No.

Statement A/D Justification

The management representative (MR or
Correct. ISO 9001 requires that Top
1 QMR) is appointed by Top A
Management assign the MR/QMR.
Management.
Correct. The MR/QMR must have the
The MR/QMR must be a member of the
2 A authority and position to influence
organization’s management.
management decisions.
Disagree. While it can be full-time, ISO does
The MR/QMR position should be a full-
3 D not mandate this—it can be an added
time, dedicated job.
responsibility.
The complete competency requirements
Disagree. These are necessary, but not
of an MR/QMR position are:
4 D complete; leadership, auditing, analysis, and
Knowledge of ISO 9001:2008 and the
communication skills are also essential.
organization’s QMS.
The MR/QMR is responsible for Agree. The MR/QMR plays a key role in
5 A
documenting the QMS manuals. managing QMS documentation.
The MR/QMR reports to top
management regarding the status of Agree. This is a core responsibility of the
6 A
QMS performance and any needs for MR/QMR.
improvement.
Disagree. The MR/QMR facilitates and
The MR/QMR is responsible for supports audits but does not solely determine
7 identifying the scope of QMS internal D audit scope—it’s usually part of the audit
audits. planning process with input from top
management.
The MR/QMR should be very familiar
with quality terminologies, tools, Agree. This is necessary for effectively
8 A
technologies, and principles to be managing and improving the QMS.
effective.
Agree. Often, the MR/QMR manages key
The MR/QMR owns some processes in
9 A QMS processes like document control, audits,
the QMS.
or training.
Quality Assurance has the same Disagree. QA is proactive (process-focused),
10 meaning as Quality Control. QA is just a D while QC is reactive (product-focused). They
modern term for QC. are not the same.
Disagree. Quality also applies to services,
11 Quality pertains to products only. D processes, and systems. It’s about meeting
customer and stakeholder needs.
Disagree. ISO 9001 defines customers as
Buyers of products or services for
anyone receiving a product or service,
12 further processing are not considered D
including those in the supply chain for further
customers.
processing.
No. Statement A/D Justification
13 A process means the same as procedure. D Disagree. A process is a set of interrelated
activities with inputs and outputs. A procedure
No. Statement A/D Justification
is a documented way to carry out a process.
They are not the same.
Quality Planning entails setting quality
objectives, product or service features, Agree. This matches the definition of quality
14 A
and specifying necessary processes and planning in ISO and TQM principles.
resources.
Quality improvement means increasing Disagree. While some improvements may
the ability to fulfill quality requirements. occur informally, systematic quality
15 D
This can be done without tools or improvement usually requires appropriate tools
techniques. and techniques.
An effective process means planned
activities are realized and planned Agree. This aligns with ISO 9000 definitions
16 A
results are achieved. An effective of effectiveness and customer satisfaction.
process leads to customer satisfaction.
An efficient process means desired Disagree. Efficiency involves resource
results are achieved using optimized optimization, but customer satisfaction should
17 D
resources. Cost should always be not be sacrificed for cost savings. Both should
prioritized over customer satisfaction. be balanced.
Over the years, Management of Quality
has evolved from inspection to Agree. This reflects the historical evolution of
18 A
TQC/self-quality-control to quality quality management.
management systems.
Quality Management System is the only Disagree. Organizations may have multiple
management system in an organization. management systems (e.g., EMS for
19 D
Its requirements can be found in ISO environment, OHSMS for safety). ISO
9001:2008. 9001:2008 only covers QMS.
A QMS has only two purposes:
Disagree. These are key goals, but QMS also
customer satisfaction and compliance
20 D aims for continual improvement, risk-based
with statutory and regulatory
thinking, and process efficiency.
requirements.
Disagree. A QMS must be tailored to your
Since QMS requirements are standard,
organization’s unique context, risks, products,
21 one can simply copy the QMS manuals D
and processes. Copying fails to meet ISO
of a competitor or similar company.
intent.
ISO 9001:2008 has five (5) auditable Agree. Clauses 4 to 8 are the auditable clauses
22 A
clauses. in ISO 9001:2008.
Improvement of a QMS is done through Agree. PDCA (Plan-Do-Check-Act) is the
23 process management and improvement A foundational model for continual improvement
using the PDCA approach. in ISO 9001.
Disagree. Clause 4 is about general
Support service processes are managed requirements and documentation. Support
24 under clause 4: Quality Management D processes are more related to Clause 6
System. (Resources), Clause 7 (Product Realization),
etc.
No. Statement A/D Justification
Disagree. ISO 9001:2008 requires six
The QMS under ISO 9001:2008 has six
documented procedures (control of documents,
(6) mandatory procedures. These
25 D records, internal audit, nonconformity,
procedures may or may not be
corrective and preventive actions). These must
documented.
be documented.
No. Statement A/D Justification
Quality objectives, customer
satisfaction, and compliance to
Agree. Monitoring these key outcomes gives a
26 regulatory requirements need to be A
strong indication of how effective the QMS is.
monitored. These are enough to evaluate
QMS effectiveness.
Certification of the established QMS
Disagree. Certification means the system
means that the product is conforming to
27 D conforms to ISO 9001 requirements. It does
customer, legal, and internal
not guarantee product conformity.
requirements.
Considering business risks will
influence our QMS. Risk assessment is Agree. ISO 9001:2008 doesn't formally require
28 not required by ISO 9001:2008 but we A risk assessment (unlike ISO 9001:2015), but
can use it to improve preventive action it's a valuable tool to support preventive action.
planning.
Preventive actions are formulated to Disagree. Corrective actions are for
29 prevent recurrence of problems or non- D recurrence; preventive actions are for potential
conformities. problems before they occur.
By studying procedures and how well
they’re implemented and how records
Agree. This is a core element of process-based
30 are kept, auditors can assess QMS A
auditing.
effectiveness. This is the process
approach.
Regardless of criticality, all documented Disagree. Audits should be based on
31 processes must be audited as required by D importance, performance, and risk, not just
the standard. documentation.
QMS objectives should be treated Disagree. QMS objectives should align with
32 separately from business goals. It's D business goals to ensure strategic integration
dangerous to mix them. and relevance.
Risks in attaining quality objectives and Agree. Even if not required in ISO 9001:2008,
33 process goals should be identified, A this is a best practice and aligns with
analyzed, evaluated, and treated. preventive action.
Process controls and process standards
Agree. Regular and event-based reviews help
34 should be reviewed at least once a year A
maintain process control and responsiveness.
and also when quality incidents occur.
Risk-based auditing prioritizes auditing
processes that pose greater risks to Agree. This makes audits more strategic and
35 A
product conformity, customer aligned with business impact.
satisfaction, and quality objectives.
No. Statement A/D Justification
Agree. Certification ensures system
It is possible to have ISO 9001:2008
compliance, not product conformity—issues
36 Certification and still have products not A
can still happen due to poor implementation or
meeting customer requirements.
process failure.

