Field test · Pre-release

A public test by Management Systems International

The 12-Day ISO Documentation Challenge

The documentation phase is where ISO projects stall. Not the audit, not the standard, not the registrar — the writing. MSI is testing whether that phase still has to take months.

A small company with three or more years of stable operating history, working from a complete directional template and guide package, can produce a documentation package more than 85% complete in twelve working days — one or two people, one procedure per day.
Stage
Applications open soon
Cohort
6 companies · 2 per standard
Common start date
To be announced
Day
— of 12

Still being finalized. This page describes a field test MSI is designing in the open. Dates, cohort details, the procedure sequence, the scoring instrument and the participation terms may all change before applications open. Nothing on this page is an offer, and nothing here binds MSI or any applicant — the terms that govern participation are the ones set out in the written participation agreement signed before a start date is confirmed.

The condition, stated up front

Nobody is writing from a blank page

The template condition is not a footnote. It is the point.

Each participating company works from a complete directional template and guide package built to its standard — the judgment calls already made and explained, and the decisions that are genuinely theirs marked, and no more numerous than they need to be.

Twelve days is not a claim about writing eleven procedures from scratch. Nobody does that in twelve days, and MSI would not ask anyone to try.

It is a claim about what twelve days buys when the hard thinking is already written down — when the only work left is the work that is actually yours.

Why MSI is running this in public

The template line has no independent proof behind it. Six documented before-and-after results, scored on a fixed instrument and published whatever they say, is a stronger argument than any copy MSI can write.

The packages under test are MSI's ISO Procedure Templates and Guides — the same documents anyone can buy, with nothing added for the cohort.

Results publish either way. If twelve days turns out to be insufficient, that publishes too. Findings are reported anonymized by sector, size and standard — no company names, no logos. Named quotes, if any, are requested after results are in and are never a condition of selection.

The cohort

Six companies. Two on each standard.

Six is the number MSI can properly support during the window. It is a support capacity, not a countdown.

Two places

ISO 9001

Eleven procedures plus an assembly day. A quality manual is optional, off the clock, and does not count toward the score.

About ISO 9001 at MSI →

Two places

ISO 13485

Eleven procedures plus assembly. Clause 4.2.2 mandates a quality manual by name, so day 12 is assembly plus manual — an asymmetry disclosed in the published results.

About ISO 13485 at MSI →

Two places

ISO 7101

Thirteen procedures plus assembly — fourteen days. Evaluation of compliance and emergency preparedness insert after day 8.

About ISO 7101 at MSI →

Certification status is not a filter. A certified organization rebuilding a stale system and an uncertified organization building its first one are both eligible. Status is recorded as a variable and reported separately.

Eligibility

Who this is for, and who it is not

A fit if

  • Three or more years operating, with revenue stable or growing across three years
  • One or two named people who will do the reading and the marking up
  • A named executive sponsor who will put their name on a company-wide notice
  • A real starting gap — a company already at 90% documented proves nothing
  • Willing to return a written day-30 report and sit a 30-minute recorded debrief

Not a fit

  • Consultants, advisory firms, or anyone who would adapt the package for client engagements
  • Template resellers
  • Under three years operating, or revenue not stable or growing across three years
  • No named executive sponsor
  • Already holds the MSI package for that standard

Grant terms. Challenge packages are granted, not purchased. The half day of consulting offered to early buyers, and the 100% credit toward SurePath, SureResults or consulting, apply to purchases only and are not included in this grant. The license is single-organization: no redistribution, no resale.

The work

Twelve days, in the order they are written

The sequence is not arbitrary. Procedures that govern other procedures are written first, so nothing downstream has to be revised to match.

