ISO 9001

1987 – ISO 9001: 1987 1st Edition

1994 – ISO 9001: 1994 2nd Edition

2000 – ISO 9001: 2000 3rd Edition

Clause – 01 Scope
Standards Scope – Application
Clause - 4.3 Scope

2 Type Scope
4.3 -
Scope – Generation of Electricity and
OMS Activity for PAN India.
2 Type of Standards
9001 – QMS
Requirement Standards – Certification
Standards
Reference / Normative Reference SDT
9000 – Fundamental & Vocabulary
Guideline STD - Certificate??
Non Conformity – Non fulfilment of
Requirements
 Inox Site – Fire @ Windmill -001

Correction: Action to eliminate a

detected non conformity
 Fire Eliminate @ Point – Mitigate

Corrective Action: Action to eliminate the

cause(s) of a nonconformity or an incident and
to prevent recurrence
 Root Cause:

Initial Cause: Generator Slip Ring

Overheat
RCA: Issue in Bearing Tear/ Wear
Carbon Brush Wear out
 Limit Switch not working
Malfunctioning / Bypass
Checking not done - PM

 PM for the Limit Switch Condition.

Preventive Action
Prevent to occurrence of non-
conformity
 Before @ PM for the Limit Switch
Condition @ Suzlon @ Windmill-
002.
Risk: Effect of Uncertainty
Extreme Heat : Dehydration/ Unconscious
Risk & Opportunity for ISO 9001, ISO 14001
and ISO 45001

OHS Risk : ISO 45001 – Hazard & Risk

Assessment
Likelihood of Occurrence X work-related hazardous event or
exposure(s)

OHS Risk - Hazardous event or exposure - Leakage – Slip/

Trip / Fall X Occurrence = Head Injury
4.1
Issues – Purpose & Strategic Direction of Organization
Internal & External
Low Turbine Performance - Internal – 9001 + 14001
Equipment Breakdown – Internal – 9001 + 14001
Force major – External / Internal - 9001 + 14001 + 45001
Cyclone – External – 45001 + 14001
Lighting - External – 45001 + 14001
ROW - External / Internal - 9001 + 14001 + 45001
4.2 – N&E of IP
Internal – IP Needs Expectations
Both are requirements.
Mandatory Non-
mandatory
Workers PPE Requirement (N)
Family Survive (N)
Performance Award (E)
Health Insurance (LC)
ISO 45001

Parent Company
Management
Cross Function
 Operation & Maintenance
 Purchase
 HR&A
 Project
External – IP
Local Community
Gov. Authority
 Electricity Board
 Gram Panchayat
 Nagar Nigam
 Factory Inspector – DISH
Supplier
O&M Providers
Customers
 Grid

Our Org. Scope

4.3 -
Scope – Generation of Electricity and
OMS Activity for PAN India.
Boundary = HO & All Site Address.
Document: IMS Manual CL. Ref. no. 4.3
Any Procedure????? – Ref.
Regulations – PPA –
Policy????
Operation & Maintenance Documents?????
Audit Area – Management/ MR Only.
4.4
Process Mapping/ SIPOC – Dept. Manual
S – Supplier (Internal/ External)
I – Input (4M)
P – Process (Activity)
O – Output (Product - Electricity)
C – Customer (Grid)
5.1 Leadership -
Process/ Department Audit???
HSE
FH – All Process

Internal Audit Schedule

Management/ Top Management & MR
5.1 – Top Management – Requirements????
5.1.2 - Customer Feedback Ratio
O&M
HSE
HR & Admin
Purchase
IT
CSR
Finance

5.2 IMS Policy

Management & MR
Established ??
All Commitment & IMS STD requirements are considered? ?
IMS Policy – How Communicate in organization???

All Process Audit.

Is Policy available?
Understanding?
5.3 Roles R&A
Document – Roles defined???
Organization Chart – all roles has to be covered.
All roles defined in Org. chart – Responsibility & Authority
Role: Internal Auditor
Responsibilities:
To conduct Internal audit as per schedule.
To ensure requirements.

