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• Management System Operation (Economic Prosperity and Social Value, 20 steps each): Nonconformity and corrective action example

• Management System Operation divides the work of running a management system on an ongoing basis after certification into 20 steps on two tracks (Economic Prosperity and Social Value).
  These are 4 planning steps (context of the organization → identification of legal requirements → risk assessment → establishing objectives), 12 support and operation steps (from control of measuring instruments to compliance evaluation), and 3 evaluation and improvement steps (internal audit → management review → nonconformity and corrective action). For each step you receive a draft of the practical outputs matched to the requirements of the selected standard. Because it is one connected platform, steps are not sold separately, and a pass is used for each standard. A pass costs TBA for 1 standard, and TBA is added for each additional standard (excluding VAT).
  If you press "Write with AI" for a standard without a pass, the cost is shown, and payment is made if you agree.

  In this example, a company certified to ISO 9001 receives a customer complaint and uses step 19 Nonconformity and corrective action (ISO 9001 10.2). The result of the corrective action (an action to eliminate the cause so that the problem does not recur) leads into 3 Risk assessment, 12 Process control and 18 Management review. If you save it in the Company Workspace, the next steps pick up this result.

• Where it is used among the 20 steps
• Representative company model (fictional)Food packaging company: gravure printing and laminating of snack bags, 70 employees, operating with ISO 9001 certification. In the last 4 weeks 3 customer complaints (lamination delamination) were received, and it must find the cause and prevent recurrence.
  1Register the nonconformityReceipt of complaintEnter the phenomenon, scope and figures (defect rate, lot, timing) together with what changed in "Situation and data summary".
  Nonconformity and Corrective Action

  2Cause analysis and corrective actionA few minutesYou receive immediate action, a 5 Whys (a method of repeatedly asking why) and 4M1E (a method that examines man, machine, material, method and environment) cause analysis, the root cause, and a corrective action plan with person in charge, deadline and completion criteria.
  Operate

  3Verify effectivenessAfter 8 weeks (example)Check whether the corrective action was effective according to the verification method, timing and judgment criteria set in advance, and record the result. If the criteria are not met, return to cause analysis.

  4Update risks and process controlTogetherEnter newly identified risks in 3 Risk assessment and changed control criteria in 12 Process control.
  Risk AssessmentProcess Control

  5Management review inputOnce a yearSubmit the status of nonconformities and corrective actions and the effectiveness verification results as input to 18 Management review (9.3.2). The responsible person makes the decision.
  Management Review

  A draft is produced in a few minutes, and people spend their time on fact checking and decisions. Operating data belongs to the company and is separate from the certification audit by the certification body.

• Input example: 19 Nonconformity and corrective action

• Field	Input
  Standard to operate	ISO 9001 (if several are selected, common requirements are written once and specific requirements are written with the standard name attached)
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	19 Nonconformity and Corrective Action
  Department or process	Production: gravure printing and laminating, shipping inspection
  Situation and data summary	3 customer complaints in the last 4 weeks, delamination defect rate 2.4% (target 0.5% or less), increasing since the first week of October: adhesive lot changed in the same period, defects double on days with humidity of 70% or more, 3 days of missing aging room temperature records
  Requests	Cause candidates by 4M1E, and the corrective action plan down to the person in charge and deadline columns

  Output received (structure)

  Structure	Content
  Nonconformity summary · Immediate action	Phenomenon, scope and related requirement (clause); containment, re-inspection and customer notification (correction)
  Cause analysis · Root cause	5 Whys table, cause-and-effect diagram by 4M1E (man, machine, material, method, environment); causes that cannot be known from the input are marked "to be checked"
  Corrective action plan · Effectiveness verification	Table of actions, persons in charge, deadlines and completion criteria; verification method, timing and judgment criteria
  Horizontal deployment · Update of risks and opportunities · Management system change	Check of other products and processes, lines to add to the risk assessment sheet, procedures, work standards and forms to revise
  Next steps	Items to pass on to 3 Risk assessment · 12 Process control · 18 Management review
  Document completeness check	It is checked with a customer-perspective scoring sheet, and if the score is below 80 you receive it after supplementing it

  ※ Figures and timing are examples for explanation. The actual output varies depending on the input and the excerpts of the management system AI transformation materials, and the referenced materials and revision dates are attached at the end.

• Output preview: Company F example

• This is the output you receive when you enter the following in eiso's Management System Operation: 1 Context of the organization, 3 Risk assessment, 4 Establishing objectives, 17 Internal audit, 18 Management review, 19 Nonconformity and corrective action. Using the fictional company Company F (food packaging (snack bags) gravure printing and laminating, 70 employees, certified to ISO 9001) as an example, it is a result drafted in advance by finding grounds in AGENT's knowledge materials in the same way as the actual function.

  Management System Operation: 1 Context of the organizationAnalysis of the context of the organization: SWOT and interested party requirementsFictional company Company F

  This is what was entered

  Standard to operate	ISO 9001
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	1 Context of the Organization
  Department or process	Top management and planning
  Situation and data summary	3 major food manufacturer customers account for about 65% of sales, 3 customer complaints (delamination) in the last 4 weeks, adhesive supplier lot change, strengthened hygiene audits by food customers
  Requests	Analysis method: SWOT and interested party analysis, up to a draft scope

  Summary of the context of the organization

  • Organization: Company F: food packaging (snack bags) gravure printing and laminating, 70 employees, ISO 9001 certified
  • Analysis method: SWOT + interested party analysis (as entered)
  • Key point in one line: 3 food manufacturers account for about 65% of sales (input), so the structure is most sensitive to quality complaints and raw material fluctuations. Among the requirements of interested parties, food safety and foreign matter control are addressed first. [2]

  Interested parties and their needs and expectations (4.2)

