AUDIT REPORT

720 DM 0701-43a Page 1 out of 34

Rev 6 du 01/08/2018 File n° : P602907_P1

NONCONFORMITY FORM
N° 1 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.2 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex II, § 3.1, 2nd sentence, 4th indent
Statement of the nonconformity:

The scope of the quality management system included in the quality manual is not enough detailed.
The justification for any exclusion or non-application of the scope of the quality management system included in the quality
manual is not in conformity with regulatory requirements.

Objective evidence of the non conformity:

LEAD AUDITOR OR AUDITOR

In the Quality Manual n° QM version 07 dated 7 November 2020, there is no clear details about the products for which design
and development are excluded and the products for which design and development are not excluded.

The section 4.3.4 of the Quality Manual n° QM version 07 dated 7 November 2020 indicates “Design and development
requirements are excluded only for any product which its design is based on a recognized standard (e.g. harmonized
standard) because the design requirements are covered and controlled by this standard (one of features of the state of the
art).” This justification of design and development exclusion is not in conformity to European requirements knowing that
compliance to harmonized standards gives only a presumption of compliance to essential requirements (article 5 of the
Medical Devices Directive 93/42/EEC).

In the Quality Manual n° QM version 07 dated 7 November 2020, there is no clear justification why design and development
requirements for the fistula needles and blood lines medical devices are excluded from the ISO 13485 certification whereas
the Medical Devices Directive 93/42/EEC, Annex II of “Full quality assurance system” is used for CE marking of these
devices.

The section 4.3.5 of the Quality Manual n° QM version 07 dated 7 November 2020 indicates that the chapter 7.5.9.2 of ISO
13485 standard is non-applicable of the scope of the QMS because GMS does not manufacture implantable medical devices
whereas the non-absorbable sutures are implantable devices.

Rationale for major or minor classification:

This nonconformity is classified as minor because no significant impact on regulatory compliance has been identified.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

COMPANY

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) The scope of the quality management system included in the quality manual has been
updated regarding exclusion and non application criteia to : Correction Satisfactory
 Include the applicability of design and development requirements to GMS products
Correction unsatisfactory
based on medical device classification.
see rationale below
 Include justification for exclusion of design and development in compliance with
applicable regulatory requirements.
 Remove particular requirements for implantable medical devices from non application.

Target date: Done 10 March 2021

IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of knowledge
 AUDIT REPORT
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NONCONFORMITY FORM
N° 1 / 21
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Training for relevant personnel on conformity assessment procedures in relation to
design and development requirements based on MDD 93/42/EC and ISO 13485. Corrective action
(April 2021). Satisfactory
2) Review the relevant SOPs/WIs and any other QMS documents to ensure compliance
with requirements applicable to implantable medical devices (including item # 7.5.9.2. Corrective action
and 8.2.6 in ISO 13485:2016), this will include review and update (if required) of the unsatisfactory - see
following documents e.g.: (May 2021) rationale below
 SOP # P-67 "Clean Room Validation and Routine Monitoring", {it has been reviewed
and found satisfactory for provisions of appropriate conditions of work environment
and their records}.
 Contract with GMS distributor “Contrac”. (it has been reviewed and found
satisfactory for shipping/distribution provisions).
 SOP # P-61 "Management of Sales and Distribution Activities".
 SOP # P-42 "Management of Outsourcing Activities"
 SOP # P-41 "Batch Record Review & Release".
 SOP # P-13 "Identification and Traceability".
 SOP # P-09-02 "Classification and Master List of Products".

Target date:
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 2 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 5.6.1 of ISO 13485:2016 standard
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

Maintained records from management reviews does not allow to record all the inputs reviewed and the level of information
needed to evaluate the continuing suitability, adequacy and effectiveness of the QMS.

Objective evidence of the non conformity:

In the Memo/Agenda, the Minutes and the Actions Plan records of the management review n° MR-01-2020 held on 20
October 2020 there no clear details of the input reviewed about new and updated standards, QMS changes, vigilance,
deviation report, processes KPIs measurements, internal audit. suppliers evaluation and resources needs.

Rationale for major or minor classification:

This nonconformity is classified as minor because it is mainly a lack of documentation. No impact on product performances
and safety and regulatory compliance is expected.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Update Minutes of Top Management Review for management review # MR-01-2020 to
include clear details of the inputs reviewed about new and updated standards, QMS Correction Satisfactory
changes, vigilance, deviation report, processes KPIs measurements, internal audit.
suppliers evaluation and resources needs. Correction unsatisfactory
COMPANY

see rationale below

Target date: June 2021
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of documentation

CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA

1) Update Management Reviews SOP # P-05 to include instructions for recording all the
inputs reviewed and the level of information needed to evaluate the continuing Corrective action
suitability, adequacy and effectiveness of the QMS. Satisfactory
2) Training for relevant personnel on updated P-05.
Corrective action
unsatisfactory - see
Target date: July 2021 rationale below
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 3 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 8.2.1 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex II, § 3.1, 2nd sentence, 7th indent
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

Maintained records of post market surveillance activities does not allow to demonstrate that generally acknowledged state of
the art methods is used for the scientific literature review.

Objective evidence of the non conformity:

The Post Market Periodic Safety Update Report for non-absorbable surgical sutures n° PSUR-07-2018 version 02 dated 31
December 2020 mentions consideration of scientific literature review but without any details recorded about search
methodology applied, findings and data analysis.

Rationale for major or minor classification:

This nonconformity is classified as minor because the other data analysed in this PSUR report are very favourable. Then no
significant impact on product performances and safety and regulatory compliance is expected.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Update PMS Plan and Periodic Safety Update Report for non-absorbable surgical
sutures n° PSUR-07-2018 version 02 to include search methodology applied, findings Correction Satisfactory
and data analysis. (Wait Dr Khairy review)
Correction unsatisfactory
COMPANY

see rationale below

Target date: (April 2021)
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of Knowledge.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Retraining for relevant personnel on P-14 Post market Surveillance (Target Date:
April 2021). Corrective action
2) Update PMS Plans and reports for other products to include search methodology Satisfactory
applied, findings and data analysis. (Target Date: June 2021). (Wait Dr Khairy review)
Corrective action
unsatisfactory - see
Target date: rationale below
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 4 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 8.5.2 of ISO 13485:2016 standard
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

The verification that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or
the safety and performance of the medical device is not always recorded.

Objective evidence of the non conformity:

Following the deviation report n° DR-001-2020 opened in 5 January 2020, the CAPA file n° CAPA/002/20 has been opened
for the corrective action of retraining of warehouse personnel on WI-06 considering the concept of segregation and security of
access of warehouse.
But the verification that this corrective action does not adversely affect the ability to meet applicable regulatory requirements
or the safety and performance of the medical device has not been recorded.

Rationale for major or minor classification:

This nonconformity is classified as minor because it is mainly a lack of documentation and because this retraining corrective
action does not effectively adversely affect the ability to meet applicable regulatory requirements or the safety and
performance of the medical device.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:
SOP for Management of Corrective Actions & Preventive Actions P-20 already include requirements regarding Verifying that
the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and
performance of the medical device.
CORRECTION: OPINION OF LA
1) Update CAPA effectivness reports relevant to actions associated from the deviation report
n° DR-001-2020 to ensure that verification that this corrective actions does not adversely Correction Satisfactory
affect the ability to meet applicable regulatory requirements or the safety and performance
COMPANY

of the medical device. (Wait Dr Khairy review) Correction unsatisfactory

see rationale below
Target date: April 2021
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of documentation.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Update CAPA Effectiveness Report form # P-20-05 to include a part for evaluation of
corrective action to ensure that it does not adversely affect the ability to meet applicable Corrective action
regulatory requirements or the safety and performance of the medical device. Satisfactory
2) Training for relevant personnel on updated form # P-20-05.
Corrective action
unsatisfactory - see
Target date: April 2021 rationale below
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 5 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.3.9 of ISO 13485:2016 standard
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

Procedures to control design and development changes are not clearly documented.

