E36.10 - Laboratory/Inspection Standards

SCOPE
1.1 This standard provides a guide for the information to be obtained and provides specific recommended criteria for evaluating the capabilities of an agency to conduct tests and to report on tests performed in accordance with the standards promulgated by Committee E-6 on Performance of Building Constructions.
1.2 The criteria in this standard describe the basic information used in judging the capability of an agency to perform its intended functions objectively and competently as well as to disclose possible conflicts of interest judged from the standpoint of the user of this standard. Testing, approval, and certification of a company's own products and services by its own testing agency does not necessarily constitute a conflict of interest.
1.3 The criteria presented herein are divided into three categories of endeavor, namely,
Part A-Standards and Criteria for Testing Agencies
Part B-Standards and Criteria for Quality Assurance Agencies
Part C-Standards and Criteria for Evaluating Agencies
1.4 The fundamental purpose of this standard is to provide criteria for evaluating an agency as denoted in either by a user of that service or by an accrediting authority.
1.5 It is not the purpose of this standard to provide a basis for determining the quality of a product or service being evaluated.
1.6 This standard is not intended for the evaluation of those activities normally associated with the production and sale of products and the like, such as a manufacturer's internal quality program. However, any organization may request or perform an evaluation of its own in-house facilities under this standard if it so desires.
1.7 It is not the intent of this standard to be the basis for the determination of the type of agency to be selected by the user.

SCOPE
1.1 This guide covers general requirements for data integrity for computer operations in a laboratory. This guide expands upon the requirements of paragraph 10.7 in ISO/ IEC Guide 25 (currently being balloted as a replacement for Guide E548) for those laboratories that are highly computerized and is intended to be used in conjunction with ISO/IEC Guide 25 in the assessment of testing laboratories.  
1.2 This guide presents requirements that are generally in harmony with and in addition to those in Guide E548 and ISO/IEC Guide 25; the paragraphs dealing with similar subjects carry similar numbers.  
1.3 Additional requirements may be necessary for fields of testing where the computer system(s) are integrated into the test methods themselves. These requirements can normally be found in the test methods.  
1.4 In highly computerized laboratories, computers are increasingly being used for:  
1.4.1 Direct capture of data from instruments and testing machines;  
1.4.2 Automatic control and monitoring of test processes;  
1.4.3 Control of critical environmental conditions;  
1.4.4 Capture, processing, and display of laboratory quality-control data;  
1.4.5 Basic data processing;  
1.4.6 Data storage and retrieval;  
1.4.7 Generation of test reports;  
1.4.8 Scheduling and monitoring of work throughput;  
1.4.9 Monitoring and control of inventories;  
1.4.10 Equipment inventories, and calibration and maintenance schedules;  
1.4.11 Design of statistical experiments; and  
1.4.12 Communication between laboratories (and with clients).  
1.5 The assessment of the highly computerized laboratory will depend upon the nature of the computer systems and the functions they are intended to perform. This guide may be useful in assessing portions of computer systems in less highly computerized laboratories.  
1.6 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
1.1 This standard sets forth general criteria (harmonized with ISO/IEC Guide 25-1990) for evaluating the competence of calibration laboratories or testing laboratories.