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Statement of Requirements

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Statement of Requirements STATEMENT OF REQUIREMENTS INVITATION TO TENDER MedGS/0004 SUPPLY OF INTRAOSSEOUS INFUSION EZ-IO SYSTEM & ASSOCIATED PARTS CONTENTS 1. OVERVIEW 2. REQUIREMENT 3. QUALITY MANAGEMENT 4. QUALITY ASSURANCE 5. SPECIFICATIONS 6. ORDERING 7. PACKAGING 8. LABELLING 9. REJECTION and RECTIFICATION 10. DELIVERY 11. SURGE 12. MANAGEMENT 13. PERFORMANCE MONITORING 14. MEETINGS 15. MANAGEMENT INFORMATION 16. SUSTAINABLE DEVELOPMENT/PROCUREMENT 17. END OF CONTRACT ACTIVITIES Annex: A – DEMANDING AUTHORITIES AND DELIVERY POINTS B – KEY PERFORMANCE INDICATORS C – PROCEDURE FOR P2P DEMAND ORDERS D - PROCEDURE FOR NON-P2P DEMAND ORDERS 1. OVERVIEW 1.1 This Statement of Requirements (SToR) sets out the Medical and General Supplies Team (MedGS) requirements for the supply of Intraosseous Infusion EZ-IO System and Associated Products. 2. REQUIREMENT 2.1 The Contractor shall supply the Articles detailed in the Schedule of Requirements (SoR), as they are ordered by the Demanding Authority, packaged to the appropriate level and to contracted lead times. 3. QUALITY MANAGEMENT 3.1 The Contractor shall operate a Quality Management System certified to ISO 9001-2008 and the following requirements shall apply to work under the Contract: AQAP 2120 Edition 3 – NATO Quality Assurance Requirements for Production. Defence Standard 05-61 Part 1 – Quality Assurance Procedural Requirements – Concessions. DEFCON 602b - Quality Assurance – Without Deliverable Quality Plan. AQAP 2009 Edition 2 – NATO Guidance on the use of the AQAP 2000 Series. AQAP 2070 Edition 2 – The NATO Mutual Government Quality Assurance Process. 3.2 The Authority’s Quality Assurance Representative (QAR) shall be as shown at Box 7 of the Appendix to the Contract (DEFFORM 111). 3.3 Unless otherwise directed in the Contract, the Contractor shall retain the Quality Control/Inspection Records or such of those records as may be agreed by the QAR for a period of two years from completion of all work and shall make them accessible to the Authority on request. At the end of this retention period, the Contractor shall seek advice from the QAR regarding the disposal/ continued retention of the Quality Control/Inspection Records, and the Contractor shall not dispose of such records without the written authority of the QAR. 3.4 Exceptionally, when requested by the Contractor, earlier disposal may be authorised in writing by the QAR. 4. QUALITY ASSURANCE 4.1 The Authority may undertake Quality monitoring may be undertaken by the Authority should risk analysis identify areas of concern. 5. SPECIFICATIONS 5.1 Each Article, when demanded, shall be delivered to the Authority in accordance with the specification identified against the line item on the SoR, and to the description detailed in the appropriate column. The description and specification detailed in the SoR are the definitive requirements. In the event of any inconsistency between the SoR and any other publication (e.g. ISIS), then the SoR shall take precedence. 5.2 If at any time during the Contract Period, the Contractor proposes to change or delete any Line Item (Article) then prior approval in writing must be sought from the Authority. 5.3 In the event that the Contractor cannot meet the specification for an Article, the Contractor shall propose an alternative of an equivalent quality and robustness that meets the fit, form and function criteria of the original Article. Such alternatives must be readily available and, if requested by the Authority, the Contractor shall provide samples, free of charge, for assessment. Where the Authority accepts an alternative Article as a suitable replacement, the Contractor shall provide an updated specification for use by any UK Government Department. 5.4 When the Authority has accepted an alternative Article as a suitable replacement, agreed a fair and reasonable price for its supply, and the alternative Article has been allocated a NATO Stock Number (NSN), the Contractor may supply the Article to the Authority. 5.5 The Articles shall conform to the latest issues of the Authority’s specification(s) and/or BR relating to the Article and incorporate all relevant modifications. 5.6 On no account shall the Contractor supply an alternative Article in response to a Demand Order unless agreed in accordance with paragraphs 5.3 – 5.5 above. 6. ORDERING 6.1 Demand Orders may only be placed by the Authorised Demanders listed at Annex A to this SToR. 6.2 Orders for Articles will be notified to the Contractor electronically via the Defence Electronic Commerce Service (DECS) Purchase to Payment (P2P) System detailed in DEFFORM 30 of this Contract. Orders transmitted in this way shall be known as P2P Demand Orders and the procedures detailed at Annex C to this SToR shall be followed. 