Objective evidence of the non conformity:

The QMS dispositions to control design and development changes are not clear.
Design change is mentioned in the SOP n°P-63 but very secondarily (in sections 7.3.6 & 7.3.7) and considering the statement
of section 7.2.4.2 that is not in conformity to regulatory requirements. Then this SOP seems to authorize the introduction of a
new medical device or the change of a medical device without applying the SOP n° P-24 and then without considering the
MDD regulatory requirements and the requirements of the section 7.3 of the ISO 13485:2016 standard.
In addition, there is no clear link between the SOP of Change Control n° P-50 issue n° 02 dated 22 October 2020 and the
SOP of Design Control Procedure n° P-24 issue/revision 2/3 dated 6 October 2018 that includes the requirements for change
of design and development.
Rationale for major or minor classification:
This nonconformity is classified as minor because it is mainly a lack of clear documentation and because design and
development changes are very rare (no case since 2 years). Then no significant impact on product performances and safety
and regulatory compliance is expected.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Update P-63 to include enough details regarding precautions that shall be taken into
consideration when a change occurs in a product. Correction Satisfactory
2) Update P-63 to be complied with MDD requirements regarding exclusion and inclusion of
design and development requirements and to authorize the introduction of a new medical Correction unsatisfactory
device or the change of a medical device with applying the SOP n° P-24 and considering see rationale below
the MDD regulatory requirements and the requirements of the section 7.3 of the ISO
COMPANY

13485:2016 standard.
3) Update SOP of Design Control Procedure n° P-24 issue/revision 2/3 to link it with Change
Control SOP P-50.
Target date: June 2021
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of training.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Training for relevant personnel on design and development requirement regarding
MDD 93/42/EC and ISO 13485. (April 2021). Corrective action
2) Training for relevant personnel on updated SOP # P-63 (June 2021). Satisfactory
3) Training for relevant personnel on updated SOP of Design Control # P-24 (June 2021).
Corrective action
unsatisfactory - see
Target date: rationale below
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 6 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.5.6 of ISO 13485:2016 standard
Statement of the nonconformity:

Procedures for validation of processes including requirements for managing changes are not always applied.
LEAD AUDITOR OR AUDITOR

Objective evidence of the non conformity:

The section 7.2 of the SOP of Change Control n° P-50 issue n° 02 dated 22 October 2020 indicates that any change must be
documented. The section 2.1.9 of this SOP includes the change in validated computerized system within its scope.
In addition, the section 7.4.3.7 of the SOP of EO sterilization validation n° P-64 issue n° 02 dated 29 August 2020 requires
that PQ should be performed for a modification of equipment unless equivalence to previously validated equipment has been
documented according to the SOP n° P-50.
But no evidence of application of the SOP of Change Control n° P-50 has been provided during the audit about the change of
version of the data logger software MadgeTech used in the ETO sterilization process (from version 2.07.1 to version 4)
indicated in the section 3.1 of the software validation report n° RVP001-085-2019 dated 26 December 2019.

Rationale for major or minor classification:

This nonconformity is classified as minor because it seems that the change of version of the data logger has no significant
impact on the current sterilization validation (software version most secured with electronic signatures, secure data file and
audit trail functions). Then no significant impact on product performances and safety and regulatory compliance is expected.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
Issuance of change control request to evaluate change of version of the data logger software
MadgeTech used in the ETO sterilization process (from version 2.07.1 to version 4) Correction Satisfactory
Correction unsatisfactory
COMPANY

see rationale below

Target date: (June2021)
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of communicating to the organization the importance of meeting applicable regulatory requirements (including change
control).
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
The status of change control process and its impact on the compliance level of QMS will be
escalated to the top management as part of the next management review meetings to Corrective action
communicate to the organization the importance of meeting applicable regulatory requirements Satisfactory
(including change control) and ensure that all levels of management affecting quality are made
aware of changes. (Wait Dr Khairy Review) Corrective action
unsatisfactory - see
rationale below
Target date: Oct 2021
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 7 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.4 of ISO 13485:2016 standard
LEAD AUDITOR OR AUDITOR

Statement of the nonconformity:

Changes to document are not always controlled.

Objective evidence of the non conformity:

The “Peel Characteristics Determination of Pouches” form used for the record of the lot 32050005 of stainless steel sutures is
a form modified compared to the current form n° P-65-09 issue n° 01.

Rationale for major or minor classification:

This nonconformity is classified as minor because the difference between both forms is only on the number of the form. Then
no significant impact on product performances and safety and regulatory compliance is expected.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) The person responsible for the error or his supervisor in QC department will correct the
error found in form # P-65-09 “Peel Characteristics Determination of Pouches” used for Correction Satisfactory
the record of the lot 32050005 of stainless steel sutures, the correction will be according to
SOP P-04 Control of records: Correction unsatisfactory
see rationale below
 Using single line to cross out the mistake.
 the original entry shall be still legible.
 Correction of wrong data.
 The person who corrected the data shall sign and write the date of correction.
COMPANY

Target date: Done 28 Jan 2021

IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of documentation
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Update SOP # P-03 “Control of Documents” issue # 05 to include requirements that
shall be taken into consideration after finding incorrect data in GMS documents (e.g. Corrective action
records), these requirements will include: Satisfactory
 Investigation to find root cause analysis of incorrect data taking into account the
Corrective action
possibility of modifying a form intentionally or unintentionally.
unsatisfactory - see
 Link SOP # P-03 with SOP #30 “Handling of Deviations”.
rationale below
 Importance of follow up after correction of incorrect data to ensure the mistake will
not reoccurred.
2) Training for relevant personnel on update P-03 issue # 06.
3) Retraining for relevant personnel on SOP# 41 "Batch Record Review and Release"
focusing on good documentation practices, data integrity and the possibility of
modifying a form intentionally or unintentionally, {Done}.
Target date: May 2021
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 8 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.5.7 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex II, § 3.2, 3rd paragraph (d), 1st indent
Statement of the nonconformity:

Sterilization and sterile barrier processes are not validated according to the generally acknowledged state of the art.
LEAD AUDITOR OR AUDITOR

Objective evidence of the non conformity:

No installation qualification and operational qualification documents have been provided for the validation of the ethylene
oxide sterilization process as well as aeration validation according to the requirements of the section 9.1 of the ISO
11135:2014 standard.

No installation qualification and operational qualification documents have been provided for the validation of the thermos-
sealing process of pouches (for sterile barrier systems) according to the requirements of the section 5.1.2 of the ISO 11607-
2:2017 standard.
In addition, no evidence has been provided that critical parameter of the thermos-sealing process of pouches are routinely
monitored and documented according to the requirements of the section 5.6.2 of the ISO 11607-2:2017 standard.

Rationale for major or minor classification:

This nonconformity is classified as major because it can have an impact on safety or product performances.

Auditor’s name: Pascal VANHEE & Serge THURIES Date: 15 January 2021
Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Conduction of IQ for EO sterilization process in a retrospective manner according to
ISO 11135 :2014. Correction Satisfactory
2) Conduction of OQ for EO sterilization process in a retrospective manner according to
ISO 11135 :2014. Correction unsatisfactory
3) Conduction of IQ for thermos-sealing process of pouches in a retrospective manner see rationale below
according to ISO 11607-2 :2020.
4) Conduction of OQ for thermos-sealing process of pouches in a retrospective manner
according to ISO 11607-2 :2020.
5) There is already a form in quality management system of GMS Form # W.I.15-02-005
used to monitor and document critical parameter of the thermos-sealing process of
COMPANY

pouches every hour on daily basis during routine work.

