QUALITY MANAGEMENT

AIN MEDICARE SDN BHD ( NORTHERN BRANCH)

QUALITY MANAGEMENT SYSTEM

TECHNICAL QUESTIONNAIRE

APPLICABLE TO : EN/ISO 13485:2016

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS FOR REGULATORY PURPOSES

*This document can only be used in AIN Medicare Sdn. Bhd.

Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)
 QUALITY MANAGEMENT
AIN MEDICARE SDN BHD ( NORTHERN BRANCH)

Complies (Y/N) &

No. Brief about scope/clause What to look for and how Evidence obtained Targeted Area
Remarks
CLAUSE 1.0 - SCOPE
CLAUSE 4.0 - QUALITY MANAGEMENT SYSTEM
4.1 The organization shall establish, implement Standard Operating Procedure General
and maintain any requirement, procedure,
activity or
arrangement required to be documented
by this International Standard or applicable
regulatory
requirements.

4.1.3 Does the organization….

4.1.3 ( c) Implemented actions necessary to achieve Document Management System ; or any General
planned results and maintain the SOP that shows the interaction with
effectiveness of these processes QMS such as internal
audit/deviation/risk/complaint
management

4.2.1 Does the quality management system

documentation include:
d) documents, including records, Documentation Management system: General
determined by the organization to be SOP for Document control and example
necessary to ensure the effective planning, of the DMS
operation, and control of its processes?

Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)

4.2.5 Do documented procedures include:
-The controls needed for security and
integrity of records
-Defined and implemented methods for
protecting confidential health information
contained in records in accordance with the
applicable regulatory requirements
-Defined methods for maintaining records
for not less than 2 years from the medical
device release by the organization
CLAUSE 5.0 : MANAGEMENT RESPONSIBILITY
5.4.1 Are measurable quality objectives
established?
Are the objectives consistent with the
quality policy?
CLAUSE 6.0 : RESOURCE MANAGEMENT
6.1 Are there sufficient equipment and
machines to perform all specified product
realization processes and
monitoring/measurement activities? Are
the equipment and machines adequate
(qualified/calibrated where appropriate)?
Are there sufficient qualified personnel to
operate these processes? Are customer
orders shipped on time?
QUALITY MANAGEMENT
AIN MEDICARE SDN BHD ( NORTHERN BRANCH)
-SOP:Control of Records ; -Handling of Quality Information
approval in records/SOP; -Distribution & System ; Human
storage of records ; -Training of the Resource ; General
document/record ; -Personnel health
information management ; -Document
Management System in accordance to
Good Documentation Practices
Analysis of data for all quality objectives General
-Preventive Maintenance : Machine General
related to manufacturing & inspection
with products. Training on operating the
machine related to manufacturing the
product. Order process related to the
manufactured products.
Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)

6.3 Does the organization have documented
requirements for the infrastructure needed
to achieve conformity to product
requirements, prevent product mix-up and
ensure orderly handling of the product.
*Infrastructure includes:
Buildings, workspace, and associated
utilities
Process equipment (hardware and
software)
Supporting services (transport,
communication, IT)
QUALITY MANAGEMENT
AIN MEDICARE SDN BHD ( NORTHERN BRANCH)
SOP related to : Cleanroom ( PM & General
Services), utilities related to
manufacturing such as generation of
purified water (PM), clean air (PM),
compressor (PM). SOP related to
cleanroom suit. PM for machine related
to machine in Production. SOP for
Product order and processing. Pest
control activity and cleanliness in the
product related area such as
warehouse, laboratory, production &
others that relevant.

6.4.1 Ensure that all personnel who are required Procedure for temporary staff to enter Production &
to work temporariy under special the cleanroom. Engineering ;
environmental conditions within the work Administration
environment are competent or supervised
by a competent person.

6.4.2 As appropriate, does the organization have SOP for Cleanroom monitoring ( viable Finished Goods
planned and documented arrangements for & non-viable), handling contaminated Warehouse,
the control of contaminated or potentially product ( NCR) Laboratory, Quality
contaminated product in order to prevent Assurance &
contamination of the work environment, Operation and
personnel, or product. Engineering

CLAUSE 7.0: PRODUCT REALIZATION

Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)

7.1 Has the organisation documented one or
more processes for risk management in
product realisation
7.5.1 Does the organization have documented
procedures to ensure that production /
service activities are planned, carried out,
monitored and controlled to ensure that
product conforms to specification
7.5.1 As appropriate, do production controls also Performance Qualification Report of
address the “new” requirements below:
b) qualification of infrastructure,
c) implementation of monitoring and
measurement of process parameters and
product characteristics
CLAUSE 7.0: PRODUCT REALIZATION
8.1 Are measurement, analysis and
improvement processes planned and
implemented to ▪ demonstrate conformity
of the product, ▪ ensure conformity of the
QMS, and
▪ maintain the effectiveness of the QMS?
QUALITY MANAGEMENT
AIN MEDICARE SDN BHD ( NORTHERN BRANCH)
SOP : Risk Management ; Application of General
risk management in product realisation
Product Manufacturing Instruction General except
(PMI); Lab result specific to the product Human Resource &
; PM to machine related to Administration
manufacturing of product ;SOP related
to manufacturing of product ( Mixing,
Filling, Capping, Testing & Storing the
Product); Product Process Validation (
data & continual monitoring)
Quality
Machine & working environment Management,
related to manufacturing process Engineering &
Production
;-Internal audit ; Departmental weekly General
report, PMI
Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)