Disposable non-chemical medical consumables and haematological consumables

Tender description

NHS Supply Chain seeks to establish a framework agreement which will cover a large range of products to help influence ideal wound healing environments, prevent infection and skin breakage including, but not limited to film dressings and associated products, skin protectants, medical adhesive tapes, non woven island dressings, super absorbent dressings, dressings pads, bandages, medical swabs and others TBC. Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of 50 500 000 GBP in the first year of this framework agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement. Estimated value over the total framework agreement term (including any extension options) will be circa 360 000 000 GBP. NHS Supply Chain are exploring the possibility of 4 years plus 2 years framework agreement having a total term of 6 years. The lot is for a range of film dressings (with and without pad) IV film dressings and fixation devices. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately 15 000 000 GBP in the first year of this framework agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement. Estimated value of this lot over the total 6 years term will be circa 100 000 000 GBP. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining ISO9001. The requirement is that ISO9001 is in place at prior to the commencement of the framework agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. The lot is for a range of barrier creams, films and wipes in varying sizes and applications. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £5,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £36,000,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. The lot is for adhesive medical tapes in a variety of widths and lengths including; blended paper and plastic, cloth, foam, paper, plastic, silicone, silk and zinc oxide. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £3,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £21,000,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. The lot is for sterile non-woven island dressings in a range of sizes. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £1,250,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £9,500,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. The lot is for a range of super absorbent dressings, adhesive and non-adhesive in a variety of sizes. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £6,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £46,000,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. This lot is for a range of dressing pads both sterile and non-sterile in a variety of sizes. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £750,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £6,500,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. This lot is for a range of bandages in differing widths and lengths, including cohesive, compression, retention, type 2 support, triangular, zinc paste, stockinette, tubular, elastic adhesive, support, suspensory, silk, foam and zinc oxide impregnated medicated stockings. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £14,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £94,000,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. This lot is for a range of medical swabs consisting of gauze, non woven, type 13 and x-ray detectable. These swabs have a range of various sizes, ply's, sterility and colours. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £4,500,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £37,000,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity. NHS Supply Chain considers further split for lots and would like to invite suppliers interpretation. A range of varying other Lots yet to be determined on the Lotting strategy could include: First Aid Kits - First aid kits for workplace, catering etc. Plasters - A range of wash proof plasters in various sizes. Oral Swabs - A range of products for oral use including swabs and films. Medical Prep Swabs - A range of products for Skin Preparation including Wipes, Sponges and Swabs. Cotton Wool - A range of cotton wool products, roll, balls and dental rolls. Gauze Absorbents - A range of absorbent medical gauze products including; gauze roll, gauze and cotton, dental Absorbent gauze, and gauze absorbent ribbon. Nasal Swabs and Tampons - A range of nasal products including absorbent cotton, nasal tampons and applicators. Non Woven Balls - Non-woven balls in a range of sizes, sterile and non-sterile. Ambulance and Emergency Products - A range of sterile products and mass casualty packs for use within ambulance including dressings with attached stretch Bandages, non-adherent dressing pads, and absorbent dressings. Oral Mucositis and Associated Products - A range of prevention treatment and management of oral mucositis. Precise quantities are unknown. It is anticipated that initial expenditure will be approximately £1,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. Estimated value of this lot over the total 6 years term will be circa £10,000,000. The following certification will be a requirement of the upcoming tender exercise and applicants may be required to include evidence of this with their tender submission. ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limit+O95ed to manufacturing, storage and distribution. Applicants should note that if an applicant intends to commit to obtain ISO9001 at tender submission then further evidence will be asked for with their bid to provide evidence of their current position in obtaining IS09001. The requirement is that ISO9001 is in place at prior to the commencement of the Framework Agreement (in order for NHS Supply Chain to trade with the successful applicant). Evidence of compliance to the Medical Devices Directive 93/42/EEC may be requested as part of your tender response. You will be required to submit the following 2 forms of evidence: a valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for and an EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable). There will be no option to commit to obtain the certificates and declarations of conformity.