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1 Info 15:2 TRAINING 2015/2016 Info 13:19 1

2 2 Info 13:19

3 S WELCOME TO SWEDAC ACADEMY... 4 TRAINING PROGRAM AND COURSES 2015/ HOW TO RUN AN ACCREDITATION BODY ISO/IEC LEAD ASSESSOR TRAINING ISO/IEC LABORATORIES COMBINED ASSESSOR TRAINING ISO/IEC 17025, ISO 15189, ISO/IEC 17020, INTRODUCTION TO ISO/IEC ACCREDITATION OF LABORATORIES ISO/IEC ACCREDITATION OF MEDICAL LABORATORIES ISO ACCREDITATION OF MEDICAL LABORATORIES ISO SHORT VERSION ACCREDITATION OF PROFICIENCY TESTING PROVIDERS ISO/IEC ACCREDITATION OF INSPECTION BODIES ISO/IEC ACCREDITATION OF CERTIFICATION BODIES ISO/IEC MANAGEMENT SYSTEMS ACCREDITATION OF CERTIFICATION BODIES ISO/IEC PRODUCTS ACCREDITATION OF CERTIFICATION BODIES ISO/IEC PERSONS INTERNAL AUDIT LABORATORIES / INSPECTION BODIES INTRODUCTION TO QUALITY INFRASTRUCTURE ACCREDITATION, MARKET SURVEILLANCE AND METROLOGY TERMS AND CONDITIONS BOOKING Info 15:2 3

4 WELCOME TO SWEDAC ACADEMY fruits ensure and nourish the safety and quality of products and services in an international system and contribute to global free trade in a sustainable society. The strength in Swedac s expertise and knowledge base is its involvement in a multitude of the stages of a product s or service s lifetime. Our expertise takes us from EU common market issues to drafting legislation on measuring instruments and on conformity assessment to accreditation and to the coordination of Swedish market surveillance. Our existence in all of these arenas makes us a unique body in the Swedish quality infrastructure. A major assignment allocated to Swedac by the Swedish legislation is the role as training and knowledge provider nationally and internationally. Through its legal instructions Swedac is also requested by the Swedish government to participate in international development cooperation. Swedac Academy will provide you with all facets of our expertise and know-how through off-theshelf or customized training and bench-marking programmes. We are proud to invite you to Swedac Academy, our new service concept for training and bench-marking in the areas of our core expertise. Swedac Academy represents the sum of knowledge base in Swedac and creates a platform where we can cooperate with other Swedish authorities and institutions in disseminating knowledge and experience on the Swedish outlook on quality infrastructure. Swedac s tree of life has its roots in European and Swedish legislation, international standards and active cooperation within EA, ILAC and IAF. Its We look forward to hearing from you with your needs, questions and ideas and will be honoured to provide our services. This catalogue provides an overview of the courses and programmes available for institutions and groups which may be interested in increasing their knowledge within the expert areas of Swedac. Merih Malmqvist Nilsson 4 Info 15:2

5 WHY TRAIN WITH US? Swedac s training programs and courses are led by recognized Swedac experts in their fields; all with current experience offering a first-class learning experience. They are trained to understand and meet your different learning needs, and they have many years of training experience. Within our training courses we use different learning techniques to help you progress as much as possible. We encourage interaction and collaboration because the more involved you are, the more positive the outcome. We also keep the courses varied and put your learning in context to give you an enjoyable, successful and satisfying experience. Courses will be held in English. With over 20 years of experience working internationally, Swedac has spread knowledge on conformity assessment in open systems to ensure harmonization and to facilitate the circulation of safe products and services in world trade without barriers. Providing international training programs and courses is part of Swedac s goal to support open systems for conformity assessment worldwide and especially in developing economies as it will increase trade and economic growth. The International Secretariat is responsible for Swedac s international work and contacts, under the leadership of Merih Malmqvist Nilsson. From the left Marianne Edman Falkensson, Viktoria Lindberg Martinell, Annica Poppius, Per Lundmark and Merih Malmqvist Nilsson. Info 15:2 5

