ICT - 81 - F32A - ISO - 13485 - and - MDD - IVDD - Checklist - Rev1 - 01.05.2020 - ALAMIN (1) (Recovered)

F32A 3EC Checklist for Assessment ISO 13485 & MDD / IVDD
Application or Contract No.: 310419A
Checklist for the assessment based on the standards:
 ISO 13485:2016
 ISO 13485:2016 associatedwith EC Directive 93/42/EEC as amended
 ISO 13485:2016 associatedwith EC Directive 98/79/EC
 Where applicable EC Directive 93/42/EEC as amended Annex II/V/VI
 Where applicable EC Directive 98/79/ECAnnex IV / VII
 EN ISO 19011:2018
Relevant standards, CTS (IVDD):

 https://ec.europa.eu/growth/single-market/european-standards/harmonised-
standards/medical-devices_en
 https://ec.europa.eu/growth/single-market/european-standards/harmonised-
standards/iv-diagnostic-medical-devices_en
Company name: Al AMIN for Modern Industries

Product type: 1. Sterile Syringe with Needle // IIa // MD0102, MDS7006 (EtO)
2.Sterile Infusion Set // IIa // MD0102, MDS7006 (EtO)
Scope of Manufacture of Non-active (Non Implantable) medical devices: Sterile

certification: Syringe with needle, Sterile Infusion Set / MD1, MS1 (EtO)
Attachments and Pictures from the production area
supporting
documents and Batchrecords
records:
QMS master records updated
QC testing reports
ETO,Packaging validation protocol and report
clean room validation reports
instruments calibration certificates
Enviromental and cleaning reports
Purchasing and suppliers assessments reports
Management report
Preventive maint.records and plan
rev.1, 01.05.2020 F32A 3EC Checklist for Assessment ISO 13485 & MDD Page1of41
Explanations for the application of the 3EC assessment check list
1. Applicable standards and marking

This assessment checklist is based on the requirements of the standards ISO 13485:2016,
MDD 93/42/EEC, Annex II/V/VI and the Slovak Medical Device Law (SML).
The following references are used to address the requirements of the standards:
13485 Requirement of the ISO 13485:2016
Special additional questions with regards to implants are marked with 13485 Impl.
andspecial additional questions relevant for sterile products are marked with 13485 sterile.
MDD: Questions related to the requirements of the MDD 93/42/EEC.
The numbering of the QM-Elements of EN ISO 13485:2016 is used for the chapters.
2. Use of the Assessment Checklist

The questions of this checklist are addressed to the auditor, who evaluates and documents
the fulfilment of the requirements. The auditor should formulate the questions asked to the
company’s representative/s in a different way, please remember your audit training. The
checklist can be used by Auditor for the documentation of the audit performance on voluntary
basis as annex to the F06A NR MD / IVD MD Audit Report.
In case of remote audits is the checklist mandatoryand shall be filled by the client and
verified by the auditor.
Auditor verification
(Approved (A) / Not
Standard Requirement Client Objective Evidence Approved (N) and
comments if
necessary
1.1 General questions for the certification *
Is the guideline “Regulation for the use
of the 3EC certificate symbols, the 3EC 3EC mark not used yet A
documents and the 3EC-symbol
“appliedcorrectly?
Are the improvement potentials to the yes A
QM-System, mentioned in the last audit
report used?
1.2 Additional requirements of the MDD 93/42/EEC and IVDD 98/79/EC to establish the
procedure *
Does the company keep the yes A
correspondence with 3EC? (only for
MDD / IVDD)
Was the company completely informed yes A
about the previous and present
(today’s) activities of the auditor(s)? Is
the declaration “Auditors’/ Experts’
Independence and Objectivity
“countersigned? (only for MDD / IVDD)
Are the company and the products yes A
registered to the legal authorities and
competent authorities? (only for MDD /
IVDD)
Is there a procedure in place to inform Notification to notification A
3EC about essential changes of the
Body
Medical Devices covered by the Quality
Management System? (Advice
company about the application forms ALAMIN -OP-03
(Certification application) & (Product
application) and hand it out). (only for IssueDate:01-05-2019
MDD / IVDD)
4. Quality Management System

4.1. General requirements
Is the MDD Annex II/V/VI or IVDD yes:Technical File of sterile A
Annex IV/VII referenced correctly?
with needle syringe for single
(only for MDD / IVDD)
use
ALAMIN-TF-01 , rev. 02, dated

14/01/2020. Class IIa products
along with revisions on the
respective sections of the
technical file.
Is, if necessary, an authorized Yes:EU REP Agreement A

representative designated within the
EEC? (only for MDD / IVDD) EUCEREP
Does the organization document a Quality Management system A

quality management system and
Manual With EN ISO
maintain its effectiveness in
accordance with the requirements of 13485:2016
this International Standard and
applicable regulatory requirements? QM-4.2.1
Initial IssueDate 01-05-2019
Does the organization establish, Control of Records.ALAMIN- A

implement and maintain any OP-04, Rev. 1/0, Issue Date.
requirement, procedure, activity
01/05/2019
orarrangement required to be
documented by this International
Standard or applicable regulatory
requirements?
Does the organization document the Control of Recordes No. A
role(s) undertaken by the organization ALAMIN-OP-04, Rev. -1/0, Issue
under the applicable regulatory
requirements? Date. 01/05/2019

Does the organization: Quality Manual In Compliance A
-determine the processes needed for
With EN ISO 13485:2016
the quality management system and
the application ofthese processes
throughout the organization taking into Issue date 01-05-2019
account the roles undertaken by
theorganization? Risk Management
-apply a risk based approach to the
control of the appropriate processes ALAMIN-OP-12 Issue
needed for the quality management
Date:01/05/2019
system?
-determine the sequence and
interaction of these processes? Issue Revision No: -1/0
For each quality management system Control of Recordes A

process, does the organization: No.ALAMIN-OP-04, Rev. 01, Dt.
-determine criteria and methods
01/05/2019-
needed to ensure that both the
operation and control of
theseprocesses are effective?
-ensure the availability of resources
and information necessary to support
the operation and monitoring of these
processes?
-implement actions necessary to
achieve planned results and maintain
the effectiveness of these processes?
-monitor, measure as appropriate, and
analyse these processes?
-establish and maintain records needed
to demonstrate conformance to this
International Standardand compliance
with applicable regulatory requirements
(see 4.2.5)?
Does the organization manage these Quality Management system A
quality management system processes
Manual ISO 13485:2016
in accordance withthe requirements of
this International Standard and
applicable regulatory requirements? QM-4.2.1
Are changes to these processes made:
-evaluated for their impact on the Issue date 01-05-2019
quality management system?
-evaluated for their impact on the
medical devices produced under this
quality management system? Control of Recordes No.FM-
-controlled in accordance with the
requirements of this International OP-04, Rev:-1/0, Issue
Standard and applicable regulatory Date01/05/2019
requirements?
When the organization chooses to Purchasing ALAMIN -OP- A