  Interested party	Needs and expectations	How we will address them	Basis
  Major customers (food manufacturers)	Packaging free of delamination and foreign matter, on-time delivery, match to color samples, response to hygiene audits	Shipping inspection, process check sheets, hygiene checks, records of response to customer audits	Input (3 complaints)
  Raw material suppliers (film, ink, adhesive)	Stable order forecasts, payment of invoices	Supplier evaluation, agreement on advance notice of lot changes	General industry knowledge
  Employees (printing and laminating floor)	Safe working environment (organic solvents), easing the burden of shift work	Work environment control, training	Industry model [5]
  Local community and regulators	Appropriate management of air emissions and waste (waste ink and waste solvent)	Check whether emission facilities apply, manage designated waste	To be confirmed: the applicable legal requirements in step 2 Identification of legal requirements
  Certification body	Fulfil the requirements of ISO 9001, reflect the context of the organization and risks and opportunities	This document and risk assessment	ISO 9001 4.1·4.2
  Management and shareholders	Profitability, maintaining customer trust	Report performance at management review (18)	Input

  External and internal issues (SWOT)

  Category	Content	Basis
  Strengths (S)	Experience in food packaging lamination, maintaining ISO 9001 certification, customer trust	Input
  Weaknesses (W)	Insufficient control of lot changes for raw materials such as adhesives, records management such as missing aging room records, dependence on 3 customers	Input (complaints, missing records)
  Opportunities (O)	Demand for eco-friendly and mono-material packaging, a quality trust premium from stronger food safety requirements	Industry model [5]
  Threats (T)	Fluctuations in raw material prices and quality, possibility of customers changing suppliers, stronger environmental regulations (to be confirmed)	General knowledge, to be confirmed

  • The SWOT above separates what is confirmed from the entered data and general industry knowledge. Items marked "to be confirmed" are finalized after the staff member checks them against legal and market data.

  Issues to address first (impact × likelihood)

  1. Quality fluctuation due to raw material lot changes: where weakness W and threat T meet, addressed first in risk assessment (3).
  2. Dependence on 3 customers: consider the objective of diversifying sales in establishing objectives (4).
  3. Environmental regulations: confirm whether air emissions and waste apply in identification of legal requirements (2).

  Draft scope of the management system (4.3)

  • "Printing, laminating, aging, inspection and shipping of food packaging (flexible film packaging) carried out at the Company F plant." [6]
  • Because the customer finalizes the design, the grounds for excluding design and development from the scope (8.3 not applicable) are kept in this document. Confirmation by the staff member required.

  Review and update

  • This analysis is redone once a year and at major changes (change of a major customer, new equipment, revision of laws).
  • The updated result is submitted as input to management review (18) (9.3.2: changes in external and internal issues). [4]

  Items to be confirmed (to ask the customer)

  • Sales share by customer and changes over the last 3 years
  • Actual cases of price increase and delivery shortening requests
  • Whether air emission facilities are installed, records of designated waste storage

  Next steps

  • 22 Establishing the policy: Reflect the priority issues above and write a draft quality policy.
  • 3 Risk assessment: Enter priority issue number 1 first in the assessment sheet.
  • 2 Identification of legal requirements: Check the environmental regulation items by the names of the laws.

  Document completeness check

  The AI checked the document against a 7-item scoring sheet from the customer's point of view.

  Item	Result	What was checked
  Meets the standard requirements	Met	It covers 4.1, 4.2 and 4.3 in full, and continues through SWOT, interested parties, the draft scope and the timing of updates.
  Tailored to our company	Met	The sales share, complaints and lot changes entered were used as issues as they are, and what could not be confirmed is left as "to be confirmed".
  Reflects the latest revision	Met	Compared with the background of the ISO 9001:2026 revision in the "International Standard Revision Materials": clause numbers are examples, and are finalized by comparison with the published text
  Ready to use	Met	The 3 priority issues lead into risk assessment, establishing objectives and identification of legal requirements, so it can be used right away.
  Accuracy	Met	Clause numbers are pointed out correctly, and legal and market figures are not asserted.
  Consistency	Met	Interested parties → issues → priorities → scope are connected to one another.
  Readability	Met	It is table-centered, so it can be read at a glance.

  ※ This is an AI check result and does not guarantee conformity for certification. Use the document after reviewing and approving it.

  Management system AI transformation materials referred to

  • 1. Background of the ISO 9001 2026 revision (revised 2025-02-22)
  • 04 Context of the organization and interested parties procedure [ISO 9001] (revised 2018-08-29), 0. Shared folder › 1. Documentation by standard (Korean)
  • 04 Context of the organization and interested parties procedure [ISO 9001·45001] (revised 2018-08-29), 0. Shared folder › 1. Documentation by standard (Korean)
  • 09.03 Management Review Procedure [ISO 9001] (revised 2018-08-29), 0. Shared Folder › 1. Documentation by Standard (Korean)

  Industry-specific documents referred to: industry model (rewritten for a fictional company)

  • Printing, Packaging and Paper › Quality Risks and Opportunities, Industry Model › Printing, Packaging and Paper
  • Printing, Packaging and Paper › Core Process Flow and Control Points, Industry Model › Printing, Packaging and Paper

  Expand allDownload as Word
  Management System Operation: 3 Risk AssessmentRisk and Opportunity Assessment Table: Adhesive Lot, Curing and Foreign MatterFictional company Company A Co., Ltd

  This is what was entered

  Standard to operate	ISO 9001
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	3 Risk Assessment
  Department or process	Purchasing, Production (laminating and curing), Quality, Sales
  Situation and data summary	Delamination defect rate of 2.4% after an adhesive lot change, defects twice as frequent on days with humidity of 70% or more, curing room records missing for 3 days, three major customers account for about 65% of sales, stricter hygiene audits by food customers
  Requests	Using likelihood x impact scores, through to action owners and reassessment

  Risk Assessment Summary

  • Organization: Company A Co., Ltd: gravure printing and laminating of food packaging materials, ISO 9001
  • Assessment method: likelihood (1 to 3) x impact (1 to 3) = score; action is mandatory for scores of 6 or more, and scores of 3 to 4 are maintained under control (example criteria: values set by the company) [2]
  • In one line: the highest risks are the raw material (adhesive) lot change and foreign matter contamination. Both have already appeared as customer complaints.

