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4.4.1.1IATF 16949:2016

Conformance of products & processes (IATF only)

Plain-language summary

You are accountable for the conformity of everything you supply — including outsourced processes and service/spare parts — to every customer, statutory and regulatory requirement.

What the clause is really asking

Subcontracting the work never subcontracts the responsibility. If your plater, heat-treater or software house gets it wrong, the nonconformity is yours. The clause pins that accountability explicitly, including for service parts that often escape mainstream controls.

What auditors look for

Auditors probe the edges: how outsourced operations are specified, controlled and verified (links to 8.4); whether service parts follow the same controls as production parts; how statutory/regulatory conformity (materials, substances, markings) is assured for everything shipped.

Typical evidence

Outsourced process controls and monitoring records; service part control plans; regulatory compliance evidence (e.g., material certs, IMDS submissions).

How to comply — recommendations

Treat outsourced processes as extensions of your own line: specify requirements in writing, verify on receipt, monitor performance, audit periodically. Give service parts an explicit home in your control plans rather than assuming production rules cover them.

Common nonconformities

Heat-treater quality treated as 'their problem' with no incoming verification; service parts produced without current control plan; regulatory declarations missing for shipped product.

Related clauses

Builds on ISO 9001 4.4 / 8.4

In the book

Chapter 4Context — The Questions Before the System treats this clause family in full: what it is really asking, what auditors look for, the evidence that satisfies, how to make it work on a real floor, and where companies stumble. This IATF requirement is covered in the Automotive Edition, in the same six blocks as the ISO clause around it.

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