Ce Marking is the general name of the system developed in order to ensure the free movement of goods by controlling the conformity of the products to the technical specifications within the European Union norms.

ISO Certification is the name of the common quality and safety system created by combining the technical regulations written by internationally accredited organizations. Relevant legislations are detailed in terms of product groups and processes in line with sub-breakdowns.

2014/30 / EU Electromagnetic Compatibility Regulation Conformity Assessment

There is a potential electromagnetic radiation hazard for all electrical products. Therefore, electrical products entering the EU market must comply with electromagnetic radiation standards. These requirements and regulations are controlled by the European Directive 2014/30 / EU.

Equipment covered by Directive 2014/30 / EU is divided into the following categories;

(1) Consumer goods,

(2) Devices used for domestic and similar purposes,

(3) Portable power tools,

(4) Lighting Products,

(5) Information technology,

(6) Medical equipment and tools,

(7) Laboratory and measuring equipment,

(8) Electric and electronic toys,

(9) Electrical equipment of automobiles,

(10) Industrial equipment

 

Equipment not covered by Directive 2014/30 / EU is specified in article 2 (paragraph 2) of the regulation.

Regarding conformity assessment, Annex II of Directive 2014/30 / EU states that the manufacturer has the right not to include the notified body and to make an independent assessment, but all aspects must be taken into account. Often the manufacturer cannot independently take into account all the necessary considerations. In this case, the manufacturer provides samples and technical documents applicable to the competent authority. The Notified Body issues an EU type examination Certificate (Type Test Certificate) if the documentation has been fully reviewed and the equipment meets all the requirements of the Regulation and harmonized EN standards

 

Toy Safety Regulation 2009/48 / EC – Toy Regulation

It is a priority for the EU to ensure that these products sold in the European Union do not threaten the health of children. EU legislation aims to ensure that toys meet the world’s most stringent safety requirements, particularly on the use of chemicals in toys.

Chemicals that cause cancer, alter genetic information, and damage the reproductive system (so-called CMR substances) are no longer permitted unless they are considered safe after a thorough scientific evaluation.

It cannot be used in toys accessible to children in accordance with Directive 19, 2009/48 / EC, which is called “heavy elements” such as mercury and cadmium.

55 allergic flavors are banned, but on some and 11 others, they can be used in some toys provided they are specified on the label and meet additional requirements. The scope of the Toy Safety Regulation 2009/48 / EC is included in Article 2, which defines toys: “Any product or material developed or produced only for use in the playground of children under 14 years old”.

This Regulation does not apply to the following toys;

– Equipment for children’s playgrounds,

– automatic game machines,

– Toy cars equipped with internal combustion engines,

– Steam toy engines,

– throwing equipment,

Every toy placed on the EU market goes through a conformity assessment procedure. The purpose of the conformity assessment procedure is to prove to the manufacturer and public authorities that the product complies with the legal requirements of the Directive.

There are two possible conformity assessments that allow toys to enter the EU market.

If the products are manufactured in full compliance with harmonized EU standards, it is possible to apply the internal production control procedure (Module A). In all other cases, some form of evaluation (EU-type examination) is applied along with the evaluation procedure specified in Module C. All toys sold in the EU must be CE marked. A statement from the manufacturer that the toy meets basic safety requirements.

2014/34 / EU (ATEX) Regulation – Regulation on Equipment and Protective Systems Used in Explosive Atmospheres

This Regulation applies to equipment and protective systems intended for use in potentially explosive atmospheres.

Safety systems are understood to be the building blocks of protective systems, but are not components designed to abruptly stop incipient explosions and / or limit an effective range of flame and explosion pressure.

A component is any product required for the safe operation of equipment protection systems. Definition of Group and Equipment Category In order to determine the required conformity assessment procedure, the manufacturer must first make a decision regarding the Group and Category to which the product belongs, based on the intended use of the equipment. This Regulation is divided into two groups of equipment, if applicable, including devices and components. Devices should be evaluated according to the category of equipment or protective system for which they are required or contributed to the work.

Group I, equipment intended for use in underground parts of mines and aboveground facilities where such mines may be endangered by mine gas and / or combustible dust,

Group II includes equipment designed for use in other locations that could be dangerous due to explosive atmospheres

Group I

M1 category

Products belonging to this category must function to ensure safety in the presence of an explosive atmosphere and are characterized by the use of internal explosion protection means, as discussed below.

