Day 1

1) Introduction to Quality Management System (QMS)

Quality Management System (QMS) ek structured system hai jo organizations ko

quality ko maintain karne mein help karta hai. Iska main goal hai ki organization apni
products ya services mein ek specific quality standard ko follow kare, aur continuous
improvement ko ensure kare.

A QMS ensures that:

• Processes are standardized, taaki har product ya service consistent ho.

• Customer satisfaction ko improve kiya ja sake.

• Waste and inefficiency ko reduce kiya ja sake.

• Business regulations aur standards (like ISO 9001) follow kiye ja sake.

Isme policies, procedures, aur responsibilities ka ek framework hota hai jo organization

ke goals ko achieve karne ke liye design kiya jata hai. Agar organization mein koi bhi
process QMS ke through monitor kiya jaye, toh quality improve hoti hai, aur risk kaafi
kam ho jata hai.

Key components of a QMS:

• Documented Information: Policies, manuals, procedures, aur forms ko

document kiya jata hai.

• Process Control: Har process ko define aur monitor kiya jata hai taaki quality
standards follow ho.

• Continual Improvement: Continuous feedback aur improvement cycles hoti

hain jisse organization apni processes ko upgrade kar sake.

• Customer Focus: Customer ki zarurat aur unki satisfaction par poora focus hota
hai.

QMS ka ek major part ISO 9001 standard hota hai, jo globally recognized hai aur
organizations ko apni efficiency improve karne ke liye guidance deta hai.

2) Overview of Course Structure and Learning Objectives

Is course mein aapko Quality Management System ke basics se lekar advanced

concepts tak cover kiye jayenge. Ye structure aapko systematically QMS ke components
ko samajhne mein madad karega, aur practical examples ke through aapko real-world
scenarios ke liye tayar karega.

Course Structure:

1. Introduction to QMS:

o Quality Management System kya hota hai?

o Importance of QMS in businesses and industries.

o Overview of various standards like ISO 9001.

2. Understanding ISO 9001 Standard:

o ISO 9001 standard ka structure aur clauses.

o Documentation requirements.

o Implementation of ISO 9001 in organizations.

3. Process Approach in QMS:

o Process-based thinking.

o Key processes in QMS (like production, customer service, etc.)

o Process mapping aur monitoring.

4. Risk-Based Thinking in QMS:

o Identifying risks and opportunities.

o Risk management strategies.

5. Auditing and Certification:

o Internal and external audits.

o Certification process for ISO 9001.

6. Continuous Improvement:

o Kaizen and other improvement methodologies.

o PDCA (Plan-Do-Check-Act) cycle.

Learning Objectives:

• Aapko samajh aayega ki Quality Management System kaise organization ki

quality improve karta hai.

• ISO 9001 standard ko detail mein samajhna aur usse kaise implement kiya jata
hai.
 • Risk-based thinking aur process approach ko apne business practices mein
kaise adopt karna hai.

• Auditing processes ka practical knowledge.

• Aap learn karoge ki kaise continuous improvement ka culture develop kar sakte
ho.

Is course ke end tak, aap ek solid foundation bana chuke honge jo aapko kisi bhi
organization mein QMS ko efficiently implement karne mein help karega.

Chapter 1: AUDIT -> ICE-BREAKING

Introduction Session – Participants Introductions - Exercise 1

Ye chapter ek audit session ko start karne ka tareeka batata hai. Jab ek audit hota hai,
toh sabse pehle ek ice-breaking session conduct kiya jata hai taaki sab participants
comfortable feel karein aur communication improve ho.

Ice-breaking session ka main purpose hota hai:

• Participants ko ek doosre se introduce karana: Taaki sab log ek doosre ko

pehchaan sakein aur pata chale ki kaun kis role mein kaam kar raha hai.

• Team building: Auditors aur organization ke employees ko ek-saath kaam karne

mein comfortable feel ho.

Key Aspects of Ice-Breaking Session:

1. Introduction of Participants: Sab log apna introduction dete hain. Jaise naam,
position, kaam ka experience, aur audit se related unka role kya hoga.

2. Purpose of the Audit: Audit ka main objective discuss hota hai. Yeh bataya jata
hai ki audit kaise conduct kiya jayega aur kaunse areas par focus kiya jayega.

3. Ground Rules: Jab audit ho raha ho, toh kuch rules aur expectations set ki jati
hain, jaise punctuality, honesty, aur transparency.

4. Expectations: Har participant ko apne expectations clear karne ka moka milta

hai taaki sabko pata ho ki kya anticipate karna hai.

Exercise 1:

• Har participant ko ek small activity di ja sakti hai jisme woh ek doosre se interact
karein. Example ke taur par, ek sheet distribute ki ja sakti hai jisme unko likhna
hoga ki unhone apne colleagues ke baare mein kya naya seekha.
Yeh session audit ki ek positive shuruaat karta hai aur ek healthy working environment
banata hai.

Chapter 2: INTRODUCTION TO QUALITY MANAGEMENT SYSTEM

QMS ka Introduction:

Quality Management System (QMS) ek aisa system hai jo organization ki processes ko

control aur improve karta hai taaki woh consistently high-quality products ya services
provide kar sakein.

QMS ka Main Purpose:

• Customer Satisfaction: Aapka main focus yeh hota hai ki aapke customers
satisfied rahein.

• Compliance: QMS ensure karta hai ki aapke products ya services regulatory

requirements aur industry standards ko meet karein.

• Efficiency: Yeh system aapke processes ko streamline karta hai taaki waste
minimize ho aur productivity improve ho.

QMS ke Core Elements:

1. Quality Policy: Organization ka ek documented statement hota hai jisme woh

batata hai ki quality ko leke uske kya goals hain.

2. Quality Objectives: Specific goals jo QMS ko follow karte huye achieve kiye jate
hain. Yeh measurable hote hain, jaise customer complaints ko 20% tak reduce
karna.

3. Process Management: Sab processes ko clearly define kiya jata hai, aur unko
continuously monitor kiya jata hai.

4. Documentation: Policies, procedures, aur records ko proper tariqe se maintain

kiya jata hai taaki organization ke activities track ho sakein.

5. Continuous Improvement: Ek effective QMS aisa system hota hai jo constantly

apne aap ko improve karta rehta hai, jaise customer feedback ke basis par
updates karna.

Benefits of QMS:

• Consistency in Quality: Processes standardized hote hain toh product quality

har baar same hoti hai.

• Better Efficiency: Time aur resources ko effectively utilize kiya jata hai.
 • Risk Reduction: QMS processes risk ko identify aur minimize karte hain.

Chapter 3: QUALITY MANAGEMENT SYSTEM - INTRODUCTION TO AUDIT

Audit ek systematic process hai jisme organization ki processes aur practices ko review
kiya jata hai taaki dekha ja sake ki woh established standards ko follow kar rahe hain ya
nahi.

Types of Audits:

1. Internal Audits: In-house team ke members organization ke processes ko check

karte hain. Iska main focus hota hai ki organization ke internal procedures
properly follow ho rahe hain ya nahi.

2. External Audits: Bahar ki third-party organizations, jaise certification bodies,

aapke processes ko check karti hain. For example, ISO 9001 certification ke liye
external auditors ko bulaya jata hai.

3. Supplier Audits: Jab ek organization apne suppliers ke processes ko review karti

hai taaki ensure ho sake ki woh bhi required standards follow kar rahe hain.

Purpose of Audits in QMS:

• Compliance Check: Ensure kiya jata hai ki organization legal aur industry
standards ko follow kar rahi hai.

• Process Improvement: Audit ke through weaknesses identify ki jaati hain aur

unhe improve karne ke liye suggestions diye jate hain.

• Risk Identification: Auditors processes ko review karke potential risks ko

highlight karte hain.

Audit Process:

1. Planning: Audit ka scope decide kiya jata hai, kaunse areas ko audit karna hai
aur kya objectives hain.

2. Execution: Auditors aapke documents ko review karte hain, employees ke

interviews conduct karte hain, aur processes ko observe karte hain.

3. Reporting: Audit ke end mein ek detailed report banayi jati hai jo findings aur
recommendations deta hai. Agar koi non-conformance detect hoti hai, toh
corrective action plan bhi banaya jata hai.

4. Follow-up: Non-conformance ko address karne ke baad ek follow-up audit hota

hai taaki ensure ho sake ki corrective actions implement ho chuki hain.
Importance of Audits in QMS:

• Audits help karte hain continuous improvement mein.

• Transparency aur accountability ensure hoti hai.

• Customer trust build hota hai jab audits ke results positive hote hain.

Yeh thi detailed explanation chapters ki. Agar aur clarity ya kisi aur topic par explanation
chahiye ho toh bataiye!

Process Approach & System Approach to Management

Process Approach:

Process Approach ek aisa method hai jo organization ke saare activities ko ek

systematic aur structured way mein manage karta hai. Har activity ya process ek doosre
se linked hoti hai, aur ek final outcome ya objective ko achieve karne ke liye sabko ek
flow mein operate karna padta hai.

Key Aspects of Process Approach:

1. Inputs and Outputs: Har process mein koi na koi input hota hai (like raw
material, data) jo transform hokar output (like finished product, report) ban jata
hai.

2. Interlinked Processes: Processes ek doosre se connected hote hain, matlab ek

process ka output doosre process ka input ban jata hai.

3. Efficiency: Process approach ka main objective hota hai efficiency ko maximize

karna aur resources ko effectively use karna.

4. Monitoring and Measurement: Har process ko continuously monitor kiya jata

hai aur measure kiya jata hai taaki improvements suggest ki ja sakein.

Benefits of Process Approach:

• Consistency: Processes standardized hote hain, isliye outcomes consistent

hote hain.

• Continuous Improvement: Monitoring aur feedback se aapko pata lagta hai ki

kahan improvements zaruri hain.

• Risk Management: Process ke flow ko samajhne se risks ko jaldi identify karne

ka moka milta hai.
System Approach to Management:

System Approach ek broader perspective hai jo organization ko ek system ke roop

mein dekhta hai. Is approach mein organization ke alag-alag processes aur activities ko
ek integrated system ke taur par manage kiya jata hai, jahan har part ek doosre se
dependent hota hai.

Key Aspects of System Approach:

1. Holistic View: System approach mein organization ke saare components ko ek

saath dekha jata hai, jahan har process apni jagah par important hoti hai.

2. Interconnection: Organization ke processes aur departments ek interconnected

system ka part hote hain. Ek part mein galti ya issue aane par, system ke baaki
parts pe bhi asar hota hai.

3. Optimization: Yeh approach ensure karta hai ki organization ke saare processes

optimum level par kaam karein taaki efficiency aur effectiveness dono improve
ho sakein.

4. Overall Objective: Har process apne individual objective ko achieve karta hai,
lekin system ka main focus organization ke overall goals ko achieve karna hota
hai.

Benefits of System Approach:

• Efficiency Improvement: Is approach ke through, aap puri system ki efficiency

ko improve kar sakte ho, na ki sirf ek individual process ko.

• Better Coordination: Departments aur processes ke beech mein coordination

improve hoti hai.

• Risk Reduction: Kyunki sab processes interdependent hote hain, toh potential
risks ko better manage kiya ja sakta hai.

Exercise 2:

Scenario: Aapko apne organization ke ek process ka flow map banana hai. Aapko ye
samajhna hoga ki inputs kya hain, process ka flow kaise hoga, aur final outputs kya
honge. Phir aapko ye dekhna hai ki system approach ke through aap puri organization ko
kaise optimize kar sakte hain.
Steps:

1. Choose ek specific process (jaise production, customer service, etc.).

2. Identify inputs (like raw material, data) aur define kaise woh process transform
hoga.

3. List the key outputs (final product, service).

4. Analyze kaise ye process doosre processes se connected hai, aur system

approach ko kaise implement karoge.

Terms & Definitions in Quality

Quality Management mein kuch important terms aur definitions ka samajhna bohot
zaroori hai, taaki aap proper implementation aur monitoring kar pao.

1. Quality:

• Definition: Quality ka matlab hai kisi product ya service ka customer ki

expectations aur specifications ko meet karna ya exceed karna.

• Example: Agar ek mobile phone customer ke durability aur performance ke

standards ko meet karta hai, toh uski quality achhi mani jayegi.

2. Quality Assurance (QA):

• Definition: QA ek preventive process hai jo ensure karta hai ki jo product banaya

ja raha hai, woh predefined quality standards ke according ho.

• Example: Production ke time par har step ko check kiya jata hai taaki koi defect
na ho.

3. Quality Control (QC):

• Definition: QC ek corrective process hai jo banaye hue product ko check karta

hai taaki defects ya issues ko identify karke correct kiya ja sake.

• Example: Final product ko test karna aur ensure karna ki usme koi defect na ho,
yeh QC ka kaam hai.

4. Non-conformance:

• Definition: Jab koi product ya process defined standards ko follow nahi karta,
toh usse non-conformance kaha jata hai.

• Example: Agar ek part ka size specification se alag ho, toh woh non-
conformance ka case banega.
5. Corrective Action:

• Definition: Jab koi problem ya non-conformance detect hoti hai, toh jo actions
liye jaate hain us problem ko solve karne ke liye, usse corrective action kehte
hain.

• Example: Agar QC mein koi defect milta hai, toh us defect ko fix karna corrective
action hoga.

6. Preventive Action:

• Definition: Jo steps liye jaate hain taaki future mein same non-conformance ya
issues na ho, unhe preventive actions kehte hain.

• Example: Training sessions conduct karna taaki employees ko galti na ho,

preventive action ka ek example hai.

7. Continuous Improvement:

• Definition: Organization ke processes ko regularly improve karna taaki efficiency

aur effectiveness badh sake.

• Example: Har quarter mein customer feedback lene ke baad product mein
improvements karna.

8. Audit:

• Definition: Audit ek systematic review hota hai jo ensure karta hai ki organization
ke processes aur products quality standards ko follow kar rahe hain.

• Example: Internal audit mein aap apne hi organization ke processes ko check

karte hain.

9. Customer Satisfaction:

• Definition: Yeh measure karta hai ki customer kitna satisfied hai product ya
service se. Customer satisfaction QMS ka core goal hota hai.

• Example: Agar customer repeat orders kar raha hai, toh iska matlab customer
satisfaction high hai.
Exercise 3:

Task: Aapko kuch terms define karni hain jo quality management se related hain. For
each term:

1. Definition likhiye.

2. Example provide kariye jo aapke work environment ya practical scenario se

related ho.

Example Terms: Quality, Quality Assurance, Quality Control, Non-conformance,

Corrective Action, Continuous Improvement.
Chapter 4: QUALITY MANAGEMENT SYSTEMS - Requirements of ISO 9001

Introduction to ISO 9001:2015

ISO 9001:2015 duniya bhar mein use hone wali ek widely recognized standard hai jo
Quality Management System (QMS) ke liye requirements define karti hai. Yeh standard
organizations ko apne products aur services ki quality ko improve karne mein madad
karta hai, taaki customer satisfaction aur operational efficiency badh sake.

Why ISO 9001:2015 is Important?

• Customer Trust: ISO 9001 certification organizations ko apne customers ke

beech trust build karne mein madad karta hai kyunki yeh proof hota hai ki aapke
processes internationally recognized standards follow kar rahe hain.

• Efficiency: Is standard ka implementation processes ko streamline karta hai aur

aapki business efficiency ko badhata hai.

• Continuous Improvement: ISO 9001 aapko ek framework provide karta hai jo

continuous improvement ko promote karta hai.

• Risk Management: Processes ko risk-based approach ke saath design kiya jata

hai, taaki potential risks ko jaldi identify karke minimize kiya ja sake.

Structure of ISO 9001:2015 within the Process Model for Management Systems

ISO 9001:2015 ka structure ek process model ke through explain kiya jata hai, jisme
inputs aur outputs ka continuous flow hota hai, aur saare processes interconnected
hote hain. Iska main focus hai ki organization apne processes ko ek integrated way mein
manage kare aur consistently desired outcomes achieve kare.

ISO 9001:2015 Process Model

1. Plan: Har organization ka pehla step hota hai planning karna. Is stage mein aap
quality objectives set karte ho aur yeh plan banate ho ki un objectives ko kaise
achieve karoge.

2. Do: Is stage mein aap apne processes ko implement karte ho, resources ka
effective utilization karte ho aur customer requirements ko meet karne ke liye
kaam karte ho.

3. Check: Ab, aap apne processes ka performance measure karte ho. Aap audits,
performance reviews aur customer feedback ke through yeh analyze karte ho ki
aapne jo plan banaya tha, woh sahi se follow ho raha hai ya nahi.
 4. Act: Last stage mein aap improvement activities perform karte ho. Agar check
phase mein koi non-conformance ya issue detect hota hai, toh corrective
actions implement kiye jaate hain taaki future mein same problems na ho.

Structure of ISO 9001:2015:

ISO 9001:2015 ka structure 10 clauses par based hai, jo management system ke

various aspects ko cover karta hai. Process model ke hisaab se, yeh clauses
systematically arranged hain.

• Clauses 1-3: Introduction, Scope, and Terms & Definitions. Yeh clauses ISO ke
purpose, scope, aur isme use hone wale technical terms ko explain karte hain.

• Clauses 4-10: Yeh clauses ISO 9001 ka main body hain, jo organization ke QMS
requirements ko define karte hain.

Start of Document Audit (Stage 1) – Good Glass Company Apex Documented

Information

Document Audit ka main purpose yeh hota hai ki organization ke documented

processes ko ISO 9001:2015 ke requirements ke saath match karke dekha jaye.
Document audit Stage 1 mein, auditor organization ke documented information ko
check karta hai taaki ensure ho sake ki yeh requirements ke according hai.

What is Apex Documented Information?

Apex documentation refers to highest level of documentation within an organization's

QMS. Isme organization's quality manual, policies, aur important procedures included
hote hain.

Example of Good Glass Company ke Apex Documentation mein kya-kya ho sakta hai:

• Quality Policy: Ek documented statement jo company ke commitment ko show

karta hai towards quality.

• Quality Objectives: Measurable goals jo organization achieve karna chahti hai.

• Process Procedures: Detailed step-by-step processes jinke through

organization kaam karti hai.

Stage 1 Audit Focus:

1. Compliance of Documentation: Auditors yeh check karte hain ki organization

ke documentation ISO 9001 ke requirements ko meet kar rahe hain ya nahi.

2. Proper Structure: Documents properly organized aur accessible hone chahiye,

taaki koi confusion na ho.
 3. Alignment with Quality Policy: Documentation ko organization ke quality policy
ke saath align hona zaroori hai.

Exercise:

• Ek organization ke documentation ka review karo aur ensure karo ki woh ISO

9001:2015 ke saath compliant hai.

• Identify karo ki kya missing hai aur kya improvements ki ja sakti hain.

Auditing the Requirements of ISO 9001:2015 (Clause 1 to 4)

ISO 9001:2015 mein Clause 1 se 4 tak ke requirements ko samajhna kaafi zaroori hai,
kyunki yeh organization ke scope, context, aur interested parties ke baare mein basic
requirements set karte hain.

Clause 1: Scope

Is clause mein bataya jata hai ki ISO 9001:2015 ka scope kya hai, aur yeh kis tarah ke
organizations par applicable hai. Iska main focus QMS ko implement karna aur
continuously improve karna hota hai taaki customer satisfaction achieve kiya ja sake.

• Example: Agar aapki company manufacturing, software development, ya

services sector mein hai, toh aap apne processes ko ISO 9001 ke requirements
ke according align kar sakte ho.

Clause 2: Normative References

Is clause mein standard ke applicable references ko bataya gaya hai. For example, ISO
9000 ko ek reference standard maana jata hai jo quality management ke terms aur
definitions ko define karta hai.

• Example: Auditor ko ensure karna padta hai ki organization ISO 9001 ke alawa jo
references use kar rahi hai, woh sahi hain.

Clause 3: Terms & Definitions

Is clause mein un terms aur definitions ka zikr hota hai jo ISO 9001:2015 mein
commonly use kiye jate hain. Yeh definitions globally accepted hoti hain aur unka
consistent interpretation hona zaroori hai.

• Example: Product, Service, Process, Non-conformance jaise terms ka sahi

matlab sabko pata hona chahiye.
Clause 4: Context of the Organization

Is clause mein organization ka context define kiya jata hai. Iska matlab hai organization
ko apne internal aur external factors, interested parties, aur QMS ka scope
samajhna padta hai.

1. Understanding the Organization: Internal aur external factors ko samajhna jo

organization ke performance ko impact karte hain.

o Example: Market competition, customer expectations, legal regulations,

etc.

2. Interested Parties: Organization ke stakeholders kaun hain, jaise customers,

suppliers, employees, aur regulatory bodies.

o Example: Aapko yeh samajhna hoga ki kaise aapke suppliers aur

customers aapke QMS ko influence karte hain.

3. Determining the Scope of QMS: Isme yeh define kiya jata hai ki aapka QMS ka
scope kya hoga, kaunse products ya services cover hongi aur kaunse nahi.

o Example: Agar aapki company sirf India mein kaam kar rahi hai, toh aap
QMS ka scope wahin tak limit kar sakte ho.

4. QMS and its Processes: Aapko apne saare processes ko identify karna hota hai
aur yeh ensure karna hota hai ki woh interconnected hain aur quality objectives
achieve karne mein madad kar rahe hain.

