PJLA is hosting a series of FREE, educational podcasts. Stay tuned for upcoming podcasts. To listen to any of our previously recorded podcasts please click one of the links below:
A Review of the Revised PJLA Policy PL-4 “Scopes of Accreditation” – June 28, 2023
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 – June 14, 2023
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? – June 2, 2023
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.
Presented By: Tracy Szerszen, President PJLA
Use of Accreditation Symbols and References to Accreditation – May 30, 2023
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” – May 11, 2023
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” – May 11, 2023
A Look at ISO/IEC 17025:2017 – Section 7.6 “Evaluation of Measurement Uncertainty” for Testing Labs – March 20, 2023
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 – March 20, 2023
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, PJLA Calibration Program Manager and Lead Assessor
Top FDA Warning Letters Related to Calibration with Walter Nowocin – March 20, 2023
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.
Presented By: Walter Nowocin, Perry Johnson Laboratory Accreditation, Inc.
Requirements for Internal Audits in ISO/IEC 17025:2017 – December 22, 2022
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 – December 22, 2022
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 – November 7, 2022
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 – September 29, 2022
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 PJLA’s Michael Kramer
Option A and B as Presented in ISO/IEC 17025:2017 along with the Management System Documentation 8.2 – September 2, 2022
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 PJLA’s Michael Kramer
A Look at ISO/IEC 17025:2017 – Section 7.9 “Complaints” – July 28, 2022
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.
Presented by PJLA’s Michael Kramer
ISO/IEC 17025 Section 7.6 – Evaluation of Measurement Uncertainty – July 14, 2022
Presented by PJLA’s Michael Kramer
Common Findings Detected on Environmental Lab Assessments – June 27, 2022
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.
A Look at ISO/IEC 17025:2017 – Section 7.7 & Associated Requirements Within PL-1 – June 14, 2022
ISO/IEC 17025:2017 – Section 7.7 & associated requirements within PL-1 “PJLA Policy on Proficiency Testing” The requirements in section 7.7 of ISO/IEC 17025:2017 will be reviewed. This includes activities associated with internal control and well as comparison to sources outside your organization. We will look at the requirements specified in PJLA PL-1 regarding proficiency testing which would include developing an approved four-year proficiency testing plan along with approved means of proficiency testing.
Presented By: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor
Improve Your Force Measurements: Tips to Improve Your Force Measurements – April 28, 2022
Presented by Perry Johnson Laboratory Accreditation, Inc.
A Look at ISO/IEC 17025:2017 – Section 7.8 “Reporting of Results” – April 6, 2022
Presented by Michael Kramer of Perry Johnson Laboratory Accreditation, Inc.
The Metals in Cannabis Method with first action status by AOAC & The Road to Get There… – March 26, 2022
In this webinar, we cover our new AOAC metals in the Cannabis method for the testing of the big four elements: Cadmium, Arsenic, Lead, and Mercury, and additional elements. Many of these elements are crucial to study because they play an important role in growth of the plant and plant byproducts. We looked at a variety of products, covering categories of Inhaled (Plant material, Vape Pen/cartridges, and Shatter), Oral (Pill, Tincture, and Edibles), Topical (Lotions, Oils, and Soaps), and Manufacturing (Biomass, Crude Extract, and Refined Extract) in the validation of this method. Presented by: Jenny Nelson(1), Craig Jones(1), Sam Heckle(2), and Leanne Anderson(2) (1) Agilent Technologies, Inc., 5301 Stevens Creek Blvd, Santa Clara CA 95051, U.S.; (2) CEM, Inc., 3100 Smith Farm Rd, Matthews, NC, 28104, U.S.
A Look at ISO/IEC 17025:2017 – Section 7.1 “Review of Requests, Tenders, and Contracts” – March 25, 2022
Presented by PJLA
Common Findings in PJLA Assessments to the ISO/IEC 17025:2017 Standard in 2021 – January 26, 2022
Presented by PJLA
A Look at ISO/IEC 17025:2017 – Section 5.0 “Structural Requirements” – January 21, 2022
This section specifies broad encompassing requirements concerning documentation of laboratory activities, laboratory organization, structure, and responsibilities. This webinar will look each clause within Section 5 and highlight the flexibility given to laboratories in meeting these requirements.
Presented by: Michael Kramer, PJLA Calibration Program Manager and Lead Assessor
Testing for Gluten and Allergens: Why We Do It and How To Do It Well – December 17, 2021
Presented by PJLA.
A Look at ISO/IEC 17025:2017 – Section 6.6: Externally Provided Products and Services – November 29, 2021
Presented by PJLA.
ASCA Biocompatibility and Basic Safety and Essential Performance FDA Pilot Program with PJLA – November 29, 2021
Presented by PJLA.
ISO 17034:2016 General Requirements for the Competence of Reference Material Producers – November 29, 2021
Presented by PJLA.
