• Document: Pre-inspection documentation
  • Size: 717.17 KB
  • Uploaded: 2019-02-13 04:02:53
  • Status: Successfully converted


Some snippets from your converted document:

Name of Document: G-002-09-Pre- Creation date: 08/05/2013 inspection documentation guide Effective date: 22/07/2013 Approved by: Eoin McGrath Review date: 18/07/2017 Responsible: Iris Bargalló Modification: new JACIE Office Entry: Pre-Inspection Address & Adapt references to documentation list version6.01 of the JACIE Standards Pre-inspection documentation Introduction ...................................................................................................................... 1 Language .......................................................................................................................... 1 Pre-formatted folder structure .......................................................................................... 2 When do I have to send these document?......................................................................... 2 What does JACIE do with these documents? ................................................................... 2 How does JACIE store and distribute these documents? ................................................. 3 Contact details .................................................................................................................. 3 Document checklist .......................................................................................................... 5 Introduction Centres applying for accreditation are required to submit documentation in advance of the inspection. This documentation is requested so that the inspectors can understand the centre's activity and organisation and also to check compliance with some of the standards before the on-site visit. The requested documentation includes:  Selection of key SOPs  Evidence of staff training and qualifications  Official facility licences and authorisations  Quality Management Manual or Handbook  Basic evidence that the QM system is functioning  Basic data on recent transplant activity  Consent forms and related information  Sample labels  Plans or maps of the centre  Sample agreements with third-party service providers See below for full details. Language Document should be in the language of the centre since JACIE would expect to assign inspectors that speak and understand the language. However, there may be exceptions to this:  Centre is located in a country where no inspectors are available  JACIE may not have inspectors anywhere that speak the centre’s language  The transplant community in a given country has requested that only external inspectors be assigned to avoid conflicts of interest In these cases we must resort to other inspectors to perform the inspection. For these inspectors, one of the key parts of their preparation is reading documents made available in advance. Without this it is very difficult for them to arrive on-site adequately prepared and this would clearly affect the quality of the inspection. In such cases, JACIE will ask the centre to translate a selection of the documents provided to the inspectors in advance of the inspection and will request the centre to provide local experts to facilitate interviews and understanding of documentation. Please contact the Accreditations Coordinator at jacie@ebmt.org if you have any doubts about this aspect. G-002-09-Pre-inspection documentation guide 1/16 Name of Document: G-002-09-Pre- Creation date: 08/05/2013 inspection documentation guide Effective date: 22/07/2013 Approved by: Eoin McGrath Review date: 18/07/2017 Responsible: Iris Bargalló Modification: new JACIE Office Entry: Pre-Inspection Address & Adapt references to documentation list version6.01 of the JACIE Standards Pre-formatted folder structure The documents are submitted in a pre-formatted .ZIP file ( Pre-audit documentation folders.zip) that contains folders for the various types of documents. The file and instructions can be downloaded from the Document Centre under the "Pre-Inspection Documentation" section. The zip file is organised into a series of folders and sub-folders relevant to each part of the standards: Clinical, Collection –Bone Marrow and Apheresis- and Processing. By following the folder layout, you will be able to group and classify your documents in such a way that the inspectors can easily identify the document and its purpose. See the graphic below to understand how the folders are organised. Please note that you might have to save the same document into more than one folder. This could be because: 1. The document is relevant to two different sections e.g. labelling for collection and for processing 2. A single document might cover several different areas e.g. don

Recently converted files (publicly available):