✅ KEY CHANGES IN ISO 9001:2015 VS 2008

Area ISO 9001:2008 ISO 9001:2015

Structure Based on 8 clauses Based on Annex SL, with 10 clauses
Not explicitly
Risk-Based Thinking Mandatory, integrated throughout (Clause 6.1)
required
Management Required (Clause No longer required by name, but
Representative (QMR) 5.5.2) responsibilities must be assigned (Clause 5.3)
6 mandatory No mandatory procedures; instead, requires
Documented Procedures
procedures “documented information” as needed
Separate clause Integrated into risk-based thinking; no separate
Preventive Action
(8.5.3) clause
Quality Manual Mandatory Not required
“Documents &
Terminology Replaced by “Documented Information”
Records”
Continual Improvement Required Still required, but linked to strategy and risk
Mandatory, with emphasis on managing
Process Approach Encouraged
interrelated processes

🔄 ANALYSIS OF YOUR SELF-DIAGNOSIS QUESTIONS UNDER ISO 9001:2015

 Statement Area Status in 2015 Version
Not called “QMR” anymore, but responsibilities must be assigned to one or
QMR role
more persons.
Required. Now part of planning (Clause 6.1: Actions to address risks and
Risk assessment
opportunities).
Integrated into risk-based thinking. No separate clause for "preventive
Preventive action
action."
Documented Not mandated, but you must maintain documented information where
procedures necessary.
Quality Manual No longer mandatory.
Quality Objectives Must be aligned with the organization’s strategic direction (Clause 6.2).
Process Approach Mandatory. Stronger emphasis than in 2008.
Still required (Clause 9.2), but must be based on importance, changes, and
Internal Audits
performance, not just documentation.
Risk-based auditing Expected. Risk and performance-based audit planning is emphasized.
Certification Still doesn't guarantee product quality—just that the QMS conforms.

🔁 Summary of Mindset Shift (2008 → 2015):

 From procedures and manuals → to processes and outcomes

 From compliance-only → to risk-based thinking
 From QMR-focused → to shared leadership responsibility
 From reactive preventive action → to proactive planning through risk

✅ Part 1: Updated Self-Diagnosis Quiz for ISO 9001:2015

Please answer A (Agree) or D (Disagree) for each statement.

