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    http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900445SEMINAR?developing-documents-records-SFO. 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:

o        Why should we want to become accredited?

o        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. 

Handle internal investigations thoroughly, else employees could approach law agencies

Employees have a right to approach external sources such as the Equal Employment Opportunity Commission (EEOC), the National Labor Relations Board (NLRB), Wage and Hour, private attorneys, and juries against the employers, when feel that their legitimate complaints are not being heard by their employers.

But first, a clear definition has to be made of what constitutes legitimate complaints and a distinction has to be made between legitimate and unsubstantiated complaints. This is because employers are legally empowered and obliged to carry out certain kinds of investigation, namely the kind done on what the law considers as a legitimate employee complaint, and not others. It is thus important for employers to have a thorough understanding of what type of complaint is considered by the law as legitimate and what is not.

Follow the procedures to be safe at investigations

This distinction determines whether the employee will go to any of the external agencies mentioned above to complain against the employer or not. Further, quick and sound action that is legally compliant will also help juries or other agencies decide whether or not the employers took quick and appropriate action to address legitimate employee complaints. Following the right procedures will help to protect the organization against such complaints, if the juridical sources find that the employer took the right action on time to redress the employee’s legitimate complaint.

HR has to be quick and has to think on its feet if it is to avoid giving the employee the opportunity to approach an external agency, the fallout of which can be potentially damaging. In order to help HR professionals understand the way by which to carry out a legally tenable and fair investigation of the complaints; GlobalCompliancePanel, a leading global provider of professional trainings in all areas of regulatory compliance, will organize a two-day seminar.

To enroll for this seminar, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900677SEMINAR?conducting-internal-investigations-San-Diego-CA.

Susan Fahey Desmond, a principal with Jackson Lewis PC and noted author and speaker, will be the Director of this seminar.  Susan will offer a thorough understanding of how to classify a complaint by the employee as a legitimate one. Lack of this knowledge on the part of the organization’s HR will result in having to battle it out in court.