  Risk and Opportunity Assessment Table (6.1)

  No.	Process	Risk / Opportunity	Likelihood	Impact	Score	and Response	Owner
  R1	Purchasing and Receiving	Reduced bonding strength (delamination) due to an adhesive lot change	2	3	6	Put the first lot after a change into use only after a strength test; add items to the supplier's certificate of analysis	Production Engineering Team Leader
  R2	Process (curing)	Insufficient curing on days with humidity of 70% or more	2	3	6	Curing time criteria by humidity, automatic recording of curing room temperature and humidity	Production Team Leader
  R3	Process and Hygiene	Contamination by foreign matter (film pieces, insects, hair)	2	3	6	Line clearance, hygiene inspection, pest control	Quality Team Leader
  R4	Printing	Customer returns due to color deviation	2	2	4	Comparison with customer samples, color difference criterion (ΔE of 3 or less, example)	Production Team Leader
  R5	Job changeover	Mix-up of materials (packaging for other products mixed in)	1	3	3	Signed line clearance check, quantity reconciliation	Production Team Leader
  R6	Sales	Dependence on three major customers (about 65% of sales, input)	2	3	6	Target for developing new customers, customer satisfaction checks by customer	Sales Team Leader
  R7	Measurement	Peel strength tester out of calibration	1	2	2	Calibration interval control (1 year, example), daily checks	Quality Team Leader
  O1	Opportunity	Demand for eco-friendly, single-material packaging				Material testing and quotation review	Production Engineering Team Leader
  O2	Opportunity	Zero missing records through introduction of automatic recording in the curing room				Review of introduction cost and schedule	Production Team Leader

  • The scoring criteria are examples. The company sets the actual criteria and records them in the 6.1 procedure. [2][3]
  • R1 and R2 are risks that have already appeared as customer complaints, so their scores were raised (linked to 19 Nonconformity and Corrective Action).

  Order of Priority Actions

  1. R1 Adhesive lot change control: add "change of a major raw material lot" to the change control procedure
  2. R2 Curing conditions: automatic recording and deviation alerts
  3. R3 Foreign matter: revise the hygiene inspection checklist, set an inspection interval for pest and rodent control
  4. R6 Customer dependence: include a new customer target in the annual sales plan

  Reassessment After Action

  No.	Before action	Expected after action	Timing of check
  R1	6	3	8 weeks after action is completed
  R2	6	3	8 weeks after action is completed
  R3	6	4	6 months (example)

  • The scores after action are expected values. They are confirmed after reviewing actual results, and if they do not decrease, the response is changed. [2]

  Items To Be Confirmed

  • Whether the company's procedures already contain the scoring criteria (definitions of likelihood and impact)
  • Hygiene requirements applicable to food packaging materials (customer audit criteria, laws and regulations): to be confirmed in Legal Requirements (2)
  • Number of customer complaints and returns over the past 3 years (to strengthen the basis for scores)

  Next steps

  • 4 Setting Objectives: set objectives that address the risks scoring 6 or more (R1, R2, R3, R6).
  • 12 Process Control: reflect the responses to R1 and R2 in the work standards and the control criteria table.
  • 18 Management Review: raise the risk assessment results and the status of actions as inputs to 9.3.2.

  Document completeness check

  The AI checked the document against a 7-item scoring sheet from the customer's point of view.

  Item	Result	What was checked
  Meets the standard requirements	Met	Covers 6.1 in full: risks and opportunities, responses and reassessment.
  Tailored to our company	Met	The figures provided as input (2.4%, 70%, 65%) were used as they are as the basis for scores.
  Reflects the latest revision	Met	Compared with the background of the ISO 9001:2026 revision in the "International Standard Revision Materials": clause numbers are examples, and are finalized by comparison with the published text
  Ready to use	Met	Every item scoring 6 or more has an owner and a response, so the content can be transferred into an assessment table.
  Accuracy	Met	States that the scoring criteria are examples and distinguishes the post-action scores as expected values.
  Consistency	Met	Assessment, priority, reassessment and next steps are connected in sequence.
  Readability	Met	Organized so that it reads as a single table.

  ※ This is an AI check result and does not guarantee conformity for certification. Use the document after reviewing and approving it.

  Management system AI transformation materials referred to

  • 1. Background of the ISO 9001 2026 revision (revised 2025-02-22)
  • 06.01 Risks and Opportunities Procedure [ISO 9001] (revised 2018-08-28), 0. Shared Folder › 1. Documentation by Standard (Korean)
  • 06.01.2 Appendix 2 FMEA Risk Assessment Procedure [ISO 9001] (revised 2018-08-22), 0. Shared Folder › 1. Documentation by Standard (Korean)
  • 09.03 Management Review Procedure [ISO 9001] (revised 2018-08-29), 0. Shared Folder › 1. Documentation by Standard (Korean)

  Industry-specific documents referred to: industry model (rewritten for a fictional company)

  • Printing, Packaging and Paper › Quality Risks and Opportunities, Industry Model › Printing, Packaging and Paper

  Expand allDownload as Word
  Management System Operation: 4 Setting ObjectivesQuality Objectives and Performance Indicators: Delamination, Foreign Matter, Records, Customer DiversificationFictional company Company A Co., Ltd

  This is what was entered

  Standard to operate	ISO 9001
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	4 Setting Objectives
  Department or process	Quality, Production, Sales
  Situation and data summary	Risk assessment items scoring 6 or more: adhesive lot change, curing conditions, foreign matter, customer dependence. Current delamination defect rate 2.4%, scrap rate 2.8%
  Requests	Through to formulas, target values, frequency, owners and achievement plans

  Objectives Summary

  • Organization: Company A Co., Ltd: gravure printing and laminating of food packaging materials, ISO 9001
  • Basis: priority issues from the context of the organization and the items scoring 6 or more in the risk assessment (R1 adhesive lot change, R2 curing conditions, R3 foreign matter, R6 customer dependence) [3]
  • Principle: make them measurable (formula, frequency), set an owner and a deadline, and treat the figures as examples to be set by the company.