  • In case one of the internal protections fails, at least the second protection will provide an adequate level of security; or
  • In case of two faults, an adequate level of security is provided independently of each other.

Examples of equipment that can be classified as M1 are;

  • Gas detection equipment;
  • Communication equipment;
  • Equipment used in mine rescue operations.

 

M2 Category;

These products should be sealed when an explosive atmosphere occurs. However, it can be assumed that during the operation of equipment in category M2, explosive atmospheres may appear and the equipment cannot be shut down immediately. Therefore, it is necessary to install guards that can provide a high level of security. Protection devices for products in this category provide sufficient safety during normal operation even in more severe operating conditions due to careless use and changes in environmental conditions.

Group II

Category 1

Contains products that can maintain the operating parameters specified by the manufacturer and provide a very high level of protection for use in areas where explosive atmospheres and areas likely to be constantly and permanently visible may be caused by air and gas mixtures, vapors or mists or mixtures of air and dust. . (see section 4.4). Equipment belonging to this Category is characterized by internal explosion protection devices operating as follows:

  • In case of failure of one of the internal protections, a second measure is taken to provide adequate protection:
  • The desired protection level is provided for two faults that occur independently of each other.

Category 2

Includes products that can maintain the operating parameters specified by the manufacturer and provide a high level of protection for use in explosive atmospheres caused by air and gas mixtures, vapors or mists, or air and dust mixtures (see section 4.4). or even when working in hazardous conditions that should normally be considered, it must operate in a manner that provides an adequate safety level.

Category 3

In areas where explosive atmospheres, fogs or air / dust mixtures caused by air and gas mixtures are unlikely, or in areas that may occur in frequency of use, it should contain products that protect the operating parameters set by the manufacturer, providing protection for only a short time for the purpose of use. For a short time only. The design of products in this category should provide an adequate level of protection under normal operating conditions.

Food Packaging

Food products packaging must comply with the general requirements for materials and products that must be contacted with food products by EU Regulation No 1935/2004.

This regulation is intended to protect a high level of consumer health by specifying packaging requirements that come into contact with food both directly and indirectly.

Exceptions in Regulation

Materials and products marketed as antiques;

Preservative materials or containers that form part of foodstuffs such as cheesecakes, semi-finished meat or fruit casings and intended to be consumed with it; stationary equipment for public and private water supply.

Annex I of this Regulation contains a list of materials and product groups consisting of 17 items that may be subject to special measures. To date, only six of them have been adopted and there are separate requirements for them, for example Regulation 10/2011 on plastic materials and products intended to come into contact with food products All measures and requirements set out in the Regulation, the safety of food packaging, in the composition of food products when using such packaging, and should mean no change in properties.

Special measures specified in Article 5 of this Regulation will ensure that the materials and products on which these measures are applied are accompanied by a written declaration stating that they comply with the rules applied to them.

With the participation of the European laboratory, the procedure for evaluating the safety of materials used in the production of materials to be used in contact with food products is implemented.

Directive 2011/65 / EU (RoHS) on the restriction of the use of certain hazardous substances in electrical and electronic equipment

Directive 2011/65 / EU aims to limit the following hazardous substances in electrical and electronic equipment: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers. From July 22, 2019, this list will also be supplemented with the following items: bis (2-ethylhexyl) phthalate, butyl benzyl phthalate, dibutyl phthalate, diisobutyl phthalate.

Annex II of this directive shows the concentrations of substances for homogeneous materials.

Electrical and electronic device categories covered by this Directive

1.Large appliances

Small appliances

3.Information and telecommunications equipment

4.Consumer products

5.Lighting equipment

6.Electrical and electronic equipment

7.Toys, entertainment equipment and sports equipment

8.Medical Products

9.Monitoring and control devices, including industrial monitoring and control devices

10.Automatic dispensers

Other electrical and electronic equipment not falling into the categories mentioned above; In order to verify the conformity of the equipment, the manufacturer must ensure that the design and production process conforms to the requirements of Article 4 of the 2011/65 / EU Directive, as well as prepare technical documentation and internal production control for mass production. Manufactured products. Tests and measurements have been carried out, the “4. These are electrical and electronic equipment and components that have been evaluated according to the standards accepted to comply with the requirements of this Directive.

Our laboratory has all the necessary equipment and appropriate accreditation for testing in accordance with the harmonized EN 62321 standard. As a result, ROHS is a test protocol and certificate of conformity for materials and components from an accredited laboratory.

