Questions on Accrediting - How can I gurantee that the lab is independent?

M

mikca99

#1
We plan to acreditate some tests in our lab.
How can I gurantee that the lab is independent from all other departments?
Now we have our HW and SW engineers running in the lab doing their engineeringtests
during development. The 1st customer will be the developing project on the company.

Can testengineers support developing projects with non-acredited tests and
on the validation test period with the acredited tests?
Are there requirements on the locals and instrument used for acredited test?

All viewpoints are welcome.

Best Regards Mikael
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
Mikca99,

That is a good question, and one that we run into often here in the U.S. Let me suggest that you run the same question by SWEDAC first and get their rules regarding the independence of an internal test lab.

They will be your accrediting body, so they may be the best source of help for your question.

Hope this helps.

Hershal
 
Thread starter Similar threads Forum Replies Date
C UDI Questions on Control Units Other US Medical Device Regulations 6
M NFPA 70 electrical harness questions Various Other Specifications, Standards, and related Requirements 2
L Project Managers - Questions For You Career and Occupation Discussions 0
B Toyota PPAP Process - Three Questions APQP and PPAP 3
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
D Signature Matrix questions ISO 13485:2016 - Medical Device Quality Management Systems 4
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
D Shipping and recall questions ISO 13485:2016 - Medical Device Quality Management Systems 2
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
T AMS2570E certification equipment questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
Q Asset / Tooling Management - Two Questions Manufacturing and Related Processes 3
Q VDA 6.3 questions vs IATF 16949 clauses VDA Standards - Germany's Automotive Standards 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
C CQA Test Questions Bank General Auditing Discussions 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational EU – MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Beginner in ISO 45001 here! Three questions Occupational Health & Safety Management Standards 6
D Framing FDA Questions - Validation US Food and Drug Administration (FDA) 1
M Informational US FDA – Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
F Barcoding questions - Is there a plain English primer for newbies? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Informational EU – MDCG 2019-6 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 14
A Purchasing - Internal Audit Questions Internal Auditing 8
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
F Job Travelers questions - unsigned operations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
G Auditor watching tech do procedure - Can tech ask questions? ISO 17025 related Discussions 6
A Any recommendation for ASQ's CPGP (Pharmaceutical GMP Professional) Certification exam questions? ASQ - American Society for Quality 2
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 22
S SPC (Statistical Process Control) for Unilateral Tolerance - Questions Statistical Analysis Tools, Techniques and SPC 6
Ed Panek CE REP questions about our devices ROHS compliance REACH and RoHS Conversations 1
O Reinstating a disqualified supplier—questions to ask before making a decision Supplier Quality Assurance and other Supplier Issues 2
S Two Questions about Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom