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Compliance Management Β· ISO 37301:2021

ISO 37301:2021 Documentation Toolkit

The real ISO 37301:2021 documentation set we deliver: 154 documents and four validated Excel tools that form a complete compliance management system (CMS). The manual meets every clause of ISO 37301:2021 clause by clause. You get the CMS Manual, Compliance Policy, 19 procedures, 5 work instructions, 60 forms each with a completed worked example, and the compliance risk, obligations, KPI and audit tools, covering compliance obligations, risk, culture and governance, speak-up and investigations, all editable in Word and Excel, so you can build a certification-ready compliance system without hiring a consultant.

154
Documents
and tools
19
Procedures
clause-mapped
60
Forms with
filled samples
4
Validated
Excel tools
$149
βœ“ Within 24h secure deliveryβœ“ Editable Word and Excelβœ“ Lifetime free updates
ISO 37301:2021MANUAL
Compliance Management System Manual
Clause-by-clause structure
19Clause-mapped
procedures
60Ready-to-use
forms
Written to satisfy the requirements checked byBSISGSTÜVBureau VeritasDNVIntertek
Overview

Everything you need for ISO 37301:2021, in one download

Preparing the documentation is the slowest and most confusing part of getting certified to ISO 37301:2021. You have to work out what the standard asks for, decide what to write, and turn it into a manual, procedures and records that an auditor will accept. Done from a blank page it takes months, and paying a consultant to do it can cost thousands.

The ISO 37301:2021 Documentation Toolkit gives you that whole system, already written and ready to edit. It is built by practitioners around the exact structure of the standard, so nothing an auditor expects is missing. You add your company details, adapt anything specific to your operation, and you have a complete, consistent compliance management system that is ready for audit. Every single document you receive is listed and explained further down this page, so you know precisely what you are buying before you spend anything.

What makes this set specific

Built for your real production model, not a generic template

The certifiable compliance management standard

ISO 37301:2021 replaced the ISO 19600 guidance and is a certifiable management system standard, so this set is written to its clause 4 to 10 requirements, ready for a certification audit.

Compliance obligations and risk, done properly

Procedures, work instructions and Excel tools for identifying and evaluating compliance obligations, horizon scanning for regulatory change, and assessing and treating compliance risk, the engine of an ISO 37301 system.

Speak-up, concerns and investigations

Procedures and forms for raising concerns and whistleblowing, non-retaliation, and the investigation of noncompliance from plan to case closure, which is where regulators and auditors look.

Compliance culture and governance

A compliance function charter and independence declaration, a RACI and delegation of authority, a compliance culture survey and maturity scorecard, and an incentive-scheme review, so governance and culture are evidenced.

A completed example for every form

All 60 forms come with a matching sample filled form, worked around a realistic organisation, so you can see exactly how each record should look before you fill your own.

Four ready-to-use Excel tools

Working tools for the compliance risk assessment and register, the obligations register, the compliance KPI dashboard, and the audit programme and nonconformity tracker.

How the set is structured

154 controlled documents in 8 tiers

Each tier answers a different question and is approved at a different level, and every requirement is owned in exactly one place.

MAN1Compliance Management System Manual
POL1Compliance Policy
QP19Procedures
WI5Work instructions
QF60Forms and registers
SMP60Sample filled forms
TOOL4Validated Excel tools
CUST4Customization guides and index
The full contents

Every document in this toolkit, listed and explained

No hidden contents and no vague claims. Here is the complete document set, with a short description of what each file is for and the clause it helps you meet.

ISO 37301:2021 Toolkit

A complete document set, fully editable in Microsoft Office.

Compliance Management System Manual1
Compliance Policy1
Procedures19
Work instructions5
Forms and registers60
Sample filled forms60
Validated Excel tools4
Customization guides and index4
Total documents154

MAN-01 Compliance Management System Manual

The top-level document of the CMS. It demonstrates, clause by clause, how the organisation meets ISO 37301:2021, from context and compliance obligations through governance, culture and operational controls to performance evaluation and improvement, and traces each requirement to the procedure, form, tool and record that satisfies it. This is the document an auditor opens first.