Bicycle and Stroller

  • Children’s bicycles
  • Bicycles for adults

City, hiking, mountain and racing biking

Special bikes (BMX)

  • Electric bicycles.

The tests are carried out in accordance with current EU standards, in line with the 2001/95 / EU Directive. EN ISO 4210-1: 2014

Bicycles – Safety rules for bicycles – Part 1: Terms and definitions (ISO 4210-1: 2014) EN ISO 4210-2: 2014

Bicycles – Safety rules for bicycles – Part 2: Rules for city and hiking, young adult, mountain and racing bikes (ISO 4210-2: 2014) EN ISO 4210-3: 2014

Bicycles – Safety rules for bicycles – Part 3: Common test methods (ISO 4210-3: 2014) EN ISO 4210-4: 2014

Bicycles – Safety rules for bicycles – Part 4: Test methods for the brake system (ISO 4210-4: 2014) EN ISO 4210-5: 2014

Bicycles – Safety rules for bicycles – Part 5: Test methods for handlebars (ISO 4210-5: 2014, Verified version 2015-02-01) EN ISO 4210-6: 2014

Bicycles – Safety rules for bicycles – Part 6: Test methods for chassis and fork (ISO 4210-6: 2014) EN ISO 4210-7: 2014

Bicycles – Safety rules for bicycles – Part 7: Test methods for wheel and rim (ISO 4210-7: 2014) EN ISO 4210-8: 2014

Bicycles – Safety rules for bicycles – Part 8: Test methods for pedal and driving system (ISO 4210-8: 2014) EN ISO 4210-9: 2014

Bicycles – Safety rules for bicycles – Part 9: Test methods for saddle and seat post (ISO 4210-9: 2014) EN ISO 8098: 2014

Bicycles – Bicycle safety rules for youth (ISO 8098: 2014) EN 15194: 2017

Bicycles – Electric powered bicycles (EPAC)

EPAC Bicycles Tests performed according to these standards provide a minimum level of safety and bicycle quality. The standards include safety requirements for the most important components of bicycles, such as the brake system, transmission system, bicycle handlebars, levers, chassis, front axle fork and saddle.

Following the conformity assessment results, test reports are issued from an accredited laboratory and an EU declaration of conformity is issued.

Tests of the stroller are carried out in accordance with the harmonized standard EN 1888.

The EN 1888 standard goes through a series of stringent tests for the stroller that children are transported to ensure that the child is truly safe. During the tests, the type of the stroller, the materials from which it is made, the assembly of the brakes, the adjustment of the lever, all rotating and removable elements of the seat, fastening systems, the stability of the wheels and their performance under different loads, the stability of the car during movement are checked.

The EN 1888 standard applies only to wheeled carriers or devices designed to carry a child or several children. The standard does not apply to toy cars or baby carriages.

Following the conformity assessment results, test reports are issued from an accredited laboratory and an EU declaration of conformity is issued.

Solar Keymark Certificate

The Solar Keymark labeling scheme was created to certify solar thermal collectors. The aim is to reduce trade barriers and promote the use of high quality solar products not only in the European market but also beyond.

The right to use the Solar Keymark label is granted only by an accredited certification body after the product has been tested in an accredited testing laboratory. The entire responsibility of testing and labeling rights belongs to the institution and the laboratory.

Solar Keymark provided manufacturers with

Simple testing process

Distribution of test reports to all European countries

Simplified procedures for replacing certified components

Advantages of getting Solar Keymark certification;

Low test costs

Certified product

Higher level of consumer confidence

New opportunities to increase sales

 

In our test center, we carry out the following types of tests in accordance with the harmonized EN 12975-2: 2006 standard;

Testing absorbers for internal overpressure

High temperature resistance test

Resistance test

Test for resistance to external thermal shock

Internal heat shock test

Rain test

Frost resistance test

Mechanical tensile testing

Impact test

It is very important to carry out the tests on sunny days.

Solar Keymark certificate is given according to test results.

2014/29 / EU Simple Pressure Vessels Regulation

This regulation applies to mass-produced simple pressure vessels with the following characteristics.

Welded containers with pressures above 0.5 Bar and containing air or oxygen, but not intended for burning; Vessels with a maximum working pressure (PS) and volume (V) of 50 bar x l or less must be designed and built in accordance with good engineering practice prevailing in one of the EU Member States.

