The PJLA Podcast

Common Findings in Assessments to the ISO/IEC 17025:2017 Standard in 2022

We have looked back at the ISO/IEC 17025:2017 assessments done by PJLA during the 2022 calendar year and compiled specific data from these assessments. While doing this, we identified some reoccurring issues found during these assessments and have narrowed down the top ten areas having the most nonconformances written. This webinar will look at common findings found within our 2022 ISO/IEC 17025:2017 assessments, shedding some light on the current requirements and how compliance can be achieved. Presented by Michael Kramer

Top FDA Warning Letters Related to Calibration with Walter Nowocin

The United States Food & Drug Administration (FDA) continues to intensify their compliance oversight with increased Quality System Surveillance Inspections and Warning Letters being sent to Healthcare companies. Warning Letters are issued only for violations of regulatory significance. The good news is that the FDA publishes Warning Letters on their web site as a public service. The FDA web site provides certain search filter capability to help review Warning Letters for a particular industry. In this webinar we will review the best calibration related FDA Warning Letters generated over the past few years. We will analyze the warning letters and discuss best practices that would avoid these compliance violations. With this knowledge, we can learn from these violations and ensure that our calibration programs do not negatively impact the cost of quality for our organizations. Hosted by: Perry Johnson Laboratory Accreditation, Inc. Presented by: Walter Nowocin

Requirements for Internal Audits in ISO/IEC 17025:2017

This webinar will review the requirements specified in ISO/IEC 17025:2017 for internal audits. We will explore how to maximize the benefit from these requirements to assure compliance with the ISO/IEC 17025:2017, and compliance with your own quality management system is being maintained. The importance of reviewing objective evidence will be highlighted. Ideally if there is a nonconformance issue relating ISO/IEC 17025:2017 or your own quality management system, your internal audit program will identify it. Presented By: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor

Streamlining Laboratory Efficiency with Greg Cenker

By analyzing your particular lab process, from start to stop, you will likely discover missed opportunities for improvement. Having worked in a high production, high stress environment, Greg Cenker had to figure out a way to become extremely efficient and effective without adding any additional human resources. This is but one way this metrology manager approached the problem. Hosted by: Perry Johnson Laboratory Accreditation, Inc. Presented by: Greg Cenker Greg Cenker is a metrologist and the Calibrations.com Product Manager with IndySoft. He works closely with development, marketing, and sales to ensure that Calibrations.com becomes the go-to source for calibration related content, software, and support.

A Look at ISO/IEC 17025:2017 - Section 8.9 Management Review Requirements and Utilization

We will look at the requirements specified within ISO/IEC 17025:2017 for management review which include specific requirements for inputs and outputs. This webinar will also look at the management review as a vehicle for improvement. The ISO/IEC 17025:2017 Standard will force the hand of the organization in the output section. Presented By: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor

A Look at ISO/IEC 17025 - Section(s) 6.3 & 6.4

This episode will investigate the requirements concerning facilities and environmental conditions, along with equipment specified in ISO/IEC 17025:2017. This will shed light onto records that need to be maintained for laboratory equipment. Also, requirements concerning environmental related laboratory activities performed both at the fixed facility and on site at the customer location will be discussed. This will include those requirements specific to environmental conditions which require monitoring and those that will need to bet recorded and controlled. Requirements concerning equipment will be highlighted including those related to intermediate checks and calibration programs. Presented By: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor

Option A and B as Presented in ISO/IEC 17025:2017 along with the Management System Documentation 8.2

Is the concept of Option A vs. Option B as it relates to ISO/IEC 17025:2017 confusing? This webinar will shed light on both options which has the same end results. Laboratories which are part of an organizations with ISO 9001:2015 certification in place can benefit from this. Requirements specified in ISO/IEC 17025:2017 concerning management system documents will be reviewed and attempt to aid your organization in adopting a system that both meets the requirements of the Standard along with tailoring the system to meet your organizational needs. This will include commitment from management along with stated policies and objectives. Presented By: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor

A Look at ISO/IEC 17025:2017 - Section 7.9 “Complaints”

Complaints are magnified in ISO/IEC 17025:2017. Section 7.9 regarding complaints consists of seven separate clauses. This webinar will look at what documented information is required along with what records need to be maintained when a complaint is received. Specific requirements are specified in regards to keeping the complaint informed along with the approval of any corrective action taken as a result of a complaint. Presenter: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor

ISO/IEC 17025 Section 7.6 - Evaluation of Measurement Uncertainty

Presented by PJLA's Michael Kramer

 

Common Findings Detected on Environmental Lab Assessments

This webinar will educate participants on top common findings detected during environmental laboratory assessments including assessments to the DOD ELAP, DOECAP and TNI EL standards. Additionally, an overview of PJLA’s accreditation program requirements will be provided to educate participants on what to expect prior to the on-site assessment, corrective action timelines, report submissions including requirements of state program reporting.