outsource any process that affects 16 ,Supplier Aggrement
product conformity torequirements,
does the organization monitor and
ensure control over such processes?
Does the organization
retainresponsibility of conformity to this
International Standard and to customer
and applicable regulatoryrequirements
for outsourced processes?Are the
controls proportionate to the risk
involved and theability of the external
party to meet the requirements in
accordance with 7.4? Do the controls
include written quality agreements?
Does the organization document process validation A
procedures for the validation of the
application of computersoftware used in ALAMIN -OP-18
the quality management system?Are
such software applications validated
prior toinitial use and, as appropriate,
after changes to such software or its
application?
Are the specific approach and activities N/A A
associated with software validation and
revalidation proportionate to the risk
associated with the use of the
software?
Are records of such activities N/A A
maintained (see 4.2.5)?
4.2 Documentation requirements*
4.2.1 General*
Does the quality management system Quality Management System A
documentation (see 4.2.4)include:
Manual In Compliance With
-documented statements of a quality
policy and quality objectives? ISO 13485:2016
-a quality manual?
-documented procedures and records QM-4.2.1
required by this International Standard?
-documents, including records, initial Issue Date01-05-2019
determined by the organization to be
necessary to ensure theeffective
planning, operation, and control of its
processes?
-other documentation specified by
applicable regulatory requirements?
Product documentation
Are files available, containing all yes A
products specifications and quality
assurance specifications, or is the ALAMIN -TF -01-
location of those documents described
exactly? (NB-MED 2.5.1-5) (see also
Annex II / V/ VI MDD or Annex IV / VII
IVDD and if necessary 3EC-Support

docs) (only for MDD / IVDD)
Is this information available and yes ,Control of Recordes A
comprehensible for each type or each No.ALAmin-OP-04, .Issue
model of the medical device? (if
Date:01/05/2019
necessary, also the information for
installation/ maintenance) (only for
MDD / IVDD)
Are correct declarations of conformity TF-01-A18.27 A
issued? (only for MDD / IVDD)
ALAMIN-01-A18.27
revision date 14/01/2020
Are the classifications of the Medical TF A

Devices traceable to the MDD / IVDD?
(only for MDD / IVDD) ALAMIN-TF- 01-02
Revision Date:14/01/2020
Are designated harmonized standards, TF A

which are applicable to the product /
procedures defined and available (Is ALAMIN
the adherence systematically
ensured)? If no harmonized standards
are available, is there proof, which
revision date 14-01-2020
ensures the safety and suitability of the
products? (only for MDD / IVDD)
Is it defined and documented for each TF A
product how the applicable “Essential
Requirements (Annex I) “are fulfilled ALAMIN
and are there proofs to validate the
statements made? (only for MDD /
IVDD)
Are there, for all products/product Risk mamangment ALAMIN- A

groups, complete risk analyses defined
OP-12
and documented? (copy the risk
analysis to the documents for the 3EC)
(only for MDD / IVDD) Issue Date 01/05/2019
Revision No:-1/0
Are all the possible safety risks TF A

comprehensibly determined? Are the
initial risks evaluated? Is the evaluation ALAMIN-
of the risks comprehensible? (only for
MDD / IVDD)
Report date 14-01-2020
Do designated suppliers with activities Purchasing A

having a substantial influence on the
quality identified exist? (only for MDD / ALAMIN -OP-16
IVDD)
Issue date 01/05/2019
Are they listed including their activities Approved Supplier List A

and are appropriate certificates of the
subcontractors/ suppliers available? ALAMIN-OP-16-01
(only for MDD / IVDD)
If no appropriate certificates for Supplier Assessment Form A
subcontractors/suppliers are available,
are they appropriately assessed to fulfill ALAMIN-OP-13-02
the requirements of the suppliers /
subcontractors? (only for MDD / IVDD)
Are contractual Management Review A
declarations/agreements signed with
subcontractors/suppliers with defined ALAMIN-OP-08
activities and responsibilities, if they
have a substantial influence on the
quality? (only for MDD / IVDD)
IssueDate 20/10/2020
Does the contract with e.g. OEM N.A A

suppliers contain sufficient descriptions
and regulations on notification of the
legal authorities and to ensure
appropriate information in case of
vigilance? (only for MDD / IVDD)
Is there a procedure to evaluate the Supplier Assessment Form A
actuality of the
subcontractor’s/supplier’s proofs F/ALAMIN-OP-16-02
(certificates of analysis, etc.)? (only for
MDD / IVDD)
Does the manufacturer plan, conduct and TF A
document a clinical evaluation and clinical
investigation in accordance with Annex X
ALAMIN
of MDD? (only for MDD)
Revision date 14-01-2020
Are there corresponding pre-clinical TF A

product reviews for the products? (only
for MDD) ALAMIN
Revision date 14-01-2020
Is there a evaluation of the essential TF A

requirements of the Machinery
Directive, if this is applicable to the ALAMIN
product?
(NB-MED 2.2 Rec. 5) (only for MDD)
If the destination of the products falls N.A A

below the standards for personal
protective equipment, is a notified body
involved for this? (only for MDD /
IVDD)
4.2.2 Quality Manual *
Does the organization document a Quality Management system A
quality manual that includes:
Documentation In Compliance
-the scope of the QM system, including
details of and justifications for any With EN ISO 13485:2016
exclusions and / or non-application?
-the documented procedures QM-4.2.1
established for the QM system, or
reference to them? Issue date01/05/2019
-a description of the interaction
between the processes of the QM
system?
Does the quality manual outline the yes, A
structure of the documentation used in
the quality management system? Quality Management
SystemDocuments With EN ISO
13485:2016
QM-4.2.1
Issue date: 01/05/2019
4.2.3 Medical device file *

Is there a medical device file for each TF A
medical device type or medical device
family to demonstrate conformity to the ALAMIN
requirements of this International
standard and compliance with
applicable regulatory requirements?
Does the medical device file include TF A

(but is not limited to):
-general description of the medical ALAMIN
device, intended use/purpose, and
labelling, including anyinstructions for
use?
-specifications for product?
-specifications or procedures for
manufacturing, packaging, storage,
handling and distribution?
-procedures for measuring and
monitoring?
-as appropriate, requirements for
installation?
-as appropriate, procedures for
servicing?
4.2.4 Control of documents *
Are documents required by the quality Control of document A
management system controlled?
procedure No.FM-OP-02,
Records are a special typeof
document.Are they controlled according
to the requirements given in 4.2.5? Rev Dt. 01/06/2019
Has a documented procedure been Control of Quality A

established to define the controls
RecordesALAMIN-OP-04
needed to:
-review and approve documents for
adequacy prior to issue? Issue Date . 01/05/2019
-review, update as necessary and re-
approve documents?
-ensure that changes and the current
revision status of documents are
identified?
-ensure that relevant versions of
documents are available at point of use
and that documents remain legible/
readily identifiable?
-ensure that documents of external
origin are identified and that their
distribution is controlled?
-prevent deterioration or loss of
documents?
-prevent the unintended use of obsolete
documents and apply suitable
identification to them?
Does the organization ensure that Control of Quality A
changes to documents are reviewed
RecordsALAMIN-OP-04
and approved either by the original
approving function or another
designated function which has access Issue Date01/05/2019/
to pertinent background information Notification of substantial
upon which to base its decisions? change
Alamin-OP-03-01
Is a retention period set for the keeping Control of Quality Records A

of at least one copy of obsolete
documents? Does this period ensure ALAMIN-OP-04
that documents to which medical
devices have been manufacturedand
tested are available for at least the
Issue date 01-05-2019
lifetime of the medical device as
defined by the organization,but not less

than the retention period of any
resulting record (see 4.2.5), or as
specified by applicableregulatory
requirements?
4.2.5 Control of Records*
Are records maintained to provide Control of Quality Records A
evidence of conformity to requirements
and of the effectiveoperation of the ALAMIN -OP-04
quality management system?
Isuue date 01-05-2019
Has a documented procedure been A

established to define the controls of
records (Identification, storage, security Control of quality Records
and integrity, retrieval, retention time
and disposition of records)?
ALAMIN-OP--04
Are there defined and implemented Control of Quality Records A

methods for protecting confidential
health informationcontained in records ALAMIN-OP-04
in accordance with the applicable
regulatory requirements?
Are records legible, readily identifiable Control of QualityRecord