1. The responsibilities previously assigned to a Management Representative must still be

assigned, but the formal title "QMR" is no longer required.
2. ISO 9001:2015 requires an organization to determine risks and opportunities that can
affect the achievement of intended results.
3. ISO 9001:2015 requires a documented Quality Manual.
4. ISO 9001:2015 requires a process approach to be applied to the QMS.
5. ISO 9001:2015 emphasizes aligning the QMS with the organization's strategic direction.
6. ISO 9001:2015 requires six mandatory documented procedures as in ISO 9001:2008.
7. Risk-based thinking replaces the separate clause for preventive action in ISO 9001:2015.
8. QMS objectives in ISO 9001:2015 must be measurable and consistent with the quality
policy.
9. ISO 9001:2015 uses the term “documented information” instead of “documents and
records.”
 10. ISO 9001:2015 certification guarantees that all products will meet customer
requirements.
11. ISO 9001:2015 encourages top management to take direct responsibility for the QMS.
12. Customer satisfaction, internal audits, and process performance are part of evaluating
QMS effectiveness.
13. Audits in ISO 9001:2015 must be scheduled based on process importance, performance,
and risks.
14. Context of the organization and interested parties must be considered in QMS planning.
15. ISO 9001:2015 requires continual improvement of the QMS through the use of PDCA
and risk-based thinking.

Let me know when you're ready for the answer key and explanations.

✅ Part 2: Side-by-Side Training Guide: ISO 9001:2008 vs ISO 9001:2015

Topic ISO 9001:2008 ISO 9001:2015

Structure 8 Clauses 10 Clauses (Annex SL)
Management Not mandatory by name, but responsibilities must
Mandatory
Representative (QMR) still be assigned (Clause 5.3)
Risk Management Not required Required (Clause 6.1: Risks and Opportunities)
Separate clause
Preventive Action Integrated into risk-based thinking
(8.5.3)
Quality Manual Mandatory Not required
No mandatory procedures, but "documented
Documented Procedures 6 mandatory
information" must be retained where necessary
Terminology: Documents
Separated Replaced by "Documented Information"
& Records
Process Approach Encouraged Mandatory
Based on Based on process importance, changes, and risk
Internal Audits
schedule (Clause 9.2)
Must be Must be aligned with strategic direction,
Objectives
measurable measurable, and monitored
Top Management Role Indirect Direct responsibility for QMS leadership
Still required; integrated with PDCA and risk-based
Continual Improvement Required
thinking
Context of the
Not required Required (Clause 4.1)
Organization
Interested Parties Not required Must be identified and considered (Clause 4.2)
System conforms
Certification Meaning Same – does not guarantee product quality
to ISO
✅ ISO 9001:2015 Self-Diagnosis Quiz – Answer Key

No. Statement A/D Explanation

The responsibilities previously assigned to a Correct. ISO 9001:2015 removed the
Management Representative must still be “MR” title but requires the roles and
1 A
assigned, but the formal title "QMR" is no responsibilities (Clause 5.3) to be
longer required. assigned.
ISO 9001:2015 requires an organization to
Correct. Risk-based thinking is
2 determine risks and opportunities that can A
mandatory (Clause 6.1).
affect the achievement of intended results.
Wrong. The Quality Manual is no
ISO 9001:2015 requires a documented longer required. Only necessary
3 D
Quality Manual. documented information must be
maintained.
ISO 9001:2015 requires a process approach Correct. The process approach is central
4 A
to be applied to the QMS. to ISO 9001:2015.
ISO 9001:2015 emphasizes aligning the
Correct. Clause 5.1.1 (Leadership) makes
5 QMS with the organization's strategic A
this alignment mandatory.
direction.
Incorrect. There are no mandatory
ISO 9001:2015 requires six mandatory documented procedures; instead,
6 D
documented procedures as in ISO 9001:2008. documented information is required as
necessary.
Risk-based thinking replaces the separate Correct. ISO 9001:2015 removed
7 clause for preventive action in ISO A preventive action as a separate clause
9001:2015. and replaced it with risk-based planning.
QMS objectives in ISO 9001:2015 must be
Correct. Clause 6.2 requires measurable
8 measurable and consistent with the quality A
objectives aligned with the policy.
policy.
ISO 9001:2015 uses the term “documented Correct. ISO 9001:2015 uses the
9 information” instead of “documents and A combined term "documented
records.” information".
Incorrect. Certification means the system
ISO 9001:2015 certification guarantees that
10 D is compliant. Products may still fail if the
all products will meet customer requirements.
system is not properly followed.
ISO 9001:2015 encourages top management Correct. Leadership (Clause 5) plays a
11 A
to take direct responsibility for the QMS. stronger, more active role than in 2008.
Customer satisfaction, internal audits, and Correct. Clause 9.1 requires monitoring of
12 process performance are part of evaluating A performance and satisfaction to
QMS effectiveness. evaluate effectiveness.
Audits in ISO 9001:2015 must be scheduled
Correct. Clause 9.2.2 requires a risk-
13 based on process importance, performance, A
based audit program.
and risks.
No. Statement A/D Explanation
Correct. Clauses 4.1 and 4.2 require
Context of the organization and interested
14 A analysis of internal/external context and
parties must be considered in QMS planning.
interested parties.
ISO 9001:2015 requires continual Correct. Clause 10.3 emphasizes
15 improvement of the QMS through the use of A continual improvement through PDCA
PDCA and risk-based thinking. and addressing risks and opportunities.