We at TCMS in alliance with our partner Technicka Inspekcia, a.s Slovakia having full scope to certify the products:

[2000px-EX-logo] ATEX Manufacturers Directive 94/9/EC
This directive defines each of the following product groups for use in potentially explosive atmospheres:

Electrical and non-electrical equipment
Electrical and non-electrical protective systems
Electrical and non-electrical components
Electrical and non-electrical safety devices

The directive places responsibilities on the manufacturer of these products. The main responsibility of the manufacturer is to prevent the formation and ignition of explosive atmospheres. This may be achieved by using one of the well-established protection concepts (such as flameproof protection, or intrinsic safety), or by proving compliance directly against a set of ‘essential health and safety requirements’, which are given in the directive.

Under ATEX you can put the product in the market once you have successfully achieved EC type Examination and Quality Assessment Notification (QAN)

EC Type Examination: it is the comparison of the product against the requirements of the standards which is normally performed by visual inspection and testing of the product.

Quality Assessment Notification: to put the product on the market, the manufacturer must hold valid Quality Assessment Notification (QAN), under this it basically cover the Quality Management System to be maintained by the manufacturer as per EN 80079-34 for the Ex products. It requires an onsite audit and an annual surveillance audit with issuance of limited time certificate for 3 years.

ATEX For Non Electrical Products:

For Non Electrical Products which fall into Category 2 & 3 an EC type Examination in not required.

For category 2 Non Electrical Equipment, the technical file shall be submitted to the notified body and shall be archived/stored with Notified body for 10 years. An acknowledgment for archive of technical file will be issued by Notified Body, under this the technical file is not reviewed by the Notified Body.

For Category 3 Non Electrical Equipment, there is no legal requirement to submit the technical file with the Notified Body, the manufacture can self declare the compliance and can use the marking once the technical file is complete.

We at TCMS in alliance with our partner Technicka Inspekcia, a.s Slovakia having full scope to certify the products FALLING UNDER PRESSURE EQUIPMENT DIRECTIVE:

[Gig-Karasek-Produkte-Apparatebau-Hochdruckapparat] The European Pressure Equipment Directive (PED) 97/23/EC came into force on 29 November 1999. All items of pressure equipment placed on the market in the European Economic Area (EEA) after May 2002, must comply with the Directive and have evidence of compliance by carrying the CE Marking as applicable.

Why apply the PED?
Legislation across the EEA requires that all applicable items of pressure equipment must be fully compliant with the PED. As a result, manufacturers must revise their working practice and develop the appropriate Technical Files for their full product range. The PED encompasses design verification, material selection, manufacturing/fabrication practices and qualification, product testing, product marking and user instruction compilation.

Scope of the directive :

Pressure Equipment is defined as

Vessels
Pressure accessories
Safety Accessories
Assemblies

With a pressure housing with a maximum pressure greater than 0.5bar is defined as Pressure Equipment

We at TCMS in alliance with TI have the capability to cover all aspects for PEDs conformity assessment modules which includes

Product Inspection & certification
Material Approval
Type Examination
Quality System Approval
Welder Approval

We at TCMS in alliance with our partner Technicka Inspekcia, a.s Slovakia having full scope to certify the industrial products FALLING UNDER Low Voltage DIRECTIVE:

[Productveiligheid] The Electrical Equipment (Safety) Regulations (LVD) applies to all electrical equipment designed for use with a voltage rating of between 50 and 1000 V AC and between 75 and 1500 V DC. Plugs and Sockets are covered by separate legislation namely the Plugs and Sockets Etc. (Safety) Regulations 1994 (SI 1994 No. 1768). Broadly, the scope of the LVD covers consumer and capital goods designed to operate within those voltage limits, including in particular electrical appliances, lighting equipment including ballasts, switch gear and control gear, electric wiring, appliance couplers and cord sets, electrical installation equipment, etc. and electrical equipment intended for incorporation into other equipment such as transformers and motors. The LVD lays down eleven “safety objectives”, which represent the essential requirements of this Directive.

As per the requisite law the participation of the notified body in the conformity assessment procedure is not required.