• Exercise 4:

o Har clause ke liye apne organization ka review karo.

o Identify karo ki kaunse external aur internal factors aapki company ko

influence karte hain.

o Interested parties ka analysis karo aur dekho ki unka aapke QMS par kya
asar hai.

o QMS ka scope clearly define karo aur document mein include karo.
 Day 2
Exercise 5: Auditing the Requirements of ISO 9001:2015 (Clause 5 – Leadership &
Worker Participation)

Clause 5 of ISO 9001:2015 is extremely important because it focuses on leadership

and worker participation in ensuring that the Quality Management System (QMS) is
implemented effectively. This clause defines the roles of top management and the
involvement of workers in maintaining and improving the quality standards of an
organization.

Clause 5 – Leadership

ISO 9001:2015 Clause 5 primarily emphasizes the role of leadership in creating a

quality-focused culture within an organization. Top management plays a crucial role in
the successful implementation and continuous improvement of the Quality
Management System.

Key Sections of Clause 5:

1. Leadership and Commitment (Clause 5.1)

2. Quality Policy (Clause 5.2)

3. Organizational Roles, Responsibilities, and Authorities (Clause 5.3)

1. Leadership and Commitment (Clause 5.1)

Leadership ka role ISO 9001 ke implementation mein sabse zyada important hota hai.
Top management ko commitment dikhani padti hai towards QMS aur ensure karna
hota hai ki poori organization mein quality ko importance di ja rahi hai.

5.1.1 General Leadership Commitment:

• Top Management ko yeh ensure karna hota hai ki quality objectives aur
customer requirements poori organization mein achhe se communicate ho rahe
hain.

• Customer Focus: Leadership ko focus karna hota hai ki customer ke

requirements ko samjha jaye aur unhe effectively meet kiya jaye.

Example: Agar ek organization ka CEO QMS ke implementation ko support nahi karta ya

isme interest nahi leta, toh baaki staff bhi is system ko priority nahi degi. Isliye
leadership ka engagement bohot zaroori hai.
Auditing Focus:

• Auditors yeh check karenge ki kya top management actively QMS ke goals aur
objectives ko promote kar raha hai.

• Management reviews kiye ja rahe hain ya nahi aur top management ka QMS
activities mein involvement hai ya nahi.

5.1.2 Customer Focus:

• Leadership ko ensure karna hota hai ki customer satisfaction priority hai, aur
unka feedback QMS mein integrate kiya ja raha hai.

Example: Agar company ke customers consistently complain kar rahe hain, aur
management ne unke feedback par kaam nahi kiya, toh yeh leadership ke failure ko
indicate karta hai.

2. Quality Policy (Clause 5.2)

Quality Policy ek high-level statement hota hai jo organization ke quality ke prati

commitment ko dikhata hai. Yeh document top management ke dwara banaya jata hai
aur poori organization mein communicate kiya jata hai.

Key Points in Quality Policy:

• Appropriateness: Policy organization ke context aur goals ke according honi

chahiye.

• Objectives: Quality policy ko aise design kiya jata hai ki organization ke quality
objectives ko support kare.

• Communication: Policy ko sabhi employees ko samjhana hota hai aur woh iske
implementation mein apna role samajh sakein.

Auditing Focus:

• Auditors yeh dekhenge ki organization ke paas ek clearly documented quality

policy hai ya nahi.

• Kya policy effectively communicate ki ja rahi hai sab employees tak? Kya
employees apne roles ko samajh rahe hain?

Example: Good Glass Company apni quality policy ko har team meeting mein discuss
karti hai aur har employee ko uske role ke baare mein clearly bataya jata hai.
3. Organizational Roles, Responsibilities, and Authorities (Clause 5.3)

Is clause mein organizational structure ka importance hota hai. Top management ko

yeh ensure karna hota hai ki har employee apne roles aur responsibilities ko achhi tarah
samjhe, aur QMS ke goals ko achieve karne ke liye unke pass clear authority ho.

Key Requirements:

• Roles and Responsibilities: Har employee ke role ko clearly define kiya jaye aur
unhe apne responsibility ke baare mein bataya jaye.

• Authority: Employees ke paas authority honi chahiye taaki woh apne tasks ko
effectively execute kar sakein.

• QMS Accountability: Top management ko QMS ke success ke liye accountable

hona chahiye.

Auditing Focus:

• Auditors check karenge ki organization mein roles aur responsibilities properly

assigned hain ya nahi.

• Kya har employee apne tasks ko samajhta hai, aur unhe execute karne ki
authority di gayi hai?

Example: Agar production team ko pata nahi hai ki final product ka quality check kaun
karega, toh roles aur responsibilities ka clearly defined na hona ek issue ban jata hai.

Worker Participation

Worker Participation ka matlab yeh hai ki employees ko actively include kiya jaye QMS
ke processes aur decision-making mein. Leadership ko ensure karna hota hai ki workers
ke inputs liye ja rahe hain aur unki involvement se QMS improve ho raha hai.

Key Points:

• Involvement: Employees ko process improvements aur quality-related

decisions mein involve kiya jaye.

• Training and Awareness: Sab employees ko necessary training di jaye taaki woh
QMS ke requirements ko samajh sakein.

• Feedback Mechanism: Aapke pass ek proper feedback mechanism hona

chahiye, jahan se workers apne suggestions ya concerns raise kar sakein.
Auditing Focus:

• Auditors yeh dekhte hain ki kya workers ko training aur resources mil rahe hain jo
unke QMS related tasks ke liye zaroori hain.

• Kya workers ke feedback ko consider kiya ja raha hai?

Example: Agar ek worker ne suggest kiya hai ki production line mein koi improvement
kiya jaye, lekin uska feedback management ne ignore kar diya, toh yeh worker
participation ke lack ko show karta hai.

Exercise 5: Auditing Leadership & Worker Participation

Objective: Is exercise ka main aim yeh hai ki leadership aur worker participation ke
aspects ko audit karna aur dekhna ki organization ISO 9001:2015 ke requirements ko
follow kar raha hai ya nahi.

Steps for Exercise:

1. Leadership Commitment:

o Check karo ki top management actively QMS mein involve hai ya nahi.

o Kya management quality objectives ke baare mein regularly meetings

karta hai?

2. Quality Policy:

o Quality policy ko review karo aur dekho ki woh organization ke goals ke

saath align hai ya nahi.

o Employees se poochho ki kya unhe policy ke baare mein pata hai?

3. Roles and Responsibilities:

o Organization ke structure ko check karo. Har employee ka role aur

responsibility clear hona chahiye.

o Ensure karo ki unhe proper authority di gayi hai apne tasks ko perform
karne ke liye.

4. Worker Participation:

o Dekho ki kya workers ko process improvements ya decision-making mein

include kiya ja raha hai?

o Unka feedback liya ja raha hai ya nahi?

Audit Outcome:

• Agar leadership fully committed hai, aur worker participation active hai, toh
organization QMS mein strong leadership aur participation ko demonstrate karta
hai.

• Agar koi gaps milte hain, toh auditors suggestions dete hain ki leadership aur
worker involvement ko kaise improve kiya jaye.

Yeh thi detailed explanation on Clause 5 – Leadership & Worker Participation aur
Exercise 5 ka breakdown. Agar aur detail mein kisi specific point par clarification
chahiye ho toh please bataye!

4o

You said:

Chapter 5 - Auditor Competence- Ability to apply Knowledge & skill to achieve the
intended audit outcome. KNOWLEDGE- of ISO 14001, Audit guidelines, industry sector,
processes, of the organization & audit procedures of the auditing body, AUDITING
SKILLS-for planning, conducting, reporting, and closing of audit Maintenance and
improving auditor competence. Please explain in details

ChatGPT said:

ChatGPT

Chapter 5 – Auditor Competence: Ability to Apply Knowledge & Skill to Achieve the
Intended Audit Outcome

Auditor competence is one of the most critical aspects of conducting successful

audits, especially when it comes to standards like ISO 14001 (Environmental
Management Systems) or other management systems like ISO 9001. To achieve the
intended audit outcomes, an auditor must possess the right combination of knowledge
and skills. Let’s break down each part of auditor competence in detail.

1. Auditor Competence Overview

Competence ka matlab hota hai ki auditor ke paas woh capability hai jo ek effective aur
result-oriented audit conduct karne ke liye zaroori hai. Auditor ka main goal hota hai ki
woh organization ke processes ko objectively evaluate kare, compliance check kare, aur
improvement areas suggest kare.

Competent auditors not only need technical knowledge but also specific skills that help
them carry out audits in a systematic, unbiased, and efficient manner.
Knowledge Required for an Auditor

Auditors ko apne field ka deep knowledge hona chahiye, especially jab baat aati hai ISO
standards jaisi complex systems ki auditing ki. Chaliye dekhte hain auditors ke liye
kaunse areas mein knowledge zaroori hai.

a) Knowledge of ISO 14001 Standard

• ISO 14001 ek international standard hai jo Environmental Management

Systems (EMS) ko define karta hai. Yeh organization ko help karta hai apne
environmental impact ko reduce karne mein, aur sustainability practices ko
promote karta hai.

Auditors ko is standard ke har clause ka thorough understanding hona chahiye, taaki

woh organization ke EMS ko uske against evaluate kar sakein.

Key Areas in ISO 14001:

• Environmental Policy: Auditors ko check karna hota hai ki kya organization ke

paas ek effective environmental policy hai jo ISO 14001 ke requirements ko meet
kar raha hai.

• Risk Management: Auditors ko organization ke environmental risks aur

opportunities ke baare mein pata hona chahiye aur evaluate karna hota hai ki yeh
risks kaise manage kiye ja rahe hain.

• Legal Compliance: Kya organization apne legal aur regulatory requirements ko

follow kar raha hai?

Example: Agar ek factory ko water pollution control ke rules follow karne hain, toh
auditor ko check karna padega ki unhone proper water treatment plant install kiya hai ya
nahi.

b) Knowledge of Audit Guidelines (ISO 19011)

• ISO 19011 audit guidelines provide karta hai for conducting management system
audits. Yeh ek framework deta hai jisme audit planning, execution, and reporting
ko streamline kiya jata hai.

Auditors ko yeh guidelines ko follow karna padta hai taaki unka audit process structured
aur professional ho.

Key Points in ISO 19011:

• Audit Principles: Integrity, fair presentation, and due professional care ka

importance samajhna hota hai.

• Audit Planning: Kis tarah se audit ko plan kiya jaye taaki saare necessary
processes cover ho sakein.
 • Communication Skills: Auditors ko effective communication maintain karna
hota hai auditee organization ke saath, taaki audit objectives clear ho.

c) Knowledge of Industry Sector & Organization’s Processes

• Industry-specific Knowledge: Auditors ko us sector ke practices ka deep

understanding hona chahiye jisme organization operate karta hai. Jaise
manufacturing, healthcare, finance, etc. Industry ke risks, best practices aur
compliance requirements auditor ko pata hone chahiye.

Example: Ek auditor agar automobile industry ko audit kar raha hai, toh usko pollution
control mechanisms, waste management practices aur energy efficiency ke methods
ka knowledge hona chahiye.

• Organization-Specific Processes: Auditors ko organization ke specific

operations ke baare mein bhi pata hona chahiye. Unhe samajhna hota hai ki
organization ka workflow kya hai, kaunse inputs aur outputs generate ho rahe
hain, aur environment par iska kya impact hai.

