Common misconceptions about ISO 26262

Introduction

There are many misconceptions or misunderstandings about the purpose of ISO 26262:2018 and what it means an organisation. In this article you will learn about some of the most common misconceptions and receive clarity about each one.

Misconception

ISO 26262 is an accreditation for the organisation, like ISO 9001.  We can get certified once and all our products are compliant.

The reality

Compliance is achieved only for specific development and applications defined in the item definition.  No certification is available. Instead, the organisation must compile evidence to support the argumentation that adequate functional safety has been achieved and ISO 26262 requirements are met.  This must be done for every development and application in scope of ISO 26262.

Misconception

Achieving ISO 26262 is only about producing the work products required by ISO 26262. 

The reality

An organisational and cultural framework must be in place to enable work products to be compliant.  This includes, but is not limited to:

  • An adequate safety culture,

  • Organisation-specific rules and processes for the completion of the work products.

  • Adequate competence management to ensure the work products are produced with adequate competence.

  • An adequate quality management system is in place.

Ensuring that work completed in the distributed development is also compliant is essential.

Misconception

ISO 26262 compliance is a development topic only.

The reality

ISO 26262 is a whole product lifecycle topic, from development to production, operation, service and decommissioning.  Achieving compliance requires support from all associated disciplines in the organisation, such as product development, purchasing, quality management, human resources,

Misconception

Meeting ISO 26262 means the product is safe.

The reality

ISO 26262 compliance is one part of product safety.  It demonstrates that adequate risk reduction has occured for malfunctions of the item in the product for the more signifiant hazards.  There can be more than one item in the product and there are more aspects to product safety that are not within scope of ISO 26262.  Such as

  • non-e/e safety.  e.g. Crashworthiness.

  • Safety of the intended functionality. 

  • Intrinsic risks, e.g. presence of high voltage.

  • Malfunctions of the item that are assessed and judged to be below a risk threshold requiring application of ISO 26262. i.e. QM rated hazards

We hope you found this article useful. We have other articles on functional safety that are freely available. More detailed information is available in our store.

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When IS0 26262:2018 compliance is necessary