DayProcedureWhy it sits here
1Document and Records ControlGoverns everything after it, and teaches the sixteen-section architecture
2Risk and OpportunitiesFeeds most of what follows
3Nonconformity, Corrective Action and Continual ImprovementProduces an input leadership needs
4Leadership, including Management ReviewGovernance decided early, then governs the rest
5Human Resource ManagementCompetence gates every other process
6Purchasing and Supplier Control
7Sales Management / Service User AccessCarries the contingency path
8Production Management / Operational ControlCarries the contingency path
9Control of Measuring and Monitoring
10Customer Satisfaction / Service User Experience
11Internal Audit
12Assembly — and the quality manual for ISO 13485Turns eleven documents into a package

ISO 7101 inserts Evaluation of Compliance and Emergency Preparedness after day 8, running fourteen days. Design and Development is an optional track for any standard and adds five days. Contingency is not a separate procedure — every MSI procedure carries exception and contingency paths as a numbered section, and the exposure sits inside Sales Management and Production Management.

Assembly day is not filler. It is what earns the word package: interaction maps reconciled on both sides of every interface, numbering confirmed across the set, no placeholder left unmarked, and the Open Decisions Register and WishList Log consolidated.

Calendar window: 30 days. Twelve working days inside a thirty-calendar-day window. Thirty days holds roughly twenty-one working days — real slack for the days when work gets in the way.

The finish line

85%, with every open decision named

100% is not the target. 85% is a number a working quality manager recognizes as real.

Completion threshold: 85% of marked decisions resolved across the set, with every unresolved decision logged in an Open Decisions Register carrying an owner and a target date.

The register is the honest part. A procedure at 85% with fifteen open decisions, each owned and dated, is a working document. The same procedure with fifteen silent blanks is the failure mode — an undetermined field reads, to anyone examining it, as a decision never made.

One procedure may fall below 85% provided its open decisions are registered. Purchasing is the likely one, and it is defensible: criticality criteria rated on effect rather than spend, plus evaluation and re-evaluation rules, need procurement, engineering and often finance in the room. That sits outside the writer's control by design.

Scored before the templates are released

ScoreState
0Nothing written
1Tribal knowledge, or scattered work instructions
2A written procedure exists, incomplete or unused
3Documented and in use
4Documented, in use, and measured

Scored again at day 30

ScoreState
0Not started
1Read and marked up; decisions identified but not made
2Placeholders resolved, tracked changes in, not yet reviewed
3Adapted, reviewed, approved, ready to issue
4Issued and in use

One row per procedure, one number before and one number after: 11 rows and 44 points for ISO 9001 and ISO 13485, 13 rows and 52 points for ISO 7101. Movement is reported per company and as a cohort average. Evidence of work is tracked changes, marked-up placeholders, or a completed auditable procedure — any of the three counts. The per-topic pattern matters more than the total: if five companies stall on the same procedure, that is a finding about the document, not about them.

Participation terms

The Procedure Writing Retreat

In-office, treated as off-site. These are terms of participation, not suggestions.

Priority

The retreat is the highest-priority commitment in the company for its duration, treated as an investment rather than an interruption. Existing work continues unchanged; the people writing do not.

Calendar block

The days are blocked on the actual person's electronic calendar, marked busy, declining meetings.

Company-wide notice

A written notice goes out under the sponsor's name: who is unavailable, which days, who to route to instead, and what they are doing. "Writing the procedures that stop us reinventing this every quarter" lands differently inside a company than "unavailable."

Leader dialogue

Where a procedure needs a decision another leader owns, that conversation is scheduled as priority and the guide goes to that leader in advance. On day 1 the lead maps which decisions need which leader and sends the guides out that morning. The standard failure is a two-day wait for a fifteen-minute answer.

No operational change

Nothing in how the company runs changes during the twelve days. Get it right on paper first.

WishList Log

Every improvement the writing surfaces is captured and deferred — a required deliverable, prioritized with the management team after day 30. A company finishing with thirty deferred improvements has proof the phase did something.

A reaction a day

MSI posts a dated thread in the channel each writing day. One tap: ✅ finished, 🔄 started but not finished. No reaction means the day did not happen, and MSI calls the following morning.

