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.

6.4.2 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

7.1 Has the organisation documented one or SOP : Risk Management ; Application of General
more processes for risk management in risk management in product realisation
product realisation

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

7.5.2 Does the organization have documented -Product physical inspection ; Quality Assurance &
procedures for the cleanliness of product Cleanliness of product at storage area ; Operation ; Quality
or contamination control if the product Bioburden data Control &
cannot be cleaned prior to sterilization or Warehouse
its use, and its cleanliness is of significance
in use

7.5.11 Does the organization have procedures in SOP : Product Handling & Distribution Finished Goods
place to protect product from alteration, Warehouse
contamination or damage when exposed to
expected conditions and hazards during
processing, storage, handling, and
distribution by:
(a) designing and constructing suitable
packaging, storing and distributing of the
product
(b) documenting requirements for special
conditions needed if packaging alone
cannot provide preservation

CLAUSE 7.0: PRODUCT REALIZATION

Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)
 QUALITY MANAGEMENT
AIN MEDICARE SDN BHD ( NORTHERN BRANCH)
8.1 Are measurement, analysis and ;-Internal audit ; Departmental weekly General
improvement processes planned and report, PMI
implemented to ▪ demonstrate conformity
of the product, ▪ ensure conformity of the
QMS, and
▪ maintain the effectiveness of the QMS?

8.2.6 Are product release activities documented SOP: Product Released Quality
in a procedure? Who verifies, and how, Management (RFS),
that all specified production and Order & Delivery
acceptance activities have been Processing ,
completed? Is there a checklist for the Warehouse
review of the associated data and
documentation? How are results of this
review recorded? Are product release
authorizations dated and signed?
How is the released product identified
(distinguished from product that has not
yet been released)? What measures are
implemented to ensure that product that
has not been formally released is not used
or shipped?
Ask personnel in Order & Delivery
functions how do they know (and verify)
what is the release status for any given
product (batch).

Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)
 QUALITY MANAGEMENT
AIN MEDICARE SDN BHD ( NORTHERN BRANCH)
8.3.4 Rework: -SOP : Rework ; Form & Activities -Quality Assurance
-Has the organisation documented rework related to Rework activity & Operation,
procedures? Production,
-Do the rework procedures taken into Warehouse
account the potential adverse effect ts of
the rework on the product?
-Have the rework procedures undergone
the same review and approval as the
original procedures?
-After rework is product verified to ensure
that it meets applicable acceptance
criteria?
-Are records of rework maintained?

Prepared By: Hikmal FIzar bin Jamaludin, Senior Executive Quality Management AMSB(NB)