We at TCMS in alliance with our partner Technicka Inspekcia, a.s Slovakia having full scope to certify all products FALLING UNDER MACHINERY DIRECTIVE:

[hp_pump01] This Directive applies to all machinery and safety components. A machine is defined as “an assembly of linked parts or components, at least one of which moves.”. There are exclusions such as military equipment, machines which are already covered by other, more specific, directives and equipment which falls within the scope of the Low Voltage Directive.

The essential protection requirements demand that machine manufacturers identify the hazards their products contain and assess the risks these hazards present to users. Any risks identified must be reduced to as low a level as is practicable. Detailed requirements are laid out in a series of safety standards. The administrative provisions of the Directive require manufacturers to produce a Technical File, sign a Declaration of Conformity and label the product with certain markings.

Annex IV contains a list of about 15 types of machine which are subject to special procedures. These must either be made fully in accordance with the provision of the standard, or be subjected to type examination by a Notified Body.

TCMS Can offer:

Product Evaluation and Gap analysis visits.
Testing to harmonized, international, national standards, or client’s own specification.
Technical file review
Issuance of Certificate

If you wish to export to Russia, Belarus or Kazakhstan most likely the products are subject to mandatory certification via either CY TR certificate or CU TR Declaration

CU TR CERTIFICATION OF CONFORMITY

Before the formation of the Customs Union of Russia, Kazakhstan and Belarus, all goods had to be evaluated for conformity to the domestic standards and codes called GOST-R. Once established, the regulatory compliance used to be confirmed by a document known as “GOST-R Certificate of Conformity”.

Now that Russia, Belarus and Kazakhstan have formed a Customs Union, a new set of common regulations has been put into force. Conformity now has to be established to a relevant set of Technical Regulations of the Customs Union, or TR CU (sometimes, it is transliterated from Russian as “TR TS”).

For every product type, a transitional period has been established, after which old GOST-R certificates will become null and void. For many product groups the interim period has either already expired or will expire soon.

ALERT: Old GOST-R certificates will become obsolete for most groups of products in April, 2015 !

The said conformity has to be assessed by an authorized organization in one of the three Customs Union member-countries. Once they receive a properly compiled product dossier, the regulators assess the documents, run the necessary lab tests and issue the appropriate certification.

The TR CU certification is mandatory for most consumer goods and services, equipment, foods, vehicles etc. Without TR CU certification, the product will never be cleared into the Union Customs.

Most products that fall under mandatory certification are certified either via TR CU Declaration of Conformity or TR CU Certificate of Conformity. TR CU Certificates of Conformity are issued after very rigorous and expensive tests and trials; in many cases, an onsite inspection of the manufacturing facility is required.

Several groups of products are subject to State (Federal) Registration in Russia. State Registration certificate now replaces the former Sanitary-Hygienic Certification. Among products that fall under mandatory State Registration are dietary supplements and medical devices.

Many products are subject to additional certifications: besides TR, there are 16 other mandatory certification systems (like Fire Safety Certificate, RTN Permit etc) and 129 voluntary certification systems.

If the HS Code you have selected for your product is exempt from mandatory certification, it does not mean that the merchandise would be seamlessly admitted in the Customs Union. To avoid frictions with Customs officials, many exporters obtain Voluntary Certificatesand Exemption Letters. Signed by the legitimate regulatory organizations, these two documents serve as a final argument to the Customs if they question the exemptibility of your product. Voluntary Certification as well enhances the credibility and marketability of the goods.

When deciding on the scope and type of certification your product has to go through, it is best to follow the advice of a competent Russia regulatory consultant.

Thus, you are most likely looking at ordering one or several of four most typical types of certificates:

Certificate of TR CU Conformity
Declaration of Conformity
Federal Registration
Voluntary GOST-TR and Exemption Letter

Principle of certification according to ISO 9001

The certificate issued by an independent accredited certification body guarantees that the quality management system has been established, documented and used in accordance with the requirements of ISO 9001 standard.

The internationally valid ISO 9001 standard can be applied to any production activity or services. It was drawn up by the International Organization for Standardization (ISO), whose aim is to set international requirements for Quality Management System.

ISO 9001:2008 is the latest version of the standard, issued on and valid as from 14 November 2008.