A Look at ISO/IEC 17025 2017 – Section 7.10 – Nonconforming Work Section 8.6 – Improvement – November 23, 2021
Presented by PJLA.
5 Steps to the Accreditation Process – September 27, 2021
Presented by PJLA.
A Look at the Requirements Specified in PJLA Policy on Measurement Uncertainty “PL 3” – July 23, 2021
Presented by PJLA.
A Look at the Requirements Specified in PJLA Policy on Measurement Traceability “PL 2” – July 23, 2021
Presented by PJLA.
A Look at the Requirements Specified in PJLA Policy on Proficiency Testing Requirements “PL 1” – June 14, 2021
This episode will review the requirements specified in PJLA policy PL-1 in regards to proficiency testing. This includes requirements associated with establishing a proficiency testing plan along with various type of appropriate proficiency testing schemes. We will also look at methods of analysis which can be employed in order to analyze the proficiency testing results in an appropriate and meaningful way.
Navigating Challenges Associated with PCR Technology in a Cannabis Lab – June 11, 2021
For the last century, traditional cultural methods have been the “gold standard” for microbiological analysis. However, for the cannabis industry, national harmonized culture methods are nonexistent resulting in the use of alternative methods such as molecular detection. Although this technology has many advantages over culture-based methods, there are challenges laboratories need to be made aware of. This presentation will discuss the science behind molecular detection, issues that exists and how the providers of the technology are working to resolve them. PJLA will also discuss challenges encountered during the accreditation process in regard to this area and the expectations of the ISO/IEC 17025 standard.
Presented by: Tracy Szerszen, PJLA President & Patrick Bird of PMB BioTek Consulting
An Update to AOAC International Methods in the Cannabis Industry – May 13, 2021
As the growth of the cannabis industry continues to skyrocket, laboratories and regulators are constantly evaluating techniques and methods available to perform the most accurate testing to ensure products are safe for consumers. AOAC INTERNATIONAL, through their Cannabis Analytical Science Program (CASP), is uniquely positioned to provide guidance to these key stakeholders. This presentation will provide an overview of CASP’s work in the development of standardized method performance criteria (SMPRs) and certification of methods through the AOAC Research Institute (AOAC RI) Performance Tested MethodSM (PTM) program and Official Methods ProgramSM and PJLA’s expectations for accreditation in regard to the selection of test methods.
Presented By: Tracy Szerszen – PJLA President and Patrick Bird – PMB BioTek Consulting.
An Overview of the CA ELAP Regulations Versus the TNI EL 2016 Standard – May 10, 2021
The timeline for CA environmental laboratories to transition to the TNI EL 2016 standard is approaching. Laboratories must meet the TNI EL standard by the 2023 deadline and should start implementing the changes now. This webinar will provide CA ELAP participating laboratories and other interested parties an overview of the CA ELAP Regulations versus the TNI EL 2016 standard as well as PJLA’s accreditation expectations.
Presented By: PJLA Environmental Program Manager
Implementing ISO/IEC 17020 Inspection Body Accreditation in the Information Security Industry – April 26, 2021
PJLA President, Tracy Szerszen and Inspection Program Manager, Michael Kramer together with Fred Tschirgi, a CMMC Provisional Assessor and C3PAO, will discuss how ISO/IEC 17020 can be implemented within the information security industry.
This webinar will educate participations on the requirements of the ISO/IEC 17020 standard including quality management system and technical requirements.
17025: The concepts of Measurement Uncertainty Short Course – March 26, 2021
In today’s episode we introduce the concepts of measurement uncertainty in our short course!
A Look at ISO/IEC 17025 2017 – Evaluation of Measurement Uncertainty & Validity of Results – March 19, 2021
In this episode we take a closer look at measurement uncertainty & validity of results!
Cannabis and Hemp Industry Expert Panel – March 2, 2021
Listen to a PJLA hosted Panel of cannabis and hemp industry experts discuss the latest news and events in the market and what to expect in the business landscape today!
Corrective Action Requirements and Good Practice – ISO/IEC 17025 – February 26, 2021
This webinar will look at all requirements concerning corrective action as specified in ISO/IEC 17025:2017. We will explore when this procedure needs to be implemented and what individual steps should be included in the process.
Common Findings in Assessments – ISO/IEC 17025:2017 – February 25, 2021
This webinar will look at some common findings found within our ISO/IEC 17025:2017 assessments and shed some light on the requirements and how compliance can be achieved.
Cannabis Potency: An Example of Applying ISO 17025 Principles to a Test Method – February 25, 2021
In this session we will talk about one method of testing your in-house QMS for ISO 17025 readiness.
Preparing for an ISO/IEC 17025:2017 Accreditation Assessment – February 19, 2021
During this podcast we discuss the accreditation process, the expectation of the laboratories becoming & maintaining accreditation, an overview of the key technical areas of the ISO/IEC 17025 standard, and our most common findings during an assessment.