Target date: June 2021
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
- SOP # P-64 "EO Sterilization Validation" doesn't include provisions for conduction of IQ and OQ in a retrospective
manner for already existing machines.
- The old packaging validation SOP # P-65 issue No.03 included provisions for ability to skip IQ and OQ of already
existing machines if operational and performance parameters are adequately controlled using the existing
procedures, work instructions and packaging validation (PQ).
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Update SOP # P-64, Issue # 02 titled as "EO Sterilization Validation" to include
provisions for conduction of IQ and OQ in a retrospective manner for already existing Corrective action
machines. (May 2021) Satisfactory
2) Training for relevant personnel on update P-64 (May 2021).
3) P-65 issue No.03 has been updated to include the following provisions (for existing Corrective action
machines any missed stage of qualification including IQ/OQ shall be conducted in a unsatisfactory - see
retrospective manner to complete qualification work), {kindly refer to P-65 issue No.04, rationale below
and training for relevant personnel has been conducted on updated P-65. (Done 1 Feb
2021).
Target date:
Name of company representative: Dr. Essam El Saherty
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NONCONFORMITY FORM
N° 8 / 21
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 9 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.4 of ISO 13485:2016 standard
LEAD AUDITOR OR AUDITOR

Statement of the nonconformity:

Documents’ change is not fully effective.

Objective evidence of the non conformity:

The list of the documents due for the periodic review P-03-08 rev 02 is dated of October 2020; however some procedures are
not updated as planned (e.g. P-35 rev 1/1 dated 01/02/2018, P-43 rev 01 dated 15/10/2018 and P-35 rev 2/3 dated
06/10/2018).

Rationale for major or minor classification:

This nonconformity is classified as minor because there is no significant impact on product performances and safety and
regulatory compliance is expected.

Auditor’s name: Serge THURIES Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Update all SOPs that should be updated according to their next review date mentioned
in The list of the documents due for the periodic review form # P-03-08. Correction Satisfactory
Correction unsatisfactory
see rationale below
COMPANY

Target date: July 2021

IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
P-03 "Control of Documents", issue No.05 instructs that (QA document controller shall send the prepared list of the
documents due to the concerned departments) as one of controls for Periodic Review of Controlled Documents, but SOP
doesn’t specify when QA document controller shall send the list to relevant departments.
Accordingly the RC is: no specified timeframe for prior notification of documents (with near due review status) to the
concerned departments.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Update SOP # P-03 "Control of Documents", issue No. 05 to specify a notification
timeframe for QA to send the prepared list of the documents due to the concerned Corrective action
departments to allow timely updating of documents e.g. SOPs before next review date. Satisfactory
2) Training for relevant personnel on update P-03 "Control of Documents", issue No. 06.
Corrective action
Target date: May 2021 unsatisfactory - see
Name of company representative: Dr. Essam El Saherty rationale below

REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 10 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.4 of ISO 13485:2016 standard
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

The change control process is not fully effective.

Objective evidence of the non conformity:

The action plan following management review MR-01-2020 identified point 5 update the plan of objectives to extend the
timeline for finishing the microbiology laboratory area to be Q1 2021 and the action plan associated mentioned March 2021 for
qualification and validation of the new microbiology laboratory. However the company has not used change control process for
this substantial change nor notified GMED.

Rationale for major or minor classification:

This nonconformity is classified as minor because the project is in progress at the time of the audit. Then no significant impact
on product performances and safety and regulatory compliance is expected.

Auditor’s name: Serge THURIES Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:
Ghatwary Medical GMS has notified GMED regarding establishment of a new microbiological lab (Kindly refer to attached
Notification of Substantial Changes to the Notified Body GMED form).

CORRECTION: OPINION OF LA
1) Issuance of a change control request for Upgrading of QC Microbiological Lab. (Done
20 Jan 2021). Correction Satisfactory
2) Notify GMED regarding Upgrading of New QC Microbiological Lab in GMS. (Done 18
COMPANY

Feb 2021). Correction unsatisfactory

see rationale below
Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of communicating to the organization the importance of meeting applicable regulatory requirements (including change
control).
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
The status of change control process and its impact on the compliance level of QMS will be
escalated to the top management as part of the next management review meetings to Corrective action
communicate to the organization the importance of meeting applicable regulatory requirements Satisfactory
(including change control) and ensure that all levels of management affecting quality are made
aware of changes. Corrective action
unsatisfactory - see
Target date: (Oct. 2021). rationale below
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 11 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.5.8 of ISO 13485:2016 standard
LEAD AUDITOR OR AUDITOR

Statement of the nonconformity:

The product identification is not always in accordance with the relevant procedure.

Objective evidence of the non conformity:

The reference to the model of PP is different between the QA observation and PO documents (GP64029 and GP61657) for
the same lot 42020040 dated December 2020.

Rationale for major or minor classification:

This nonconformity is classified as minor because the release is performed by lot. Then no significant impact on product
performances and safety and regulatory compliance is expected.

Auditor’s name: Serge THURIES Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Correction of code for polypropylene lot # 42020040 in QA observation form dated
December 2020 to be complied with production order Correction Satisfactory
COMPANY

Correction unsatisfactory
see rationale below
Target date: (Done 28 Jan. 2021).
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of review
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Retraining for relevant personnel on P-41 Batch Record Review & Release to restrict
on the importance of accurate review of batch records. Corrective action
Satisfactory
Target date: (Done 17 March 2021).
Corrective action
Name of company representative: Dr. Essam El Saherty
unsatisfactory - see
rationale below

REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 12 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.4 of ISO 13485:2016 standard
LEAD AUDITOR OR AUDITOR

Statement of the nonconformity:

The external documents are not fully verified by the company.

Objective evidence of the non conformity:

The certificate of analysis SANICHEM SCR0621/20 for EO residuals mentioned two different dates (August 2019 for
reception and analysis and August 2020). It was apparently a typo; however there is no confirmation from the subcontractor or
demand of issued a new certificate without error.

Rationale for major or minor classification:

This nonconformity is classified as minor because the data have been verified during the present audit. Then no significant
impact on product performances and safety and regulatory compliance is expected.

Auditor’s name: Serge THURIES Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Communicate with sanichem lab to correct EO residuals testsing reports (Done 10
Feb 2021). Correction Satisfactory
2) Review all other EO validation records to ensure there is no incorrect data in validation
reports (Done 10 Feb 2021). Correction unsatisfactory
COMPANY

see rationale below

Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of review

CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA

Retraining for relevant personnel on P-41 Batch Record Review & Release to restrict on the
importance of accurate review of batch records including validation reports. Corrective action
Satisfactory
Corrective action
unsatisfactory - see
Target date: Done 17 March 2021 rationale below
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 13 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.3.8 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex II, § 3.2, 3rd paragraph (c), 2nd indent
Statement of the nonconformity:

Product specifications for manufacturing are not always consistent with design and development outputs.
LEAD AUDITOR OR AUDITOR

Objective evidence of the non conformity:

The method applied in production and specified in the section n° 7.2.4.6.3 of the SOP of Packaging Validation Process n° P-
65 issue 03 dated 5 September 2020 for determination of strength of the seal joint for pouches is not aligned with the method
required by the section 4.5.1 & Annex D of the EN 868-5:2018 standard (in particular considering the average force discarding
10% on each side of the measuring curve instead of considering the maximal force) knowing that Ghatwary Medical GMS is
claiming conformity to EN 868-5:2018 standard (cf. item n° 4 “Standard applied” of the Technical file of Non-absorbable
sutures n° P-25 version 03 dated 10 March 2021).