Benefits of certification

Stabilization of the achieved quality level of the range of products and services;
Enhancing the company”s trustworthiness in respect of customers and other business partners;
Establishing order and rules in all activities within the company;
Possibility of subsequent backward checking of observance of the set rules in the quality management system;
Prevention of possible nonconformities and defects by means of preventive actions

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

Registration of the application
Agreement for conducting a certification audit (Note: the certification audit is conducted in two stages)
Appointing a team of auditors
Preparing an audit plan
Audit ” verification of facts in the following stages:
a) examination of the client”s documentation
b) checking facts on site
Elaboration of the Certification Audit Report
Assessment of the Audit Report by the Certification Body
Issuing the Certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year. One of the following is issued depending on the surveillance findings

Decision on confirmation of the certificate validity until the next surveillance;
Decision on suspension of the certificate;
Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

Principle of certification according to ISO 13485

The certificate issued by an independent accredited certification body guarantees that the quality management system of a supplier and manufacturer of medical devices has been established, documented, used and maintained in accordance with the requirements of ISO 13485:2003 standard.

As more stringent quality management system demands are placed on suppliers and manufacturers of medical devices, ISO 13485/13488:2001 standard has been developed, extending the requirements of ISO 9001 standard (sterilization, technical documentation requirements, traceability, etc.).

In 2003, ISO 13485:2003 standard was published as a revised standard, with structure corresponding to ISO 9001:2000 and containing criteria for the whole range of the quality management system for medical devices. The certificate according to ISO 13485:2003 standard applies to the whole management system of an organization manufacturing or supplying medical devices and related services.

Benefits of certification

Guarantee of production process stability and thus steady and high quality of services and products supplied to customers;
Simplifying the process of attestation of conformity to requirements of EU directives and corresponding Government Orders;
Attestation of efficiency and effectiveness of the established quality management system by an independent third party;
Optimization of costs ” reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources savings,
Enhancing trust of public and public monitoring bodies in respect of the medical devices manufacturer.

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

Registration of the application
Agreement for conducting a certification audit (Note: the certification audit is conducted in two stages)
Appointing a team of auditors
Preparing an audit plan
Audit ” verification of facts in the following stages:
a) examination of the client”s documentation
b) checking facts on site
Elaboration of the Certification Audit Report
Assessment of the Audit Report by the Certification Body
Issuing the Certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year. One of the following is issued depending on the surveillance findings

Decision on confirmation of the certificate validity until the next surveillance;
Decision on suspension of the certificate;
Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

Principle of certification according to ISO 14001:2004

[Air_.pollution_1] The certificate guarantees that the environmental management system has been established, documented, used and maintained in accordance with the requirements of ISO 14001:2004 standard. As the certificate is issued by an accredited third party – certification body ” the organization actively minimizes environmental impacts of activities, products and services.

The internationally recognized standard ISO 14001:2004 includes the crucial elements of the efficient environmental management system, which can be used both for services and for production sectors. The standard describes requirements for the management system of businesses, which enables them to reduce environmental impacts related to operation of organizations. The standard requires the company to define its environmental objectives and target levels and to build the management system necessary for achieving them. Besides, the standard requires that the company fills such a system with processes, procedures and activities.

Crucial elements of the standard

Environmental policy
Planning
Establishment and operation
Surveillance and corrective actions
Organization’s management review

Differences from ISO 14001:1996

Achieving higher compatibility of ISO 14001 with ISO 9001
Enhancing unambiguity of requirements

Benefits of certification

Assurance and improvement of care for environment
Awareness of one”s own responsibility
Identification and description of risks and their reduction
Improving the company”s profile/image
Motivation of employees
Timely identification of environmental problems
More guarantees for meeting legal and other requirements
Competitive advantages
Management tool for suitable exploitation of resources

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting SM into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

The certification audit takes places in two stages.

1st stage audit

Registration of application for certification
Agreement for conducting a 1st stage audit
Appointing a team of auditors
Assessment of SM documentation
Preparing an audit plan
On-site audit in connection with examination of documentation
Elaboration of the 1st stage audit report documenting nonconformities

2nd stage audit

Agreement for conducting a 2nd stage audit
Appointing a team of auditors
Assessment of SM documentation
Preparing an audit plan
On-site audit from the point of view of the environmental aspect
Elaboration of the 2nd stage audit report
Assessment of the audit reports by the certification body
Issuing the certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year, whose aim is to make sure that the environmental management system is maintained and further developed. One of the following is issued depending on the surveillance findings:

Decision on confirmation of the certificate validity;
Decision on suspension of the certificate;
Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

Principle of certification according to EN 16001 – Energy Management Systems

The standard specifies the energy management system to enable the organization to develop and implement a policy and objectives that are in line with legal requirements and are based on the identified energy aspects of the organization. The standard is designed for all types and sizes of organizations regardless of their geographical, cultural and social conditions.