  Quality Objectives and Performance Indicators (6.2)

  No.	Target	Indicator and formula	Target value (example)	Frequency	Owner	Linked risk
  Q1	Reduce delamination defects	Delamination defect rate at final inspection = defective quantity ÷ inspected quantity x 100	0.5% or less	Monthly	Quality Team Leader	R1·R2
  Q2	Reduce customer complaints	Number of customer complaints	1 or fewer per month	Monthly	Sales Team Leader	R1·R3
  Q3	Zero foreign matter complaints	Number of complaints related to foreign matter	0 cases	Monthly	Quality Team Leader	R3
  Q4	Complete process records	Number of days with missing curing room records	0 days	Monthly	Production Team Leader	R2
  Q5	Scrap rate control	Scrap quantity ÷ input quantity x 100	3% or less	Monthly	Production Team Leader	Environment and cost [4]
  Q6	Customer diversification	Share of sales from the top 3 customers	65% → 60% or less	Half-yearly	Sales Team Leader	R6

  Plan To Achieve Objectives (6.2.2)

  Target	What	Resources required	Who	By when	Evaluation of results
  Q1	Lot change control, curing condition criteria, stronger sampling	Test time, automatic recorder	Staff ·	Start within 1 month	Monthly defect rate trend
  Q3	Revise the hygiene inspection checklist, pest control inspection	Inspection time, pest control contractor	Staff	Within 1 month	Number of complaints
  Q4	Automatic recording, signed daily check	Budget to purchase a recorder	Staff	Within 1 month	Number of missing days
  Q6	Visits and quotations for new customers	Sales time, sample cost	Staff	By half-year	Share of sales

  Points To Check

  • Linkage: every objective is linked to the policy and to the items scoring 6 or more in the risk assessment. No indicator that is not linked has been set.
  • Realism: the Q1 target of 0.5% or less is a large reduction from the current 2.4%. The responsible person should decide whether to set stage targets (for example 1.5% in 3 months and 0.5% in 6 months).
  • Measurement data: confirm that the source data for every indicator (inspection reports, complaint register, recorder) already exists. An indicator without data cannot be used. [2]

  Items To Be Confirmed

  • Whether the policy statements (22) and the objectives are consistent
  • The basis for target values (results of the past 12 months)
  • Whether to set separate environmental and safety objectives (if ISO 9001 stands alone, the focus is on quality objectives)

  Next steps

  • 18 Management Review: raise the status of objective achievement as an input to 9.3.2.
  • 15 Analysis and Evaluation: set the data collection method and analysis frequency for each indicator.
  • 12 Process Control: include the control criteria needed to achieve Q1 and Q4 in the work standards.

  Document completeness check

  The AI checked the document against a 7-item scoring sheet from the customer's point of view.

  Item	Result	What was checked
  Meets the standard requirements	Met	Covers all of 6.2: what will be done, resources, responsibility, deadline and evaluation.
  Tailored to our company	Met	All four risks provided as input are linked to the six objectives.
  Reflects the latest revision	To be confirmed	Compared with the background of the ISO 9001:2026 revision in the "International Standard Revision Materials": clause numbers are examples, and are finalized by comparison with the published text
  Ready to use	Met	With formulas and frequencies included, the content can be transferred directly into an indicator definition sheet.
  Accuracy	Met	States that the target values are examples set by the company, and leaves realism as a decision for the responsible person.
  Consistency	Met	Policy, risks, objectives and plans are connected to one another.
  Readability	Met	Organized into two tables for easy reading.

  ※ This is an AI check result and does not guarantee conformity for certification. Use the document after reviewing and approving it.

  Management system AI transformation materials referred to

  • 1. Background of the ISO 9001 2026 revision (revised 2025-02-22)
  • 06.03.3 Appendix 1 Quality Objectives [ISO 9001] (revised 2018-08-29), 0. Shared Folder › 1. Documentation by Standard (Korean)
  • 06.01 Risks and Opportunities Procedure [ISO 9001] (revised 2018-08-28), 0. Shared Folder › 1. Documentation by Standard (Korean)

  Industry-specific documents referred to: industry model (rewritten for a fictional company)

  • Printing, Packaging and Paper › Example Objectives and Performance Indicators, Industry Model › Printing, Packaging and Paper

  Expand allDownload as Word
  Management System Operation: 17 Internal AuditInternal Audit Plan and Checklist: Laminating, Curing and ShipmentFictional company Company A Co., Ltd

  This is what was entered

  Standard to operate	ISO 9001
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	17 Internal Audit
  Department or process	Production (laminating and curing), Quality (final inspection), Purchasing, Production Engineering
  Situation and data summary	3 recent delamination complaints, adhesive lot change, curing room records missing for 3 days, 2 findings (minor) from the previous internal audit
  Requests	Through to audit scope, schedule, checklist and report format

  Internal Audit Plan

  • Organization: Company A Co., Ltd: gravure printing and laminating of food packaging materials, ISO 9001
  • Audit scope: the laminating, curing and final inspection processes (where the recent delamination complaints occurred), purchasing (adhesive receiving) and change control
  • Audit criteria: ISO 9001 8.4 (externally provided processes, products and services), 8.5.1 (control of production), 8.5.6 (control of changes), 8.6 (release), 8.7 (control of nonconforming outputs), 9.1 (monitoring and measurement), 10.2 (nonconformity and corrective action), company procedures and work standards [2][3]
  • Audit type: regular audit plus an additional audit after the complaints (example); independence: auditors do not audit their own department (9.2.2). [2]

