Basic Lab Practices - related to ISO 17025 testing labs

R

Raulinho

Registered
#1
#1
Hi,
We are an ISO 17025:2017 accredited lab. One of our corrective actions involves a basic/fundamental error where a test was being performed and the sample was poured back into the source container. It was flagged as a deficiency, rightfully so. I have ruled out using GLP (Good Laboratory Practice) guide since it does not explicitly reference the treatment of samples/discarding after use etc.

I am struggling to find a standard from a reputable body to address this corrective action since it is a basic chemistry and lab principle. Can anyone point me in the right direction?

Thanks.
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
D

dwperron

Trusted Information Resource
#2
#2
ISO 17025 covers this in sections 7.4.1:
"Precautions shall be taken to avoid deterioration, contamination, loss or damage to the
item during handling, transporting, storing/waiting, and preparation for testing or calibration "
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
D Profile callout to a basic dimension calculation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
T PMCF Surveys for Class II a devices: basic requisites EU Medical Device Regulations 0
T PMCF Surveys for Class II a devices : basic requisites CE Marking (Conformité Européene) / CB Scheme 0
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
D Basic udi-di to not appear on IFU? EU Medical Device Regulations 4
T Customer Rejecting Part for Basic Dimension Inspection, Prints (Drawings), Testing, Sampling and Related Topics 16
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
A Basic UDI and UDI-DI for hip implant systems EU Medical Device Regulations 1
P Basic UDI-DI and Legacy Devices EU Medical Device Regulations 19
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 8
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 8
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
J How to measure a Critical Characteristic that is a Basic Dimension Misc. Quality Assurance and Business Systems Related Topics 6
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
L Unacceptable risk for basic safety prior to or after mitigation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
Marc Basic - How to Start a New Discussion Thread Elsmar Xenforo Forum Software Instructions and Help 1
S Basic Dimension W/O using FCF Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
V Carbon Black (Master Batch) - Basic Requirements Manufacturing and Related Processes 5
P Basic Minitab Help - It's about Linear Regression Using Minitab Software 1
L Lean Book for Basic Knowledge Lean in Manufacturing and Service Industries 2
L Seeking help in Basic Maintenance Knowledge Manufacturing and Related Processes 4
M "Basic Safety" versus "Essential Performance" IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
M Use of Excel and VBA (visual basic for applications) in quality systems Excel .xls Spreadsheet Templates and Tools 3
P Basic questions about earning TSOA (Technical Standard Order Authorization) and PMA Federal Aviation Administration (FAA) Standards and Requirements 2
J Excel spreadsheet to use Basic and Mini MOST for Line Balancing Document Control Systems, Procedures, Forms and Templates 1
T How to report Basic Dimensions on a Dimensional Report (ISIR) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A Basic ISO 13485 Training Material ISO 13485:2016 - Medical Device Quality Management Systems 5
M Basic Dimensions on Machining Prints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Basic International Standards required for a Manufacturing Industry (Optical Media) Other ISO and International Standards and European Regulations 4
L How to set up a basic electronic test equipment calibration laboratory General Measurement Device and Calibration Topics 3
R Rejecting a Part when Dimension Feature is Basic Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
O Metrology Devices to Measure the Basic Dimensions of Plastic Specimens General Measurement Device and Calibration Topics 6
F ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
E How can I measure three true positions? GD&T basic question General Measurement Device and Calibration Topics 5
M SPC, Moving Range Chart and Weighted Graph Basic Questions Statistical Analysis Tools, Techniques and SPC 1
T Basic Document Control Database (Excel/Access) Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom