quality manual - dr-arabin.de · the qm describes the scope of application of the qm system of dr....

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Valid from: 31.01.2019

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Page 0 of 18 QM Handbuch Arabin 12-07-

2018 Rev. 2 EN revised by SOP

31-1-2019

QUALITY MANUAL

Signature Date

Author: R.A. Thieme Groen 04-01-2019

Released

Upper management:

Prof. Dr.med. Dr.h.c. B. Arabin

CEO 04-01-2019

Revision Date Description of the change

1.0 01-02-2018 First version

2.0 10-07-2018 (BA) Added: Applicable Standard

Operating Procedures (SOPs)

Dr. Arabin GmbH & Co. KG

Alfred-Herrhausen-Strasse 44

58455 Witten

info@ dr-arabin.com

+49 (0)2302-189214

Quality Manual

QMH Rev. 2.0 Page 1 of 17

Content

1. Foreword .......................................................................................................................................... 3

2. Corporate information ..................................................................................................................... 3

3. Services of Dr. Arabin GmbH & Co. KG ............................................................................................ 4

4. Quality management system .............................................................................................................. 4

4.1 General requirements .................................................................................................................... 4

4.2 Documentation requirements ....................................................................................................... 5

4.2.1 General information ................................................................................................................ 5

4.2.2 Quality Manual (QM) .............................................................................................................. 5

4.2.3 Medical device file .................................................................................................................. 6

4.2.4 Control of documents ............................................................................................................. 6

4.2.5 Steering of records .................................................................................................................. 6

5. Management responsibility ................................................................................................................. 6

5.1 Management commitment ............................................................................................................ 6

5.2 Customer orientation .................................................................................................................... 7

5.3 Quality policy ................................................................................................................................. 7

5.4 Planning ......................................................................................................................................... 7

5.4.1 Quality objectives .................................................................................................................... 7

5.4.2 Quality management system planning ................................................................................... 7

5.5 Responsibility, authority and communication ............................................................................... 7

5.5.1 Responsibility and authority ................................................................................................... 7

5.5.2 Quality Officer ......................................................................................................................... 8

5.5.3 Internal Communication ......................................................................................................... 8

5.6 Management review ...................................................................................................................... 8

5.6.1 General information ................................................................................................................ 8

5.6.2 Inputs for review ..................................................................................................................... 8

5.6.3 Results of the review ............................................................................................................... 9

6. Management and resources................................................................................................................ 9

6.1 Provision of resources.................................................................................................................... 9

6.2 Personnel resources ...................................................................................................................... 9

6.3 Infrastructure ................................................................................................................................. 9

6.4 Working Environment and Control of Contamination................................................................. 10

7. Product realization ............................................................................................................................ 10

7.1 Planning of product realisation.................................................................................................... 10

7.1.1 Risk management .................................................................................................................. 10

7.2 Customer-related processes ........................................................................................................ 10

7.2.1 Identification of requirements related to the product ......................................................... 10

7.2.2 Assessment of requirements related to the product............................................................ 11

7.2.3 Communication ..................................................................................................................... 11

Quality Manual


7.4 Procurement ................................................................................................................................ 11

7.4.1 Procurement processes......................................................................................................... 11

7.4.2 Procurement information ..................................................................................................... 12

7.4.3 Goods Receipt / Verification of Procurements ..................................................................... 12

7.5 Production and service provision ................................................................................................ 12

7.5.1 Control of production and service provision ........................................................................ 12

7.5.2 Cleanliness of products ......................................................................................................... 12

7.5.3 Installation activities ............................................................................................................. 13

7.5.4 Maintenance activities .......................................................................................................... 13

7.5.5 Specific requirements for sterile medical devices ................................................................ 13

7.5.6 Validation of production and service delivery processes ..................................................... 13

7.5.7 Specific requirements for validation of sterilisation processes and sterile barrier systems 13

7.5.8 Identification ......................................................................................................................... 13

7.5.9 Traceability ............................................................................................................................ 13

7.5.10 Ownership by the customer ................................................................................................ 14

7.5.11 Product maintenance .......................................................................................................... 14

