Point of Attention (POA-01)

According to ISO 13485 : 2016 MDQMS

Dear Sir,

Please peruse the following significant Infrastructure , MDQMS standard requirements points when
implementing ISO 13485 :2016 MDQMS in your organization

No Function Point of Attention

1 o Site map with details of double door system, direction, windows, rodent
traps, insect traps, , air curtains, hand wash facilities, water taps, drains,
storage areas, material flow, machines is required and must be
established.
o List of plant and machinery with details of Sr. No., Identification code, year,
make, size, capacity, speed, critical spares, use or function of machine, etc.,
Facilities and shall be established.
infra structure o Day, date Wise Equipment cleaning and sanitation SOP and Records are not
evidenced. These are a must. Also painting required on machine
o Cleaning record of Insecto catcher near the entrance and exits to be made
( note : cob web seen )
o The double doors to process, Finishing and packing hall must be put in
place
o Water sources should be tested for pot ability, ox disable matter, nitrites,
pathogens etc., and records maintained.
o Raw Material (needs to be kept it in order as per MSDS and storage
condition.
o Kota stone flooring, coving required in raw material storage, / Pattern
Making/ coating , finishing and packing area
o Yellow Demarcation / Pathway to be made
o Light fittings should be done with poly carbonate cover
o Bio burden test required .
o Plastic / Oil painting to be done on walls
o Rack required for storage of shell /die
o Positive air / clean room recommended
o AC duct line needs to be repaired
o Rollover Furnace area, Dewaxing area and finishing area needs to be
covered, cleaned and re arranged.

2 Personnel 1. Dress code, head gear, gloves for all as appropriate.

/storage 2. Medical Check up required for Concern personnel and workmen who are
working in investment casting div.
 3. Visual management and intensive training of hygiene and sanitation is
recommended
4. De-dusting area to be made before final entry of raw material at stores
.
3 Supplier o Supplier for Raw Material needs to agree and comply with defined terms
approval and and conditions of Medical Device safety requirements
qualification o Supplier for all intimate for MSDS. And medical grade
program
4 Utility control o water required to test at external lab at least once in a year
system
5 Regulatory o All applicable IS / ASTM standard
Req.
7 Supply chain o Scope should cover systems for product re call / withdrawal up to
Distributors
o Recall procedures and mock recall demo required
8 Live activity o Birds, insect entry control required
o No live activity should be observed
9 Trace ability o B. No system to be implemented
o Line clearance report to be made as and when Medical Equipments are
manufacture
10 Cleaning o Plan and Procedure required
o Protocol and record required for cleaning validation
11 Plant o Lube oil is potential chemical contaminant
chemicals / o MSDS required for all plant chemicals and Lab regent
Lab regent
12 Pest control o Plan and program required
13 Micro o Trend of chemical and microbiological evaluation of all medical products
required
15 Storage o Storage condition of all raw material to be followed .
condition
16 Machine o Machine /equipment installation qualification, operational qualification
and performance qualification (IQ,OQ,and PQ) required

Documentation MDQM Manual including , Scope , Policy , Organisation Chart , Roles and
responsibility , Process flow chart is to be made

Medical Device File / Technical file to be made

Risk assessment to be done
Control Plan , Work instruction / SOP to be made to each process
Following Mandatory SOP to be made
SOP FOR CHANGE CONTROL MANAGMENT
SOP FOR CONTROL OF DOCUMENT
SOP FOR COTROL OF RECORD
SOP FOR MRM
SOP FOR TRAINING PROGRAM OF EMPLOYEE
SOP FOR ENTRY & EXIT OF CLEAN ROOM
SOP FOR CALIBRATION OF EQUIPMENT & INSTRUMENT
SOP FOR CUSTOMER COMPLAIN
SOP FOR SUPPLIER APPROVAL
SOP FOR INTERNAL AUDIT
 SOP FOR RECALL PROCEDURE
SOP FOR PREPRATION OF DISINFECT ANT SOLUTION
SOP FOR PERSONAL HYGINE IN THE FACTORY
SOP FOR PEST AND RODENT CONTROL TREATMENT SERVICES
SOP FOR CLEAN ROOM CLEANING AND SANITISATION
SOP FOR PROCESS VALIDATION
SOP FOR CA/PA
SOP FOR BATCH RELEASE
NON CONFORMING PRODUCT
GOWNING POLICY
ANNUL PRODUCT REVIEW
SOP FOR MARKET SURVEILLANCE
SOP FOR “ISSUE AND IMPLEMENTATION OF ADVISORY
NOTICES”

Notes

The clear purpose of my documented mail is to provide direction and focus for Implementation of
ISO 13485 : 2016 MDQMS so that you can easily review and take appropriate action. My reports
are may not covered all the specific requirements of clauses of ISO 13485. It will be covered at the
time of department/ functions wise depth gap analysis during implementation visit.

Kindly decide your road map and target dates to achieve success on time

Thanking you,
Sincerely yours
For Excel Consultancy Services

Jawed
Consultant
Cell : 9824460607

Please acknowledge the receipt of this email without fail.