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Wednesday, September 30, 2026

From Risk-Based Thinking to Predictive Quality Management: The Next Evolution of Quality Management

 For years, quality management has asked organizations a relatively simple question:

What could go wrong?

The next generation of quality management is beginning to ask a more ambitious question:

Can we identify the warning signs before something goes wrong?

This represents an important shift in the way organizations think about quality.

Risk-based thinking became much more prominent with ISO 9001:2015. The standard moved organizations away from relying primarily on corrective action after problems occurred and toward identifying risks and opportunities that could affect the intended results of the quality management system. ISO describes risk-based thinking as an essential element of an effective QMS.

Now, with ISO 9001:2026, the direction has become even clearer.

The new edition retains risk-based thinking but provides a clearer distinction between risks and opportunities, encouraging organizations to proactively address both as part of decision-making and continual improvement.

This raises an important question for quality professionals:

Is the future of quality management simply better risk management — or is it predictive quality management?


From reactive quality to predictive quality

Traditional quality management can be viewed as a sequence:

Problem → Inspection → Nonconformity → Corrective Action → Improvement

This model remains important.

If a concrete cube fails a compressive-strength test, for example, the project team investigates the cause, determines corrective action and prevents recurrence.

But by the time the cube has failed, the undesirable outcome has already happened.

Risk-based thinking changes the sequence:

Risk identification → Risk assessment → Preventive action → Monitoring

This is more proactive.

But predictive quality goes one step further:

Data → Early warning → Prediction → Intervention → Quality outcome

The difference may appear subtle, but it changes the role of the quality function.

Instead of asking only:

“What risks do we have?”

the organization begins asking:

“What measurable signals indicate that a quality problem is becoming more likely?”

That is the beginning of predictive quality management.


What exactly is predictive quality management?

Predictive quality management is an approach in which historical and real-time information is used to identify patterns, trends or warning signals that may indicate a future quality problem.

It does not necessarily require artificial intelligence.

An organization can begin with relatively simple techniques:

  • trend analysis;

  • control charts;

  • Pareto analysis;

  • regression analysis;

  • statistical process control;

  • leading indicators;

  • supplier performance trends;

  • inspection data;

  • complaint patterns;

  • defect recurrence analysis.

More advanced organizations can use:

  • machine learning;

  • anomaly detection;

  • predictive analytics;

  • digital twins;

  • automated inspection;

  • sensor data;

  • AI-assisted quality analysis.

The important principle is not the technology itself.

It is the transition from detecting failure to detecting the conditions that precede failure.


The limitation of the traditional risk register

Many organizations already have a risk register.

It may contain entries such as:

RiskProbabilityImpactMitigation
Concrete strength failureMediumHighIncrease testing
Supplier delayMediumHighMonitor supplier
Waterproofing defectsMediumMediumIncrease inspection
Design errorLowHighDesign review

This is useful.

But there is a potential weakness.

A risk register can become a static document.

The organization identifies the risk at the beginning of the project, assigns a probability and impact, identifies mitigation, and then reviews the register periodically.

The problem is that risk does not remain static.

A supplier that had a 5% defect rate in January may have a 12% defect rate by June.

A subcontractor may begin accumulating inspection failures.

Concrete temperature may progressively increase during hot weather.

Rework may increase from 1% to 3% to 5%.

Customer complaints may begin clustering around one product.

These changes may represent signals that the probability of a future quality problem is increasing.

A traditional risk register may not capture this dynamic movement quickly enough.


From risk register to risk intelligence

This is where predictive quality management becomes interesting.

Instead of treating risk as a static entry, organizations can connect risk to measurable indicators.

For example:

Traditional approach

Risk: Waterproofing failure

Probability: Medium

Impact: High

Mitigation: Increase inspection

Predictive approach

Monitor:

  • number of waterproofing defects;

  • defect recurrence;

  • installer productivity;

  • substrate moisture;

  • inspection rejection rate;

  • weather conditions;

  • material batch information;

  • previous repair locations.

The organization can then identify whether these indicators are moving toward an undesirable pattern.

For example:

Inspection rejection rate

2% → 3% → 4% → 7% → 9%

The organization should not wait until widespread waterproofing failure occurs.

The trend itself becomes a warning signal.

This is the difference between risk documentation and risk intelligence.


Leading indicators become more important

One of the biggest changes associated with predictive quality is the growing importance of leading indicators.

A lagging indicator tells us what has already happened.

Examples include:

  • number of defects;

  • number of complaints;

  • rejected materials;

  • failed tests;

  • rework cost;

  • NCRs;

  • warranty claims.

A leading indicator attempts to show what may happen next.

Examples include:

  • inspection rejection trends;

  • percentage of overdue inspections;

  • subcontractor competency;

  • calibration status;

  • percentage of unresolved technical queries;

  • frequency of repeated defects;

  • supplier delivery variability;

  • percentage of work performed without approved inspection;

  • design changes occurring late in the project.

The distinction is important.

A project could have:

Low NCRs today

but simultaneously have:

Increasing inspection rejection rates.

The first indicator looks positive.

The second may provide an early warning.

A mature QMS therefore needs to look at both.


Construction provides a powerful example

Consider a large building project.

The project has a KPI called:

Concrete Cube Test Pass Rate

Suppose the results are:

MonthPass Rate
January100%
February100%
March98%
April97%
May94%

A traditional approach might react when the pass rate falls below the acceptance criterion.

A predictive approach asks:

What caused the trend to deteriorate?

The organization could investigate:

  • concrete temperature;

  • batching plant performance;

  • cement source;

  • aggregate moisture;

  • mix design changes;

  • transportation time;

  • placement time;

  • curing conditions;

  • testing laboratory performance;

  • subcontractor practices.

The objective is not simply to record that the pass rate decreased.

The objective is to identify the conditions associated with deterioration.

That information can then be used to intervene before the problem becomes significantly larger.


AI can accelerate this process

Artificial intelligence can potentially make predictive quality management much more powerful.

Imagine a project with thousands of quality records.

The data could include:

  • inspection requests;

  • material approvals;

  • laboratory results;

  • NCRs;

  • photographs;

  • weather information;

  • subcontractor performance;

  • equipment records;

  • progress data;

  • design changes;

  • RFI records;

  • audit findings.

A human quality engineer may find it difficult to identify relationships across all of these datasets.

AI and advanced analytics can help identify patterns that deserve human attention.

For example:

“Projects using Supplier A under conditions X, Y and Z have historically shown a higher frequency of defects.”

Or:

“The current combination of inspection rejection rate, subcontractor performance and rework frequency resembles patterns observed before previous quality deterioration.”

The system is not necessarily declaring that a failure will happen.

Instead, it can provide an early warning.

The final decision remains with the quality and project management professionals.


Predictive does not mean certain

This distinction is extremely important.

Predictive quality management does not mean that an organization can know the future with certainty.

A prediction is based on information and patterns.

It can be wrong.

For example, an AI system might identify a high probability of a defect because similar historical conditions previously produced defects.

But the current project may have additional controls that prevent the problem.

Therefore:

Prediction ≠ Fact

and:

AI warning ≠ Nonconformity

A predictive QMS should treat predictions as decision-support information, not as unquestionable conclusions.

Human review remains essential.


ISO 9001:2026 does not require AI

It is important not to misunderstand the new direction.

ISO 9001:2026 does not mean that every organization must implement artificial intelligence or predictive analytics.

The standard remains a management-system standard.

ISO 9001:2026 continues to emphasize customer focus, the process approach, risk-based thinking and continual improvement.

The new edition provides a clearer distinction between risks and opportunities and encourages organizations to take proactive action.

Therefore, an organization can develop predictive quality capabilities without claiming that AI is an ISO requirement.

The technology is optional.

The management principle is more fundamental:

Use information to make better quality decisions before undesirable outcomes occur.


ISO 31000 and the wider risk-management ecosystem

Predictive quality management also fits into the broader risk-management discipline.

ISO 31000:2018 provides guidelines for identifying, analyzing, evaluating, treating, monitoring and communicating risk. It also emphasizes monitoring, review and continual improvement of risk management.

This provides an important foundation.

Predictive quality management can therefore be viewed as an evolution of risk management rather than a replacement for it.

The progression could look like this:

Risk identification

↓

Risk assessment

↓

Risk treatment

↓

Risk monitoring

↓

Trend analysis

↓

Early-warning indicators

↓

Predictive analytics

↓

Proactive intervention

The maturity of the organization increases as risk information becomes increasingly dynamic and decision-oriented.