7.6 Control of monitoring and measuring equipment....................................................................... 14

8. Measurement, analysis and improvement ....................................................................................... 14

8.1 General information .................................................................................................................... 14

8.2 Monitoring and measurement .................................................................................................... 15

8.2.1 Feedback messages ............................................................................................................... 15

8.2.2 Handling complaints .............................................................................................................. 15

8.2.3 Reporting to regulatory authorities ...................................................................................... 15

8.2.4 Internal Audit ........................................................................................................................ 15

8.2.5 Monitoring and measuring processes ................................................................................... 15

8.2.6 Monitoring and measurement of the product ...................................................................... 15

8.3 Control of non-compliant products. ............................................................................................ 16

8.3.1 General information .............................................................................................................. 16

8.3.2 Measures taken in response to non-compliant products identified prior to delivery .......... 16

8.3.3 Measures taken in response to non-compliant products identified after delivery .............. 16

8.3.4 Rework .................................................................................................................................. 16

8.4 Data Analysis ................................................................................................................................ 16

8.5 Improvement ............................................................................................................................... 17

8.5.1 General information .............................................................................................................. 17

8.5.2 Corrective actions & .............................................................................................................. 17

8.5.3 Preventive measures (CAPA) ................................................................................................. 17

Quality Manual


1. Foreword This Quality Management Manual (QM) describes the quality management system (QM system) of Dr.

Arabin GmbH & Co KG. The QM system was established based on the requirements of DIN EN ISO

13485 "Medical devices - Quality management systems - Requirements for regulatory purposes" in its

current version, as Dr. Arabin manufactures and sells pessaries for urogynaecology and obstetrics. The

QM, which is based on the structure of this international standard, describes all quality-relevant pro-

cesses and responsibilities within the company. This is intended to achieve a uniform understanding

of the QM system at all levels of the company.

2. Corporate information Dr. Arabin GmbH & Co KG was founded in Siegen in 1967 by the gynaecologist Dr. Hans Arabin. He

developed various models of pessaries "at home", initially for the treatment of sedimentation prob-

lems and later for the treatment of patients at risk of premature birth. His daughter Prof. Birgit Ara-

bin took over the management of the company in 1997. She decided to locate the company in Witten

and relocate most of the production to a workshop for the disabled. Increasingly, work processes in

both manufacturing and sales have been standardized, automated and certified. In 2012, an addi-

tional training centre (Villa Clara Angela) was acquired in Berlin, where training courses on pessary

therapy take place and studies can be coordinated.

The basic principle of the company is not only economic advantage, but the development of clinical

and scientific fundamentals. Profits from Dr. Arabin GmbH & Co. KG flow into the Clara Angela Foun-

dation (www.clara-angela.info), founded by Prof. Birgit Arabin in 1997. Independently of this, the co-

operation with uro-gynaecologists will be intensified in order to stimulate studies and develop new

models.

Address

Company: Dr Arabin GmbH & Co. KG

Address Alfred Herrhaussen Street 44

D-48544 Witten, Germany

website www. dr-arabin. de

Phone +49 (0)2302-189214

email [email protected]

http://clara-angela.info/

mailto:[email protected]

Quality Manual


3. Services of Dr. Arabin GmbH & Co. KG

Dr. Arabin GmbH & Co. KG has many years of experience in the manufacture, sale and final testing of

pessaries in the uro-gynaecological and obstetric field. The following products are offered:

GYNAECOLOGY

Adjustment kit

Indication: Incontinence

Urethra Pessary, Urethra Bowl Pessary

Indication: Genital prolapse

Ring Pessary, Thick Ring, Sieve Bowl Pessary, Bowl Pessary, Hodge Pessary, Cube Pessary with button,

Cube Pessary perforated with button, Tandem Pessary perforated and unperforated, Club Pessary

Indication: Anatomical anomalies:

Vaginal dilator

OBSTETRICS

Indication: Prevention of preterm birth

Cerclage Pessary perforated/unperforated

COUNSELING

4. Quality management system

4.1 General requirements

The quality management system of Dr. Arabin GmbH & Co KG is based on the standard

DIN EN ISO 13485 in all areas of the company.