Regarding conformity assessment, Article 13 of this Directive specifies possible conformity assessment procedures:

Before the production phase, the product of PS and V exceeding 50 bar x l should be subjected to EU type inspection as follows (Module B)

(a) For ships manufactured in accordance with harmonized standards in the manufacturer’s selection, in one of the following ways:

(i) Conformity assessment of the ship’s technical design by checking the technical documentation and supporting the data without checking the sample (Module B – project type)

(ii) Conformity assessment of the technical design of the boat (Module B – product type) through verification of technical documentation and supporting data as well as verification of the prototype

(b) For ships not manufactured in accordance with harmonized standards or only partially manufactured, the manufacturer must provide a prototype of the product and technical documentation, as well as support data (Module B – product type) for checking and evaluating the technical design of the boat.

Before Releasing, Vessels Must Go Through The Following Procedures

(a) If PS and V product exceed 3000 bar x l – conformity to type based on internal production control and testing under the supervision of a notified body (Module C1)

(b) If the product of PS and V does not exceed 3000 bar x l, but exceeds 200 bar x l, if the manufacturer chooses one of the following actions

(i) Compliance on the basis of internal production control and tests under the supervision of a notified body (Module C1)

(ii) Type conformity based on internal production control and testing of ships under the control of a notified body at optional time intervals (Module C2)

(c) The product of PS and V does not exceed 200 bar x l, but exceeds 50 bar x l if the manufacturer chooses one of the following actions.

(i) Type conformity based on internal production control and testing under the supervision of a notified body (Module C1)

(ii) Type conformity based on internal production controls (Module C)

Detailed information about each Conformity Assessment Module is provided in Annex II of this Directive.

Ships whose parts and accessories are made of high quality unalloyed steel or unalloyed aluminum or high quality aluminum alloys

Ships Consisting of the Following Elements

  • The cylindrical part of the circular cross section is covered by an outer and / or flat base that rotates about the same axis as the cylindrical part.
  • The cylindrical part of the circular cross section is closed with the cylindrical part around an axis with two flat bases

305/2011 / EU Building Materials Regulation

This Regulation establishes the legal regulatory framework for placing construction products on the EU market.

Construction products include any construction product that is produced and placed on the EU market for subsequent use in construction work and whose properties may directly affect the performance of construction works, with regard to their compliance with the essential requirements of this Directive.

The essential requirements for construction products are specified in Annex I of this Regulation and in the relevant EU harmonized standards. The list of standards is published in the Journal of the European Commission. Harmonized standards determine the test methods, the basic characteristics of the products to be declared and the duties of both the manufacturer and the notified body in terms of conformity assessment.

According to the regulations, there are five conformity assessment systems;

1) System 1+. The basic properties of building materials must be declared by the manufacturer based on the following points.

Factory production control (analogue of QMS ISO 9001)

  • Testing samples taken in the workplace according to the approved test program
  • Determination of conformity certificate construction tests from the notified body issued according to the following principles through type test (ITT), model calculations or descriptive documents, factory production control and production control

Subsequent audit audits for the production, monitoring and evaluation of factory production control

Control tests of product samples taken before placing on the EU market

2) System 1. The basic properties of building materials must be declared by the manufacturer according to the following;

Factory production control (analogue of QMS ISO 9001)

  • Testing samples taken in the workplace according to an approved testing program;
  • Certificate of conformity from the notified body issued according to the following principles

Determination of building tests by type testing (ITT), model calculations or descriptive documents

Carrying out primary inspection of production and inspection of factory production control

Subsequent production inspection audits, monitoring and evaluation of factory production control

3) System 2+. The basic properties of construction products must be declared by the manufacturer based on the following points;

  • Determining the type of construction products through type tests (ITT), model calculations or descriptive documentation

Factory production control (analogue of QMS ISO 9001)

  • Testing samples taken in the workplace according to the approved test program
  • Certificate of conformity from the notified body issued according to the following principles

Factory production control and production control

Subsequent production inspection audits, monitoring and evaluation of factory production control

4) System 3. The basic properties of construction materials must be declared by the manufacturer based on the following points;

  • Factory production control by the manufacturer
  • Determination of the type of construction products of the approved laboratory on the basis of test samples sent by the manufacturer, table values ​​and descriptive documentation.

5) System 4. Basic properties of construction products must be declared by the manufacturer based on the following points;

  • Factory production control by the manufacturer
  • Determination of the type of construction product on the basis of test samples, table values ​​and explanatory documentation.

