When one of my former employers talked about functional safety for the first time on one of the new projects, I saw two types of expression. The first facial expression of many colleagues was: I do not know that, I never heard of it. The second look expressed a kind of worry that much more work would be coming to the organization than expected. This is a well-known situation in lot of companies and their concerns are often explained by the fact that in addition to the implemented QM standards such as ISO 9001 or IATF 16949, the organization is now facing another – for them as yet unknown – standard: ISO 26262. This standard is no less complicated than the two previously mentioned, but the positive thing is that many requirements and topics of the above mentioned standards overlap.
In this blog I would like to take fears away from companies that are for the first time dealing with ISO 26262, and want to implement its requirements. The focus will be on the similarities between IATF 16949 and ISO 26262. To begin with, let me briefly explain the main differences in the general definition of the two standards:
- IATF 16949 specifies requirements for quality management systems in the automotive industry.
- ISO 26262 standard is the adaptation of the IEC 61508 (basic functional safety standard applicable to all kinds of industry) for the automotive industry and serves to identify functional and non-functional hazards and to prove that the product does not violate the relevant safety objectives.
As you can see, IATF is actually a QMS implemented in an organization and the company works according to these rules and approaches. ISO 26262 is mainly project- or product-related and is requested by the customer through an RFQ (Request for Quotation).
In ISO 26262 the following is stated: Safety is intertwined with common function-oriented and quality-oriented activities and work products. While in ISO 26262 the IATF 16949 is mentioned a few times as reference for a QM standard, conversely in the IATF 16949 it is not spoken directly about the ISO 26262 as a functional safety standard. Nevertheless IATF 16949 standard deals with the product safety standards and the handling of safety-relevant products that can not be assigned directly, but in a general way to functional safety. However, about functional safety and how to handle this standard or how to integrate it into the QMS, is not much there in IATF 16949. The definition of product safety in the IATF 16949 only refers to features on the product and in the production process that affect more the final assembly safety requirement.
If we deal with the ISO 26262 standard in the course of a project, it can be said approximately that about half of the work products of this standard are already covered by the IATF 16949. That means that indeed organizations which are using IATF 16949 as a QMS, already practice many requirements of ISO 26262 in different parts of the organization. One of the common keywords in both standards is risk management. As we know, risk management and especially risk analyzes are capitalized in the IATF 16949. These are also one of key terms and requirements in ISO 26262 such as Hazard Analysis and Risk Assessment (HARA), Automotive Safety Integrity Level (ASIL) classification, and failure analysis of the system and components by FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) or FMEDA (Failure Modes, Effects and Diagnostic Analysis). In each of these ISO 26262 processes, the task is using a risk-based approach to analyze and evaluate risks and threats to ultimately make the product safer.
Another important topic in both standards are the CSRs (Customer Specific Requirements). While IATF 16949 is based on the evaluation, implementation and sustainable auditing of customer-specific requirements within the scope of the QMS, the ISO 26262 standard includes the integration & handling of safety goals and the strategy for CSRs.
As you can see, ISO 26262 has an overlap with IATF at new product development.
In the next part of the blog I will cover the overlaps more deeply and directly compare parts of the two standards.
By Dijaz Maric, Quality Management & Reliability Engineering Consultant