The full ISO 9001 Clause 8.3 procedure with both other requirements folded into it at the points they genuinely touch — the trigger, the inputs, the hierarchy of controls, worker consultation, the outputs, the change significance test and the records. Sixteen numbered sections, three appendices, and an IMS process interaction map. Environmental content is marked ▲ and occupational health and safety content ■, inline rather than in separate sections.
01 · The hierarchy of controls is applied from the bottom up
Every OH&S system has the hierarchy written into it, and almost every one applies it upside down. Organizations reach for administrative controls and personal protective equipment because those are the levels still available once the design is fixed. Elimination and substitution — the only two the standard calls most effective — expire at design. By the time the OH&S function sees the equipment, the top of the hierarchy is gone. That is not a failure of judgement; it is a failure of sequence, and it is the one this procedure exists to correct.
02 · The registers and the design procedure never meet
The aspects register lists design as a life cycle stage. The hazard register identifies hazards arising from equipment design. Both are current, both are defensible, and neither is connected to the document engineers actually follow. ISO 14001 Clause 8.1 a) and ISO 45001 Clause 6.1.4 are those connections, and they are what an auditor checks first in an integrated system.
03 · The people who will work on it are never asked
ISO 45001 Clause 5.4 requires the organization to emphasize the consultation of non-managerial workers on determining applicable controls. In most design projects the people who will build, install, operate, maintain and dismantle the thing are represented by nobody, and see it for the first time on installation. They then invent an access method the designer did not intend, and that becomes the method. Twenty minutes with a maintenance technician at concept stage is the cheapest control measure in the whole procedure.
Every appendix, form, map and worked example is part of the document. Nothing is sold separately.
Quality, environmental and OH&S managers at organizations certified to all three standards that design products, equipment or services. Particularly useful where the three systems are managed by different people, where the registers are strong and the design procedure is silent on both environment and safety, or where control measures keep landing at the bottom of the hierarchy and nobody can say why.
Not sure yet? The free Design and Development Maturity Check scores eight elements in under five minutes, and your score appears without entering anything.
No — this one supersedes it. The IMS version contains everything in the Q/EMS version plus the ISO 45001 content. If you hold all three certificates, buy this one instead. If you hold ISO 9001 and ISO 14001 only, the Q/EMS version is the right one and is cheaper.
It is written in the operations clause, and that is exactly the problem. Elimination and substitution cannot be applied to a design that already exists — removing a hazard or replacing a hazardous material after release is a design change, not an operational control. So the two levels the standard calls most effective are available only during design. Treating Clause 8.1.2 as purely operational is what produces systems where every control is a procedure or a piece of protective equipment.
No. It connects to them. Hazards and aspects are determined under your existing processes; this procedure is how they reach the design as inputs, and how the design records what it did about them. The interfaces are identified in Section 9.0 rather than duplicated.
This one if you hold ISO 9001, ISO 14001 and ISO 45001. ISO 9001 and ISO 14001 only, take the Q/EMS version. ISO 9001 alone, take the single-standard version. Medical devices, take the ISO 13485 or the integrated 9001/13485 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.