The new role of the Quality Manager

This evolution could change the role of quality professionals.

The traditional Quality Manager may spend considerable time asking:

“Are we compliant?”

The modern Quality Manager increasingly needs to ask:

“What does the data tell us about where quality is heading?”

This requires a broader skill set.

A future-oriented Quality Manager may need to understand:

  • quality standards;

  • process management;

  • statistics;

  • data visualization;

  • KPI design;

  • risk management;

  • root-cause analysis;

  • digital systems;

  • AI applications;

  • organizational behaviour.

The Quality Manager therefore becomes not simply an inspector of past performance, but a decision-support professional for future quality performance.


Five levels of predictive quality maturity

Organizations could conceptualize their development in five stages.

Level 1 — Reactive Quality

The organization responds to defects after they occur.

Question:

What went wrong?


Level 2 — Preventive Quality

The organization identifies potential problems and establishes preventive controls.

Question:

What could go wrong?


Level 3 — Measured Quality

The organization systematically collects KPI and process-performance data.

Question:

What is happening?


Level 4 — Predictive Quality

The organization identifies trends and early-warning indicators.

Question:

What is likely to happen?


Level 5 — Quality Intelligence

The organization integrates data, risk, process performance, AI and human decision-making.

Question:

What should we do now to influence the future outcome?

This five-level model is not an ISO classification. It is a conceptual way of describing organizational maturity.


What should organizations do first?

Organizations do not need to begin by purchasing an expensive AI platform.

The first step is usually much simpler:

Improve the quality of the data.

An organization should identify:

  1. What quality problems occur repeatedly?

  2. What data are already being collected?

  3. Which indicators appear before those problems?

  4. Can the indicators be measured consistently?

  5. What threshold should trigger investigation?

  6. Who receives the warning?

  7. What action should follow?

  8. Was the intervention effective?

For example:

Defect → Cause → Precursor → Indicator → Threshold → Warning → Action → Result

This creates a feedback loop between risk management and quality management.


The future may be “quality before failure”

For decades, quality management has developed through several stages.

Quality Control

“Find the defect.”

↓

Quality Assurance

“Build a system to prevent the defect.”

↓

Quality Management

“Manage the processes that create quality.”

↓

Risk-Based Quality

“Identify what could prevent quality objectives.”

↓

Predictive Quality

“Identify the warning signs before failure.”

↓

Quality Intelligence

“Use data, technology and human judgment to influence future quality performance.”

This does not make traditional quality methods obsolete.

Inspection, testing, audits, corrective actions and root-cause analysis remain essential.

But they become parts of a larger system.


The real challenge: turning prediction into action

Predictive technology alone will not improve quality.

An organization may have an excellent dashboard showing that a problem is becoming more likely.

But if nobody acts, the prediction has little value.

This creates a new quality-management equation:

Prediction + Decision + Action = Quality Improvement

Without action, predictive analytics becomes another reporting system.

The objective should therefore not be to produce more dashboards.

It should be to produce better decisions earlier.


From “What went wrong?” to “What is the signal?”

The evolution of quality management is not about abandoning the principles that organizations have used for decades.

It is about extending them.

Risk-based thinking taught organizations to consider uncertainty before problems occur.

ISO 9001:2026 reinforces the proactive treatment of risks and opportunities while maintaining the process approach and continual improvement.

The next question is therefore increasingly data-driven:

Can we recognize the signal before the failure?

For construction companies, manufacturers, infrastructure owners and service organizations, this could become one of the defining capabilities of modern quality management.

The future Quality Manager may spend less time simply documenting what went wrong.

Instead, the quality function may increasingly become responsible for identifying where performance is heading — and helping the organization act before a quality problem becomes a quality failure.

The ultimate goal is not to predict everything.

It is to create an organization capable of seeing earlier, deciding faster and preventing better.

That is the transition from risk-based thinking to predictive quality management.

Tuesday, September 29, 2026

Why Quality Culture May Matter More Than Another 100-Page Procedure

An organization can have excellent procedures, impressive certificates and hundreds of quality records. But what happens when nobody is watching?

At 8:00 in the morning, everything looks perfect.

The Quality Management System is documented.

The procedures have been approved.

The inspection checklists are available.

The internal audit has been completed.

The corrective actions have been recorded.

And somewhere on the wall, there is an ISO 9001 certificate.

Then a problem occurs.

A production worker discovers a defect.

A project engineer realizes that a specification has not been followed.

A supplier delivers material that does not meet the expected requirement.

The team is under pressure to meet a deadline.

Nobody from the Quality Department is there.

What happens next?

That moment may tell us more about an organization's quality culture than a shelf full of procedures.

This is one reason the publication of ISO 9001:2026 is attracting attention among quality professionals.

The new edition, published on 16 September 2026, retains the established foundations of ISO 9001 but places greater emphasis on leadership, quality culture, ethical behaviour and accountability.

The message is significant:

Quality is not created only by procedures. It is also created by what people actually do when they face real decisions.


A procedure can tell people what to do

Imagine a company with a 100-page Quality Management System manual.

It contains procedures for:

  • document control;

  • purchasing;

  • inspection;

  • testing;

  • nonconformity;

  • corrective action;

  • internal audit;

  • management review;

  • training;

  • supplier evaluation.

On paper, the organization appears highly structured.

But procedures have a limitation.

They describe expected behaviour.

They cannot completely determine what a person will do when circumstances become difficult.

Consider a simple example.

A worker discovers a defect shortly before an important delivery.

The procedure says:

Report the nonconformity.

But the project manager is under pressure.

The customer is waiting.

The team is behind schedule.

The defect appears relatively small.

The worker now faces a decision.

Does the worker report it?

Or does the worker remain silent?

The answer may depend less on the procedure and more on the organization's culture.


What is quality culture?

Quality culture can be understood as the shared attitudes, behaviours and values that influence how people approach quality in an organization.

ISO already has a dedicated standard on this subject: ISO 10010:2022 — Quality management — Guidance to understand, evaluate and improve organizational quality culture.

ISO 10010 provides guidance for evaluating and developing organizational quality culture, with particular attention to leadership and people engagement. It also includes approaches for self-assessing quality-culture maturity.

In simple terms:

Quality culture is what people actually do about quality.

Not what the manual says.

Not what the presentation says.

Not what the auditor is told.

But what happens during real work.


Why ISO 9001:2026 puts culture in the spotlight

ISO 9001 has always recognized the importance of leadership and people.

But ISO 9001:2026 makes the emphasis more visible.

ISO identifies stronger leadership, quality culture and ethical behaviour among the significant changes in the new edition. The standard also strengthens awareness related to quality culture and ethical behaviour.

This changes the conversation.

Quality is not simply:

Quality Department → Inspection → Audit → Report

It becomes:

Leadership → Culture → People → Process → Behaviour → Performance

That is a much broader system.


The Quality Department cannot create quality alone

This is perhaps one of the most important misunderstandings in organizational quality management.

A company may have:

Quality Manager

QA/QC Engineers

Quality Inspectors

Internal Auditors

Document Controllers

But quality is produced by the entire organization.

Consider a construction project.

The Quality Department may inspect concrete placement.

But quality is also influenced by:

  • the Project Manager's decisions;

  • the Construction Manager's planning;

  • the Site Engineer's supervision;

  • the procurement team's supplier selection;

  • the subcontractor's workmanship;

  • the laboratory's testing;

  • the workforce's competence;

  • the commercial team's decisions;

  • the client's requirements.

A Quality Manager can identify a problem.

But the organization determines whether that problem is prevented from happening again.

This is why ISO says quality is a leadership responsibility and emphasizes creating an environment where people contribute to the effectiveness of the QMS.


The hidden test of a quality culture

There is a useful thought experiment.

Imagine two organizations.

Both have:

  • ISO 9001 certification;

  • identical procedures;

  • similar organizational structures;

  • trained auditors;

  • documented corrective actions.

Now remove the auditors.

What happens?

In Organization A, employees continue to report problems.

In Organization B, employees begin hiding problems.

The difference is not the procedure.

The difference is the culture.

This illustrates why culture can be difficult to measure.

A procedure can be inspected.

A document can be reviewed.

A training record can be checked.

Culture is more visible through behaviour.


What happens when bad news is punished?

Consider another example.

A project engineer identifies a recurring defect.

If the engineer reports it, management reacts angrily:

"Why did you let this happen?"

The next time the engineer discovers a similar problem, what might happen?

The organization may still have a perfect NCR procedure.

