ISO FAQ

1.
WHAT IS ISO- INTERNATIONAL ORGANIZATION FOR STANDARDIZATION.
2.
ISO 9001:2008- 9001 IS NUMBER ALLOCATED FOR QUALITY MANAGEMENT
SYSTEM BY ISO
2008 IS VERSION.
3.
MR STANDS FOR MANAGEMENT REPRESENTATIVE? INTERNAL
COORDINATOR WITHIN
ORGANIZATION FOR ISO.
4.
EIGHT PRINCIPLES IMPORTANT FOR ISO:
1.Customer focus
2.Leadership
3.Involvement of people
4.Process Approach
5.System approach to Management
6.Continual Improvement
7.Factual approach to decision making
8. Mutually beneficial supplier relationships
5.
ISO BASED ON PDCA
P-PLAN; D-DO; C-CHECK; A-ACT
ISO 9001 HAS REQUIREMENTS MENTIONED AS 8 CLAUSES
Clause Title
Clau
se
No
1.0
2.0
3.0
4.0
5.0

6.0

Scope
Normative
references
Terms and
definitions
Quality
Management
System
Management
Responsibility

Resource
Management

Sub clauses

1.1 General
1.2 Application

4.1 General requirements-All

4.2 Documentation Requirements-All
5.1 Management Commitment-All
5.2 Customer focus-All
5.3 Quality Policy-( defines Company approach
towards Quality)-All
5.4 Quality Objectives-Should be SMARTSpecific; Measurable; Actionable; Realistic;
Time-bound
5.5 Responsibility, authority and
Communication-All
5.6 Management Review-Six monthly-April
/Oct

6.1 Provision of Resources-Employees and

assets-Director
6.2 Human Resources-Employee resume
and competency data; Training Data-HR
6.3 Infrastructure-Office equipment
maintenance data-Maintenance and
Admin
6.4 Work Environment-Housekeeping and

safety Production,QC,Stores and

Office
7.0
Product
7.1 Planning of Product Realization
Realization
7.2 Customer related processes-Customer
enquiry to order realization data;
Customer complaint data-Sales and
marketing
7.3 Design and Development- Planning
/Inputs /Outputs /Review /Verification
/Validation/Changes-Design
7.4 Purchasing-Purchase data /Supplier
approval/ evaluation-Purchase
7.5.1 Production and Service ProvisionPlanning, monitoring and execution of
production;
7.5.2- Welding and brazing -Production
7.5.3 -Product identification; -Stores and
Production, QC
7.5.4-Customer Property-Stores,QC,Prodn
customer property (Equipment repair);
7.5.5 Stock controls; ensuring dispatch
documentation-local /export as per customer
requirements and servicing-Stores
7.6 Control of measuring and monitoring
Equipment- (Instrument Calibration)QC
8.0 Measurement,
8.1 General
Analysis and
8.2.1- Customer satisfaction-Sales
Improvement
8.2.2-Internal audits-Internal auditorsApril, Oct
8.3 Control of nonconforming productSegregation; identification and follow-up
actions for nonconformities-material-Prodn,
QC, Stores
8.4 Analysis of data-Graphs /Trends of
processes/activities-All
8.5.1 Improvement-Continual improvement
data;
8.5.2-Correctiv actions-All
8.5.3-Preventive actions
6.
INTERNAL QUALITY AUDIT- to be done internally by organization to verify
compliance to
Internal procedures-SIX MONTHLY-APRIL AND OCT
7.
MANAGEMENT REVIEW- internal meeting to be conducted by Top mgt and
process owners to
review performance of various processes such as Sales; purchase;
Production, Servicing, QC;
Dispatch, HR,Admin. SIX MONTHLY-APRIL AND OCT.
8.
NONCONFORMITY-NC-Corrective action request /deviation if ISO norms are
not followed; NC to

be raised during internal audit by internal auditor; NC will be raised by

external auditor during
external audit in case of any deviation /non-compliance.
9.
CONTRACT REVIEW-Initials on customer order by Sales.
10.
CUSTOMER FEEDBACK-Customer satisfaction survey to be obtained from
customer for
customer satisfaction assessment.
11.
CUSTOMER FEEDBACK-Major customer issues related to Quality or
negative feedback received
from customer.
12.
DOCUMENT-Any paper which specifies rules-ex-Quality plan; Specifications;
13.
DOCUMENT CONTROL-Controlled copy; Master copy controls; Right
document in right place;
Obsolete document identified; Latest document identified.
14.
RECORD-Any paper which shows implementation of rules- inspection
reports; production
reports; calibration reports.
15.
RECORD CONTROL-Proper filing, maintenance of records
16.
PROPER WORK ENVIRONMENT-Proper lighting; noise control; dust control;
pollution control;
safety practices.
17.
SPECIAL PROCESS-Any Process where the output quality cannot be verified
immediately; exwelding; brazing;
18.
INTERNAL AUDITOR-Organizational person to verify implementation of ISO
within the Company
19.
COMPETENCE-Education + skills + experience
20.
QUALITY PLAN-Inspection specifications-Checkpoints for incoming
inspection of material /
product procured from supplier.
21.
OUTSOURCED PROCESS-Outsourced process is any process which is
obtained from service
providers such as training; computer maintenance; labour jobwork
22.
CONTROL OF OUTSOURCED PROCESS-Control of process is ensured
through procurement of
services from approved suppliers and evaluation of suppliers regularly23.
QUALITY MANUAL-Manual of organization describing how organization
follows ISO 9001 in
brief.
24.
QSP-QUALITY SYSTEM PROCEDURES-System procedures which describe
the mandatory six
procedures-1-Control of documents; 2-Control of records;3-Control
of nc product; 4-Corrective
action; 5-Preventive action; 6-Internal audit
25.
FORMAT- Structure for providing information-when filled format becomes
document or record.
26.
CORRECTION- Immediate action for resolving nonconformity
27.
CORRECTIVE ACTION-Long term action to prevent nonconformity from
happening again(recurrence)

28.
PREVENTIVE ACTION-Advance action to prevent nonconformity from
happening(occurrence)
29.
QUALITY POLICY-The overall commitment of Company towards Quality as
expressed by Top
Management
30.
QUALITY OBJECTIVES-The objectives make the Quality Policy happen.
Quality objectives need to be SMART-Specific; M-Measurable; A-Actionable;
R-Realistic;
T-time bound