Educational Services

About the Service

CErttrace Certification Training Audit Inspection Service. Ltd. Şti. is one of the leading companies in the sector in education services.

Our company, with its experienced and specialized staff, offers quality and effective training in line with the needs of the business world and aims to contribute to the success of businesses and individuals.

In our company, the training areas offered are;

  • ISO 14971:2019 Training on Application of Risk Management to Medical Devices
  • ISO 14064-1:2018 Measurement and reporting of greenhouse gas emissions and removals
  • ISO 14064-3:2019  Verification and validation of greenhouse gas claims
  • ISO/IEC 17029:2019 General principles and requirements for verification and verification bodies
  • ISO/IEC 17065:2012 Conformity assessment – Requirements for organizations performing product, process and service certification
  • EU 2017/745 Medical Device Regulation (MDR) Training
  • EU 2017/746 Invitro Medical Diagnostic Device Regulation (IVDR) Training
  • ISO 13485:2016 Medical Devices Quality Management System
  • ISO 15189:2022 Medical Laboratories-Requirements for Quality and Competence Standard Training
  • ISO/IEC 17020:2012 Requirements for Inspection Bodies Standard Training
  • ISO/IEC 17024:2012 Personnel Certification Bodies Standard Training
  • ISO/IEC 27001:2022 Information Security Management System Training
  • ISO 9001:2015 Quality Management Systems Standard Training
  • ISO 14001:2015 Environmental Management System Standard Training
  • ISO 45001:2018 Occupational Health and Safety Management System Standard Training
  • ISO 10002:2018 Customer Satisfaction Quality Management System Standard Training
  • ISO 50001:2018 Energy Management System Standard Training
  • ISO 22000:2018 Food Safety Management System Standard Training
  • FSSC 22000 (Food Safety System Certification) Management System
  • BRCGS Food Safety Management System
  • ISO/IEC 17025:2017 Experiment and Calibration Laboratories Standard Training
  • Internal Audit Training  (ISO 19011)
  • Risk Management Training  (ISO 31000)
  • Method Validation/Verification Training for Experimental Laboratories
  • Measurement Uncertainty Training for Experimental Laboratories
  • Measurement Uncertainty Training for Calibration Laboratories
  • General Metrology and Calibration Evaluation Training
  • Experiment Laboratory Device/Equipment Performance/Interim Control Training
  • Experimental Laboratories Internal Quality Control Training
  • Analysis Trainings for Experimental Laboratories
  • Root-Cause Analysis Training
  • Legal Legislation/National/International Standard Trainings
  • Hygiene and Sanitation Trainings
  • General GMP Training
  • Cleaning Validation Training

Our trainings can be customized according to the needs of businesses and individuals, open to general participation and/or organized in-house. With our efficient and effective training programs, participants are provided with both theoretical knowledge and help to reinforce this knowledge with practical applications.

At CErttrace, our customers’ success is our success. Trust us and ensure your success with our training services.

To get information about our trainings, you can submit your desired training request with the Get a training service quote option in the training services section of our website, or you can contact us via our e-mail address, phone numbers and/or WhatsApp line in the contact section.

Training Materials: Training notes, sample documents and records, case studies, theoretical and practical excel  etc. The studies are shared with the participants.

Examination and Certification: At the end of the training, a training certificate is issued to all participants.

Explanation :
By following current developments, relevant legal regulations, national and international relevant authorities and standards, the contents of our existing trainings are updated and new trainings are included in our list when necessary.

Our instructor staff consists of experienced Experts/Auditors who have industry experience, are competent and have the necessary knowledge. The CVs of our educators are shared during the training details.

Our trainings are held face to face or online in our training hall open to general participation; Company-specific or group training is provided face to face (closed training) or online (online) in organizations upon request.

