The ISO 9000 series provides a framework for a comprehensive quality management system (QMS) that
ensures consistency, efficiency, and customer satisfaction in organizational processes. For successful
implementation, organizations must understand and apply all 20 elements of the ISO 9000 quality
system. Below is a summary of these elements:
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1. Management Responsibility
Management must define and document its quality policy and objectives. Responsibilities and
authorities should be clearly assigned. Adequate resources must be provided, a management
representative appointed, and periodic reviews conducted to assess system effectiveness.
.# 1 is dapat ang CEO or boss sa isa ka company dapat clear ang pag define ang mga policy sa company
and then each person have clear responsibility and assign to their expertise.
Example:Sa usa ka furniture company, ang general manager nagtudlo ug quality manager nga mag-
monitor sa tanang produkto nga mogawas sa planta.
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2. Quality System
A documented QMS should be established, including a quality manual, procedures, work instructions,
and quality records. This ensures consistency in quality-related activities.
#2 In one company dapat naa quality manuals, mga procedure , work instructions para iwas mali ang
mga trabaho ug same tanan ang result sa inyong work.
Example: Ang electronics company naghimo og manual nga naglatid kung giunsa paghimo, pagsusi, ug
pagpadala sa mga produkto.
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3. Contract Review
Customer requirements must be formally reviewed to ensure the organization’s capability to meet
them. These reviews should be documented and retained as records.
Always review ang mga contract na atong gipang receive if kaya ba eh produce sa isa ka company or dili
para aware pod ang costumers ug kaya or dili sa isa ka company mo hatag ug sakto ug naay quality.
Example : Sa printing company, gi-review una ang specifications sa kustomer sa banner aron masiguro
nga available ang materials ug kapasidad.
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4. Design Control
Design activities must be planned and documented. Inputs and outputs must be clearly defined,
reviewed, and controlled to meet requirements and accommodate changes effectively.
#4 Design activities dapat planado ug documented sa pag drawing until sa pag gawas sa output dapat
ipakita sa costumers or clint kung uk ba or dili before mag produce ug daghan.
Example: Ang shoe manufacturing company nagplano ug bag-ong disenyo sa rubber shoes ug gi-review
kini sa R&D team ug marketing team.
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5. Document Control
All documents relating to the QMS must be controlled. This includes methods for document approval,
distribution, and revision to ensure only current documents are in use.
#5 dapat naay tao nka assign ani na work to compiled all the documents gikan sa pag approval, pag
distribusyon or gi revise bana siya. Para maka update akways.
Example: Ang pharmaceutical company nagbutang og document control officer nga mo-update ug
mopanagtag lang sa pinakabag-o nga version sa SOPs.
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6. Purchasing
Procedures must be in place for evaluating suppliers and subcontractors. Purchase data should clearly
specify product requirements to ensure quality of incoming materials and services.
# dapat mag assign pod kag tao that good in evaluating na nag palit ug mga product to ensure ang
quality sa nga mo abot na stocks sa inyong company.
Example: Ang food manufacturing company nagsusi sa supplier sa harina kung naay updated sanitary
certificate ug ISO certification.
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7. Purchaser-Supplied Product
When the customer provides products (e.g., raw materials), systems must be in place to manage
inspection, storage, usage, and record any damage or loss.
# if ma abot na ang mga order na product sa inyo always inspect and record is Tama ba tanan gi order or
naa bay damage para ma return.
Example: Sa garment company, ang tela nga gikan sa kustomer gi-check, gi-label, ug gilista sa inventory
system.
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8. Product Identification and Traceability
Products must be clearly identified throughout all stages of production. Traceability ensures the ability
to track items back to their source or process stage.
#if ma storage na ang mga product dapat ma identity inyo asa gikan ang product ug kanusha ni abot.
Para aware mo kung asa eh uli kung naay expired or daot.
Example: Ang bottled water company nagbutang og batch code sa matag botelya aron masubay kung
kanus-a ug asa kini gihimo.
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9. Process Control
Production processes affecting quality must be planned and conducted under controlled conditions. This
includes proper documentation, equipment, environment, standards, and monitoring.
# if uk na tanan then during production sa inyong company dapat need jpon ug Documentary , proper
ang equipment gi gamit and always monitor kung tama ba ang gi buhat.
