4.2 Documentation requirements 文件要求
4.2.4 Control of documents 文件控制
Documentsrequired by the quality management system shall be controlled. Records are aspecial type of document and shall be controlled according to the requirementsgiven in 4.2.5.
質(zhì)量體系所需的文件應(yīng)當(dāng)被控制。記錄是一個(gè)特殊文件，應(yīng)當(dāng)依據(jù)4.2.5中的要求進(jìn)行控制。
A documentedprocedure shall define the controls needed to:
應(yīng)當(dāng)用文件化的程序?qū)⑦@些控制明確下來(lái)，至少包括：
a) review and approve documents for adequacyprior to issue;
下發(fā)前應(yīng)當(dāng)進(jìn)行審核和批準(zhǔn)，以確保文件的充分性和適宜性;
b) review, update as necessary and re-approvedocuments;
必要時(shí)對(duì)文件進(jìn)行評(píng)審、更新并重新批準(zhǔn)文件；
c) ensure that the current revision status ofand changes to documents are identified;
保證文件更改和現(xiàn)行修訂狀態(tài)得到識(shí)別；
d) ensure that relevant versions of applicabledocuments are available at points of use;
在應(yīng)用文件的區(qū)域能夠獲得適用文件有關(guān)版本；
e) ensure that documents remain legible andreadily identifiable;
確保文件保持清晰、易于識(shí)別；
f) ensure that documents of external origin,determined by the organization to be necessary for the planning and operationof the quality management system, are identified and their distribution controlled;
確保外來(lái)文件得到識(shí)別、并控制其分發(fā);這些文件是由組織確定的，對(duì)質(zhì)量管理體系策劃和運(yùn)行來(lái)說(shuō)都是必須的。
g) prevent deterioration or loss of documents;
防止損壞或丟失文件。
h) prevent theunintended use of obsolete documents and apply suitable identification to them.
防止作廢文件的非預(yù)期使用，并對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí)。
The organizationshall ensure that changes to documents are reviewed and approved either by the originalapproving function or another designated function that has access to pertinentbackground information upon which to base its decisions.
組織應(yīng)保證文件的更改得到原審批部門(mén)或其他指定部門(mén)的審核和批準(zhǔn)，該被指定的審批部門(mén)應(yīng)能獲取用于作出決定的相關(guān)背景信息。
The organizationshall define the period for which at least one copy of obsolete documents shallbe retained. This period shall ensure that documents to which medical deviceshave been manufactured and tested are available for at least the lifetime ofthe medical device as defined by the organization, but not less than theretention period of any resulting record (see 4.2.5), or asspecified by applicable regulatory requirements.
組織應(yīng)當(dāng)規(guī)定一個(gè)期限來(lái)保留至少一份作廢的受控文件。這個(gè)期限應(yīng)確保至少在組織所規(guī)定的醫(yī)療器械壽命期內(nèi)，可以得到此醫(yī)療器械的制造和試驗(yàn)的文件，但不要少于記錄(見(jiàn) 4.2 .5 )或相關(guān)法規(guī)要求所規(guī)定的保存期限。
4.2.5 Control of records 記錄控制
Records shall bemaintained to provide evidence of conformity to requirements and of theeffective operation of the quality management system.
應(yīng)當(dāng)保留記錄以便供符合法規(guī)要求和質(zhì)量管理體系有效運(yùn)行的證據(jù)。
The organizationshall document procedures to define the controls needed for the identification,storage, security and integrity, retrieval, retention time and disposition ofrecords.
組織應(yīng)當(dāng)建立文件化的程序，來(lái)規(guī)定記錄的標(biāo)識(shí)、貯存、保護(hù)、檢索、保存期限和處置所需的控制
The organizationshall define and implement methods for protecting confidential healthinformation contained in records in accordance with the applicable regulatoryrequirements.
組織應(yīng)根據(jù)適用的法規(guī)要求，制定并實(shí)施記錄中包含的機(jī)密健康信息的方法。（新增）
Records shallremain legible, readily identifiable and retrievable. Changes to a record shallremain identifiable.
記錄應(yīng)保持清晰、易于識(shí)別和檢索。更改記錄應(yīng)保持可識(shí)別。（新增）
The organizationshall retain the records for at least the lifetime of the medical device asdefined by the organization, or as specified by applicable regulatoryrequirements, but not less than two years from the medical device release bythe organization.
組織應(yīng)當(dāng)保存記錄至少到組織規(guī)定的醫(yī)療器械壽命期，或是按相應(yīng)的法律法規(guī)要求來(lái)實(shí)施，但從組織放行產(chǎn)品的日期起不少于2年。
注：這部分新增內(nèi)容一個(gè)亮點(diǎn)是器械文檔（Medical devicefile），描述要比YY/T0287-2003內(nèi)容充實(shí)的多。另外就是記錄控制又增加了點(diǎn)內(nèi)容。大家注意一下。