and retrievable? Are changes to a
record identifiable? AlAMIN-OP-04 A
Issue / Change request
F/ALAMIN-OP-02-05
Are the quality records maintained for A

the lifetime of the medical device as
defined by theorganization, or as Control ofQuality Records
specified by applicable regulatory
requirements (at least 2 years after
product release/ date of shipment) or
ALAMIN-OP-04
according to the storage requirements
of the relevant rules (SML min. 5 years, Issue date 01-05-2019
for implants min. 15 years)?
5 Management responsibility
5.1 Management Commitment
Does top management provide Management Review A
evidence of its commitment to the
development and implementation ofthe ALAMIN-OP-08
quality management system and
maintenance of its effectiveness by:
-communicating to the organization the Last Management 20-10-2020

importance of meeting customer as well
as applicable regulatory requirements?
-establishing the quality policy?
-ensuring that quality objectives are
established?
-conducting management reviews?
-ensuring the availability of resources?
5.2 Customer focus
Does top management ensure that Customer Complaint A
customer requirements and applicable
regulatory requirements are determined ALAMIN-OP-26
and met?
5.3 Quality Policy

Does top management ensure that the Management Review A
quality policy:
-is applicable to the purpose of the ALAMIN-OP-0
organization?
-includes a commitment to comply with
requirements and to maintain the
Last Management 20-10-2020
effectiveness of the quality
management system?
-provides a framework for establishing
and reviewing quality objectives;
-is communicated and understood
within the organization?
-is reviewed for continuing suitability?
5.4 Planning
5.4.1 Quality Objectives
Does top management ensure that Quality Objective A
quality objectives, including those
needed to meet applicable regulatory ALAMIN-OP-06
requirements and requirements for
product, are established at relevant
functions and levels within the
organization?
Are the quality objectives measurable Quality Objective A
and consistent with the quality policy?
F\ALAMIN-OP-06-01.Rev
5.4.2 Quality management system planning

Does top management ensure that: Quality Objective A
-the planning of the QM system is
carried out in order to meet the ALAMIN-OP-06
requirements given in 4.1, as well as
the quality objectives?
-the integrity of the quality management
system is maintained when changes to
the quality management system are
planned and implemented?
5.5 Responsibility, authority and communication

5.5.1Responsibility and authority
Does the top management ensure that Quality Management System A
the responsibilities and authorities are
Documentation With EN ISO
defined, communicated and
documented within the organization? 13485:2016
QM-4.2.1
Issue date01-05-2019
Does the top management document Quality Management system A

the interrelation of all personnel who
documentation In Compliance
manage, perform and verify work
affecting quality? Is the necessary With EN ISO 13485:2016
independence and authority to perform
these tasks ensured? QM-4.2.1
5.5.2 Management representative

Has the top management appointed a Management Review A
member of the organization's
management who, irrespective of other ALAMIN-OP-08
responsibilities, has responsibility and
authority that includes:
-ensuring that processes needed for
the QM system are documented?
-reporting to top management on the
effectiveness of the QM system and
any need for improvement?
-ensuring the promotion of awareness
of applicable regulatory requirements
and qualitymanagement system
requirements throughout the
organization?
Who is appointed (and trained) as Yes: Production Manger. A
Medical Device Safety Representative?
Is the expertise provided sufficiently?
(only MDD / IVDD).
Are the Medical Device Safety Yes: Production Manger A
Representative’s responsibilities and
competencies defined and documented
and was the Medical Device Safety
Representative notified to the legal
authorities? (only MDD / IVDD).
5.5.3 Internal Communication
Does top management ensure that -QualityManagement system A
appropriate communication processes
document Manual In
are established within the organization
and that communication takes place Compliance With EN ISO

regarding the effectiveness of the QM
13485:2016
system?
QM-4.2.1
5.6 Management Review*

5.6.1 Management Review General*
Does the organization document Management Review A
procedures for management review?
Does top management review the ALAMIN-OP-05
organization’s QM system at planned
intervals, to ensure its continuing
suitability, adequacy and effectiveness?
Does this review include assessing Management Review A

opportunities for improvement and the
need for changes of the QM system, ALAMIN-OP-08
including the quality policy and quality
objectives?
Are records from management reviews Meeting Agenda&Minutes of A

Meeting
F/ALAMIN-OP-08-01
5.6.2 Review input *

Does the input to management review Meeting Agenda&Minutes of A
include, but is not limited to, information
Meeting F/ ALAMIN-OP-08-01
arising from:
-feedback?
-complaint handling?
-reporting to regulatory authorities?
-audits?
-monitoring and measurement of
processes?
-monitoring and measurement of
product?
-corrective action?
-preventive action?
-follow-up actions from previous
management reviews?
-changes that could affect the QM
system?
-recommendations for improvement?
-applicablenew or revised regulatory
requirements?
5.6.3 Review Output*
Is the output from management review Management Review output A

recorded (see 4.2.5)?
F/ALAMIN-OP-08-01
Does the output of the management Minutes of Meeting A

review include the input reviewed
andany decisions and actions related F/ALAMIN-OP-08-01
to:
-improvement needed to maintain the
suitability, adequacy, and effectiveness
Management Review output
of the QM system and its processes?
-improvement of product related to F/ALAMIN-OP-08-01
customer requirements?
-changes needed to respond to
applicable new or revised regulatory
requirements
-resource needs?
6 Resource management
6.1 Provision of resources
Does the organization determine and yes A
provide the resources needed to:
-implement the quality management
system and to maintain its
effectiveness?
-meet applicable regulatory and
customer requirements?
6.2 Human Resources
Are personnel performing work Human Resources A
affecting product qualitycompetent on
the basis of appropriate education, ALAMIN-OP-10
training, skills and experience?
F/ALAMIN-OP-10-02
Is the training of new medical device Training A

representatives and sales personnel
planned, executed and recorded? ALAMIN-OP-10
(MDD / IVDD only)
Does the organization document the Training A

process(es) for establishing
competence, providing neededtraining, ALAMIN-OP-10
and ensuring awareness of personnel?
Training Needs
F/ALAMIN-OP-10-22
Does the organization: Human Resources A

-determine the necessary competence
for personnel performing work affecting ALAMIN-OP-10
product quality?
-provide training or take other actions to
achieve or maintain the necessary
competence?
-evaluate the effectiveness of the Job Description Card
actions taken?
-ensure that its personnel are aware of F/alamin-OP-07-01
the relevance and importance of their
activities and howthey contribute to the
achievement of the quality objectives?
-maintain appropriate records of
education, training, skills and
experience (see 4.2.5)?
NOTE The methodology used to check

effectiveness is proportionate to the risk
associated with the work forwhich the
training or other action is being
provided.
6.3 Infrastructure
Does the organization document the ALAMIN-Work instruction A
requirements for the infrastructure
needed to achieveconformity to product
requirements, prevent product mix-up
and ensure orderly handling of
product?
Does infrastructure include, as ALAMIN-Work instruction A
appropriate:
-buildings, workspace and associated
utilities?
-process equipment (both hardware
and software)?
-supporting services (such as transport,
communication or information
systems)?
Does the organization document INfrastruction Maintenance A
requirements for the maintenance
activities, including the intervalof ALAMIN-OP-11
performing the maintenance activities,
when such maintenance activities, or
lack thereof, can affectproduct quality?
Does as appropriate, the requirements Device Master Record

apply to equipment used in production,
thecontrol of the work environment and ALAMIN-OP-05 A
monitoring and measurement?
Issuedate 01-06-2019
Are records of such maintenance The Annual Maintenance A

