Let's say that your organization is certified to be compliant with ISO 9001 (or an industry-specific interpretation, such as AS 9100 for aerospace) and that your quality management system applies across the organization, including to software development efforts. However, no document in your QMS traces to ISO 90003 (or AS 9115), which provide software-specific interpretations of the documents. Does not tracing to the software-specific interpretations mean that your software development efforts do not need to address the issues?
Let's take a specific example.
In AS9100, section 7.3.3 (Design and Development Outputs) adds a requirement beyond those in ISO 9001 that reads:
e) specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items
The definition of critical item is given as:
Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.
And the definition of key characteristic is given as:
An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation.
If you trace to AS9115, it becomes clear what a key characteristic means for software:
Key characteristics in software are those measurable attributes where variability can be measured by the project and can, if left unchecked, adversely impact the project or product in areas (e.g., schedule, cost, maintainability, testability, reliability, portability). Examples of key characteristics include defect severity, complexity factors, nested menus, memory, timing, response time, and throughput targets.
If your organization's QMS has process documentation that is designed to meet the intent of AS9100's Design and Development Output, does that documentation have to account for key characteristics in software? Would a QMS that doesn't address key characteristics in software be in non-compliance?
My interpretation of ISO 9001 and AS 9100 is that it applies to all product development, regardless of the type of product that is being developed. These software-specific documents are additional guidance to remove ambiguities or add additional clarity between the hardware/manufacturing terms of ISO 9001 and AS 9100. If software is part of your product and you are certified to ISO 9001 or AS 9100, you need to ensure that your software development processes conform to the intent of the process. Is this a correct interpretation?