Dr. Arabin GmbH & Co KG, as manufacturer and sales organization of pessaries, has introduced, docu-

mented and implemented a QM system in accordance with DIN EN ISO 13485 and the applicable reg-

ulatory requirements and undertakes to maintain its efficacy.

The processes and validations required for the QM system as well as the application throughout the

entire organization were identified and the interactions defined accordingly. These processes are man-

aged using a risk-based approach.

4.1.2 Outsourced Processes

The processes of manufacturing and further processing of individual products are outsourced in our

company. The outsourced processes are defined; the nature and extent of the monitoring depends on

the complexity and risks, with responsibility for which lies with our company. These processes are de-

scribed in more detail in the production documents, procurement, supplier audits and test reports.

Quality Manual


The processes are monitored by systematic incoming goods inspection and visual inspections of each

product. When processes are outsourced, compliance with standard requirements and regulatory re-

quirements is checked.

Applicable Operating Procedure

SOP 07.5.1-01 Control of production

4.1.3 Validation of software

Computer software that falls within the scope of the QM system of Dr. Arabin GmbH & Co. KG must

be validated. The specific activities related to software validation and revalidation (following changes

to this software or its application) depend on the risk associated with the use of the software.


SOP 04.1.3-01 Validation of software used in Q processes

4.2 Documentation requirements

4.2.1 General information

The documentation of the QM system of Dr. Arabin GmbH & Co. KG follows the structure of DIN EN

ISO 13485. The QM system is hierarchically structured, whereby the QM manual is the main document.

It describes the entire QM system of Dr. Arabin GmbH & Co. KG. The following documents serve to

maintain the QM system:

Operating instructions

Forms / Work instructions / Records / Medical device file

4.2.2 Quality Manual (QM)

This quality manual is subject to an annual inspection. The handbook exists in central digital and writ-

ten form, i.e. one edition of the handbook is in the company's internal network, another written ver-

sion in the company's office. This presentation of the manual guaranties a version-conflict-free han-

dling, easy updating and is accessible for every employee from every area of our company.

The QM describes the scope of application of the QM system of Dr. Arabin GmbH & Co. KG and repre-

sents the superordinate document of the entire QM system of the company.

The interactions of the processes of the QM system, i.e. the procedures, are described in the manual

and in the associated operating instructions. Applicable operating instructions and forms or work

instructions can be found in the "Annex QM Manual: Form Approved Documentation for the QM

System", which is intended to provide an overview and control element without having to correct

basic procedures too frequently.

Non-applicable standard requirements (justification in respective chapter) after ISO 13485-2016

7.5.3 Installation activities

7.5.4 Maintenance activities

7.5.5 Specific requirements for sterile medical devices

7.5.7 Particular requirements for the validation of sterilisation processes and sterile barrier systems

Quality Manual


7.5.9.2 Specific requirements for implementable medical devices

Exclusions

The process of design and development and development change does not (currently) fall within the

scope of the quality management system of Dr. Arabin GmbH & Co. KG. A standard exclusion item

7.3.

4.2.3 Medical device file

For each type or group of medical devices, we have created a file (medical device file, technical dossier)

that is updated. It contains the regulatory requirements described or a reference to them. The file

either contains the information or refers to its location.

The medical device file contains:

A general description of the product

Intended use / intended purpose

The unique identification/label or label (sample without batch or size)

The instruction manual (current form with revision status offline/online)

The detailed product specifications

Processes / Procedures and Specifications for o manufacture o subsequent processing o packing o storage o sales

Processes / procedures for measurement and monitoring

4.2.4 Control of documents

All quality-relevant documents of the QM system are subject to document control in order to ensure

that only checked and approved (internal/external) documents are used within the company. The as-

sociated procedural instructions describe and record all control measures required by DIN EN ISO

13485 as well as the necessary applicable regulatory requirements.

4.2.5 Steering of records

Quality records are also subject to document control. The associated procedural instruction defines

the necessary control measures of records (identification, retention, protection of confidential infor-

mation, retrievability, retention time).