But employees may become reluctant to use it.

Over time, the organization can develop an unintended culture:

Good news is rewarded.

Bad news is hidden.

That is dangerous for quality.

A healthy quality culture requires organizations to be capable of identifying problems without automatically turning every problem into a search for someone to blame.

The purpose of identifying a defect should include understanding:

What happened?

Why did it happen?

What allowed it to happen?

How can recurrence be reduced?

That is the logic behind continual improvement.


Quality culture and psychological safety

This creates an important connection between quality management and organizational behaviour.

If employees are afraid to report problems, the organization may receive less accurate information.

If employees feel able to report problems, the organization may discover problems earlier.

This does not mean that accountability disappears.

There is an important distinction between:

honest human error,

systemic process failure,

and

deliberate misconduct.

A mature organization needs to distinguish among them.

That is where ethical behaviour becomes relevant.

ISO 9001:2026 specifically increases the visibility of ethical behaviour within its approach to quality culture and leadership.


The difference between "quality is someone's job" and "quality is everyone's responsibility"

These two statements sound similar.

They are not.

"Quality is someone's job"

Usually means:

The Quality Department is responsible for checking whether other departments have produced quality.

"Quality is everyone's responsibility"

Means:

Every function has responsibility for controlling the quality of its own work.

For example:

Procurement is responsible for supplier and material quality.

Engineering is responsible for design quality.

Construction is responsible for execution quality.

Quality is responsible for assurance, verification and system effectiveness.

Management is responsible for creating the environment in which quality can succeed.

This creates a much stronger organizational model.


When productivity and quality collide

Quality culture becomes particularly visible when two objectives conflict.

Imagine a project where the team has two targets:

Complete the work this week.

and

Ensure the work meets all quality requirements.

Most of the time, these objectives support each other.

But sometimes they conflict.

The organization then has to make a decision.

If employees repeatedly receive the message:

"Finish first; we will fix the quality later."

the organization may gradually create a culture of rework.

The result can be:

Work → Defect → Rework → Additional Cost → Delay

A stronger quality culture attempts to prevent the defect rather than normalize the rework.


Quality culture is not the same as perfection

There is another important point.

A strong quality culture does not mean that an organization never makes mistakes.

No complex organization operates without errors.

Instead, a quality culture can be understood through how the organization responds.

When a problem occurs, does the organization:

hide it?

blame someone?

fix it temporarily?

or

learn from it?

The last approach connects directly with continual improvement, which remains one of the foundations of ISO 9001.


How can quality culture be measured?

This is where quality professionals face a difficult challenge.

You cannot simply ask:

"Do we have a good quality culture?"

and expect a reliable answer.

Instead, organizations can examine indicators of behaviour.

For example:

Reporting behaviour

  • How quickly are defects reported?

  • Are near misses reported?

  • Are employees willing to raise concerns?

Corrective-action behaviour

  • Are root causes genuinely investigated?

  • Are recurring problems accepted as normal?

  • Do corrective actions prevent recurrence?

Leadership behaviour

  • Does management discuss quality during business meetings?

  • Are quality objectives connected to strategic objectives?

  • Are quality decisions supported when they create short-term inconvenience?

Learning behaviour

  • Are lessons learned documented?

  • Are lessons applied to future projects?

  • Do different projects share quality knowledge?

Ethical behaviour

  • Are inspection results reported honestly?

  • Are test results protected from manipulation?

  • Are deviations transparently communicated?

These indicators can provide a much richer picture than simply counting audit findings.

ISO 10010:2022 specifically provides guidance and self-assessment approaches for evaluating organizational quality culture.


From Quality KPI to Quality Behaviour

This creates an interesting opportunity for modern QMS design.

Traditional quality measurement often focuses on outcomes:

Defect rate

NCR rate

Customer complaints

Rework cost

These remain important.

But organizations can also examine behavioural indicators.

For example:

Outcome KPIBehavioural indicator
NCR rateEarly reporting of potential nonconformities
Rework costParticipation in preventive improvement
Customer complaintsSpeed of escalation
Audit findingsResponse quality and learning
Recurring defectsEffectiveness of knowledge sharing
Supplier defectsEarly supplier risk communication

The objective is not to replace traditional KPIs.

It is to understand why performance is occurring.


Can AI measure quality culture?

This is where the future becomes particularly interesting.

AI can potentially analyse large amounts of organizational information.

For example:

  • recurring NCR descriptions;

  • audit findings;

  • employee feedback;

  • customer complaints;

  • corrective-action records;

  • project lessons learned;

  • response times;

  • recurring process failures.

AI could potentially identify patterns such as:

Which problems are repeatedly reported?

Which problems remain unresolved?

Which departments experience recurring quality issues?

Which corrective actions repeatedly fail?

However, AI should not automatically determine that a department has a "bad culture."

Culture is complex.

Data can reveal patterns, but interpretation requires context, appropriate governance and human judgement.


The role of leadership

Culture ultimately reflects what an organization consistently rewards, tolerates and prioritizes.

Leadership therefore has a central role.

If management says:

"Quality is important."

but consistently rewards only speed and short-term output, employees receive another message.

If management says:

"Report problems early."

and then uses every report to punish the person who discovered the problem, employees learn another lesson.

Culture is created through repeated signals.

That is why ISO 9001:2026 places stronger emphasis on leadership and the environment in which people contribute to the effectiveness of the QMS.


The 100-page procedure problem

There is nothing inherently wrong with a 100-page procedure.

Some processes genuinely require detailed documentation.

The problem occurs when documentation becomes a substitute for management.

An organization may respond to every quality problem by creating another:

procedure,

form,

checklist,

approval step,

or

signature requirement.

Eventually, the QMS becomes heavier.

But the underlying behaviour may not change.

A better question after a quality failure might be:

"Do we need another document—or do we need a different behaviour?"

Sometimes the answer will be a new procedure.

Sometimes it will be better training.

Sometimes it will be better supervision.

Sometimes it will be a leadership decision.

And sometimes the process itself needs to be redesigned.


Quality culture in construction

Construction provides a particularly clear example.

A project can have hundreds of method statements and inspection checklists.

Yet quality problems may continue because of:

  • rushed activities;

  • poor coordination;

  • inadequate supervision;

  • weak communication;

  • late design information;

  • poor material control;

  • subcontractor pressure;

  • insufficient competence.

The response cannot always be:

"Create another checklist."

Sometimes the problem is cultural.

For example:

If workers believe that reporting a defect will delay the project and create blame, defects may be hidden.

If supervisors believe that production is more important than quality, inspections may become formalities.

If management consistently supports early reporting and corrective action, the behaviour can move in a different direction.

The QMS therefore becomes part of the way the project is managed, not simply a separate Quality Department activity.


ISO 9001:2026 does not eliminate procedures

This distinction is important.

The new edition does not say:

"Procedures are no longer important."

It continues to require organizations to establish, implement, maintain and continually improve their quality management systems.

The point is different:

Procedures and culture must work together.

A procedure provides structure.

Competence provides capability.

Leadership provides direction.

Culture influences behaviour.

Data provides evidence.

Improvement creates learning.

Together they form a functioning QMS.


The new quality equation

Perhaps quality culture can be understood through a simple conceptual equation:

Quality Performance = Process × People × Culture × Leadership

If any one component is weak, the overall system can be affected.

A perfect process operated by people who do not follow it will not produce the intended result.

Highly competent people working inside a dysfunctional process will struggle.

A strong procedure without leadership support may become bureaucracy.

And leadership commitment without effective processes may remain only a statement.

Quality requires the elements to work together.


What should organizations do?

Organizations preparing for ISO 9001:2026 can use the transition as an opportunity to examine culture—not simply documentation.

Five questions may be particularly useful:

1. Do employees report problems early?

2. Does management respond constructively to bad news?

3. Are quality decisions protected when they conflict with short-term pressure?

4. Do corrective actions create organizational learning?

5. Do leaders demonstrate the quality behaviours they expect from employees?

The answers may reveal more about the effectiveness of the QMS than another document review alone.


The future of quality management

For many years, the image of quality management has been associated with:

documents, checklists, inspections and audits.

These remain important.

But the future of quality management may increasingly involve:

culture, behaviour, data, leadership, learning and decision-making.

ISO 9001:2026 reflects this broader direction by strengthening the role of leadership, quality culture and ethical behaviour while retaining the established foundations of customer focus, process approach, risk-based thinking and continual improvement.

The result is a more challenging question for organizations.