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EU Declaration of Conformity - Sample

  1. EU fertilization product (product, batch or type number):
  2. Name and address of the manufacturer and the authorized representative, if any:
  3. This EU declaration of conformity is issued under the sole responsibility of the manufacturer. (This declaration of conformity is issued under the sole responsibility of the manufacturer.)
  4. Subject of the declaration (identification of the EU fertilizer product for traceability; may include, where necessary, an image to identify the EU fertilizer product):
  5. The subject matter of the declaration defined above is consistent with:
    – Regulation (EU) 2019/1009 ( 2 ),
    – If there is other harmonized union legislation:
  6. References to relevant harmonized standards or common specifications used or other technical specifications for which conformity is declared:
  7. Where appropriate, the notified body … (name, number) carried out … (description of change) and issued the certificate or approval decision … (number):
  8. Where applicable, this EU declaration of conformity is annexed to the EU declarations of conformity for the EU fertilization products component of the fertilization product blend.
  9. Additional information:
    Signed for or on behalf of …………………………………….
    (place and date of issue):
    (name, position/title) (signature):

MODULE D1- Quality Assurance of the Production Process

  1. Quality assurance of the production process is the conformity assessment method in which the manufacturer fulfills the obligations listed in the second, fourth and seventh articles and ensures and declares the compliance of EU fertilization products with the relevant rules of the technical legislation within the framework of its own responsibility.
  2. .The producer creates a technical file containing the necessary risk analyzes and assessments to determine that the EU fertilization product complies with the relevant legislation. This file is directly related to the conformity assessment of the product and details the design, manufacturing process and functionality of the product. In each case, the technical file must contain at least the following information:

a) a comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,

b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,

c) Declaration of conformity of the EU fertilization product,

d) Drawings, diagrams and explanations necessary to understand the manufacturing, storage and recovery process of the EU fertilization product,

d) Sample of a label or brochure or both containing the required information

e) In the case of partially applied harmonized standards or common specifications, technical documents shall include the applied sections,

f) technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products;

g) If the EU fertilizer product contains derived products, the commercial documents or health certificates required under the legislation in question and documents proving that the derived products have reached the final point in the production chain within the scope of this legislation,

h) the results of the calculations and examinations carried out,

I) Product test reports

i) Hazardous waste calculations for EU fertilizer products containing certain substances

  1. The manufacturer must keep technical documentation available to the relevant national authorities for 5 years after the EU fertilizer product is placed on the market.
  2. The manufacturer must operate an approved quality system for production, final product control and testing for EU fertilizer products referred to in Article 5 and must be subject to the inspection referred to in Article 6.
  3. The procedures and principles regarding the quality system are stated below:

a) The manufacturer applies to a notified body of his choice to evaluate the quality system he applies for his products. The application must contain the following information:

a-1) The name and address of the manufacturer, and in case the application is made by the authorized representative, also the name and address of the authorized representative.

a-2) Written statement stating that the same application has not been made to another approved organization,

a-3) All relevant information for the planned EU fertilization product category,

a-4) Documentation regarding the quality system.

a-5) The technical file specified in the second article.

b) The quality system ensures that the products comply with the relevant rules of the technical legislation. All elements, rules and provisions adopted by the manufacturer are maintained by filing in the form of written policies, procedures and instructions in a systematic and orderly manner. Quality system documentation; It is organized in a way that allows quality programs, plans, manuals and records to be interpreted consistently. The quality system documentation includes sufficient information and explanations, in particular:

b-1) Management's quality objectives and organizational structure, as well as its responsibilities and authorities regarding product quality.

b-2) Relevant production, quality control and quality assurance techniques, processes and systematic actions to be taken.

b-3) Inspections and tests to be carried out before, during and after production and the frequency of their performance.

b-4) Quality records such as inspection reports, test and calibration data, qualification reports of the relevant personnel.

b-5) Tools for the supervision of ensuring the desired product quality and the effective operation of the quality system.

c) The notified body evaluates the quality system to determine whether it meets the conditions specified in paragraph (b). The notified body assumes that the elements of the quality system in accordance with the relevant rules of the national standard implementing a relevant harmonized standard and/or technical specification comply with the requirements specified in point (b). In addition to experience in quality management systems, at least one member of the auditing group must have evaluation experience in the relevant product field and product technology and knowledge of the relevant rules of technical legislation. The audit also includes an assessment visit to the manufacturer's workplace. The inspection team reviews the technical file referred to in the second article in order to verify the manufacturer's ability to diagnose the relevant rules of the technical legislation and to carry out the necessary inspections to ensure that its product complies with these rules. The notified body notifies the manufacturer of its decision. The notification also includes the results of the audit and justified evaluations of the decision.

d) The manufacturer undertakes to fulfill its obligations arising from the quality system as approved and to maintain the quality system in a way that remains adequate and effective.

d) The manufacturer informs the notified body that approved the quality system about any changes it intends to make in the quality system. The notified body evaluates the proposed changes and decides whether the changed quality system meets the conditions specified in paragraph (b) or whether a re-evaluation is required. The notified body notifies the manufacturer of its decision. The notification also includes the results of the audit and justified evaluations of the decision.