Rationale for major or minor classification:

This nonconformity is classified as minor because it has been verified during the audit that the tensile tests for the strength of
the seal joint of pouches performed for the Performance Qualification of the packaging validation by the external laboratory
ISEGA GmbH were done according to the EN 868-5:2018 standard. Then no significant impact on product performances and
safety and regulatory compliance is expected.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

COMPANY

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) Update Packaging Validation Process P-65 issue No.03 to update method of seal
strength test to be complied with EN 868-5 :2018 (Done 1 Feb.2021). Correction Satisfactory
Correction unsatisfactory
Target date: see rationale below

IDENTIFICATION OF CAUSES ON THE NONCONFORMITY

After publication of the new edition of standard EN 868-5, GMS planned to comply with the updated standard by using the
change control process raised a change request in Sep 2019. As part of action plan of this change, a new automatic tensile
tester shall be provided and its relevant documents (SOPs/WIs) shall be updated/generated. Provision of the tensile tester
has been unintentionally delayed due to COVID-19 pandemic, and subsequently the change request (audited by GMED in
Jan 2021) has been updated in Apr 2020, to extend the plan to Jan 2021. While waiting the tensile tester, the packaging
validation has been conducted by external lab in Oct 2020 including the tensile seal strength in accordance with the new
standard. The tensile tester has been provided and calibrated in Nov 2020, and the associated documents (SOPs/WIs) were
planned to be updated/generated in Jan 2021, but extended due to the audit conducted in Jan 2021. The associated
documents (SOPs/WIs) have been updated/generated in Feb 2021.
Also, there are controls for periodical tracking of updated/new standards, but there are no provisions for gap analysis of the
standard and planning of results in link with change control, if applicable, and action plan (CAPA procedure), {contributing
cause}.
Accordingly, the most probable causes include:
- Unintended delay in provision of resources due to time constraint during COVID-19 pandemic.
- No provisions for gap analysis of the standard and planning of associated actions.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Packaging validation has been conducted by external lab including the tensile seal
strength in accordance with the new standard EN 868-5, 2018, {done in Oct 2020}. Corrective action
2) Update SOP # P-42 "Management of Outsourcing Activities" to include procedural Satisfactory
arrangements for potential use of outsourced activities as part of handling of issues
facing time constraint or as part of contingency planning e.g. crisis management, Corrective action
{Planned May 2021}. unsatisfactory - see
3) Generation of provisions for gap analysis of the updated/new standards/regulations rationale below
and planning of associated actions, {Planned June 2021}.
4) Training for relevant personnel on updated P-65 Packaging Validation Process issue
No.04 (Done Feb 2021).
 AUDIT REPORT
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NONCONFORMITY FORM
N° 13 / 21
Target date:
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
720 DM 0701-43a Page 17 out of 34
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NONCONFORMITY FORM
N° 14 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of the
company:
§ 8.2.6 of ISO 13485:2016 standard
Statement of the nonconformity:

Conformity to the acceptance criteria for measurement of product is not always recorded clearly.
Records do not always identify the test equipment used to perform measurement activities.

Objective evidence of the non conformity:

The form “Testing of Finished Product” completed on 30 December 2020 for the tensile tests performed on the lot 42020002
LEAD AUDITOR OR AUDITOR

of Nylon non-absorbable surgical sutures includes only one force value for each type of tensile test whereas 8 units have
been tested and whereas the acceptance criteria are related to individual results and average result on 5 units (cf. pages 5 to
8 of the document “7-Quality Test and Acceptance Criteria” n° P-25 issue/revision 2/3 dated 28 May 2018).
In addition, this completed form does not identify the test equipment used.

The form “Receiving Inspection of Sutures” completed on 19 October 2019 including incoming inspection of Nylon 3/0 suture
thread of lot 182736 (1 reel) includes no record of value of diameter measurement whereas the document “7-Quality Test and
Acceptance Criteria” n° P-25 issue/revision 2/3 dated 28 May 2018 requires 3 measurements of each suture with 5 sutures to
be measured and with criteria on individual and average measurements.
The form “Receiving Inspection of Sutures” completed on 19 October 2019 including incoming inspection of Nylon 3/0 suture
thread of lot 182736 (1 reel) includes no record of value of tensile strength whereas the document “7-Quality Test and
Acceptance Criteria” n° P-25 issue/revision 2/3 dated 28 May 2018 requires measurements of 5 sutures and with criteria on
individual and average measurements.
In addition, this completed form does not identify the test equipment’s used.

The form “Receiving Inspection of Needles” completed on 26 September 2020 including incoming inspection of needles of lot
Z-4-3328 includes no record of value of outer diameter measurement whereas the indicated sample size is 80 units.
In addition, this completed form does not identify the test equipment used.
Rationale for major or minor classification:
This nonconformity is classified as minor because, for the in process tensile tests, the value recorded for each type of tensile
test is the minimum of all measured values according to what has been said to the auditor and because this value is well
above the inferior limit of the criteria. Then no significant impact on product performances and safety and regulatory
compliance is expected.
Auditor’s name: Pascal VANHEE Date: 15 January 2021
COMPANY

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
1) 7-Quality Test and Acceptance Criteria” n° P-25 document has been cancelled and a
new WI (WI-10) has been issued to clarify testing methods required for non-absorbable Correction Satisfactory
sutures during received material inspection, in-process and final product. (Done 10
March 2021). Correction unsatisfactory
2) New forms relevant to testing of Non-absorbable sutures during recieved material, see rationale below
inprocess and final product inspection have been issued including the following :
 The test equipment’s used and their calibration code.
 Testing results for samples that have been tested.
(Done 10 March 2021)
Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of documentation
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NONCONFORMITY FORM
N° 14 / 21
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Training for relevant personnel on (WI-10) Testing of Non-Absorbable Sutures and
associated forms (Done 10 March 2021). Corrective action
2) Overall review of testing procedures/WIs to ensure that the associated testing forms Satisfactory
include the minimum items to be reported in accordance with P-55 Generation of
Product Specifications and Testing Methods taking into considerations e.g.: Corrective action
- Test equipment’s used and their calibration code. unsatisfactory - see
rationale below
- Testing results for samples that have been tested.
Training on updated SOPs/WIs will constitute a part of this action.
{Due date: Oct 2021}
Target date:
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 15 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.2.3 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex II, § 3.2, 3rd paragraph (b), 2nd indent
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

There are no clear documented arrangements for communicating with customers in relation to customer feedback, including
complaints.

Objective evidence of the non conformity:

Within the contract signed on 20 February 1996 between Ghatwary Medical GMS and its unique customer “Contrac” acting as
distributor, and within the addendum signed on 1 March 2008 and 2 February 2012, all translated in English for the audit
purposes, there are no requirement regarding the immediate notification to Ghatwary Medical GMS of any customer complaint
and any incident and the cooperation regarding complaint handling and serious incident reporting.

Rationale for major or minor classification:

This nonconformity is classified as major because it can have an impact on product performances and safety and regulatory
compliance.

Auditor’s name: Pascal VANHEE Date: 15 January 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
GMS has updated distributor agreement with Contrac to include requirement regarding the
following: (Done 1 March 2021) Correction Satisfactory
 If « Contrac » has obtained any customer feedback relating to products including
Correction unsatisfactory
customer complaints shall inform « GMS ».
see rationale below
 In item #8 Complaints and incident reports - first subpharagraph stated that ( If
« Contrac » recieved complaints or reports frpm healthcare professional, patient or
COMPANY

users about suspected incidients related to a device they have made available, shall
immediately forward this information to GMS.
 In item #9 Non conforming product - 5th subpharagraph stated that (if « Contrac »
consider or have a reason to believe that a device which they have made available on
market is not in conformity with applicable regulatory requirements « Contrac » shall
immediately inform GMS).
Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
No provisions in P-42 regarding distributor agreements.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Updating P-42 Management of Outsourcing Activities to include provisions required
to be included in distributor agreements e.g. immediate notification to Ghatwary Corrective action
Medical GMS of any customer complaint and any incident. Satisfactory
2) Training for relevant personnel on updated P-42.
Corrective action
Target date: May 2021 unsatisfactory - see
Name of company representative: Dr. Essam El Saherty rationale below

REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 16 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.1.5 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex II, § 3.2, 3rd paragraph (d), 1st indent
Statement of the nonconformity:

The controls over some outsourced processes that can affect Ghatwary Medical GMS product conformity to requirements are
not demonstrated to be proportionate to the risk involved and the ability of the supplier to meet the requirements.