Not:

"Do we have an ISO 9001 procedure for this?"

But:

"What do our people actually do when the procedure meets reality?"

That is where quality culture begins.

And sometimes, the most important quality improvement is not another 100-page procedure.

It is creating an organization where people are willing to do the right thing even when nobody is watching.

Monday, September 28, 2026

Can AI Predict a Quality Failure Before It Happens?


Artificial intelligence is moving into the quality department. The question is no longer whether AI can analyse quality data, but whether it can help organizations prevent problems before they become defects.

By Yelna Yuristiary

For decades, quality management has largely been about finding problems.

An inspector discovers a defect.

An auditor identifies a nonconformity.

A customer submits a complaint.

An engineer investigates the root cause.

A corrective action is then introduced.

This familiar cycle has helped organizations control quality for generations.

But artificial intelligence is beginning to change the sequence.

Instead of waiting for a defect to appear, organizations are increasingly exploring whether data can be used to identify patterns, anomalies and potential failures before they occur.

The idea sounds simple.

If a company already has thousands—or millions—of quality records, could an AI system recognize the warning signs that humans might miss?

That question is becoming increasingly relevant as organizations move toward digital Quality Management Systems.

And in 2026, the discussion is no longer purely theoretical.

The ISO 9001 Auditing Practices Group published a paper in June 2026 specifically addressing auditing a QMS that uses Artificial Intelligence.

At the same time, ISO has published ISO 9001:2026, an updated edition of its quality management standard that places greater emphasis on strategic decision-making, risks and opportunities, leadership, quality culture and the changing digital business environment.

The result is a new question for quality professionals:

What happens when the Quality Management System can learn from its own data?


From inspection to prediction

Traditional quality management often follows a familiar pattern:

Process → Inspection → Defect → Analysis → Corrective Action

AI potentially introduces another layer:

Process → Data → Pattern Detection → Prediction → Preventive Action

This does not mean that AI eliminates inspection.

Instead, it can change where organizations focus their attention.

Imagine a construction project producing thousands of inspection records.

The records might contain:

  • concrete test results;

  • temperature measurements;

  • slump results;

  • curing records;

  • material test certificates;

  • inspection requests;

  • NCRs;

  • weather conditions;

  • subcontractor performance;

  • equipment information;

  • rework records.

Individually, each piece of information may appear relatively ordinary.

But when these data are analysed together, patterns may emerge.

For example, an AI model might identify that certain combinations of:

high temperature + delayed concrete placement + particular supplier + specific curing conditions

are associated with a higher frequency of later quality problems.

The engineer still needs to investigate.

But the system has provided an early warning.

That is the fundamental difference between reactive quality management and predictive quality management.


AI does not "know" quality

There is an important misconception to avoid.

AI does not automatically understand what quality means.

An AI system learns patterns from the data and objectives it is given.

If the underlying data are incomplete, inaccurate or biased, the output can also be unreliable.

This makes data quality a central issue.

ISO/IEC 5259-4:2024, for example, provides a standardized process framework for managing data quality in analytics and machine learning, including issues such as data labelling, evaluation and lifecycle management.

This creates an interesting paradox:

The future of AI-driven quality management depends on the quality of the data used to manage quality.

Poor data can produce poor predictions.

And a sophisticated algorithm cannot automatically compensate for fundamentally unreliable information.


The new Quality Data Chain

A useful way to understand AI in quality management is to think of five stages.

1. Data collection

The organization collects information from its operations.

Examples include:

  • inspection results;

  • test results;

  • equipment data;

  • customer complaints;

  • audit findings;

  • NCRs;

  • supplier performance;

  • environmental conditions.

2. Data quality

The organization verifies whether the data are reliable.

Questions include:

  • Is the data complete?

  • Is it accurate?

  • Is it consistent?

  • Is it traceable?

  • Was it collected correctly?

3. Data analysis

AI or advanced analytics searches for relationships and patterns.

4. Prediction

The system identifies situations associated with increased probability of a quality problem.

5. Human decision

An engineer, manager or quality professional evaluates the information and decides what action is appropriate.

This final stage remains critical.

AI can support a decision.

It should not automatically become the organization’s unquestioned decision-maker.


From NCRs to early warnings

Consider the traditional NCR.

A nonconformance report tells the organization:

Something has gone wrong.

That is valuable information.

But it is also historical information.

An AI-enabled QMS could potentially identify a pattern before an NCR occurs.

For example:

Traditional QMSAI-enabled QMS
NCR occursWarning generated
Defect identifiedAnomaly identified
Root cause investigatedRisk pattern detected
Corrective actionPreventive intervention
Historical analysisPredictive analysis
Periodic reportingContinuous monitoring

The objective is not to eliminate NCRs completely.

That would be unrealistic.

The objective is to increase the organization's ability to detect emerging problems earlier.


Can AI predict construction defects?

Construction provides an interesting test case.

Unlike manufacturing, construction projects are highly variable.

Projects differ in:

  • location;

  • weather;

  • materials;

  • design;

  • contractors;

  • subcontractors;

  • workforce;

  • equipment;

  • sequencing;

  • project management;

  • site conditions.

This makes prediction challenging.

But it also creates enormous amounts of potentially useful data.

Imagine a project where the quality team has historical data from 20 similar projects.

The database contains thousands of observations about:

  • concrete;

  • steel reinforcement;

  • waterproofing;

  • finishing;

  • earthworks;

  • pavement;

  • marine works;

  • suppliers;

  • inspections;

  • defects;

  • rework.

An AI model could potentially identify relationships between project conditions and quality outcomes.

For example:

Which conditions are associated with higher waterproofing defect rates?

Which suppliers show recurring quality patterns?

Which work packages generate the greatest rework risk?

Which inspection findings tend to precede major defects?

The answers would still require engineering judgement.

But the data could help direct that judgement.


The same idea applies to manufacturing

Manufacturing may provide an even more structured environment for predictive quality.

A production system can generate continuous information about:

  • temperature;

  • pressure;

  • vibration;

  • machine speed;

  • production cycle time;

  • material properties;

  • equipment condition;

  • product dimensions.

AI can analyse these variables to identify abnormal patterns.

Suppose a machine normally operates within a certain range.

A traditional system might wait until a product fails inspection.

A predictive system could detect a gradual change in machine behaviour and alert the quality or maintenance team.

The intervention may happen before the defective product is produced.

This is where quality management and predictive maintenance begin to overlap.


What about healthcare, laboratories and services?

AI-driven quality management is not limited to physical products.

Hospitals, laboratories, universities, financial institutions and service organizations also produce large amounts of operational data.

For example, a service organization might analyse:

  • complaint patterns;

  • response times;

  • transaction errors;

  • customer behaviour;

  • employee workload;

  • service interruptions.

The "defect" may not be a cracked component.

It may be:

a delayed service, an incorrect transaction, a missed requirement or a dissatisfied customer.

The principle remains similar:

detect → analyse → predict → intervene → learn.


AI and the Quality Auditor

One of the most interesting developments is what AI means for auditors.

The ISO 9001 Auditing Practices Group's June 2026 publication on auditing a QMS that uses AI is an indication that AI is becoming a practical issue for QMS auditing.

The auditor may increasingly need to ask questions such as:

What AI system is being used?

What quality decision does it support?

What data does it use?

How was the system validated?

How is its performance monitored?

What happens when the AI produces an incorrect result?

Who has authority to override it?

These questions introduce a new dimension to quality auditing.

The auditor is no longer examining only human-designed procedures.

The auditor may also need to understand AI-supported processes and controls.


The danger of trusting the algorithm

There is another side to the AI revolution.

An AI prediction can be wrong.

This is particularly important when the prediction affects safety, compliance, customer requirements or major financial decisions.

Consider a system that predicts a low probability of a concrete defect.

Should the project team skip the inspection?

No.

The prediction is information—not proof.

This distinction is fundamental.

AI can identify a pattern.

An engineer must still determine whether the pattern is meaningful in the actual context.

This is why the future of quality management is unlikely to be simply:

Human versus AI.

It is more likely to be:

Human + AI.


The importance of explainability

Another challenge is understanding why an AI system produced a particular prediction.

Imagine a dashboard that says:

HIGH QUALITY RISK

A Quality Manager may immediately ask:

Why?

If the system cannot provide useful information about the factors contributing to the prediction, it becomes difficult to use responsibly.

For quality management, an AI system should therefore ideally provide more than a score.

It should help users understand:

  • what changed;

  • which variables matter;

  • what historical pattern was detected;

  • how confident the prediction is;

  • what evidence supports the warning.

