P03.12 Identification
The organization shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.
The organization shall establish documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product組織應(yīng)確定產(chǎn)品的合適的方法，在產(chǎn)品實(shí)現(xiàn)和應(yīng)建立形成文件的程序，對這種產(chǎn)品的標(biāo)識 。 組織應(yīng) 建立 書面的程序，以確保返回給組織的醫(yī)療設(shè)備是確定和區(qū)分合格產(chǎn)品
P03.13 Traceability
The organization shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required. Where traceability is a requirement, the organization shall control and record the unique identification of the product組織應(yīng)建立文件化的可追溯性控制程序。這種程序應(yīng)規(guī)定產(chǎn)品可追溯性和記錄所需的程度。當(dāng)可追溯性為要求時，組織應(yīng)控制并記錄產(chǎn)品的唯一性標(biāo)識
P03.16 Customer property
The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained. NOTE Customer property can include intellectual property or confidential health information. 本組織應(yīng)愛護(hù)顧客財產(chǎn)時根據(jù)本組織的控制或正在使用的組織。組織應(yīng)識別、驗(yàn)證、保護(hù)和維護(hù)供其使用或?qū)⒓{入產(chǎn)品一部分的顧客財產(chǎn)。如果任何顧客財產(chǎn)發(fā)生丟失、損壞或發(fā)現(xiàn)不適合使用，應(yīng)報告顧客，并保持記錄。注意到一部分的顧客財產(chǎn)可包括知識產(chǎn)權(quán)或保密的健康信息。
P03.24 Process capability studies
The production process should be capable to produce goods parts. Capability could be expressed in Cpk indices. For example Cpk > 1,33生產(chǎn)過程應(yīng)該有能力來生產(chǎn)貨物的部件。Cpk指數(shù)可以表達(dá)能力。例如Cpk>1,33
P03.25 Sufficient production capacity
Necessary production capacity must be available. A systematic approach should evaluate the available capacity against updated customer forecasts. Sufficient flexibility must be built in in the production provision to absorb short term higher demand. 必要的生產(chǎn)能力必須可用。一個系統(tǒng)的方法應(yīng)該評估對更新的客戶預(yù)測的可用容量。足夠的靈活性，必須建立在生產(chǎn)提供吸收短期內(nèi)更高的要求。
P03.27 Statistical Techniques and Control
Manufacturer should use valid statistical techniques required for establishing, controlling and verifying the acceptability of process capability and product characteristics制造商應(yīng)建、控制和驗(yàn)證過程能力和產(chǎn)品特性的可接受性所需的有效統(tǒng)計技術(shù)的應(yīng)用
P04.04 Internal laboratory
An organization's internal laboratory facility shall have a defined scope that includes its capability to perform組織內(nèi)部的實(shí)驗(yàn)室設(shè)施應(yīng)有一個包括其有能力履行的定義的范圍
the required inspection, test or calibration services. This laboratory scope shall be included in the quality所需的檢驗(yàn)、試驗(yàn)或校準(zhǔn)服務(wù)。實(shí)驗(yàn)室范圍應(yīng)包括在質(zhì)量
management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for管理體系文件。實(shí)驗(yàn)室應(yīng)指定和實(shí)現(xiàn)，作為最低技術(shù)要求
? adequacy of the laboratory procedures, 實(shí)驗(yàn)室程序，足夠
? competency of the laboratory personnel, 實(shí)驗(yàn)室人員的勝任力
? testing of the product, 測試的產(chǎn)品，
? capability to perform these services correctly, traceable to the relevant process standard (such as ASTM,EN, etc.), and有能力履行這些服務(wù)是否正確，可追溯到相關(guān)的過程標(biāo)準(zhǔn)（如ASTM、 EN 等），和
? review of the related records. 審查的相關(guān)記錄。
NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory conformity to this requirement but is not mandatory 請注意到 ISO/IEC 17025認(rèn)證可用于證明組織內(nèi)部實(shí)驗(yàn)室的整合。