SBS - The best value in QMS software

Analytical Environmental Laboratory ISO 17025 Registration Scope

H

Hanged

#1
well let's say that there's a lab only perform some tests related to environment such as ( oil , Soil and Gas tests ) they do more than 30 different test according to the customer requirment ..

they are wish to be ISO17025 certified .. so my question is should the scope of the certificate include all the 30 tests ? so the lab should have a procedure of each test including the technical elemnts like method selection and validation , testing , handling , reporting .. etc

or what ?

waiting your answers
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
Re: About analytical environmental lab

If the lab is going for accreditation, I would say start with the "bread and butter" then add the remaining standards in a scope expansion.

However some of that will depend on the accrediting body (AB) selected. If the lab is in the U.S. there are several and the lab should not select one until a thorough examination is made of all 6.

Starting with a smaller scope makes the accreditation process easier to control in general, and will likely reduce the number of technical demonstrations to be observed, thus saving some money perhaps.

Hope this helps.
 
H

Hanged

#3
Thanx alot ..

so the lab should choose the basic tests to add to certificate scope

in such a case .. can they put a " generic " technical procedures to handle all tech. requirments in ISO17025 standard .. and develop some work instruction for every single test .. or should they create a procedure for every test ?

for example the lab will create a procedures titled : Test Method & Method Validation contains a generic steps about how the operators select the different method according to the type of the test and how they validate that method they selected ..

and on the other side the lab will creat a specific WI about a single test which is included in the scope specify all the required tech. steps from the Sampling to Reporting ..

waiting for your valuable answer :agree:
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
Where possible, use published methods and if the customer needs a different test point but the published method can otherwise be used that is easy to work with.

If the laboratory develops its own methods then those must be validated before they can be used for tests under the scope. A working procedure distilled directly from a published method and referenced back to that published method however is generally considered validated.

If sampling is consistent in the method and plan across the tests conducted, a single procedure for that can suffice. If each type of test has different sampling requirements however then put it in the applicable procedure.

Where are you at in terms of preparation? Just starting, almost ready to go for accreditation, or some point between? There may be much more information that can be suggested depending on that. Also, this board (17025 board) has several discussions regarding various aspects of preparation. You may find some good tips in other messages also.

Hope this helps.
 
Thread starter Similar threads Forum Replies Date
B Analytical Lab Environmental Condition (Temperature & Humidity Control Limit) General Measurement Device and Calibration Topics 5
R Tolerances for Analytical Balances General Measurement Device and Calibration Topics 1
D Tolerance when verifying an analytical balance General Measurement Device and Calibration Topics 3
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
M Analytical Test Instruments Used in V&V Manufacturing and Related Processes 2
K QMS Software Recommendations for an Analytical Laboratory General Measurement Device and Calibration Topics 2
V For Analytical Laboratory Equipment, is PQ = Calibration Criteria? Qualification and Validation (including 21 CFR Part 11) 2
K Validation of an Analytical Method that relies on Multi-Variate Calibration General Measurement Device and Calibration Topics 7
V Pharmaceutical Analytical Method Validation and Gauge R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
V Drift and Variation over Time of an Analytical Balance. Qualification and Validation (including 21 CFR Part 11) 2
K Do we need to perform Analytical Method Validation upon Relocation? General Measurement Device and Calibration Topics 5
AnaMariaVR2 Innovation In Assays And Analytical Methods Urgently Needed [article] US Food and Drug Administration (FDA) 0
I Statistical Stability for the PQ of Analytical Equipment Qualification and Validation (including 21 CFR Part 11) 1
A Writing a Procedure for Validation of an Analytical Method General Measurement Device and Calibration Topics 5
J Log Book for Analytical Balance Calibration Verification General Measurement Device and Calibration Topics 4
H Analytical Balance Calibration and Verification General Measurement Device and Calibration Topics 9
Q FDA Bacteriological Analytical Manual (BAM) - Health Care Items Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Flexural Strength Testing - Analytical Laboratory recommendations for Testing Alumina Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Q Analytical Tools to increase or improve Analytical Skills Problem Solving, Root Cause Fault and Failure Analysis 1
V Operating Range & Calibration for Analytical Balance General Measurement Device and Calibration Topics 3
E Process Capability Analytical Tools Statistical Analysis Tools, Techniques and SPC 1
F How to determine Minimum Weight of analytical Balance Measurement Uncertainty (MU) 11
smryan Analytical Scale - Seeking brand and buying advice General Measurement Device and Calibration Topics 7
G Analytical Balances - Looking for Variance Source Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
J Association of Analytical Communities validation study data - How deep should I go? General Measurement Device and Calibration Topics 1
Geoff Cotton NWA (Northwest Analytical, Inc.) SPC software - Your Opinion, Review and Experiences Statistical Analysis Tools, Techniques and SPC 2
C Time Crunch on ASQ's More Analytical Exams Professional Certifications and Degrees 12
O Analytical Method Transfer Approval and Use Document Control Systems, Procedures, Forms and Templates 4
B Validation vs. Confirmation in the context of an Analytical Laboratory General Measurement Device and Calibration Topics 10
C AIAG Attribute MSA - Analytical Method - Page 135 of MSA manual 3rd edition Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
R Document for daily check of analytical balance and criteria General Measurement Device and Calibration Topics 2
R MSA Analytical Method Acceptance Criteria and Requirements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P Pareto Charts - Analytical tools - Form Attached Quality Tools, Improvement and Analysis 5
H Food and Drink in Production Areas - Manufacturer of FDA analytical and diagnostic ISO 13485:2016 - Medical Device Quality Management Systems 5
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4
S Laboratory Environmental Conditions Outside of limits ISO 17025 related Discussions 4
A How to address Environmental & OHS Opportunities? ISO 14001:2015 Specific Discussions 6
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
I Environmental Policy Content - ISO 14001 Clause 5.2 ISO 14001:2015 Specific Discussions 2
dhuot1990 Issues with REES Environmental Monitoring System Manufacturing and Related Processes 1
K How to verify the Storage and Transport environmental condition for Medical Device Miscellaneous Environmental Standards and EMS Related Discussions 3
D Templates for Environmental, Safety and quality Management System wanted Document Control Systems, Procedures, Forms and Templates 3
M What is Environmental intelligence specific to IVDs or Medical devices? Miscellaneous Environmental Standards and EMS Related Discussions 1
A Environmental Management System Lead Auditor Competence ISO 14001:2015 Specific Discussions 2
W Organizational Responsibility for Environmental Compliance of Products REACH and RoHS Conversations 4
M PDCA cycle - Process mapping - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 1
V Environmental aspects in a bank ISO 14001:2015 Specific Discussions 7
C Legal or Regulatory Requirements as identified in our Environmental Aspects ISO 14001:2015 Specific Discussions 9

Similar threads

Top Bottom