SOP 04.2-01 Control of documents and records

5. Management responsibility

5.1 Management commitment The management develops the quality management system with the help of the quality management

officers and the other employees. Furthermore, the management is obliged to monitor the effective-

Quality Manual


ness and improvement of the quality management system. The management ensures that specifica-

tions and rules, in particular with regard to customer requirements as well as legal and official require-

ments, are sufficiently known to the employees and taken into account in the performance of the

tasks.

5.2 Customer orientation Customer satisfaction determines the success of the Dr. Arabin GmbH & Co. KG company. Our com-

pany is designed to answer customer enquiries as quickly and completely as possible and to complete

orders within the agreed time frame. As part of our company philosophy, Dr. Arabin GmbH & Co. KG

aims to achieve comprehensive customer satisfaction and thus long-term customer loyalty. Manage-

ment ensures that customer requirements and applicable regulatory requirements are identified and

met.

5.3 Quality policy The top management defines the quality policy and carries out a management evaluation at regular

intervals in order to ensure compliance with requirements, and the implementation, maintenance,

and effectiveness of the QM system.

5.4 Planning

5.4.1 Quality objectives

The quality targets are set by the top management of Dr. Arabin GmbH & Co. KG. They are measurable

and in line with the quality policy. The fulfilment and appropriateness of the quality objectives are

evaluated and documented during the annual management evaluation. If it is determined that the

quality objectives no longer correspond to the current requirements, the management updates the

quality objectives.

5.4.2 Quality management system planning

The QM system is planned by the management in cooperation with the QO. Within the scope of this

function, the processes necessary for the fulfilment of the quality objectives and their application in

the company as well as their interaction are identified and defined.

In order to ensure its functionality, the QM system including its documents (QM, operating instruc-

tions, forms) is checked at regular intervals for its effectiveness and timeliness. Necessary changes are

incorporated into the QM system in accordance with a risk-based approach.


SOP-07.1-02 Change Management

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

The corporate structure of Dr. Arabin GmbH & Co. KG is represented by an organizational chart. The

positions and corresponding areas of responsibility of the individual employees can be found in the

Quality Manual


function matrix. In the case of a new position, a position description must first be created by the man-

agement. Furthermore, responsibilities and responsibilities are also described directly in the proce-

dural instructions.

5.5.2 Quality Officer

The management appoints the Quality Officer (QO) and ensures that this person has the necessary

competences and resources to fulfil the tasks. The QO has the responsibility and authority to

(a) ensure that the processes necessary for the quality management system are documented;

(b) report to senior management on the effectiveness of the quality management system and

any need for improvement;

(c) ensure the promotion of awareness of applicable regulatory requirements and quality man-

agement system requirements throughout the organisation.

5.5.3 Internal Communication

The management ensures that appropriate communication processes have been introduced within Dr.

Arabin GmbH & Co. KG and that communication about the effectiveness of the QM system takes place.

Daily stand-up meetings and monthly team meetings are used for this purpose, whereby "input" and

"output" are checked using to-do lists.

5.6 Management review


The management evaluation takes place at least once a year in order to ensure the continued suitabil-

ity, appropriateness and effectiveness of the QM system of Dr. Arabin GmbH & Co. KG. This assessment

shall include an assessment of potential for improvement and the need for change, including quality

policy and quality objectives. If a requirement is not met, either a reasoned opinion can be prepared

and documented or a corrective and preventive action can be taken.

5.6.2 Inputs for review

The inputs for the management assessment shall contain information based on, but not limited to, the

following:

(a) customer feedback;

b) complaint handling;

(c) reporting to regulatory authorities;

(d) result of audits;

(e) process monitoring and measurement;

(f) monitoring and measurement of products;

(g) corrective measures;

(h) preventive measures;

(i) follow-up to previous management assessments;

j) changes that could affect the quality management system;

(k) recommendations for improvements;

(l) applicable new or revised regulatory requirements.

Quality Manual


5.6.3 Results of the review

The results of the management assessment shall include the evaluated inputs and any decisions and

actions concerning the following:

a) improvements required to maintain the suitability, adequacy and effectiveness of the quality

management system and its processes;

b) product improvement in relation to customer requirements;

c) amendments necessary to respond to applicable new or revised regulatory requirements;

d) the need for resources.