6.3 If the Contractor does not already have a P2P link with the Authority, orders will be generated in the meantime by the Demanding Authority’s provisioning systems and sent, generally in the form of DEFCON 300, to the Contractor by post, fax or e-mail. Such orders shall be known as Non-P2P Demand Orders and the procedures detailed at Annex D to this SToR shall be followed. 6.4 If the Article is listed on the SoR the Contractor shall provide the Article detailed within the Demand Order fully in compliance with the specification for that Article and within the timescales required. 6.5 In the event that the Contractor cannot meet the contracted delivery date the Authorised Demander may cancel the Demand Order and invoke DEFCON 614 (Default) in relation to the item covered by the Demand Order, in anticipation of the Contractor’s default. 6.6 The Denomination of Quantity (DofQ) for each Article is specified in the SoR. It is essential that the specified DofQ be observed, as the Authority’s systems cannot accommodate any deviations. 6.7 The Authority’s systems require exact matching of receipts to orders. Any variance in the quantity to be delivered, for whatever reason, must be notified to the Demanding Authority prior to despatch of the goods, to allow sufficient time for ‘dues in’ records to be amended. Goods will be rejected if the delivered quantity does not match the (amended) order. 6.8 The quantities stated in the SoR are estimates only and the Authority cannot guarantee the volume of demand within any given timescale. 7. PACKAGING 7.1 All Articles shall conform to the packaging requirements of DEFCON 129 and will normally be to Trade Export standard unless another standard is specified. All costs for the packaging of these Articles shall be included in the Line Item Unit Price of the Articles in the SoR. 7.2 The Contractor shall be responsible for ascertaining whether the Articles being supplied are, or contain, Dangerous Goods as defined in the regulations set out below. Articles delivered under the Contract may be required to be transported, either UK or worldwide, as a normal part of the logistic support of HM Forces. Therefore, unless otherwise specified in the Contract, all Articles that are, or that contain Dangerous Goods are to be packaged for UK or worldwide shipment by all modes of transport. This means, Articles that contain Dangerous Goods shall be classified and packaged to the prescribed Primary Packaged Quantity (PPQ) in accordance with the applicable requirements of: (i) The Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO), IATA Dangerous Goods Regulation, (ii) The International Maritime Dangerous Goods (IMDG) Code, (iii) The Regulations concerning the International Carriage of Dangerous Goods by rail (RID), and (iv) The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), with particular reference to the certification marking of packaging, incorporating the UN logo, the package code and other prescribed information indicating that the package corresponds to the successfully designed type. 8. LABELLING 8.1 All items shall be marked legibly and indelibly with the Manufacturer’s name or Trade Mark, year of supply, CE marks, batch serial numbers and expiry dates where applicable. All Articles shall also be marked and packaged to Retail Trade Standard as specified by DEFCON 129). All costs for the packaging of Articles shall be included in the Line Item Unit Price of the Article. In addition to the retail trade packaging requirements specified in DEFCON 129, each primary package shall be marked with a label containing the following information as a minimum: Contract Number NSN D of Q Weight of Individual Articles Combined weight of package Brief Description of Contents N.B The Contractor shall, following investigation, advise the implementation date for bar code labelling and advise any associated costs. These costs will be amortised over the contract prices to allow costs to be recovered. 9. REJECTION and RECTIFICATION 9.1 Due to the volume of stores received by the Authority, it is essential that goods be delivered in accordance with the provisions of Section 6 & 7 above. Failure to mark, package or label any Article in accordance with these instructions will result in the rejection of the consignment. 9.2 A Defect Report (DR) will be raised by the Commercial Manager, his nominated representative or the Authorised Demander and forwarded for action to the Contractor as a result of an Article or Service failing to meet its specified requirements. Defect reports raised by Authorised Demanders will be copied to the Commercial Manager for information purposes only. 9.3 The Contractor shall complete and return Part 2 of the Defect Report within 3 Working Days of receipt. A full investigation of the contents of the defect report shall be completed within 20 Working Days of receipt. However, defect reports with Health and Safety implications shall be acknowledged immediately and fully investigated within 5 Working Days. The investigation will not be considered complete until the Contractor has completed and returned Part 3 of the defect report, detailing their findings, actions taken and any subsequent recommendations.
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