Objective evidence of the non conformity:

The Purchase Specifications (form n° P-60-01 issue n° 01) for needle (supplier: Quality Needles Private) approved on 16
October 2019 request for cleanliness requirements “clean & free from any matter” and for material composition “Stainless
steel grade 420” with a Certificate of Analysis attached with each lot.
The Risk Management Report for the non-absorbable surgical sutures n° QR-05-2018 dated 9 January 2021 indicates in its
FMEA table as risk mitigation for the risk of contamination by supplier (cf. second risk listed in the section “Sampling and
LEAD AUDITOR OR AUDITOR

inspection of received materials”) that Supplier Bioburden testing results shall be provided with each lot or Ghatwary Medical
GMS can conduct the test.
But in the Purchase Specifications document there is no reference to the European or US Pharmacopoeia and there is no
clear requirement for the precise definition of the full geometrical 3D shape as for example using an engineering drawing.
But for the lot Z-4-3328 of needles inspected at reception on 26 September 2020 (cf. Quality Needles Pvt Ltd Packing list
dated 5 August 2020 associated to the invoice n° QN/2020-21/400) no evidence of bioburden testing and no Certificate of
Analysis has been provided.

The Purchase Specifications (form n° P-60-01 issue n° 01) for Nylon suture thread (supplier: Pearsalls) approved on 30
September 2019 request for cleanliness requirements “clean & free from any matter” and for material composition “Nylon”
with a Certificate of Analysis attached with each lot.
The Risk Management Report for the non-absorbable surgical sutures n° QR-05-2018 dated 9 January 2021 indicates in its
FMEA table as risk mitigation for the risk of contamination by supplier (cf. second risk listed in the section “Sampling and
inspection of received materials”) that Supplier Bioburden testing results shall be provided with each lot or Ghatwary Medical
GMS can conduct the test.
But in the Purchase Specifications document there is no reference to the European or US Pharmacopoeia.
But for the lot 182736 of Nylon 3/0 suture thread inspected at reception on 19 October 2019 (cf. PEARSALLS packing list
dated 3 October 2019 associated to the Proforma invoice n° 39725) no evidence of bioburden testing and no Certificate of
Analysis has been provided.

Then the purchasing specifications and the incoming inspection activities related to needles and Nylon suture thread are not
demonstrated to be sufficient to mitigate the risk of component contamination and biocompatibility.

Rationale for major or minor classification:

This nonconformity is classified as major because it can have an impact on product performances and safety.
Auditor’s name: Pascal VANHEE Date: 15 January 2021
Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
 AUDIT REPORT
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NONCONFORMITY FORM
N° 16 / 21
COMPANY

COMMENT:
 For purchase specification of needle (supplier: Quality Needles Private):
 The European or US Pharmacopoeia is not applicable on stainless steel needle as a raw material, Pharmacopoeia
is only applicable on suture thread and non absorbable suture as final product.
 Needle shape is mentioned in purchase specifications (Reverse Cutting), we don’t attach 3D drawings because it is
not necessary if we mentiond shape required e.g. reverse cutting so supplier know what is the shape, in GMS we
verify that point by visual inspection according to supplier catalouge to ensure that recieved needle is complied with
specifications required.
 Bioburden test on recieved batch of needle has been conducted by GMS and Certificate of analysis has been
recieved.
 For purchase specification of suture thread (supplier: Pearsalls):
 US pharmacopeia (USP) mentioned in item (required physical/chemical tests) seal strength according to USP (USP
is an abbreviation of US pharmacopeia).
 GMS conducted bioburden test on recieved batch of suture and certificate of analysis was provided by supplier.
So this NCR can’t be a major NCR as No impact on safety and performance of device. Purchase specifications of Needle and
Suture thread need to be updated to include more details regarding cleanliness requirements but it just lack of documentation
because all requirements regarding COA and bioburden testing have been already taken into consideration and included in
quality managment system e.g. P-60, P-33 testing of bioburden.
CORRECTION: OPINION OF LA
1) Update Stainless Steel Needle purchase specifications form # P-60-01 to clarify
cleanliness requirements e.g. bioburden limit. (Done 28 March 2021) Correction Satisfactory
2) Update Nylon Suture purchase specifications to clarify cleanliness requirements e.g.
bioburden limit. (Done 28 March 2021). Correction unsatisfactory
3) Update purchase specifications of Nylon suture to clearly specifiy in details nature of see rationale below
suture thread « Nylon » material. (April 2021)
Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
The procedure # P-60 issued in May 2019 for generation of purchase specifications is a new SOP integrated in the quality
management system to comply with the requirements of purchasing information. This procedure covers the general
requirements referred to in ISO 13485 that represent the minimum threshold of purchasing information, taking into
consideration e.g. "the adequacy of specified purchasing requirements prior to their communication to the supplier". However,
the adequacy of purchase specifications is proportional to the level of details that normally varies from a product to a product
(e.g. design and associated risks) and from a technical reviewer to another, knowing that the ISO 13485 standard does not
specify detailed provisions as a default for the extent of adequacy. Accordingly, the procedure will be normally subjected to a
series of updates based on the gained knowledge and growing QMS taking into account the results of audits.
Accordingly, P-60 has been updated to provide more details to ensure adequacy of purchase specifications.
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Update purchase specifications (form # P-60-01) for all shapes/types of Stainless Steel
Needles to clarify cleanliness requirements e.g. bioburden limit. {Done June 2021}. Corrective action
2) Update purchase specifications (form # P-60-01) for all types of non absorbable sutures to Satisfactory
clarify cleanliness requirements e.g. bioburden limit and to clearly specifiy in details nature
of suture thread material. {Done June 2021} Corrective action
3) SOP # P-60 titled as "Generation of Purchase Specifications has been updated, e.g.: unsatisfactory - see
- To link P-60 with other relevant SOPs for risk management, change control, rationale below
qualifications of suppliers and purchasing activities;
- To integrate purchasing information of materials to the risk associated with the relevant
product.
- To add more provisions regarding proactive communication of purchase specs with
suppliers;
- To add provisions for control and notification of changes in purchase specs;
- To clarify requirements for different shapes, sizes and colors of components;
- To clarify information on material composition including nature, chemical composition,
origin, grade and additives;
- To provide details for applicable tests;
- To detail requirements for documents provided by suppliers e.g. information on
certificate of analysis.
{Done June 2021}
4) Training for relevant personnel on updated P-60, issue # 03. {Done June 2021}
5) Update risk management studies of non absorbable sutures regarding hazards associated
with specifications of purchased materials and purchasing information provided by
suppliers. {Aug 2021}
Target date:
 AUDIT REPORT
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Rev 6 du 01/08/2018 File n° : P602907_P1

NONCONFORMITY FORM
N° 16 / 21
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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Rev 6 du 01/08/2018 File n° : P602907_P1

NONCONFORMITY FORM
N° 17 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
LEAD AUDITOR OR AUDITOR

the company:
§ 4.2.3 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex I
Statement of the nonconformity:

For the technical file of Non-absorbable sutures n° P-25 version 03 dated 10 March 2021, the conformity to essential
requirement regarding the following points is not fully demonstrated according to the state of the art:
- identification of all devices covered by the technical file,
- device lifetime
- packaging validation
- list of standard applied
- biological evaluation
- clinical evaluation
- CE marking on labels
 AUDIT REPORT
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NONCONFORMITY FORM
N° 17 / 21
Objective evidence of the non conformity:

- Within the technical file of Non-absorbable sutures n° P-25 version 03 dated 10 March 2021 and in particular in the EC
Declaration of conformity dated 10 March 2021, there is no an exhaustive list of all variants / codes (combining thread
materials, thread colors, thread types, needle types, needle shapes, size/diameter, thread lengths, needle lengths) of the
GHATWARY non-absorbable sutures.

- The lifetime of the device once it is used on patient is not defined.

- Within the item n° 13 “Life time of device” of the Technical file of Non-absorbable sutures n° P-25 version 03 dated 10 March
2021, several tests are presented after 5 years of real life.
But no documented rationale for the selection of the suture types as worst-case, no evidence of ISO 11737-2 standard used
for sterility test, no evidence of accreditation or competence of the microbiological laboratory used, no documented protocol
and no evidence of standard used for packaging tests, no documented raw data on suture performance tests and no
documented testing and measuring equipment used have been provided.
No document regarding packaging system performance testing (according to section 8.2 of the ISO EN 11607-1:2019
standard) has been provided.
No document about testing considering the temperature and humidity conditions indicated in the labelling (between 10 to
30°C and humidity < 60%) has been provided.