SOP 05.6.-01 Management review

6. Management and resources

6.1 Provision of resources Management identifies and provides the resources required to implement and maintain the effective-

ness of the QM system and to meet regulatory and customer requirements.

6.2 Personnel resources The management of Dr. Arabin GmbH & Co KG uses position descriptions to ensure that employees

carry out activities that benefit product quality. Competences should be created through:

Education,

Training,

Skills development and

Experience based on long-term employment.

Training courses are conducted to achieve and maintain competencies. Training measures are assessed

according to their effectiveness. Staff are informed about the importance of their own activities and

their contribution to the achievement of quality objectives.

Documentation / Quality records

Training certificates (confirmation, participation protocols, plans) are kept for all internal and external

training courses, whereby the topic, date and participants should be visible.


SOP 06.2-01 Trainings

6.3 Infrastructure The necessary infrastructure is recorded, documented and provided by the management. The com-

pany provides the infrastructure required for quality control, packaging and distribution of the prod-

ucts.

Documentation of the infrastructure

Buildings, areas, workplaces and utilities are displayed,

Listings of the machines with planned maintenance intervals are listed,

Supporting services exist for transport, communication, information systematics.

Quality Manual


Maintenance activities

Maintenance work is carried out on all machines and equipment that affect product quality.

Maintenance intervals are listed and evaluated.

The records are kept by the department.

Data backup

Our EDP data are regularly backed-up by means of mirroring by an external provider.

6.4 Working Environment and Control of Contamination Management and the Quality Officer help to design and maintain the working environment necessary

to achieve conformity with product and service requirements. Documented requirements for control

of contamination are in place.


SOP 06.3-01 Maintenance schedule

SOP 06.4-01 Handling contaminated products

7. Product realization

7.1 Planning of product realisation The Dr. Arabin GmbH & Co. KG plans and develops all necessary processes in order to carry out the

realisation of the medical devices and any associated services in compliance with the implemented

quality management system. The established risk management process is applied in all phases of prod-

uct realization.

The development of new or modified products currently does not fall within the scope of the quality

management system of Dr. Arabin GmbH & Co. KG, therefore this element is excluded.

7.1.1 Risk management

Dr. Arabin GmbH & Co KG has developed documented requirements for risk management activities in

accordance with EN ISO 14971 in its currently valid version during the entire planning of product real-

isation. This ensures that any risks arising from production are avoided. New products or services must

always be reviewed using risk management.


SOP 07.1-01 Risk management

SOP 07.1-02 Change management

7.2 Customer-related processes

7.2.1 Identification of requirements related to the product

Within the framework of the sales activities of Dr. Arabin GmbH & Co. KG, customer requirements are

determined and recorded. This ensures that customer requirements for the product, including availa-

bility, delivery, support and other additional requirements, are fully identified. Requirements not spec-

ified by the customer for the intended use are also determined in this way.

Quality Manual


7.2.2 Assessment of requirements related to the product

Before submitting an offer, accepting a contract or an order from our customers, the sales department

of Dr. Arabin GmbH & Co. KG determines and evaluates the requirements regarding the product. The

evaluations are recorded by the sales department. If there are no written requirements, this must be

clarified in advance with the customer and, if necessary, a note made.

In the event of deviations or contradictions between the requirements specified in the order/offer (if

applicable also from earlier contractual relationships), these must be clarified and recorded with the

customer in advance. Contract changes always lead to a new contract check with determination of the

changed conditions. All relevant departments are informed about contract changes.

7.2.3 Communication

Communication with customers and users takes place through direct or indirect communication, e.g.

through product information, inquiries, orders, orders or order changes.

Feedback from customers is also of interest in the form of complaints, which are recorded and pro-

cessed via the correction and prevention procedures. Any communication of recommended measures

to our customers and communication with the regulatory authorities is ensured via the established

vigilance procedure.

The results and evaluation of previous and clinical studies, as presented in the clinical evaluation, can

be accessed and communicated to customers and stakeholders at any time.