This is especially important when the output is used in an audit, engineering decision or corrective action.


AI creates a new quality problem: AI itself must be controlled

There is a fascinating implication here.

If AI becomes part of the QMS, then AI becomes part of the quality system that itself needs to be managed.

Organizations may need to consider:

  • data quality;

  • model performance;

  • validation;

  • access control;

  • cybersecurity;

  • version control;

  • human oversight;

  • monitoring;

  • changes to the AI model;

  • error handling;

  • records and traceability.

In other words:

The organization cannot simply install AI and assume that quality will improve.

The AI application itself becomes another process that requires appropriate controls.


ISO 9001:2026 and the AI era

ISO 9001:2026 does not turn ISO 9001 into an AI standard.

The standard remains a general quality management system standard applicable across sectors. ISO describes the 2026 edition as an evolution of the established framework, with greater emphasis on leadership, quality culture, strategic alignment and risks and opportunities.

But these principles provide a useful environment for discussing AI.

For example:

Leadership
Management needs to understand how AI affects quality decisions.

Risk and opportunity
AI can introduce new risks while creating opportunities for better prediction and efficiency.

Competence and awareness
Employees need appropriate understanding of AI-supported processes.

Performance evaluation
Organizations need to determine whether AI actually improves process performance.

Improvement
AI models and workflows may need to be continually evaluated and improved.

This means AI can become part of the QMS without replacing the fundamental principles of quality management.


The rise of "Quality Intelligence"

A new concept may emerge from this transformation:

Quality Intelligence

Traditional Quality Management asks:

What happened?

Quality Intelligence asks:

Why did it happen?

Predictive Quality asks:

What is likely to happen next?

Prescriptive Quality asks:

What should we do about it?

This creates a possible evolution:

Quality Control

↓

Quality Assurance

↓

Quality Management

↓

Data-Driven Quality

↓

Predictive Quality

↓

Quality Intelligence

The boundaries between these stages are not absolute.

But they illustrate the direction in which digital quality management is moving.


What should Quality Managers do now?

The first step is not necessarily to purchase an AI platform.

It may be to examine the organization's existing data.

Ask five questions:

1. What quality data do we already have?

Many organizations have more data than they realize.

2. Is the data reliable?

AI cannot solve fundamentally poor data quality.

3. What quality problems occur repeatedly?

Recurring problems are particularly useful candidates for analytical approaches.

4. Can we identify leading indicators?

Look for signals that appear before the final defect.

5. Where should humans remain in control?

Define which decisions AI can support and which decisions require professional judgement.

These questions can provide a more realistic starting point than simply asking:

"How can we use ChatGPT in Quality?"


The future quality professional

The role of the Quality Manager may gradually change.

The traditional skill set includes:

  • standards;

  • auditing;

  • inspection;

  • corrective action;

  • root-cause analysis;

  • process control.

The emerging skill set may additionally include:

  • data literacy;

  • statistical analysis;

  • digital QMS;

  • AI awareness;

  • predictive analytics;

  • data governance;

  • model validation.

The Quality Manager of the future may therefore spend less time manually searching through spreadsheets and more time interpreting information generated by digital systems.

But the core responsibility remains.

Quality decisions still require context, judgement and accountability.


The real question is not whether AI can replace the Quality Manager

The more useful question is:

Can AI help the Quality Manager see problems earlier, understand them better and make better-informed decisions?

That question has a much more practical answer.

AI can potentially help organizations process large volumes of information, identify patterns, detect anomalies and support prediction.

But the effectiveness of an AI-driven QMS depends on the quality of its data, the suitability of its models, the controls surrounding its use and the people responsible for interpreting its outputs.

The technology is therefore only one part of the equation.

The future can be represented simply:

Quality Data + AI + Human Expertise + Governance = Intelligent Quality Management


From detecting defects to preventing them

For much of its history, quality management has been built around a powerful but fundamentally reactive question:

"What went wrong?"

The next generation of quality management may increasingly ask:

"What is beginning to go wrong?"

And eventually:

"What can we do now to prevent it?"

That is where AI could make its greatest contribution to quality management.

Not by replacing the inspector.

Not by replacing the auditor.

Not by replacing the engineer.

But by giving them something they have always needed:

better information, earlier.

The future of Quality Management System may therefore not be about creating a system that simply records failures.

It may be about creating a system that learns from data, detects emerging patterns and helps people prevent failures before they become costly problems.

And that could transform the meaning of quality itself—from finding defects to anticipating them.

Sunday, September 27, 2026

ISO 9001:2026: From Compliance to Performance


The world's most widely used quality management standard has entered a new era. But the biggest change may not be the new requirements—it may be the way organizations think about quality.

By Yelna Yuristiary

For decades, ISO 9001 has been associated with something many organizations know well: procedures, audits, corrective actions and certificates hanging on office walls.

But the business environment around those certificates has changed dramatically.

Digital technology has transformed how organizations operate. Supply chains have become increasingly interconnected. Customers expect faster responses. Organizations face new risks while being expected to remain resilient and adaptable.

Against this background, the International Organization for Standardization (ISO) published ISO 9001:2026 – Quality management systems — Requirements on 16 September 2026.

It replaces ISO 9001:2015 and represents the sixth edition of the standard. ISO says the revision is designed to improve clarity, usability and relevance while helping organizations strengthen resilience, deliver long-term value and respond to changing customer expectations.

But there is an important point that organizations should understand.

ISO 9001:2026 is not a completely new quality management philosophy.

Instead, it builds on the familiar ISO 9001 framework while placing greater emphasis on several issues that have become increasingly important: leadership, quality culture, ethical behaviour, strategic alignment, risks and opportunities, and organizational performance.

That raises a bigger question:

Is ISO 9001 moving from a system designed primarily to demonstrate compliance towards a system designed to help organizations perform better?

The answer can be explored through the changes in the new edition.


Why did ISO 9001 need to change?

ISO 9001:2015 was published in September 2015.

At that time, many organizations were already dealing with digital transformation, globalization and increasingly complex supply chains. But over the following decade, those changes accelerated.

Artificial intelligence, cloud systems, digital inspection, real-time dashboards and increasingly data-driven decision-making have changed the way organizations manage operations.

At the same time, organizations are facing greater expectations around resilience, sustainability, transparency and stakeholder expectations.

ISO says the 2026 revision reflects this changing environment while maintaining the established foundations of quality management.

The objective, therefore, is not to abandon the previous system.

It is to make the system more relevant to the organizations that use it today.


From "Do we comply?" to "Does the system work?"

This may be the most important way to understand the direction of ISO 9001:2026.

A traditional approach to certification can sometimes become focused on questions such as:

  • Do we have the required procedure?

  • Do we have the required record?

  • Was the audit completed?

  • Was the NCR closed?

  • Is the document controlled?

These questions remain relevant.

But a mature quality management system needs to go further.

It should also help management answer questions such as:

  • Are our processes actually performing?

  • Where are the biggest sources of defects?

  • What risks could affect our strategic objectives?

  • Which opportunities should we pursue?

  • Are corrective actions preventing recurrence?

  • Are employees contributing to a culture of quality?

  • Is quality information helping management make better decisions?

This is where the distinction between compliance and performance becomes important.

ISO 9001:2026 strengthens the connection between quality management and the wider business environment. ISO specifically highlights stronger leadership, quality culture, strategic alignment and clearer consideration of risks and opportunities.


1. Leadership becomes more than signing the Quality Policy

Leadership has always been part of ISO 9001.

But the 2026 edition places stronger emphasis on leadership, quality culture, accountability and ethical behaviour.

This has practical implications.

Imagine a construction company with a perfectly written Quality Policy.

The policy says:

"We are committed to delivering high-quality projects and achieving customer satisfaction."

But on the project site, employees are under pressure to complete work quickly.

A concrete defect is discovered.

The team faces a choice: stop the work and investigate, or continue because stopping could affect progress.

A quality management system is tested not when everything goes according to plan, but when quality conflicts with short-term pressure.

This is where quality culture becomes important.

ISO 9001:2026 explicitly strengthens attention to the organizational environment in which quality decisions are made.

The Quality Manager therefore cannot be the only person responsible for quality.

Quality becomes a leadership issue.


2. Quality policy moves closer to business strategy

Another important change is the stronger relationship between the quality policy, organizational context and strategic direction.

This matters because a QMS can become isolated from the actual business.