6 Swedac can customise training programmes or courses to your needs and we also offer study visits and coaching in our fields of expertise. SWEDAC s CORE COMPETENCE Swedac offers training in the following areas: International agreements and relations in the area of conformity assessment and accreditation Quality infrastructure development Drafting and implementing legislation for accreditation, conformity assessment and legal metrology Accreditation of Laboratories Certification bodies Inspection bodies Bodies for validation and verification Providers of proficiency testing schemes Producers of reference materials. Assessment of notified bodies Training of technical/lead assessors Coordination of national market surveillance among regulators Market surveillance within the areas of legal metrology and hallmarking of precious metals TAILOR-MADE TRAINING Swedac offers you the possibility to tailor your own training according to your personal and organizational needs. We can adapt the trainings, remove parts or make additions to already offered courses. We can also offer courses for groups from the same organization or country and decide course venue where most convenient for you. It is also a possibility to deliver distance learning or coaching. Please contact Swedac Academy for an offer for your tailor-made course. Swedac has provided training and courses for national and international customers for many years. Swedac Academy is our concept for offering you our know-how and an exchange of experiences. 6 Info 15:2

7 TRAINING PROGRAM AND COURSES 2015/ HOW TO RUN AN ACCREDITATION BODY ISO/IEC Introduction and background How to fulfil the requirements on impartiality and independence What does it mean to be accountable and transparant Confidentiality Management of the present and the future Competence Diligence How to become a signatory to mutual recognition agreements COURSE This is an advanced training for accreditation organisations wishing to improve their performance and achieve a deeper knowledge of all the requirements on an accreditation body, including the ISO/ IEC 17011, MLA/MRA requirements of EA/ILAC/ IAF, and local requirements. Your aim should be to develop your organisation and increase your efficiency, and become an internationally acknowledged accreditation body. TARGET GROUP Persons working for accreditation bodies or who are involved in developing accreditation bodies. The course will be given in a combination of lectures, case studies and workshops. 3 days SEK per person Info 15:2 7

8 2. LEAD ASSESSOR TRAINING ISO/IEC LABORATORIES Preparation of assessments Planning assessments Different kinds of assessments Building assessment teams Behaviour and listening skills Leading a closing meeting 4 days SEK per person COURSE This is an advanced training for assessors with previous experience from assessment. This training is based on knowledge of conformity assessment standards for accreditation and can be combined with other trainings on ISO/IEC 17025, ISO/IEC or ISO Your aim should be to become a Lead assessor. The target group for this course is persons with skills or willing to improve their skills in leadership of an assessment team including technical assessors. The goal is to reach raised awareness on how to lead an assessment and the various challenges connected with that task. You will also train your listening skills and your ability to communicate with your customer. TARGET GROUP Persons working for accreditation bodies or who will be involved in establishing or developing an accreditation body. The course will be given in a combination of lectures, case studies, workshops and a final role play. 8 Info 15:2

9 3. COMBINED ASSESSOR TRAINING ISO/IEC ISO 15189, ISO/IEC INTRODUCTION TO ISO/IEC PART 1 Requirements in ISO/IEC Preparation of assessments Planning assessments Different kinds of assessments Building assessment teams Behaviour and listening skills Closing meeting PART 2 Requirements in ISO or, Requirements in ISO/IEC PART 3 Introduction to accreditation of certification bodies ISO/IEC management systems 5 days SEK per person COURSE This is an advanced training for assessors with limited experience of assessment. Your aim should be to become a lead assessor or technical assessor. This training is based on knowledge of conformity assessment standards for accreditation. The training also provides you with a basic knowledge of requirements for certification bodies. The goal is to reach a deeper knowledge of the standard ISO/IEC and also to learn more on one additional standard, i.e. ISO or ISO/IEC One part of the training covers an introduction to certification of management systems and the requirements in ISO/IEC The target group for this course is persons with skills or willing to improve their skills in doing assessments. The goal is to reach raised awareness on how to perform an assessment and the various challenges connected with that task. You will also train your listening skills and your ability to communicate with your customer. TARGET GROUP Persons who want to become lead assessors or technical assessors for accreditation bodies. The course will be given in a combination of lectures, case studies, workshops and role play. Info 15:2 9

10 4. ACCREDITATION OF LABORATORIES ISO/IEC Deeper knowledge of ISO/IEC Non-conformance or not? Calibration, traceability and uncertainty of measurement Monitoring and witnessing Internal audit and managements review The human factor in assessments Assessment reporting Flexible scope COURSE This is a training course for persons who will work with assessments of laboratories with scopes in testing and/or calibration. The goal is to reach a deeper knowledge of the standard ISO/IEC in general and to understand the requirements of the standard. TARGET GROUP Persons with earlier experience of laboratory services who want to develop their skills in assessment in this particular area to become a technical assessor. In addition you need to have senior skills and knowledge in different technical laboratory areas. The course will be given in a combination of lectures, case studies, workshops and role play. 3 days SEK per person 10 Info 15:2