General and introductionScope, normative references and terms4. Context, needs, compliance obligations and scope5. Leadership, governance and compliance policy6. Planning: risks, opportunities and objectives7. Support: resources, competence, awareness8. Operation: controls, concerns, investigation9. Performance evaluation10. ImprovementAnnexes: process map, clause matrix
POL Compliance Policy (1)
  • POL-01 Compliance Policy. Top management commitment to compliance and the framework for compliance objectives, aligned to ISO 37301 Clause 5.2.
QP Procedures (19)
  • QP-01 Context, Interested Parties and CMS Scope. How the organisation determines its context, interested parties and needs, and sets the scope of the CMS (Clause 4).
  • QP-02 Compliance Obligations Identification and Evaluation. How compliance obligations are identified, evaluated and kept current (Clause 4.5, 4.6).
  • QP-03 Compliance Risk Assessment. How compliance risks are identified, analysed and evaluated (Clause 4.6).
  • QP-04 Roles, Responsibilities, Authorities and Compliance Governance. How the compliance function, governing body and roles are defined and governed (Clause 5.1, 5.3).
  • QP-05 Compliance Culture. How a culture of compliance is built and monitored (Clause 5.1.2).
  • QP-06 Planning, Compliance Objectives and Change Management. How compliance objectives are set and changes to the CMS planned (Clause 6).
  • QP-07 Competence and Employment Compliance Due Diligence. How competence is managed and compliance due diligence applied to employment (Clause 7.2, 7.3).
  • QP-08 Compliance Training and Awareness. How training and awareness are delivered across staff and third parties (Clause 7.3).
  • QP-09 Compliance Communication. How internal and external compliance communication is managed (Clause 7.4).
  • QP-10 Control of Documented Information. How documented information is created, approved, issued and retained (Clause 7.5).
  • QP-11 Operational Controls and Third-Party Control. How operational compliance controls and third-party and outsourced processes are controlled (Clause 8.1, 8.2).
  • QP-12 Raising Concerns. How concerns are raised and whistleblowing is handled with non-retaliation (Clause 8.3).
  • QP-13 Investigation of Noncompliance. How suspected noncompliance is investigated from plan to closure (Clause 8.4).
  • QP-14 Monitoring, Measurement, Analysis and Feedback. How compliance performance is monitored and evaluated (Clause 9.1).
  • QP-15 Compliance Reporting and Record-Keeping. How compliance is reported and records are kept (Clause 9.1).
  • QP-16 Internal Audit. How internal audits of the CMS are planned, conducted and reported (Clause 9.2).
  • QP-17 Management Review. How top management reviews the CMS and sets actions (Clause 9.3).
  • QP-18 Nonconformity, Corrective Action and Continual Improvement. How nonconformities and noncompliance are handled and improvement driven (Clause 10).
  • QP-19 Toolkit Maintenance and Standard Revision. How the CMS is maintained and updated when ISO 37301 or obligations change.
WI Work instructions (5)
  • WI-02-01 Regulatory Horizon Scanning. How to scan for new and changing compliance obligations.
  • WI-03-01 Scoring Compliance Risk. How to score compliance risk consistently.
  • WI-12-01 Receiving and Triaging a Raised Concern. How to receive and triage a concern or whistleblowing report.
  • WI-13-01 Conducting a Compliance Investigation Interview. How to conduct an investigation interview.
  • WI-16-01 Conducting a Compliance Internal Audit. How to plan and run a compliance internal audit.
QF Forms and registers (60)
  • QF-01-01 Context (Issues) Register. Records the internal and external issues affecting compliance.
  • QF-01-02 Interested Parties and Requirements Register. Records interested parties and their requirements.
  • QF-01-03 CMS Scope Statement. States the boundaries and applicability of the CMS.
  • QF-02-01 Compliance Obligations Register. The master register of compliance obligations.
  • QF-02-02 Obligations Horizon-Scanning and Change Log. Logs new and changing obligations from horizon scanning.
  • QF-02-03 Obligation Impact Evaluation Record. Records the impact evaluation of an obligation.
  • QF-03-01 Compliance Risk Assessment Worksheet. Works through the assessment of a compliance risk.
  • QF-03-02 Compliance Risk Register. The register of compliance risks.
  • QF-03-03 Risk Treatment and Action Plan. Plans the treatment of compliance risks.
  • QF-04-01 Compliance RACI Matrix. Assigns compliance responsibilities and authorities.
  • QF-04-02 Compliance Function Charter and Independence Declaration. Charters the compliance function and declares its independence.
  • QF-04-03 Delegation of Authority Record. Records delegation of compliance authority.
  • QF-05-01 Compliance Culture Survey. Surveys the organisation compliance culture.
  • QF-05-02 Culture Maturity Scorecard. Scores the maturity of the compliance culture.
  • QF-05-03 Code of Conduct Acknowledgement. Records acknowledgement of the code of conduct.
  • QF-06-01 Risks and Opportunities Action Plan. Plans actions on risks and opportunities.
  • QF-06-02 Compliance Objectives and Plan. Records compliance objectives and the plan to achieve them.
  • QF-06-03 CMS Change Request and Impact Assessment. Requests a change to the CMS and assesses its impact.
  • QF-07-01 Competence Requirements and Skills Matrix. Maps roles against the competencies they need.
  • QF-07-02 Competence Evaluation Record. Records the evaluation of competence.
  • QF-07-03 Role Compliance Due-Diligence Record. Records compliance due diligence for a role.
  • QF-07-04 Incentive and Performance Scheme Review. Reviews incentive and performance schemes for compliance risk.
  • QF-08-01 Training Needs Analysis. Identifies compliance training needs.
  • QF-08-02 Annual Compliance Training Plan. Plans the year compliance training.
  • QF-08-03 Training Attendance Register. Records attendance at training.
  • QF-08-04 Training Effectiveness Evaluation. Evaluates whether training was effective.
  • QF-08-05 Awareness Communication Record. Records awareness communications.
  • QF-08-06 Third-Party Awareness and Training Record. Records awareness and training for third parties.
  • QF-09-01 Communication Plan. Plans internal and external compliance communication.
  • QF-09-02 Communication Log. Logs compliance communications made.
  • QF-10-01 Master Document and Controlled-Document Register. The master index of controlled documents.
  • QF-10-02 Document Change Request. Requests and records a document change.
  • QF-10-03 Records Retention and Disposition Schedule. Sets retention and disposition for records.
  • QF-10-04 Document Distribution List. Records who holds controlled documents.
  • QF-11-01 Compliance Control Register. Registers the controls that manage compliance risks.
  • QF-11-02 Control Testing and Effectiveness Record. Records the testing and effectiveness of controls.
  • QF-11-03 Third-Party Compliance Due-Diligence. Records compliance due diligence on a third party.
  • QF-11-04 Third-Party and Outsourced Process Monitoring Record. Monitors third-party and outsourced processes.
  • QF-12-01 Concern and Whistleblowing Report. Captures a raised concern or whistleblowing report.
  • QF-12-02 Concern Case Register. The register of concern and whistleblowing cases.
  • QF-12-03 Non-Retaliation Assessment. Assesses and safeguards against retaliation.
  • QF-13-01 Investigation Plan. Plans an investigation of suspected noncompliance.
  • QF-13-02 Investigation Report. Reports the findings of an investigation.
  • QF-13-03 Investigation Outcome and Case-Closure Record. Records the outcome and closure of a case.
  • QF-14-01 Monitoring and Measurement Plan. Plans what compliance parameters are monitored.
  • QF-14-02 Compliance Performance Feedback Log. Logs feedback on compliance performance.
  • QF-14-03 Compliance Indicator Definition Sheet. Defines a compliance performance indicator.
  • QF-15-01 Periodic Compliance Report. The periodic report on compliance.
  • QF-15-02 Exception and Ad-hoc Report. Reports an exception or ad-hoc compliance matter.
  • QF-15-03 Compliance Records Index. Indexes the compliance records.
  • QF-16-01 Annual Audit Programme. Plans the internal audit programme for the year.
  • QF-16-02 Individual Audit Plan. Plans a single internal audit.
  • QF-16-03 Audit Checklist. The checklist used to audit the CMS.
  • QF-16-04 Audit Report. Reports the findings of an internal audit.
  • QF-16-05 Auditor Competence and Impartiality Evaluation. Evaluates auditor competence and impartiality.
  • QF-17-01 Management Review Agenda and Input Pack. The agenda and inputs for a management review.
  • QF-17-02 Management Review Minutes and Action Log. Records the management review decisions and actions.
  • QF-18-01 Nonconformity and Noncompliance Report. Records a nonconformity or instance of noncompliance.
  • QF-18-02 Corrective Action Request and Root-Cause Analysis. Raises a corrective action and analyses the root cause.
  • QF-18-03 Continual Improvement Log. Logs continual improvement actions.
Every form above is also provided as a completed sample filled form, worked around the example organisation, so you can see exactly how each record should look. That is 60 additional worked examples included in the set.
TOOL Validated Excel tools (4)
  • T-01 Compliance Risk Assessment and Register. Working tool that scores compliance risks and maintains the register.
  • T-02 Compliance Obligations Register. Working register of compliance obligations.
  • T-03 Compliance KPI Dashboard. Tracks the compliance KPIs and shows performance at a glance.
  • T-04 Audit Programme and Nonconformity Tracker. Tracks the audit programme and nonconformities to closure.
CUST Customization guides and index (4)
  • 00 Toolkit Index and Contents. The index and contents list of the whole toolkit.
  • GUIDE-01 Customization Guide. How to tailor the whole toolkit to your organisation before certification.
  • GUIDE-02 Placeholder Replacement Guide. The list of placeholders to replace, so no example content is left behind.
  • GUIDE-03 Configuration Decision Checklist. The configuration decisions the toolkit leaves to you, in one checklist.
What you gain

