Training course and workshop on accreditation for Appliances Burning Gaseous Fuel Regulation (GAR) –(EU) 2016/426
The purpose of the training was to cover Regulation (EU) 2016/426 which sets out the essential requirements that must be met before appliances or fittings burning gaseous fuels can be place into the EU Market.
The training consisted of a detailed review of the Regulation and the application of ISO/IEC 17065 when assessing against the requirements of the regulation.
The training covered:
- Background surrounding the standard, how it came into being and the transition from the Gas Appliance Directive (GAD) to the GAR.
- The scope of the Regulation was reviewed and the use of harmonised standards and the applicability of other Regulations were also covered.
- The Articles covering the obligations of parties involved within the Regulation were detailed.
- The Annexes of the GAR were covered with specific detail covering the Essential Requirements and the different types of conformity assessments were also reviewed.
- Qualifications of the assessment team
- Managing impartiality
- Resource requirements
- Management requirements
- Areas to consider when assessing against Annex I (ER) and Annex III (Assessment of Conformity)
- A Test of Understanding (TOU) was then undertaken to assess the knowledge of the participants covering the Regulation.
The workshop consisted of the participants undertaking a range of group exercises, thus providing them with an opportunity to apply their knowledge and understanding to a range of scenarios. The scenarios covered the GAR and the application of ISO/IEC 17065 across the following areas:
- Management of impartiality
- Resource requirements
- Process requirements
Training course and workshop on accreditation for Transportable Pressure Equipment Directive -2010/35/EU
The training course focused on how the Transportable Pressure Equipment Directive (TPED) works to link to the gases specific parts of ADR and with the caveat that there are some areas of TPED that are not in ADR at all – conformity marking and re-assessment of conformity.
There was a strong emphasis on the difficulties in adjudging competency as these varied widely across the Directive scope.
Another major point was that this Directive is through life and not just the placing on the market and as such the diversity in thought required is greatly extended.
The workshop was specifically designed to further push the main difficulties with the Directive and to allow participants to practice the lessons from the 2 days training. There were three case studies to assess and the covered the periodic examination of a road tanker, a receptacle test house and the reassessment of conformity of a complex composite receptacle. Within each case study a number of issues were addressed and allowed some discussion to develop.
Training course and workshop on accreditation to Cableway Installations Regulation (EU) 2016/424
The training went through the Cableway Installations Regulation accreditation scheme and guidelines and included as well some examples of daily business of Austrian Notified Body. The following topics were dealt with:
- Technical Introduction Cableways: Types, designs, modes of operation
- Cableways and the Cableways Regulation (EU) 2016/424
- (EU) 2016/424: Essential requirements and relevant harmonized standards
- Modules of conformity assessment according to (EU) 2016/424
- Requirements for national accreditation bodies (NAB=TURKAK) and for conformity assessment bodies (CAB)
- Accreditation of CABs – general procedure and the most important points regarding (EU) 2016/424
- CAB/NB certification programme for ropeway subsystems/safety-components (requirements of EN 17065, 17025)
- Special features of the certification programme for ropeway components: Various subsystems, various modules, on-site acceptance, quality assurance, document review, manufacturing inspection (from the perspective of the NAB and the CAB)
- Best practice:
Example of the certification process of a manufacturer’s subsystem: from the examination of the documentation to the acceptance of the subsystem on site – documentation of the results, correspondence with the customer, issue of the certificates
The workshop dealt with 2 different scenarios. On the one hand, a certification scheme for conformity assessment was to be elaborated, on the other hand, a checklist for the acceptance and inspection of a subsystem/safety component on site at a plant. Both tasks were set in such a way that they had to be processed from the point of view of an accreditation body and a notified body respectively.
Training course and workshop on accreditation for Point of Carte Testing (POCT)
The 2 days trainings were focused on:
Application of ISO 22870 and related guidance documents
- EA, ILAC, IAF considerations
- Other ISO publications
ISO 22870 and its relationship with ISO 15189
- Why do we need ISO 22870?
- Definitions of POCT
- What isn’t POCT?