11 5. ACCREDITATION OF MEDICAL LABORATORIES ISO Deeper knowledge in ISO Non-conformance or not? Calibration and traceability Quality indicators and quality control Quality assurance and witnessing Internal audit and management review Pre- and post-examination processes Laboratory information management The human factor in assessments Assessment reporting Closing meeting Flexible scope COURSE This is an advanced training for assessors who will perform assessment for accreditation of medical laboratories. The aim of the course is to reach a deeper knowledge of ISO You will study the role of accreditation and the processes of assessment for accreditation. TARGET GROUP Persons with limited experience of the standard ISO who will work as assessors of medical laboratories. The course will be given in a combination of lectures, case studies, workshops and a final realistic role play. 3 days SEK per person Info 15:2 11

12 6. ACCREDITATION OF MEDICAL LABORATORIES ISO SHORT VERSION Deeper knowledge in ISO Non-conformance or not? Quality indicators and quality control Quality assurance and witnessing Internal audit and managements review Pre- and post-examination processes Laboratory information management COURSE This is an advanced training for assessors who will perform assessment for accreditation of medical laboratories. The aim of the course is to reach a deeper knowledge of ISO You will study the role of accreditation and the processes of assessment for accreditation. TARGET GROUP Persons with earlier experience of assessment of ISO/IEC scopes, who want to become assessor of medical laboratories. The course will be given in a combination of lectures, case studies and workshops. 2 day SEK per person 12 Info 15:2

13 7. ACCREDITATION OF PROFICIENCY TESTING PROVIDERS ISO/IEC General PT review, principles Management requirements Technical requirements 2 days SEK per person COURSE Proficiency testing programs are important tools to develop confidence in testing, inspection and calibration. This course will give a deeper understanding of the requirements set out for accreditation of a proficiency testing provider. The course contains a review of the content of the standard ISO/IEC both from a management system view and from a technical perspective. TARGET GROUP AND PURPOSE Persons with earlier experience of assessment of ISO/IEC scopes who need an overview of statistical standards/schemes available in the area and how to develop a proficiency testing program. The course is based on lectures and practical examples from performed proficiency testing activities. Info 15:2 13

14 8. ACCREDITATION OF INSPECTION BODIES ISO/IEC Why inspection? General requirements Independence Structural requirements Resource requirements Process requirements Management system requirements COURSE This is an advanced training for assessors who will perform assessments for the accreditation of various types of inspection bodies. The aim of the course is to reach a deeper knowledge of the implementation of ISO/IEC TARGET GROUP Persons with earlier experience of assessment of ISO/IEC scopes or ISO/IEC It may be convenient to combine this course with the Lead assessor course. The course will be given in a combination of lectures, case studies and workshops. 2 days SEK per person 14 Info 15:2

15 9. ACCREDITATION OF CERTIFICATION BODIES ISO/IEC MANAGEMENT SYSTEMS Management system certification Requirements in ISO/IEC Principles General requirements Structural requirements Resource requirements Information requirements Process requirements Management system requirements Other documents ISO/IEC ISO/IEC series ISO/TS and relevant IAF MD and EA documents Management system certification at a certification body COURSE This is an advanced training for assessors for accreditation of certification bodies, certifying different management systems e.g. quality, environment, information security, food safety, energy and occupational health and safety. TARGET GROUP Persons working with certification in certification bodies, accreditation body personnel, or persons working in organisations applying for certification, who wish to extend their knowledge of the standard ISO/IEC The course will be given in a combination of lectures, case studies and workshops. 3 days SEK per person Info 15:2 15

16 10. ACCREDITATION OF CERTIFICATION BODIES ISO/IEC PRODUCTS Product certification Requirements in ISO/IEC17065 Principles General requirements Structural requirements Resource requirements Process requirements Management system requirements Other documents Guidance for drafting normative documents - ISO/IEC Certification scheme ISO/IEC Marks of conformity ISO/IEC EA documents Product certification at a certification body COURSE This is an advanced training for assessors for accreditation of certification bodies, certifying products, processes or services. TARGET GROUP Persons working with certification in certification bodies, accreditation body personnel, or persons working in organisations applying for certification, who wish to extend their knowledge of product, process and service certification, and the requirements and structure of the standard ISO/IEC The course will be given in a combination of lectures, case studies and workshops. 3 days SEK per person 16 Info 15:2