  Audit Schedule (Draft)

  Time	Departments and processes audited	Auditor	Auditee
  09:00	Opening meeting	Audit team leader	Chief executive officer, all team leaders
  09:30	Purchasing and receiving (receiving inspection of adhesive and film)	Auditor A (from another department)	Purchasing Team Leader
  11:00	Laminating and curing (process and records)	Auditor B (from another department)	Production Team Leader
  13:30	Final inspection (peel strength test and calibration)	Auditor A	Quality Team Leader
  15:00	Change control and corrective action	Auditor B	Production Engineering Team Leader
  16:30	Auditors' meeting, closing meeting	Audit team leader	Chief executive officer, all team leaders

  • Appoint auditors whose auditor qualifications and training records have been confirmed. The company decides the names.

  Audit Checklist (Excerpt)

  No.	Items to be confirmed	Requirement	Verification method and evidence	Judgment
  1	Is there a procedure for prior verification (certificate of analysis, strength test) when the adhesive lot changes, and is it followed?	8.5.6, 8.4	Receiving records, certificates and test records for the last 3 lots	□ Conforming □ Nonconforming □ Observation
  2	Are there criteria for curing conditions (time, temperature, humidity), and are the records complete?	8.5.1	Curing room records for the last 3 months, deviation handling records	□ Conforming □ Nonconforming □ Observation
  3	Is the peel strength tester within its calibration period?	7.1.5	Calibration certificate, daily check records	□ Conforming □ Nonconforming □ Observation
  4	Do the final inspection sampling and acceptance criteria match the documents?	8.6	Inspection reports, standards	□ Conforming □ Nonconforming □ Observation
  5	Are there records of segregation, identification and disposition of nonconforming products (delamination)?	8.7	Segregation area, nonconformity register	□ Conforming □ Nonconforming □ Observation
  6	Does complaint corrective action proceed through cause analysis to effectiveness verification?	10.2	Corrective action request form	□ Conforming □ Nonconforming □ Observation
  7	Are the results of monitoring environmental conditions such as humidity used in the analysis?	9.1.3	Humidity records, analysis data	□ Conforming □ Nonconforming □ Observation
  8	Do operators know the adhesive mixing ratio and pot life?	7.2	On-site questioning, training records	□ Conforming □ Nonconforming □ Observation

  Sample Interview Questions (On Site)

  • "What checks do you carry out when you switch to a new adhesive lot? When did you last switch?"
  • "How do you handle days when the curing room temperature record is missing?"
  • "Do working conditions change on days with high humidity? Please show me in the standard."
  • "When a defect occurs, whom do you notify and where do you place it?"

  Audit Report Format

  Item	Content
  Finding number and type	Nonconformity / Observation / Improvement suggestion
  Requirement	(Clause, procedure)
  Objective evidence	(What was seen, heard and recorded)
  Finding	(Facts only; do not write evaluative remarks)
  Corrective action owner and deadline	Set by the audited department

  • Write each finding with both the evidence and the requirement. Do not write a finding without evidence. [2]

  Follow-up Actions

  • Hand nonconformities over to 19 Nonconformity and Corrective Action and complete a corrective action request (cause analysis, action, effectiveness verification).
  • Raise the summary of audit results as the audit results input (9.3.2) to the next management review.
  • Schedule the next regular audit starting with the processes at highest risk (those scoring 6 or more in the risk assessment).

  Items To Be Confirmed

  • Auditor qualifications and training records (whether internal auditors have been trained)
  • Findings from the previous audit and whether the actions are completed
  • Whether the audit schedule overlaps with the production schedule

  Next steps

  • 19 Nonconformity and Corrective Action: transfer the findings into a corrective action request.
  • 18 Management Review: raise the audit results as an input.

  Document completeness check

  The AI checked the document against a 7-item scoring sheet from the customer's point of view.

  Item	Result	What was checked
  Meets the standard requirements	Met	Covers scope, criteria, schedule, independence, reporting and follow-up under 9.2.
  Tailored to our company	Met	Set the processes with recent complaints as the audit scope and transferred the facts provided as input into the checklist.
  Reflects the latest revision	To be confirmed	Compared with the background of the ISO 9001:2026 revision in the "International Standard Revision Materials": clause numbers are examples, and are finalized by comparison with the published text
  Ready to use	Met	With columns for what to verify, evidence and judgment, it can be used on site as it is.
  Accuracy	Met	Clause numbers are left as examples, and it states that the company appoints the auditors.
  Consistency	Met	Plan, checklist, report and corrective action are connected in sequence.
  Readability	Met	Table-based, and it states that only an excerpt of the long checklist is shown.

  ※ This is an AI check result and does not guarantee conformity for certification. Use the document after reviewing and approving it.