Applicable Operating Procedure SOP 08.2.1-01 Confirmation and complaint SOP 7.2-01 Clinical Evaluation

7.3 Design and development - excluded The process of design and development of new or modified products does not (currently) fall within

the scope of the quality management system of Dr. Arabin GmbH & Co. KG, as the selected conformity

assessment procedure according to Annex VI of the Medical Device 93/42/EEC provides for a quality

assurance system for the final inspection of the products. All products of Dr. Arabin GmbH & Co. KG

are subject to this process. Therefore, this element of the standard is excluded.

7.4 Procurement

7.4.1 Procurement processes

Dr. Arabin GmbH & Co KG has established an appropriate process to ensure the quality of our products.

This enables us to assess whether all products/services meet the specified quality requirements and

whether our (future) suppliers are capable of meeting our requirements. All suppliers are managed in

the merchandise management system and undergo an annual supplier evaluation based on objective

and subjective criteria. New suppliers must be qualified as part of an initial evaluation. In the event of

deviations of a supplier (also during the year), appropriate measures shall be taken which may lead to

the exclusion of the supplier.

Quality Manual



SOP 07.4.1-01 Procurement and supplier management

7.4.2 Procurement information

The procurement data of Dr. Arabin GmbH & Co. KG clearly contain the ordered product or service.

Orders shall be made in writing and shall be checked for adequacy before being transmitted to the

supplier or service provider.

The supplier must notify Dr. Arabin GmbH & Co. KG of any changes to the purchased product prior to

the implementation of any changes. This applies in particular to changes that affect the suitability of

the procured product to meet defined procurement requirements.

7.4.3 Goods Receipt / Verification of Procurements

All purchased products are tested by Dr. Arabin GmbH & Co. KG. The type and scope of such testing

activities depend on the product to be procured and are determined individually on the basis of the

risk. This ensures that the identity and quantity of the products received match the triggered order.

Within the framework of specific quality requirements of the products to be procured, further tests

and the associated documentation may be necessary if necessary. Should Dr. Arabin GmbH & Co. KG

become aware of any changes to the purchased product, it will be determined immediately whether

these changes affect the product realization process or the respective medical product.


SOP 07.4.3-01 Incoming goods inspection

SOP 07.4-3-02 Test status

7.5 Production and service provision

7.5.1 Control of production and service provision

The provision of production and services at Dr. Arabin GmbH & Co KG is controlled by defined proce-

dures in order to meet the product specifications laid down in the technical documentation.

The procedures also include provisions on product release and post-delivery activities. The documen-

tation of the required and executed processes is carried out in general and in documents accompany-

ing production at each manufacturer. In this way, the manufacturing process or the service activity can

be controlled and the quality of the products ensured. In accompanying documents, the documented

traceability of the products takes place via batch numbers.


SOP 07.5.1-01 Steering Product realization

SOP 07.5.1-02 bis-05 Production (DINO, Schneider, Van Kempen, WEZO)

SOP 07.5.1-06 Process control for further processing

SOP 07.5.1.-07 Visual inspection Storage, Packaging, shipping

7.5.2 Cleanliness of products

Dr. Arabin GmbH & Co KG has defined measures to control the germ load of pessaries by external

suppliers ("bioburden"). Appropriate quality assurance measures also ensure that there is no risk of

infection for patients at any time.

Quality Manual


7.5.3 Installation activities

None of the pessary types of Dr. Arabin GmbH & Co. KG require any installation in the technical sense.

The selection of the respective sizes is described in the corresponding instructions for use for the med-

ical profession. Therefore, this element of the standard is considered not to be applicable.

7.5.4 Maintenance activities

None of the pessary types of Dr. Arabin GmbH & Co. KG require any maintenance in the technical

sense. The cleaning that may be necessary during application is described in the respective instructions

for use. Therefore, this element of the standard is considered not to be applicable.

7.5.5 Specific requirements for sterile medical devices

All pessary types of Dr. Arabin GmbH & Co KG are marketed non-sterile. It is not necessary to sterilize

the products so that they can be used for the intended purpose. Therefore, this element of the stand-

ard is considered not to be applicable.

