The New PPE Regulation (EU) 2016/425

Transcription

1 The New PPE Regulation (EU) 2016/425 Dave Tuplin Certification Manager, BSI 1

2 PPE Regulation (EU) 2016/425 changes Agenda Who is BSI Landscape and timeframes Scope of the new PPE Regulation Categorisation under the PPE Regulation Modules under the PPE Regulation Module B Module C2 Module D Kitemark and PPE Regulation Summary 2

3 Who is BSI? Leading Global Standards Creation Body: British, European, ISO, Public, Private The UK National Standards Body: The source of British Standards Specialist Focus on Standards Creation, Training and Certification Experienced: The world s first National Standards Body established in 1901 and a founding member of ISO Thought Leaders: Shaped the world s most adopted standards, incl. ISO 9001, ISO 14001, OHSAS Trusted: We re a Royal Charter Company, reinvesting profits back into our business to improve our clients experience Global Network: 80,000 clients in 172 countries worldwide including governments, global brands and SME s 3

4 A truly global brand and network trusted and recognized 172 Countries 80,000 clients Clients in 172 countries 75 offices worldwide 3 regional hubs in UK, US and Hong Kong 75 Offices 4 4

5 Over 100 years expertise shaping global standards to facilitate trade and improve business Product Specification Standards Business Process Standards Business Potential Standards Beginning in 1901, initial Standards focused on product specifications to harmonize and facilitate commerce and reduce duplication Railroad gauges Steel specifications Construction standards Agricultural commodities Consumer and electrical products Personal safety equipment Medical devices Product Specification Standards remain relevant today driving interoperability and innovation in areas such as smart cities and regenerative medicine (e.g. stem cells) The next generation of standards focused on business processes to ensure consistent quality output BSI shaped the original standards for: Quality Management (ISO 9001) Information Security (ISO/IEC 27001) Environment Management (ISO 14001) Health & Safety (OHSAS 18000) IT Services Management (ISO/IEC ) Business Continuity (ISO 22301) Sustainable Events (ISO 20121) BSI s new generation of Standards are centred around people behaviour and values to help organizations reach their full potential and protect their corporate reputation Key standards include: Anti-Bribery Corporate Social Responsibility Collaborative Business Relationships Cyber Security Customer Service Product Specification Standards Founded

6 The PPE Directive Landscape One of the first new Approach Directives Now almost 30 years old New technologies need to be reflected development of Regulation and final adoption 12 February Period of transition for Notified Bodies and Member States Throughout months to work to either the old PPE Directive or new PPE Regulation 2019 onwards New Regulation (EU) 2016/425 applies 6

7 Timescales for implementation 7

8 Timescales for implementation Key Dates PPE Directive 89/686/EEC is repealed with effect from 21 April 2018 This PPE Regulation (EU) 2016/425 shall apply from 21 April 2018 Member States shall not impede the making available on the market of products covered by the old PPE Directive 89/686/EEC before 21 April 2019 EC type-examination certificates issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date 8

9 The new PPE Regulation (EU) 2016/425: scope This Regulation applies to PPE Definitions; 'personal protective equipment' (PPE) means: a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety; b) interchangeable components for equipment referred to in point (a) which are essential for its protective function; c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use; 9

10 PPE Regulation (EU) 2016/425: exemptions This Regulation does not apply to PPE: (a) specifically designed for use by the armed forces or in the maintenance of law and order; (b) designed to be used for self-defence, with the exception of PPE intended for sporting activities; (c) designed for private use to protect against: (i) atmospheric conditions that are not of an extreme nature, (ii) damp and water during dishwashing; (d) PPE use on seagoing vessels or aircraft (e) helmets and their visors for drivers and passengers of motor cycles and mopeds. 10

11 Understanding the changes Who is now responsible for compliance? Old PPE Directive 89/686/EEC New PPE Regulation (EU) 2016/425 Manufacturers Manufacturers Authorised Representatives Authorised Representatives Importers/Distributors 11

12 Obligations on Importers and Distributors Article 10 and 11 Importers and Distributors shall place only compliant PPE on the market Before placing PPE on the market, Importers and Distributors shall ensure that the appropriate conformity assessment procedures have been carried out by the manufacturer Where an Importers and Distributors considers or has reason to believe that PPE is not in conformity he shall not place it on the market. Furthermore, the importer shall inform the manufacturer and the market surveillance authorities to that effect Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted 12

