Build one engineering process. Satisfy every regulated obligation.
Regulated engineering organizations may face dozens — sometimes hundreds — of overlapping standards and internal requirements. Applied SAFe® Platform lets you design one effective way of working as a Lean-QMS and map those obligations onto it, instead of turning every reference model into another process layer.
A standard describes what must be satisfied. It does not define the best way for your organization to work.
A regulated product may be subject to many standards, regulations, internal policies, and customer requirements at once. Translating each of them independently into process creates:
- Overlapping activities
- Duplicate work products
- Conflicting terminology
- Unnecessary controls
Compliance-by-replication becomes unmanageable at scale.
What looks simple for one standard becomes a maze when dozens of reference models apply. Teams end up executing the same intent several times under different names, maintaining parallel mappings, and carrying process overhead that exists because of the standards rather than because the work requires it.
Map standards to the process — not the process to the standards.
Start with the operating model that fits how your organization needs to engineer products. Map applicable requirements from standards, regulations, and internal policies onto the activities, work products, roles, and practices intended to satisfy them. Then identify where the process does not provide sufficient coverage and improve it where needed.
- Standards
- Regulations
- Internal policies
- Customer requirements
How the mapping runs
- 1AI maps requirements
Use AI to map individual requirements from standards, regulations, and internal policies to the activities, work products, roles, and practices in the operating model that are intended to satisfy them. One process element can support requirements from multiple sources.
- 2AI identifies coverage and gaps
Analyse the mappings to distinguish requirements that are addressed, partially covered, or not covered. Surface the specific obligations for which the current process is insufficient.
- 3AI recommends how to close them
Generate concrete recommendations for the operating model — for example adding or modifying an activity, work product, role, guidance, or relationship — with every recommendation linked back to the requirement that triggered it.
- 4Govern the process change
Process owners review the recommendations and decide which changes to adopt. Approved changes become part of the governed operating model, after which the affected standards and policies can be reassessed.
One process. Many requirements. Gaps made visible.
The platform maps requirements from Automotive SPICE (ASPICE), ISO 26262, IEC 62304, and internal policies to the same company process — automotive, medical device, or any other applicable set. It shows where existing activities and work products already provide coverage, identifies what is only partially or not covered, and recommends the process changes needed to close the gaps — without creating another standard-specific process.
One way of working. Many obligations satisfied.
A Lean-QMS designed for the organization and its products, with traceable coverage across applicable obligations — ASPICE, ISO 26262, IEC 62304, internal policies, customer requirements — and clear recommendations where coverage is insufficient, rather than a collection of standard-specific processes teams have to reconcile themselves.
- Less process duplication
- Less manual mapping effort
- Gaps visible earlier
- One process can satisfy many standards
“Applied SAFe® is a very valuable tool for an agile transition project in a regulated environment. You need less time and less investment in work to be able to implement a complete agile standard process with Applied SAFe®.”
Product capabilities behind this use case
See how Applied SAFe® Platform maps obligations to the operating model, identifies gaps, and keeps compliance connected as standards and processes evolve.
Questions we get
- Do we need a separate process for every standard?
- No. The goal is the opposite: maintain one effective company process and map requirements from multiple standards, regulations, and internal policies to the process elements that satisfy them.
- Can this be our QMS?
- It can be. Applied SAFe® implements SAFe® as a Lean-QMS, with the standards mapped onto it and the evidence read back from execution. Whether it satisfies a particular certification scope remains your organization's and your assessor's determination.
- Can one process element satisfy requirements from several standards?
- Yes. Where requirements from different sources express overlapping intent, they can map to the same activity, work product, role, or practice instead of creating duplicate process steps.
- What happens when the process does not fully cover a requirement?
- AI identifies the requirement as partially or not covered and recommends targeted changes to the operating model, such as modifying an activity, work product, role, guidance, or relationship.
- Does AI automatically change the process?
- No. AI maps requirements, analyses coverage, and proposes improvements. Process owners review the recommendations and decide which changes become part of the governed operating model.
- What happens when a standard or regulation changes?
- The existing mappings make it possible to identify which process elements and variants are affected, so teams can review the impact and update the operating model without rebuilding the compliance mapping from scratch.
Need help building the operating model?
PEDCO can support the work around Applied SAFe® Platform on both sides: engineering one fitted process and mapping the obligations onto it, then verifying that it is the process actually being followed — and keeping it that way.
Design for the work. Map the obligations. Close the gaps.
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