7.5.6 Validation of production and service delivery processes

At present, Dr. Arabin GmbH & Co. KG does not have any processes requiring validation within the

framework of production and service provision. Possible future production and service processes of

Dr. Arabin GmbH & Co. KG, the results of which cannot be verified by monitoring or measurement, or

which show deficiencies only after the product has been put into use, will be validated.

Validation plans are created to carry out the validation. Validation protocols and records are docu-

mented and the resulting results are evaluated and summarised in the corresponding validation report.

It must show that the process is capable of delivering the expected results.

Computer software used in production and service provision shall be validated before first use and,

where applicable, revalidated after modifications to such software or its application. Corresponding

records are created.

Other Applicable Operating Procedures

SOP 07.5.6-01 Order processing

7.5.7 Specific requirements for validation of sterilisation processes and sterile barrier sys-

tems

All products of Dr. Arabin GmbH & Co KG are marketed non-sterile. It is not necessary to sterilize the

products so that they can be used for the intended purpose. Therefore, this element of the standard

is considered not to be applicable.

7.5.8 Identification

An identification of procured products and possible intermediate products as well as the final products

is possible via the respective article number or assigned production batch. The final products receive

a product batch, which can consist of several production batches due to different components. The

corresponding test status of the product can be identified at any time via the respective accompanying

documents. There are documented procedures for unambiguous identification of returned products.

7.5.9 Traceability

7.5.9.1 General information

In accordance with the applicable regulatory requirements, records are kept for each medical device,

documenting the quantity produced, the components or parts used for manufacture, the related

Quality Manual


equipment, the persons performing the work and the delivery information, so that traceability from

production (including deliveries from raw material suppliers) to the customer can be traced via the

enterprise resource planning system.

7.5.9.2 Specific requirements for implantable medical devices

None of the pessary variants of Dr. Arabin GmbH & Co. KG are implants. Therefore, this element of

the standard is considered not to be applicable.


SOP 07.5.9-01 Identification and Traceability

7.5.10 Ownership by the customer

Corresponding products will be marked as customer property upon receipt by Dr. Arabin GmbH & Co.

KG. The further procedure must be discussed with the customer and documented in writing. Dr. Arabin

GmbH & Co KG also understands customer property to include intellectual property, documents (in-

cluding regulations/prescriptions), drawings or confidential information. Should customer property be

made accessible to third parties, the customer must be informed immediately in order to discuss the

further procedure.

In the event of loss, damage or unusability of a product provided by the customer, this shall be docu-

mented and communicated to the customer without delay.

7.5.11 Product maintenance

The processes for manufacturing, further processing, storage, distribution and the corresponding tech-

nical documentation of the medical devices regulate the procedures and requirements for maintaining

the conformity of the product components or intermediate products and the later final medical devices

in the respective process steps.

7.6 Control of monitoring and measuring equipment All measuring instruments (test equipment) used by Dr. Arabin GmbH & Co. KG to ensure valid test

results for product conformity are subject to control and are clearly identifiable. In order to maintain

our product quality, we ensure the calibration of these measuring instruments in accordance with the

normative requirements. We also ensure proper handling and storage to avoid damage and deteriora-

tion of the measuring instruments used.

In the event of a failure of the measuring equipment due to damage or deviations outside the permis-

sible tolerance range, measures shall be taken to evaluate previous test results. The use of measuring

equipment and the corresponding test results are part of the product documentation.


SOP 07.6-01 Test equipment management

8. Measurement, analysis and improvement

8.1 General information Dr. Arabin GmbH & Co. KG has defined and implemented the necessary monitoring, measurement,

analysis and improvement processes to demonstrate the conformity of the products and to ensure and

Quality Manual


maintain the effectiveness of the QM system. The responsibility lies with the management in cooper-

ation with the QO.

8.2 Monitoring and measurement

8.2.1 Feedback messages

Dr. Arabin GmbH & Co. has established a feedback system that contains regulations for collecting data

from the production and for activities after the production. The results flow into risk management and

the product realization or improvement process.

8.2.2 Handling complaints

Dr. Arabin GmbH & Co. has established a procedure for the timely processing of complaints in accord-

ance with applicable regulatory requirements.