Two consecutive silent days and the place is withdrawn, the license terminates, and the company is not included in the published results. Six places, limited by MSI's support capacity — a place that goes quiet is one another company could have used.

Support

One shared channel. Every question visible.

All six companies share a single Teams channel. Everyone sees every question and every answer.

Answered in-channel

How the document works.

  • Where the appendices live
  • How the interaction map is filled in
  • Placeholder conventions
  • How the sixteen sections relate to each other

Not answered during the thirty days

What the company should decide.

  • Retention periods
  • Tiers and thresholds
  • Scope exclusions

Those are the decisions under test. Deferred questions are logged, answered at the debrief, and the list is published.

No individual consulting during the window. If MSI works alongside a participant, the test proves that MSI plus templates works — which nobody doubted.

How to apply

Seven stages, and one of them does the work

  1. Apply

    A written form, roughly ten minutes. Not a booking.

  2. Screen

    Applications are checked against the hard disqualifiers above.

  3. Selection call

    Twenty minutes with the shortlist.

  4. Pre-release gate

    Baseline scores returned, terms signed, calendar screenshot supplied, and the company-wide announcement already sent. A sponsor who will not put their name on that notice has not approved the time — they said yes in a meeting.

  5. Named alternates

    MSI runs a named alternate for each standard through the same gate — three more companies, fully prepared. In the seventy-two hours before the common start date, any place whose gate has gone soft is offered to the alternate. Being named an alternate is not a rejection, and alternates are told so plainly.

  6. Common start date

    All six companies start on the same day. There are no mid-run replacements — once writing begins, the cohort is closed.

  7. Day 30

    Written report plus a thirty-minute recorded debrief.

Consent, not a question: results publish anonymized by sector, size and standard. No company names, no logos.

Register interest

Applications are not open yet

Leave your details and MSI will contact you on the day the application window opens — before it is announced anywhere else.

Apply

Start your application

Roughly ten minutes, and it is not a booking. MSI screens against the disqualifiers above and comes back either way.

Results publish anonymized by sector, size and standard — no company names, no logos.
Rather talk first? Call 760-434-9141, email info@msi-international.com, or schedule time with MSI .

Updated daily

The log

One entry per writing day, posted as the cohort works. Nothing here is edited after the fact.

0
Writing days elapsed
0
Procedures drafted across the cohort
0
Decisions resolved
0
WishList items logged
Company 123456 789101112
9001 · A
9001 · B
13485 · A
13485 · B
7101 · A
7101 · B

procedure finished  ·  🔄 started, not finished  ·  blank means no reaction was logged that day. Companies are anonymized by standard. ISO 7101 runs fourteen days; days 13 and 14 are reported with the results.

Day01Date TBC
Not started
PROCEDURE 007

Document and Records Control

Governs everything after it, and teaches the sixteen-section architecture.

Entry posts at the end of the writing day.

Day02Date TBC
Not started
PROCEDURE 002

Risk and Opportunities

Feeds most of what follows.

Entry posts at the end of the writing day.

Day03Date TBC
Not started
PROCEDURE 008

Nonconformity, Corrective Action and Continual Improvement

Produces an input leadership needs on day 4.

Entry posts at the end of the writing day.

Day04Date TBC
Not started
PROCEDURE 001

Leadership, including Management Review

Governance decided early, then governs the rest.

Entry posts at the end of the writing day. The management review input table will reference records from procedures not yet written — document numbers are assigned today and confirmed on assembly day.

Day05Date TBC
Not started
PROCEDURE 003

Human Resource Management

Competence gates every other process.

Entry posts at the end of the writing day.

Day06Date TBC
Not started
PROCEDURE 010

Purchasing and Supplier Control

The procedure most likely to finish below threshold — and the one where that is defensible.

Entry posts at the end of the writing day.

