The full ISO 9001 Clause 8.3 procedure with the ISO 14001 environmental requirement folded into the six places it genuinely touches — the trigger, the inputs, the input question set, the outputs, the change significance test and the records. Sixteen numbered sections, three appendices, and a Q/EMS process interaction map. Environmental content is marked inline rather than pulled into a separate section.
01 · The aspects register and the design procedure never meet
Organizations do life cycle perspective properly. Design is listed as a life cycle stage in the aspects register, the impacts are assessed, the register is current and defensible. And nothing connects it to the design process — the register says design matters, the design procedure has no environmental input, and no document links the two. Clause 8.1 a) is that link, and it is the one thing an auditor can check in five minutes.
02 · Environmental review happens after the design is fixed
Where environmental requirements are checked at the end, the answer is always the same: the design complies, or it does not and it is too late to do much about it. A life cycle perspective applied at input capture changes what gets designed; applied at release it only records what was. This procedure asks seven life cycle questions during input capture, before the material is chosen.
03 · Nobody owns the question
The commonest structural reason Clause 8.1 a) goes unmet is that no role is responsible for determining which environmental requirements apply to a given design project. The answer then arrives from whoever happens to know, late. This procedure gives the Environmental Manager three named trigger routes, a determination to make before the input set is fixed, and a confirmation at the release gate — including a recorded nil return where nothing applies.
Every appendix, form, map and worked example is part of the document. Nothing is sold separately.
Quality and environmental managers at organizations certified to both ISO 9001 and ISO 14001 that design products or services. Particularly useful where the two systems are managed by different people, where the aspects register is strong and the design procedure is silent on environment, or where a 14001 auditor has asked how environmental requirements reach the design and the answer took some assembling.
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No. This one covers ISO 9001 and ISO 14001. If you also hold ISO 45001, the IMS variant covers all three and is the one to buy — buying this one as well would duplicate most of it.
The clause text is one sentence, and that sentence is exactly the point. It requires environmental requirements to be addressed in the design process considering each life cycle stage, which touches inputs, outputs, change control and records. What this document does is put that requirement where a designer will actually encounter it, rather than leaving it in the environmental manual where designers do not look.
No, and the standard says so in its guidance: thinking carefully about the environmental aspects the organization can control or influence at each life cycle stage is sufficient. Seven questions answered honestly at input capture meets Clause 8.1 a). A consultant-led assessment does not, if the answers never reach the designer.
This one if you hold ISO 9001 and ISO 14001. ISO 9001 alone, take the single-standard version. Medical devices, take the ISO 13485 or the integrated 9001/13485 version. All three of 9001, 14001 and 45001, take the IMS version.
Both, deliberately. It is written as a filled-in worked example so you can see what each element looks like when done properly, with bracketed placeholders wherever a value is genuinely yours to set — thresholds, roles, stage names, systems, retention periods. You are editing a working document rather than filling in a hollow outline.
Editable Microsoft Word (.docx), with the process interaction map embedded in the document and supplied separately as an editable SVG. Adapt it, rebrand it, and adopt it into your own document control system.
A procedure does not pass an audit; an organization does. What this gives you is a procedure that addresses every requirement of the clauses it covers, with a named owner and a named record, describing a process people can actually follow. Conformity is demonstrated by implementation and evidence. Unfilled placeholders are unmet requirements, so fill them.
Every cross-reference sits in a table at the back rather than baked into the body text, precisely so you can renumber without unpicking the procedure.
The course teaches the method — how to get the process out of the heads of the people who do the work. This is the document. Where a form appears in both, this template carries the current revision; the version stamp in the footer tells you which you are holding. The template contains no video.
Yes. Call MSI at 760-434-9141 to schedule a planning session.