8.2.3 Reporting to regulatory authorities

Dr. Arabin GmbH & Co. has implemented a procedure for the provision of reports to the relevant reg-

ulatory authorities. The reports are made in accordance with the requirements of MEDDEV 2.12-1

"Guidelines on a medical devices vigilance system".

8.2.4 Internal Audit

The QM system of Dr. Arabin GmbH & Co. is checked annually by an internal audit in accordance with

the specifications in the associated procedure. This is to determine whether the QM system effectively

implements and maintains the planned and documented regulations, the requirements of EN ISO

13485, the requirements defined by Dr. Arabin GmbH & Co. and the applicable regulatory require-

ments.

Measures are taken to eliminate identified faults and their causes and their effectiveness is checked.

The results of the internal audit are included in the management evaluation. The selection of auditors

and the conduct of the audit ensure the objectivity and impartiality of the audit process.


SOP 08.2.1-01 Feedback and complaints

SOP 08.2.4-01 Internal Audit

8.2.5 Monitoring and measuring processes

Dr. Arabin GmbH & Co. applies suitable methods for monitoring and measuring the processes of the

QM system. Where possible, they shall be determined directly within the procedure. If the planned

results are not achieved, corrective measures must be taken where appropriate.

8.2.6 Monitoring and measurement of the product

Dr. Arabin GmbH & Co. records all necessary characteristics of its products and systematically monitors

compliance with the requirements in suitable intermediate and final tests. Proof of conformity is doc-

umented in production records and batch records. The records always show the function and name of

the person performing the task. In addition, the test equipment used is noted.

Quality Manual


8.3 Control of non-compliant products.


Dr. Arabin GmbH & Co. ensures that a product that does not meet the product requirements is labelled

and directed in order to prevent unintentional use or application to the patient (delivery). The control

measures, responsibilities and powers for the handling of non-compliant products are laid down in the

associated procedure.

8.3.2 Measures taken in response to non-compliant products identified prior to delivery

Non-compliant products that are identified before delivery must always be labelled immediately.

Other provisions, such as associated responsibilities and powers for handling non-compliant products

(or services), are described in the associated procedure.

8.3.3 Measures taken in response to non-compliant products identified after delivery

Should a non-conforming product only be detected after delivery or application has already begun, the

safety representative of Dr. Arabin GmbH & Co. shall be responsible for further action. The activities

to be performed are defined in the associated procedural instruction.

8.3.4 Rework

Rework in the sense of necessary corrections will only be carried out by Dr. Arabin GmbH & Co. in

exceptional cases and only after approval by the upper management. The amount of rework is propor-

tional to the risk. The associated procedure describes the procedure.


SOP 08.3-01 Steering of non-compliant products

SOP 08.3-02 Handling returned deliveries and complaints

SOP 08.3-03 Rework

8.4 Data Analysis In order to assess the suitability and effectiveness of the QM system, data from the following areas is

determined, recorded, analysed, and documented as part of the management review:

Documentation on the suitability, effectiveness and appropriateness of the QM system (qual-

ity objectives, management evaluation, development documentation, risks, training)

feedbacks

Declaration of conformity of the product with the product requirements

Process and product characteristics, including opportunities for improvement

Supplier assessments and contracts

Audits


SOP 08.4-01 Data analysis

SOP 08.4-02 Post marketing Clinical Follow-up Plan

SOP 08.4-03 Post Marketing Surveillance Plan

Quality Manual


8.5 Improvement


Dr. Arabin GmbH & Co. determines and implements all changes that are necessary to ensure and main-

tain the continued suitability, appropriateness and effectiveness of the QM system as well as the as-

surance and performance of the medical device. Serving this purpose:

Forms on quality policy and quality objectives

Results of audits and their follow-up,

Monitoring analyses after "placing on the market" of the products

data analyses

Corrective and preventive measures

Management reviews

Analysis results serve as a basis for possible corrective and preventive measures.

8.5.2 Corrective actions &

8.5.3 Preventive measures (CAPA)

Dr. Arabin GmbH & Co. has established a procedure for the handling and implementation of corrective

and preventive actions with sequential numbering and date.


SOP 08.5.2-01 Corrective and preventive measures

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