Plan( (‫خطة الصيانة السنوية‬
F/ALAMIN-OP-11-01
‫طلب شراء قطع غيار‬
F/ALAMIN-OP-16-01
‫إخطار بحلول ميعاد الصيانةتقرير عملية‬
‫سجل صيانة معدة‬
F/ALAMIN-OP-11-04
‫نموذج إصالح عطل مفاجئ‬
F/ALAMIN-OP-11-03
6.4 Work environment

6.4.1 Work environment
Does the organization documentthe Health &Hygiene (ALAMIN-OP- A
requirements for the work environment
35)
needed to achieveconformity to product
requirements?
Work Enviroment(ALAMIN-OP-
36)
Contamination
Control(ALAMIN-OP-37)
Environmental Control
ALAMIN-WI-02
If the conditions for the work Health &Hygiene (ALAMIN-OP-

environment can have an adverse
35)
effect on product quality, does A
theorganization document the
requirements for the work environment Work Enviroment(ALAMIN-OP-
and the procedures to monitorand 36)
control the work environment?
Contamination
ALAMIN-WI-02
Does the organization: Health &Hygiene (ALAMIN-OP- A

-document requirements for health,
35)
cleanliness and clothing of personnel if
contact between suchpersonnel and
the product or work environment could Work Enviroment(ALAMIN-OP-
affect medical device safety or 36)
performance?
-ensure that all personnel who are Contamination
required to work temporarily under
special environmentalconditions within Control(ALAMIN-OP-37)
the work environment are competent or
supervised by a competent person? Environmental Control
ALAMIN-WI-02
6.4.2 Contamination control

Does, as appropriate, the organization Health &Hygiene (ALAMIN-OP- A
plan anddocument arrangements for
35)
the control of contaminatedor
potentially contaminated product in
order to prevent contamination of the Work Enviroment(ALAMIN-OP-
work environment,personnel, or 36)
product?
Contamination
ALAMIN-WI-02
Does the organizationdocument for Health &Hygiene (ALAMIN-OP- A

sterile medical devices requirements for
35)
control of contaminationwith
microorganisms or particulate matter
and maintain the required cleanliness Work Enviroment(ALAMIN-OP-
during assembly orpackaging 36)
processes?
Contamination
ALAMIN-WI-02
7 Product realization*
7.1 Planning of product realization*
Does the organization plan and develop Quality objective A
the processes needed for product
realization? Is the planning of product F/ALAMIN-OP-06-01
realization consistent with the
requirements of the other processes of
the QM system?
Does the organization document one or Risk Management (ALAMIN- A
more processes for risk management in OP-12)
product realization?
Are records of risk management A
activities maintained (see 4.2.5)?
Does the organization determine the A
following, as appropriate, in planning
product realization: Quality objective
-quality objectives and requirements for
the product?
-the need to establish processes and
F/ALAMIN-OP-06-01
documents (see 4.2.4), and to provide
resources specific to the product
including infrastructure and work
environment?
-required verification, validation,
monitoring, measurement, inspection Management Review
and test, handling, storage, distribution
and traceability activities specific to the ALAMIN-OP-08
product together with the criteria for
product acceptance?
-records needed to provide evidence Last Management 20-10-2020
that the realization processes and
resulting product meet requirements
(see 4.2.5)?
Is the output of this planning Management Review output A
documented in a suitable form for the
organization’s method of operations? F/ALAMIN-OP-08-01
7.2 Customer-related processes

7.2.1 Determination of requirements related to the product
Are procedures and competencies for Contract Review A
contract reviews defined?
ALAMIN-OP-14
Does the organization determine: TF A

-requirements specified by the
customer, including the requirements ALAMIN-
for delivery and post-delivery activities?
-requirements not stated by the Report date 14-01-2020

customer but necessary for specified or
intended use, as known?
-applicable regulatory requirements
related to the product?
-any user training needed to ensure
specified performance and safe use of
the medical device?
-any additional requirements
determined by the organization?
7.2.2 Review of requirements related to the product
Does the organization review the Purchasing A
requirements related to the product? Is
this review conducted prior to the ALAMIN-OP-16
organization’s commitment to supply
product to the customer (for example:
submission of tenders, acceptance of
Issue Date 01-05-2019
contracts or orders, acceptance of
changes to contracts or orders)?
Does this review ensure that: Purchasing A
-product requirements are defined and
documented? aALAMIN-OP-16
-contract or order requirements differing
from those previously expressed are
resolved?
ALAMIN date 01-05-2019
-applicable regulatory requirements are
met? Contract Review
-any user training identified in
accordance with 7.2.1 is available or ALAMIN-OP-14
planned to be available?
-the organization has the ability to meet
the defined requirements?
Are the records of the results of the Yes A
review and actions arising from the
review maintained and stored (see
4.2.5)?
Does the organization confirm the Contract Review A
customer requirements before
acceptance, where the customer ALAMIN-OP-14
provides no documented statement of
requirement?
Does the organization ensure that Purchasing A

relevant documents are amended and
that relevant personnel are made ALAMIN-OP-12
aware of the changed requirements?
Issue date01-05-2019
Purchasing Order
F/ALAMIN-OP-16-05
7.2.3 Communication
Has the organization planed and ALAMIN-OP-26 A
documented arrangements for
communication with customers in Customer Complain
relation to:
-product information?
-enquiries, contracts or order handling,
including amendments?
-customer feedback, including
complaints?
-advisory notices?
Does the organization communicate Authority&Responsibility A
with regulatory authorities in
accordance with applicableregulatory ALAMIN-OP-07
requirements
7.3 Design and Development*

7.3.1General*
Does the organization document N.A A
procedures for design and
development?
7.3.2 Design and development planning*
Does the organization plan and control N.A A
the design and development of
product?
As appropriate, are designand N.A A
development planning documents
maintained and updated as the design
and developmentprogresses?
During design and development N.A A
planning does the organization
document:
-the design and development stages?
-the review(s) needed at each design
and development stage?
-the verification, validation, and design
transfer activities that are appropriate at
each design anddevelopment stage?
-the responsibilities and authorities for
design and development?
-the methods to ensure traceability of
design and development outputs to
design anddevelopment inputs?
-the resources needed, including
necessary competence of personnel?
7.3.3 Design and development inputs*
Are inputs related to product N.A A
requirements determined and records
Do these inputs include: N.A A
-functional, performance, usability and
safety requirements according to

intended use?
-applicable regulatory requirements and
standards?
-applicable output(s) of risk
management?
-as appropriate, information derived
from previous similar designs?
-other requirements essential for design
and development of the product and
processes?
Are these inputs reviewed for adequacy N.A A
and approved?
Are these requirements complete, N.A A
unambiguous, able to be verified or
validated, and not in conflict with each
other?
Are the applicable harmonized N.A A
standards for safety requirements for
medical devices systematically
identified?
If no harmonized standards were N.A A
applied: Are the safety requirements
completely identified (systematically)?
7.3.4 Design and development outputs
Are the outputs of the design and N.A A
development in a form suitable for
verification against the design and
development input and are approved
prior to release?
Do design and development outputs: N.A A
-meet the input requirements for design
and development?
-provide appropriate information for
purchasing, production and service
provision?
-contain or reference product
acceptance criteria?
-specify the characteristics of the
product that are essential for its safe
and proper use?
Are records of design and development N.A A
outputs maintained (see 4.2.5)?
7.3.5 Design and development review *
At suitable stages, are systematic N.A A
reviews of design and development
performed in accordance with planned
and documented arrangements to:
-evaluate the ability of the results of
design and development to meet
requirements?
-identify and propose necessary
actions?
Do the participants in such reviews N.A A

