IATF 16949 and cite their applicability to non-automotive quality systems.
The webinar's primary learning objective is to show how IATF 16949 fills in numerous gaps in the capabilities of an ISO 9001 system; gaps that would otherwise go unnoticed by those unfamiliar with the automotive standard. The goal is an "ISO 9001-Plus" system with a clearly recognizable edge over competitors' "ISO 9001-Only" systems.
- Clause 4.3, Scope of the quality management system. IATF 16949 adds the need to address supporting and logistics functions.
- Clause 5.1, Leadership and commitment. IATF 16949 adds requirements, the most important of which is the need to consider effectiveness and efficiency. This relates to the lean manufacturing objective of minimizing all forms of waste (muda) as opposed to just poor quality.
- Clause 6.1, Actions to address risks and opportunities. ISO 9001 implies a need for preventive action with this clause; IATF 16949 requires a process for preventive action. We will see that IATF 16949 is far more prescriptive than ISO 9001 with regard to documented processes, and it is beneficial to have them even if they are not required by the latter standard.
- IATF 16949 clause 184.108.40.206 requires contingency plans to ensure continuity of operations in the event of a supply chain disruption, the kind of event that can disable even the best and leanest factory in the world.
- Clause 7.1.3, Infrastructure; IATF 16949 adds the need to consider lean manufacturing principles.
- Clause 7.1.5 Monitoring and Measuring Resources. ISO 9001 may require measurement system analysis (where relevant to the gage or instrument) by implication. IATF 16949 requires it explicitly, and the AIAG sells a manual devoted to this activity. Other MSA resources also are available.
- Clause 7.3 Awareness. IATF 16949 requires a documented process for employee motivation and empowerment, which can convey an overwhelming competitive advantage.
- Clause 8.3 Design and Development. IATF 16949 adds a huge array of useful and effective processes such as advanced quality planning (AQP), design for manufacture (DFM), design for assembly (DFA), and failure mode effects analysis (FMEA).
- Clause 8.4 Control of Externally Provided Inputs. IATF 16949 adds the need for supplier development as practiced, with decisive benefits for both customer and supplier, by Henry Ford almost 100 years ago (C.R. Wilson Body case study).
- Clause 8.5.1 Control of Production and Service. IATF 16949 adds process failure mode effects analysis (PFMEA) for which AIAG offers the most advanced (2019) reference. IATF 16949 also cites control plans, which are very helpful in ensuring quality, and standard work, which supports not just quality but also production control (through standard work times). IATF 16949 features total productive maintenance as well.
- Clause 8.5.2 Identification and Traceability is enhanced significantly by IATF 16949's requirements.
- Clause 8.5.6 Control of Changes is extremely important because anything "changed" or "new" can create new risks. IATF 16949 expands on this and requires a documented process for control of changes.
- Clause 9.1 Monitoring, Measurement, Analysis, and Evaluation. IATF 16949 adds process capability studies to this requirement. Process capability assessment tells us if, for example, we have a Six Sigma process or a process that is not capable of meeting specifications consistently.
- Clause 9.3 Management Review. IATF 16949 adds cost of poor quality, and process effectiveness and efficiency.
- Clause 10.2 Nonconformity and Corrective Action. Corrective and preventive action (CAPA) is a leading source of audit findings in ISO 9001 and IATF 16949, and also FDA Form 483 observations. IATF 16949 adds clauses not found in ISO 9001 to require a documented process for problem solving, and AIAG offers a manual (CQI-20) for this purpose. The similar 8D (Eight Disciplines) process, for which numerous references are available, is also very effective. IATF 16949 also requires a process for error proofing (poka-yoke) which prevents generation of poor quality in the first place.
- Clause 10.3 Continual Improvement. IATF 16949 requires a documented process for this.
- Awareness of IATF 16949 core tools, available from the Automotive Industry Action Group (AIAG)
- Knowledge of the most important IATF 16949 clauses that can enhance the effectiveness of the quality management system.
- Understanding the benefit of having documented processes for vital activities, even where not required by ISO 9001.
Who Should Attend
- Quality managers
- Others with responsibility for the quality management system (ISO 9001:2015, with some concepts carrying over into IATF 16949)