Your Partner For

ISO Compliance Audits, Training & Consultancy

Expert guidance and support to ensure your ISO compliance aligns with international standards, enhances operational efficiency, and upholds the highest levels of quality, reliability, and regulatory adherence.

Services to Support ISO Standards Compliance

At The Knowlogy, we offer comprehensive ISO compliance services to help your organisation meet the stringent requirements of ISO 9001, ISO 17025, and ISO 15189. Our expertise ensures quality management, operational efficiency, and adherence to international standards.

Whether you’re seeking certification, maintaining compliance, or improving existing processes, our experts develop a tailored approach to address your unique challenges and support your long-term quality and regulatory goals.

ISO Compliance Auditing Services

ISO compliance audits are essential for ensuring your organisation meets international quality, safety, and efficiency standards while maintaining regulatory adherence.

Our expert auditors conduct in-depth assessments to evaluate your compliance with ISO 9001, ISO 17025, and ISO 15189, identifying gaps and areas for improvement. We provide actionable insights and recommendations to enhance quality management, mitigate risks, and strengthen operational reliability.

With a comprehensive range of ISO audit services, including focused ISO audits for specific compliance areas, ISO gap analysis to identify areas needing improvement, and ISO surveillance audits for ongoing compliance monitoring, we help you maintain certification and continuously improve your processes.

ISO 9001

Improvement Opportunities:
Our in-depth audits go beyond simple compliance checks, identifying areas for improvement and streamlining your Quality Management System (QMS) for optimal efficiency.

Drive Continuous Excellence: Leverage audit findings to implement effective improvement strategies, fostering a culture of quality and innovation throughout your organization.

Proactive Risk Management: Mitigate potential risks impacting your QMS and operational integrity with our thorough risk assessment and mitigation strategies.

ISO 17025

Laboratory Competence:
Aim to ensure your laboratory meets the highest international standards of testing and calibration with our technical competence assessments.

Accurate Results: Assure the integrity of your results through audits that focus on equipment calibration, maintenance, and adherence to documented procedures.

Foster Transparency and Accountability: Achieve complete traceability and accountability with documented procedures and records that meet ISO 17025 requirements.

ISO 15189

Prioritize Patient-Centric Care:
Our audits emphasize a patient-centric approach, ensuring your medical testing practices deliver the highest standards of quality, accuracy, and patient safety.

Validated Personnel Competency:
Verify the qualifications and skills of your medical staff through detailed audits, guaranteeing reliable and accurate testing results.

Optimize Healthcare Quality:
Integrate ISO 15189 principles into your healthcare processes, promoting a culture of quality and safety while meeting all regulatory requirements.

How We Work

Our structured approach to ISO compliance ensures your organisation meets international standards, operates efficiently, and maintains the highest levels of quality and safety. Each step is customised to your specific requirements, ensuring smooth implementation and continuous compliance with the relevant ISO standards.

Step 1: ISO Evaluation and Gap Analysis

We begin with a thorough consultation to assess your organisation’s processes, systems, and current ISO compliance status. Our team conducts a detailed gap analysis to identify areas where your practices may fall short of ISO standards and uncover opportunities for improvement.

Step 2: Customised ISO Compliance Strategy

Based on the findings, we develop a tailored ISO compliance plan that addresses your organisation’s specific challenges. This strategy includes best practices for quality management, process optimisation, and documentation to ensure alignment with relevant ISO standards.

Step 3: Implementation and Integration

Our experts collaborate with your team to implement the ISO compliance strategy, ensuring that all processes, procedures, and documentation meet regulatory requirements. We offer hands-on support in system integration, training, and process optimisation to ensure seamless alignment with ISO standards.

Step 4: Continuous ISO Compliance Monitoring

To help you maintain ongoing compliance, we provide continuous monitoring, periodic audits, and re-evaluations of your systems and processes. Our proactive approach ensures you stay ahead of regulatory changes, mitigating risks and fostering continuous improvement in your ISO compliance efforts.

  • We highly recommend The Knowlogy for their exceptional service and outstanding QA consultancy.

    Over the past 10 months, we worked with The Knowlogy to set up our GCLP laboratory and validate the method for measuring a primary biomarker.

    Their thorough understanding of our project’s complexity, attention to detail, and clear communication of GCLP requirements were impressive. The team’s professionalism, responsiveness, and technical proficiency helped us enhance our efficiency and effectiveness.

Key Benefits

Use this short paragraph to write a supporting description of your list item. Remember to let your readers know why this list item is essential.

Expertise

Our team of certified ISO professionals possesses extensive experience in the laboratory sciences, ensuring a deep understanding of ISO guidelines and regulatory requirements.

Commitment to Quality

We are committed to providing exceptional quality of service, ensuring that your ISO journey is compliant, efficient, and risk-mitigated.

Proven Track Record

We have a proven track record of successfully supporting laboratory teams of all sizes across diverse industries.

Customer-Centric Approach

We prioritise customer satisfaction and value your input throughout every phase of your ISO engagement.

MEET THE TEAM

The Knowlogy will never offer a one-size fits all solution.

As an agile company, we provide bespoke services, from single solutions to comprehensive suites, to support your unique situations.

IMG 4456 Enhanced NR scaled

Cate Ovington

Founder & Managing Director
IMG 4460 Enhanced NR scaled

Stuart Ovington

Company Director
IMG 4506 Enhanced NR scaled

Elaine McLachlan

Quality Consultant

Contact Us

Whether you need assistance with ISO certification, compliance audits, training, or customised solutions, our team is here to guide you through every step of the process.

Contact us today to discover how our comprehensive ISO services can help ensure your organisation meets international standards and operates with efficiency and quality.