include representatives of functions
concerned with the design and
development stage being reviewed, as
well as other specialist personnel? Is
specialist personnel included, where
necessary?
Are records of the results of the reviews N.A A
and any necessary actions
maintainedand include theidentification
of the design under review, the
participants involved and the date of
the review (see 4.2.5)?
7.3.6 Design and development verification*
Are design and development N.A A
verification performed in accordance
with planned and
documentedarrangements to ensure
that the design and development
outputs have met the design and
developmentinput requirements?
verification plans that include methods,
acceptance criteria and, asappropriate,
statistical techniques with rationale for
sample size?
If the intended use requires that the N.A A
medical device be connected to, or
have an interface with, othermedical
device(s), does verification include
confirmation that the design outputs
meet design inputs when so connected
or interfaced?
Are records of the results and N.A A
conclusions of the verification and
necessary actions maintained (see
4.2.4 and 4.2.5)?
7.3.7 Design and development validation*
Are design and development validation N.A A
performed in accordance with planned
and documentedarrangements to
ensure that the resulting product is
capable of meeting the requirements
for thespecified application or intended
use?
validation plans that include methods,
acceptance criteria and, asappropriate,
statistical techniques with rationale for
sample size?
Are design validation conducted on N.A A
representative product? Representative
product includesinitial production units,
batches or their equivalents. Is the

rationale for the choice of product used
for validation recorded (see 4.2.5)?
As part of design and development N.A A
validation, does the organization
perform clinical evaluations
orperformance evaluations of the
medical device in accordance with
applicable regulatory requirements? A
medical device used for clinical
evaluation or performance evaluation is
not considered to be releasedfor use to
the customer.
If the intended use requires that the N.A A
medical device be connected to, or
have an interface with, othermedical
device(s), does validation include
confirmation that the requirements for
the specifiedapplication or intended use
have been met when so connected or
interfaced?
Is validation completed prior to release N.A A
for use of the product to the customer?
Are records of the results and N.A A
conclusion of validation and necessary
actions maintained (see 4.2.4 and
4.2.5)?
7.3.8Design and development transfer
procedures for transfer of design and
development outputs to manufacturing?
Do these procedures ensure that
design and development outputs are
verifiedas suitable for manufacturing
before becoming final production
specifications and that
productioncapability can meet product
requirements?
Are results and conclusions of the N.A A
transfer recorded (see 4.2.5)?
7.3.9 Control of design and development changes *
procedures to control design and
development changes?
Does the organization determine the N.A A
significance of the change to function,
performance, usability, safetyand
applicable regulatory requirements for
the medical device and its intended
use?
Are design and development changes N.A A
identified and records maintained and
reviewed, verified and validated, as
appropriate? Are design and

development changes approved before
implementation?
Does the review of design and N.A A
development changes include
evaluation of the effect of the changes
onconstituent parts and product in
process or already delivered, inputs or
outputs of risk managementand product
realization processes?
Are records of the results of the review N.A A
of changes and any necessary actions
Which procedures guarantee that the N.A A
3EC is informed when substantial
modifications are done to the products?
(MDD / IVDD Only)
7.3.10 Design and development files
Does the organization maintain a N.A A
design and development file for each
medical device type or medical device
family?
Does this file include or reference N.A A
records generated to demonstrate
conformity to therequirements for
design and development and records
for design and development changes?
7.4 Purchasing
7.4.1 Purchasing process
Does the organization document Purchasing A
procedures (see 4.2.4) to ensure that
purchased product conforms ALAMIN-OP-16
tospecified purchasing information?
purchase Order
F/ALAMIN-OP-16-05.
Does the organization establish criteria Supplier Assessment A

for the evaluation and selection of
suppliers?Are the criteria: ALAMIN-OP-16
-based on the supplier’s ability to
provide product that meets the
organization’s requirements?
New Supplier Evaluation
-based on the performance of the ReportF/ALAMIN-OP-16-03
supplier?
-based on the effect of the purchased Approved Suppliers List
product on the quality of the medical
device?
-proportionate to the risk associated F/ALAMIN-OP-16-01

with the medical device?
Supplier Assessment Form
F/ALAMIN-OP-16-02
Does the organization plan the Supplier Assessment Form A

monitoring and re-evaluation of
suppliers? Is supplier performance F/ALAMIN-OP-16-02
inmeeting requirements for the
purchased product monitored? Do the
results of the monitoring provide an
input into the supplier re-evaluation
process?
Are non-fulfilment of purchasing Risk Management Report FOR A
requirements addressed with the
PURCHASING
supplier proportionate to therisk
associated with the purchased product
and compliance with applicable Issue date 01-06-2019
Are records of the results of evaluation, Supplier Assessment A
selection, monitoring and re-evaluation
of supplier capability orperformance ALAMIN-OP-16
and any necessary actions arising from
these activities maintained (see 4.2.5)?
Supplier Assessment
FormF/ALAMIN-OP-16-02
7.4.2 Purchasing information

Does the purchasing information Purchasing A
describe or reference the product to be
purchased? ALAMIN-OP-16
purchase Order
F/ALAMIN-OP-16-05.
Does the information include, where purchase Order A

appropriate:
-product specifications? F/ALAMIN-OP-16-05.
-requirements for product acceptance,
procedures, processes and equipment?
-requirements for qualification of
ALAMIN-IMS 01 to IMS 13
supplier personnel?
-quality management system
requirements?
Is the adequacy of specified purchasing purchase Order A
requirements ensured, prior to their
communication to the supplier?
F/ALAMIN-OP-16-05.
Does purchasing information include, purchase Order A

as applicable, a written agreement that
the supplier notify theorganization of F/ALAMIN-OP-16-05.
changes in the purchased product prior
to implementation of any changes that
affectthe ability of the purchased
product to meet specified purchase
requirements?
To the extent required for traceability Purchasing A
given in 7.5.9, does the organization
maintain relevant ALAMIN-OP-16
purchasinginformation in the form of
documents (see 4.2.4) and records
(see 4.2.5)?
purchase Order
F/ALAMIN-OP-16-05
7.4.3 Verification of purchased product

Does the organization establish and Inspection Report for the A
implement the inspection or other
Incoming Material
activities necessary for ensuring that
purchased product meets specified
purchase requirements? Is the extent of F/ALAMIN-OP-28-01
verification activitiesbased on the
supplier evaluation results and
proportionate to the risks associated
with the purchased product?
When the organization becomes aware YES,
of any changes to the purchased
product, does the organization F/ALAMIN-OP-28-01-- ‫طلب فحص‬
determine whether these changes
affect the product realization process or )‫خامة (عينه جديده‬
the medical device?
Where the organization or its customer Purchasing A
intends to perform verification at the
supplier’s premises: are the intended ALAMIN-OP-16
verification activities and method of
product release stated in the
purchasing information?
purchase Order
F/ALAMIN-OP-16-05
Are records of the verification YES A