Management system key requirements
- To include responsibilities and legal entities
- Management groups
- Technical issues
- Common pitfalls
Competencies required to suitably assess a POCT service
Constitution of a competent assessment team
The workshop consisted of 2 case studies – 1) Implementation of New Devices and Gap Analysis. The aim of this exercise is to gain an insight in the planning and implementing of a PoCT service. Being informed in the awareness of where risks and critically lie will provide greater assurance for the assessors to manage the conformity and increase assurance in released results and 2) Critical discussion of specific 22870/15189 Clauses.
Training course and workshop on the assessment of the assessment of Laboratory Information Management Systems (LIMS)
The 2 days training addressed the compliance and assessment and laboratory information management systems of laboratories, main focus on the computerized systems. The first training day concentrated on describing the LIMS applications and possible solutions, when the second day concentrated on the compliance, management and assessment of these systems. The training included the following information:
- What is a LIMS and what technical options and possible functionalities are available in the market, including latest developments in the area?
- ISO Standards, guides and other requirements, such as EU regulations, related to LIMS
- Management and validation of LIMS including the differences on how to approach commercial applications versus in-house produced applications
- Data integrity in computerized and non-computerized information management systems
- Information security of these systems and real-life examples of pitfalls
- Assessment of laboratories using these systems with suggestions on assessor competence requirements
The workshop consisted of four case studies covering the main types of LIMS conformity assessment situations that the participants could come across in a real-life laboratory assessment. At the end of the workshop day, after all four case studies a comprehensive list of questions and important topics for LIMS assessment was achieved. TÜRKAK can develop the list as a checklist for the future real-life LIMS assessments.
Training course and workshop on accreditation of conformity assessment bodies for Certification for Service Management Systems to ISO/IEC 20000-1 and ISO/IEC 20000-6
The training went through the ISO/IEC 20000 accreditation process, provided guidelines and included the details of:
- Principles and concepts of service management
- Past, present and future of the ISO/IEC 20000 series
- Scoping and applicability of a service management system
- All the relevant conformity assessment aspects to be considered
- The use of the corresponding tables (CT) for calculating audit time, increasing and decreasing factors
- The presumption of conformity and the responsibility of the NB to ensure those essential are met when not covered by the harmonised standard or normative document
The workshop consisted of three case studies based on real service management accreditation assessments and gave the delegates an opportunity to explore the Normative Document (ND) and Corresponding Tables (CT) for themselves. The delegates were divided into 3 groups and after each scenario one group presented their views which were commented on by another group and the ensuing discussions clarified any other point raised
Training course and workshop on accreditation to Explosives for Civil Uses 2014/28/EU
The scope of the 2 days training was:
- Aims & Objectives of the module
- Explosives for Civil Uses Directive 2014/28/EU (Recast) overview, structure, Accreditation Scheme and Guidelines, including possible scopes of accreditation
- Conformity assessments and product certification – applicability of the Accreditation Scheme
- Requirements of personnel and technical expertise
- Requirements for Notification Bodies (NB) assessing product certification and declaration of manufacturer’ conformity
- Explosive Directive accreditation process, aligned with the requirements of ISO17065, process requirements, complaints and appeals
- Obligations of the NB to the Notifying Authority
- Understanding the use of the Guidelines and Module selection.
The workshop consisted in practical exercises. 4 working groups were created with varied members in each group, made up from personnel from TURKAK, staff involved in manufacture and Chemical Engineering, including delegates responsible for their organisations Quality management Systems (QMS).
- Practical Exercise for Management of Impartiality
- Practical Exercise in Resource Requirements for conducting conformity Assessment of Explosives for Civil Uses Directive 2014/28/EU
- Practical Exercise for scope versus product, process and service selection regarding emulsion explosive manufacture, module selection and NB resourcing requirements
Training course and workshop on assessment and accreditation of laboratories for the Construction Products Regulation – 305/2011/EU
The 2 days training included the following specific topics from the perspective of CE marking of construction products:
- For Assessment and Verification of Constancy of Performance, (AVCP) System 1+ and 1, how to assess the competence and other aspects of the laboratories that conduct the type tests of the products and routine tests and how these aspects affect product certification.
- For AVCP System 2+, how to assess the competence and other aspects of the laboratories that conduct the routine tests for factory production control (FPC) and how these aspects affect product certification.
- How to assess manufacturer’s laboratories during the assessment of the NB. Most of the time tests are performed by manufacturer’s laboratories. These laboratories need to be audited by Notified Bodies whether responsibility of testing lies within Notified Body or manufacturer according to the regulation.
- Even though the competence of the laboratories must be verified by the Notified body, there is a need to understand what to expect from NBs and laboratories under accreditation rules.
- For AVCP System 3, whole field must be under the scope of training. Specific product examples may be introduced such as fire endurance and resistance tests for doors/windows.
- Besides 305/2011 EU Regulation, Commission guides must be the topic of training, and last but not least GNB Position Papers (not all of them but the most relevant ones) must also be a main topic of the training.
The workshop covered two accreditation case studies to be undertaken by participants (certification of cement and testing of aggregates) and introduced the knowledge test for participants.
Training course and workshop on accreditation of conformity assessment bodies for Recreational Craft and Personal Watercraft
The training went through the Recreational Craft and Personal Watercraft Directive requirements, TURKAK Accreditation Scheme (TAS-RCD) and TURKAK Guideline for Assessors (TGfA-RCD) providing information about:
- Scope of Recreational Craft and Personal Watercraft Directive,
- Essential Requirements,
- Modules and their Recreational Craft and Personal Watercraft Directive – specific application,
- Risk-based approach to Recreational Craft and Personal Watercraft Directive products and assessment procedures,
- Guidance for witness and on-site audits by TURKAK.
Based on the intensive training the participants got a complete overview over the Recreational Craft and Personal Watercraft Directive, especially how to apply the foreseen modules specific to the different products of Recreational Craft and Personal Watercraft Directive, an inside view on key items for the assessment of the different products and in particular for the module PCA (Post Construction Assessment), being a unique module under Recreational Craft and Personal Watercraft Directive.
During the case studies on day 3 the participants received in depth knowledge about the assessment by CAB’s working under Recreational Craft and Personal Watercraft Directive. The breakout sessions brought up fruitful discussions for future TURKAK accreditation processes.
Overall, the three day training granted a solid basis for TURKAK for future activities under Recreational Craft and Personal Watercraft Directive. In addition it brought transparency about the processes for the participating representative from the only CAB under Recreational Craft and Personal Watercraft Directive in Turkey.
Training course and workshop on accreditation to ISO 20387:2018 – General Requirements for Biobanking
The trainer went through the accreditation scheme, guidelines and the ISO 20387 included the details of:
- General requirements of biobanking activities (normative and informative) ISO 20387
- General information of the technical report – implementation guide ISO 22758 :2020
- General information about practical implementation strategies, applicable documented information examples and best practices
- Question and Answer sequences
The workshop consisted of four biobank use cases, covering the main types of biobanking activities and conformity assessment procedures, and gave delegates the opportunity to explore and discuss the ND and its practical implementation and subsequent accreditation scenarios for themselves
Training course and workshop on accreditation of conformity assessment bodies for Interoperability of the Rail System
The training and workshop were delivered remote with a total of 28 participants consisting of Turkak staff, Turkak Assessors and Technical Experts and representatives from CABs, public institutions and the private sector involved in the accreditation of CABs to the Interoperability of the Rail System Directive 2016/797/EU.
The training and workshop went through the IOD accreditation scheme and guidelines and included the details of:
- Introduction of the railways and the EU rail system
- The Rail Interoperability Directive – 2016/797/EU (IOD)
- The IOD Notified Bodies
- The IOD Scheme Stakeholders; what TURKAK needs to do
- TURKAK Team Requirements; IOD Assessment Application and Planning
- TURKAK IOD Office Assessment
- TURKAK IOD Witness Assessment, Surveillance, Re-assessment and Scope Extension.
The workshop was planned as four review and discussion exercises:
- Exercise 1 –Planning of the IOD NoBos
- Exercise 2 –Design and Type Examination work of the IOD NoBos
- Exercise 3 –QMS Manufacturing Assessment of the IOD NoBos
- Exercise 4 –Certification of the subsystems and constituents by the IOD NoBos
Training course and workshop on accreditation of conformity assessment bodies for Pressure Equipment Directive (2014/68/EU)
The training and workshop took place via Zoom with a total of 36 participants consisting of Turkak staff, Turkak Assessors and Technical Experts and representatives from CABs, public institutions and the private sector.