- The item n° 4 “Standard applied” of the Technical file of Non-absorbable sutures n° P-25 version 03 dated 10 March 2021
does not include several standards effectively applied for the biological evaluation such as ISO 10993-5:2009 standard, ISO
10993-10:2013 standard, ISO 10993-11:2009 standard, ISO 10993-3:2014 standard, ISO 10993-6:2016 standard and
European Pharmacopoeia for rabbit pyrogen test.

- Within the Biological Evaluation Report of Surgical Suture issue n°05 dated 1 February 2021, there are no detailed
information about grade of polymer for synthetic threads, colorant or other additive in threads composition, manufacturing
processes of threads and needles and corresponding manufacturing additives used, surface characteristics of threads and
needles, leachable substances.
And the justification for the selection of the model of suture as worst case in the entire biological tests program is not detailed.
- The Clinical Evaluation Report for Non-absorbable surgical sutures n° CER/12/2019 version 02 is not signed.
The devices covered are not clearly identified and detailed in particular regarding each code (sections 2.1 & 2.2 and sections
5.1.2.1 of the Clinical Evaluation Report for Non-absorbable surgical sutures n° CER/12/2019 version 02).
The medical fields and relevant medical conditions, the applicable standards and guidance documents, the available
therapeutic/management options are not clearly identified and detailed (sections 2.1 & 2.2 and sections 5.1.2.1 of the Clinical
Evaluation Report for Non-absorbable surgical sutures n° CER/12/2019 version 02).
There is no clear documented literature search for presentation of information on the current knowledge and state of art.
The pages 16 to 24 of the Clinical Evaluation Report for Non-absorbable surgical sutures n° CER/12/2019 version 02 present
3 devices (from LUXSUTURES, NINGBO BONNME MEDICAL INSTRUMENTS and ETHICON LLC manufacturers) for
equivalence analysis. But no detailed description of devices (materials, dimensions, shapes, sizes) and no documents from
the 3 manufacturers have been provided to support the information presented.
The analysis of the 19 articles identified by the literature search does not clearly consider the following points:
- Several articles are not related to clinical data on human (in particular articles #1, 7, 8, 17 & 18)
- Several articles are about case series (in particular articles #9, 11 & 12)
- Several articles are not clearly related to the 3 devices for which equivalence has been previously analysed (in particular
articles #2, 3, 6, 13, 14, 16 & 19)
- Several articles do not give favorable results for non-absorbable sutures (in particular articles #2, 10 & 15)
- The intended uses considered in all relevant articles (such as specific abdominal, dermatologic or ophthalmology surgeries),
and considering each type of suture material, are not covering the large intended use claimed by GHATWARY MEDICAL
GMS

- The CE conformity marking included in both pouch label and sales carton label and indicated on the item n° 11 “Labelling
and Instruction for Use” of the Technical file of Non-absorbable sutures n° P-25 version 03 dated 10 March 2021 is not in
conformity to Annex XII requirements.

Rationale for major or minor classification:

This nonconformity is classified as major because it can have an impact on regulatory compliance and on product
performances and safety.

Auditor’s name: Pascal VANHEE Date: 24 March 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
 AUDIT REPORT
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NONCONFORMITY FORM
N° 17 / 21
COMMENT:

CORRECTION: OPINION OF LA
1) Update DOC chapter in technical file of Non-absorbable sutures to include an exhaustive
list of all variants / codes (combining thread materials, thread colors, thread types, needle Correction Satisfactory
types, needle shapes, size/diameter, thread lengths, needle lengths) of the GHATWARY
non-absorbable sutures. (May 2021) Correction unsatisfactory
2) Update technical file of Non-absorbable sutures n° P-25 to define the lifetime of the device see rationale below
once it is used on patient. (May 2021)
3) Update Chapter #13 « Shelf Life » in technical file of Non-absorbable sutures n° P-25 to
include the following: (Target date: July 2021)
 Documented rationale for the selection of the suture types as worst-case in shelf life
study.
 Evidence of using ISO 11737-2 standard for sterility test.
 Attach accreditation of the microbiological laboratory used during shelf life (Alexandria
University Institue).
 Issuance of retrospective protocol and report for shelf life of non absorbable sutures
according to SOP of Stability Study P-36 including standards used for packaging tests,
documented testing methods, measuring equipment used during shelf life and
temperature and humidity conditions during stabuility study testing.
 Conduction of performance tests (Vibration and Shock tests) for packaging system
according to applicable references for non absorbable sutures.
4) Update Chapter #4 standards applied in Non Absorbable sutures TF to include all
standards applied for the biological evaluation e.g. ISO 10993-6:2016.
5) Update biological evaluation report of Surgical Suture to include : (Aug.2021)
 Detailed information about grade of polymer for synthetic threads, colorant or other
additive in threads composition, manufacturing processes of threads and needles and
corresponding manufacturing additives used, surface characteristics of threads and
needles, leachable substances.
COMPANY

 justification for the selection of the worst cases during biological testing.
 The updated risk analysis considering the lack of information and the possibility of any
contamination or change by the relevant suppliers and presence of undetected
substances and its potential impact on toxicity.
6) Update chapter #11 « Labelling and Instructions for Use » to update the format of CE
mark on pouches and sales carton of Non absorbable sutures as per Annex XII. (May
2021).
7) Update CER report of Non absorbable sutures to: (July 2021)
 Clearly identify devices covered.
 Identify the medical fields and relevant medical conditions, the applicable standards,
guidance documents and the available therapeutic/management options.
 Clearly document literature search for presentation of information on the current
knowledge and state of art.
 Describe in details the (materials, dimensions, shapes, sizes) of equivalent devices
based on documented evidences from manufacturer of equivalent devices.
 Include adequate analysis of articles identified by the literature search taking into
consideration (chosen articles shall be related to clinical data on human, to be related
to equivalent devices and to give favorable results for non-absorbable sutures).
 Evaluate the articles of case series for inclusion or exclusion.
 Include the articles relevant to intended use of Non-absorbable sutures determined by
GMS.
 Detailed description and analysis of difference with equivalent devices in term of
intended uses, materials, dimensions, shapes, sizes. In particular the impact of smaller
range of dimensions, shapes and sizes of GMS sutures compared to equivalent
devices.
 Include clinical data on equivalent device to cover the clinical performances and safety
of GMS stainless steel and polyester sutures.
 Clinical data to cover the intended uses of “general soft tissue approximation and/or
ligation including use in skin, vascular, ophthalmic procedures”.
 Conclude on the need or not of a PMCF study with adequate justification.
Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of Knowledge
 AUDIT REPORT
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NONCONFORMITY FORM
N° 17 / 21
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1. For correction # 1:
1.1. Update the procedure # P-31, issue # 2 titled "Generation of Declaration of Corrective action
Conformity" to include provisions for exhaustive listing of all variants/codes of GMS Satisfactory
products taking into considerations any additional data required for adequate
traceability (e.g. color and size), as appropriate. Training for relevant personnel on Corrective action
updated procedure shall be conducted. (Aug 2021) unsatisfactory - see
1.2. Update the procedure # P-59, issue # 1 titled "Generation of Technical rationale below
Documentation" to include provisions for exhaustive listing of all variants/codes of
GMS products taking into considerations any additional data required for adequate
traceability (e.g. color and size), as appropriate. Training for relevant personnel on
updated procedure shall be conducted. (Aug 2021)
2. For correction 2:
2.1. Update the procedure # P-59, issue # 1 titled "Generation of Technical
Documentation" to include the provisions for defining the lifetime of the device once
it is used on patient. Training for relevant personnel on updated procedure shall be
conducted. (Aug 2021)
3. For Correction #3:
3.1. Update the procedure # P-59, issue # 1 titled "Generation of Technical
Documentation" to include considerations that shall be taken into account during
review/update of technical documentation including e.g.:
- Provisions for updating the technical documentation after any change.
- Adequacy, accuracy and correctness of documented information.
- If any, retrospective documentation of any missing data e.g. if no documented
protocol for stability study.
- If any, retrospective conduction of missing tests.
- Appropriate level of reporting information on used laboratories, equipment,
standards and tests. (Aug 2021)
3.2. Issuance of SOP for vibration and shock tests.(May 2021)
3.3. Conduction of vibration and shock tests for other products.(July 2021)
3.4. Update WI-40 issue # 01 to instruct conduction of performance testing for products
if planned to be marketed in EU.
4. For correction #4:
4.1. Review all standards applied relevant to Non absorbable sutures technical file to
be included in Chapter #4 Standard applied. (May 2021)
5. For Corrections #5:
5.1. Training for relevant personnel on ISO 10993-1:2018. (April 2021)
5.2. Updating P-72 Biocompatibility Evaluation to:
- Include sufficient details regarding gathering of data of raw materials from suppliers
and chemical characterization.
- Link to the procedure # P-60 titled "Generation of Purchase Specifications" to
ensure considerations of all data required for biological evaluation.
- Consider in the risk analysis the lack of information and the possibility of any
contamination or change by the relevant suppliers and presence of undetected
substances and its potential impact on toxicity.
- Evaluate the collected information provided by suppliers.
Training for relevant personnel on updated P-72. (Aug 2021)
6. For Correction #6:
6.1. Update P-66 Rules for Use of CE Mark to include an accurate method for adjusting
dimensions of CE mark and to avoid the manual configuration that may cause
incorrect stretching. Training for relevant personnel on P-66 titled Rules for Use of
CE Mark. (Aug 2021).
6.2. Review the format of CE mark on pouches of other devices as per Annex XII.
(April 2021)
7. For correction #7:
7.1. Updating Clinical Evaluation procedure P-29 to:
- Add detailed instructions regarding adequate analysis of articles and to comply
with all requirements of MEDDEV 2.7/1 revision 4. (Aug. 2021)
- Detailed description and analysis of difference with equivalent devices in term of
intended uses, materials, dimensions, shapes, sizes, if applicable.
- Include clinical data on equivalent device to cover the clinical performances and
safety of all variants of the product/product family.
- Clinical data to cover the current intended use.
Training for relevant personnel on Updated P-29.
- conclude on the need or not of a PMCF study with adequate justification.
 AUDIT REPORT
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NONCONFORMITY FORM
N° 17 / 21
Target date:
Name of company representative: Dr. Essam El Saherty
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
720 DM 0701-43a Page 28 out of 34
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NONCONFORMITY FORM
N° 18 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.3 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex I
Statement of the nonconformity:

