Technical Steps to ISO 17025 Accreditation

ScottBP

Involved In Discussions
#1
I’ve done internet searches for “Steps to becoming 17025 accredited”, and the vast majority of the results are about getting administrative things in order like the quality manual, document control, approved vendor lists, training records, customer feedback, etc., but I'd like to see more details for getting technically prepared. I'm thinking the steps would go something like this:

1. Decide which parameters are to be accredited (are they customer or industry driven?)
2. Identify which lab equipment can produce the lowest uncertainties for those parameters
3. Work up uncertainty budgets for each range/parameter that will be added to the Scope of Accreditation
4. Establish traceability; i.e. ensure the lab equipment has accredited calibrations to start with
5. Document the parameters in a draft Scope of Accreditation, following guidance by the Accreditation Body chosen by the company
6. Identify which units under test (UUTs) can be used to demonstrate each of the parameters
7. Identify which lab technicians are qualified to demonstrate the parameters (be able to provide training records to an assessor)
8. Do sample accredited calibrations on those same UUTs which are used to demonstrate the parameters
9. Go over assessment checklists to make sure everything is in place

Is there anything else I can add?
 
Elsmar Forum Sponsor

dwperron

Trusted Information Resource
#2
Assuming you are working from the new Draft version of 17025 (this is the document you will need to work with) I will chip in with these other items to be considered:

* Suitability of laboratory environment
* Define your training program
* System of intermediate checks for your standards (cross checks)
* Proficiency test program for all disciplines in your scope
* Procedures. Validated unless you are directly using internationally recognized procedure
* Test report - Verify that all required elements are included
* Determine your decision rule for pass/fail interpretation
* A program to deal with Nonconforming work

Other areas fall into that gray region of not being "technical" but is still technical, like contract review with customers, establishing approved vendors, maintaining data integrity, impact analysis and recall system, stuff like that.

Also, chances are that the accrediting body (AB) you choose to work with will have their own individual requirements. Check with them, they will guide you into what they will be looking for. They most likely will have a checklist for you to follow.

Good luck!
 
Thread starter Similar threads Forum Replies Date
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 2
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
V Iso13485 certification vs CE technical audit ISO 13485:2016 - Medical Device Quality Management Systems 3
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
F Recommended practice for furnishing Technical Procedures ISO 17025 related Discussions 1
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Special Processes - Technical reason concerning torque - Anaerobic compounds Manufacturing and Related Processes 10
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
M Medical Devices and ASD-STE100 (Simplified Technical English) Other Medical Device Related Standards 0
B IATF 16949:2016 – Technical Specification (eBook edition) IATF 16949 - Automotive Quality Systems Standard 1
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
I MDD Class I software technical documentation sample EU Medical Device Regulations 2
M Annex II - Technical Documentation. V&V, Performance and Safety EU Medical Device Regulations 3
TechnicalGuy Technical File Review - Transfer to a new NB EU Medical Device Regulations 3
J Brazil - Submitting Technical Files Other Medical Device Regulations World-Wide 2
A CTD (Common Technical Document) for a Topical Preparation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 3
S. Moore Technical or Systemic cause for 8D Nonconformance and Corrective Action 7
Q New Casting Supplier System Assessment - What technical questions to ask? Supplier Quality Assurance and other Supplier Issues 3
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3
D MDR and Summary Technical Documentation Files EU Medical Device Regulations 13
B Gap analysis of new start-up company technical documentation CE Marking (Conformité Européene) / CB Scheme 1
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9

Similar threads

Top Bottom