  1. The procedures and principles of surveillance under the responsibility of the approved body are stated below:

a) The purpose of surveillance is to ensure that the manufacturer fully fulfills its obligations arising from the approved quality system.

b) The manufacturer allows the notified body to enter the production facilities, inspection and testing laboratories and warehouses in order to make an evaluation, and provides the notified body with all necessary information and documents, especially the following:

a-1) Documentation regarding the quality system.

a-2) The technical file referred to in the second article.

a-3) Quality records such as inspection reports, test and calibration data, qualification reports of the relevant personnel.

b) The notified body carries out periodic inspections to ensure that the manufacturer maintains and implements the quality system and issues an inspection report to the manufacturer.

c) The notified body may additionally make visits to the manufacturer without notice. During these visits, the notified body may, if necessary, conduct or have product tests performed to confirm that the quality system is functioning correctly. The notified body issues a visit report to the manufacturer and a test report if testing has been carried out.

  1. Manufacturer;

a) The manufacturer shall place the CE marking and the identification number of the notified body specified in Article 5 on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation, or, if supplied without packaging, in a document submitted together with the EU fertilizer product.

b) The manufacturer must issue a written EU declaration of conformity for an EU fertilizer product or type and keep it, together with the technical documentation, for submission to national authorities for 5 years after the EU fertilizer product has been placed on the market. The EU declaration of conformity must identify the EU fertilizer product or type for which it is issued.

c) A copy of the EU declaration of conformity must be available upon request from the relevant authorities.

  1. The manufacturer must keep the following documents available to national authorities for 5 years after the EU fertilizer product has been placed on the market:

a) Documents specified in paragraph (a) of the fifth paragraph.

b) The changes specified in paragraph (d) of the fifth paragraph, in their approved form,

c) Notified body decisions and reports specified in subparagraph (d) of the fifth paragraph and subparagraphs (c) and (d) of the sixth paragraph.

  1. Each notified body shall inform the competent bodies that designated it of the quality system approvals it has granted or withdrawn, and shall regularly or upon request provide to these competent bodies a list of the quality system approvals it has refused to grant, suspended or otherwise restricted. Each notified body shall inform other notified bodies of the quality system approvals it has refused, suspended, withdrawn or otherwise restricted and granted upon request.
  2. The obligations of the manufacturer listed in the third article, in the fifth article (a) and (d) and in the seventh and eighth articles can be fulfilled by its authorized representative, provided that it is done on behalf of the manufacturer, is under its responsibility and is specified in the relevant assignment.

MODULE C - Type Conformity Based on Internal Production Control

  1. Type conformity based on internal production control is a conformity assessment in which the manufacturer fulfills the obligations set out in Articles 2 and 3 and ensures and declares on his own initiative that the relevant EU fertilizer products comply with the type defined in the EU type examination certificate and meet the requirements applicable to them under the relevant legislation. process.
  2. The manufacturer must take production process and monitoring measures to ensure that the EU fertilizer products produced comply with the approved type defined in the EU type-examination certificate and with the legislative requirements applicable to them.
  3. The manufacturer shall affix the CE marking on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation or, if supplied unpackaged, in a document accompanying the EU fertilizer product.The manufacturer issues a written EU declaration of conformity for an EU fertilizer product or type and makes it available to national authorities together with technical documentation for 5 years after the EU fertilizer product is placed on the market.
    A copy of the EU declaration of conformity should be available upon request from the relevant authorities.
  4. The manufacturer's obligations under Article 3 may be fulfilled by its authorized representative. For this purpose, the authorized representative must be specified in the authorization document, acting on behalf and under the responsibility of the manufacturer.

.

MODULE B- EU Type Examination

1. EU type examination is a conformity assessment process in which the technical design of the EU fertilization product is examined and it is verified and approved that this design complies with the relevant rules of technical legislation.