The training and workshop were designed to enhance the delegates’ awareness of both the Pressure Equipment Directive (PED) itself and the new PED Conformity Assessment Bodies (CAB) accreditation scheme and guideline.
The training was focused on an overview of the PED and the key points as:
- Equipment classification,
- Conformity assessment activities,
- Essential Safety Requirement (ESRs),
- The role of Harmonized Standard (HAS).
- And important elements from the scheme and guideline, in particular office and witness assessment phases.
Training course and workshop on accreditation of conformity assessment bodies for Measuring Instruments Directive (2014/32/EU)
The training and workshop were delivered remote with a total of 34 participants consisting of Turkak staff, Turkak Assessors and Technical Experts and representatives from CABs, public institutions and the private sector involved in the accreditation of CABs to the Measuring Instrument Directive 2014/32/EU.
The training and workshop went through the MID accreditation scheme and guidelines and included the details of:
- The scope of the MID and the optionality clause
- All the relevant conformity assessment procedures for each type of measuring instrument
- The general essential requirements and the specific essential requirements for each instrument
- The harmonized standards (HS) and normative documents (ND) that relate to each type of instrument
- The use of the corresponding tables (CT) for each of the normative documents to determine for which essential requirements the presumption of conformity can be given and to highlight the essential requirements not covered by the HS or ND
- The presumption of conformity and the responsibility of the NB to ensure those essential are met when not covered by the harmonised standard or normative document.
Training course and workshop on accreditation of conformity assessment bodies for Machinery Directive 2006/42/EC.
This was the first remote training provided for 30 participants including TURKAK assessment staff, technical experts of Notified Bodies, standards and manufacturer staff delivered from 23 – 25 June 2020.
The aim was to provide an understanding of the ISO 17065 accreditation scheme and how it should be applied in assessment of Turkish Notified Bodies, plus general understanding of how Machinery Directive works in practice.
Accreditation of conformity assessment bodies for Directive 2014/34/EU – Equipment and Protective Systems for use in potentially explosive atmospheres (recast).
The training and workshop took place in the Anadolu Hotel Downtown, Ankara from 25th to 27th February 2020. The aim of the sessions was to increase and harmonize the knowledge and awareness of the participants on the Directive 2014/34/EU. The activity provided the participants with general knowledge on the ATEX legislation and the safety concepts of explosion protection. It also gave an excellent opportunity to further enhance the accreditation procedure for ATEX Notified Bodies.
30 participants from TÜRKAK personnel, assessors from TÜRKAK, experts from Turkish ATEX Notified Bodies and Turkish industry participated in the training and workshop.
The workshop has involved experts from industry, with the intention to gain confidence in the accreditation procedures of TÜRKAK, to foster the communication between TÜRKAK and industry and help them bring the different perspectives of the stakeholders together. At the end of the workshop, the participants agreed to form a permanent working group consisting of TÜRKAK assessors and experts from industry, to keep the communication and experience exchange alive between TÜRKAK assessors, Turkish ATEX Notified Body staff and experts from industry. The name of this expert board is “ATEX Council Turkey”. This will ensure that the communication between Turkish ATEX experts, independent of their origin, can take place in a structured manner.
Accreditation to ICAO CORSIA scheme
The first training was on accreditation to the ICAO CORSIA scheme and took place on 6th and 7th January 2020 in the Hotel Wyndham in Ankara. The workshop took place on 8th January 2020.
The training provided in-depth knowledge on CORSIA as well as on the CORSIA accreditation and verification requirements. The workshop on the third day facilitated the implementation of some of the newly acquired knowledge on the ICAO CORSIA scheme.
A general understanding of the main CORSIA provisions, the current status of the CORSIA implementation in Turkey and in the European Union was explained and discussed.
A total of 27 participants from TURKAK personnel, assessors, technical experts in the accreditation of conformity assessment bodies and employees of public and private institutions participated in the training and the workshop.
An examination was prepared to measure the level of knowledge of the participants. Throughout, the results were positive reflecting that all participants have managed to build up a reliable knowledge on CORSIA and the CORSIA specific accreditation and verification requirements.