ISO 17025 Explained

ISO 17025 is among the internationally recognized standard that is about testing and calibration laboratories majorly consisting of the detailed set of requirements for testing and calibration laboratories to be fully complained with Quality Management system.

Structure of ISO 17025

The structure of ISO 17025 comprises of five clauses which are stated below:

  • Scope: Covers scientific and technical requirements that ensure lab is working according to prescribed quality standards.
  • Normative References
  • Terminologies and Definitions
  • Management Requirements: covers documentation and its procedures, Document Control, Corrective Actions, Preventive Actions and Internal Audits and Gap closures.
  • Technical Requirements: Covers testing and validation methods, Uncertainty methods and its estimation, measurement criteria and results traceability.

The two major sections of ISO 17025 are Clause 4 “Management Requirements” and Clause 5 “Technical Requirements”.

Testing and calibration laboratories work within rigid guidelines and are responsible to deliver accurate and precise results for mainly following tasks:

  • Identification of Samples
  • Labeling of Samples
  • Testing of Samples
  • Analysis of Samples
  • Documentation of test results

ISO 17025 Certification Process Steps

ISO 17025 Certification Process Steps Explained Briefly:

  • Hire an ISO Consultant
  • Conduction of Gap Analysis via Internal Audits
  • Gap Closures
  • Implementation of Quality Plans and Strategies
  • External Audits
  • Certification

What Is the Purpose of Laboratory Accreditation?

ISO 17025 Accreditation is a voluntarily, third party re-viewed process and can be only granted by an accreditation body where a laboratory’s quality management system is deeply reviewed and evaluated to check the technical competence and compliance of testing and calibration bodies.

Difference between Certification and Accreditation

Certification involves third party attestation related to products, processes and systems while Accreditation covers third party attestation linked with conformity assessment body that checks testing and calibration body competence to carry out specific conformity assessment.

The Never Ending Journey to Continuous Improvement

How ISO 17025 Includes Corrective and Preventive Actions?

Clause 4.11 “Corrective Action”

4.11.1: Procedure for implementing Corrective Action

4.11.2: Cause Analysis – Investigation of root cause

4.11.3: Selection and implementation of Corrective Action Selection and implementation of most suitable Corrective Action. Document and implement any changes as result of Corrective Action

4.11.4: Monitoring of Corrective Action

4.11.5: Additional Audits (if needed)

4.12:  “Preventive Action”

4.12.1: Identification and implementation of Preventive Actions

4.12.2: Procedure for Preventive Action shall include initiation and control

Process Steps of Corrective Actions:

Following are the process steps of Corrective Actions:

  • Root Cause Analysis: For detailed root cause analysis, it is important to find the actual root cause by correctly investigating the issue. A cross-functional team should be formed so that each and every aspect of the problem can be investigated.
  • Analyzing Non-conformity: Every potential non-conformity (whether it is major or minor) having the chance of potential occurrence or re occurrence must be addressed by Corrective Action team.
  • Selection and Implementation of Corrective Actions: Screening out of all selected corrective actions must be carried out by Corrective Action Team under some senior’s supervision so that right decision can be made and appropriate corrective actions can be implemented to problem resolution.
  • Corrective Actions’ Monitoring: After implementation of corrective actions, observe and record the effects of implemented corrective actions and specifically keep a check on re-occurrence of the same problem.
  • Additional Audits (if needed): Carry out additional audits if gaps analyzed during internal audits are higher in quantity or leads to any major non-conformity.

Process Steps of Preventive Actions:

  • Facts and Figures Collection for Non-conformity: Collect data for all potential non-conformity that have occurred or might occur in the process and has the probability to negatively affect your certification system.
  • Root Cause Analysis: The root cause (not quick fixes or immediate solutions) should be determined by Preventive Action team and devise a list of preventive actions that can be taken to prevent the re occurrence of non-conformity. It has additional advantage of saving cost, time and money spend on repetitive issues.
  • Screening out Selected Preventive Actions: Among all the enlisted Preventive actions devised by Preventive action team, it is important to screen out the best preventive action. During selecting the best preventive action, the selected preventive action should be sustainable and long lasting so that re occurrence of non-conformity should be prevented.
  • Preventive Actions Monitoring: After implementation of selected preventive actions, it is advised to closely monitor the impact after making preventive actions live in your system.
  • Record Keeping of Preventive and Corrective Actions: Maintain a record after implementation of corrective and preventive actions so that a trend, behavior and the reaction of your system can be seen quantitatively and qualitatively also. Record keeping of corrective and preventive actions will further assist you in making decision of screening out best corrective and preventive actions strategy.
  • Corrective and Preventive Actions Evaluation: After record keeping, monitoring the performance of corrective and preventive actions it is preferable for Quality Assurance department to evaluate the result of corrective and preventive actions periodically. The periodic evaluation report should be presented in Management reviews and the minutes of meeting should be kept and saved that will come into use during Audit reviews.

Top Five Core Benefits of Being ISO 17025 Accredited Laboratory:

  • Better Position in Market
  • Risk Minimization
  • Cost and Waste Reduction
  • Enhanced credibility
  • Better Trust

Why Having Continuous Improvement Cycle Embedded in Your System?

The sole purpose of having continuous improvement cycle  and Six Sigma Quality Management in your current management system is to ensure never ending process of getting things better on daily basis. Moreover, one can check the current level of sustainability of Quality Management System (QMS) in one’s organization. The benefits of having continuous improvement cycle is as follows:

  • Remain Up to date About Feedback data of Improvements Being Carried Out
  • Possess Data Bank from Multiple Areas to assess QMS sustainability
  • Evaluation of QMS effectiveness
  • Seeking other untapped opportunities for improvement
  • Kicking off continual betterment via Corrective and Preventive Actions
  •  Review and verification of effectiveness of implemented Corrective and Preventive Actions
  • Reduction in number of non-conformity present in the system
  • Ease in certification or re-certification for ISO certification
  • Minimization of Customers’ complaints leading to meeting and going beyond customers’ requirements

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