7.5 Production and service provision *
7.5.1 Control of production and service provision *

Are production and service provision Product Identification A
planned, carried out, monitored and
controlled to ensure thatproduct ALAMIN-OP-19
conforms to specification?
As appropriate, does production yes , A

controls include but are not limited to:
-documentation of procedures and ALAMIN-TF-OP-22 -Production
methods for the control of production
(see 4.2.4)? Flowchart
-qualification of infrastructure?
-implementation of monitoring and ALAMIN-OP-14---(Production
measurement of process parameters Control)
and product characteristics?
-availability and use of monitoring and
measuring equipment?
-implementation of defined operations
for labelling and packaging?
-implementation of product release,
delivery and post-delivery activities?
Does the organization establish and Product Traceability A
maintain a record (see 4.2.5) for each
medical device or batch ofmedical ALAMIN-OP-17
devices that provides traceability to the
extent specified in 7.5.9 and identifies
the amountmanufactured and amount
approved for distribution?Is the record
verified and approved?
7.5.2 Cleanliness of product*
requirements for cleanliness of product
or contamination control ofproduct if:
a) product is cleaned by the
organization prior to sterilization or its
use?
b) product is supplied non-sterile and is
to be subjected to a cleaning process
prior to sterilization or its use?
c) product cannot be cleaned prior to
sterilization or its use, and its
cleanliness is of significance in use?
d) product is supplied to be used non-
sterile, and its cleanliness is of
significance in use?
e) process agents are to be removed
from product during manufacture?
Was the product cleaned in accordance N.A A
with a) or b) above?(The requirements
contained in 6.4.1 do not applyprior to
the cleaning process).
7.5.3 Installation activities

requirements for medical device
installation and acceptance criteriafor
verification of installation, as
appropriate?
If the agreed customer requirements N.A A
allow installation of the medical device
to be performed by anexternal party
other than the organization or its
supplier, does the organization provide
documentedrequirements for medical
device installation and verification of
installation?
Are records of medical device N.A A
installation and verification of
installation performed by the
organization orits supplier maintained
(see 4.2.5)?
7.5.4 Servicing activities
If servicing of the medical device is a N.A A
specified requirement, does the
organization document
servicingprocedures, reference
materials, and reference
measurements, as necessary, for
performing servicingactivities and
verifying that product requirements are
met?
Does the organization analyse records N.A A
of servicing activities carried out by the
organization or itssupplier:
-to determine if the information is to be
handled as a complaint?
-as appropriate, for input to the
improvement process?
Are records of servicing activities N.A A
carried out by the organization or its
supplier maintained (see 4.2.5)?
7.5.5 Particular requirements for sterile medical devices *
Does the organization maintain records EO-Sterlization Batch Report A
of the sterilization process parameters
used for each sterilization batch (see
4.2.5)?Are sterilization records
traceable to each production batch of
medical devices?
7.5.6 Validation of processes for production and service provision*
Does the organization validate any Process validation A
processes for production and service
provision where the resulting output ALAMIN-OP-18
cannot be or is not verified by
subsequent monitoring or
measurement and, as a
consequence,deficiencies become
apparent only after the product is in use

or the service has been delivered?
Does validation demonstrate the ability yes A
of these processes to achieve planned
results consistently?
Does the organization document Process Validation A
procedures for validation of processes,
including: ALAMIN-OP-18
-defined criteria for review and approval
of the processes?
-equipment qualification and
List Of Validation Process.
qualification of personnel?
-use of specific methods, procedures F/ALAMIN-OP- 18-01
and acceptance criteria?
-as appropriate, statistical techniques
with rationale for sample sizes?
-requirements for records (see 4.2.5)?
-revalidation, including criteria for
revalidation?
-approval of changes to the processes?
Does the organization document ALAMIN-OP-18 A
application of computer softwareused in
production and service provision?Are
such software applications validated
prior to initialuse and, as appropriate,
Process Validation
after changes to such software or its
application? Are the specific approach
andactivities associated with software
validation and revalidation
proportionate to the riskassociated with
the use of the software, including the
effect on the ability of the product to
conform tospecifications?
Are records of the results and Process Validation A
actions from the validation maintained ALAMIN-OP-18
(see 4.2.4 and 4.2.5)?
F/ALAMIN -OP- 18-01
7.5.7 Particular requirements for validation of processes for sterilization and

sterilebarrier systems*
Does the organization document Sterilizers validation Report A
procedures (see 4.2.4) for the
validation of processes for sterilization 2020-VE-12
and sterile barrier systems?
Are processes for sterilization and Sterilizers validation Report A
sterile barrier systems validated prior to
implementation andfollowing product or 2020-VE-12

process changes, as appropriate?
Are records of the results and, Sterilizers validation Report A
actions from the validation maintained 2020-VE-23
(see 4.2.4 and 4.2.5)?
Clean room validation Report -
2020-VC-34
F/ALAMIN -OP- 18-01
7.5.8Identification*
Does the organization document Product Traceability A
procedures for product identification
and identify product by suitablemeans ALAMIN-OP-09
throughout product realization?
Does the organization identify product Product Traceability A

status with respect to monitoring and
measurementrequirements throughout ALAMIN-OP-09
product realization? Is identification of
product maintainedthroughout
production, storage, installation and
servicing of product to ensure that only
product thathas passed the required
inspections and tests or released under
an authorized concession is
dispatched, used or installed?
If required by applicable regulatory Product Traceability A
requirements, does the organization
document a system to assignunique ALAMIN-OP-09
device identification to the medical
device?

procedures to ensure that medical
devices returned to theorganization are ALAMIN-OP-09
identified and distinguished from
conforming product?
‫سجل تتبع الرقم التعريفي‬
F/FM-OP-17-03
7.5.9 Traceability
7.5.9.1 General
procedures for traceability?
ALAMIN-OP-09
Do these procedures define the Product Traceability A

extentof traceability in accordance with
applicable regulatory requirements and ALAMIN-OP-09
the records to be maintained (see
4.2.5)?
7.5.9.2Particular requirements for implantable medical devices*

Do the records required for traceability N.A A
include records of components,
materials, and conditions forthe work
environment used, if these could cause
the medical device not to satisfy its
specified safetyand performance
requirements?
Does the organization require that N.A A
suppliers of distribution services or
distributors maintain recordsof the
distribution of medical devices to allow
traceability and that these records are
available for inspection?
Are records of the name and address of N.A A
the shipping package consignee
7.5.10 Customer property
Does the organization identify, verify, N.A A
protect, and safeguard customer
property provided for useor
incorporation into the product while it is
under the organization’s control or
being used by the organization?
If any customer property is lost, N.A A
damaged or otherwise found to be
unsuitable for use, does the
organization report this to the customer
and maintain records (see 4.2.5)?
7.5.11 Preservation of product
Does the organization document Storage A
procedures for preserving the
conformity of product to ALAMIN-OP-21
requirementsduring processing,
storage, handling, and distribution?
Does preservation apply to the Storage A

constituent parts of a medical device?
ALAMIN-OP-21
Does the organization protect product Storage A

from alteration, contamination or
damage when exposed toexpected ALAMIN-OP-21
conditions and hazards during
processing, storage, handling, and
distribution by:
-designing and constructing suitable
packaging and shipping containers?
-documenting requirements for special
conditions needed if packaging alone
cannot providepreservation?
If special conditions are required, are YES A
they controlled and recorded (see
4.2.5)?
7.6 Control and monitoring of measuring equipment
Does the organization determine the control of monitoring and A
monitoring and measurement to be
measuring Equipment
undertaken and themonitoring and
measuring equipment needed to
provide evidence of conformity of ALAMIN-OP-25
product to determined requirements?
List Of Measuring , Inspection
And Test Equipment
F/ALAMIN-OP-25-01
Periodic calibration card
F/ALAMIN-OP-25-02
Does the organization document Control of monitoring and A

procedures to ensure that monitoring
measuring Equipment
and measurement can becarried out
and are carried out in a manner that is
consistent with the monitoring and ALAMIN-OP-25
measurementrequirements?
Is the measuring equipment, where control of monitoring and A

necessary to ensure valid results:
measuring Equipment
-be calibrated or verified, or both, at
specified intervals, or prior to use,
ALAMIN-OP-285
against measurement standards
traceable to international or national
measurement standards? List Of Measuring , Inspection