  Management system AI transformation materials referred to

  • 1. Background of the ISO 9001 2026 revision (revised 2025-02-22)
  • 09.02 Internal Audit Procedure [ISO 9001] (revised 2018-09-22), 0. Shared Folder › 1. Documentation by Standard (Korean)
  • Form_09.02.1_ISO 9001:2015 Internal Audit Checklist (revised 2018-08-23), 0. Shared Folder › 1. Documentation by Standard (Korean)
  • 10.2 Corrective Action Request (revised 2026-07-20)

  Industry-specific documents referred to: industry model (rewritten for a fictional company)

  • Printing, Packaging and Paper › Core Process Flow and Control Points, Industry Model › Printing, Packaging and Paper

  Expand allDownload as Word
  Management System Operation: 18 Management ReviewManagement Review Meeting Materials: Inputs, Review and Decisions (9.3)Fictional company Company A Co., Ltd

  This is what was entered

  Standard to operate	ISO 9001
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	18 Management Review
  Department or process	Top management, Quality, Production, Sales, Purchasing
  Situation and data summary	First half of 2026. Delamination defect rate 2.4% (target 0.5% or less), scrap rate 2.8%, corrective action for 3 delamination complaints in progress, budget needed for an automatic recorder for the curing room
  Requests	Through to the inputs table, decisions to be made and the minutes format

  Management Review Meeting Materials

  • Organization: Company A Co., Ltd: gravure printing and laminating of food packaging materials, ISO 9001
  • Review period: first half of 2026 (example)
  • Attendees (draft): Chief executive officer (chair), Quality Team Leader, Production Team Leader, Production Engineering Team Leader, Sales Team Leader, Purchasing Team Leader
  • Basis: ISO 9001 9.3. Covers both inputs (9.3.2) and outputs (9.3.3). [2]

  1. Inputs (9.3.2)

  Input	Content to be reported this time (input criteria)	Owner
  Status of actions from previous management reviews	3 of 4 actions from the previous meeting completed, 1 (automation of curing room records) in progress	Quality Team Leader
  Changes in external and internal issues	Stricter hygiene audits by food customers, adhesive supplier lot change	Sales and Purchasing
  Customer satisfaction and feedback from relevant interested parties	3 delamination complaints in the last 4 weeks, evaluations from other customers good	Sales Team Leader
  Extent to which quality objectives have been met	Delamination defect rate 2.4% (target 0.5% or less) not met, scrap rate 2.8% (target 3% or less) met	Quality Team Leader
  Process performance and conformity of products	Final inspection pass rate, 3 days of missing process records	Production Team Leader
  Nonconformity and Corrective Action	Corrective action for delamination complaints in progress: immediate action completed, root cause being tested	Quality Team Leader
  Monitoring and measurement results	Defects twice as frequent on days with humidity of 70% or more	Quality Team Leader
  Audit results	2 internal audit findings (minor), 1 customer audit	Quality Team Leader
  Performance of external suppliers	Adhesive supplier changed the lot without prior notice	Purchasing Team Leader
  Adequacy of resources	Budget needed to purchase an automatic recorder for the curing room	Production Team Leader
  Effectiveness of actions taken to address risks and opportunities	Actions for R1 and R2 in progress (score 6 → target 3)	Production Engineering Team Leader
  Opportunities for improvement	1 quotation request for eco-friendly single-material packaging	Sales Team Leader

  • The above was compiled from the data provided as input and fictional figures. At the actual meeting, the responsible person should replace them with the latest figures. [3]

  2. Review Opinions (Proposal)

  • Biggest problem: delamination defects. Because the root cause test (2 weeks) results are not yet available, no conclusion is drawn, and the candidate causes (adhesive lot, humidity, missing records) are reported.
  • Resources: the feasibility of introducing an automatic recorder for the curing room will be reviewed against the cost of defects and complaints. The amount is to be confirmed.
  • Policy and objectives: it is proposed to keep the quality policy and to change objective Q1 to stage targets (1.5% in 3 months, 0.5% in 6 months).

  3. Outputs (9.3.3): Decisions To Be Made

  No.	Decision	Owner	Deadline
  D1	Receive the delamination root cause test results and finalize the corrective action	Quality Team Leader	2 weeks
  D2	Whether to approve introduction of an automatic recorder for the curing room (budget)	Chief executive officer	This meeting
  D3	Include prior notice of adhesive lot changes in the supply contract	Purchasing Team Leader	1 month
  D4	Finalize the stage targets for quality objective Q1	Chief executive officer	This meeting
  D5	Add raw material lot changes to the change control procedure (opportunity for improvement)	Production Engineering Team Leader	1 month

  • The outputs cover needed changes to the management system, resource needs and opportunities for improvement. If there is no change, write "None". [3]

  4. Minutes Format

  Item	Content
  Date and place	(To be entered)
  Attendees	(To be entered)
  Summary of discussion	(To be entered)
  Decisions, owners and deadlines	Whether D1 to D5 are confirmed
  Next meeting	Second half of the year (example)

  • The minutes are retained as documented information (last sentence of 9.3.3). The retention period follows company rules.

  Next steps

  • 19 Nonconformity and Corrective Action: reflect the D1 result in the cause and action fields of the corrective action request.
  • 4 Setting Objectives: revise the Q1 objective according to decision D4.
  • 21 Improvement: raise D5 and the opportunities for improvement in the improvement plan.

  Document completeness check

  The AI checked the document against a 7-item scoring sheet from the customer's point of view.

  Item	Result	What was checked
  Meets the standard requirements	Met	Covers all twelve inputs of 9.3.2 and the outputs of 9.3.3 (changes, resources, improvement).
  Tailored to our company	Met	The figures provided as input were transferred to the inputs table as they are, and it states that they should be replaced with actual figures.
  Reflects the latest revision	To be confirmed	Compared with the background of the ISO 9001:2026 revision in the "International Standard Revision Materials": clause numbers are examples, and are finalized by comparison with the published text
  Ready to use	Met	Each decision has an owner and a deadline, and a minutes format is included so it can be used immediately.
  Accuracy	Met	A root cause that cannot be determined is not asserted; it is written as awaiting the test results.
  Consistency	Met	Inputs, review, decisions and next steps are connected in sequence.
  Readability	Met	Easy to read with two tables and a short list.

  ※ This is an AI check result and does not guarantee conformity for certification. Use the document after reviewing and approving it.

