ISO 13485:2016 QUALITY MANAGEMENT SYSTEM QUOTATION QUESTIONNAIRE

Select a date
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Contact: (person)
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Your Email Address
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Physical Address:
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Customer: (full company name)
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Telephone Number:
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Postal Address:
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In terms of the Medicines & Related Substances Act 101 of 1965, are you classified as a Manufacturer of Medical Devices (MD) i.e. manufacture, pack, label, service, import, export and/or distribute?
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Do you design or develop any of these products?
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What products are involved?
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What products are involved?
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How many employees do you have?
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Does your production staff work shifts?
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How many branches do you have?
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Please list any outsourced manufacturing or service processes
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Do you subscribe voluntarily to any industry related requirements? (e.g. Codes of Practice/Ethics, industry guidelines)
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Scope of Certification (what you want your registration to cover and to appear on your certificate) For example: “The importation, distribution and servicing of medical Infusion Pumps”.
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What products are involved?
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Are you classified as a Distributor of MD i.e. import, export & distribute?
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Are you classified as a Wholesaler of MD i.e. storage, transportation & delivery?
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Are any of your products registered with SAHPRA in terms of the 2016 MD&IVD Regulations of 9.12.16? If not, do you have a Medical Device File for a/each product?
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How many are in production/service?
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How many are in product design and/or research?
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Please list manufacturing equipment and processes.
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Do you process customer supplied product or information?
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Target date for certification to ISO 13485:2016.
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Notes. (any further information to assist our consultant in understanding your requirements)
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Thank you and please submit your questionnaire.