This energy management system can be used independently or it can be applied along with requirements of any other management systems such as the quality management system (ISO 9001), environmental management system (ISO 14001), occupational health and safety management system (ISO 18001), etc.

The structure of this standard is similar to the structure of ISO standard, to facilitate implementation of the requirements of this standard into the already established management systems.

The certificate guarantees that the energy management system has been established, documented, used and maintained in compliance with the requirements of ČSN EN 16001:2010 standard. As the certificate is issued by an accredited third party – certification body – the entity is actively involved in enhancing energy efficiency of its processes (activities) in the course of products realization and provision of services. The validity of the issued certificate is 3 years

Benefits of certification

• Stabilization of the achieved quality level of the range of products and services;
• Enhancing the company’s trustworthiness in respect of customers and other business partners;
• Establishing order and rules in all activities within the company;
• Possibility of subsequent backward checking of observance of the set rules in the quality management system;
• Prevention of possible non conformities and defects by means of preventive actions

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
4) Surveillance audit
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Principle of certification according to OHSAS 18001

[ohsas] OHSAS 18001 certificate guarantees that the occupational health and safety management system established in the company has been assessed by an accredited certification bodyand satisfies the requirements of OHSAS 18001 standard.

Occupational health and safety make an important part of management of each organization, especially in connection with legal requirements of the country where the organization runs its business. The group of OHSAS 18001 standards (Occupational Health and Safety Assessment Specification) was established to assist organizations to set up their occupational health and safety policy. Its structure is related to ISO 9001 and ISO 14001 standards; differences from the mentioned standards can be found especially in the areas related to identification, control and reduction of work hazards.

Certification according to OHSAS 18001 is established as an independent system beside QMS and EMS, or these systems are built simultaneously as integrated systems

Benefits of certification

Improving occupational health and safety system established on all organization”s levels;
Systematic reduction of hazards impeding safety and health of all people influenced by the organization”s activities, products or services;
Reducing incidence of occupational diseases and injuries ” improving performance;
Minimising costs associated with accidents at the workplace;
Attestation of the commitment to meet the statutory requirements in the area of occupational safety.

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting OHSAS 18001 into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

The certification audit takes places in two stages.

1st stage audit

Registration of application for certification
Agreement for conducting a 1st stage audit
Appointing a team of auditors
Assessment of SM documentation
Preparing an audit plan
On-site audit in connection with examination of documentation
Elaboration of the 1st stage audit report documenting nonconformities

2nd stage audit

Agreement for conducting a 2nd stage audit
Appointing a team of auditors
Assessment of SM documentation
Preparing an audit plan
On-site audit from the point of view of the environmental aspect
Elaboration of the 2nd stage audit report
Assessment of the audit reports by the certification body
Issuing the certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year, whose aim is to make sure that the environmental management system is maintained and further developed. One of the following is issued depending on the surveillance findings:

Decision on confirmation of the certificate validity;
Decision on suspension of the certificate;
Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

Principle of certification according to ISO/TS 16949

[TS16942] The certificate issued by an independent accredited certification body guarantees that the quality management system has been established, documented and used in accordance with the requirements of ISO/TS 16949. This working group IATF (International Automotive Task Force) consists of car manufacturers and industrial associations. This technical specification ISO/TS 16949 lays down requirements for the quality management system in organizations engaged in series production and production of spare parts in automotive industry.

Considering the specific requirements of car manufacturers in respect of their suppliers’ quality management system and harmonization thereof, the requirements of ISO 9001:2000 standards were supplemented by the international working group for automotive sector (IATF) and issued summarily as a technical specification ISO/TS 16949. This working group IATF (International Automotive Task Force) consists of car manufacturers and industrial associations. This technical specification ISO/TS 16949 lays down requirements for the quality management system in organizations engaged in series production and production of spare parts in automotive industry.