The notified body or laboratory does not participate in this evaluation system.

In cases where construction products are not covered by the harmonized EU standard, the European Technical Certification (ETA) application is applied. Such a process is based on the manufacturer’s collaborative work and technical evaluation commission, which consists of writing a test program, evaluation methods and the project of the questionnaire itself. Detailed information on this procedure is reflected in Annex II of these Regulations.

2014/53 / EU Directive Radio Equipment Regulation

Directive 2014/53 / EU sets the legal framework for placing radio equipment on the EU market. The regulation provides a single market for electromagnetic compatibility and efficient use of the radio frequency spectrum, setting the basic requirements for safety and health for radio equipment. It also provides a framework for further regulation defining additional aspects that include privacy, personal data, and technical functions to protect against fraud. In addition, there are additional considerations such as interoperability, access to emergency services and compatibility with a radio device and software combination.

This Regulation applies to all radio equipment except:

If the equipment is not placed on the market, radio equipment used by radio amateurs includes the following;

Radio kits for assembly / installation

Radio devices modified and used by radio amateurs

Equipment created by individual radio amateurs for amateur radio-related research and scientific purposes

Equipment for ships subject to Directive 96/98 / EC;

Aviation equipment;

Individual evaluation kits designed for professionals that can only be used in research and development for such purposes;

Radio devices used only for public and state security, defense-related activities

Radio devices subject to this Regulation are not subject to Directive 2014/35 / EC, except for those specified in paragraph (a) of article 3 (1) of this Regulation.

Equipment covered by Directive 2014/53 / EU must comply with the essential requirements set out in Article 3 of this Directive and harmonized EU standards.

Depending on which of the conditions specified in Article 3 are met, the manufacturer fulfills the following:

  1. A) Internal production control (Annex II);
  2. B) Type assessment (EU type examination), with assessment of internal production control (Annex III)
  3. B) Evaluation based on full quality assurance (Annex IV).

This Regulation is closely related to two other EU Directives – 2014/30 / EU Electromagnetic Compatibility and 2014/35 / EU Low Voltage Equipment.

Despite the exception from paragraph 6 of this article, all radio equipment must be tested for electrical safety in accordance with the current version of EN 60950-1, in compliance with Directive 2014/35 / EU.

Therefore, during the design and development phase, it is very important to determine the harmonized standards applicable to products and to consider their requirements to avoid the problems of product inconsistencies during testing in a notified laboratory.

2006/42 / AT Machinery Safety Directive (Machinery and Equipment)

The aim of Regulation 2006/42 / EU is to increase the safety of machines and mechanisms placed on the EU market. The Directive sets out the basic health and safety requirements for the development and production of the following products.

Machines and mechanisms

Spare equipment

Safe components

Lifting devices

Chains, ropes and nets

Removable mechanical transmission devices

Partially completed machines and mechanisms

The regulation contains a real explanation of the concept of “machines and mechanisms” (Article 2). The important thing is that the interconnected parts or components of the unit must move. In addition, the Regulation specifies equipment that is not subject to the Directive (Article 1). It is very important for the manufacturer to learn the scope of the Directive and compare its products with it, for example, when the tractor-connected lifting / attachment equipment for agricultural work falls under the MD Directive and the tractor itself is a vehicle and belongs to the Approval Regulation.

ISO 9001: 2015 Quality Management System

The valid ISO 9001 Quality Management System is the standard that ensures all processes from the preparation of the product and / or service based on the principle of customer focus to the sales and after-sales customer satisfaction.

Benefits of ISO 9001: 2015 Quality Management System Certificate

  • Meeting customer expectations and needs,
  • Increasing efficiency by reducing costs,
  • Provides a control mechanism in all processes (purchasing, design, production, service delivery, sales, etc.) according to the scope of the product / service offered by the organization,
  • In today’s increasingly competitive environment, it offers the organization a new market opportunity and increases the difference with its competitors
  • Ensures the continuous improvement and development of the organization,
  • It ensures the participation of employees in the activities in the current processes and increases the awareness of quality.

Who Can Get ISO 9001: 2015 Certificate?

Regardless of the service and product offered (technical service, production, organization, etc.), all public institutions, private companies, etc. organizations.

FSSC 22000: 2010 Food Safety Management System

FSSC 22000: 2010 WHAT?

FSSC 22000 is an internationally recognized ISO-based standard used in the inspection and certification of food safety systems of organizations in the food sector in the entire food chain.

