ISO9001 Toolkit Version 4 Release Notes
RELEASE DATE: RELEASE SUMMARY:
October 2026 Version 4 updates the ISO9001 toolkit to comply with the 2026 version of the standard. Various document enhancements are also made across the board.
AREA
DOC REF
DOCUMENT
All
All
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00. Implementation Resources
None None None None None QMS-DOC-00-1 QMS-DOC-00-2 QMS-DOC-00-3 QMS-DOC-00-3 QMS-FORM-00-1 QMS-FORM-00-2 QMS-FORM-00-3 QMS-FORM-00-4 QMS-FORM-00-5
CERTIKIT Completion Instructions CERTIKIT ISO9001 Toolkit v3 Implementation Guide CERTIKIT ISO9001 Toolkit Index CERTIKIT ISO9001 Toolkit v3 Release Notes CERTIKIT Standard Licence Terms Quality Management System PID ISO9001 QMS Presentation ISO9001 Project Plan (Microsoft Project) ISO9001 Project Plan (Microsoft Excel) Project Kick-off Meeting Agenda ISO9001 Assessment Evidence ISO9001 Progress Report ISO9001 Gap Assessment Tool Certification Readiness Checklist
01-03. Scope, Normative References, Terms and Definitions
None
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04. Context of the Organization
QMS-DOC-04-1 QMS-DOC-04-2
QMS Context, Requirements and Scope QMS Processes and Interactions QMS Process Interaction Overview
Document simplified and restructured. New document, describing the processes of the QMS. New document, showing a diagram of the processes of the QMS.
05. Leadership
None QMS-DOC-05-1 QMS-DOC-05-2 QMS-DOC-05-3 QMS-DOC-05-4 QMS-DOC-05-5 QMS-DOC-05-6 QMS-DOC-05-7 QMS-FORM-05-1
EXAMPLE Statutory and Regulatory Requirements Quality Policy Quality Manual QMS Roles Responsibilities and Authorities Top Management Communication Program Executive Support Letter Statutory and Regulatory Requirements Procedure Statutory and Regulatory Requirements Meeting Minutes Template
Examples updated. Duplication with Quality Manual removed.
06. Planning
None QMS-DOC-06-1 QMS-DOC-06-2 QMS-DOC-06-3 QMS-DOC-06-4 QMS-DOC-06-5 QMS-FORM-06-1 QMS-FORM-06-2 QMS-FORM-06-3
EXAMPLE Risk and Opportunity Assessment Tool Quality Management Plan Risk and Opportunity Assessment Process Risk and Opportunity Assessment Report Risk and Opportunity Action Plan QMS Change Process Risk and Opportunity Assessment Tool Quality Objectives and Planning Tool QMS Change Log
Updated to more fully address risks to and opportunities for the QMS. Specific objectives and plan separated out into spreadsheet. Impact criteria and likelihood descriptions amended to match the tool. Aligned with Context document. Contents rationalised and references to planning integration and evaluation added. New document. Dashboard added. New document. New document.
07. Support
None None None QMS-DOC-07-1 QMS-DOC-07-2 QMS-DOC-07-3 QMS-DOC-07-4 QMS-DOC-07-5 QMS-DOC-07-6 QMS-DOC-07-7 QMS-DOC-07-8 QMS-FORM-07-1 QMS-FORM-07-2
EXAMPLE Asset Maintenance Register and Schedule EXAMPLE Competence Development Questionnaire ISO9001 Quality Poster Procedure for the Control of Documented Information QMS Documentation Log Competence Development Procedure Competence Development Report Quality Management Awareness Presentation Quality Communication Plan Organizational Knowledge Management Policy Procedure for the Maintenance of Assets Competence Development Questionnaire Asset Maintenance Register and Schedule
Note added to heading.
08. Operation
QMS-DOC-08-1 QMS-DOC-08-2 QMS-DOC-08-3 QMS-DOC-08-4 QMS-DOC-08-5
Requirements Process Design and Development Process External Provider Management Process Production and Service Provision Process Standard Operating Procedure
09. Performance Evaluation
None None QMS-DOC-09-1 QMS-DOC-09-2 QMS-DOC-09-3 QMS-DOC-09-4 QMS-DOC-09-5 QMS-FORM-09-1 QMS-FORM-09-2 QMS-FORM-09-3 QMS-FORM-09-4 QMS-FORM-09-5
EXAMPLE Customer Satisfaction Questionnaire EXAMPLE Internal Audit Action Plan Process for Monitoring Measurement Analysis and Evaluation Procedure for Internal Audits Internal Audit Plan Procedure for Management Reviews Internal Audit Report Internal Audit Schedule Internal Audit Action Plan Management Review Meeting Agenda Internal Audit Checklist Customer Satisfaction Questionnaire
None QMS-DOC-10-1 QMS-FORM-10-1
EXAMPLE Nonconformity and Corrective Action Log Procedure for the Management of Nonconformity Nonconformity and Corrective Action Log
10. Improvement
06/10/2026
UPDATES FROM VERSION 3
Page 1 of 1
Compatibility with other office suites clarified. Sections on what's new in 2026 and IMS added. Accreditation information updated. Changed to show just index by requirement. Updated for new version of the toolkit.
Updated to reflect the new standard. Removed from toolkit. Document reference renamed. Gantt chart and Dashboard added. Minor changes to agenda items. Clause headings changed for new standard. Reformatted to have clearer question references. New document, intended as a final check before certification audit.
Minor changes to role titles.
Header pages added to form.
New documents added.
Updated to reflect the new standard.
Flowchart corrected. Note added to heading.
Frequencies in example table adjusted. Rewording of section 2.6. Provision for remote audits added. Agenda table replaced with reference to Agenda form. Year references of standard removed. Scope of audit table updated. Next visit plan removed. Replaced with Excel-based tool. Header pages added to form. Amended to match updated list in standard. Updated for new structure of the standard.
Columns added for Closed By and Reviewed By. Columns added for Closed By and Reviewed By.