Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard.

A highly meaningful and valuable learning session on how to accomplish this is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. The Director at this two-day seminar is Michael Brodsky, President of Brodsky Consultants and a Past President of the Ontario Food Protection Association (OFPA), The International Association for Food Protection (IAFP) and AOAC International. To enroll for this seminar, please log on to This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Compliance with ISO is a core requirement

A QMS that complies with the management and technical requirements of the ISO/IEC 17025:2005 standard is the core criterion for accreditation, as well as the backbone of this standard. Michael will familiarize participants with how with how laboratories can accomplish this in depth.


The Quality System Manual (QMS) is indispensable in a QMS environment because, much like its predecessor –Good Laboratory Practice (GLP) –it contains the policies that the laboratory is expected to follow to achieve Quality results. However, it is only the “what to do” component of a QMS. What laboratories also need are the “how to do it” or procedures and methods, and equally importantly, the controls or evidence that it was done properly. These are the critical requirements that documentation has to address, and are what this seminar will cover.

Doesn’t end with accreditation

Achieving accreditation is only half the job done, because once this has been done, the tougher part –that of maintaining the QMS –begins. The high number of non-conformances cited during the subsequent biannual audits is proof of this fact. This seminar will explain how to maintain the QMS in the long run to the satisfaction of regulatory authorities, as well as to meet the laboratory’s needs.

Those in Laboratory Management/Supervision, Laboratory Quality Development, Laboratory Quality Management,  Laboratory Quality Control and Analytical support need to ask critical questions at the time of embarking on the process of developing documents and records that meet the requirements of ISO 17025, such as:

  • Why should we want to become accredited?
  • Where do we start?
  • If our laboratory is already accredited, how do we ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Michael will help participants at this seminar develop the critical thinking that is essential for developing documents and records in compliance with ISO 17025.

Finessing the ways of using lineament analysis in geological exploration

Geological exploration has many benefits for mankind. Yet, there are a few limitations with the current set of methods being used by geologists. The full extent of technologies is yet to be harnessed.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process if the best possible confidence in resultant mineral resource and reserve estimates are to be achieved.

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.


Learn to get Quality Assurance and Quality Control procedures and protocols right

The way to do this effectively for better results will the learning offered at a two-day in person, live seminar that GlobalCompliancePanel,  a highly reputable provider of professional trainings for regulatory compliance, will organize. More details of this seminar can be had from

The Director, Ricardo Valls, will introduce the participants to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology helps participants to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

  • The adherence to written protocols; up-to-date and suitable training of personnel
  • The use of reliable laboratories with excellent QA&QC systems in place
  • The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)
  • Diligent record keeping.

The impact of effective complaint handling on quality system

Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling on quality system is meaningful when complaints are thoroughly analyzed and investigated.

Helps in correcting flaws

Complaints serve as a great means for making manufacturers of medical devices understand the problem at its root. It is this understanding that will help them to come up with solutions to these problems. Having an effective complaint handling on quality system in place is an FDA requirement from a medical device manufacturer. Complaints are the platform from which to evaluate, investigate and analyze the device and later take corrective action.


To facilitate effective complaint handling on quality system; the FDA has a mechanism. Called the Medical Device Reporting (MDR); this system is meant for receiving medical device adverse events from manufacturers, importers and user facilities. This mechanism helps in quick detection and correction of adverse events. User Facilities (e.g., hospitals, nursing homes) need to report suspected medical device related deaths to both the FDA and the manufacturers.


CAPA risk assessment

Corrective and Preventive Action (CAPA) is an integral part of a medical device organization’s Quality System. CAPA is one of the dreaded terms for a quality professional; yet, very few realize that putting a CAPA in place for each and every event is a liability. Rather, putting a CAPA for critical activities of the medical device’s manufacturing process is more commonsensical. This is where CAPA risk assessment gains importance.

What is CAPA risk assessment?

Doing CAPA on risk assessment is considered the most pragmatic approach to CAPA. Why is this so? As we just saw, doing a CAPA on every event is eventually going to turn out to be a waste of time. So, the trick is in doing CAPA on what may be called a “life threatening” event. In other words, something that poses capital risk to the organization’s bottom line could be taken up for mandatory and immediate CAPA.

This is why CAPA risk assessment is considered the best approach. By making this, organizations understand to identify the event that requires the most immediate and critical CAPA. When an organization can identify this, it has got a hang of the ways of dealing with CAPA. CAPA risk assessment is the most effective medium towards understanding this. The simple thumb rule for carrying out CAPA risk assessment is that the greater the risk of the event; the higher its need for having corrective action taken against it.

Risk to check effectiveness

It is common sense that if an action is not going to be effective; it need not be done. It is for assessing the effectiveness of a corrective action that CAPA risk assessment is done. How? It helps to identify if an event’s CAPA is within the risk limits of the organization’s compliance standards.



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API Process Inspection –what does the FDA expect?




API Process Inspection –what does the FDA expect?

Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to.

The FDA and API Process Inspection

Rules regarding what the FDA expects are mentioned clearly in the document that lays down the principles of an FDA API process inspection, namely FDA Program Guidance Manual (Program 7356.002F). So, the FDA sticks to what is prescribed in this document:

–        GMP is a must for the FDA

–        It recognizes Q 7 as the primary API GMP. If you cannot follow Q 7, you can expect an equivalent activity, but are expected to demonstrate that the alternative activity you used did not in any way violate the basic requirements set out in this document.

–        This program manual is applicable for API manufactured by synthesis/fermentation and not for dosage forms

–        This document applies to domestic and foreign inspections

–        Uses a six-system approach

Other requirements

–        Expects compliance with FDA regulations

–        Compliance with Q 7 or equivalent

–        Procedures and documents must be clearly written down

–        Should have appropriate Quality System in conformance with Q 7, to ensure that an international or domestic guidance is adhered to

–        Should have sound Quality Practices

–        A sound and documented QMS that is “shown to work”

–        Appropriate Change Control Systems

–        Cleaning systems and records

–        Appropriate Validation and Qualification performed and documented

–        Written contracts and Quality Agreements where appropriate

–        Auditing programs and documentation

Systems that will be examined

During an FDA API process inspection, it inspects the following types of systems:

–        Quality System

–        Facilities and Equipment

–        Materials System

–        Production

–        Packing and labeling

–        Laboratory Control System




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Fax: 302-288-6884

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