  Management system AI transformation materials referred to

  • 1. Background of the ISO 9001 2026 revision (revised 2025-02-22)
  • 09.03 Management Review Procedure [ISO 9001] (revised 2018-08-29), 0. Shared Folder › 1. Documentation by Standard (Korean)
  • 09.3 Management Review Procedure [ISO 9001·45001] (revised 2018-08-29), 0. Shared Folder › 1. Documentation by Standard (Korean)

  Industry-specific documents referred to: industry model (rewritten for a fictional company)

  • Printing, Packaging and Paper › Example Objectives and Performance Indicators, Industry Model › Printing, Packaging and Paper

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  Management System Operation: 19 Nonconformity and Corrective ActionCustomer Complaints on Laminating Delamination: Nonconformity and Corrective ActionFictional company Company A Co., Ltd

  This is what was entered

  Standard to operate	ISO 9001
  Industry	Food packaging (snack bags) gravure printing and laminating, 70 employees
  Operation steps	19 Nonconformity and Corrective Action
  Department or process	Production: gravure printing and laminating, shipping inspection
  Situation and data summary	3 customer complaints in the last 4 weeks (delamination of snack bag laminating), delamination defect rate 2.4% (target 0.5% or less), rising since the first week of October at the same time as an adhesive lot change, defects twice as frequent on days with humidity of 70% or more, curing room temperature records missing for 3 days
  Requests	Candidate causes by 4M1E, and the corrective action plan through to the owner and deadline fields

  Nonconformity Summary

  • Organization: Company A Co., Ltd: gravure printing and laminating of food packaging (snack bags)
  • Phenomenon: 3 customer complaints in the last 4 weeks: lifting (delamination) of the laminate on snack bags
  • Extent: delamination defect rate at final inspection 2.4% (target 0.5% or less), rising since the first week of October
  • What changed at the same time: adhesive lot change in the same period / defects twice as frequent on days with humidity of 70% or more / curing room temperature records missing for 3 days
  • Related requirements: ISO 9001 8.7 Control of nonconforming outputs, 10.2 Nonconformity and corrective action, 8.5.1 Control of production, 8.5.6 Control of changes [2] [3]

  Immediate Action (Correction)

  Action	Owner	Deadline
  Segregate warehouse and customer stock from production lots made since the first week of October, and re-inspect peel strength on all items (or by lot sampling)	Quality Team Leader	Immediately (within 2 days)
  Notify the customer of the list of affected lots and the re-inspection plan, and discuss replacement delivery	Sales Team Leader	Within 3 days
  Suspend use of the new adhesive lot: use the previous lot first if stock remains; if not, strengthen the curing conditions, confirm strength, and then use it	Production Team Leader	Immediately
  Switch curing room temperature recording to an automatic recorder, or record manually every 2 hours	Production Team Leader	Within 1 week

  Cause Analysis

  5Why

  Step	Question	Answer (based on input)
  Why 1	Why did delaminated products reach the customer?	Lots that were not caught by the final inspection samples were shipped (defect rate 2.4%).
  Why 2	Why did delamination increase?	Bonding strength was not sufficient. This has occurred since the first week of October, and more often on humid days.
  Why 3	Why was the bonding strength insufficient?	The adhesive may not have cured sufficiently: to be confirmed which of the new adhesive lot, humidity or curing conditions is the cause.
  Why 4	Why could the curing conditions not be verified?	Curing room temperature records are missing for 3 days, so it is not known whether the conditions were met.
  Why 5	Why were records missing and the effect of the lot change not known?	Possibly because the adhesive lot change was not treated as subject to change control and responsibility for checking curing condition records was not assigned; to be confirmed.

  Candidate Causes by Cause-and-Effect Diagram (4M1E)

  • Man (people): competence of operators who adjust the mixing ratio of the two-component adhesive, missing curing room records during night and shift work, to be confirmed
  • Machine: wear of the laminator coating roll and variation in coating weight, drying tunnel temperature, curing room temperature control, check coating weight records
  • Material: new adhesive lot (composition, viscosity, expiry date), film surface treatment (corona treatment intensity), compatibility between ink and adhesive, check the adhesive certificate of analysis and film surface tension [7]
  • Method: curing time and temperature criteria, pot life after mixing, frequency of bond strength tests and sample size of final inspection, check whether the criteria take humid days into account
  • Environment: humidity of 70% or more: humidity may affect the adhesive curing reaction (general knowledge; confirm with the adhesive supplier's technical data), whether the workplace is dehumidified
  • Measurement: calibration status of the peel strength tester, timing of the test (before or after curing), to be confirmed

  Root Cause

  It cannot be asserted from the input alone. The responsible person decides after confirming the two hypotheses below by testing.

  1. Hypothesis A: insufficient curing with the new adhesive lot under high humidity: prepare specimens of the previous lot and the new lot under the same conditions (humidity of 50% and 75%) and compare peel strength after curing
  2. Hypothesis B: curing conditions not followed (period of missing records): compare the defect rate of production lots from the 3 days with missing records against the other lots

  • Common management causes (to be confirmed): adhesive lot changes are not included in 4M change control, and no one is responsible for checking curing condition records

  Corrective Action Plan

  Action	Owner	Deadline	Completion criteria
  Conduct the confirmation tests for hypotheses A and B and report the results	Quality Team Leader	Within 2 weeks	Test report, record of root cause decision
  Include lot changes of major raw materials such as adhesive and film in change control, and put the first lot after a change into use only after a strength test	Production Engineering Team Leader	Within 1 month	Revise the change control procedure and work standards, training records
  Automatic recording of curing room temperature and humidity with deviation alerts, signed daily check	Production Team Leader	Within 1 month	Start automatic recording, operate the checklist
  Establish condition criteria such as longer curing time when humidity is 70% or more (based on the supplier's technical data)	Production Engineering Team Leader	Within 1 month	Revise the work standards
  Temporarily strengthen the peel strength sample size at final inspection (for example, twice per lot, example)	Quality Team Leader	Immediately until effectiveness is verified	Temporary revision of inspection criteria
  Ask the adhesive supplier to confirm lot quality and add items to the certificate of analysis	Purchasing Team Leader	Within 2 weeks	Supplier reply, revision of receiving inspection criteria

