ISO 9001 Lab Accreditation has specific mandatory requirements for labs and running lab operations that need to be fulfilled while preparing for audit satisfaction and certification.

ISO 9001 Audit Checklist Preparation for Labs

Laboratories do operate under two working conditions. First, lab either work in any of the organizations to perform and validate various relevant tests needed for that organization or labs can work as independent third parties to perform tests and validate results without being affiliated with any organization.

If any of the previously stated condition of the working condition of labs is being followed, then few process steps have to done sequence wise as mentioned below:

  1. Test Samples Receiving
  2. Test Samples Classification
  3. Testing Preparation
  4. Test Analysis
  5. Test Reports

In order to produce precise test results, labs need to take the following steps so that tests can be done in the right direction and being done flawlessly along with complete documentation system, competent lab staff to perform tests and validate the results, maintenance staff for lab equipment maintenance and calibration, proper traceability criteria and management for test results.

Sections of Lab Quality Standards

Following are sections of lab quality standards:

  1. Organization and Management
  2. Quality Management System
  3. Human Resources
  4. Lab Safety
  5. Lab Equipment
  6. Procurement and Supplies Management
  7. Information Management
  8. Management of Lab Specimens
  9.  Complaints’ Resolution
  10. Outbreak Alert
  11. Lab Network

ISO 9001 ISO 9001 Lab Accreditation Checklist

  1. Risk and Opportunities related to operations of laboratories
  2. Objectives and Targets of the lab and plan to achieve those objectives and targets
  3. Requirements of resources along with their provision plan to perform smooth lab operations.
  4. The competencies building of lab staff who perform tests and analyze it
  5.  the fitness record of testing equipment
  6. Calibration records of testing equipment
  7. Maintained documentation system for processes of lab
  8. Defined Sample taking criteria and relevant information required for the classification of samples and their identification
  9. Retention of information for test results
  10. Control of Non-conforming test results

Technical Competency Building of Lab and its Staff

The technical competency building of lab staff usually depends on the following factors:

  1. Educational qualification, Training, exposure and experience of lab staff
  2. The right equipment for the lab which is appropriately calibrated and well-maintained
  3. QA and QC Adequacy
  4. Sampling practices
  5. Testing and inspection procedures
  6. Precise reporting and recording of data
  7. The testing environment of the lab as per standard

Steps to Develop and Implement Quality System

  1. Quality Policy
  2. Mission Statement
  3. Quality Plan
  4. Implementation of Policy
  5. Quality Manual
  6. Policy, Plan, and application of standard
  7. Procedures, development, and use of SOPs
  8. Work Instructions
  9. Methodology to carry out specific tasks
  10. Training of Staff
  11. Quality System implementation with the help of SOPs
  12. Monitoring and Evaluation
  13. Assessment of quality and correction process

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Benefits of ISO 9001 Lab Accreditation

Accreditation is defined as the process for providing recognition in the form of accreditation to acknowledge its technical and administrative competency and its conformity assessment tasks, which includes testing, certification, and inspection. Accreditation is also applicable to calibration laboratories, proficiency testing, and manufacturing of certified reference materials while certification is the third party attestation relevant to products, processes, systems, or staff.

Advantages of ISO 9001 Accreditation

 The benefits of getting ISO 9001 Lab Accreditation is not only limited to laboratories only, but it has expanded to local regulators, to consumers, and to the industrial trade sector too.

  1. For labs to be accredited to ISO 9001, it demonstrates the ability and high competency level to lab’s potential clients to exhibit accuracy, precision, and reliability of the lab results.
  2. For regulators, by ISO 9001 lab accreditation provides a reliable and impartial basis for flawless decision making and risk management.
  3. For consumers, ISO 9001 accreditation is a kind of guarantee for reliable and comparable test results, and it increases the products’ reliability.
  4. For industry and trade, ISO 9001 accreditation gives a competitive advantage that can successfully remove the need for recurring testing and helps in trade facilities.

While auditing any lab against ISO 9001, auditors will always check the conformity by using a checklist to verify the effectiveness whereas laboratories need to maintain complete documentation of all the processes that are being conducted in the lab for sample testing.

The whole concept of ISO 9001 audit in labs is to seek any non-conformance existing in the lab operations be it technical or administrative or to highlight any opportunities for improvement. The lab operations should conform to the documentation provided by the lab staff as evidence to satisfy the audit purpose.

Here, the auditor will raise the questions to verify the competency of lab staff who are performing tests on a routine basis, as stated in Clause 8 of ISO 9001. Auditors will raise concerns where they will found any observation of non-conformity.

Even ISO 9001 Quality systems can be applied to medical testing laboratories too very effectively. The improvements in business quality and improvement have been observed after religiously implementing ISO 9001.

The improvements have been observed in technical grounds of lab operations, quality of service provided by labs, and overall betterment in the lab business were the outcomes of ISO 9001 implementation of lab practices.

ISO 9001 implementation in a lab network can be done with minimum cost investment too hence making the process more feasible and technically sound for the business owners, stakeholders, regulatory bodies, and for customers also. However, the significant impact is seen when it is applied to the whole organization and all its departments.

Get the ISO 9001 Certification Cheat Sheet.