It includes five sections with information that is mostly common sense. The classification as described on the following page is well accepted in chemical laboratories.
A description of the methods used to calculate the measurement result and its uncertainty from the experimental measurements The values and sources of all corrections A list of all components of uncertainty with full documentation about how each of these was evaluated. Alternative well-defined methods also called primary or definitive methods agreed upon by all parties can also be used to establish traceability.
Agilent engineers bring along calibrated test tools that meet traceability requirements. The whole procedure should be documented in such a way that sufficient information is available for the result to be reevaluated if new information or data become available.
Management should define and maintain tasks, job descriptions, and required skills for each job. You did an excellent job and made the information sink in my head.
I was especially excited that everyone is now on the same page and believe we accomplished changing attitudes about the process and value. We will focus on topics that most likely are new to laboratories without a quality system. Areas with incompatible activities should be separated.
As the first step in the process, the root cause of the nonconformity should be identified. These activities should be monitored for effectiveness.
Only competent personnel should perform testing and calibrations. In addition to the more frequent tests that only challenge a subset of all specifications, annual repetition of all initial tests is recommended to repeat all the initial tests as described above, for example, for chromatographs, once a year.
The following parameters should be considered for validating in-house developed methods: This chapter describes how to ensure that all laboratory personnel who can impact test and calibration results are adequately qualified.
Suggestions for improvements should be taken from audit reports, analysis of data, customer complaints and suggestions, corrective and preventive actions, and management reviews. An ISO compliant lab claims to meet all standard requirements, where as an ISO accredited lab has proven competence and met standard conditions to an accrediting body.
The audit program should be managed by the quality manager.
Sources contributing to the uncertainty can include the reference materials used, the methods and equipment used for sampling and testing, environmental conditions and personnel.
This report provides advice on validation steps for different software and system risk categories, as well as recommendations for how to ensure the security, availability, integrity, and confidentiality of electronic records.
Recommended review frequency is once a year. Very few slides and more interactive exercises.
The accreditation process includes document review, process audit, and accreditation result. Equipment Equipment that is performing well and properly maintained is a prerequisite for the ongoing accuracy of test and calibration results.
The procedures should prevent sample deterioration and cross-contamination during storage and transport. The type and frequency of tests should be planned, justified, documented, and reviewed.
Control of Records This chapter describes how to ensure that all records in a laboratory are uniquely identified, readily available when needed, and protected against unauthorized access for viewing or changing.
Category B instruments such as balances and pH meters should be calibrated according to manufacturer SOPs, and more complex instruments such as chromatography systems should be fully tested according to their intended use.
These activities should be monitored for effectiveness. As a result, the test selection and sequence is optimized for the highest speed and lowest instrument downtime, without comprising accuracy or calibration specifications.
Verify that the location meets the environmental specifications as defined by the vendor. The scope of this primer does not go into all the details and we cannot cover all requirements.
The main activities are calibration and checking to verify specified performance and maintenance. The requirements are similar to ISO The name and address of the client. Even if an organization were to research internal controls and processes, they may not know what to look for in regards to conformance.
Documents should be regularly reviewed and updated if necessary. Sometimes, standard and in-house validated methods need to be adjusted or changed to ensure continuing performance.
If the training is related to a specific test method, the trainee can demonstrate adequate qualification through successfully running a quality control or proficiency test sample. Internal, customer, or regulatory guidelines are becoming firmer with time.
Requirements will often dictate the use of a third party, ISO accredited calibration laboratory. Many times this is to decrease risk throughout a supply chain.
When choosing a calibration laboratory, don’t mistake ISO compliance with accreditation. The feed analysis laboratory: Establishment and quality control. Setting up a feed analysis laboratory, and implementing a quality assurance system compliant with ISO/IEC High Level Importance: ISO Microbiology compliance Thamolwan Laoviitayanurak, 3M FSD Professional Service APEC Regional Workshop, BKK Thailand on Aug 25, Topic Outline Lab Accreditation: ISO/IEC Lab Accreditation ISO – Establishing quality management.
ISO compliant laboratory in a university setting, with the goal of providing guidance to other university labs that may need to travel down the same road. Our laboratory, the Middlefield Research and Testing Laboratory, (MRTL) is located.
Steps to ISO/IEC Perry Johnson Laboratory Accreditation, Inc. 7/09 Page 2 of 13 A laboratory that establishes a laboratory management system compliant with ISO/IEC joins the growing world partnership of accredited laboratories.
Steps to ISO/IEC Accreditation, was created by Perry Johnson Laboratory Accreditation, Inc. ISO/IEC (E) seen as compliant with ISO as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO that are relevant to the scope of testing and calibration Laboratory customers, regulatory authorities and .Establishing an iso 17025 compliant laboratory