Auditing Skills Required for Auditor

Knowledge ke saath auditor ke paas strong auditing skills bhi hone chahiye. Yeh skills
ensure karte hain ki audit smoothly aur effectively conduct ho sake.

a) Planning the Audit

• Planning ek auditor ke liye sabse pehla aur important step hota hai. Auditor ko
pehle se audit ka scope define karna hota hai, kis area ka audit hoga, kaunse
resources chahiye, aur time schedule kya hoga.

Key Aspects of Planning:

• Scope & Objectives: Auditor ko pehle se audit ka scope decide karna hota hai,
jaise ki kaunse processes audit kiye jayenge, aur audit ka objective kya hai.

• Audit Team Selection: Agar ek team of auditors hai, toh roles assign karna,
responsibilities define karna aur team members ko prepare karna zaroori hota
hai.

Example: Agar ek large-scale factory ka audit ho raha hai, toh auditor ko pehle decide
karna hoga ki production line ka audit kaise hoga, kaunse departments cover honge,
etc.

b) Conducting the Audit

• Audit conduct karna means physically going to the organization, interviewing

employees, reviewing documents, and inspecting processes.
Key Skills for Conducting:

• Interviewing: Auditors ko organization ke staff se interview lena hota hai taaki

unhe processes ke baare mein samajh aaye. Unhe effective questioning skills ka
use karna hota hai.

• Observation: Auditor ko keen observation karni hoti hai to identify any non-
conformities (NCs) ya potential improvement areas.

Example: Auditor ko check karna hota hai ki kya factory ke workers environment-
friendly practices follow kar rahe hain, aur yeh observe karna padta hai ki unka waste
disposal process efficient hai ya nahi.

c) Reporting the Audit

• Audit Report likhna ek skill hota hai. Report clear aur detailed honi chahiye,
jisme saare findings, non-conformities, aur suggested improvements ko include
kiya jaye.

Key Reporting Skills:

• Clarity & Detail: Report ko simple language mein likhna hota hai taaki sab
samajh sakein. Saath hi findings ko clearly present karna hota hai.

• Actionable Recommendations: Auditor ko suggest karna hota hai ki kaunse

areas mein improvement chahiye, aur steps kya ho sakte hain for corrective
actions.

d) Closing the Audit

• Audit ko close karna ka matlab hota hai ki jo corrective actions suggest kiye
gaye the, unhe implement karna aur follow-up audits karna agar zaroorat pade.

Key Closing Skills:

• Follow-up: Auditor ko ensure karna hota hai ki jo improvements recommend kiye

gaye hain, unhe implement kiya gaya hai ya nahi.

• Continuous Improvement: Auditor ko organization ke QMS ya EMS ko

continuously improve karne ke opportunities identify karni chahiye.

Maintenance and Improving Auditor Competence

Ek auditor ka competence static nahi hona chahiye, balki woh continuous learning aur
improvement process hona chahiye. Auditors ko constantly apne skills aur knowledge
ko refresh karna chahiye taaki woh updated rahein latest standards, guidelines, aur
industry practices ke saath.
a) Training and Development

• Ongoing Training: Auditors ko regular training programs mein participate karna

chahiye. Isme new auditing techniques, updated ISO standards, aur latest tools
aur technologies ke baare mein learning hoti hai.

Example: Agar ISO 14001 mein koi naya amendment aata hai, toh auditor ko us change
ke baare mein timely update hona chahiye, aur training attend karna chahiye.

b) Experience & Exposure

• Experience ek bohot important factor hota hai auditor competence ke liye. Jitna
zyada experience auditor ko milega alag-alag industries aur processes ka audit
karne ka, utna hi woh competent banega.

Exposure to different types of audits (internal, external, supplier, environmental)

enhance karta hai auditor ki ability to understand diverse processes aur risks.

Conclusion

Ek competent auditor ke paas ISO standards, industry processes, aur audit

guidelines ka deep knowledge hona chahiye, saath hi unke pass strong auditing skills
hone chahiye taaki woh audits effectively plan, conduct, report, aur close kar sakein.
Competence ko maintain karna aur improve karna ek continuous process hai, jo
training, experience, aur learning ke through achieve kiya jata hai.
Exercise 6: Auditing the Requirements of ISO 9001:2015 - Clause 6: Planning

Clause 6 – Planning of ISO 9001:2015 focuses on how an organization plans its quality
management system (QMS) to ensure the achievement of intended outcomes and risk
management. It specifically deals with Hazard Identification and Risk Assessment
under the framework of quality planning.

1. Planning for the Quality Management System

Clause 6 ke andar organization ko apne QMS ke objectives ko plan aur define karna hota
hai. Iska main aim hota hai ki quality ko consistently maintain karna, aur jo risks aur
uncertainties organization face kar rahi hai, unhe address karna.

Planning Includes:

• Quality Objectives: Organization ko apne quality-related goals set karne hote

hain. Jaise customer satisfaction ko improve karna, product defects ko minimize
karna, etc.

• Risk Management: Isme un sab risks ko identify karna hota hai jo quality ko
impact kar sakte hain, aur phir in risks ke liye suitable mitigation plans banane
hote hain.

2. Hazard Identification and Risk Assessment

• Hazard Identification ka matlab hai un sab cheezon ko identify karna jo kisi

product, service, ya process ki quality ko compromise kar sakti hain.

Example: Ek manufacturing unit mein agar raw materials poor quality ke hain, toh yeh
ek hazard hai jo final product ki quality ko affect karega.

• Risk Assessment is process mein hazards ko evaluate kiya jata hai taaki unka
impact aur likelihood samjha ja sake. Risk assessment ke basis par organization
control measures plan karti hai.

Key Auditing Points for Clause 6:

• Objective Evaluation: Auditor ko dekhna hota hai ki organization ne apne

objectives achhi tarah se define kiye hain ya nahi. Kya objectives measurable
hain? Kya unhe achieve karne ke liye resources available hain?

• Risk Identification: Auditor ko ensure karna hota hai ki organization ne apne

QMS se related risks ko properly identify kiya hai.

• Risk Mitigation: Auditor check karta hai ki kya organization ne risks ke liye
effective mitigation strategies develop ki hain. Agar nahi, toh corrective actions
suggest kiye jate hain.
Exercise 7: Auditing the Requirements of ISO 9001:2015 - Clause 7: Support

Clause 7 – Support ka main focus hota hai ki organization ke paas apni QMS processes
ko support karne ke liye saare necessary resources available hain. Isme human
resources, infrastructure, communication systems aur documentation management ki
baat hoti hai.

1. Resources for the QMS

Is clause ke andar organization ko apne QMS ke liye sufficient resources allocate karne
hote hain. Yeh resources include karte hain:

• People: Kya organization ke paas skilled aur trained staff available hai jo QMS ko
support kar sake?

• Infrastructure: Kya organization ke paas infrastructure available hai jo quality

objectives ko achieve karne mein madad kar sake? Isme equipment, tools,
buildings, aur technology sab included hain.

• Environment: Yeh check kiya jata hai ki working environment suitable hai ya
nahi. Kya work conditions quality ko promote kar rahi hain ya nahi?

2. Competence & Training

• Competence: Kya employees ke paas woh knowledge aur skills hain jo unhe
unka kaam efficiently aur effectively karne ke liye chahiye?

• Training: Agar koi skill gap hai, toh organization training provide kar rahi hai ya
nahi? Is training ka impact organization ki performance par kaise ho raha hai?

Example: Agar ek manufacturing company mein machine operators ke paas proper

training nahi hai, toh unka kaam product quality ko negatively affect kar sakta hai.

3. Communication

• Effective communication kaise ho raha hai? Kya employees tak QMS related
important information timely aur clearly communicate ki ja rahi hai? Auditor
check karta hai ki organization ke paas ek proper communication system hai ya
nahi.

4. Documented Information

Is clause ke under document control aur record management bohot important

aspects hote hain. Auditor ko yeh dekhna hota hai ki kya organization apne quality
records ko properly maintain kar rahi hai, jaise audits ke records, non-conformities ke
reports, etc.
Key Auditing Points for Clause 7:

• Resource Availability: Auditor check karta hai ki organization ke paas apne QMS
ko support karne ke liye sufficient resources hain ya nahi.

• Training Programs: Auditor ko ensure karna hota hai ki employees ke liye regular
training programs conduct kiye ja rahe hain.

• Document Control: Auditor ko organization ke document control practices

evaluate karne hote hain. Kya documents properly maintained aur updated hain?

Exercise 8: Auditing the Requirements of ISO 9001:2015 - Clause 8: Operations

Clause 8 – Operations ka main focus hota hai ki organization apne daily operations ko
kaise manage kar rahi hai taaki customer requirements meet ho sakein aur
product/service ki quality maintained rahe.

1. Operational Planning and Control

Yeh ensure karta hai ki organization ne apne operational processes ko effectively plan
aur control kiya hai. Yeh har step define karta hai from product/service development to
delivery.

Key Aspects:

• Operational Procedures: Auditor ko dekhna hota hai ki kya organization ke paas

standard operating procedures (SOPs) hain jo kaam ko streamline karte hain.

• Process Control: Auditor ensure karta hai ki organization apne processes ko

effectively control kar rahi hai. Agar koi non-conformance hoti hai, toh usse kaise
handle kiya jata hai?

2. Requirements for Products and Services

Is part mein organization ke products aur services ke requirements ko audit kiya jata hai.
Kya products aur services customers ke expectations ko meet kar rahe hain? Kya koi
customization ki zaroorat hai?

3. Design and Development

Agar organization new products ya services develop kar rahi hai, toh auditor ko ensure
karna hota hai ki design aur development process properly followed ho raha hai ya nahi.
Isme customer feedback, testing, aur continuous improvement ke factors included
hain.
4. Control of Externally Provided Products and Services

Kya organization jo products ya services outside suppliers se le rahi hai, unka quality
control sahi se ho raha hai? Auditor check karta hai ki suppliers ke products ko proper
inspection aur validation ke through pass kiya jata hai ya nahi.

5. Non-Conforming Outputs

• Non-conformance ka matlab hota hai ki agar koi product ya service expected

quality ko meet nahi kar raha, toh usse kaise manage kiya jata hai. Auditor ko
ensure karna hota hai ki organization ke paas proper non-conformance handling
process hai.

Key Auditing Points for Clause 8:

• Process Control: Auditor check karta hai ki operational processes well-defined

aur well-controlled hain ya nahi.

• Product/Service Quality: Auditor ko ensure karna hota hai ki organization ke

products aur services customer requirements ko meet kar rahe hain.

• Non-conformance Handling: Auditor ensure karta hai ki non-conforming

products ko properly segregate kiya ja raha hai aur corrective actions liye ja rahe
hain.

