ASME CA-1 pdf download Conformity Assessment Requirements
2.1.2 An application for each facility shall be sub- mitted when an organization plans to produce items conforming to the requirements of ASME codes and standards, listed in Table 1, at more than one location.
2.1.3 The organization shall obtain and retain a copy of the governing standard(s) from an authorized seller of ASME codes and standards. Reproductions and translations from other sources are not acceptable for ASME accreditation and certifcation.
2.1.4 The organization shall agree that each Certifcate of Authorization and each ASME Certifcation Mark are, and remain at all times, the property of ASME, that they will be used only in accordance with the governing standard, and that they will be promptly returned to ASME upon request, or when the organization discontinues the code or stand- ard activities covered by this Certifcate, or when the Certifcate of Authorization has expired and a new Certifcate has not been issued.
2.2 Quality Management System
2.2.1 Any organization holding or applying for a Certifcate of Authorization shall demonstrate a quality management system that establishes that all require- ments of the governing standard will be met. The qual- ity management system shall be in accordance with the governing standard specifed in Table 1. The organization shall (a) make available to the ASME Designees a copy of the quality management system manual during ASME’s evaluation of the system (b) provide the ASME Designees with access to all documents and areas covered under the scope of the quality management system (c) require a controlled copy of the accepted qual- ity management system manual to be fled with ASME when indicated in Table 1
2.2.2 A written description of the quality manage- ment system shall be provided in a quality management system manual that establishes the responsibilities, authority, and controls for the system and identifes the documents and procedures the organization will use to provide an item and/or service that conforms to the applicable standard. The quality management sys- tem manual shall be available for review and accept- ance by the individual identifed in Table 1 prior to its implementation.
2.2.3 An organization may make changes to its quality management system refecting changes to its methods of achieving the results required to conform to a particular standard. These changes are subject to acceptance by the entity identifed in Table 1 prior to their implementation. Depending on how substantive and extensive the changes are, an on-site evaluation may be required to demonstrate the changes.
2.3 Evaluation of the Quality Management System
2.3.1 General. The issuance or renewal of a Certifcate of Authorization is based upon ASME’s evaluation and acceptance of the quality management system. The type of evaluation (audit, interview, review, survey) performed is determined by the governing standard.
2.3.2 Program Implementation and/or Demonstration. The organization’s quality management system and its implementation shall be evaluated by a team estab- lished by ASME.
(a) The organization shall demonstrate all elements of its quality management system to show knowledge, understanding, and ability to produce the items (includ- ing services) covered by the quality management sys- tem. The organization may use current work, a mock-up, or a combination of the two to demonstrate the ASME- required elements of the quality management system. If at the time of the evaluation there is work being per- formed in-house under the accepted quality manage- ment system manual, it shall be included as part of the demonstration and evaluated by the team. (b) Under certain conditions, the quality manage- ment system may be implemented before receipt of a Certifcate of Authorization (see para. 2.3.5). (c) The team shall visit all addresses identifed on an ASME Certifcate of Authorization to witness and evalu- ate the activities being performed at that site under the quality management system.
2.3.3 Capacity Certifcation Testing. For Certifcates of Authorization requiring capacity certifcation testing as indicated in Table 1, the organization shall demonstrate to the satisfaction of the ASME Designee that the manufacturing, production, test facilities, and quality control procedures ensure close agreement between the performance of random production samples and the performance of those devices submitted for capacity certifcation. The organization shall successfully complete operational and capacity tests in accordance with the governing standard in the presence of an ASME Designee at the ASME-accepted testing laboratory.