Detailed Twinning Light Project Fiche
Strengthening of the EU acquis communautaire implementation in the field of Standardization, Certification, Accreditation and Conformity Assessment
1. Basic Information
1.1 Publication and Twinning Number: Twinning Light Transition Facility 2005/017-488.01.08 Flexible Reserve
1.2 Title: Strengthening of the EU acquis communautaireimplementation in the field of Standardization, Certification, Accreditation and Conformity Assessment
1.3 Location: Poland
2. Objectives
2.1 Overall Objective(s): Strengthening of the institutional and operational capacities of the national bodies responsible for standardisation, accreditation, certification and conformity assessment in line with the European practice.
2.2 Project purpose: Institutional and operational capacities of the beneficiary institutions improved for implementing and interpreting the European Union acquis communautaire in the field of standardization, certification, accreditation and conformity assessment bodies.
2.3 Contribution to National Development Plan/Cooperation agreement: n.a.
3. Description
3.1 Background and justification:
The conformity assessment policy of the European Union is an integral part of the functioning internal market, which can only function properly where there are common rules and procedures applied to the products and services put on the market. These common rules have also to be interpreted in the same way by all national notified bodies responsible for conformity assessment with the European Directives.
At the same time, the Polish national bodies responsible for standardisation and accreditation, which joined the European system of the standardisation (CEN) and of the accreditation (EA) have to reinforce their structures and develop their competences and institutional capacities in order to function properly in the European structures. In this respect, the institutional assistance and expertise will help the Polish beneficiaries to adopt, or to adjust their structures and functioning according to the best European practices.
All national bodies, selected to participate in the present project, were beneficiary of one Twinning projects under Phare programme Phare 2001 Project PL01.02.01: PL2001/IB/EC/03), which supported these institutions in their preparation to join the European structures of the standardisation and accreditation and to prepare the designed bodies to their notification.
However, although Poland has already harmonised its legislation with the acquis communautaire, the integration is in progress and the Polish notified bodies have to compare their practice in testing as well as the interpretation of the standards. Some additional needs, not covered by the former twinning projects, also appeared (EU Ecolabel implementation, the improvement of the alimentary security in Poland through the development of the ISO 22000 certifications and accreditations and the application of HACCP rules, accreditation processes within ISMS and GHG programmes, assessment of the notified bodies within selected Directives (2006/42/EC, 2004/108/EC, 2000/14/EC), and accreditation of medical laboratories within EN-ISO 15189.
The beneficiaries also need to up-date their knowledge related to the implementation of the selected New Approach Directives:
- Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on Machinery, amending Directive 95/16/EC
- Council Directive 89/336/EEC of May 1989 relating to Electromagnetic Compatibility (EMC) amended by Directive 92/31/EEC of 28 April 1992 and amended by Directive N° 93/68/EEC of 22 July 1993;
- Directive N° 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to Electromagnetic Compatibility and repealing Directive 89/336/EEC
- Directive 98/37/EC of the European Parliament and of the Council of June 22nd, 1998 on the approximation of the laws of the Member States relating to Machinery and its modification
- Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys
- Council Directive 93/42/EEC of 14 June 1993, Council Directive 90/385/EEC of 20 June 1990, Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998: “Medical Directives”
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
- Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
- Council Directive 2004/22/EC related to Measuring Instruments
- Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment (RoHS Directive)
- Commission Decision 2005/618/EC of 18 August 2005 amending Directive 2002/95/EC of the European Parliament and of the Council for the purpose of establishing the maximum concentration values for certain hazardous substances in electrical and electronic equipment (notified under document number C(2005) 3143).
- Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000, on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors
- Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community Eco-label award scheme.
Relevant European Standards:
EN 45000 series, EN ISO/IEC 17025, EN-ISO 15189, EN ISO/IEC 17011, EN ISO 14001:2004, EN ISO 9001:2000, EN ISO 13485, OHSAS 18001, EN ISO 19011:2002, ISO 22000, HACCP, ISO 22003, IEC 62321
3.2 Linked activities:
All national bodies, selected to participate in the present project, were beneficiary of one Twinning projects under Phare programme Phare 2001 Project PL01.02.01: PL2001/IB/EC/03), which supported these institutions in their preparation to join the European structures of the standardisation and accreditation and to prepare the designed bodies to their notification.
3.3 Results:
- The institutional and operational capacities of the beneficiaries increased;
- The knowledge in the selected European Directives up-dated;
- The competences reinforced in the area of accreditation, standardization, testing, certification and conformity assessment.
3.4 Activities:
A. Assistance to the Notified Body
Activity A.1 : Assistance in the implementation of the 2006/42/EC Machinery Directive
- Organisation of trainings (4 trainings x 1 day x 1 expert) for national producers and suppliers of machinery and of safety components as well as for representatives of the interested parties (e.g. Ministry of Economy, Market surveillance organisation as National Labour Inspectorate) about new requirements of 2006/42/CE Machinery Directive.
- Elaboration of a guide and leaflets for Polish manufacturers and suppliers related to putting on the market machines and safety elements according to 2006/42/CE Directive requirements. (1 expert x 2 day x 2 missions)
Result: A group of 30 participants trained during each training. Polish manufacturers are aware of the new EU requirements concerning machines.
Activity A.2 : Tests of Toys and Medical Devices
Expert’s analysis concerning comparison of testing practices in the field of Toys Directive (chemical, mechanical, physical, electrical tests) with an European laboratory (3 missions x 2 days x 1 expert) and comparison of testing practices in the field of selected medical devices (mechanical and electrical tests) according to 3 Medical Devices Directives: 93/42/EEC, 98/79/EC and 90/385/EEC (2 missions x 2 days x 1 expert).
Results: improved proficiency of PCBC’s laboratory; expert’s report elaborated.
Activity A. 3: Chemical tests according to RoHS Directive
- Training for the PCBC’s laboratory staff on the basic rules of the RoHS Directive and on specific aspects related to the six substances of the RoHS Directive (1 expert x 2 days x 3 missions)
- Study visit (2 WD x 2 persons) for the chemical laboratory staff in the EU homologue laboratory performing the same kind of tests (2 persons x 4 PD + APEX ticket)
- Results: new competencies for chemical laboratory gained in the field of the new European regulation (The ROHS directive is mandatory in Poland starting from 1 of July 2006); Polish enterprises able to demonstrate their conformity to the ROHS directive via test reports
Activity A.4 : Assistance concerning the presentation of the notified body within MI Directive (2004/22/EC Measuring Instruments Directive)
- Training for PCBC’s staff on the requirements of the 2004/22/EC Directive and the presentation of notified body activities (1 expert x 2 missions x 2 days)
- Results: Knowledge of the Directive upgraded. Preparation for the future implementation of the Directive.
Activity A. 5 : Support in the field of EU Ecolabel
- Organisation of the seminar improving the understanding of Ecolabel rules, assessment procedures and the organization of the administrative management by a “competent body” (1 expert x 2days x 1 mission for 10 persons from PCBC’s staff)
- Promotion of the European Ecolabel in Poland through the assistance including preparation of documentation (“application packs”) for Polish firms in some selected sectors in view of obtaining EU Ecolabel (2 experts x 2 days x 3 missions)
- Results: Polish firms able to apply for European Ecolabel; PCBC’s staff trained on best competent body practices
Activity A.6 : Assistance for up-dating the knowledge concerning EMC and Medical Devices directives
- Technical assistance in PCBC’s premises to discuss current problems related to the implementation of EMC Directive and 3 Medical Devices Directives (93/42/EEC, 98/79/EC, 90/385/EEC directives, standards interpretation, solving EMC problems at the stage of product’s conception) (3 missions x 1 expert x 2 days for EMC directive; 2 missions x 1 expert x 2 days for 3 Medical Devices Directives)
Results:
- Competence for solving problems encountered in daily practice of the „new” notified body since the 1 May 2004 gained by the PCBC staff; expert’s report elaborated;
Activity A.7: Assistance for the application of ISO 22 000 standard
- Training in the field of ISO 22 000 and ISO 22 003 Standards. (1 expert x 3 days x 1 mission)
- Result: PCBC able to provide ISO 22 000 certification to Polish firms willing to go beyond of HACCP rules. The level of alimentary security in Poland improved. The training on ISO 22 003 standard will reinforce the reliability of PCBC’s certification process according to European practices.
Activity A.8 : New technical expertise capabilities
- Assistance of a EU expert in order to present the methodology of the preparation of the technical security reports for market surveillance authorities. (1 expert x 2 days).
- Result: PCBC’s staff able to give professional support to polish market surveillance authorities; expert’s mission report elaborated.
Estimated budget Activity A: 135 269 €
B. Assistance to Accreditation Body (PCA)
Activity B.1 : Principles of management system and products certification bodies according to 4 new accreditation programs responding to European requirements
B.1.1: Training sessions (4 trainings x 2 working days x 1 expert) dedicated to :
- accreditation of information safety management system certification bodies (ISMS);
- accreditation of green house gases verifiers (GHG);
- accreditation of food safety management system certification bodies (FSMS) – HACCP, ISO 22000, ISO 22003.
- accreditation of medical laboratories (EN-ISO 15189).
Content of these 4 trainings :
- theoretical training complying with standard requirements, union regulations and assessment procedure ;
- methods for development of process documentation;
- criteria and principles of audit team selection.
Results: Obtaining of competence of PCA personnel to accreditation in specific fields. Theoretical and practical preparation to perform accreditation processes. Preparation for development of new accreditation programmes.
B. 1.2: Elaboration of a guide for assessors of Accreditation Body and medical laboratories concerning the particular requirements of the standard for the accreditation of medical laboratories (EN-ISO 15189) (3 missions x 2 working days x 1 expert)
Results: Polish Accreditation Body and medical laboratories will obtain a practical tool helping them to accredit and to be accredited to in this specific area of accreditation
B. 1.3: 4 study visits x 2 working days x 1 Polish expert in the European accreditation
body (4 x 4 PD+ APEX ticket): process witnessing, process documentation principles
of audit team selection
Activity B.2: Principles of notification bodies’ assessment to 3 selected directives according to accreditation requirements – theoretical and practical aspects.
B. 2.1: Training sessions ( 3 training sessions x 2 working days x 1 expert) dedicated to:
- Machinery directive 2006/42/EC published on 9 June 2006.
- Electromagnetic compatibility – 2004/108/EC;
- Noise – Directive 2000/14/EC
Content of these 3 trainings:
a) theoretical training complying with directive and assessment procedure ;
b) activity principles of notified bodies;
c) the role of accreditation body in assessment of notified bodies;
d) documentation of notified body related to accreditation and notification;
e) competence of personnel of notified body – especially accreditation aspects;
Results: Technical competence of PCA for assessment of bodies in the field of directives improved. Understanding by PCA personnel procedure for assessment of notified bodies in specific fields increased. PCA personnel prepared for future activity in these regulatory areas.
B. 2.2: 3 study visit x 3 working days for 1 Polish expert in the European accreditation body (3 x 5 PD+ APEX ticket): process witnessing, process documentation principles of audit team selection
Estimated budget Activity B: 46 340 €
C. Assistance to Standardization Body (PKN)
Activity C. 1 : Awareness campaign to promote the involvement of the SMEs in the standardization works at the national and European levels
- Organization of seminars ( 5 seminars x 1 working day x 2 experts) in several cities of Poland (out of Warsaw) for small and medium enterprises with the participation of Regional Chambers on Industry and Commerce and other industry associations in the aim to promote the participation of the industry in the standardization works. Western European entrepreneurs involved in standardization are welcomed to share their experience with Polish participants. (A group up to 50 participants during each meeting).
Results: Polish industry and enterprise representatives having knowledge and understanding of standardization as a support for their business strategy (benefits of standardization). More stakeholders involved in standardization work.
Activity C. 2: Assistance to PKN related to the modification of its functioning and status
- Organization of expert visits to PKN (4 missions x 2 days x 1 expert) in the field of finance planning and financial status of private non-profit association in order to exchange experience concerning its structure and organization, to be acquainted with the law system as well as to discuss about its activities and the support from public authorities. Experts hosting financial directors functions are invited.