-is the basis used for calibration or
And Test Equipment
verification recorded, where no such
standards exist?
F/ALAMIN-OP- 25-01
-have identification in order to
determine its calibration status?
-be safeguarded from adjustments that Periodic calibration card
would invalidate the measurement
result? F/ALAMIN-OP- 25-02
-be protected from damage and
deterioration during handling,
maintenance and storage?
Does the organization perform Control of monitoring and A
calibration or verification in accordance
measuring Equipment
with documented procedures?
ALAMIN-OP-25

And Test Equipment
F/ALAMIN-OP- 25-01
Periodic calibration card
F/ALAMIN-OP- 25-02
Is the validity of previous measuring YES A

results assessed and recorded, when
the measuring equipment is found not Periodic calibration card
to conform to requirements? Does the
organization take appropriate action on
the measuring equipment and any
F/ALAMINOP- 25-02
product affected?
Are records of the results of calibration Control of monitoring and A
and verification maintained (see 4.2.5)?
measuring Equipment

And Equipment/ Personal List
Qualification Reference
F/ALAMIN-OP- 18-03
Date:01/07/2020
Does the organization document - A

application of computer softwareused
for the monitoring and measurement of
requirements?
Are such software applications - A
validated prior to initial use and, as
appropriate, after changes to such
software or its application?
Are the specific approach and activities - A
associated with software validation and
revalidation proportionate to the risk
associated with the use of the software,
including the effect on the ability ofthe
product to conform to specifications?
Are records of the results and Validation cycle Result. A
actions from the validation maintained F/ALAMIN -OP- 18-05
(see 4.2.4 and 4.2.5)?
8 Measurement, analysis and improvement
8.1 General
Does the organization plan and product quality plan A
implement the monitoring,
measurement, analysis and ALAMIN-OP-13
improvement processes needed to:
-demonstrate conformity of product?
-ensure conformity of the QM-System?
-to maintain the effectiveness of the
QM-System?
Does this include determination of stastical analysis . A
appropriate methods, including
statistical techniques, and the extent of ALAMIN-OP-30
their use?
8.2 Monitoring and measurement
8.2.1 Feedback
As one of the measurements of the All organization gather and A
effectiveness of the quality monitor information met
management system, does the
customer requirments
organization gather and monitor
information relating to whether the
organization has met
customerrequirements? Are the
methods for obtaining and using this
information documented?
Does the organization document procedures of
procedures for the feedback process?
Does this feedback process include production control ALAMIN- A
provisions to gather data from
production as well as post-production OP-22
activities?
Product tracibility ALAMIN-OP-
09
post market survillance
ALAMIN-OP-40
Does the information gathered in the A

feedback process serve as potential
input into risk managementfor ALAMIN-TF-01-08
monitoring and maintaining the product
requirements as well as the product
realization orimprovement processes?
Risk Management
If applicable regulatory requirements customer complaints A

require the organization to gain specific
experience from ALAMIN-OP-26
postproductionactivities, does the
review of this experience form part of
the feedback process?
8.2.2 Complaint handling*
Does the organization document customer complaints A
procedures for timely complaint
handling in accordance withapplicable ALAMIN-OP-26
Do these procedures include at a Recall follow -up form A
minimum requirements and
responsibilities for: F/alamin-OP-31-03
-receiving and recording information?
-evaluating information to determine if
the feedback constitutes a complaint?
-investigating complaints?
-determining the need to report the
information to the appropriate
regulatory authorities?
-handling of complaint-related product?
-determining the need to initiate
corrections or corrective actions?
If any complaint is not investigated, is yes corrective and preventive A
justification documented? Is any actions was done F/ALAMIN-
correction or correctiveaction resulting
OP-31-01
from the complaint handling process
documented?
If an investigation determines activities yes corrective &preventive A
outside the organization contributed to actions was done ALAMIN_OP-
the complaint, are relevantinformation
31
exchanged between the organization
and the external party involved?
Are complaint handling records customer complaints A
8.2.3 Reporting to regulatory authorities*
If applicable regulatory requirements Feedback system A
require notification of complaints that
meet specified reportingcriteria of ALAMIN-OP-17
adverse events or issuance of advisory
notices, does the organization
document proceduresfor providing
notification to the appropriate regulatory
authorities?
Are records of reporting to regulatory yes rocods maintained in A
authorities maintained (see 4.2.5)? archive
8.2.4 Internal audit*
Does the organization conduct internal yes A
audits at planned intervals to determine
whether the qualitymanagement internal audit plan F/ALAMIN-
system:
-conforms to planned and documented OP-27-01
arrangements, requirements of this
International Standard, quality
management system requirements
established by the organization, and
applicableregulatory requirements?
-is effectively implemented and
maintained?
Does the organization document a ALAMIN-OP-27 include A
procedure to describe the procdure of internal audits
responsibilities and requirements
forplanning and conducting audits and
recording and reporting audit results?
Is an audit program planned, taking into yes area to be audited is A
consideration the status and
determined .
importance of the processesand area to
be audited, as well as the results of
previous audits? audit results F/FM-OP-06-03
Are the audit criteria, scope, interval Internal audit procedure A

and methods defined and recorded
(see 4.2.5)? ALAMIN-OP-27
Does the selection of auditors and YES A

conduct of audits ensure objectivity and
impartiality of the audit process? Do
auditors not audit their own work?
Are records of the audits and their yes maintained in archive A
results, including identification of the
processes and areas audited andthe
conclusions, maintained (see 4.2.5)?
Does the management responsible for corrective & preventive actions
the area being audited ensure that any
was done F/ALAMIN-OP-0
necessary correctionsand corrective
actions are taken withoutundue delay to
eliminate detected nonconformities and 31-01
their causes? Do follow-up activities
include the verification of the actions
taken and the reporting of verification
results?
8.2.5Monitoring and measurement of processes
Does the organization apply suitable yes A
methods for monitoring and, as
appropriate, measurement of thequality
management system processes? Do
these methods demonstrate the ability announced internal audit

of the processes to achieve planned
results? When planned results are not follow of corrective and
achieved, are correction and corrective
action taken, as appropriate? preventive actions
8.2.6Monitoring and measurement of product

Does the organization monitor and yes AA
measure the characteristics of the
product to verify that product inspections and tests
requirements have been met? Is this
carried out at applicable stages of the
product realizationprocess in
ALAMIN-OP-28
accordance with the planned and
documented arrangements and
documented procedures?
Is evidence of conformity to the Product Quality Plan A
acceptance criteria maintained?Is the
identity of the personauthorizing F/ALAMIN-OP-13-03
release of product recorded (see
4.2.5)? As appropriate, do records
identify thetest equipment used to
perform measurement activities?
Does product release and service yes product Basic Data A
delivery not proceed until the planned
and documented arrangementshave F/ALAMIN-OP-13-02
been satisfactorily completed?
For implantable medical devices, does N.A A
the organization record the identity of
personnel performing any inspection or
testing?
8.3 Control of nonconforming product*
8.3.1General*
Does the organization ensure that control of non conformance A
product which does not conform to
report
product requirements is identified and
controlled to prevent is unintended use
or delivery? F-ALAMIN-OP-29-01
Does the organization documenta Quality Management system A

procedure to define the controls and
Docmention
related responsibilities and authorities
for the identification,documentation,
segregation, evaluation and disposition ALAMIN-OP-01
of nonconforming product?
Does the evaluation of nonconformity Yes:Control of Non-Conformity A
include a determination of the need for
Product
an investigation andnotification of any
external party responsible for the
nonconformity? ALAMIN-OP-29
Are records of the nature of yes decisions actions taken A

