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TRAINING 2015/2016
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CONTENTS
WELCOME TO SWEDAC ACADEMY .......................................................................... 4
TRAINING PROGRAM AND COURSES 2015/2016 ..................................................... 7
1. HOW TO RUN AN ACCREDITATION BODY – ISO/IEC 17011 ...................................................... 7
2. LEAD ASSESSOR TRAINING – ISO/IEC 17025 LABORATORIES .............................................. 8
3. COMBINED ASSESSOR TRAINING – ISO/IEC 17025, ISO 15189, ISO/IEC 17020,
INTRODUCTION TO ISO/IEC 17021-1 ............................................................................................... 9
4. ACCREDITATION OF LABORATORIES – ISO/IEC 17025 ........................................................ 10
5. ACCREDITATION OF MEDICAL LABORATORIES – ISO 15189 ................................................ 11
6. ACCREDITATION OF MEDICAL LABORATORIES – ISO 15189 SHORT VERSION ................. 12
7. ACCREDITATION OF PROFICIENCY TESTING PROVIDERS – ISO/IEC 17043 ...................... 13
8. ACCREDITATION OF INSPECTION BODIES – ISO/IEC 17020 ................................................. 14
9. ACCREDITATION OF CERTIFICATION BODIES – ISO/IEC 17021 MANAGEMENT SYSTEMS .. 15
10. ACCREDITATION OF CERTIFICATION BODIES – ISO/IEC 17065 PRODUCTS ..................... 16
11. ACCREDITATION OF CERTIFICATION BODIES – ISO/IEC 17024 PERSONS ....................... 17
12. INTERNAL AUDIT – LABORATORIES / INSPECTION BODIES ............................................... 18
13. INTRODUCTION TO QUALITY INFRASTRUCTURE – ACCREDITATION, MARKET
SURVEILLANCE AND METROLOGY ................................................................................................. 19
TERMS AND CONDITIONS ....................................................................................... 20
BOOKING ............................................................................................................... 21
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WELCOME TO SWEDAC ACADEMY
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 insti-tutions 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
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 legis-lation 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 internation-ally. 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-the-shelf or customized training and bench-marking programmes.
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
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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 inter-nationally, 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.
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SWEDAC’s CORE COMPETENCESwedac 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 organiza-tional 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.
Swedac can customise training programmes or
courses to your needs and we also offer study visits
and coaching in our fields of expertise.
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1. HOW TO RUN AN ACCREDITATION BODY ISO/IEC 17011
CONTENT• 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
DURATION3 days
FEE17 500 SEK per person
COURSE CONTENTThis is an advanced training for accreditation organi-sations wishing to improve their performance and achieve a deeper knowledge of all the require-ments 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 effi-ciency, and become an internationally acknowledged accreditation body.
TARGET GROUPPersons 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.
TRAINING PROGRAM AND COURSES 2015/2016
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2. LEAD ASSESSOR TRAININGISO/IEC 17025 LABORATORIES
CONTENT• Preparation of assessments• Planning assessments• Different kinds of assessments• Building assessment teams• Behaviour and listening skills• Leading a closing meeting
DURATION4 days
FEE21 000 SEK per person
COURSE CONTENTThis 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 17020 or ISO 15189. 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 GROUPPersons working for accreditation bodies or who will be involved in establishing or developing an accredi-tation body.
The course will be given in a combination of lectures, case studies, workshops and a final role play.
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3. COMBINED ASSESSOR TRAINING ISO/IEC 17025ISO 15189, ISO/IEC 17020INTRODUCTION TO ISO/IEC 17021-1
CONTENTPART 1Requirements in ISO/IEC 17025• Preparation of assessments• Planning assessments• Different kinds of assessments• Building assessment teams• Behaviour and listening skills• Closing meetingPART 2Requirements in ISO 15189 or,Requirements in ISO/IEC 17020PART 3 Introduction to accreditation of certification bodiesISO/IEC 17021-1 management systems
DURATION5 days
FEE23 000 SEK per person
COURSE CONTENTThis 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 require-ments for certification bodies.
The goal is to reach a deeper knowledge of the standard ISO/IEC 17025 and also to learn more on one additional standard, i.e. ISO 15189 or ISO/IEC 17020. One part of the training covers an introduc-tion to certification of management systems and the requirements in ISO/IEC 17021-1.
The target group for this course is persons with skills or willing to improve their skills in doing assess-ments. 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 GROUPPersons who want to become lead assessors or tech-nical assessors for accreditation bodies. The course will be given in a combination of lectures, case studies, workshops and role play.
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4. ACCREDITATION OF LABORATORIES ISO/IEC 17025
CONTENT• Deeper knowledge of ISO/IEC 17025• 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
DURATION3 days
FEE17 500 SEK per person
COURSE CONTENTThis 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 17025 in general and to understand the requirements of the standard.
TARGET GROUPPersons 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 knowl-edge in different technical laboratory areas.
The course will be given in a combination of lectures, case studies, workshops and role play.
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5. ACCREDITATION OF MEDICAL LABORATORIES ISO 15189
CONTENT• Deeper knowledge in ISO 15189• 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
DURATION3 days
FEE17 500 SEK per person
COURSE CONTENTThis 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 15189. You will study the role of accreditation and the processes of assessment for accreditation.
TARGET GROUPPersons with limited experience of the standard ISO 15189 who will work as assessors of medical labora-tories.
The course will be given in a combination of lectures, case studies, workshops and a final realistic role play.