13 Documentation needed by Importers and Distributors So what do you need? Copy of the Manufacturers Module B EU Type Examination Certificate AND (if applicable) a copy of the Module C or D certificate The Declaration of Conformity for the product you are handling Ensure the User Instructions are in the correct language Be prepared to hold records for at least 10 years 13

14 Understanding the changes Categorisation of PPE PPE Directive 89/686/EEC New PPE Regulation (EU) 2016/425 Category I Simple PPE Category I Simple PPE Category II Intermediate PPE Category II Intermediate PPE Category III Complex PPE Category III Complex PPE 14

15 Categorisation of PPE under Regulation (EU) 2016/425 Category definitions Annex I Category I - includes exclusively for minimal risks Category II - risks other than those listed in Categories I and III Category III - includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health 15

16 Categorisation of PPE Category I - Simple PPE PPE Directive 89/686/EEC superficial mechanical action minor impacts and lesions contact with hot surfaces <50 C atmospheric conditions that are not exceptional sunlight (sunglasses) New PPE Regulation (EU) 2016/425 superficial mechanical injury contact with hot surfaces <50 C atmospheric conditions that are not of an extreme nature exposure to sunlight (not observing the sun) contact with cleaning materials weak action or prolonged contact with water 16

17 Categorisation of PPE Category II Intermediate PPE PPE Directive 89/686/EEC Category II includes risks other than those listed in Categories I and III New PPE Regulation (EU) 2016/425 Category II includes risks other than those listed in Categories I and III 17

18 Categorisation of PPE Category III - Complex PPE PPE Directive 89/686/EEC filtering respiratory devices respiratory protective devices PPE for chemical attack or ionizing radiation high-temp environments >100 C low-temp environments <-50 C Fall arrest PPE against electrical risks New PPE Regulation (EU) 2016/425 substances & mixtures hazardous to health oxygen deficient atmospheres harmful biological agents ionising radiation high- air temp environments >100 C low-air temp environments <-50 C falling from a height electric shock and live working drowning cuts by hand-held chain-saws high-pressure jets bullet wounds or knife stabs harmful noise 18

19 Categorisation of PPE under Regulation (EU) 2016/425 Significant changes Substances & mixtures hazardous to health (a catch all) Life Jackets moving from Category II to Category III Hearing protection moving from Category II to Category III Clarification and specific references in Category III for e.g.; PPE to protect against cuts by hand-held chain-saws PPE used high-pressure jet cutting operations bullet wounds or knife stabs 19

20 The PPE Regulation (EU) 2016/425 modules The Regulation changes from articles to modules and falls in line with terminology used in similar European legislation PPE Category Activity Old PPE Directive 89/686/EEC New PPE Regulation (EU) 2016/425 Cat I Simple PPE Placing product onto the market Manufacturers self declaration Module A (Annex IV) Manufacturers self declaration Both Cat II Intermediate PPE and Cat III Complex PPE Initial product approval Article 10 EC Type Examination Module B (Annex V) EU Type Examination Cat III Complex PPE only On-going surveillance through testing Article 11A Module C2 (Annex VII) or Cat III Complex PPE only On-going surveillance through factory auditing Article 11B Module D (Annex VIII) 20

21 The PPE Regulation (EU) 2016/425 modules Module B EU Type Examination (Annex V) Similar to current Article 10 process EU type-examination is the part of a conformity assessment procedure in which a Notified Body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of this Regulation that apply to it. On completion manufacturer is given EU Type examination which has a max 5 year validity The Notified Body shall keep a copy of the documents for 5 years after the expiry of the certificate The manufacturer shall keep a copy of the technical documentation for 10 years after the PPE has ceased production. 21

22 The PPE Regulation (EU) 2016/425 modules Module B (Annex V) EU Type Examination certificate renewal The manufacturer shall ensure that the PPE continues to fulfil the applicable essential health and safety requirements in light of the state-of-the-art. The manufacturer shall ask the Notified Body to review the EU Type Examination certificate either: (a) in the case of a modification to the product or documentation (b) in the case of a change in standards, Essential Health & Safety Requirements or state-of-the art (c) at the latest, before the date of expiry of the certificate. The manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU Type Examination certificate. 22

