Steps for ISO 17025-2005 Accreditation Consultancy
We are globally leading ISO 17025-2005 accreditation consultancy firm and so far more than 50 laboratories had got ISO/IEC 17025 accreditation with our help from leading ISO/IEC 17025 MRA accreditation body like IAS, DAC, NABL. UKAS etc. Our clients are in material testing, metal, chemicals, water, instrument calibration, effluent, air testing, radiation, geological esting, cement, concrete, asphalt etc. Below are the steps we follow for smooth execution of ISO 17025 accreditation within 4 to 6 months for our clients.
- Conduct ISO/IEC 17025awareness program (All employees).
- Micro level survey and discussion with team for preparation of documents.
- Identify and define Quality Manual, Procedures and other documents
- Define quality policy and establish quality objectives
- Prepare documents of ISO 17025 quality system.
- Implementation & train all personnel in the use of procedures & formats.
- Application for ISO 17025 accreditation
- Train internal auditors.
- Assess the system through first internal audit for ISO 17025 certification.
- Take corrective actions for non-conformities and review system through management review meetings
- Adequacy of Quality Manual by accreditation body
- Assess the system through second round of internal audit.
- Avail pre-assessment audit by certifying body.( Optional)
- Take actions on suggestions given by them.
- Final Assessment of ISO 17025 by accreditation body
- Take corrective actions on findings and suggestions given by auditor in final iso audit
ISO 17025 Consultancy phases for Global Clients
Following Phases are involved in actual implementation of ISO 17025 2005 under ISO 17025 consultancy for global clients during visits of our consultants at the laboratory site.
Phase-1 Kick off meeting - micro level survey, gap analysis and ISO 17025 awareness training to all staff and preparation of record templates.
Phase-2 Offside document preparation by our consultant in our office (implementation of gap analysis findings and change in system as per suggestions.)
Phase-3 Implementation follow up, Calibration advice as well s training, internal auditor training, uncertainty measurement training, method validation training and finalization of documentation. Apply to certifying
Phase-4 1st internal audit as per ISO17025. measurement Uncertainty; Inter lab result or PT program analysis and take corrective actions
Phase-5 Action on adequacy audit report and witness testing for assessment agenda
Phase-6 Management review, mock audit and assess status of implementation and identify problems if any
Phase-7 Final assessment by accreditation body
Phase-8 Take corrective actions on findings and submit evidences to certifying body.
ISO 17025 Accreditation Process
- Review globally ILAC/APLAC recognized MRA international accreditation body gives ISO/IEC 17025 certificate.
- Selection of accreditation body.
- Submit initial application to ISO 17025 certification body.
- Adequacy audit of documents offsite by accreditation body.
- Pre-registration audit (optional)
- Final accreditation audit by ISO 17025 certification body.
- During audit the test methods needs to be demonstrated as per details below.
Test Methods to be demonstrated:
- Test to be demonstrated
- Test report for review by assessors
- Purchase reagents review as per ASTM/BS or applicable test standards
- Equipment review
- Calibration records review
- Intermediate checks
- Review maintenance and calibration records.
Where test methods require samples to be conditioned for certain duration, these need not be demonstrated. Test demonstrations may be accomplished by using test specimens specifically prepared by the laboratory for this purpose, or the demonstration tests may be actual tests conducted for a client.
- Submit corrective actions on findings of the audit
- Annual surveillance audits by ISO 17025 certifying body
Management Role in ISO 17025 Implementation
- Full involvement and commitment.
- Identify the staff members who will be leading and coordinating the project. (selection of quality leader and technical leader)
- Visionary and make Quality Policy.
- Establish your timeline for implementation
- Set SMART targets / Quantifiable objectives of Departments / functions / etc.
- Attend management review meetings (Once in six month) and ask for non achievements (justification or actions )
- Interested in more analysis of data and ask for improvement
ISO 17025:2005 Accreditation is not For Those -
- Who hate documentation
- Who resist assessment / Audit
- Who hang on to their own ways of working
- Who has built wtrong walls / compartments
- Who identify a “PROBLEM” in every “SOLUTION”
- Who treat temporary solution as “PERMANENT ONE”
- Whom “WHO IS WRONG” is more important than “WHAT IS WRONG”
- Whom “RESULTS” are more important than “PROCESSES”
- Whom “TEAM WORK” means “YES” master