VERTICAL ASSESSMENT INSPECTION ISO/IEC 17020:2012

Transcription

1 VERTICAL ASSESSMENT INSPECTION ISO/IEC 17020:2012 Organisation s SANAS No/s. Date/s of evaluation Name of Organisation Organisation Representative Area/Field of Accreditation as per schedule of accreditation Assessor/s & Observers Technical Signatory / Inspector performing this inspection (If the technical signatory and inspector is not the same person, please record both names) 1 2 Note: ISO/IEC paragraph number referenced on the left Technical Signatory Inspector Technical Signatory Inspector Please tick 7.4a Inspection Reports and Inspection Certificates - General (Select one or more final Report / Certificate) a) Identification of report or certificate? b) Date of issue? c) Applicable Inspection Methodology/Scope, as per Scope of Accreditation? d) Inspection method? e) Description of work ordered? f) Sub-contractor s results clearly identified if applicable? g) R 04 SANAS symbol correctly used? (not applicable at initial assessments) h) Electronic signature correctly applied as per SANAS Policy (PM 01, paragraph 10)? 7.4b Inspection Reports and Inspection Certificates QA X-Ray specific items a) Description of work ordered? The IB must ensure that the complete imaging chain is covered (see 6.11, STC ) b) Process in place that verify that report was submitted to client and compliance to 7.3.2a (Electronic Submission) c) All the relevant tests were performed d) Data captured is sufficient (complete with settings (kv, ma, exposure time, focus detector/phantom distance, field size) test setup, etc) for another IB to reproduce results in follow-up SANAS Page 1 of 6

2 Assessor's Notes (This may be used for rough notes as well) SANAS Page 2 of 7

3 7.3 Records a) All raw specified data, calculations and derivations available and correct? b) Traceability of all results to the performing inspector? c) Records contain sufficient information to permit satisfactory evaluation of the inspection? d) Data transfers checked and correct? Are data transfer control checks appropriate and effective? e) Records permanent - no pencil, erasure fluid, and all corrections made in such a manner that original records are clearly legible and correction authorised and dated? f) Records safely stored, held secure and in confidence to the customer? g) Retention times defined? 6.1 Personnel a) The inspection body shall employ, or have contracts with, a sufficient number of personnel to perform the type, range and volume of its inspection activities. Is the technical signatory/inspector who performed this inspection permanently employed or does he/she have a contract with the inspection body? If the technical signatory/inspector is a contracted employee, the requirements in b) to f) apply in exactly the same way as for permanent employees. b) Do staff responsible for Inspections have the appropriate qualifications, training and experience and a satisfactory knowledge of the requirements of the inspections being carried out? c) Record of competence of each member of staff performing specific inspection tasks and authorisation to use specific equipment. (applicable Table in TR document) d) Records of academic and other qualifications, training and experience maintained? e) Training system to ensure training with respect to technical and administrative aspects is kept up-to-date? f) R 03 Signatory as per schedule of accreditation? SANAS Page 3 of 7

4 Assessor's Notes (This may be used for rough notes as well) SANAS Page 4 of 7

5 7.1 Inspection Methods and Procedures a) Methods and Procedures used against which conformity can be determined; as per Schedule of Accreditation? b) Methods and Procedures adequately addressed; instructions on inspections, planning, sampling and inspection techniques? c) Non-standard Methods and Procedures appropriate and fully documented? d) Methods, written procedures, instructions, standards, worksheets, checklists and reference data maintained up-to-date and readily available to staff? e) Documented instructions for carrying out inspections safely? 7.2 Handling Inspection Samples and Items a) Are the samples and items to be inspected uniquely identified to avoid confusion regarding the identity of such items at any time? b) Abnormalities recorded and customer informed accordingly? c) Sample preparation. Is this the responsibility of the customer or Inspection Body? d) Documented procedures for the deterioration or damage to Inspection items? e) Samples, if applicable, statistically calculated to be adequate? 6.2 Facilities and Equipment a) Facilities and Equipment suitable to permit all activities associated with the Inspection Body service to be carried out. b) Equipment properly identified? c) Equipment properly maintained. In accordance with documented procedures and instructions? d) Equipment is calibrated before being put to service? e) Equipment is subjected to in-service checks between calibrations? f) Traceability to National or International Standards where applicable? g) Requirements for automated or computerised equipment are being followed? h) Were Non-conformances and corrective actions raised for defective equipment, if applicable to this inspection? SANAS Page 5 of 7

6 Assessor's Notes (This may be used for rough notes as well) SANAS Page 6 of 7

7 6.3 Sub-contracting (pertaining to this inspection) a) Was any part of this inspection sub-contracted? if yes, assess b), c) and d) b) What were the criteria for declaring the sub-contractor competent to perform the service? c) Customer informed of intention to sub-contract part of the inspection? d) Record and details of investigation of the competence and compliance of sub-contractors? 4.2 Confidentiality (pertaining to this inspection) a) Confidentiality of information maintained during the course of this inspection activities? b) Propriety rights protected? 7.5 & 7.6 Complaints and Appeals (pertaining to this inspection) a) Any complaints and appeals with regards to the records being examined? b) Records of complaints and appeals available as well as action taken by the Inspection Body? General/additional comments and matters to follow up at next assessment Was this inspection carried out competently? YES NO Signed: Technical Assessor Signed: Lead Assessor Date SANAS Page 7 of 7