23 The PPE Regulation (EU) 2016/425 modules Module C2 (Annex VII) Similar to Article 11A The Notified Body shall carry out product checks in order to verify the consistency of production The product checks shall be carried out at least once a year and at random intervals Where the C2 Notified Body is not the body that issued the relevant EU type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production If the examination and testing reveal that the production is not consistent, the Notified Body shall take measures appropriate to the fault(s) recorded and inform the Notifying Authority 23

24 The PPE Regulation (EU) 2016/425 Modules Module D (Annex VIII) Similar to Article 11B The manufacturer shall maintain a documented quality system The manufacturer shall lodge an application for assessment of his quality system with a single Notified Body of their choice Similar activities are assessed by the Notified Body as current 11B during periodic audits, at least once a year 24

25 EU Declaration of Conformity for PPE Regulation (EU) 2016/425 Annex IX The contents for the declaration of conformity is contained within Annex IX of the Regulation Similar in structure to the old PPE Directive Major change The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the products user instructions and information or web link as to where EU declaration of conformity can be accessed 25

26 Summary PPE Regulation (EU) 2016/425 has now published. Two years to transition After three years PPE Regulation only Specific scope and exclusions Now has provisions for distributors and importers Changes to module names (OLD Article 10, 11A & 11B NEW Modules B, C2 & D) Changes is product categorisation; life jackets and hearing to Category III Bespoke PPE covered by the Regulation Declaration of Conformity (or web link) available with each product 5 years validity for EU Type Examination certificates from April

27 REMEMBER! 27

28 Use of the BSI Kitemark PPE Regulation & Differentiation Chrishna Vaja, Propositions Manager, BSI 28

29 Use of the BSI Kitemark to meet PPE Regulation requirements We run PPE Kitemark schemes for industrial safety helmets, equestrian helmets and safety eyewear. Requirements are that a product is tested to and meets a published standard and the manufacturer has a quality system which meets the requirements of ISO Once a licence is issued there are regular on-going product testing and factory assessments. 29

30 Use of the BSI Kitemark to meet PPE Regulation requirements The activities manufacturers use to maintain their Kitemark certificates can be used to maintain their legal regulatory requirements 30

31 Why do more than CE marking? BSI Kitemark goes beyond meeting minimum legal safety requirements and delivers a reassurance of quality, trust and safety to the end user. Differentiation Commercial Advantage 31

32 Use of the BSI Kitemark to meet PPE Regulatory requirements Activity Pre-market approval On-going surveillance PPE Regulation (EU) 2016/425 Kitemark process Module B Type Test Test data can be used for both Module C2 OR Module D Twice annual product audit test AND Continuing Assessment Visit Kitemark audit can be used for Module C2 A CAV can be combined with Module D 32

33 BSI Kitemark a brief overview of BSI s rigorous process Initial Assessment Type testing Initial Assessment Stage 1: Pre-Audit Visit of the Quality Management System Stage 2: Initial Assessment visit for QMS & Manufacturing processes Type testing Certification Evaluation KM Award Continuing Assessments Certification evaluation by BSI Certification Manager and recommendations made BSI s Compliance and Risk Team review and if successful, award BSI Kitemark On-going continuing assessment visits Audit Testing On-going audit testing of products 33

34 What reassurance will BSI Kitemark give you? Consistency of performance of products, independently tested by BSI against recognised industry standards Evidence of a manufacturer s due diligence: Commitment to using current standards to benchmark their products On-going commitment to quality manufacturing, with samples tested annually Customer focused approach Reassurance of product quality 34

35 How to be sure product is BSI Kitemark approved? Clear choice for the end user All Kitemark approved products are listed on 35

36 How is BSI Kitemark valued? Our survey said Consumers associate BSI Kitemark with rigour Consumers know that products and services displaying BSI Kitemark are tried and tested Consumers trust products and services displaying the BSI Kitemark 58% of consumers say BSI Kitemark is an indication of quality 36

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38 Useful links PPE Regulation webpage BSI Kitemark information Kitemark Directory search for a BSI Kitemark approved product or service Product Development and Manufacturing Seminar 24 November, Hemel Hempstead OHSAS information 38

39 Thank you Any Questions? If you want a copy of the slides please pass on your business card to us 39