Why teams choose a ready-made kit

βœ“
Save months of work

The writing is done. You edit instead of authoring from a blank page.

βœ“
Avoid consultant fees

Get a professional system for a fraction of the cost of hiring one.

βœ“
Nothing missed

Mapped clause by clause so every requirement is covered.

βœ“
Written in plain English

Easy to read, easy to adapt, no jargon you have to decode.

βœ“
Audit-ready evidence

Forms and registers capture exactly what an auditor asks to see.

βœ“
Yours to keep

A perpetual licence for your whole team, with free updates.

How to use it

From download to audit ready in five steps

Download

The full set arrives by email in minutes, in Word and Excel.

Customise

Swap the highlighted placeholders for your own company details.

Implement

Roll out the procedures and capture evidence on the forms.

Audit and review

Use the internal audit checklist and management review templates.

Get certified

Face the auditor with a complete, consistent system.

Who it is for

Built for the people who have to get it done

  • Companies going for ISO 37301:2021 certification for the first time.
  • Quality and compliance managers who want a proven framework, not a blank page.
  • Businesses asked for a documented system for a tender, a client, or pre-qualification.
  • Consultants and trainers who need an editable base to adapt for clients.
How it is delivered

Secure, editable, and yours to keep

πŸ“₯

24-hour delivery

Files sent securely within 24 working hours of payment.

✍️

Fully editable

Microsoft Word and Excel, with placeholders to fill in.

♾️

Free updates

If the standard is revised, you get the update free.

πŸ‘₯

Team licence

One organisation, unlimited internal users, perpetual.

Compare the options

Kit, consultant, or from scratch

What mattersFrom scratchHire a consultantisofolder kit
Time to a full document setMonthsWeeksThe same day
Typical costYour timeThousands$149 once
Written by expertsNoYesYes
Mapped to every clauseRiskyUsuallyYes
You keep full controlYesLimitedYes, fully editable
Free updates on revisionNoExtra feeIncluded
Our experience

Documentation is all we do, and we have done it since 2017

isofolder is a team of auditing and consulting professionals with more than 80 years of combined experience. Our kits are written by practitioners and reviewed by working auditors, then refined across many real certification projects. When you buy from us, you are buying a system that has already helped companies pass their audits.

If you ever need a document that is specific to your operation and not already in the kit, our team will prepare it for you.

2017Trading since
2,000+Products delivered
750+Projects completed
100+Standards covered
What buyers say

Trusted by teams getting certified

β˜…β˜…β˜…β˜…β˜…

The documents were well structured and easy to adapt. We cleared our certification audit with no major findings.