nonconformities and any subsequent
actions taken, including evaluation,any

investigation and the rationale for
decisions maintained (see 4.2.5)?
8.3.2Actions in response to nonconforming product detected before delivery *
Does the organization deal with corrective and prevention A
nonconforming product by one or more F/ALAMIN-OP-31
of the following ways:
-taking action to eliminate the detected
nonconformity?
-taking action to preclude its original
intended use or application?
-authorizing its use, release or
acceptance under concession?
Does the organization ensure that ALAMIN-OP-29 A
nonconforming product is accepted by
concession only if thejustification is
provided, approval is obtained and
applicable regulatory requirements are
met? Are recordsof the acceptance by
concession and the identity of the
person authorizing the concession
8.3.3Actions in response to nonconforming product detected after delivery*
When nonconforming product is Recall Fllow- UP Form A
detected after delivery or use has
started, does the organization F/ALAMIN-OP-31-04
takeaction appropriate to the effects, or
potential effects, of the nonconformity?
Are records of actions taken maintained
(see 4.2.5)?
Does the organization document Vigilance System A
procedures for issuing advisory notices
in accordance with applicableregulatory ALAMIN-OP-21
requirements? Are these procedures
capable of being put into effect at any
time?Are recordsof actions relating to
the issuance of advisory notices
8.3.4Rework*
Does the organization perform rework Yes:Control of Non-Conformity A
in accordance with documented ALAMIN-OP-29
procedures that takes intoaccount the
potential adverse effect of the rework
on the product? Do these procedures
undergo thesame review and approval
as the original procedure?
After the completion of rework, is Yes:Control of Non-Conformity A
product verified to ensure that it meets ALAMIN-OP-29
applicable acceptancecriteria and
Are records of rework maintained (see Yes:Control of Non-Conformity A
4.2.5)? ALAMIN-OP-29
8.4 Analysis of data

Does the organizationdocument yes data documented in A
procedures to determine, collect and
analyze appropriate data to operating procedures
demonstrate the suitability, adequacy
and effectivenessof the QM system?Do
theprocedures include determination of
finished product specifications
appropriate methods, including
statistical techniques and the extent of qulity manual
their use?
standard operating procedures
work instruction
test method
Does the analysis of data include data stastical analysis A

generated as a result of monitoring and
measurement and fromother relevant ALAMIN-OP-30
sources and include, at a minimum,
input from:
-feedback?
-conformity to product requirements?
-characteristics and trends of
processes and product, including
opportunities for improvement?
-suppliers?
-audits?
-service reports, as appropriate?
If the analysis of data shows that the stastical analysis A
quality management system is not
suitable, adequate or effective, does ALAMIN-OP-30
the organization use this analysis as
input for improvement as required in
8.5.?
Are records of the results of analyses stastical analysis A
ALAMIN-OP-30
8.5 Improvement*
8.5.1 General
Does the organization identify and Yes A
implement any changes necessary to
ensure and maintain thecontinued
suitability, adequacy and effectiveness
of the quality management system as
well as medicaldevice safety and
performance through the use of the
quality policy, quality objectives, audit
results, post-marketsurveillance,
analysis of data, corrective actions,
preventive actions and management
review?
Is a procedure defined and Vigilance System A
documented for notify the regulatory
authorities and the 3EC of those ALAMIN-OP-31
adverse events which meet the
reporting criteria? (DIMDI-Data base for
incidents, or rather initial and final
reporting of incidents forms) (MEDDEV
2.12/1) (only MDD / IVDD)
8.5.2 Corrective action*
Does the organization take action to yes A
eliminate the causes of
nonconformities in order to prevent corretive & preventive actions
recurrence?
ALAMIN-OP-29
Are any necessary corrective actions yes A

taken without undue delay? Are
corrective actions appropriate to the corretive & preventive actions
effects of the nonconformities
encountered?
ALAMIN-OP-29
Does the organization document a yes reviweing of non confor A

procedure to define requirements for: mance and actions in
-reviewing nonconformities (including
management review ALAMIN-
complaints)?
-determining the causes of OP-08
nonconformities?
-evaluating the need for action to
ensure that nonconformities do not
recur?
-planning and documenting action
needed and implementing such
action, including, as
appropriate,updating documentation?
-verifying that the corrective action
does not adversely affect the ability to
meet applicableregulatory
requirements or the safety and
performance of the medical device?
-reviewing the effectiveness of
corrective action taken?
Are records of the results of any maintained on archive A
investigation and of action taken
8.5.3 Preventive Action*
Does the organization determine Corrective & Preventive Action A
action to eliminate the causes of
potential nonconformities in order to ALAMIN-OP-29
prevent their occurrence?
Are preventive actions proportionate yes A
to the effects of the potential

problems?
Corrective Action Request
FM-OP-08-01
Is a documented procedure PCAR (Preventive /Corrective A

established to define requirements for:
Action Request)
-determining potential nonconformities
and their causes?
F/ALAMIN-OP-31-01
-evaluating the need for action to
prevent occurrence of
nonconformities?
-planning and documenting action
needed and implementing such
action, including, as
appropriate,updating documentation?
-verifying that the action does not
adversely affect the ability to meet
applicable regulatoryrequirements or
the safety and performance of the
medical device?
-reviewing the effectiveness of the
preventive action taken, as
appropriate?
Are records of the results of any maintained on archive A
investigations and of action taken
Items marked with * – must be audited each year!!!
In case of remote audit – all Items must be filled by the Client and verified by the Auditor.

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F32A 3EC Checklist for Assessment ISO 13485 & MDD / IVDD

Application or Contract No.: 310419A

Checklist for the assessment based on the standards:

Relevant standards, CTS (IVDD):

Company name: Al AMIN for Modern Industries

2.Sterile Infusion Set // IIa // MD0102, MDS7006 (EtO)

Scope of Manufacture of Non-active (Non Implantable) medical devices: Sterile

ETO,Packaging validation protocol and report

clean room validation reports

instruments calibration certificates

Enviromental and cleaning reports

Purchasing and suppliers assessments reports

Preventive maint.records and plan

Explanations for the application of the 3EC assessment check list

1. Applicable standards and marking

2. Use of the Assessment Checklist

4. Quality Management System

ALAMIN-TF-01 , rev. 02, dated

Is, if necessary, an authorized Yes:EU REP Agreement A

Does the organization document a Quality Management system A

Initial IssueDate 01-05-2019

Does the organization establish, Control of Records.ALAMIN- A

requirements? Date. 01/05/2019

For each quality management system Control of Recordes A

When the organization chooses to Purchasing ALAMIN -OP- A

IVDD and if necessary 3EC-Support

revision date 14/01/2020

Are the classifications of the Medical TF A

Are designated harmonized standards, TF A

Are there, for all products/product Risk mamangment ALAMIN- A

Are all the possible safety risks TF A

Report date 14-01-2020

Do designated suppliers with activities Purchasing A

Are they listed including their activities Approved Supplier List A

Does the contract with e.g. OEM N.A A

Revision date 14-01-2020

Are there corresponding pre-clinical TF A

Revision date 14-01-2020

Is there a evaluation of the essential TF A

If the destination of the products falls N.A A

Issue date: 01/05/2019

4.2.3 Medical device file *

Does the medical device file include TF A

Has a documented procedure been Control of Quality A

Is a retention period set for the keeping Control of Quality Records A

defined by the organization,but not less

Has a documented procedure been A

Issue date 01-05-2019

Are there defined and implemented Control of Quality Records A

Are records legible, readily identifiable Control of QualityRecord

Issue / Change request

Are the quality records maintained for A

-communicating to the organization the Last Management 20-10-2020

5.3 Quality Policy

5.4.2 Quality management system planning

5.5 Responsibility, authority and communication

Does the top management document Quality Management system A