A company may have an excellent ISO system but still struggle with:

  • declining productivity;

  • excessive rework;

  • customer complaints;

  • supply-chain problems;

  • project delays;

  • increasing costs.

If the QMS does not provide useful information about these problems, its strategic value becomes limited.

ISO 9001:2026 reinforces the connection between quality management and organizational strategy.

Consider a construction organization whose strategic objective is to reduce project rework by 20%.

A traditional QMS might report:

NCRs = 35

A more performance-oriented QMS would ask:

What caused those 35 NCRs?

Then:

How much rework did they create?

Then:

Which process generated the largest proportion of the rework?

And finally:

What management action will prevent recurrence?

The difference is subtle but important.

The QMS moves from reporting quality problems towards supporting management decisions.


3. Risk is no longer the only side of the equation

Risk-based thinking was already a major element of ISO 9001:2015.

The 2026 edition provides greater clarity around risks and opportunities, including a clearer distinction between managing risks and pursuing opportunities.

This introduces an interesting change in mindset.

Risk management often asks:

"What could go wrong?"

Opportunity management asks:

"What could we do better?"

For example, a company may identify a risk associated with manual quality inspections.

The traditional response could be to introduce additional checking.

But the organization could also identify an opportunity:

Can digital inspection technology reduce inspection time while improving traceability?

The first approach protects the organization.

The second may improve it.

A mature QMS needs both.


4. People become central to quality

Quality systems are often described using processes, procedures and documents.

But processes are ultimately operated by people.

ISO 9001:2026 places greater emphasis on awareness related to quality culture and ethical behaviour.

This has significant implications for training.

Training should not only answer:

"What procedure must I follow?"

It should also help employees understand:

"Why does this process matter?"

For example, a QA/QC inspector may know how to complete a concrete inspection checklist.

But quality culture requires a deeper understanding:

What happens if I record an incorrect result?

What happens if I ignore a defect?

What happens if production pressure influences my inspection decision?

Quality therefore becomes partly a question of organizational behaviour.


5. The QMS is becoming increasingly data-driven

ISO 9001:2026 does not turn ISO 9001 into an artificial intelligence standard.

But the broader direction of quality management is increasingly connected to data.

Organizations already collect enormous amounts of information:

  • inspection results;

  • NCRs;

  • customer complaints;

  • audit findings;

  • defect rates;

  • rework costs;

  • supplier performance;

  • equipment failures;

  • project delays;

  • customer satisfaction;

  • process performance.

The challenge is no longer simply collecting data.

The challenge is turning data into decisions.

A quality dashboard that shows 15 KPIs is not automatically a good quality system.

The more important question is:

What decision does each KPI enable?

This distinction is likely to become increasingly important as organizations combine QMS data with analytics and AI.


From Lagging Indicators to Leading Indicators

This also changes how organizations think about Quality KPIs.

A traditional quality KPI may measure something that has already happened.

For example:

NCR rate

Customer complaints

Defect rate

Rework cost

These are valuable indicators, but they are often lagging indicators.

By the time the number increases, the problem may already have occurred.

A more proactive system could monitor leading indicators such as:

  • inspection readiness;

  • training completion;

  • supplier risk;

  • overdue preventive actions;

  • process capability;

  • recurring defect trends;

  • inspection nonconformance patterns.

The objective is not to eliminate traditional KPIs.

It is to combine lagging and leading indicators so that management can understand both performance and emerging risk.


What about construction projects?

The change is particularly relevant to construction.

Construction projects generate enormous amounts of quality information.

Consider a large infrastructure project.

Every week the project may generate:

  • inspection requests;

  • material test results;

  • concrete test results;

  • NCRs;

  • method statements;

  • shop drawings;

  • supplier inspections;

  • laboratory results;

  • punch lists;

  • audit findings.

If these records remain separate documents, the organization has information.

But it may not yet have quality intelligence.

Imagine instead that the project QMS identifies that:

70% of recurring defects originate from three work processes.

Management can then focus resources on those processes.

The QMS becomes an analytical system.

That is a very different role from simply preparing documents for an audit.


Does ISO 9001:2026 mean more paperwork?

Not necessarily.

In fact, one of the opportunities created by the new edition is to ask whether existing documentation actually adds value.

ISO emphasizes that organizations already using ISO 9001 should build on their existing systems rather than start again.

This means organizations can ask:

Which documents help us control quality?

Which records provide useful evidence?

Which reports help management make decisions?

Which documents exist mainly because "the auditor might ask for them"?

That last question can be uncomfortable.

But it may also be one of the most useful questions during transition.


The new Annex A

ISO 9001:2026 also introduces a new Annex A, intended to help users understand concepts, terminology and the intent behind requirements.

This is important because standards can sometimes be interpreted too literally.

Two organizations may both claim compliance while implementing the requirements very differently.

Greater clarification of intent can help organizations understand not only what a requirement says, but also how it is intended to function within the management system.


What has not changed?

The revision should not be interpreted as a complete departure from ISO 9001:2015.

The fundamental foundations remain.

These include:

Customer focus

Process approach

Risk-based thinking

Continual improvement

ISO 9001:2026 retains the Harmonized Structure used by ISO management system standards, which also supports integration with other management systems.

The new edition therefore represents an evolution of the existing system rather than a complete replacement of its underlying philosophy.


The transition has already begun

For organizations certified to ISO 9001:2015, the transition will not happen overnight.

ISO/TC 176 states that organizations certified to ISO 9001:2015 have until 30 September 2029 to complete the transition to ISO 9001:2026.

The transition timetable includes several milestones.

Accreditation bodies are expected to be ready to assess ISO 9001:2026 by 31 March 2027.

From 31 March 2028, new and initial accredited certifications may only be issued to ISO 9001:2026.

Existing ISO 9001:2015-certified organizations have until 30 September 2029 to complete the transition.

For organizations, this creates a practical opportunity.

The transition period can be used not simply to update documents, but to examine whether the QMS is actually delivering value.


What should Quality Managers do now?

The first step does not necessarily need to be rewriting procedures.

A more useful starting point may be to ask five questions:

1. Is our QMS connected to our strategy?

Can management clearly see how quality objectives contribute to organizational objectives?

2. Do our KPIs help management make decisions?

Or are we simply collecting numbers because they have always been collected?

3. Do employees understand quality culture?

Do people understand why quality matters, rather than simply knowing which forms to complete?

4. Are we managing opportunities as well as risks?

Can the QMS identify opportunities for innovation, efficiency and improvement?

5. Does our QMS predict problems or only report them?

This may ultimately become one of the most important questions for the next generation of quality management.


The bigger change: the meaning of "quality"

ISO 9001:2026 does not eliminate compliance.

Organizations still need controlled processes, evidence, monitoring, evaluation and continual improvement.

But the revision provides a stronger foundation for thinking about quality as part of organizational performance.

The Quality Department should not necessarily become larger.

It may need to become more influential in decision-making.

The Quality Manager should not necessarily produce more reports.

The reports may need to become more useful.

And the QMS should not necessarily contain more procedures.

The procedures that remain should help the organization control, learn and improve.

That may be the most important message behind ISO 9001:2026.


From Quality System to Performance System?

For almost 40 years, ISO 9001 has provided organizations with a common language for quality management.

The 2026 edition keeps that language.

But the context has changed.

Quality now operates alongside digital transformation, complex supply chains, artificial intelligence, sustainability pressures, organizational resilience and rapidly changing customer expectations.

The future of quality management may therefore depend less on how many procedures an organization possesses and more on how effectively its QMS connects:

Strategy → Risk → Process → People → Data → Decision → Improvement

That is a very different way of thinking about certification.

Instead of asking:

"Are we ISO 9001 compliant?"

organizations may increasingly need to ask:

"Is our quality management system helping us perform better?"

The answer to that question will ultimately determine whether ISO 9001:2026 becomes another certification exercise—or a genuine management tool for the next decade.

Saturday, September 26, 2026

ISO 9001:2015 vs ISO 9001:2026: Apa yang Berubah dan Mengapa Perusahaan Perlu Bersiap?

 

Hampir satu dekade setelah ISO 9001:2015 diperkenalkan, dunia manajemen mutu kembali memasuki babak baru.

Pada 16 September 2026, International Organization for Standardization (ISO) secara resmi menerbitkan ISO 9001:2026 – Quality management systems — Requirements, menggantikan ISO 9001:2015 sebagai edisi terbaru standar sistem manajemen mutu yang paling banyak digunakan di dunia.

