THE IMPORTANCE OF ACCREDITATION IN MACHINE CONFORMITY ASSESSMENT ACTIVITIES

Nowadays, conformity assessment activities in machines have changed. This is mainly due to developing technology and increasingly important standards. As Szutest Machinery Department, we call this process new generation machine conformity assessment activities.

Based on this context, an institution that carries out machine conformity assessment activities must first be accredited by the European Commission and then by our accreditation body, the Turkish Accreditation Agency, which is affiliated with our relevant ministry. Therefore, the notified body carries out and reports the necessary examinations and tests regarding the standards under the regulation for which it is accredited. Based on this logic, services such as PL verification and ESPE measurements performed within the scope of EN 13849-1 and EN 13855 standards, which have become increasingly important on machines recently, should also be performed by organizations accredited in the relevant regulation.

The importance of accreditation in machinery conformity assessment activities should be considered from several aspects.

Reliability and Trust: An accredited organization has a structure that independently verifies compliance with a certain standard or guideline and gives credibility to this verification. Therefore, assessment results by an accredited organization are generally considered more reliable.

Legal and Regulatory Compliance: In some countries, testing and certification by accredited organizations are required to evaluate certain products or processes. Accreditation is important to comply with such legal and regulatory requirements.

International Acceptance and Recognition: Accredited organizations generally operate in accordance with international standards and thus have the advantage of being recognized and accepted internationally. This may facilitate the entry of products or processes into international markets.

Quality and Process Management: The accreditation process can help organizations improve their processes and quality management systems. Accreditation criteria can provide organizations with a framework for continuous improvement and strengthening quality assurance systems.

Consumer and Corporate Trust: Certifications or reports issued by an accredited organization can create a reliable reference for consumers and other business partners. This can provide an advantage in market competition and increase customer satisfaction.

Potential harms of non-accredited organizations performing conformity assessment on machines may include:

Reliability Issues: There may be doubts about the reliability of evaluations made by non-accredited organizations. These organizations may not be able to fully implement quality control procedures required by certain standards or guidelines.

Legal Issues: In some countries, testing and certification by accredited organizations are legally required to evaluate certain products or machines. Certificates issued by a non-accredited organization may not be valid for legal compliance and this may lead to legal problems.

Deficiencies in Quality Standards: Non-accredited organizations may be inadequate to ensure compliance with national or international quality standards. This may result in products or machines not meeting expected standards in terms of safety, performance and quality.

Cost Increase and Inefficiency: Documents obtained as a result of the certification or evaluation processes of non-accredited organizations may not be accepted in international markets. This can make commercial acceptance of products or machines difficult and therefore lead to increased costs or operating inefficiencies.

Loss of Customer Trust: Certificates or evaluation reports issued by a non-accredited organization may cause loss of trust in customers. Customers may have concerns about the conformity of products or machines to certain standards, which may negatively affect sales.

When a notified body carries out conformity assessment activities on machines, it does not care which brand or model of components the manufacturer or designer uses. What he is interested in is whether that component has undergone a conformity assessment activity or not. An accredited notified body does not pursue any purpose other than conformity assessment activity.

As a result, accreditation in machine conformity assessment activities brings many important advantages such as reliability, legal compliance, international acceptance, quality management and consumer confidence. Therefore, it is important to consider these factors when researching and evaluating an organization’s accreditation. Conformity assessment of machines by non-accredited organizations may cause problems in important areas such as reliability, legal compliance, quality standards and customer confidence. For this reason, choosing accredited organizations in conformity assessment processes will generally be a healthier and more reliable approach.

 

İbrahim Aydeniz

SZUTEST Machinery Department Manager

Personal Protective Equipment

Personel Protective Equipments are evaluated under 2016/425/EU Personel Protective Equipment Directive issued by the European Commission. 2016/425 /EU Personal Protective Equipment Directive has determined three categories as category I, II and III. Products are evaluated and certified according to these categories. At the end of the successful certification process, the manufacturer has the right to affix CE labels to its products.

Dust Masks

There are two types of masks, which are with and without valves and which protect against dust particles are subject to conformity assessment and certification according to the EN 149 standard, a harmonized standard under this regulation. There is a classification as FFP1, FFP2 and FFP3 in the standard, and the tests in the conformity assessment process are designed and carried out according to which manufacturers choose these classes.

The FFP classification described in the EN 149 standard is as following;

The European Commission has developed a procedure for half filter masks that will be newly documented due to the COVID 19 pandemic. This procedure is a new certification process for half masks with filters during this special emergency period we live in. Masks will only be evaluated to provide protection for the COVID 19 virus. The assessment saves time and money, by considering the EN 149 standard, ignoring all the details that are not required for virus protection. The table below compares the tests to which only masks providing protection for the COVID 19 virus and are subjected to the tests to which all protection types of the EN 149 standard are subjected to.

The World Health Organization has published an informative guide on the use of FFP2 and FFP3 class masks defined in this regulation and the standard, as required by the Covid-19 pandemic precautions. You can find the link of the relevant guide document in the resources section of this article.

Masks covered by the EN 149 standard are considered as Category III products described in the regulation. The certification process for the products in this category is as follows:

1. Step :EC Type Examination Certification

Module B Certificate

For this, the manufacturer should create a technical file containing all the details of the products’ features. In addition, product samples must be tested in the accredited laboratory of the notified body. ‘EC Type Examination Certificate’ is published after the technical file is approved and the tests are completed successfully. The validity of the certificate is 5 years.

2. Step : Module C2 or Module D Certificate

The EC Type Examination Certificate alone does not offer the right to affix CE labels to products. In addition to the Type Examination Certificate, manufacturers who want to affix a CE label to their products must have a certificate according to one of the following options. Manufacturers determine which complementary modules to implement.

1. Option Module C2 Certificate (Conformity to based on internal control of production)

The Notified Body performs the production control stages carried out by the manufacturer regarding the mass production of the products and the inspection and tests carried out at the factory. In addition, in order to ensure the validity of the certificate, the notified body conducts audits at the production facility at least once a year at random intervals.  The validity of the module C2 certificate continues depending on the realization of surveillance audits.

2. Option Modul D Certificate (Conformity to based on the quality assurance of the production)

Manufacturers who prefer to receive certificates according to this module must operate a quality management system. The notified body carries out the inspection of the quality management system applied at the production facility and publishes the certificate after the positive inspection.

In summary, mask manufacturers who want to affix CE labels to their products must have obtained Module B + Module C2 or Module B + Module D certificates. For more detailed information, you can review the regulation or contact Szutest Uygunluk Değerlendirme A.Ş. experts and get information.

Resurces:

2016/425/EU Personal Protective Equipment Regulation

EN 149+A1 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking

Link to the guide document published by the World Health Organization https://www.who.int/docs/default-source/documents/advice-on-the-use-of-masks-2019-ncov.pdf

PPE-R/02.075 Usage Suggestion Guide