Documente Academic
Documente Profesional
Documente Cultură
8O 8O
Document Document
Writing Writing
SO Document Writing Training 2
Objectives
Provide overview of the
documentation requirement of
ISO 13485
Demonstrate procedure writing
steps & tips
Share the proposed
documentation system for
InQpharm
QMS success & QMS success &
effectiveness is effectiveness is
from and for ALL from and for ALL
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ontent..
Documentation Defined...
ISO 13485 Documentation
Requirement
Process Approach
Procedure Writing
Documentation System
Q & A
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What ?
%erm Definition
Document
information and its supporting
medium
Procedure
specified way to carry out an activity
or a process (Note: Procedures can
be documented or not)
QuaIity ManuaI document specifying the QMS of an
organization
Record
document stating resuIts achieved or
providing evidence of activities
performed
Specification document stating requirements
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Why ?
ommunication of nformation
for information transmission and
communication.
Evidence of onformity
provision of evidence that what was
planned. has actually been done.
Knowledge 8haring
to disseminate and preserve the
organization's experiences. A typical
example would be a technical
specification. which can be used as a
base for design and development of a
new product.
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8O 13485 8O 13485
Documentation Documentation
Requirement Requirement
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4.0 Ouality Management 8ystem
4.1 General Requirements
Document. implement. maintain an
effective OM8.
dentify processes.
its application.
8equence & interaction
riteria & method for OM8 control are
effective
Provide resources & information {refer
section 6
Ensure MA {refer section 8
mplement actions to achieve planned result
& maintain effectiveness
Adequate control over outsourced processes.
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4.2 Documentation requirements
4.2.1 General
The organization needs to document
quality policy & quality objectives.
quality manual.
Documented Procedures as required {e.g design
project. order processing. purchasing. document
control. internal audit. supplier management.
customer complaints. training
Documents {records needed {e.g purchase orders.
sales contracts. inspection records. design review
notes. audit report. supplier contract etc..
Any others as required by national or regional
regulation
Technical file {DMR for each type of devices.
The quantity. detail. and form of the documentation
can differ from one organization to another depending
on size. type of activities. or complexity of processes.
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4.2.2 Ouality manual
The quality manual describes;
extent of OM8 and exclusion with justification
procedures {included/referenced
Business process map
4.2.3 ontrol of documents
Written Procedure on documents control {that requires
procedures are legible. identified. reviewed.
authorized. up-to-date. issued. distributed. and
periodically updated
Obsolete documents to be identified and protected
from unintended use.
External origin Documents identified and controlled.
4.2.4 ontrol of records
records to demonstrate/evidence OM8 operation
legible. and easy to identify and retrieve.
Written procedure on records control {records are
identified. stored. protected. retrievable. and define
their retention and disposal times
Process Approach
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What is What?
Process ~ A sef of inferreIofed or
inferocfinq ocfivifies which fronsforms
inpufs info oufpufs.
Procedure ~ Specified woy fo corry ouf on
ocfivify or o process (moy be documenfed)
Product ~ PesuIfs of o process
Effectiveness ~ AbiIify fo ochieve desired
resuIfs.
Efficiency ~ Meosure of resuIfs ochieved
versus pIonned resources.
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Process Training What is your Business?
nput Process Output
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The Process
INPU%
ncIudes Pesources
PROCESS
Sef of inferreIofed or
inferocfinq processes
OU%PU%
PesuIfs of o Process
What is a Process?
set of interrelated or interacting
activities which transform inputs into
outputs
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The Process
ISO 134b:Z003 stresses the importunce
to identify, impIement, munuqe & muintuin
effectiveness of the whoIe processes in
order to uchieve the compuny ob|ectives
Inputs und Outputs muy incIude
equipment, muteriuIs, components,
enerqy, informution & finunciuI
resources, umonq others
INPU%s and OU%PU%s
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Process then Procedure
1. 1. You are the owner of a coffee shop. You are the owner of a coffee shop.
2. 2. You require a PROCESS. You require a PROCESS.
3. 3. %hen you require a PROCEDURE for a cup of %hen you require a PROCEDURE for a cup of
Coffee. Coffee.
What are your inputs from the customer?
What do you need for the coffee?
How do you fiII the order?
What is the finaI product?
Some Questions you may wish to ask yourseIf (among others)
EXERCISE
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Where does it fit In ?
What other processes are invoIved?
Effectiveness ~ AbiIify fo ochieve desired resuIfs.
Efficiency ~ Meosure of resuIfs ochieved versus pIonned resources.
Feedbuck Specificution
Hof Wuter Coffee Disputch
Purchusinq
Inspection
Trunsport
Troininq
PIunninq
ReIeuse
Improvement
Monitorinq
Process then Procedure EXERCISE
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ORDER(Customer Input)
Cup
*Hot Wuter
Coffee
Suqur
MiIk
Spoon
MANUFACTURE
HoId Cup
Add wuter
Add Coffee
Add Suqur
Add MiIk
Stir
RECEIPT(Customer
Feedbuck)
A Stundurd Cup of
Coffee
Customer Feedbuck
Specificution
Instruction Product
onofher procedure wifhin our fociIify
MAKING a CUP of COFFEE
Procedure {low detail
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ORDER(Customer Input)
1 Zb0 mI cup
Z *Hot Wuter
3 Stundurd Coffee
4 rown Suqur
b FuII Creum MiIk
Teu Spoon
MANUFACTURE
1 HoId Cup
Z Pour Wuter
3 1 tsp Coffee
4 Z tsp Suqur
b Dush of MiIk
Stir 4
RECEIPT(Customer Feedbuck)
1 A Stundurd Cup of
Coffee
Z At the TubIe
3 After Dinner
4 Customer Feedbuck
form
HAT 7
HO 7 HEM7 HEPE 7
How Much DetaiI Is Required?
onofher procedure wifhin our fociIify
Procedure {high detail
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