SPRING DISCOUNT
Get 30% off on toolkits, course exams, and Conformio yearly plans.
Limited-time offer – ends April 25, 2024
Use promo code:
SPRING30

Search results for "iso17025 vs gmp"

Home / Search

Category:
Select
Select

1218 results

Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • What is the acceptable range of RH for a laboratory? 

    I would like to ask you a question. The ISO17025 standard has a clause that explains how important environmental conditions are for a lab. What is the acceptable range of RH for a laboratory?

  • Requlatory Requirements for a DNA testing lab

    Hi, I am in the process of starting a DNA testing lab in Canada, but I’m unsure of the regulatory requirements for offering my testing services to other businesses in Canada. Specifically, I am interested in offering microbial identification services to GMP pharmaceutical companies. I have worked for a pharmaceutical company in the regulatory side of the business (QA) and in QC (microbiology) and I am well versed in GMP requirements for the pharmaceutical industry. However, I have very little knowledge of what is required of outsourced labs that process samples that they receive from GMP pharmaceutical companies. I assume accreditation is mandatory for outsourced testing labs. Is ISO 17025 the relevant accreditation? Is it possible to speak to you or send follow up questions to better understand the regulatory framework for a DNA testing lab in Canada?

  • Calling organization's products after certified ISO 13485 QMS in place

    With a certified ISO 13485 QMS in place  which is in alignment to national regulatory body as well (though not audited by national regulatory body), can an organization call its products:
    1. GMP grade products or
    2. ISO13485 conforming products or
    3. ISO 13485 and GMP conforming products
    Note: I have not used the word compliant for GMP since as I understand that the organization needs to be audited by regulatory body to claim the same?

  • Pulverizing samples

    According to iso17025 how many samples can be pulverized in 10 hours for 8 min per sample?

  • ISO 17025 accrediting

    could you please me explain ISO17025 on the following main issue: I want to get accredited my company *** according to ISO17025 for analytical radiocarbon dating services. Is it possible to get accreditation, if our company do not have ISO9001, and do not have own equipment and facilities, needed for that service? But we have employed high-skilled personnel and providing this services for two years borrowing needed equipment and facilities (which meet needed requirements).

     

  • Questions related to accreditation and calibration

    ... number of ISO17025-accredited certificates.

    3. One last question, we use a subfraction of an ISO 12103-1 standard dust for calibrating our dust monitors. Does this material need to be tested (particle distribution) by an ISO 17025 accredited laboratory? we have a particle distribution from a non-accredited lab for the material. I am concerned that as we are using it as a reference material we would need to have an accredited certificate of the particle distribution.

  • Checklist to see if we should become ISO 17025

    I was wondering if you could assist.  I’m looking for a check list of sorts to be able to determine what I would need to do in my department to see if we should become ISO17025.  Is that something that exists?  I’m not looking to go on a course to find that out.  I’m more on a fact finding mission at the moment.

     

  • Can a process be ISO 17025 certified but the lab where the process was done is not ISO 17025 certified?

    Can a process be ISO17025 certified but the lab where the process was done is not iso17025 certified?

  • Do I need ISO 17025 certification in order to audit laboratories?

    I am a molecular diagnostics lab expert with decades worth of experience. I am also well versed in ISO17025.I am interested in ISO9001 lead auditor certification. My question is, as a lab expert, do I also need ISO17025 certification in order to audit laboratories? Or is 9001 is sufficient? Thank you
Page 3 of 122 pages

Didn’t find an answer?

Start a new topic and get direct answers from the Expert Advice Community.

CREATE NEW TOPIC +