Authority:
Outcome Conclude – Compliance / non-compliance.
5.4 – Participation & Consultation of Workers – ISO 45001
Worker
“Non-Managerial Workers” – Below Supervisors i.e.
Operator/ Technician, Housekeeper
Participation – Involvement “Non-Managerial Workers”
Consultation – Seeking View “Non-Managerial Workers”
Participation
Hazard Identification
How/ Method: Daily Talk | HSE Committee Meeting ???|
Hazard reporting register – Siet HSE

Issues: ROW – Disatisfaction about Salary & Wages

Risk/ Effect: Generation Loss due Low Performance
Action: Prevention: Time Salary / Equal Wages Policy
Implements / Minimum Wages/ Living Wages Policy/
Improve Structure Salary

Mitigation: Settlement
Issue: Lighting
Risk/ Effect: Damage of Solar Module

Issue: PM on Height Work

Effect: Fatality/ Injuries
Nos. of Issue: 50+ Nos.
Improvement – NP
Define Process – To identify Significant Risk
Top 05 issues identify.
Assessment Criteria –
Severity – 1 Low 10- Major
Probability – 1 Rare – 10 Frequency
Score – Out 100 : Cut Off – 40 for Take Improvement Action

Issue: Policy Change on Renewable Energy – Old tech Molde

Mgf. Shutdown
  Risk: Generation Loss
Action: Plan restore - / New Module – Upgrade your
Structure – Setup
 Opportunity: Increase Generation Capacity
o Project / Modification Activity in Structure
Action on Potential Failure/ NC – Risk - Mitigation
Action???
Action for Improvement – Opportunity - Technology Update
– Vibration Monitoring Manual – iOT.
Retrofitting – Opportunity
Environment Elements: Activity:
O&M: Water Cleaning of Module
Reason Aspect: Usage of Wate
Result Impact: Water Depletion/ Ground
Water Depletion

Daily Vehicle Transportation

Aspect - Fume Generation/ CO2
Emission - Reason
Impact - Air Pollution – Result
Aspect: Usage of Fuel “Diesel/
Petrol”
Impact – Diesel/ Petrol Depletion

Identification of Signification Aspects

2 Method – Quantitative and Qualitative
Score Model - S x P X D = Cut off Score: >65 S E
A
Qualitative – Overriding Factor
LC/ E – SEA (Module Waste – E-waste – E-
waste Rules) - Lighting/ Fire – Emergency
SEA - Action
Use of Waste @ Cleaning Activity
Action: Reduce Usages / Consumption/ Alternat less
significant – Dry Cleaning Robot/ Rain Waste Harvesting
Action Document: Action Plan/ Management Program
Action Plan - Rain Waste Harvesting
Action Item Frequency Responsible
Area feasibility 30/7 O&M
Budget Approval 30/8 MGT
Work Order 16/9 PUR
Execution 30/10 O&M
Monitoring 15/10 EHS
Prepared OCP/ Procedure – Control Procedrue – Effective
Cleaning – How to Save Waste during Cleaning/ Minimum
Waste
Environment Elements:
Activity:
O&M: Water Cleaning of Module
Source
Hazard - Slip/ Trill Fall – due to obstacle/ Slippery Surface
Risk: Head Injury/ Body Injury/ Leg Fracture

Hazard Snack/ Reptile bite due Contact

Risk: Fatal/ unconscious
Hazard : Electrical Shock due current leak
Risk - Burn Injury/ Fatality
Hazard - Dust Particle Contact in Eyes
Risk - Eye Injury

Daily Vehicle Transportation

Hazard - Road Accident due to Over speeding
Risk – Fatality/ Injury

Over speeding X Injury = Risk

Risk Classification
Acceptable / Not Acceptable
Quantitative Method
S x P x F = Risk Score 125 – Cutt off score: >65 - Not
Acceptable Risk
Qualitative Method
E/ LC/ DC/ CE – Not Acceptable Risk
Action to Control the Risk
Management Program/ Procedure