For the technical file of Solution administration sets n° P-02-02.1 with last amendment n° 83 dated 18 March 2021, the
conformity to essential requirement regarding the following points is not fully demonstrated according to the state of the art:
- device classification
- shelf life validation
Objective evidence of the non conformity:
LEAD AUDITOR OR AUDITOR

- The solution administration sets are medical devices that are non-invasive devices intended for channeling liquids others
than blood or other body liquids, organs, parts of organs or body tissues for the purpose of infusion or administration. Then
they are of class I according to rule n°2 of the Annex IX of the MDD.
But the item n° 2 “Classification and rationale” of Solution administration sets n° P-02-02.1 with last amendment n° 83 dated
18 March 2021 indicates a classification in class IIa.

- Within the item n° 13 “Life time of device” of the technical file of Solution administration sets n° P-02-02.1 with last
amendment n° 83 dated 18 March 2021, several tests are presented after 5 years of real life.
But no evidence of ISO 11737-2 standard used for sterility test, no evidence of accreditation or competence of the
microbiological laboratory used, no documented protocol and no evidence of standard used for packaging tests, no
documented raw data on other performance tests and no documented testing and measuring equipment used have been
provided.
And no document regarding packaging system performance testing (according to section 8.2 of the ISO EN 11607-1:2019
standard) has been provided.

Rationale for major or minor classification:

This nonconformity is classified as minor because it is mainly a lack of documentation and then no significant impact on
regulatory compliance and on product performances and safety is expected.

Auditor’s name: Pascal VANHEE Date: 24 March 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:
 AUDIT REPORT
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NONCONFORMITY FORM
N° 18 / 21
COMPANY

CORRECTION: OPINION OF LA
1) The Correction for Part#1
- GMS has updated the classification of the device : Solution administration sets n° P- Correction Satisfactory
02-02.1 in chapter # Classification and Rationale
- Review and update the other related chapters in the technical file Correction unsatisfactory
(Done 25 March 2021) see rationale below
The Classification of the device is class I Sterile with the applicable (Annex V, Rule 2)
According to the MDD 93/42/EEC (amended by MDD 2007/47/EEC of 5 September 2007),
Rule 2: "All non- invasive devices intended for channeling or storing blood, body liquids or
tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into
the body are in Class IIa"
- If they may be connected to an active medical device in class IIa or higher class,
- If they are intended for use storing or channeling blood or other body liquids or for
storing organs, parts of organs or body tissues
- In all other cases they are in Class I
-
2) Update Chapter #13 « Shelf Life » in technical file of solution adm. sets to include the
following: (Target date: July 2021)
 Evidence of using ISO 11737-2 standard for sterility test.
 Attach accreditation of the microbiological laboratory used during shelf life
(Alexandria University Institue).
 Issuance of retrospective protocol and report for shelf life of solution adm. Sets
according to SOP of Stability Study P-36 including standards used for packaging
tests, documented testing methods, measuring equipment used during shelf life
and temperature and humidity conditions during stabuility study testing.
 Conduction of performance tests (Vibration and Shock tests) for packaging
system.

Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of Knowledge
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) Training for relevant personnel on classification rules in relation to design and
development requirements based on MDD 93/42/EC. (April 2021) Corrective action
2) Retraining for relevant personnel on P-36 Stability Study.(April 2021) Satisfactory
3) Issuance of SOP for vibration and shock tests.(May 2021)
4) Conduction of vibration and shock tests for other products.(July 2021) Corrective action
unsatisfactory - see
rationale below
Target date:
Name of company representative:
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 19 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.3 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex I
Statement of the nonconformity:
For the Technical file of Tubing sets n° P-02-02.4 with last amendment n° 84 dated 20 March 2021, the conformity to essential
requirement regarding the following points is not fully demonstrated according to the state of the art:
- device classification
- shelf life validation
- biological evaluation
- risk management documentation

Objective evidence of the non conformity:

- According to the item n° 2 “Classification and rationale” of the Technical file of Tubing sets n° P-02-02.4 with last
amendment n° 84 dated 20 March 2021, the Tubing sets are medical devices that are invasive devices intended for
removal/suction of blood or other fluids and with transient use (< 60 minutes). Then they are of class IIa according to rule n°6
LEAD AUDITOR OR AUDITOR

of the Annex IX of the MDD.

But the item n° 2 “Classification and rationale” of the Technical file of Tubing sets n° P-02-02.4 with last amendment n° 84
dated 20 March 2021 indicates a short-term use and the use of rule n°7 for classification.

- Within the item n° 13 “Life time of device” of the technical file of Tubing sets n° P-02-02.4 with last amendment n° 84 dated
20 March 2021, several tests are presented after 5 years of real life.
But no evidence of ISO 11737-2 standard used for sterility test, no evidence of accreditation or competence of the
microbiological laboratory used, no documented protocol and no evidence of standard used for packaging tests and no
documented testing and measuring equipment used have been provided.
And no document regarding packaging system performance testing (according to section 8.2 of the ISO EN 11607-1:2019
standard) has been provided.
And no document about testing considering the temperature and humidity conditions indicated in the labelling (between 10 to
30°C and humidity < 60%) has been provided.

- Within the Biological Evaluation Report of Tubing set issue n°05 dated 1 February 2021, there are no detailed information
about grade of polymer, colorant or other additive for Yankauer handle, manufacturing processes of Yankauer handle and
corresponding manufacturing additives used, leachable substances.

- Within the FMEA table for risk Management Report for Tubing Sets n° QR-10-2018, the risks of tissue damage due to
inappropriate stiffness or presence of sharp edge of the distal tip of the Yankauer handle and the risks due to clogged tubing
or Yankauer handle are not clearly documented.

