Do you envision structure of documentation when you think about Quality Management System (QMS) documentation? Perhaps needless processes and concerned much about effectiveness? This is the sad truth for certain businesses, who erroneously believe that the more documentation they provide, the more compliant they would seem. Avoid falling into this trap with your company.
The
three main goals of ISO
13485 documentation are as
follows:
·
To offer an
accurate framework for the business's activities
·
To improve
comprehension of the Quality Management System and promote process consistency
·
To demonstrate
that the business has accomplished its aims and objectives.
Therefore,
when you start writing your QMS documentation, you should concentrate on
efficiency and only write procedures and papers that will be advantageous to
your company.
Medical
Devices QMS Documents Structure
Among
the many documents found in a typical QMS are the following:
·
Quality Manual
·
Quality Policy
·
Procedures
·
Quality Plans and
Records
Not all information must have a distinct
document, however, the ISO 13485 standard mandates that different kinds of
information be documented. An organization can use the standard to determine
how much documentation it needs and how much detail to add. Small businesses
might decide to provide a basic summary of their processes in the Quality
Manual, for example.
How
to Structure Medical Devices QMS Documentation?
"ISO
10013:2001 Guidelines for Quality Management System Documentation" is a
separate standard that guides the quantity and dimensions of documents that
your company is likely to require. It also offers instructions on how each
document should be organized and what should be included. Some of these ISO
10013 guidelines are summarized here.
Quality
Manual: The Quality Manual should contain the
rules that apply to the organization, with reasons provided for any that are
left away according to ISO 13485:2016 article 4.2.2. The organization itself,
including its size, complexity of operations, and personnel skills, will
determine the contents of the book and its general structure. Although a small
business may likely document its full quality management system in a single
manual, a huge multinational corporation might require many quality manuals in
addition to all other necessary documentation.
A
quality manual should include;
·
The table of
contents and title
·
Details regarding
the approvals and versions of the documents
·
An explanation of
the QMS
·
The extent of the
QMS
·
Any modifications
from ISO 13485 and justification for them
·
The
business process model used by the corporation
Quality Policy: The company’s dedication to quality,
compliance with legal and regulatory requirements, and ongoing improvements are
outlined in the Quality Policy. It describes your company’s quality targets,
which are determined by measuring them. Keep the Quality policy short and
simple because some businesses decide to use it for marketing.
Quality
Procedures: An
organization's quality management system is based on its quality procedures.
Their goal is to put procedures in place that will guarantee the business's
operations meet ISO 13485 criteria. Quality processes can take many different
forms. They can take the shape of stories, which are descriptive; more
structured tables; flow charts, which are more shown; or a mix of such formats.
The
following components must be incorporated into quality procedures:
·
The title to
determine the process
·
Its objective, or
the rationale behind the process
·
Defining its
scope, or what is and is not part of the process
·
The authority,
roles, and duties of people doing the procedure
·
A list and
definition of the documents produced by the procedure's activities
·
Identification of
modifications, the document's version, and the date of review and approval, in
compliance with accepted document management procedures
An
explanation of the steps involved in the process (the procedure's major body)
that includes what needs to be done, how, when, where, and by whom. In certain
situations, the "why" should also be explained, along with the inputs
and outputs of the duties, as well as the required materials. If necessary,
supplementary.
Records: The low-level records that demonstrate that a
process is in place and being carried out by the work instruction or procedure
are these. Inspection documents, for instance, provide proof that an inspection
was conducted in addition to certain particular conclusions.
Audit
Checklist: Audit questions are covered by the ISO
13485 Audit Checklist, which is based on the department- and
clause-by-department requirements of ISO 13485:2016. You can create your
internal audit checklist by altering this ISO 13485 checklist.
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