Conclusion

In exercises 6, 7, and 8, we focused on auditing the key aspects of planning, support,

and operations under the ISO 9001:2015 standard. Clause 6 focuses on risk
management and planning, Clause 7 on providing necessary resources and support,
and Clause 8 on managing day-to-day operations to ensure quality objectives are met.
Auditors need to evaluate these areas carefully to ensure the organization's QMS is
compliant and efficient.
 Day 3
Exercise 9: Auditing the Requirements of ISO 9001:2015 - Clause 9: Performance
Evaluation

Clause 9 – Performance Evaluation ka focus organization ke quality management

system (QMS) ke performance ko monitor aur evaluate karne par hota hai. Is clause ka
main objective hota hai ki organization ko apne QMS ke effectiveness aur efficiency ka
pata chale.

1. Monitoring, Measurement, Analysis, and Evaluation

Iske andar yeh define kiya gaya hai ki organization kaise apne QMS ke processes aur
performance ko monitor aur measure karegi.

• Monitoring: Iska matlab hai ki processes ko regular intervals par track karna.
Isme key performance indicators (KPIs) define karne hote hain jo organization ki
success ko measure karne mein madad karte hain.

• Measurement: Iska matlab hai ki organization ko apne processes ke results ko

quantify karna hoga. Yeh metrics ya data collect karne se hota hai.

Example: Ek manufacturing company ke liye, production efficiency ya customer

complaints ka number measure kiya ja sakta hai.

• Analysis: Data ko analyze karna taaki trends aur patterns ko samjha ja sake. Is
analysis ki madad se improvement opportunities identify kiye ja sakte hain.

Example: Agar kisi product ke liye customer complaints badh rahe hain, toh analyze
karna hoga ki iska reason kya hai.

• Evaluation: Performance ko evaluate karna aur determine karna ki kya

objectives meet ho rahe hain ya nahi. Isme comparative analysis bhi ho sakta
hai.

2. Internal Audit

Clause 9 ka ek important aspect internal audit hai. Internal audits organization ko yeh
samajhne mein madad karte hain ki kya unka QMS effective hai ya nahi.

• Frequency: Audits ko regular intervals par conduct karna hota hai.

• Planning: Auditor ko audit plan banate waqt risk-based approach rakhni

chahiye.
3. Management Review

Management review ek formal process hai jisme senior management organization ke

QMS ki performance ka review karta hai. Is review ka focus hota hai:

• Effectiveness: Kya QMS effectively kaam kar raha hai?

• Resource Needs: Kya organization ke paas required resources hain?

• Continual Improvement: Kya organization mein continuous improvement ki

culture develop ho rahi hai?

Key Auditing Points for Clause 9:

• Performance Metrics: Auditor ko dekhna hoga ki kya organization ne relevant

KPIs define kiye hain aur kya unhe monitor kiya ja raha hai.

• Audit Process: Auditor ko ensure karna hoga ki internal audits sahi tarike se
conduct kiye ja rahe hain aur unka outcome analyze kiya ja raha hai.

• Management Review Records: Auditor ko management review ke records

evaluate karne honge taaki yeh samajh sake ki kya senior management actively
QMS ki performance ko monitor kar raha hai.
Exercise 10: Auditing the Requirements of ISO 9001:2015 - Clause 10:
Improvements

Clause 10 – Improvements ka focus organization ki QMS ke continuous improvement

par hota hai. Iska goal hota hai ki organization apne processes aur performance ko
improve karne ke liye initiatives le.

1. Non-Conformity and Corrective Action

Agar koi non-conformance hoti hai, toh organization ko uska proper documentation aur
corrective action lena hota hai.

• Non-Conformity: Jab koi product ya service expected quality standards ko meet

nahi karti, usse non-conforming output kaha jata hai.

• Corrective Actions: Non-conformance ke baad organization ko analyze karna

hota hai ki yeh kyun hui aur isse prevent karne ke liye kya actions lene hain.

Example: Agar ek product mein defect aata hai, toh organization ko identify karna hoga
ki production process mein kya kami thi.

2. Continual Improvement

Yeh organization ki performance ko enhance karne ki ongoing process hai. Isme

different strategies aur methodologies include ki ja sakti hain, jaise:

• Kaizen: Continuous improvement philosophy jo small, incremental changes par

focus karti hai.

• PDCA (Plan-Do-Check-Act): Is framework ka use karke organization apne

processes ko evaluate aur improve kar sakti hai.

3. Preventive Actions

Preventive actions woh actions hote hain jo organization lete hain taaki future mein
potential non-conformities se bacha ja sake.

Example: Agar kisi product line par defects ka trend identify hota hai, toh organization
uss line ko upgrade karne ya employee training improve karne ka plan bana sakti hai.

Key Auditing Points for Clause 10:

• Non-Conformance Handling: Auditor ko check karna hoga ki organization ne

non-conformities ko identify aur document kiya hai ya nahi.

• Corrective Action Records: Auditor ko ensure karna hoga ki corrective actions

ka proper implementation hua hai aur unka effectiveness monitor kiya gaya hai.
 • Improvement Initiatives: Auditor ko evaluate karna hoga ki kya organization ke
paas koi structured approach hai jo continuous improvement ko support karta
hai.

Exercise 11: Stage 1 Document Review - Report Preparation

Stage 1 Document Review ka process kisi bhi audit ka pehla step hota hai, jisme
auditor organization ke documented information ko evaluate karta hai. Yeh stage audit
ki planning aur preparation ke liye crucial hoti hai.

1. Purpose of Stage 1 Audit

Stage 1 audit ka main objective hota hai:

• Readiness Assessment: Kya organization audit ke liye ready hai ya nahi.

• Documentation Review: Organization ke QMS documents ko review karna, taaki

yeh dekha ja sake ki kya yeh ISO 9001:2015 standards ko meet karte hain.

• Identifying Gaps: Kya koi gaps hain jinke wajah se audit successful nahi ho
payega.

2. Document Review Process

• Documented Information: Auditor ko organization ke quality manual,

procedures, work instructions, records, aur policies ko review karna hota hai.

Key Documents Include:

• Quality Policy: Kya organization ka quality policy clearly defined hai?

• Objectives: Quality objectives kya hain aur kya woh measurable hain?

• Processes and Procedures: Kya organization ne apne processes aur

procedures ko document kiya hai?

• Understanding Context: Auditor ko organization ka context samajhna hoga,

jaise stakeholders, internal and external issues, etc.

3. Report Preparation

Document review ke baad, auditor ko ek detailed report prepare karna hota hai. Is report
mein following elements included hone chahiye:

• Findings: Auditor ke findings ko summarize karna.

• Identified Gaps: Kya koi gaps hain jo audit ke time pe address karne hain.
 • Recommendations: Auditor ko improvement suggestions dene chahiye jo
organization ko help kar sakte hain.

• Preparation for Stage 2 Audit: Kya organization ko stage 2 audit ke liye prepare
hone ki zaroorat hai ya nahi.

Conclusion: Stage 1 document review organization ke liye critical hota hai taaki woh
apne QMS ki effectiveness aur compliance ko evaluate kar sake. Is process ki madad se
auditor organization ki readiness ka assessment karte hain, jo ultimately stage 2 audit
ke liye foundation ready karta hai.

Summary

In exercises 9, 10, and 11, we explored the importance of performance evaluation,

improvement, and the document review stage in the context of ISO 9001:2015.
Clause 9 focuses on how organizations can monitor and evaluate their QMS
performance, while Clause 10 emphasizes continuous improvement and corrective
actions. The Stage 1 document review process is crucial for assessing an organization’s
readiness for a formal audit, ensuring that necessary documents are in place and
End of Document Audit (Stage 1) – Good Glass Company Apex Documented
Information

Document Audit ka yeh phase kisi bhi organization ke quality management system
(QMS) ke liye bohot zaroori hota hai, kyunki yeh organization ki documentation ko
evaluate karta hai aur yeh ensure karta hai ki sab kuch ISO 9001:2015 standards ke
hisaab se aligned hai. Is context mein, "Good Glass Company" ke documented
information ka audit conduct karna humara focus hai.

1. Purpose of Document Audit

Stage 1 Document Audit ka purpose hai:

• Readiness Assessment: Audit ke liye organization ki readiness ko assess karna.

• Compliance Check: Documented information ki compliance ko verify karna

against ISO 9001:2015 requirements.

• Identify Gaps: Koi bhi gaps ya shortcomings identify karna jo future audits ke liye
issues create kar sakte hain.

2. Documented Information Categories

Good Glass Company ki documented information ko review karne ke liye, auditor ko

kuch key categories par focus karna hota hai:

• Quality Manual: Kya organization ka quality manual clearly define karta hai uske
QMS ke scope ko aur relevant policies ko?

• Procedures: Procedures ka documentation kaisa hai? Kya yeh well-defined aur

easily understandable hain?

• Work Instructions: Kya specific work instructions hain jo employees ko unke

roles aur responsibilities ke liye guide karte hain?

• Records: Kya records ka maintenance sahi tarike se kiya gaya hai, jaise audit
records, training records, corrective action records, etc.?

3. Key Audit Points

• Documentation Requirements: ISO 9001:2015 ke according documentation ki

kya requirements hain, aur kya Good Glass Company inhe fulfill karti hai?

Example:

o Quality Policy: Kya yeh clearly defined hai aur sab stakeholders ko
communicate kiya gaya hai?

o Objectives: Kya quality objectives measurable hain aur review kiye ja

rahe hain?
 • Document Control: Document control process ko review karna, jaise:

o Version Control: Kya documents ke versions ko track kiya ja raha hai?

o Access Control: Kya documents ko access karne ke liye proper controls

hain?

• Compliance with ISO Standards: Kya documentation ISO 9001:2015 standards

ko meet kar raha hai?

4. Findings and Observations

Audit ke dauraan kuch findings aur observations ko note karna zaroori hai:

• Strengths:

o Good Glass Company ne apne quality manual aur procedures ko

effectively document kiya hai, jo clarity aur compliance ko enhance karte
hain.

o Regular updates aur training sessions ki wajah se employees ko quality

policy aur objectives ka pata hai.

• Areas for Improvement:

o Kuch procedures outdated hain aur inhe update karne ki zaroorat hai taaki
wo current practices ke saath aligned ho sakein.

o Document control system mein kuch gaps hain jisse ye ensure nahi hota
ki sabhi employees ko latest documents ka access hai.

5. Recommendations

Audit ke outcomes ke basis par kuch recommendations deni chahiye:

• Document Review and Update: Good Glass Company ko apne procedures ko

regularly review aur update karna chahiye taaki inhe current industry standards
aur practices ke saath align kiya ja sake.

• Improve Document Control Process: Document control process ko enhance

karna chahiye, taaki access aur version control ko ensure kiya ja sake.

