ISO 9001:2015

Presented by: Tan Ru Yih

Date & Time: 21/12/2023, 8.30am – 9.30am
The entire ISO9001 clause involves the use of
the PDCA cycle
 Clause 5 – Leadership
• Clause 5.1.2 – To meet customer requirement and enhance customer
satisfaction (This is the MAIN REASON to establish ISO9001 in the
organization)
• Clause 5.2 – Policy shall appropriate to the purpose and context of the
organization and supports the organization’s strategic direction. It also
provides framework for setting quality objectives (clause 6.2).
• Clause 5.3 – To show the roles & responsibilities. Example, Organization
chart & Job Description
 Clause 6 - Planning
• Clause 6.1 – Actions to address risks and opportunities (related to clause
9.1.3e, 9.3.2e) (next slide)
• Clause 6.2 – Quality Objectives shall be consistent with the quality policy
(clause 5.2). Establish using SMART analysis. (slide 6)
Risks and Opportunities

when
there is
MRM changes
periodic in the
review process

when
there is
nonconfo
rmity

Review & Update the Risk & Opportunity

Clause 6.2 – Quality Objective
 Clause 7 - Support
• 5 M + 1 C + 1E: Man, Machine, Material, Method, Measurement/Money, Environment,
Communication
• Clause 7.1.1 – Usually refer budget/money
• Clause 7.1.2 – People
• Clause 7.1.3 – Infrastructure (e.g., forklift, IT, transportation, etc.)
• Clause 7.1.4 – Environment for the operation of processes (e.g., social, psychological, physical)
• Clause 7.1.5 – Monitoring and measuring resources (usually refer to calibration of the
equipment used)
• Clause 7.1.6 – Organizational knowledge (experience, gathering knowledge from customers, etc.)
 Clause 7 - Support
• Clause 7.2 – Competence (e.g., Who are the people performing work under
your control? How do you assess employee competency effectiveness?)
• Clause 7.3 – Awareness (Quality policy, quality objectives, employee
contribution, NC existence)
• Clause 7.4 – Communicate (Internal and External)
Clause 7.5 – Documented information

Document

Documented
information

Record
 Clause 7.5 – Documented information
• Maintain the document that can ask for latest/updated version.
• Retain the record.
• Clause 7.5.2 - Creating and updating
a) identification and description
b) format (e.g. language, software version, graphics) and media (e.g. paper,
electronic); → Indicates the video is also accepted, language on the document must be
familiar to the user
c) review and approval for suitability and adequacy
 Clause 8.5 - Production and service provision
• All departments that involved in the processing of products and services, such as:
- Raw material store
- Quality Assurance and control
- Production
- Maintenance
- Warehouse
- Logistics
- Customer service
 Clause 8.5 - Production and service provision

• Clause 8.5.1 – Any control activities such as monitoring, testing

- a) characteristics of the products (e.g. Product specification)
- b) results to be achieved (refer to acceptance criteria)
• Clause 8.5.2 – Identification and traceability (e.g., batch number, lot
number, barcode)
• Clause 8.5.3 – Property belonging to customers or external providers (e.g.,
repair products, product specification from customer)
 Clause 8.5 - Production and service provision

• Clause 8.5.4 – Preservation (identification, handling, contamination control,

packaging, storage, transmission or transportation, and protection)
• Clause 8.5.5 – Post-delivery activities (after sales services)
 Clause 8.6 – Release of products and services

• It acts as a checkpoint for each process output and is dependent on the

business process.
• Example, QAQC conducts some testing and obtains approval before the
raw material/finished goods proceeds further.
• Example, a business planner generates a daily schedule every day, and that
schedule must be reviewed and approved before it can be published.
 Clause 8.7 – Control of nonconforming
outputs
• Ensure that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery.
• Related to clause 10.2
• ALL departments/processes are involved.
• E.g., set acceptance criteria for output
 Clause 9.1 Monitoring, measurement, analysis
and evaluation
• Clause 9.1.1 – Determine and collect data (ALL departments shall determine
what, method, when to perform, when to analyse results)
• Clause 9.1.2 – Customer satisfaction (e.g., survey form)
• Clause 9.1.3 – Analysis and evaluation (Analyse data to see trends and
performance)
 Clause 9.2 Internal Audit (IA)
• Audit means to evaluate any process against requirements and help make
decisions or continual improvements.
• It is recommended to incorporate both clause-based and process-based
audit approaches for a comprehensive assessment.
• Example, when auditing clause 7.2 (Competence), the IA process involves
traversing through the associated processes:
Recruitment -> Identify competency needs -> Provide relevant training ->
Evaluation -> Record keeping
 Clause 9.3
• Clause 9.3.1 – To show top management involvement
• Clause 9.3.2 – All criteria should be considered
• Clause 9.3.3 – To find opportunities for improvement
 Clause 10 - Improvement
• Clause 10.1 – Determine, select and implement opportunities for
improvement
• Clause 10.2 – Nonconformity and corrective action
- a) correction
- b) root cause analysis and take corrective action
- d) need to review the effectiveness
- e) update risk and opportunities once there is NC, if necessary
 Clause 10.3 – Continual improvement
• Suitability: Organization direction by review quality policy & quality
objectives
• Adequacy: Review effectiveness of performance of process & procedure
• Effectiveness: Review measurable achievement

END OF THE SLIDES