ISO/IEC 17025:2017 Awareness Series # 10 Clause 6.2 Personnel – Key Questions

ISO/IEC 17025:2017 Awareness Series # 10 Clause 6.2 Personnel – Key Questions

ISO/IEC 17025:2017 Awareness Series # 10 Clause 6.2 Personnel – Key Questions

?? Key Questions for Understanding Clause 6.2 of ISO/IEC 17025:2017 ??

Clause 6.2 of ISO/IEC 17025:2017 focuses on Personnel, a critical factor in ensuring accurate and reliable laboratory results. Asking the right questions can help you assess compliance and strengthen your quality management system. Here are some key questions to consider:

  1. Is laboratory has documented competence requirement for each function influencing the results of laboratory activities?
  2. Are personnel in the laboratory competent to perform specific tasks?
  3. How does laboratory assess and maintain records of their competence – including, education, qualifications, experience, skills, technical knowledge and training?
  4. Is laboratory communicated to personnel their duties, responsibilities and authorities?
  5. Do lab staff fully understand their roles, responsibilities, and authorities?
  6. Are job descriptions clearly defined?
  7. Is there an effective training procedure is in place, including determining training need, provision of training and monitoring the competence?
  8. How does laboratory manage personnel performance?
  9. Is laboratory conducting regular performance reviews and competency assessments?
  10. Does Laboratory have contingency plans in place for personnel shortages or absences for key personnel? How does this impact the quality and timeliness of lab activities?
  11. Does laboratory retain personnel records of all personnel including- competence requirement, selection of personnel, actual competence, training need identification, training provision, supervision of personnel under training, training records, effectiveness of training, monitoring the competence, authorization of personnel?
  12. Does personnel authorizing / reviewing / issuing Laboratory Report / Certificate / Results competent?

By addressing these questions, your lab can ensure that your personnel meet the required competency levels, ultimately supporting the accuracy and validity of results. Clause 6.2 emphasizes the importance of having qualified and competent personnel within a laboratory. It requires laboratories to clearly define roles, maintain detailed competence records, ensure proper training and evaluation, and formally authorize personnel for specific tasks. The goal is to ensure that all lab activities are carried out by individuals who have the necessary knowledge and skills, thereby maintaining the reliability and accuracy of testing and / or calibration results.

If you have any further questions or insights? Drop them in the comments below!

#ISO17025 #LabManagement #QualityAssurance #LabExcellence #Testing #Calibration # Caluse6 #Resource Management #QualityManagement #Accreditation #competence

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Aswadh Infinite - NABL CONSULTANCY

ISO 17025:2017 Testing and Calibration Labs;ISO 15189:2012 Medical Testing laboratories ; Medical Testing laboratories of RT-PCR RNA Virus/ COVID-19; ISO 9001:2015: Quality management systems — Requirements

6 天前

Very useful questions regarding the personnel and training

回复
Chandrashekhar Ganiger

Assistant Manager Supply Chain Quality, Senvion Wind Technology

4 个月

Very helpful

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Rama Venugopal

30 years exp in Business Consulting, Management Systems Consulting, Strategic Consulting

5 个月

Important and Fundamental question to ask is : - what is regulators definition when it comes to personnel qualification, their engagement in CABs. Regulatory spec in many sectors is clear on this spec. They have specified clearly what should be the engagement of technical personnel - core (signatories) orbotze technical personnel. So, nature of their engagement has to be spelled out very clearly by CABs and the same can be shared by ABs to Regulators for clarification when in doubt. FAQ should address this engagement too - fulltime, parrtime, contractual etc . Let Regulators confirm that all these models are acceptable

Mirza Ghufran Ali

Seller Support & Operations||Sanction compliance|| Coupon approval|| Risk Operations|| Reseller Risk|| Loyalty||Negative Wallet|| Reseller Validation||Quality Audit||FC Operations|| Reverse logistics

5 个月

Very informative sir

MIRZA FARMAN

Teaching Professional at Jatpura

5 个月

Very knowledgeable?

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