ISO13485：2016文件控制程序-英文版
This procedure provides general rules for controlling different categories of documents, and
documents in different media.
The procedures is based on the assumption that the IMSXpress system is used for
controlling most of the documents, but that there also are some paper documents (legacy
drawings, customer documents, etc.).
IMSXpress Document Control system is suitable for controlling any category and type of
documents, including engineering drawings, specifications, reports, etc.
I PURPOSE
The purpose of this procedure is to provide for a system and instructions, and to assign
responsibilities for the establishment, review, authorization, issue, distribution, and revision
of controlled documents.
II APPLICATION
This procedure applies to the following categories of documents:
Make sure to coordinate this list with Quality Manual Section 4.2 where these documents
are also listed and defined. Edit the list to be appropriate for your company, for example, if
you don't install or service your devices, delete any references to installation and servicing.
?Quality manual;
?Operational procedures;
?Work instructions;
?Forms;
?Device, labeling and packaging specifications;
?Manufacturing, installation and servicing specifications;
?Quality assurance procedures and specifications; and
?Standards and codes.
III PROCEDURE
1 IMSXpress electronic document control system
1.1 Whenever possible and practical, documents are controlled and distributed through the
IMSXpress electronic document management system. The system consists of two modules:
Document Library and Document Control.
1.2 The Document Library module is for distributing company’s documents. From this module
users can display and print documents, but cannot change them. When available, users can
also view and/or download attachments associated with the document. Only the current
(Active) approved and released document revisions are available in the Document Library.
Users can view only those document folders (categories) for which they have explicit
viewing permission.
1.3 The Document Control module is for managing documents, to include:
?Creating new documents and document revisions
?Organizing documents in a folder tree
?Administrating Document training
?Approving and releasing documents
?Controlling document viewing and editing permissions
2 Paper document control systems
2.1 Paper documents are controlled using manual document control system based on hand signed
approvals, master lists, physical distribution, and identification/segregation of obsolete
documents. This specifically applies to:
?Legacy paper engineering design documents, specifications and drawings;
?Various confidential documents regarding legal, financing, personnel, contracts and other
such confidential documents and records.
Edit this list of excluded the types of documents as applicable in your company.
3 Categories of controlled documents
3.1 Quality System Records (QSR): Documents defining the quality management system, in
particular the quality manual, operational procedures, and work instructions that are not
specific to any particular device or its manufacturing process, are referred to as Quality
System Record (QSR). QSR documents are established and controlled following the same
rules that generally apply to all controlled documents, e.g., as defined in this document
control procedure.
Documents in this category include:
?Quality System Manual (QM): This top-level document defines the company's quality
policies and quality objectives; defines the scope of the quality system, including details
and justification for any exclusions (refer to QM Section 1.4); describes the overall quality
system, its processes, and their sequence and interaction; and references applicable
operational procedures.
?Quality System Operational Procedures (QOP): These are second-level documents
defining specific quality system processes. Operational procedures explain the what,
when, who and how for a process, and define what records must be established to
document the results. Operational procedures are code numbered QOP-SS-xx. QOP stands
for Quality Operational Procedure, SS is the section in the quality manual to which the
procedure pertains, and xx is the consecutive number of a procedure pertaining to the
same section. For example, QOP-75-03 is the third operational procedure pertaining to
QM Section 7.5.
?Quality Procedure Forms (QOP**F): These are usually one-page manual forms
providing a blank template for establishing a record. Forms are code numbered
QOP-SS-xx-Fx. SS-xx is the code-number of the procedure to which the form pertains,
and F is the designation for Form, followed by a consecutive number of a form pertaining
to the same procedure (to distinguish between different forms associated with the same
procedure). For example QOP-82-01-F2 is the second form associated with procedure
QOP-82-01.
Forms are established as separate documents, but are associated with specific procedures
through the numbering system.
3.2 Device Master Records (DMR): Documents that define the device, manufacturing process,
and quality assurance specifications are organized into a file and/or are referenced in an
index called a Device Master Record (DMR). Operational Procedure QOP-42-03, Device
Master Record, defines how DMRs are established and maintained. DMR documents are
established and controlled following the same rules that generally apply to all controlled
documents, e.g., as defined in this document control procedure.
Device Master Record (DMR) is a term used in CFR 820.181. In ISO 13485 the file
containing the same set of documents is referred to as Medical Device File. Requirements
for this file are in ISO 13485 Clause 4.2.3. We use the DMR designation because it seems to
be more popular, especially in the US.
Documents in this category include:
?Product specifications: These documents include component, subassembly, assembly,
packaging and labeling drawings and specifications; bills of materials (or lists of
ingredients); compositions; formulations; wiring and piping diagrams; software
specifications; user manual, packaging artwork, and other such documents defining the
product and its packaging. For some contracts these documents may be of external origin,
i.e., supplied by customers.
Refer to these documents as is customary in your industry and company. For example, in
your industry, specifications may be called data sheets, and there may be no drawings but
diagrams. If labeling or packaging specifications are not applicable, delete these references
accordingly. Whatever the format and names, this clause refers to documents defining your
product. If you never receive such documents from your customers, delete the last sentence.
?Manufacturing specifications: Documents under this category include process flow
charts; diagrams of process/assembly lines; specifications for equipment, tools, and molds;
setup procedures; operator instructions; machine maintenance procedures; blank work
orders (job travelers), nonconforming product/process forms, and other reporting forms;
and other such documents defining the manufacturing processes and the manner of
production.
As written now this clause mentions too many things. This is intentional to give you
examples of what types of documents to include. You must edit this clause to include only the
types of documents that exist and are actually used in your company. For example, don’t
mention molds if you don’t use molds, and don’t include setup procedures if they are not
relevant.
?Quality control procedures and specifications: Documents in this category include
process control specifications/charts; control plans, instructions and acceptance criteria for
incoming, in-process, and finished product inspection and testing; procedures and
acceptance criteria for the verification of packaging, labeling, installation, and servicing
activities; blank forms for inspection/testing reports and other quality records; release
document review list; and other such documents defining how products and