2. EU type examination may be carried out following one of these methods:
a) Analysis of a sample (production type) representing the finished product in the production process.
b) Determination of the suitability of the product design and evaluation of a sample of at least one of the important components of the planned product (combination of production and design types), by review of the technical dossier of the product and the additional evidence specified.
c) Determining the suitability of the product design by evaluating only the technical file and additional documents without the need to examine the design type (sample) sample.

  1. The manufacturer applies to a single competent authority of its choice for EU type examination. Application documents available include:
    a) Name and address information of the manufacturer; If the application is made by an authorized representative, the name and address information of this representative is also added,
    b) A written statement stating that the relevant application has not been submitted to any other authorized organization,
    c) Technical file. This technical file must contain all the information required to evaluate the compliance of the product with the relevant legislation and must present the risk analysis and evaluation processes in a comprehensive manner. The technical dossier describes all applicable standards and rules for the product and details the design, manufacture and functionality of the product in relation to the evaluation process. The technical dossier must contain at least the following information wherever applicable:
    a) a comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
    b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,
    c) Declaration of conformity of the EU fertilization product,
    d) Drawings, diagrams and explanations necessary to understand the manufacturing process of the EU fertilization product,
    d) Sample of a label or brochure or both containing the required information
    e) In the case of partially applied harmonized standards or common specifications, technical documents apply sections,
    f) technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products;
    g) If the EU fertilizer product contains derived products, the commercial documents or health certificates required under the legislation in question and documents proving that the derived products have reached the final point in the production chain within the scope of this legislation,
    h) results of calculations made, examinations carried out, etc.
    i) Product test reports
    d) Samples representing the product intended to be produced. The notified body may request additional samples if necessary for the testing programme.
    d) Evidence supporting the adequacy of technical design solutions. This supporting evidence refers to any documents used, particularly where relevant harmonized national standards and/or technical specifications have not been fully implemented. This supporting evidence shall include, where necessary, the results of tests performed by the manufacturer's appropriately qualified laboratory or by another laboratory on behalf of and under the responsibility of the manufacturer.
  2. By the approved body;
    a) Regarding the product, the technical file and relevant supporting evidence are reviewed in order to determine whether the technical design of the product is sufficient,
    b) Regarding the sample;
    b-1) The conformity of the produced sample with the conditions in the technical file is confirmed and the items designed both in accordance with harmonized national standards and/or technical specifications and those designed without adhering to these standards or specifications are determined,
    b-2) In cases where the manufacturer has adopted harmonized national standards and/or solutions in technical specifications, it carries out or ensures that the necessary tests and inspections are carried out to check whether these solutions are implemented correctly,
    b-3) In cases where the methods specified in harmonized national standards and/or technical specifications are not used, it carries out or has the necessary tests and examinations carried out to determine whether the alternative solutions chosen by the manufacturer meet the basic requirements of the technical regulations,
    b-4) It reaches an agreement with the manufacturer about the place to be used for the examination and tests.
  3. The notified body creates an inspection report covering the transactions carried out in accordance with the fourth article and their results. The notified body may disclose part or all of the contents of this report only with the consent of the manufacturer, without prejudice to its responsibilities towards the authorized body that appointed it.
  4. The manufacturer follows these steps:
    The manufacturer shall affix the CE marking on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation or, if supplied unpackaged, in a document accompanying the EU fertilizer product.
    The manufacturer issues a written EU declaration of conformity for an EU fertilizer product or type and makes it available to national authorities together with technical documentation for 5 years after the EU fertilizer product is placed on the market.
    c) A copy of the EU declaration of conformity must be available upon request from the relevant authorities.
  5. The manufacturer's obligations specified under Article 4 may be fulfilled by its authorized representative. For this purpose, the authorized representative must be specified in the authorization document, acting on behalf and under the responsibility of the manufacturer.


