ASME QPS-2021 pdf download
ASME QPS-2021 pdf download.Quality Program for Suppliers: General Industry.
1-1 INTRODUCTION (a) General. This Standard identifies the basic requirements to be addressed under a QualityProgram Supplier (QPS) Certificate. The QPS Certificate Holder shall establish a formalized setofcontrolled documents such as a QualityManual, procedures, instructions, forms, and other discretionary documents that are specific to each of their processes. This formalized set of controlled documents establishes the quality program that has been implemented and proven to provide, on a consistent basis, products satisfying the specified requirements in a technical job file. The 17 essential requirements addressed in Chapter2 ofthis Standard shall be addressed in a QualityManual; elements thatdo notapply shall be identified in the manual with rationale supporting the basis for their exclusion. (b) Requirements. The requirements of this Standard, in total, shall be addressed in a quality program. These re- quirementsshouldbeaddressedinastand-alonequalityprogram.Whenintegratinginto anexistingqualitymanagement system or quality program, the Certificate Holder shall documentand demonstrate how all 17 essential requirements in Chapter 2 of this Standard are fully addressed. The established quality program is to be developed, maintained, and implemented to ensure the outputs ofeach process are in compliance with the mandatoryrequirements specified in this Standardandtheoriginalsourcespecificationfortheproduct, i.e.,thecustomeragreementoraproductspecification.The Certificate Holder shall notify the ASME Conformity Assessment Department ofany significant changes that may affect conformance with this Standard and seek ASME approval prior to implementation. (c) Implementation. The implementation of the quality program described in this Standard emphasizes the importance of (1) producing a technical job file to provide quality products under a controlled environment (2) management’s commitment to fostering an atmosphere of continual process improvements
1-3 TERMS AND DEFINITIONS The following are terms and definitions used in this Standard. annual: a 12-month period in which an eventis to occur in the same month for each successive year. The specific month completing the 12-month cycle and identified as “month 12” is initially established and identified under the Certificate Holder’s qualityprogram. Otherthan the numberofdays inagivenmonth, there is no allowance foragrace period unless specifically permitted under ASME QPS. authorized personnel: as documented within the Certificate Holder’s quality program, identified personnel or role titles given specific authorization to perform a specific activity, function, process, or special process. customeragreement:adocument,inclusiveofanyamendments,annexes,orattachments,thatisissuedbythecustomerto the Certificate Holder and specifies a product, including its technical and quality requirements; may also be known as a “contract” or “customer purchase order.” Certificate Holder: an organization having or renewing a QPS Certificate issued by ASME, or an organization operating under a QPS Certificate issued by ASME. competencyexamination: a written or practical test, or a combination ofboth, administered to determine an individual’s knowledge and competence. competencyrequirements: attributes necessaryto perform a taskorprocess satisfactorily, such as specificskills, abilities, personal attributes, training, experience, knowledge, oranycombination thereofwhen identified in the qualityprogram. These attributes may be further grouped as requisites or prerequisites. competencymatrix: a document identifying a specific task or process and the elements ofthe competency requirements thatmustbe satisfiedbyanindividual. The specifictaskorprocess is undertakenbysomeone who meets thecompetency requirements. credentialed person: see credentialed personnel. credentialed personnel:executivemanagement:apersonorgroupofpeoplewho directandcontroltheCertificateHolder’sactivitiesatthehighest level. The person ultimately responsible for the establishment ofthe quality program need not be physically situated at the location where activities are performed. This is a generic term used to establish a functional role and may notbe the actual title assigned bythe Certificate Holder; the title ofthe person or group is established bythe Certificate Holder and identified in its organizational chart. grace period: an allowance that modifies the term “annual” by a maximum period of plus or minus 3 months when specifically permitted by this Standard. The performance of an activity within the bounds of this allowance does not change the original 12-month cycle or “month 12” as defined under the term “annual.” inspection:activities performedbyauthorizedpersonnelto verifythataproductis inconformancewiththerequirements ofthisStandardandthetechnicaljobfile.Nondestructiveexamination(NDE) activitiesareconsideredtobeaninspection. internal audit: an activity initiated by the Certificate Holder to provide impartial assurance that its quality program has been properly documented and is being effectively implemented as documented in the quality program manual and subtier documents. manufacture: an all-inclusive term for one or more ofthe following processes to produce a product: certification, design, assembly, fabrication, installation, purchasing, testing, inspection, quality control, quality assurance. monitor: to observe or check an individual’s performance or the operation of a process for compliance with the re- quirements specified in the technical job file, this Standard, or the Certificate Holder’s quality program.
