@ Your service! A WORLD IN WHICH PRODUCTS CAN BE TRUSTED

Transcription

1 @ Your service!

2 Nice to meet you! Saskia van Orden Caspar ter Horst Arthur van der Meijden FAST File assembly support team

3 Why?

4 4" Distinguish yourself Quality Made in Holland Guard and improve working conditions Extra dimension to personal comfort Thoroughly tested and extremely reliable

5 5" Roles & Obligations (NLF) Manufacturers Draw up, keep and update technical file and DoC Importers Ensure technical file available and keep copy DoC Distributors Only act with due care Create! Manage! Share

6 6" Formal non-compliance The CE marking rules are violated; The EU declaration of conformity is wrong; Technical documentation is not complete; NLF Obligations are not fulfilled.

7 7" Everybody involved Manufacturers, importers and distributors: When requested by a national authority, provide all information and documentation necessary to demonstrate the conformity of the product, in a language easily understood by that authority.

8 8" ISO Compliance Management

9 Who?

10 10" All you need is? " Time " In time " Power " Manpower # Persuasion # Money

11 11" And knowledge

12 What?

13 13" Prioritise Products important for your business Products with highest risks Critical or strategic suppliers Experience(s)

14 Let s create

15 15" Market release date Date determines applicable requirements Align with Declaration of Conformity New batch = new date, new file

16 16" My name is

17 17" Product categories Descriptions may deviate Translations also (snake glue) You can search by standards Not found? We know!

18 18" Grouped in one file Only if same manufacturer Only if same requirements list Keep it clear

19 19" Representative model Only if the answer to the question is yes : Does the assessment of the representative model cover for all (not assessed) related models? Are all models mentioned in reports / certificates?

20 20" Q&A Know your products, in detail An answer results in a requirement Unclear Question: [email protected]

21 21" Know your countries

22 Invite

23 23" Invite, then explain

24 24" Push, push, push QQ

25 25" Our experience shows: has no idea may not co-operate step-by-step time and time again patience lack of information check a lot of things - accurately not actually that confidential

26 Collect

27 27" Archive for 10 years Available for 10 years after the product has been placed on the market (NLF) Will it be clear for somebody else? In a few years from now

28 28" Informative filenames

29 29" Match it! helps

30 30" Traceable DECLARATION of PRODUCT IDENTITY ACME (China) Industrial Co. Ltd declares that <ACME LED4PIR> is completely identical with <your product ABC123> <responsible> <title> <place, date>

31 Artwork

32 32" Symbols

33 33" Have you seen these today?

34 Documents

35 35" Issued by SGS Bureau Veritas (BV) Intertek (ITS) TüV Nord / Süd / PS / Rheinland DEKRA Eurofins And many, many more

36 36" Accreditation What is the scope? Is it still valid?

37 37" Falsifications

38 38" Valid until No rules in legislation But standards may have changed And retailers have their own demands And how about the product itself?

39 Review

40 40" Compare pictures Report Product

41 41" Be curious

42 42" Stay curious

43 43" And what happened here? Or Resubmitted sample date Why was another sample submitted?

44 44" Tests as requested by client

45 Requirements

46 46" Buy and sell safe products New approach Essential requirements Start with a risk assessment Harmonised standards are useful, not mandatory

47 47" Standards Main EN ISO 14982:2009 ETSI EN V1.8.1 ( ) Amendment EN :1994/A12:1996 Corrigendum EN :2004/AC:2006 NEN-EN :2007/C1:2009

48 48" Expiry date The new edition determines when the previous edition will be superseded.

49 49" Expiry date The latest list (17 Dec 2014) will replace the previous list (16 June 2014) six months after its publication (17 June 2015)

50 50" REACH: 161 SVHC s?

51 51" Bill of Materials (BoM)

52 52" Materials Safety Data Sheet Share information on hazardous substances First aid measures Handling, storage, transport Regulatory information Labelling and packaging

53 Quality Control

54 54" (Easy) quality control

55 55" Piece of Cake Ltd.

56 56" Quality Control (NLF) Ensure that procedures are in place for series production to remain in conformity. Changes in product design and changes in standards shall be taken into account. Production needs a Quality Management System.

57 57" Factory audit

58 58" Inspections (NLF) When appropriate with regard to the risks of a product, manufacturers and importers shall, to protect the health and safety of consumers. carry out sample testing of marketed products investigate register complaints, non-conformities, recalls inform distributors Inspections are used to check factories, during-production, packaging, pre-shipment.

59 59" Pre-shipment inspection

60 Pre-final

61 61" Decisions What is still missing (A, B1)? What are the business risks? What are the product risks? Perform tests, inspections, audits? How about the next order?

62 62" Requirement categories A: Design Verified by type testing (TSD, LVD, EMC) B: Production, materials, labelling B1: REACH, warnings B2: Energy labels B3: Traceability

63 Finally

64 64" Learn from recalls

65 65" Golden File GOLDEN FILE

66 19/05: REACH 26/05: Panel 02/06: Quality CN 09/06: Service Desk