Bagi perusahaan yang selama ini menggunakan ISO 9001:2015, perubahan ini mungkin menimbulkan pertanyaan sederhana: apakah seluruh sistem mutu harus dibuat ulang?

Jawabannya: tidak.

ISO menyatakan bahwa organisasi tidak perlu memulai dari nol. Sistem dan proses yang sudah berjalan dapat dipertahankan, sementara perubahan dilakukan pada bagian-bagian yang perlu disesuaikan dengan persyaratan edisi 2026.

Namun, meskipun struktur dasarnya tetap familiar, ada perubahan penting dalam cara ISO memandang kepemimpinan, budaya mutu, strategi, risiko dan peluang, serta peran manusia dalam sistem manajemen mutu.

Dari kepatuhan menuju kinerja

ISO 9001:2015 muncul pada masa ketika organisasi semakin banyak menggunakan pendekatan berbasis proses dan risk-based thinking.

Edisi 2026 mempertahankan fondasi tersebut, tetapi memberikan perhatian lebih besar terhadap bagaimana sistem manajemen mutu membantu organisasi membuat keputusan dan mencapai tujuan bisnis.

ISO menjelaskan bahwa revisi ini dibuat untuk mencerminkan perubahan lingkungan bisnis: digitalisasi, rantai pasok yang semakin kompleks, perubahan ekspektasi pelanggan, serta kebutuhan organisasi untuk lebih adaptif dan tangguh.

Dengan kata lain, pertanyaan yang ingin dijawab oleh ISO 9001:2026 bukan hanya:

“Apakah perusahaan sudah memenuhi persyaratan?”

Tetapi juga:

“Apakah sistem manajemen mutu benar-benar membantu organisasi bekerja lebih baik?”

Perubahan cara pandang tersebut menjadi salah satu perbedaan penting antara edisi 2015 dan 2026.


Apa yang berubah?

Secara umum, ISO 9001:2026 bukanlah standar yang sepenuhnya baru. ISO mempertahankan fondasi ISO 9001:2015 dan melakukan perubahan yang lebih terarah untuk memperjelas serta memperkuat beberapa area tertentu.

Lima perubahan utama menjadi perhatian.

1. Kepemimpinan mendapat penekanan lebih kuat

Dalam ISO 9001:2015, leadership sudah menjadi bagian penting dari sistem manajemen mutu.

Namun ISO 9001:2026 memperkuat perhatian terhadap quality culture, ethical behaviour dan accountability.

Artinya, kualitas tidak hanya dilihat sebagai tanggung jawab departemen QA/QC atau Quality Manager.

Manajemen puncak diharapkan menciptakan lingkungan di mana seluruh organisasi memahami pentingnya kualitas dan berkontribusi terhadap efektivitas sistem manajemen mutu.

Perubahan ini terutama tercermin pada Clause 5.1.

Dalam praktiknya, hal tersebut dapat mengubah pertanyaan auditor.

Bukan hanya:

“Apakah perusahaan mempunyai Quality Policy?”

Tetapi semakin penting untuk melihat:

“Bagaimana kepemimpinan perusahaan membangun budaya yang membuat Quality Policy tersebut benar-benar dijalankan?”


2. Quality Policy semakin dekat dengan strategi bisnis

ISO 9001:2026 juga memperkuat hubungan antara quality policy, konteks organisasi dan strategic direction.

Pada ISO 9001:2015, organisasi sudah diwajibkan menetapkan kebijakan mutu yang sesuai dengan tujuan dan konteks organisasi.

Edisi 2026 membuat hubungan tersebut lebih eksplisit.

Sistem manajemen mutu tidak seharusnya berdiri sendiri sebagai sistem dokumentasi.

Ia seharusnya membantu organisasi mencapai tujuan strategisnya.

Misalnya, sebuah perusahaan konstruksi mempunyai target strategis:

  • mengurangi rework;

  • meningkatkan kepuasan pemilik proyek;

  • mengurangi defect;

  • meningkatkan produktivitas;

  • meningkatkan ketepatan waktu proyek.

Dalam pendekatan ISO 9001:2026, sistem mutu semakin relevan apabila indikator dan proses Quality Management System dapat dikaitkan dengan sasaran tersebut.

Dengan demikian, Quality Management System tidak berhenti pada compliance, tetapi semakin dekat dengan performance management.


3. Risiko dan peluang mendapat pendekatan yang lebih jelas

Salah satu konsep penting ISO 9001:2015 adalah risk-based thinking.

ISO 9001:2026 mempertahankan konsep tersebut tetapi memberikan kejelasan yang lebih besar mengenai risiko dan peluang.

ISO menjelaskan bahwa revisi ini memberikan pembedaan yang lebih jelas antara mengelola risiko dan mengejar peluang.

Perbedaannya dapat digambarkan secara sederhana:

ISO 9001:2015ISO 9001:2026
Risk-based thinking menjadi bagian penting perencanaanRisiko dan peluang diperjelas sebagai dasar pengambilan keputusan
Fokus kuat pada pencegahan dampak negatifLebih jelas antara mitigasi risiko dan pemanfaatan peluang
Risiko terintegrasi dalam prosesPendekatan lebih proaktif terhadap risiko dan peluang
Fokus pada efektivitas QMSLebih kuat hubungannya dengan keputusan dan improvement

Hal ini menarik bagi organisasi yang menghadapi lingkungan bisnis yang cepat berubah.

Misalnya dalam proyek konstruksi, risiko bukan hanya kemungkinan terjadinya defect.

Ada pula peluang:

  • penggunaan teknologi baru;

  • metode konstruksi yang lebih efisien;

  • digital inspection;

  • peningkatan kompetensi tenaga kerja;

  • penggunaan data untuk memprediksi defect.

Dengan pendekatan tersebut, Quality Management System dapat menjadi alat untuk mengurangi risiko sekaligus menemukan peluang peningkatan kinerja.


4. Manusia dan budaya mutu menjadi semakin penting

Perubahan lain terdapat pada awareness.

ISO 9001:2026 memberikan perhatian lebih besar pada pemahaman orang-orang di dalam organisasi mengenai quality culture dan ethical behaviour.

Ini membawa konsekuensi menarik.

Sistem mutu tidak cukup hanya mempunyai:

  • SOP;

  • work instruction;

  • checklist;

  • inspection report;

  • audit report;

  • corrective action.

Orang yang menjalankan sistem tersebut juga harus memahami mengapa kualitas penting dan bagaimana perilaku mereka mempengaruhi efektivitas QMS.

Dalam industri konstruksi, misalnya, seorang inspector mungkin memiliki checklist inspeksi yang lengkap.

Tetapi apabila budaya organisasi mendorong pekerja untuk menutup defect agar progress terlihat bagus, maka checklist tersebut tidak otomatis menghasilkan kualitas.

Di sinilah konsep quality culture menjadi penting.


5. Munculnya Annex A untuk membantu memahami persyaratan

ISO 9001:2026 juga memperkenalkan Annex A baru yang memberikan penjelasan mengenai konsep, terminologi dan maksud dari persyaratan tertentu.

Tujuannya adalah membantu pengguna memahami intent dari persyaratan sehingga penerapannya lebih konsisten.

Hal ini penting karena salah satu masalah dalam implementasi ISO adalah kecenderungan organisasi menerjemahkan standar menjadi sekumpulan dokumen.

Padahal, ISO 9001 pada dasarnya merupakan management system, bukan sekadar sistem dokumentasi.


Lalu, apa yang tidak berubah?

Perubahan besar sering kali membuat organisasi berasumsi bahwa sistem lama harus dibongkar.

ISO justru menekankan kontinuitas.

Customer focus, process approach, risk-based thinking dan continual improvement tetap menjadi bagian penting dari sistem manajemen mutu.

Struktur klausul juga tetap menggunakan Harmonized Structure, sehingga organisasi yang sudah mengintegrasikan ISO 9001 dengan standar seperti ISO 14001 atau ISO 45001 tidak perlu menghadapi perubahan struktur secara total.

Dengan demikian, perbedaan ISO 9001:2015 dan ISO 9001:2026 lebih tepat dipahami sebagai evolusi daripada revolusi.


Bagaimana dengan perubahan terkait climate change?

Ini juga penting.

Pada 2024, ISO menerbitkan amendment terhadap ISO 9001:2015 yang memasukkan pertimbangan perubahan iklim ke dalam konteks organisasi dan kebutuhan pihak berkepentingan.

Namun amendment tersebut kemudian ditarik setelah ISO 9001:2026 diterbitkan.