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6. ACCREDITATION OF MEDICAL LABORATORIES ISO 15189SHORT VERSION
CONTENT• Deeper knowledge in ISO 15189• 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
DURATION2 day
FEE13 000 SEK per person
COURSE CONTENTThis 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 15189. You will study the role of accreditation and the processes of assessment for accreditation.
TARGET GROUPPersons with earlier experience of assessment of ISO/IEC 17025 scopes, who want to become assessor of medical laboratories.
The course will be given in a combination of lectures, case studies and workshops.
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7. ACCREDITATION OF PROFICIENCY TESTING PROVIDERSISO/IEC 17043
CONTENT• General PT review, principles• Management requirements• Technical requirements
DURATION2 days
FEE13 000 SEK per person
COURSE CONTENTProficiency testing programs are important tools to develop confidence in testing, inspection and calibra-tion. This course will give a deeper understanding of the requirements set out for accreditation of a profi-ciency testing provider. The course contains a review of the content of the standard ISO/IEC 17043 both from a management system view and from a tech-nical perspective.
TARGET GROUP AND PURPOSEPersons with earlier experience of assessment of ISO/IEC 17025 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 exam-ples from performed proficiency testing activities.
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8. ACCREDITATION OF INSPECTION BODIESISO/IEC 17020
CONTENT• Why inspection?• General requirements• Independence• Structural requirements• Resource requirements• Process requirements• Management system requirements
DURATION2 days
FEE13 000 SEK per person
COURSE CONTENTThis 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 17020
TARGET GROUPPersons with earlier experience of assessment of ISO/IEC 17025 scopes or ISO/IEC 17020. 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.
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9. ACCREDITATION OF CERTIFICATION BODIES ISO/IEC 17021-1 MANAGEMENT SYSTEMS
CONTENT• Management system certification• Requirements in ISO/IEC 17021-1 Principles General requirements Structural requirements Resource requirements Information requirements Process requirements Management system requirements• Other documents ISO/IEC 27006 ISO/IEC 17021 series ISO/TS 22003 and relevant IAF MD and EA documents • Management system certification at a certification body
DURATION3 days
FEE17 500 SEK per person
COURSE CONTENTThis is an advanced training for assessors for accred-itation of certification bodies, certifying different management systems e.g. quality, environment, information security, food safety, energy and occupa-tional health and safety. TARGET GROUPPersons 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 17021.
The course will be given in a combination of lectures, case studies and workshops.
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COURSE CONTENTThis is an advanced training for assessors for accred-itation of certification bodies, certifying products, processes or services.
TARGET GROUPPersons 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 require-ments and structure of the standard ISO/IEC 17065.
The course will be given in a combination of lectures, case studies and workshops.
10. ACCREDITATION OF CERTIFICATION BODIES ISO/IEC 17065 PRODUCTS
CONTENT• 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 17007 Certification scheme– ISO/IEC 17067 Marks of conformity – ISO/IEC 17030 EA documents• Product certification at a certification body
DURATION3 days
FEE17 500 SEK per person
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11. ACCREDITATION OF CERTIFICATION BODIES ISO/IEC 17024 PERSONS
CONTENT• Certification of persons• Requirements in ISO/IEC 17024 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
DURATION2 days
FEE13 000 SEK per person
COURSE CONTENTThis is an advanced training for assessors for accredi-tation of certification bodies certifying persons.
TARGET GROUPPersons 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 17024.
The course will be given in a combination of lectures, case studies and workshops.
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COURSE CONTENTThis is a course that aims to develop and provide an understanding of how internal audits and manage-ment review can be conducted in order to contribute to the improvement of processes and generate increased business value.
TARGET GROUPThis 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 accredi-tation 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.
12. INTERNAL AUDITLABORATORIES / INSPECTION BODIES
CONTENTPART 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
DURATION2 days
FEE13 000 SEK per person
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COURSE CONTENTThis 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 sustain-able 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 GROUPPersons who want to learn more about quality infra-structure 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 rele-vant Swedish organisation.
13. INTRODUCTION TO QUALITY INFRASTRUCTUREACCREDITATION, MARKET SURVEILLANCE AND METROLOGY
CONTENT• 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
DURATION4 days
FEE21 000 SEK per person
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GlobalCompetitveness
Evolve toExport led
growth
FacalitateTrade
ImproveProductquality
Spur Innovation
Enhanceproductivity
SupportEconomic
Diversification
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BOOKINGBooking is made by the booking form on our website. For more information, please e-mail [email protected]
Once we have processed your booking, we will send you a confirmation e-mail. If you have not received a confirmation within seven days, please contact us again by mail or telephone.
FEES AND PAYMENTPayment 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 informa-tion 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 accommoda-tion 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 REFUNDSSwedac 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 [email protected]
TERMS AND CONDITIONS
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Please fill in the booking form available on our website www.swedac.se and we will get back to you as soon as possible. The reservation is not binding until you have paid the course fee.
BOOKING*
Personal details
Title Surname Name
Organisation Department division
Position E-mail
Address
Telephone
Other delegates
Name Name
Position Position
E-mail E-mail
Course details
Course title/number
Course date
*Preferably filled in on our website.
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Swedac is a signatory to all international agreements of mutual recognition signed by members of EA (European co-operation for accreditation), IAF (Inter-national Accredita•tion Forum) and ILAC (International Laboratory Accredita-tion Cooperation).
Swedac has, between 1999-2015, 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.
FACTS
Head OfficeÖsterlånggatan 5
Box 878, SE-501 15 BoråsSweden
Stockholm OfficeGustavslundsvägen 151 E, 8th floor, Box 733, SE-167 51 BrommaSweden
+46 771 99 09 00 • www.swedac.se • [email protected]