Rationale for major or minor classification:

This nonconformity is classified as minor because it is mainly a lack of documentation and then no significant impact on
regulatory compliance and on product performances and safety is expected.

Auditor’s name: Pascal VANHEE Date: 24 March 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:
 AUDIT REPORT
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NONCONFORMITY FORM
N° 19 / 21
COMPANY

CORRECTION: OPINION OF LA
1) The Classification and rationale” of the Technical file of Tubing sets n° P-02-02.4 has
updated Where the Tubing sets are medical devices that are invasive devices intended Correction Satisfactory
for removal/suction of blood or other fluids and with short term use (intended for
continuous use for not more than 30 days ( < 30 days). The Tubing set device the Correction unsatisfactory
duration use is short term (The duration time is between few minutes to few hours see rationale below
the duration of the surgery as max )
2) Update Chapter #13 « Shelf Life » in technical file of tubing sets to include the
following: (Target date: July 2021)
 Evidence of using ISO 11737-2 standard for sterility test.
 Attach accreditation of the microbiological laboratory used during shelf life
(Alexandria University Institue).
 Issuance of retrospective protocol and report for shelf life of Tubing Sets
according to SOP of Stability Study P-36 including standards used for packaging
tests, documented testing methods, measuring equipment used during shelf life
and temperature and humidity conditions during stabuility study testing.
 Conduction of performance tests (Vibration and Shock tests) for packaging
system.
3) Update biological evaluation report of tubing sets to include detailed information about
grade of polymer, colorant or other additive for Yankauer handle, manufacturing
processes of Yankauer handle and corresponding manufacturing additives used,
leachable substances. (July 2021)
4) Update risk Management Report for Tubing Sets n° QR-10-2018 to include the risks
of tissue damage due to inappropriate stiffness or presence of sharp edge of the distal
tip of the Yankauer handle and the risks due to clogged tubing or Yankauer handle.
(July 2021)
Target date:
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of Knowledge
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
1) For correction #1
1.1. Training for relevant personnel on classification rules in relation to design and development Corrective action
requirements based on MDD 93/42/EC. (April 2021) Satisfactory
2) for correction #2
2.1. Retraining for relevant personnel on P-36 Stability Study.(April 2021) Corrective action
2.2. Issuance of SOP for vibration and shock tests.(May 2021) unsatisfactory - see
2.3. Conduction of vibration and shock tests for other products.(July 2021) rationale below
3) For correction #3
3.1. Training for relevant personnel on ISO 10993-1:2018. (April 2021)
3.2. Updating P-72 Biocompatibility Evaluation to include sufficient details regarding gathering of
data of raw materials from suppliers and chemical characterization. (May 2021)
3.3. Training for relevant personnel on updated P-72. (May 2021)
4) for correction # 4
Retraining for relevant personnel on P-47 Risk Management. (April 2021)
Target date:
Name of company representative:
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
LEAD AUDITOR

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
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NONCONFORMITY FORM
N° 20 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 4.2.3 of ISO 13485:2016 standard and Medical Devices Directive 93/42/EEC, Annex I
LEAD AUDITOR OR AUDITOR

Statement of the nonconformity:

For the technical file of Blood transfusion sets and Disposal extracorporeal circuit tubing sets (adult and pediatric) the
Biological Evaluation Reports are not fully effective.

Objective evidence of the non conformity:

Within the Biological Evaluation Reports there are no detailed information and raw data relating components & raw material,
additives, manufacturing processes and leachable substances. The physical and chemical characterization is only based on
suppliers’ certificates (not submitted during the audit).

Rationale for major or minor classification:

This nonconformity is classified as minor because all the relevant biological tests have been performed.

Auditor’s name: Serge THURIES Date: 24 March 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:

CORRECTION: OPINION OF LA
Updating Biological evaluation Reports for Blood transfusion sets and Disposal extracorporeal
circuit tubing sets (adult and pediatric) to include detailed information and raw data relating Correction Satisfactory
components & raw material, additives, manufacturing processes and leachable substances.
Correction unsatisfactory
COMPANY

see rationale below

Target date: July 2021
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of Knowledge

CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA

1) Training for relevant personnel on ISO 10993-1:2018. (April 2021)
2) Updating P-72 Biocompatibility Evaluation to include sufficient details regarding Corrective action
gathering of data of raw materials from suppliers and chemical characterization. Satisfactory
Training for relevant personnel on updated P-72. (May 2021)
Corrective action
unsatisfactory - see
Target date: rationale below
Name of company representative:
REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
(to be filled in before transmission of the report to the project manager)
Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
LEAD AUDITOR

Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

NONCONFORMITY FORM
N° 21 / 21
 AUDIT REPORT
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NONCONFORMITY FORM
N° 20 / 21
NONCONFORMITY ESTABLISHED Minor Major
Audit criterion not respected (§ and version) of the document references and / or, where applicable, reference to the documentation of
the company:
§ 7.5.6 of ISO 13485:2016
Statement of the nonconformity:
LEAD AUDITOR OR AUDITOR

The frequency of revalidation of VMP is not fully effective.

Objective evidence of the non conformity:

Seen packaging validation for blood transfusion sets and Disposal extracorporeal circuit tubing sets.
This validation work (PQ) is conducted only after any significant change evaluated to have impact on packaging validation
status. However no revalidation frequency is defined for special process.

Rationale for major or minor classification:

This nonconformity is classified as minor because of the results of QP and periodic monitoring of the equipment and
associated processes.

Auditor’s name: Serge THURIES Date: 24 March 2021

Note : the date to provide the non conformity form completed with corrective action is specified on the statement of
conclusions of the closing meeting. It is to be completed and returned with evidence of the activities undertaken.
COMMENT:
Based on requirements of BS EN ISO 11607-2:2020 (item # 5.7 Process changes and revalidation):
There are no provisions to establish a frequency for revalidation. The standard does not require PERIODICAL validation, but it
requires to evaluate changes to decide whether revalidation is required or not. And if the situation does not require that all
aspects of the original validation be repeated, this revalidation does not have to be as extensive as the initial validation.

Historical Feedback from Interested Auditing Parties:

The old version of SOP (P-65 Packaging Validation Process) included PERIODICAL validation on annual basis, and GMS has
been strongly advised by G-MED auditors and the National Authority (Egyptian Drug Authority "EDA") to demonstrate strict
adherence to the requirements of BS EN ISO 11607-2 and eliminate the PERIODICAL validation, but keep only original (first)
validation and revalidation after significant changes.
CORRECTION: OPINION OF LA
COMPANY

Update P-65 "Packaging Validation Process" issue # 04 to include review of the validation
status on annual basis and the corresponding protocol and report showing the items to be Correction Satisfactory
subjected to review taking into considerations:
Correction unsatisfactory
- Risks from potential undetected changes (e.g. control on changes by suppliers of
materials). see rationale below
- Assessing the need for revalidation if the level of available data (subjected to review) is not
adequate to ensure the maintenance of the previous validation status. (Wait Dr Khairy
Review)
Target date: June 2021
IDENTIFICATION OF CAUSES ON THE NONCONFORMITY
Lack of Knowledge
CORRECTIVE ACTION(S) PROPOSED: OPINION OF LA
Training for relevant personnel on updated P-65. (June 2021)
Corrective action
Satisfactory
Corrective action
Target date: unsatisfactory - see
Name of company representative: rationale below

REVIEW OF THE IMPLEMENTATION OF THE PROPOSED ACTIONS (CORRECTION & CORRECTIVE ACTIONS)
LEAD AUDITOR

(to be filled in before transmission of the report to the project manager)

Erreur! Signet non défini. The nonconformity is closed The proposed actions are to be verified
Rationale (Elements enabling to close the NC, elements not sent, insufficient information, points to review, verification
recommended…)

Name of the Lead Auditor (LA): Date:

 AUDIT REPORT
720 DM 0701-43a Page 34 out of 34
Rev 6 du 01/08/2018 File n° : P602907_P1