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.
質量體系所需的文件應當被控制。記錄是一個特殊文件，應當依據4.2.5中的要求進行控制。
A documentedprocedure shall define the controls needed to:
應當用文件化的程序將這些控制明確下來，至少包括：
a) review and approve documents for adequacyprior to issue;
下發前應當進行審核和批準，以確保文件的充分性和適宜性;
b) review, update as necessary and re-approvedocuments;
必要時對文件進行評審、更新并重新批準文件；
c) ensure that the current revision status ofand changes to documents are identified;
保證文件更改和現行修訂狀態得到識別；
d) ensure that relevant versions of applicabledocuments are available at points of use;
在應用文件的區域能夠獲得適用文件有關版本；
e) ensure that documents remain legible andreadily identifiable;
確保文件保持清晰、易于識別；
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;
確保外來文件得到識別、并控制其分發;這些文件是由組織確定的，對質量管理體系策劃和運行來說都是必須的。
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期使用，并對這些文件進行適當的標識。
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.
組織應保證文件的更改得到原審批部門或其他指定部門的審核和批準，該被指定的審批部門應能獲取用于作出決定的相關背景信息。
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.
組織應當規定一個期限來保留至少一份作廢的受控文件。這個期限應確保至少在組織所規定的醫療器械壽命期內，可以得到此醫療器械的制造和試驗的文件，但不要少于記錄(見 4.2 .5 )或相關法規要求所規定的保存期限。
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.
應當保留記錄以便供符合法規要求和質量管理體系有效運行的證據。
The organizationshall document procedures to define the controls needed for the identification,storage, security and integrity, retrieval, retention time and disposition ofrecords.
組織應當建立文件化的程序，來規定記錄的標識、貯存、保護、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.
組織應根據適用的法規要求，制定并實施記錄中包含的機密健康信息的方法。（新增）
Records shallremain legible, readily identifiable and retrievable. Changes to a record shallremain identifiable.
記錄應保持清晰、易于識別和檢索。更改記錄應保持可識別。（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.
組織應當保存記錄至少到組織規定的醫療器械壽命期，或是按相應的法律法規要求來實施，但從組織放行產品的日期起不少于2年。
注：這部分新增內容一個亮點是器械文檔（Medical devicefile），描述要比YY/T0287-2003內容充實的多。另外就是記錄控制又增加了點內容。大家注意一下。