ISO 9001 Awareness

By
Suhas Agawane
Chief Consulting Officer
Simple Solutions Consultant
Agenda

• General introduction on ISO

• Diff between process determination Vs process
identification
• What is process approach
• Process Indicators – Effectiveness Vs Efficiency
• Macro view of ISO 9001 framework
• Amendment vs revisions of documents
• Importance of document control
• Records are means to captured data and further to
generate information through it
• Understanding fundamental terms
• Clarity of understanding among terms correction ,
corrective action , preventive action

Continued
●
Agenda
• MRM meeting requirements
• What Quality policy & objectives means for various
department
• P-D-C-A / Demings Cycle
• Outsourced process control ( Why & how)
• Supplier Capability Assessment
• Quick read through ISO 9001 Standard Requirements
General Info – ISO Standards
• ISO standards are published by International Organization for
Standardization
• ISO has it’s head quarters at Geneva and more than 180
countries are members of this institution
• ISO publishes various standards on technical specs , testing
methods as well as management systems
• In management system domain , following standards (which
are relevant to constructions sector) are available from ISO
ISO 9001 (QMS) ISO 9000 (Vocabulary)
ISO 14001 (EMS) ISO 9004 (Performance Improvement Guideline)
ISO / OHSAS 18001 (Safety) ISO 10007 (Project Mgt Guidelines)
ISO 27001 (ISMS) ISO 19011 (Audit Guidelines)

• ISO certificates are issued by certification bodies (CBs) & these

CBs are authorized to do so by accreditation boards
• ISO certificates are valid for 3 yrs. There are surveillance audit
conducted by CB every yr & re-registration audit every 3 years
• Latest standard edition for ISO 9001 is 2008. Superseded
editions includes 2000 , 1994 , 1987
What is Process

Continued
●
 Process Mapping
Inputs
Inputs Purchasing
Purchasing Outputs
Outputs
Process •• Receipt
•• Required
Requireditem
item// ProcessSteps
Steps Receiptof
ofMaterials
Materials
quantity on
onright
rightconditions
quantity//date
date conditions
•• Applicable •• Right
RightQuality,
Quality,Right
Applicablespecs
specs Right
•• Supplier Quantity
Suppliersource
source Quantity
•• Suppliers •• Right
RightTime.
Supplierscapability
capability Interactions
Interactionsto
to
Time.
to
tomeet
meetourour •• Storage
requirements Storage
requirements •• Inspection
Inspectionand
andTesting
Testing
•• Manufacturing
Manufacturing
•• Finance
Finance
Customers
Customers
Suppliers
Suppliers Performance
PerformanceMeasurements
Measurements •• Production
Production
•• Finance •• Delivery
Deliverystatus
status––On-time,
On-time,
Finance •• Stores
On
Onspec,
spec,NCP
NCPetc
etc Stores
•• Supplier
Supplierevaluation
evaluation Continued
●
Process identification Vs determination

• Process Identification – picking up what is appearing in

business operation
• Process Determination – exploring what is required for
business operation
• So for determination business context is important
 Marco View of ISO 9001 Framework

Continued
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 Marco View of ISO 9001 Framework

4 Quality 5 Management 6 Resource 7 Product 8 Measurement

Management Responsibility Management Realization Analysis &
System Improvements
Requirements

Management
General Commitment Provision of Planning
General
Requirements Resources

Customer Focus Customer Monitoring &

Documentation Human Related
Requirements Resources Measurements
Processes
Quality Policy
Infrastructure Control of NCP’s
Design &
Development
Planning Analysis of Data
Work
Environment Purchasing
Responsibility, Improvements
Authority & Production &
Communication Service
Provision
Management
Reviews Calibration
Documentation Structure

• Quality Manual - Summarized information how Org‘s

systems addresses ISO requirements
• Process Manual – Detailed information how organization’s
management processes are executed , controlled and
managed
• Procedure Manual – Documented procedural steps to be
followed w.r.t. specific ISO / Org‘s requirements
• Forms – Structured document to be used as generating for
different types of records
• Record Content (RC) – List out essential information
component / details that particular record should contain. It
is free form to be used generating specific type of records
Document Control
• Document – The source of information where information is
dynamic
• Use of Document –
– Action criteria
– Reference information for monitoring / execution
– Basis for decision making
• These can be in any form
• Why need control
– Dependability
– Authenticity
– Likelihood of changes
– Information is collated in context of business
• What controls
– Check for correctness
– Management/ Authority Endorsement
– Know latest changes
– Change counter reference
– Periodically reflect business context / changes into document
Record Control
• Record – These are special type of documents .
It is post event / action outcome
Once prepared can’t be changed
• Interesting examples regarding records–
– Death Will
– Degree / Birth Certificate
– Purchase Order (Before Vs After Receipt)
– Blank form Vs Filled up form
– Project Plan Vs Project Review record
• There are no revisions for record , but it might get amendment
• They can be in any form – hard / soft copy , database files
• Use of Record
– Evidence what happened
– Framework for gathering relevant data for various information
– Statutory & regulatory requirements
– To establish traceability ●
Continued
Record Control
• Attribute for record use , influencing type of control
– Records are kept for substantial period even 10 – 20 years
– Records are likely to be recalled any time during it’s retention period
– Records may be recalled a another person/s who has not kept it
initially
– Records might contain crucial information
• Principal of Record – Record in the File and File is at the
location
• Records controls include
– To list out
– Retention period
– Filing approach to facilitate easy retrieve - ability over complete
retention period as well as by another person
– Access & disposition
– Prevent deteroriation / damage of record during retention period
 Understanding fundamental terms

Requirement Characteristic
Need or expectation that is Distinguish feature
stated, generally implied or
obligatory

Quality
Conformity Degree to which a set of
Fulfilment of requirement inherent characteristics
fulfils requirements

Grade
Nonconformity Category or rank given to
Non Fulfilment of different quality requirements for
requirement products ,, processes or systems
Continued
●

having the same functional use

 Understanding fundamental terms
DISPOSITION CONFORMITY
Action taken to resolve a T
non-conformity situation E DEFECT
M NON CONFORMITY (NC) Non-fulfilment of a
SCRAP P Non-fulfilment of a requirement related to an
requirement intended or specified use.
ALTERNATE USE S
O
RE-GRADE L PERMENANT / LT SOLUTIONS
DEVIATION / U
CONCESSION T
I CORRECTIVE ACTION PREVENTIVE ACTION
CORRECTION O Action to eliminate the Action to eliminate the
Action to eliminate a a N cause of a detected NC or cause of a potential NC or
detected nonconformity S other undesirable situation other undesirable situation

REWORK REPAIR
Action on NC product to make Action on a NC product to make
it conform to the requirements it acceptable for the intended use
Mastering CA-PA
• Corrective action (CA) – does ensure the similar NCs does not
recur again or it’s frequency reduces
• Preventive action (PA) – does ensure that potential NC does
not occur or it’s probability reduces
• Steps for CA – PA
Corrective Actions Preventive Actions
1. Analyze different 1. Analyze different performance data & identify
performance data & adverse Or Explore issue risk assessment
identify recurring Or Explore possible application of CA as PA
issues Or Major in other area /process /project
category issue 2. Determine Potential NC
detected

A. Evaluate need for CA/PA

B. Root / Vital cause/s analysis
C. Working appropriate action/s to eliminate these root /vital cause /s
D. Authorization of action /s plan /s
E. Deployment / implement plans
F. Monitor outcome
G. Verify effectiveness
MRM Meeting Requirements
• MRMs are conducted periodically once in 3/6 months
• Objective of MRM is to review organizational process
performance review
• Important agenda includes following
– Quality objective and process indicator status review
– Internal audit result review
– Review of customer complaints , satisfaction and feedback
– Resource requirements and training plan
– Improvement planned – Analysis reports and CA-PA status
– Review of previous MRM decisions / actions
– BEM re-visit and QMS changes
– Project performance (Cost-Time-Quality)
• Concerned HODs needs to present following during meeting
– Process indicator status and data
– Departmental analysis report & CA-PA Log
– Actions for & status of internal audit NCs
– Status & progress on actions from previous MRM
What is mean by Policy & Objective
• Policy gives direction and framework for operational activity
focus as well as decision making
• Various elements of policy needs to be interpreted by
concerned functional team in terms how it is relevant to them
• Certain elements relevant to all functional team where as some
are relevant to few functional team
• Objectives are statement on performance goals with targets
• Quality Objectives are at apex level and responsibility is
assigned to main contributing function
• Various other functional team then needs to contributed
through supporting these objectives in it’s relevant functional
parameter
• These objectives should & can be linked to appropriate
process indicators for various functional team
• Objective targets needs to be SMART
Stretchable , Measurable , Achievable , Relevant , Time-bound
PDCA (Demings Cycle)
• It talks about the continual improvements in small steps which
are cascaded
• Plan the actions > Execute the actions > check the outcome
> take necessary corrective measures wherever results are
not as expected
●
Plan ●
Do

P D

A C

●
Act ●
Check
Outsourcing process control
(Why & How)
• Organization buys products & services
• These products & services are of three categories
a. Supplier’s own branded / standard products
b. Products & services supplied as organization requirements and
of which quality can checked through inspection
c. Products & services supplied as organization requirements and of
which quality can not be checked through inspection
• The category ‘c’ case is called as outsourcing
• This outsourcing in some cases goes complete back to back
activity e.g. – Third party licensing manufacturing of pharma
products , Complete construction work sub-contracting
• Whether you carry out the process or your supplier , ISO 9001
requirements must be met.
• So in outsourcing process control , first thing required is to
identify which are ISO 9001 requirements shall be applicable
for particular out sourced
●
Continued
Outsourcing process control
(Why & How)
• Next step is to discuss what kind of controls the specific
supplier can establish for these applicable requirements
• For non addressed requirements , then workout suitable
alternate controls that organization should put in place
• If supplier is ISO certified , organization may consider this
third party certification for it’s control
Supplier Evaluation
• Supplier’s evaluation is carried out from two perceptive
• (I) Supplier’s capability assessment / re-assessment
– In this focus to assess supplier facilities , capability ,
credibility
– This is required to be done fore selection of supplier
– Periodic re-assessment to re-assess changes if any in above
• (II) Supplier’s performance evaluation
– In this objective is to review how was the performance of
supplier for purchase transaction done during specified period
– Performance factor generally include Quality , Timely delivery ,
Price and Support
– Outcome of evaluation – rating , CAs , delisting
• Capability assessment & performance evaluation criteria can
vary based on type of products & services