Example: Ang car parts manufacturer naggamit ug checklist kada shift aron maseguro nga ang machines
naka-set sa saktong specification.
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10. Inspection and Testing
Inspection and testing must be conducted at receiving, in-process, and final stages to ensure product
conformity. Records must be kept at each stage.
#each level sa pag ka himo sa isa ka product dapat eh testing or inspeksyonon kung tama ug quality ba
ang pag ka himo dapat bawat levels us eh record guyd.
Example:Ang electronics company nag-inspect sa circuit boards human assembly, ug usab sa final testing
sa produkto.
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11. Inspection, Measuring and Test Equipment
All measuring and testing equipment must be identified and calibrated to maintain accuracy and
reliability of inspection results.
# Dapat eh testing od ang tanan gi gamit nimo na equipment para mas quality ang resulta sa product.
Example: Ang calibration team sa oil refinery plant nagsiguro nga ang pressure gauges sa pipeline kay
na-calibrate matag 6 ka bulan.
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12. Inspection and Test Status
Systems must indicate inspection and test status of products at every production stage to ensure only
conforming products proceed further.
# eh Klaro dapat kung ang produkto nakapasar na ba o wala.
Example: Sa electronics company, ang product naay red tag kung “Under inspection” ug green tag kung
“Approved”.
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13. Control of Non-Conforming Product
Products that do not meet specifications must be identified, documented, segregated, evaluated, and
appropriately disposed of. Records of such actions must be maintained.
#Ang sayop nga produkto dapat ilain, dokumentohan, ug desisyunan.
Example: Ang chocolate factory nag-ilain ug gi-record ang mga tab-ang nga produkto nga wala nakaabot
sa standard flavor.
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14. Corrective and Preventive Action
Systems must be in place to handle non-conformities, customer complaints, and potential issues. Root
cause analysis and preventive measures must be applied to avoid recurrence.
Kung naay problema Ayohon ang problema ug pugngan nga mausab ug ma fix dayun.
Example: Sa contact center company, human sa daghang reklamo sa slow service, gitrain pag-usab ang
agents ug gi-improve ang call routing system.
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15. Handling, Storage, Packaging, Servicing, and Delivery
Procedures must ensure that products are properly handled, stored, packaged, and delivered without
quality degradation.
# dapat tama ang product gikan sa handle, storge, package ug pag deliver sa mga consumer.
Tarongon ang pagdala sa produkto aron dili madaut.
Example: Ang meat processing company naggamit ug refrigerated trucks aron masiguro nga presko ang
delivery sa mga karne.
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16. Control of Quality Records
All records related to QMS activities (e.g., audits, inspections, subcontractor assessments) must be
maintained for reference and verification purposes during audits or reviews.
Ang tanan na documents na related sa QMS dapat taguan para sa references ug verification during sa
audits or review.
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17. Internal Quality Audit
Organizations must conduct internal audits using trained personnel to verify QMS effectiveness. Results
must be documented, reported, and used for corrective actions.
Dapat mag conduct mog internal audit para gamit ang trained personalidad para mas mapadali nlng sa
inyo kung mag audit na puhon dapat documentary pod tanan buhaton.
Example: Ang chemical company nagpa-audit kada quarter aron masiguro nga nagsunod pa gihapon sa
GMP standards.
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18. Training
Training needs must be identified and provided to ensure that personnel are competent in their roles.
Records of all training activities should be maintained.
# need mamili ug person na eh trained na competent ug sakto na makaya niya ug mas mo
knowledgeable paguyd ana na butang.
Example: Ang HR sa call center company nag-organize og product training para sa bagong batch sa
agents.
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19. Servicing
Where required, a defined plan for servicing must be implemented, and all services rendered should be
properly recorded.
#Ang serbisyo nga gikinahanglan human ibaligya dapat klaro.
Example: Ang company sa industrial machines nagtudlo ug technician nga motabang kung maguba ang
makina sa site sa customer.
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20. Statistical Techniques
Organizations should identify and apply relevant statistical tools (e.g., Pareto analysis, histograms, PERT)
to monitor, control, and improve processes.
Always use statistical techniques para mas ma improved paguys inyong company ug ma identity ang
mga dapat bagohon.
Example:Ang factory sa cellphones naggamit ug control charts ug Pareto analysis aron mahibal-an ang
pinakadaghan nga root causes sa defects.