ISO menyatakan bahwa ISO 9001:2026 tetap membawa pertimbangan perubahan iklim yang sebelumnya diperkenalkan melalui amendment 2024.

Artinya, organisasi tidak seharusnya menganggap isu climate change hilang hanya karena amendment 2024 sudah tidak menjadi dokumen yang berdiri sendiri.


Apakah perusahaan harus membuat QMS baru?

Tidak.

Menurut ISO, organisasi yang sudah menerapkan ISO 9001:2015 seharusnya membangun dari sistem yang sudah ada, mempertahankan proses yang masih efektif dan melakukan perubahan yang diperlukan.

Pendekatan praktisnya dapat dimulai dengan lima langkah:

Pertama, pahami perubahan.

Identifikasi klausul dan area yang mengalami perubahan.

Kedua, lakukan gap analysis.

Bandingkan sistem ISO 9001:2015 yang sedang berjalan dengan ISO 9001:2026.

Ketiga, perbaiki sistem yang diperlukan.

Tidak semua prosedur harus ditulis ulang. Fokus pada bagian yang benar-benar membutuhkan perubahan.

Keempat, libatkan manusia.

Manajemen, Quality Manager, auditor internal, engineer, supervisor dan pekerja perlu memahami perubahan yang relevan bagi pekerjaan mereka.

Kelima, susun transition plan.

Organisasi yang sudah tersertifikasi perlu berkoordinasi dengan certification body mengenai jadwal dan mekanisme transisi.


Kapan ISO 9001:2015 tidak lagi dapat digunakan?

Ini salah satu informasi yang paling penting bagi perusahaan bersertifikat.

ISO 9001:2026 diterbitkan pada 16 September 2026.

Organisasi yang masih memiliki sertifikasi ISO 9001:2015 diberikan waktu transisi selama tiga tahun. Batas transisi yang ditetapkan adalah 30 September 2029.

Selain itu, berdasarkan panduan transisi ISO/TC 176:

  • badan akreditasi harus siap melakukan assessment terhadap ISO 9001:2026 paling lambat 31 Maret 2027;

  • certification body harus menyerahkan deklarasi transisi paling lambat 30 Juni 2027;

  • keputusan transisi badan akreditasi ditargetkan selesai 30 September 2027;

  • mulai 31 Maret 2028, sertifikasi baru dan sertifikasi awal yang terakreditasi hanya dapat diterbitkan terhadap ISO 9001:2026;

  • organisasi yang telah tersertifikasi ISO 9001:2015 harus menyelesaikan transisi paling lambat 30 September 2029.

Dengan kata lain, perusahaan memang memiliki waktu, tetapi transisi bukan sesuatu yang perlu ditunggu sampai tahun 2029.


Apa artinya bagi Quality Manager?

Bagi seorang Quality Manager, perubahan terbesar mungkin bukan bertambahnya jumlah dokumen.

Justru sebaliknya.

Pertanyaan yang semakin relevan adalah:

Apakah Quality Management System benar-benar menghasilkan informasi yang berguna bagi manajemen?

Misalnya, daripada hanya melaporkan:

“Jumlah NCR bulan ini: 15.”

sistem yang lebih matang dapat membantu menjawab:

Apa penyebab utama NCR?

Proses mana yang paling banyak menghasilkan defect?

Berapa biaya rework?

Apakah defect tersebut menunjukkan systemic problem?

Risiko apa yang sedang meningkat?

Peluang perbaikan apa yang dapat dimanfaatkan?

Apakah corrective action benar-benar menurunkan recurrence?

Di sinilah KPI, data analysis, Pareto analysis, root cause analysis, trend analysis dan continual improvement menjadi semakin relevan.

ISO 9001:2026 tidak mengubah QMS menjadi sistem KPI. Namun arah revisinya semakin memperkuat hubungan antara quality, decision-making dan organizational performance.


ISO 9001:2015 vs ISO 9001:2026 dalam satu tabel

AspekISO 9001:2015ISO 9001:2026
StatusEdisi sebelumnyaEdisi terbaru
Fokus utamaQMS berbasis proses dan risikoQMS yang lebih terhubung dengan strategi dan kinerja
LeadershipPentingDiperkuat
Quality cultureAda secara implisit melalui berbagai persyaratanLebih ditekankan
Ethical behaviourTidak menjadi penekanan utamaLebih eksplisit
Quality PolicyTerkait konteks dan arah organisasiHubungan dengan strategi diperjelas
RisikoRisk-based thinkingRisiko dan peluang diperjelas
People awarenessCompetence & awarenessLebih menekankan quality culture dan ethical behaviour
Climate changeDiperkenalkan melalui amendment 2024Dipertahankan dalam edisi baru
Annex AStruktur sebelumnyaAnnex A baru untuk memperjelas konsep dan intent
Harmonized StructureYaTetap
Continual improvementYaTetap
Customer focusYaTetap
Process approachYaTetap
Transition—Sampai 30 September 2029 bagi sertifikasi 2015

Sumber utama perbandingan: ISO dan ISO/TC 176.


Bukan sekadar mengganti sertifikat

Pada akhirnya, perubahan dari ISO 9001:2015 menuju ISO 9001:2026 bukan hanya persoalan mengganti tulisan “2015” menjadi “2026” pada sertifikat.

Perubahan yang lebih penting berada pada cara organisasi melihat kualitas.

Jika sistem mutu hanya digunakan untuk menghadapi audit, maka transisi kemungkinan besar akan dipandang sebagai pekerjaan administratif.

Namun jika QMS digunakan untuk membantu manajemen memahami risiko, meningkatkan proses, mengembangkan manusia, mengambil keputusan dan mencapai sasaran organisasi, maka revisi ini dapat menjadi kesempatan untuk mengevaluasi kembali fungsi Quality Management System itu sendiri.

Selama hampir satu dekade, ISO 9001:2015 menjadi bahasa bersama bagi organisasi dalam mengelola kualitas.

Kini ISO 9001:2026 membawa bahasa tersebut ke tahap berikutnya—dengan perhatian yang lebih besar pada leadership, quality culture, strategy, risk and opportunity, people dan organizational performance.

Dan bagi banyak organisasi, pertanyaan terpenting bukan lagi:

“Bagaimana kita mendapatkan sertifikat ISO 9001:2026?”

Melainkan:

“Bagaimana sistem manajemen mutu kita dapat benar-benar membantu organisasi menjadi lebih baik?”

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Monday, September 14, 2026

Reconceptualizing Project Management Cycles: The PRIME (Plan–Review–Implement–Monitor–Evaluate) Model within the (PRIME)² Framework by Yelna Yuristiary as an Advanced Extension of the PDCA Paradigm

 ABSTRACT

The Plan–Do–Check–Act (PDCA) cycle, widely recognized as the Deming process, has long served as a foundational framework for continuous improvement and project management since its formalization and widespread adoption in the 1950s. Despite its extensive application across industries, increasing complexity in contemporary project environments has highlighted limitations in its relatively simplified structure, particularly in differentiating between planning validation, execution oversight, and evaluative learning processes.

To address this gap, the (PRIME)² Framework, developed by Yelna Yuristiary in 2026, is introduced as a dual-layer conceptual model for enhancing project management and quality improvement systems. This paper focuses specifically on the first layer, the PRIME cycle (Plan–Review–Implement–Monitor–Evaluate), proposed as an extension of the PDCA paradigm. The PRIME model introduces a distinct Review phase between planning and implementation to strengthen pre-execution validation, while further separating monitoring and evaluation functions to improve process clarity, accountability, and feedback precision throughout the project lifecycle.

The PRIME cycle is not intended to replace PDCA but to function as an evolutionary enhancement that increases structural granularity in iterative project governance. Comparative conceptualization with PDCA and DMAIC frameworks suggests that PRIME may offer improved suitability for complex, dynamic, and high-stakes project environments where decision accuracy and real-time control are critical. This study adopts a conceptual and literature-based approach, supported by comparative diagrams and preliminary analytical observations emphasizing the importance of structured review prior to execution.

It is important to note that this paper addresses only the first layer of the (PRIME)² Framework. The second layer, which focuses on quality excellence dimensions, will be discussed in a separate publication. Furthermore, the framework remains at a conceptual stage and has not yet undergone full empirical validation, indicating the need for future applied research and case-based testing.

 

 

Keywords: framework, process-cycle, project management, quality management, review-process


ABSTRACT BOOK FROM 9th International Conference on Advanced Research in Management, Economics and Accounting available here!