  Effectiveness Verification Plan

  • Method: track the delamination defect rate at final inspection and customer complaints, and tally the defect rate separately for days with humidity of 70% or more
  • Timing: 8 weeks after corrective action is completed (example)
  • Criteria for judgment: delamination defect rate maintained at 0.5% or less, zero customer complaints from the same cause, zero days of missing curing room records
  • If the criteria are not met, return to cause analysis and take action again. The result is recorded in the effectiveness verification field of the corrective action request. [4]

  Horizontal deployment · Update of risks and opportunities · Management system change

  Horizontal Deployment

  • Check the delamination defect rate of other laminated products that use the same adhesive (coffee and instant noodle packaging, etc.)
  • Apply lot change control to other two-component materials (coating agents, ink hardeners)
  • Check for missing records in other processes where curing and drying conditions determine quality (coating drying) [7]
  • Reconfirm that each customer's required peel strength value matches the final inspection criteria [8]

  Update of Risks and Opportunities (6.1)

  Risk / Opportunity	Until now	To be changed
  Reduced bonding strength due to raw material lot change	Not in the assessment table	Add as a risk: likelihood medium, impact high, response = strength test of the first lot after a change
  Insufficient curing on days of high humidity (70% or more)	Recorded only as a seasonal factor	Raise the risk level, response = curing condition criteria (by humidity)
  Introduction of automatic recording in the curing room	:	Add as an opportunity: zero missing records, immediate alert on deviation

  Changes to the Management System (10.2 f)

  • Change control procedure: include adhesive and film lot changes in "planned changes" (8.5.6)
  • Work standards: add curing time criteria by humidity, revise the curing room checklist form
  • Receiving inspection criteria: add items to the adhesive certificate of analysis

  Next steps

  • 3 Risk Assessment: enter the three lines of "Update of Risks and Opportunities" above into the assessment table and re-rate the levels.
  • 12 Process Control: include the curing conditions and the strength test of the first lot after a change in the operational control criteria table.
  • 18 Management Review: raise the result of the effectiveness verification of this nonconformity and corrective action as an input to the next management review (9.3.2: nonconformities and corrective actions).

  ※ Draft for reference: it does not guarantee obtaining certification. Check clauses and requirements against the published text of the standard.

  Document completeness check

  The AI checked the document against a 7-item scoring sheet from the customer's point of view.

  Item	Result	What was checked
  Meets the standard requirements	Met	Covers the structure of 10.2 (immediate action, cause analysis, root cause, corrective action, effectiveness verification) as well as the update of risks and opportunities and changes to the management system.
  Tailored to our company	Met	The defect rate, adhesive lot, humidity and curing room records provided as input were used as they are as candidate causes, and causes not yet confirmed are kept as hypotheses.
  Reflects the latest revision	Met	Compared with the background of the ISO 9001:2026 revision in the "International Standard Revision Materials": no major change in 10.2; check clause details against the published text
  Ready to use	Met	Each action has an owner, a deadline and a completion criterion, so it can be transferred into a corrective action request.
  Accuracy	Met	The ISO 9001 clauses (8.5.6, 8.7, 10.2) are cited correctly, and the figures are stated to be examples.
  Consistency	Met	Cause, action, effectiveness verification and next steps are connected to one another.
  Readability	Met	Organized with tables and short lists for easy reading.

  ※ This is an AI check result and does not guarantee conformity for certification. Use the document after reviewing and approving it.

  Management system AI transformation materials referred to

  • 1. Background of the ISO 9001 2026 revision (revised 2025-02-22)
  • 10.3 Nonconformity and Corrective Action Procedure [ISO 9001·45001], 0. Shared Folder › 1. Documentation by Standard (Korean) (revised 2018-08-29)
  • 10.01 Nonconformity and Corrective Action Procedure [ISO 9001], 0. Shared Folder › 1. Documentation by Standard (Korean) (revised 2018-08-28)
  • 10.2 Corrective Action Request (revised 2026-07-20)
  • 08.07.10 Rubber and Plastics Manufacturing Procedure [ISO 9001·14001], 0. Shared Folder › 1. Documentation by Standard (Korean) (revised 2018-08-24)

  Industry-specific documents referred to: industry model (rewritten for a fictional company)

  • Printing, Packaging and Paper › Core Process Flow and Control Points, Industry Model › Printing, Packaging and Paper
  • Printing, Packaging and Paper › Example Objectives and Performance Indicators: Industry Model › Printing, Packaging and Paper
  • Food Manufacturing (HACCP·ISO 22000) › Example Objectives and Performance Indicators, Industry Model › Food Manufacturing (HACCP·ISO 22000)

  Expand allDownload as Word

  ※ This is an example created with a fictional company, and the quality and content of the example may differ from the actual service results. Actual output varies with the input and the supporting materials. Output created by AI is a draft for reference and does not guarantee obtaining certification. The downloaded file is created inside your browser and is not sent anywhere.

• Points to prepare in advance
• 1. Describe the situation with facts and figures. State since when, how much, where, and what changed at the same time, using figures, so that the candidate causes can be narrowed down. What is not known, the AI leaves as "to be confirmed".
  2. People make the decisions. The responsible person decides and records the root cause, the countermeasures and the judgment of effectiveness.
  3. Connect to the next step. If you save the result in the Company Workspace, 3 Risk Assessment and 18 Management Review take it over.
  4. Some information must not be entered. Do not enter customer names, personal information or trade secrets.
  5. Operation and certification audits are separate. Operation data belongs to the company and is not used for an audit without the company's consent. AI drafts are for reference and do not guarantee certification.
  Operate 19 Nonconformity and Corrective Action Management System Operation Guide Company Workspace