17 11. ACCREDITATION OF CERTIFICATION BODIES ISO/IEC PERSONS Certification of persons Requirements in ISO/IEC Principles General requirements Structural requirements Resource requirements Records and information requirements Certification scheme Certification process requirements Management system requirements Develop a scheme of persons Certification of persons at a certification body Examination process COURSE This is an advanced training for assessors for accreditation of certification bodies certifying persons. TARGET GROUP Persons working with certification in certification bodies, accreditation body personnel, or persons working in organisations applying for certification, who wish to extend their knowledge of accreditation, certification, the requirements and structure of the standard ISO/IEC The course will be given in a combination of lectures, case studies and workshops. 2 days SEK per person Info 15:2 17

18 12. INTERNAL AUDIT LABORATORIES / INSPECTION BODIES PART 1 Purpose and principles of internal audits Requirements and guidance documents for internal audits Human aspects and auditing technology Planning and implementation How to handle deviations Examples of problems, independent, regular flaws Cause Analysis, prevention and continuous improvement Documentation PART 2 Purpose and principles for management review Requirements and guidance documents for management review Planning and implementation Action plans and follow-up Examples of problems Documentation COURSE This is a course that aims to develop and provide an understanding of how internal audits and management review can be conducted in order to contribute to the improvement of processes and generate increased business value. TARGET GROUP This course is for accredited inspection bodies and laboratories which face the challenge of improving both auditing practices and management to a more value-creating level. The course is also a good start for you, whose activities relate to start the accreditation process, operations Staff (at different levels), quality managers, internal auditors and staff with similar tasks. The course will be given in a combination of lectures, practical section with detailed discussions concerning certain key areas. 2 days SEK per person 18 Info 15:2

19 13. INTRODUCTION TO QUALITY INFRASTRUCTURE ACCREDITATION, MARKET SURVEILLANCE AND METROLOGY What is a quality infrastructure? Benefits of a quality infrastructure The role of trade agreements Standards Background to accreditation Role of accreditation Introduction to market surveillance Introduction to metrology Scientific and legal metrology 4 days SEK per person COURSE This course gives you an introduction to the benefits of a well-functioning quality infrastructure, why a developed quality infrastructure is important and why it lays the foundation for the trust between countries that is needed for freer trade and sustainable development. Apart from training on the need for regulation and standardization, the training will focus on the role of accreditation, market surveillance and metrology in an open system. TARGET GROUP Persons who want to learn more about quality infrastructure in general, and to understand the role of accreditation, market surveillance and metrology in an open system. Persons working as government officials, and/ or persons involved in the process of developing the national quality infrastructure. The course will be given in a combination of lectures, case studies, workshops and a study visit at a relevant Swedish organisation. Improve Product quality Evolve to Export led growth Global Competitveness Facalitate Trade Spur Innovation Support Economic Diversification Enhance productivity Info 15:2 19

20 TERMS AND CONDITIONS BOOKING Booking is made by the booking form on our website. For more information, please Once we have processed your booking, we will send you a confirmation . If you have not received a confirmation within seven days, please contact us again by mail or telephone. S AND PAYMENT Payment shall be made to Swedac 30 days before the training is to take place. The course fees above are per person. Contact Swedac for more information about how to make the payment. If there are places available and the booking is made later than 30 days before the course starts the fee shall be paid immediately in order to secure a place. Training material, refreshments and lunches are included in the training fee. Costs for travel and accommodation are not included in the course fee and is booked individually by each participant. Swedac will assist in recommending suitable hotels close to the training facilities. CANCELLATION AND REFUNDS Swedac reserves the right to cancel a course up to 30 days prior to the course date, if there are too few participants. If the course is cancelled by Swedac a full refund will be made. A full refund of the fee will be made if the participant cancels the booking 30 days prior to the course starts. If the cancellation is made by the delegate later than 30 days before the course starts, 50 % of the paid fee will be refunded. However, no refund will be made if the cancellation is made less than seven days before the course starts. The notice of cancellations must be made in writing to 20 Info 15:2

21 BOOKING* Please fill in the booking form available on our website and we will get back to you as soon as possible. The reservation is not binding until you have paid the course fee. Personal details Title Surname Name Organisation Department division Position Address Telephone Other delegates Name Name Position Position Course details Course title/number Course date *Preferably filled in on our website. Info 15:2 21

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24 FACTS Swedac has, between , successfully completed 70 International Training Programmes, with 1750 participants from 90 countries. Swedac has in addition been involved in 49 international development projects as project leader or junior partner and received high appreciation. Swedac is a signatory to all international agreements of mutual recognition signed by members of EA (European co-operation for accreditation), IAF (International Accredita tion Forum) and ILAC (International Laboratory Accreditation Cooperation). Head Office Österlånggatan 5 Box 878, SE Borås Sweden Stockholm Office Gustavslundsvägen 151 E, 8th floor, Box 733, SE Bromma Sweden

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