Quality ManagerManufacturing, United Kingdom
β˜…β˜…β˜…β˜…β˜…

Saved us weeks of writing. Everything was mapped to the clauses, so we knew nothing was missing.

Operations LeadFood business, UAE
β˜…β˜…β˜…β˜…β˜…

Clear, professional and fully editable. Far better value than the consultant quotes we received.

FounderServices company, United States
See it first

Not sure yet? Look inside before you buy

Preview 10 real pages from the ISO 37301:2021 toolkit right here, including a full form and part of an actual procedure. Judge the quality and writing style for yourself, with no sign-up.

Questions

ISO 37301:2021 toolkit, frequently asked

What is ISO 37301 and is it certifiable?+
ISO 37301:2021 is the international standard for a compliance management system. It replaced the ISO 19600 guidance and, unlike ISO 19600, it sets requirements, so an organisation can be certified to it by an accredited body. This toolkit is written to ISO 37301:2021.
What is the difference between ISO 37301 and ISO 37001?+
ISO 37301 is the broad compliance management system standard, covering all of an organisation's compliance obligations. ISO 37001 is the narrower anti-bribery management system standard. ISO 37301 can sit above an ISO 37001 system, and this kit treats anti-bribery as one of the compliance areas it manages.
Does it cover whistleblowing and investigations?+
Yes. There are procedures and forms for raising concerns and whistleblowing, non-retaliation assessment, and the investigation of noncompliance from the investigation plan to the case-closure record.
Does every form come with a filled example?+
Yes. All 60 forms are provided both blank and as a completed sample filled form, worked around the example organisation, so you can see exactly how each record is meant to look before completing your own.
What formats do I get?+
Everything is editable Microsoft Word and Excel, including the risk register, obligations register, KPI dashboard and audit tracker in Excel. You replace the placeholders and the example organisation details with your own before use.
What does the ISO 37301:2021 toolkit include?+
A clause-by-clause ISO 37301:2021 manual, 19 procedures, and 60 ready-to-use forms and records, plus sample filled examples. Everything is editable in Microsoft Word and Excel, and the full list is shown on this page.
Will it help me pass a certification audit?+
Yes. The documents are structured to the ISO 37301:2021 clauses an auditor checks and are written by experienced practitioners. You customise and implement them, and the kit gives you a complete, auditor ready system as your foundation.
What formats do I get, and can I edit them?+
Everything comes in editable Microsoft Word and Excel, with any presentations in PowerPoint. You replace the highlighted placeholders with your own details. No special software is needed.
How long does it take to customise?+
Most organisations tailor the core documents within a few days rather than the weeks or months it takes to write from a blank page. The manual and procedures are already written, so you are editing, not authoring.
How is it delivered?+
After your payment is confirmed, we send your files to you securely within 24 working hours, and usually much sooner. To keep the documents safe, we do not store them on public-facing servers.
Is there a licence limit or a subscription?+
There is no subscription. One purchase gives your organisation a perpetual licence with unlimited internal users, so your whole team can work on the documents.
Do I get updates when the standard changes?+
If ISO 37301:2021 is revised, you receive the updated documents free of charge, so your system stays current without buying again.
Is it suitable for my industry?+
The kit is written to the ISO 37301:2021 requirements, which apply across sectors. The documents are editable, so you keep what fits your operation and adapt or set aside anything that does not. It has been used by manufacturers, food businesses, laboratories, healthcare, IT and service companies.
How is this different from free templates online?+
Free templates are usually incomplete, generic, or out of date, and they leave you guessing what an auditor expects. This kit is a complete, current, clause-mapped set written by practitioners, with every document listed and explained so there are no surprises.
Can I check the toolkit before I buy?+
Yes. You can download a free sample document first to check the quality and writing style, so you can decide with confidence.
Complete your system

Frequently bought together

Get your ISO 37301:2021 system, ready today

Download the complete, editable toolkit and start building an audit ready system in minutes, with a free sample available before you buy.

ISO 37301:2021 Documentation Toolkit 154 documents, Word and Excel, delivery within 24 working hours $149