6.1.3 – Legal Requirement

Rules, Regulation, Low, Act set by Gov. Authority
Safety
Factory Act 1948
Stage Factory Rules – 1963 GFR
PESO – License
Indian Electrical Act
Environment
Environment Protection Act 1986
Water Act/ Air Act
Haz Waste Rules
Wild life protection Act
Plastic waste management rules

Other Requirements
OEM Req.
Management
Customer Requirements

Identification Requirements of Legal & Others – applicable

Factory License
Consent to Operate CTO/ CTE
Health – Pre & Post
Air Monitoring
WC Policy
PLI
9.1.2 – Compliance of Legal & Other Requirements
14001 & 45001
Evaluation & Compliance
WC Policy – Valid???
FL – Valid???
Quarterly Air Monitoring – Done????

If Not Complied - NC, Correction, RCA & CA

Objective: To Construct 03 nos. HW Storage Facility
Action Plan - Construct 03 nos. HW Storage Facility
Action Item Frequency Responsible
Area feasibility 30/1 O&M
Budget Approval 28/2 MGT
Work Order 16/3 PUR
Execution 30/4 O&M
Utilization of Storage Facility 15/5 EHS
Prepared OCP/ Procedure – Control Procedrue – Effective
Cleaning – How to Save Waste during Cleaning/ Minimum
Waste
Purchase - Product, Process & Services
Outsource Activity??
Transport Facility – Services
 Scope of Work
 Evaluation & Approval Agency
 Legal Compliance - WC Policy
Security – Services
 Gov. License
 Scope of Work
 Evaluation & Approval Agency
 Competent Person
Generation Forecasting – Process
Third Party Inspection – Testing/ Calibration – Services

Product – Energy
Initial Stage - Solar Ray/ Wind Speed
Generation
O&M
 Waste Generation due to damage of module – 25 years
Switch Yard – Step-up
Transmission Line – Charge
 Transmission Loss
Distribution
 Distribution Loss
Step down
Usage

Control - Define
Vendor Evaluation/ Vendor Authorization
 Competency of Personnel
Scope of Work
 Rate Contract
Work Procedure
Risk Assessment
Performance Rating
  Based on previous Year Data
Evidence
 Test Report/ Certificate
OEM/ NABL/ Authorized Party
8.2 – 45001 + 14001
Emergency Situations
Fire - EHS
Flood/ Earthquake/ Land Slide - EHS
Lighting – EHS
Heavy/ Major Leak/ Spill - EHS
Medical Emergency
 Fall form Hight - OHS
 Electric Shock - OHS
 Fire Burn - OHS
 Road Accident - OHS
 Reptile Bit - OHS
Response Plan
 Prevention Action
 Mitigation Action/ Response Activity

Mock Drill - Fire Scenario

Training – Fire Fighting Training
Immediate Support/ Resources – FE/ Ambulance/ First Aid
Kit/ Skill Kit/
Mutual Aid Services – Hospital/ Fire Stations/ Police Stations
Emergency Response Team
 Incident Control / Site Control
 Fire Fighter Team
 First Aider Team
 Rescue Team
Internal Calibration/ Testing
Procedure/ Method
Calibrated Master - NABL
Authorized & Competent Person – for Calibration
External – National / Internation STD Traceable - NABL /
ISO 17025
Competency Mapping / Training Records / Take Demo. &
Interview.

Calibration Schedule – Cal .Date & Due Date

Ensure – Verification of Certificate – Conclusion

Checking – Violation
Self – NC - Close
Cross IA – NC Closer
Management Level - MRM : Action Plan (MRM - Give
Cause)
Process for Purchase
Indent from User
RFQ Is Approved Supplier
RFQ Floating Evaluation (Techno-Com +
Legal) & Selection
Offer Received
Offer Comparison
PR
PO (PO Follow up - OTD)
Receipt - Invoice - GRN Supplier Performance Rating
PC (Quality + Delivery + Qty. )
Frequency – Six Monthly
Communication – Positive of
Negative – Demand Improve
Plan
Improvement – Evidence
 Mock Drill Findings Improvements
 IMS Objective Target Sheet
 Action Plans
 Idea/ Suggestion/ Kaizen
 MRM – Improvements
 DPR/ MPR – Performance Improvement
Auditors Qualification
12+2/ 3/ 4 = Education Minimum