6. Conclusion

Stage 1 Document Audit ka yeh process Good Glass Company ke liye bohot important
hai, kyunki yeh organization ko apne QMS ki effectiveness ko evaluate karne mein
madad karta hai. Is audit ke results aur recommendations ko consider karte hue, Good
Glass Company apne QMS ko continuously improve karne ki taraf kadam utha sakti hai,
jo ultimately customer satisfaction aur compliance ko enhance karega.
Is prakar, yeh Stage 1 Document Audit ka detailed overview hai, jo Good Glass
Company ke context mein document auditing ko highlight karta hai. Is audit ke findings
aur recommendations organization ko apne QMS ko aur bhi mazboot karne mein madad
karte hain.
Attributes, Competence, Roles, and Responsibilities Required of Management
System (MS) Auditors

Management System (MS) auditors ka role organization ke quality management systems

ki effectiveness aur compliance ko evaluate karne mein hota hai. Inki competencies,
attributes, roles, aur responsibilities bahut important hain taaki audit process ko
successfully conduct kiya ja sake.

1. Attributes of MS Auditors

Attributes ka matlab hai wo qualities jo ek auditor mein honi chahiye:

• Integrity: Auditor ko ethical hona chahiye aur honesty se kaam karna chahiye.
Unhe bina kisi bias ke results ko report karna chahiye.

• Open-mindedness: Different perspectives aur viewpoints ko samajhne ki ability.

Auditor ko feedback ko sunna aur accept karna aana chahiye.

• Confidentiality: Auditor ko sensitive information ko confidential rakhna chahiye.

• Assertiveness: Auditor ko apne findings ko confidently present karna aana

chahiye.

• Systematic Approach: Auditing ke process ko structured aur systematic tarike

se follow karna chahiye.

2. Competence of MS Auditors

Competence se matlab hai wo skills aur knowledge jo auditor ko auditing karne ke liye
chahiye:

• Knowledge of Standards: ISO standards (e.g., ISO 9001, ISO 14001) ke bare
mein gyaan hona zaroori hai.

• Audit Techniques: Different audit techniques aur methodologies ko samajhna.

• Industry Knowledge: Auditor ko un industry sectors ki knowledge honi chahiye

jisme wo audit kar rahe hain.

• Interpersonal Skills: Effective communication aur interpersonal skills ki

zaroorat hoti hai taaki stakeholders ke sath achhe se interact kiya ja sake.

• Analytical Skills: Data ko analyze karne ki ability, jo auditor ko findings ko

interpret karne aur report karne mein madad karti hai.

3. Roles of MS Auditors

Roles define karte hain ki auditor ko kya karna hai:

• Audit Planning: Audit ka plan banana, including scope, objectives, and criteria.
 • Conducting Audits: Audit process ko implement karna, including evidence
collection and interviews.

• Reporting Findings: Audit ke findings ko document karna aur stakeholders ko

report karna.

• Follow-up: Corrective actions ke implementation ka follow-up karna taaki

ensure ho sake ki non-conformities address hui hain.

• Training and Mentoring: Naye auditors ko train karna aur unhe guide karna.

4. Responsibilities of MS Auditors

Responsibilities define karte hain ki auditor ka accountability kya hai:

• Preparation: Audit se pehle ki preparation karna, including documentation

review aur team coordination.

• Objectivity: Audit ke dauraan objectivity maintain karna, bina kisi bias ke.

• Evidence Collection: Sahi evidence collect karna jo audit objectives ko meet

karta ho.

• Compliance Verification: Ensure karna ki organization ki practices ISO

standards ke sath compliant hain.

• Feedback Collection: Audit ke dauraan stakeholders se feedback lena aur unki

concerns ko address karna.

Exercise 12: Audit Plan Preparation

Audit plan preparation ek structured approach hai jisse auditor apne audit objectives
aur scope ko define karte hain. Iska main purpose audit process ko systematic aur
effective banana hai.

1. Purpose of Audit Plan

Audit plan ka purpose hai:

• Define Scope: Audit ke scope ko clearly define karna, jo ki kya audit hoga aur
kya nahi hoga.

• Set Objectives: Audit ke objectives ko specify karna, jisse pata chale ki auditor
kya achieve karne ki koshish kar raha hai.

• Resource Allocation: Required resources aur team members ko allocate karna

taaki audit effectively conduct ho sake.
2. Components of an Audit Plan

Ek effective audit plan mein kuch key components hone chahiye:

• Audit Objectives: Clear objectives define karna, jaise compliance verification,

process evaluation, etc.

• Scope of Audit: Audit ka scope kya hoga, isme departments, processes, aur
geographical locations ka inclusion ya exclusion.

• Audit Criteria: Kya standards ya criteria ke against audit conduct kiya jayega,
jaise ISO 9001:2015.

• Audit Schedule: Audit ki timeline aur schedule define karna, jis se sab
stakeholders ko pata ho ki kab audit hoga.

• Team Members: Audit team ki composition aur responsibilities ko define karna.

3. Audit Plan Development Process

Audit plan develop karne ke steps:

1. Preliminary Assessment: Organization ki current practices aur previous audit

findings ka assessment karna.

2. Stakeholder Consultation: Stakeholders se consultation karna taaki unki

expectations aur concerns samjhe ja sake.

3. Drafting the Plan: Plan ko draft karna, jis mein sab components ko include kiya
gaya ho.

4. Review and Approval: Draft audit plan ko review karna aur management se
approval lena.

5. Finalization: Audit plan ko finalize karna aur team members aur stakeholders ke
sath communicate karna.

4. Considerations for Audit Plan Preparation

Audit plan prepare karte waqt kuch considerations dhyan mein rakhni chahiye:

• Risk Assessment: Risk-based approach ko follow karte hue audit priorities set
karna.

• Regulatory Requirements: Kya kuch specific regulations ya standards hain jinke

against audit karna hai?

• Past Audit Performance: Previous audits ke results ko consider karna aur unse
learnings lena.
Conclusion

Management System auditors ke liye attributes, competence, roles, aur responsibilities

ka samajhna zaroori hai taaki wo effectively audits conduct kar sakein. Audit plan
preparation ek crucial step hai jo audit ke success ko ensure karta hai. Ismein clear
objectives, scope, aur timelines define karna bohot zaroori hai, taaki audit process
smooth aur productive rahe.
 Day 4
Exercise 13: Audit Preparation - Audit Checklist

1. Purpose of an Audit Checklist

Audit checklist ka purpose hai audit process ko systematic aur organized banana. Yeh
auditor ko madad karta hai ensure karne mein ki saari necessary aspects ko cover kiya
ja raha hai.

2. Components of an Audit Checklist

Audit checklist mein kuch key components hote hain:

• Audit Criteria: ISO standards, company policies, aur other regulatory

requirements jo audit ke dauraan review kiye jayenge.

• Checklist Items: Specific questions ya items jo auditors ko evaluate karna hoga.

Har item ke saath relevant clauses mention hone chahiye.

• Evidence Requirements: Kya evidence chahiye hoga kisi bhi item ko verify karne
ke liye, jaise records, reports, or documented procedures.

• Remarks/Comments Section: Auditor ko findings ko note karne ka ek space

hona chahiye taaki wo observations ya recommendations ko likh sakein.

3. Sample Checklist Items

Here are some examples of checklist items for ISO 9001:2015 audit:

• Clause 4: Context of the Organization:

o Kya organization ne internal aur external issues ko identify kiya hai?

• Clause 5: Leadership:

o Kya top management quality policy ko communicate karta hai?

• Clause 6: Planning:

o Kya organization ne risk and opportunities ko assess kiya hai?

• Clause 7: Support:

o Kya employees ke training records available hain?

4. Using the Audit Checklist

Audit ke dauraan checklist ka use karte waqt, auditor ko systematically har item ko
review karna chahiye. Agar kisi item mein compliance nahi hai, toh usse note karna
zaroori hai aur subsequent discussions ke liye prepare karna hoga.

Exercise 14: Determine and Write Non-Conformities

1. Understanding Non-Conformities

Non-conformity ka matlab hai kisi requirement ka failure ya violation, jo standards ya

internal policies se align nahi hai. Non-conformities ko record karna aur document
karna zaroori hai, taaki corrective actions implement kiye ja sakein.

2. Types of Non-Conformities

• Minor Non-Conformities: Choti violations jo ki operational efficiency ko

significantly affect nahi karte. Inka timely correction zaroori hai.

• Major Non-Conformities: Yeh significant violations hain jo quality objectives ya

compliance ko serious impact karte hain. Inki zaroorat hai immediate corrective
actions.

3. Writing Non-Conformities

Non-conformities likhne ke liye following format use kiya ja sakta hai:

• Non-Conformity ID: Unique identification number for tracking.

• Description: Clear aur concise description of the non-conformity.

• Evidence: Kya evidence hai jo non-conformity ko support karta hai, jaise

inspection reports, observations, etc.

• Impact: Kya impact hai non-conformity ka on quality, compliance, or operational

effectiveness.

• Proposed Corrective Action: Kya actions liye jayenge is non-conformity ko

address karne ke liye.

Introduce On-Site (Stage 2) Activities

1. Purpose of Stage 2 Audit

Stage 2 audit ka objective hai ki organization ke QMS ki effectiveness ka detailed

assessment kiya jaye. Is stage mein auditors on-site visit karte hain taaki organization ki
practices aur processes ko evaluate kar sakein.
2. Key Activities during Stage 2 Audit

• Opening Meeting: Audit ki shuruaat ek opening meeting se hoti hai, jisme audit
objectives, scope, schedule aur key personnel ko discuss kiya jata hai.

• On-Site Observations: Auditors organization ke processes ko observe karte

hain, records aur documentation ko review karte hain.

• Interviews: Auditors relevant personnel se interviews karte hain taaki unki roles,
responsibilities aur practices ko samjha ja sake.

• Evidence Collection: Collecting evidence from documents, records, and

physical observations.

• Reporting: Findings aur non-conformities ko document karna aur audit report

tayaar karna.

Audit Questioning Techniques, Gathering, and Verifying Information

1. Effective Questioning Techniques

• Open-Ended Questions: Aise questions jo detailed responses ki taraf le jate

hain, jaise “Can you explain how you handle customer complaints?”

• Closed Questions: Aise questions jo simple “Yes” ya “No” ke responses dete

hain, jaise “Do you have a documented procedure for handling complaints?”

• Probing Questions: Aise questions jo kisi specific point ko detail mein samjhne
ke liye hote hain, jaise “Can you give an example of how this procedure was
followed?”

2. Gathering Information

• Documentation Review: Relevant records aur documents ko analyze karna.

• Observations: Processes aur activities ka on-site observation.

• Interviews: Staff se unke processes aur roles ke bare mein discuss karna.

3. Verifying Information

Information verify karne ke liye auditors ko ensure karna chahiye ki collected evidence
reliable hai. Yeh evidence direct observation, documents, ya witness statements se ho
sakta hai.

Opening Meeting and Mock Opening Meeting

1. Opening Meeting

Opening meeting ka aim hai audit ke objectives, scope, aur schedule ko clear karna. Yeh
meeting audit team, management aur key personnel ke beech hoti hai.

Key Elements of Opening Meeting:

• Introduction of Audit Team: Audit team ke members ka introduction.