Module A1 - Internal Production Control Sign


Internal audit of the production process and testing of the EU fertilization product under supervision indicates that the manufacturer has fully fulfilled the duties and responsibilities listed in the second, third, fourth and fifth paragraphs, ensured under its own initiative that the product complies with the standards required by the technical regulations, and officially declares this conformity. It is a conformity assessment procedure declared by.
The manufacturer creates a technical dossier containing the necessary risk analyzes and assessments to determine that the EU fertilization product complies with the relevant legislation. This file is directly related to the conformity assessment of the product and details the design, manufacturing process and functionality of the product. In each case, the technical file contains at least the following information:
a) a comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,
c) Declaration of conformity of the EU fertilization product,
d) Drawings, diagrams and explanations necessary to understand the manufacturing process of the EU fertilization product,
d) A sample label or brochure containing the required information,
e) In the case of partially applied harmonized standards or common specifications, technical documents apply sections,
f) technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products;
g) results of calculations made, examinations carried out, etc.
h) test reports, including reports on product checks for oil retention and explosion resistance,
I) Documents showing that the EU fertilization product complies with the adopted national measures, as well as technical and administrative evidence showing that they comply with the criteria established by the authorized actions,
i) Names and addresses of the sites and site operators where the EU fertilization product and its main components are produced
The manufacturer carries out all necessary measures throughout the production process and the supervision of this process in order to guarantee compliance of the produced EU fertilization product with the content of the previously mentioned technical dossier and the relevant requirements of the technical legislation.
One or more elements of each manufactured product are subjected to one or more tests by the manufacturer or by a different organization on its behalf in order to verify its compliance with the relevant rules of the technical legislation. These tests are carried out by an in-house accredited unit or under the responsibility of a notified body determined by the manufacturer, at the choice of the manufacturer. In cases where the tests are carried out by a notified body, the manufacturer puts the identity registration number of this organization on the product during the production stage, under the responsibility of this organization.
The manufacturer follows these steps:
The manufacturer shall affix the CE marking on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation or, if supplied unpackaged, in a document accompanying the EU fertilizer product.
The manufacturer issues a written EU declaration of conformity for an EU fertilizer product or type and makes it available to national authorities together with technical documentation for 5 years after the EU fertilizer product is placed on the market.
c) A copy of the EU declaration of conformity must be available upon request from the relevant authorities.
The manufacturer's obligations specified under Article 4 may be fulfilled by its authorized representative. For this purpose, the authorized representative must be specified in the authorization document, acting on behalf and under the responsibility of the manufacturer.

Module A - Internal Production Control Sign

  1. Internal control of the production process is the process of fulfilling the responsibilities set out in the second, third and fourth paragraphs, by which the producer ensures, on his own initiative, that his EU fertilization product complies with the technical regulations and officially declares this compliance.
  2. The manufacturer creates a technical dossier containing the necessary risk analyzes and assessments to determine that the EU fertilization product complies with the relevant legislation. This file is directly related to the conformity assessment of the product and details the design, manufacturing process and functionality of the product. In each case, the technical file contains at least the following information:
    a) A comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
    b) AB fertilization product concept design, a list of component materials used, information on manufacturing processes,
    c) EU declaration of conformity of the fertilization product,
    ç)Drawings, diagrams and descriptions necessary to understand the manufacturing process of the AB fertilization product,
    d) Sample of a label or brochure, or both, containing the required information
    e) In the case of partially applied harmonized standards or common specifications, technical documents include the applied sections,
    f) Technical and administrative evidence to show that the EU fertilization product, if it contains by-products, complies with the application procedures or accepted national measures.
    g) results of calculations made, examinations made, etc.
    e) Product test reports
  3. The manufacturer carries out all necessary measures throughout the production process and the supervision of this process in order to guarantee compliance of the produced EU fertilization product with the content of the previously mentioned technical dossier and the relevant requirements of the technical legislation.
  4. The manufacturer follows these steps:
    The manufacturer shall affix the CE marking on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation or, if supplied unpackaged, in a document accompanying the EU fertilizer product.
    The manufacturer issues a written EU declaration of conformity for an EU fertilizer product or type and makes it available to national authorities together with technical documentation for 5 years after the EU fertilizer product is placed on the market.
    c) A copy of the EU declaration of conformity should be available upon request from the relevant authorities.
  5. The manufacturer's obligations specified under Article 4 may be fulfilled by its authorized representative. For this purpose, the authorized representative must be specified in the authorization document, acting on behalf and under the responsibility of the manufacturer.