Day07Date TBC
Not started
PROCEDURE 004

Sales Management / Service User Access

Carries the contingency path.

Entry posts at the end of the writing day.

Day08Date TBC
Not started
PROCEDURE 006

Production Management / Operational Control

Carries the contingency path.

Entry posts at the end of the writing day.

71018aDate TBC
ISO 7101 only
PROCEDURE 011

Evaluation of Compliance

Inserted after day 8 for the healthcare cohort.

Entry posts at the end of the writing day.

71018bDate TBC
ISO 7101 only
PROCEDURE 013

Emergency Preparedness

Inserted after day 8 for the healthcare cohort.

Entry posts at the end of the writing day.

Day09Date TBC
Not started
PROCEDURE 012

Control of Measuring and Monitoring

Entry posts at the end of the writing day.

Day10Date TBC
Not started
PROCEDURE 014

Customer Satisfaction / Service User Experience

Entry posts at the end of the writing day.

Day11Date TBC
Not started
PROCEDURE 009

Internal Audit

Entry posts at the end of the writing day.

Day12Date TBC
Not started
ASSEMBLY

Assembly — and the quality manual for ISO 13485

Turns eleven documents into a package.

Entry posts at the end of the writing day.

Day 30

What the cohort found

Anonymized by sector, size and standard.

Results publish here. Reported figures: movement score per company and cohort average · decisions resolved versus deferred · where deferrals clustered by topic · aggregate WishList count · the question log · and the ISO 13485 manual asymmetry noted against the comparison.

Questions

What people ask before applying

Is this a claim that procedures can be written from scratch in twelve days?

No, and MSI will not make that claim. Every participant works from a complete directional template and guide package. The test measures what twelve days buys when the judgment is already written down and the only remaining work is the decisions that are genuinely the company's own.

Why 85% and not 100%?

Because 100% invites easy dismissal, and 85% is a number a working quality manager recognizes as real. What makes 85% honest is the Open Decisions Register: every unresolved decision carries an owner and a target date rather than sitting as a silent blank.

Does MSI work alongside participants during the window?

No. Questions about how the documents work are answered in the shared channel; questions about what the company should decide are logged and answered at the debrief. Individual consulting during the window would prove that MSI plus templates works, which nobody doubted.

What happens if a company misses the threshold?

It is reported. Results publish either way, including a finding that twelve days is insufficient. A shortfall clustered on the same procedure across several companies is a finding about the document, not about the companies.

Will our company be named?

Not unless you decide otherwise after results are in. Publication is anonymized by sector, size and standard — no company names, no logos. Named quotes are requested separately, after the fact, and are never a condition of selection.

We already have some documentation. Does that disqualify us?

No. A certified organization rebuilding a stale system is as eligible as one starting from nothing, and existing state is captured in the baseline score. What does weigh against an application is having almost nothing left to do — a company already at 90% documented cannot demonstrate movement.

Who is running it

Diana Lynn — President

Management Systems International is a veteran-owned, female-owned ISO consulting firm founded in 1998. MSI implements and maintains management systems to ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 7101, and integrated combinations of them.

Twenty-eight years of watching the documentation phase stall projects from inside client systems is where this test comes from — and why the results publish whichever way they land.

80+companies certified through implementations
600+professionals trained
200+audits attended
28years, since 1998

Next

Not applying, but interested in the documents?

The packages under test are on general sale. Nothing in the cohort's version is different.

See the procedure templates and guides Run the free gap analysis

Prefer the whole build run for you? SurePath is the turnkey implementation, and SureFinish™ is six weeks of one-on-one advising for a quality manager doing it in-house. Questions: 760-434-9141 · info@msi-international.com

Page last updated: August 13, 2026 — initial release. This page is maintained while the field test runs and is revised as the design settles and as the cohort works. Details, dates and terms are subject to change; where a figure here differs from the written participation agreement, the agreement governs. Published results, when they appear, are final and are not edited after publication.

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