• Audit Scope and Objectives: Audit ke scope aur objectives ko define karna.

• Schedule: Audit schedule ko discuss karna, including timing for interviews and
observations.

2. Mock Opening Meeting

Mock opening meeting ek training activity hai jahan auditors audit process aur opening
meeting ka practice karte hain. Yeh unhe prepare karta hai real scenarios ke liye.

Audit Process, Non-Conformities, and Its Classifications

1. Audit Process Overview

Audit process typically kuch steps mein divide hota hai:

• Preparation: Audit plan tayaar karna aur checklist ready karna.

• Conducting the Audit: Opening meeting, on-site observations, evidence

collection, and interviews conduct karna.

• Reporting: Findings ko document karna aur audit report tayaar karna.

2. Non-Conformities

As previously discussed, non-conformities audits ke dauraan identify kiye jate hain.

Inhe record karna zaroori hota hai taaki corrective actions liye ja sakein.

3. Classifications of Non-Conformities

• Minor Non-Conformities: Operational procedures mein choti violations.

• Major Non-Conformities: Significant lapses jo organization ke QMS ke

effectiveness ko impact karte hain.

Conclusion

Yeh detailed overview hai audit preparation, non-conformities, on-site activities,

questioning techniques, opening meetings, aur audit process ke bare mein. Effective
auditing ke liye in aspects ko achhe se samajhna aur implement karna zaroori hai, taaki
quality management systems ko optimize kiya ja sake. Agar aapko in topics par aur
detail chahiye ya koi specific area discuss karna hai, toh aap mujhe bata sakte hain!
Exercise 15: Role Play (Audit Interview Process & Recording NCs)

1. Purpose of Role Play

Role play ka objective hai participants ko ek realistic environment mein audit interview
process samjhane ka mauka dena. Is exercise se participants ko practical experience
milega, jo unhe real-world audits ke dauraan hone wale scenarios ko handle karne mein
madad karega.

2. Setup of Role Play

Group Formation

• Divide Participants: Groups ko 4-5 members mein divide karein, ensuring ki har
group mein alag-alag departments represented ho.

o Suggested Departments:

▪ Quality Assurance: Jo quality control measures aur standards par

dhyan dete hain.

▪ Production: Jo manufacturing processes aur product quality ko

manage karte hain.

▪ Customer Service: Jo customer interactions aur complaints

handle karte hain.

▪ HR: Jo employee training aur performance management ko

oversee karte hain.

Roles Assignment

• Auditor: Unka role hoga ki wo questions puchhein aur interviews conduct karein.
Unhe neutral aur professional rehna hoga.

• Interviewee: Department ke representative jo information share karega.

• Observer: Ek observer ko assign karein jo process ko dekhega aur feedback

dega.

3. Conducting the Role Play

Audit Interview Process

Opening the Interview:

• Introduction: Auditor ko apna parichay dena chahiye, jaise unka naam, position,
aur audit ka purpose.

o Example: "Hello, main [Auditor's Name] hoon, aur main aaj is audit ka
purpose samjhane ke liye yahan hoon."
Setting Expectations:

• Clarify Objectives: Audit ke objectives ko clearly define karna.

o Example: "Hum is interview mein quality management processes ko

evaluate karenge aur compliance check karenge."

Asking Questions:

• Auditor ko questions puchhne chahiye jo specific aur relevant hon. Questions ko

achhe se prepare karna hoga.

o Examples of Effective Questions:

▪ "Kya aapne quality control procedures ke liye documented policies

tayaar ki hain?"

▪ "Kya employees ko regular training di jati hai, aur unke records

kahan hain?"

Recording Non-Conformities (NCs)

Identifying Non-Conformities:

• Agar kisi answer se pata chalta hai ki compliance nahi hai, toh auditor ko usse
note karna hoga.

o Example: Agar HR ne bataya ki training records absent hain, toh yeh ek

non-conformity hai.
Documentation:

• Sample Format for NC Documentation:

Non- Proposed
Conformity Department Description Evidence Impact Corrective
ID Action

Training
Interview Lack of Implement a
records not
notes, trained staff training record
001 HR available for
missing may lead to management
new
records errors. system.
employees.

Quality control
Develop and
procedures not Risk of
Quality implement a
002 documented Observations inconsistent
Assurance documented
for certain quality.
procedure.
products.

Regular Potential
Create a
maintenance machinery
maintenance
003 Production not recorded Missing logs failure could
schedule and
for critical disrupt
log.
machinery. production.

No Establish a
documented Delay in documented
Customer Interview
004 response time customer complaint
Service response
for customer satisfaction. handling
complaints. process.

Debriefing:

• Role play ke baad, har group ko findings present karne ka mauka milega. Yeh
process unhe feedback aur improvement suggestions ko samjhne mein madad
karega.
Exercise 16: Keywords Approach in QMS

Keywords approach ka istemal Quality Management System (QMS) mein ek effective

strategy hai jo key concepts ko samajhne aur yaad rakhne mein madad karta hai. Is
approach ka main maksad hai ki key terms aur unke meanings ko identify karke unhein
better samjha ja sake, taaki quality management principles ko effectively implement
kiya ja sake.

1. Keywords ka Importance

• Clarity aur Focus: Keywords ko identify karne se humein clarity milti hai ki hum
kis topic par kaam kar rahe hain. Yeh focus banaye rakhne mein bhi madad karta
hai, taaki hum important points ko miss na karein.

• Memory Aids: Keywords yaad rakhne mein asani hoti hai. Jab hum kisi complex
topic ko keywords ke through samajhte hain, toh humari memory bhi strong hoti
hai, aur hum jaldi se relevant information recall kar sakte hain.

• Effective Communication: Quality management ki field mein communication

bahut zaroori hai. Keywords ko samajhne se hum apne thoughts aur ideas ko
achhe se communicate kar sakte hain.

2. Key Keywords in QMS

Kuch key keywords hain jo QMS mein bahut important hain:

• Quality: Yeh term product ya service ki ability ko describe karta hai ki kya wo
customer ki expectations ko pura karti hai.

• Management: Iska matlab hai kisi organization ke resources (log, processes,

materials) ko effectively coordinate aur control karna.

• System: Yeh ek aisa structured framework hai jisme processes, people, aur
technology judte hain taaki quality objectives achieve kiye ja sakein.

• Continual Improvement: Yeh process hai jisme quality practices ko regular

basis par improve kiya jata hai taaki organization ki performance ko enhance kiya
ja sake.

• Customer Satisfaction: Yeh focus karta hai customer ki needs aur expectations
par, jisse ki product ya service unki ummeedon par khari utar sake.

• Non-Conformity: Yeh term use hota hai jab kisi product ya service ne quality
standards ya specifications ko meet nahi kiya.

• Corrective Action: Yeh wo action hai jo non-conformity ko address karne ke liye

liya jata hai taaki future mein waisa na ho.
 • Audit: Yeh ek systematic examination hai jo quality management system ki
effectiveness ko assess karne ke liye kiya jata hai.

3. Keywords Approach ka Implementation

Step 1: Identify Keywords

• Sabse pehle, QMS ke relevant documents, jaise ISO 9001:2015 standard, quality
manuals, aur policies ko padhkar important keywords ko identify karein.

Step 2: Create a Keywords List

• Ek list banayein jisme aap identified keywords ko likhein. Ismein unka brief
definition ya explanation bhi include karein.

Step 3: Use Mnemonics

• Keywords ko yaad rakhne ke liye mnemonics ka use karein. Jaise, agar aapko
"Customer Satisfaction" yaad rakhna hai, toh "CS" ya "Happy Customer" jaisa
mnemonic create karein.

Step 4: Regular Review

• Keywords ki list ko regularly review karein. Isse aap unhein yaad rakhne aur unki
understanding ko improve karne mein madad milegi.

Step 5: Discussion and Application

• Team ke sath in keywords par discussion karein aur unhein practical scenarios
mein apply karne ki koshish karein. Isse aapko aur clarity milegi ki in keywords ka
real-world mein kya importance hai.

4. Conclusion

Keywords approach QMS mein ek powerful tool hai jo quality management ke concepts
ko samajhne aur yaad rakhne mein madad karta hai. Yeh approach na sirf learning ko
enhance karta hai balki effective communication aur implementation ko bhi support
karta hai. Isse aap QMS practices ko better apply kar sakte hain aur organization ki
overall performance ko improve karne mein contribute kar sakte hain.
 Day 5
Exercise 16: Keywords Approach in QMS - Detailed Explanation

Keywords approach ka istemal Quality Management System (QMS) mein karne se

concepts ko samajhne aur yaad rakhne mein bahut madad milti hai. Is approach ka
main goal hai ki important terms aur unke meanings ko clearly define kiya ja sake, taaki
quality management principles ko effectively apply kiya ja sake. Chaliye, is approach ko
aur detail se samjhte hain:

1. Keywords Approach Kya Hai?

Keywords Approach ka matlab hai quality management ke key terms ko identify karna,
unhein samajhna aur unka istemal karna. Yeh approach aapko ek structured framework
provide karta hai jo aapko quality standards aur practices ko effectively manage karne
mein madad karta hai. Yeh process har organization ke liye beneficial hai kyunki isse
clarity, focus, aur understanding badhti hai.

2. Keywords ki Importance

• Conceptual Clarity: Jab aap QMS ke key concepts ko keywords ke through

define karte hain, toh aapko ek clarity milti hai ki aap kis area par kaam kar rahe
hain. Yeh clarity aapko quality objectives ko set karne aur achieve karne mein
madad karti hai.

• Memory Retention: Keywords ko yaad rakhna asaan hota hai. Jab aap kisi
complex topic ko keywords ke through samajhte hain, toh aap unhein easily
recall kar sakte hain, jo learning aur application mein helpful hota hai.

• Effective Communication: Quality management ke field mein communication

zaroori hai. Keywords ko samajhne se aap apne thoughts aur ideas ko effectively
communicate kar sakte hain, jo teamwork aur collaboration mein bhi madad
karta hai.

3. Keywords ko Identify Karna

A. Documentation Analysis

• Quality Standards: Jaise ISO 9001:2015, aapko in standards ko padhkar

important keywords identify karne honge. Ismein "Quality", "Non-Conformity",
"Corrective Action", "Leadership", aur "Continuous Improvement" jaise terms
shamil ho sakte hain.

• Internal Policies: Organization ke internal documents, quality manuals, aur

procedures ko review karke bhi keywords identify kiye ja sakte hain.
B. Team Collaboration

• Brainstorming Sessions: Team ke sath brainstorming sessions conduct karein

jahan sabhi members apne perspectives se keywords discuss karein. Yeh
sessions aapko diverse viewpoints denge aur important terms ko aur better
samajhne mein madad karenge.

C. Industry Research

• Best Practices: Industry mein best practices ko analyze karein. Isse aap
industry-specific keywords identify kar sakte hain jo aapki organization ke liye
relevant hain.