Experience
 4-5 Year work experience
 Min 1 Audit Experience
 Trainee Auditors
External Auditors – 20 Nos. Audit/ Days as Observations.
Audit Criteria
IMS Requirements – i.e. IMS Policy
Customer Requirements – i.e. Agreement – Jointly Calibration
of Energy Meter – Witness
Legal & Other Requirement – i.e. Hazardous Waste disposal
withing time frame. (Used/ Spent Oil - >10 ton 6 month) - <5
365 Days.
Org. Own Req. – i.e. Drug Test, Monthly Review Meeting.

Audit Checklist
5.2 IMS Policy
Mgt Process
 Is IMS Policy established?
 Is IMS Policy as per ISO 9001, 14001 & 45001
requirements.
 Is IMS communicated in the organization, and how?
O&M
 Is IMS policy available, latest copy??
 How to communicated within dept.?
 Person is understood the IMS policy?
 Major NC
 Legal Violation
 Complete STD requirements missing i.e. Objective &
Targets – 6.2 missing
 Repeated Minor NC

Minor
 Isolate case STD requiremenrs missing
 Repeated Observation

Observation
 Potential NC

OFI
 Scope of Improvement Near-miss identification by
manual/ physical form however QR Code – Digitally
Collect Near-miss records.
NC -01
In Maintenance of Transformer, activity of carried out Oil
Replacement - 200 Liter Transformer Oil Drum, same time
drum Fall due to slippery surface and more than 25 liters oil
spill on land, however incident report is not evident.
ISO 45001 9001 14001 14001/
No. 45001
CL. 8.1/ 7.1.5 8.1/6.1.2 9.1.1/
No 10.2 10.2
NC/ NC
C
CASE NO. 02
When auditing the production department on HIRA register, it was found that hazard and risk
register did not include the recently installed new machine No. 10B (3 month ago) for
operations. Mr. Mahesh was working on the machine. When asked to the production manager
about not updating HIRA register, he explained that we revise HIRA register once in year
generally before the external surveillance audit.

ISO No. 45001

CL. No 6.1.2 10.2 10.3

NC/ C NC
CASE NO. 03
Purchasing Department personnel are not aware of the department objective of Maintenance
Department.

ISO No. 9001 9001 IMS

CL. No 8.4 7.3 7.3

NC/ C NC NC C - OFI

CASE NO. 04
It is seen that some of the equipment's of the Company such as crane are not covered under
the maintenance plan. The trouble free operation of the crane is critical towards smooth and
safe handling of materials. Crane failures do occur sometimes. The plant personnel have been
complaining that rectification of the faults now a days takes much more time than it used to 2
years back. This is attributed to non-availability of spares, which are not adequately
maintained in stock. This delays maintenance activities leading to downtime of the crane.

ISO No. 9001 9001 9001 14 + 45

CL. No 8.0 9.1.1 8.2.2 7.1.3 8.1

NC/ C NC NC NC NC
CASE NO. 05
The organization has recruited a new technician to work in the electrical testing laboratory.
The work involves taking readings of current value and continuity during testing. The
previous technician who was doing the same work had resigned abruptly and left due to
certain reasons. The new technician has been performing the job for the last 8 months;
however, no formal evaluation has been made whether he is qualified for doing that work. No
records of any competence or training are available.

ISO No. IMS

CL. No 9.1.1 7.1.2 7.2

NC/ C NC
CASE NO. 06
During the process round audit of the boiler operation observed leakages, however, the
auditee explained leakages have identified and a tag was also displayed at the point of
leakages, a leakages notification has generated and a status report was also maintained as
evidence.

ISO No. 14001 9001 14001 45001 9001

CL. No 8.1 9.1.1 6.1.2 7.1.3

NC/ C C C
Dinesh Patel – 8155951262

External Audit

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