FSSC (Food Safety System Certification) 22000 is fully recognized by the GFSI (Global Food Safety Initiative) Board of Directors and has been accepted by EA (European Cooperation for Accreditation).

FSSC 22000 was designed in order to harmonize and make transparency of standards related to food safety internationally.

Thanks to ISO 10002 Standard, Customer Complaints are Managed More Effectively

Meeting customer expectations and satisfaction rate increases,

It enables the organization to improve itself and to determine the areas where it will eliminate the causes of complaints.

It increases profitability by creating a customer-oriented environment.

ISO 16949 Automotive Quality Management System

The IATF 16949 Automotive Quality Management Standard is an internationally accepted standard, which is based on the ISO 9001: 2015 Quality Management System Standard, which frames the special technical requirements for the automotive industry, which replaces the ISO / TS 16949 standard.

The IATF 16949 Standard brings together the standards in Europe and America and enables you to perform the best practice in all processes of automotive products (design, development, manufacture, installation or maintenance, etc.).

ISO 14001: 2015 Environmental Management System

WHAT IS ISO 14001? It should be taken into consideration that the resources in our world are not infinite, and the environmental effects of products and activities are not local and regional, but globally accepted all over the world. For this reason, the ISO 14001 Environmental Management System Standard, prepared by the ISO (International Organization for Standardization), is in compliance with the regulations for environmental laws and practices in force all over the world.

ISO 14001 Standard In the process from the raw material to the market;

Protection of environmental features and natural structure,

To lay the groundwork for more efficient management by considering environmental risks and opportunities,

To reduce the damage to the environment in the activities of industrial organizations,

It is a management system created to show that it is an environmentally friendly and reliable organization.

Benefits of ISO 14001 Environmental Management System

Complying with national and international legal regulations, gaining reputation of the organization,

Facilitating the obtaining of national and international permits and authorization documents,

Reducing costs due to natural resources used effectively, increasing productivity,

Increasing customer satisfaction and confidence by meeting environmental management obligations,

Reputation and competitive advantage of the organization

Decreasing incidents resulting in loss by determining potential danger situations in the establishment and taking measures against emergency situations (earthquake, fire, flood, etc.) and accidents,

Decrease of financial burdens (such as fines) arising from environmental legal violations,

With the increase in the quality of the organization, the increase of the morale of the employees and the increase of loyalty to the organization.

ISO 13485 Medical Devices – Quality Management System

What is ISO 13485 Standard? The ISO 13485 standard is a quality management system for medical devices. The organization has undertaken the design and development, production, sterilization, facility, purchasing, delivery, etc. It helps to determine the processes according to the quality management system conditions and to be taken into consideration continuously. This standard has been prepared on the basis of the ISO 9001 standard. Although ISO 13485 and ISO 9001 standards are parallel, compliance with the ISO 9001 standard does not indicate compliance with the ISO 13485 standard.

Why Is ISO 13485 Necessary?

For medical device organizations to comply with legal requirements

Identifying the disruptive aspects of the processes within the organization

For CE Marking work on medical devices

What are the Benefits of ISO 13485 Certificate?

Compliance with the standards and legal requirements including medical devices

Increasing the quality in all processes carried out in the establishment (design, production, sales, service, etc.)

Increased confidence in devices in the organization

To provide a competitive advantage in the medical device establishment.

Increasing the quality awareness of the employees in the organization

Meeting customer expectations

To increase customer satisfaction

Reducing errors in production processes

What is the relationship between ISO 13485 and CE Marking? For the establishment, ISO 13485 is one of the important arguments used for CE marking of medical device manufacturers. If the Production Quality Assurance module is selected within the CE Marking, it is the system that the establishment should establish. Basic changes according to the ISO 13485: 2016 standard The results of the evaluations of both experts and users’ feedback in many regions of the world have been included in the new version.

There is a need for a revision in the ISO 13485 standard due to the constant change of regulations on medical devices (legal requirements, standards, etc.). Key changes to the ISO 13485: 2016 standard:

Complying with the requirements of the regulations

Incorporating risk management into Quality Management Systems

Making several issues (validity, validation, and design) clearer and clearer

Highlighting the processes in supplier controls

ISO 9001: 2015 Quality Management System

The valid ISO 9001 Quality Management System is the standard that ensures all processes from the preparation of the product and / or service based on the principle of customer focus to the sales and after-sales customer satisfaction.

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