4. Keywords ki List Banana

Ek baar aap keywords identify kar lete hain, toh unki ek list tayyar karein. Is list mein har
keyword ke saath uska definition ya brief explanation bhi shamil karein. Yeh list aapke
liye reference material ban jayegi.

Example Keywords List:

Keyword Definition

Product ya service ki ability jo customer ki expectations ko

Quality
fulfill kare.

Jab product ya service quality standards ya specifications ko

Non-Conformity
meet nahi karta.

Actions jo non-conformity ko address karne ke liye liye jaate

Corrective Action
hain.

Continual
Regular basis par quality practices ko improve karna.
Improvement

Customer
Customer ki needs aur expectations par focus karna.
Satisfaction

Quality management ko achieve karne ke liye effective

Leadership
leadership ka role.

Performance
Organizational performance ko assess karne ka process.
Evaluation
5. Keywords Approach ka Implementation

Step 1: Training Material Development

• Training Modules: Keywords ko training materials mein shamil karein. Har

training module ke end par keywords ki list rakhein jisse participants concepts ko
aur achhe se samajh sakein.

Step 2: Awareness Programs

• Internal Campaigns: Quality awareness programs conduct karein jahan

keywords ko highlight kiya ja sake. Yeh programs employees ko quality
management ki importance samjhaenge.

Step 3: Performance Metrics

• KPIs ka Link: Keywords ko performance indicators ke sath link karein. Jaise,

"Customer Satisfaction" ke liye aap customer feedback score ko KPI bana sakte
hain.

Step 4: Continuous Review

• Regular Review Sessions: Keywords ki list ko regularly review karein. Isse aapko
ensure karna hai ki aap latest trends aur practices se updated hain.

6. Keywords Approach ke Benefits

A. Enhanced Learning and Understanding

• Quick Learning: Keywords approach se aap jaldi se concepts samajh sakte hain
aur unhein yaad rakhne mein madad milti hai. Is approach se aapko key points
ko summarize karna aasan hota hai.

B. Improved Team Collaboration

• Common Vocabulary: Organization mein sabhi members ke liye common

vocabulary create hoti hai. Yeh effective communication aur collaboration ko
enhance karta hai, jo quality management mein crucial hai.

C. Structured Problem-Solving

• Identification of Issues: Keywords ko samajhne se aap easily identify kar sakte

hain ki kahaan issues hain. Jaise agar aap dekhte hain ki "Non-Conformity"
keyword baar-baar aa raha hai, toh yeh signal hai ki us area par focus karna
zaroori hai.
D. Facilitation of Continuous Improvement

• Trends Analysis: Keywords ka istemal karne se aap trends ko track kar sakte
hain. Jab aap observe karte hain ki koi keyword frequently use ho raha hai, toh
aapko us par focus karne ki zaroorat hai.

7. Example of Keywords in QMS Context

• Customer Feedback: Yeh term customer ki opinions aur suggestions ko refer

karta hai.

o Usage: Customer feedback ka analysis quality improvement initiatives ko

guide karta hai.

• Risk Management: Yeh ek structured approach hai jo potential risks ko identify

karne aur unhein mitigate karne mein madad karta hai.

o Usage: Risk management process mein "Risk Assessment" aur "Risk

Mitigation" keywords critical hote hain.

• Internal Audit: Yeh ek systematic review hai jo organization ke processes ko

assess karne ke liye kiya jata hai.

o Usage: Internal audits ko schedule karne ke liye "Audit Schedule" aur

"Audit Checklist" jaise keywords ka istemal hota hai.

8. Conclusion

Keywords approach Quality Management System (QMS) mein ek powerful tool hai jo
quality management ke concepts ko samajhne aur yaad rakhne mein madad karta hai.
Yeh approach na sirf learning ko enhance karta hai balki effective communication aur
implementation ko bhi support karta hai. Isse aap QMS practices ko better apply kar
sakte hain aur organization ki overall performance ko improve karne mein contribute kar
sakte hain.
Exercise 17: Audit Report Preparation - Stage 2 On-site Assessment

1. Stage 2 Audit Kya Hai?

Stage 2 audit ko “On-site Assessment” bhi kaha jata hai, jo ki Quality Management
System (QMS) ki effectiveness ko evaluate karne ke liye conduct kiya jata hai. Is stage
par auditors organization ke processes, documentation, aur performance ko assess
karte hain.

2. Audit Report Ki Importance

Audit report ek formal document hoti hai jo audit findings, conclusions, aur
recommendations ko summarize karti hai. Yeh report management ko inform karti hai ki
QMS kaisa perform kar raha hai aur kahaan improvements ki zaroorat hai.

3. Audit Report Prepare Karne ke Steps

A. Audit Findings Ko Document Karna

• Observations: Audit ke dauran jo bhi observations hui hain, unhein detail mein
note karna zaroori hai. Yeh observations non-conformities (NCs) ya compliance
issues ko highlight karti hain.

• Evidence Collection: Audit ke dauran jo bhi evidence collect kiya gaya hai, uska
documentation zaroori hai. Isme interviews, records, aur process observations
shamil hote hain.

B. Report Structure

• Title Page: Report ka title, audit date, aur organization ka naam shamil karein.

• Table of Contents: Report ki structure ko clear karne ke liye ek table of contents

tayyar karein.

• Executive Summary: Is section mein audit ka overall conclusion aur key findings
summarize karein. Yeh section management ke liye helpful hota hai.

• Audit Objectives and Scope: Audit ke objectives aur scope ko clearly define
karein, taaki report ka purpose samajh aaye.

• Findings: Yeh section detailed findings ko cover karega. Har finding ko clearly
describe karein aur unka reference evidence ke sath provide karein.

• Non-Conformities: Jo non-conformities identify hui hain, unhein list karein. Har

NC ke sath uski severity aur impact ko bhi mention karein.

• Recommendations: Audit findings ke basis par recommendations dena bhi

zaroori hai. Yeh recommendations organization ko improvement mein madad
karti hain.
 • Conclusion: Is section mein overall assessment ko summarize karein aur
suggest karein ki organization kis direction mein ja sakti hai.

C. Report Review

• Peer Review: Report ko kisi senior auditor ya quality manager ke sath review
karein. Isse report ki accuracy aur clarity ensure hoti hai.

• Finalization: Feedback ke baad report ko finalize karein aur relevant

stakeholders ko distribute karein.

Exercise 18: Audit Follow-up – NC Closures

1. NC Follow-up Kya Hai?

Non-Conformities (NCs) ki follow-up process zaroori hai taaki identified issues ko timely
address kiya ja sake. Yeh process ensure karta hai ki organization ne NCs ko effectively
resolve kiya hai aur improvement actions implement kiye hain.

2. NC Closure Process

A. Action Plan Development

• Root Cause Analysis: Har NC ke liye root cause analysis karna zaroori hai. Isse
aapko samajh aata hai ki issue kyun hua aur future mein kaise prevent kiya ja
sakta hai.

• Action Plan: Ek action plan tayyar karein jo specific actions ko define karta hai jo
NCs ko close karne ke liye liye jayenge. Is plan mein responsible persons aur
timelines shamil hone chahiye.

B. Implementation of Actions

• Action Execution: Action plan ko implement karne ke liye relevant teams ko

involve karein. Unhein required resources aur support provide karein taaki
actions ko effectively execute kiya ja sake.

• Monitoring: NCs ka follow-up karte waqt actions ki implementation ko monitor

karein. Yeh ensure karega ki sab kuch time par ho raha hai.

C. Verification of NC Closure

• Verification Audit: NC closure ke baad, ek follow-up audit conduct karein jahan

verify karein ki actions implemented hain ya nahi. Is audit mein dekhein ki kya
actions effective hain ya nahi.

• Documentation: Closure process ka documentation zaroori hai. Ismein action

plans, verification audits, aur closure status shamil honi chahiye.
D. Reporting NC Closure

• Closure Report: Har NC closure ka ek report tayyar karein jisme closure ke

details aur outcomes ko mention karein. Is report ko management ke sath share
karein taaki unhein NC closure ka status samajh aaye.

Sample Exam Discussions

1. Exam Preparation Ki Importance

Exam preparation ke dauran, sample questions aur discussions karna zaroori hota hai.
Yeh process candidates ko exam ke format aur topics ki clarity deta hai.

2. Discussion Topics

• Key Concepts: QMS ke key concepts, jaise leadership, risk management, aur
internal audits.

• Case Studies: Real-life scenarios ke through discussions karna, taaki

candidates ko practical application samajh aaye.

• Mock Exams: Practice exams conduct karein taaki candidates ko apni

preparedness assess karne ka mauka mile.

Final Questions & Clarifications

1. Importance of Final Questions

Exam se pehle final questions ka session candidates ko last-minute doubts clear karne
mein madad karta hai. Yeh session interactive hota hai jahan candidates apne queries
pooch sakte hain.

2. Common Areas of Confusion

• Audit Processes: Audit process ke various stages ki clarity.

• Non-Conformity Definitions: NCs ki definitions aur examples.

• Reporting Mechanisms: Audit report preparation aur follow-up mechanisms.

Course Feedback Form

1. Feedback Ka Importance
Course feedback form learners se valuable insights gather karne ka ek method hai. Isse
course improvement mein madad milti hai aur future sessions ko enhance kiya ja sakta
hai.

2. Feedback Areas

• Course Content: Course ke topics ki relevance aur depth.

• Teaching Methods: Teaching techniques aur methodologies ki effectiveness.

 • Overall Experience: Learners ka overall experience aur satisfaction level.

Introduction to the Exam

1. Exam Overview
Exam ka objective yeh hota hai ki learners ko assess kiya ja sake ki unhone course
material ko kitna effectively samjha hai. Isme theoretical aur practical dono types ke
questions hote hain.

2. Exam Format

• Multiple Choice Questions (MCQs): Concepts ko assess karne ke liye.

• Descriptive Questions: In-depth understanding ki assessment ke liye.

Practice Exam Paper

1. Purpose
Practice exam paper learners ko exam ke actual format ke sath familiarize karne ke liye
hota hai. Isse unhe time management aur question handling skills develop karne mein
madad milti hai.

2. Sample Questions

• Q1: ISO 9001:2015 ki key principles kya hain?

• Q2: Non-conformity kya hoti hai aur isse kaise address kiya jata hai?

End of Course

1. Course Summary
Course ke end par ek summary session conduct kiya jata hai jahan key takeaways aur
learnings ko discuss kiya jata hai. Isse learners ko course ka overall recap milta hai.

2. Next Steps

• Continuous Learning: Learners ko encourage kiya jata hai ki wo continuous

learning ki taraf focus karein.

• Certification: Course completion ke baad certification provide kiya jata hai jo

unki knowledge aur skills ko validate karta hai.

Conclusion

Is detailed overview mein humne Audit Report Preparation (Stage 2) aur NC follow-up
process ko cover kiya. In processes ka samajhna aur implement karna organization ki
quality management practices ko improve karne mein madad karta hai.