The PJLA Podcast

A Review of the Revised PJLA Policy PL-4 “Scopes of Accreditation”

PJLA has updated it’s PL-4 policy regarding scopes of accreditation to not only address calibration scopes but now contains requirements for all PJLA programs to include testing, inspection, proficiency testing providers, reference material producers, and medical. The revisions to PL-4 will be highlighted during this webinar. This will include an additional discipline added to calibration scopes along with flexible scopes which can be utilized for testing organizations. These policies will be required elements for scopes of accreditation for organizations accredited by PJLA and consider those requirements specified by the International Laboratory Accreditation Cooperation “ILAC”. Presented By: Tracy Szerszen & Michael Kramer

Understanding the Types of Reference Materials, Their Differences, and Their Uses

ISO/IEC 17025 accredited laboratories often use reference materials, including certified reference materials for a variety uses in the laboratory. These uses may range from method develop to the calibration of instrumentation to analyze samples. This webinar will discuss the differences between reference materials, certified reference materials, quality control materials and their appropriate uses in the laboratory. Attendees will gain an understanding of the production and certification aspects of each type of material, each impacting the uncertainty of the product used and its metrological traceability. Understanding refence materials will assist in maintaining compliance to the traceability requirements of ISO/IEC 17025 in your laboratory. Presented by: Matthew Sica, PJLA Program Manager

I Submitted a Complaint - Why is this Organization Still Accredited?

Complaints on various topics are received by PJLA from any interested party. We must evaluate each to ensure they are valid, then allow CABs (i.e., labs, inspection bodies, etc.) to respond and act as necessary. Some may take the opinion that aggressive approaches should be taken, such as immediate suspension or withdrawal of accreditation, without really understanding what the process is from an accreditation body perspective. This webinar will educate participants on PJLA’s processes for handling complaints including: • Information required when filing a complaint, • the evaluation process by the PJLA investigation team, • timelines for response, • and potential repercussions or actions taken. Presenter Tracy Szerszen, President PJLA

Use of Accreditation Symbols and References to Accreditation

Accreditation provides formal recognition that a conformity assessment body (CAB) is capable of meeting certain standards. Once accredited, a CAB may wish to make reference to its accreditation status in its reports or certificates. Accreditation normally entitles the accredited CAB to endorse the relevant documents in the name of the accreditation body, by using an accreditation symbol and/or by using appropriate words, in accordance with prescribed procedures and rules. This webinar will look at proper use of accreditation symbols and reference to this accreditation. Individual accreditation bodies like PJLA are required as per. ISO/IEC 17011:2017, to have a policy governing the use of its accreditation symbols and claims of accreditation status by its accredited organizations.

A look at ISO/IEC 17025:2017 - Section 7.2 “Selection, Verification, and Validation of Methods”

This webinar will look at what the requirements are for methods as specified in ISO/IEC 17025:2017. This will address the need to verify or validate prior to implementing them and providing results to the customers of the laboratory. Also, these requirements will give assurance that the methods are being performed in a unified manner within your organization. Through accreditation customers of your organization can be assured that appropriate methods are adopted within your organization.

A Look at ISO/IEC 17025:2017 - Review of Section 8.5 “Actions to Address Risks and Opportunities”

A Look at ISO/IEC 17025:2017 - Section 7.6 “Evaluation of Measurement Uncertainty” for Testing Labs

Measurement uncertainty always seems to be a challenging requirement for testing laboratories. This webinar will look at some approaches to evaluating measurement uncertainty in testing laboratories. We will look at the requirements related to measurement uncertainty within ISO/IEC 17025:2017 and the discuss objective evidence which can be produced to demonstrate conformity with this section. Presented by: Matthew Sica, PJLA Testing Program Manager

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