Benefits of certification

Possibility to supply products and services to automotive industry;
Integrated approach to the quality management system – elimination of multiple certification audits (ISO 9001, VDA 6.1, QS 9000);
Recognition of the certification according to ISO/TS 16949 by foreign customers;
Preferring prevention of defects and reducing variability and losses in the supply chain;
Identification, management and continual improvement of processes implemented in the organization (customer-oriented processes, auxiliary processes and management processes);
Application of modern methods and tools for the organization’s management and quality of supplied services and products;
Guarantee of production process stability and related quality of products and services supplied to customers;
Attestation of suitability, efficiency and effectiveness of the established quality management system by an independent third party;
Enhancing trust of the public and public monitoring bodies;
Established system responding flexibly to changes in customer requirements, legislative requirements as well as changes within an organization.

Certification process

Certification is carried out by approved auditors of DQS (Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH ) according to DQS procedures. Certification Body has one trained and approved auditor, who communicates with clients and conducts certification of the quality management system according to ISO/TS 16949 in co-operation with IQNet and the accredited certification body DQS.

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
4) Surveillance audit
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

Registration of application for certification and its examination;
Agreement between the certification body and the organization;
Appointing a team of auditors;
1st stages audit – examination of preparedness;
2nd stages audit – audit of the manufacturing site;
Elaboration of the final report;
Management of nonconformities;
Issuance of the certificate;
Record into the IATF database.

Principle of certification according to HACCP

[haccp-ppt-3-2-728] The certificate issued by an independent accredited certification body guarantees that the food quality and safety management system has been established, documented and used in accordance with the requirements of HACCP standard.

HACCP is a prevention based food quality and safety management system. It provides systematic methods for analysing agricultural and food industry production processes, identification of all possible risks, hazard analysis, determining the critical control points necessary for ensuring quality and safety of food products and consistent management and control of such critical points. HACCP is based on Codex Alimentarius, developed by Food and Agricultural Organization of the United Nations and World Health Organization.

Benefits of certification

Attestation of suitability, efficiency and effectiveness of the established critical points system by a third independent party;
Attestation of meeting the HACCP requirements beyond the scope of the minimum requirements laid down by the national legislation;
Meeting the requirements of the most demanding customers (trade chains and multinational companies);
Guarantee of production process stability;
Optimizing costs;
Enhancing trust of the public and public monitoring bodies;

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

Assessment and registration of the client”s application for certification;
Signing an agreement for conducting a certification audit (Note: the certification audit is conducted in two stages);
Appointing a team of auditors;
Preparing an audit plan;
Verification of facts in the following stages:
a) examination of the client’s documentation
b) checking facts on site;
Elaboration of the Certification Audit Report;
Evaluation of the Audit Report by the Certification Body;
Issuing the Certificate.

During the three year validity period of the certificate, a surveillance audit takes place once a year. One of the following is issued depending on the surveillance findings

Decision on confirmation of the certificate validity until the next surveillance;
Decision on suspension of the certificate;
Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

Principle of certification according to ISO 22000

[food-safety] The certificate issued by an independent accredited certification body guarantees that the food safety management system established in the company has been assessed by an accredited certification body and satisfies the requirements of ISO 22000:2005 standard.

Food safety and health unobjectionability issues have been the focus of consumers”s attention for many years. In order to consolidate the disintegrated approach to food safety management, a standard was drawn up within the scope of the International Organization for Standardization (ISO) oriented to the whole chain of entities engaged in food business, including manufacturers of feedingstuffs, primary manufacturers, manufacturers of food, carriers, wharehouses operators, suppliers, wholesalers, retailers and eating facilities.

The standard refers to the Hazard Analysis and Critical Control Points System principles (HACCP) and to the steps for this system implementation elaborated by the Committee of Codex Alimentarius, further developing them, while being closely related to ISO 9001.

Benefits of certification

Effective utilisation of the previously acquired certificates (HACCP, ISO 9001);
Reducing cost of implementing the food safety system requirements according to other standards in the field of food safety (IFS, BRC”);
Trustworthy guarantee of food safety confirmed by an independent third party;
Contribution to the process of facilitating communication with trade chains.

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

Registration of the application;
An agreement for conducting a certification audit (Note: The certification audit is conducted in two stages);
Appointing a team of auditors;
Audit
(a system documentation audit and a proper audit of the management system working, elaboration of the Certification Audit Report);
Assessment of the Audit Report by the Certification Body;
Issuance of the Certificate.