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How To Structure Quality Management System Documentation According To ISO 13485

The document provides guidance on how to structure Quality Management System documentation according to ISO 13485. It discusses establishing a documentation hierarchy with a Quality Manual at the top level to define the quality management system. It also recommends having procedures, work instructions, and records to define processes and provide evidence of conformance. The goal of the documentation is to provide a framework for operations, ensure process consistency, and demonstrate achievement of goals.

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Pavan Mujawdiya
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309 views4 pages

How To Structure Quality Management System Documentation According To ISO 13485

The document provides guidance on how to structure Quality Management System documentation according to ISO 13485. It discusses establishing a documentation hierarchy with a Quality Manual at the top level to define the quality management system. It also recommends having procedures, work instructions, and records to define processes and provide evidence of conformance. The goal of the documentation is to provide a framework for operations, ensure process consistency, and demonstrate achievement of goals.

Uploaded by

Pavan Mujawdiya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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How to structure Quality Management System


documentation according to ISO 13485
When you think about Quality Management System (QMS) documentation, do you picture piles of
documents? Maybe bureaucratic red tape and unnecessary procedures? For some companies, this is
the unfortunate reality, because they mistakenly believe that the more documents they create – the
more compliant they will appear to be. Don’t let your company fall into this trap.

Of course, being the international standard for Quality Management Systems in the medical device
industry, ISO 13485 does require certain documentation (see this article: List of Mandatory
Documents required by ISO 13485:2016). But, that documentation serves a number of purposes –
and not one of them involves making your company simply appear to be compliant.

The real purpose of QMS documentation is threefold:

to provide a clear framework for the company’s operations


to facilitate process consistency and better understanding of the Quality Management
System
to show evidence of the company’s achievement of its goals and objectives

So, when you set out to create your QMS documentation, your focus should be on efficiency, and
on creating only those processes and documents that will benefit your organization.

QMS documentation hierarchy


A typical QMS will contain a variety of documents, some of which include:

Quality Policy
Quality Manual
Procedures and Work Instructions
Quality Plans and Records

The hierarchy of this QMS documentation is depicted in the diagram below:


The ISO 13485 standard requires various types of information to be documented; but, not every
piece of information has to have its own separate document. The standard allows an organization
the flexibility to decide on the amount of documentation it needs, and the level of detail to include.
For example, small companies may choose to document a simple overview of their procedures in
the Quality Manual.

How to structure your QMS documentation


There is a separate standard, called “ISO 10013:2001 Guidelines for quality management system
documentation,” which offers some direction as to the number and size of the documents your
organization will likely need. It also provides guidance on the structure and contents of each
document. The following is a summary of some of these ISO 10013 guidelines.

Quality Manual. Clause 4.2.2 of ISO 13485:2016 states that the Quality Manual should include
those clauses that are applicable to the organization, with a reason given for any clauses omitted.
The contents of the manual, as well as the overall structure, are going to be dependent on the
characteristics of the organization itself, such as size, operational complexity, and staff
competencies. While a small company can probably document their entire Quality Management
System in a single manual, a large multi-national company may need several Quality Manuals, plus
all the other required documents.

A typical Quality Manual will include:

title and table of contents


information about document version and approvals
a description of the QMS
the scope of the QMS
any exclusions from ISO 13485, and the reasoning behind them
the company’s business process model
roles and responsibilities of personnel
references to additional relevant documents and appendices
the Quality Policy and objectives

You can learn more about how to write an effective Quality Manual in this article: ISO 13485: How
to write a short quality manual.

Quality Policy. The Quality Policy is a statement of the company’s commitment to quality, to
continual improvement, and to fulfilling its legal and regulatory obligations. Basically, it outlines
your organization’s quality goals, which are defined by quantifying its quality objectives. Some
companies choose to use the Quality Policy for promotional purposes; you’ll want to display it on
the premises and on the company website, so keep it simple and concise.

Quality procedures. The quality procedures are the very backbone of an organization’s QMS.
Their purpose is to establish processes that will ensure the company’s activities conform to ISO
13485 requirements. Quality procedures come in all shapes and sizes. They can be descriptive,
such as in narrative form; they can be in a more structured format, like tables; they can be more
illustrative, such as a flow chart; or they can be a combination of any or all of the above.

Quality procedures should include the following elements:

the title – to identify the procedure


its purpose – the reasons for the procedure
its scope – to define what is included in the procedure, and what is not
roles responsibilities and authorities of those involved in the procedure
roles, responsibilities, and authorities of those involved in the procedure
a list and definition of records that result from the activities described in the procedure

identification of changes, date of review and approval, and version of the document, in
accordance with the established practice for document control
a description of the activities in the procedure (this is the main body of the procedure) –
describing what should be done, how, when, where, and by whom. In some cases, the
“why” should be clarified as well, plus the inputs and the outputs of the activities,
including the necessary resources.
appendices, if needed

Work instructions. You can include work instructions as a part of a procedure, or simply reference
them in the procedure. Work instructions are typically structured in the same way as the
procedures, and cover the same elements; but, the work instructions provide greater detail about the
activities that need to be performed, with an emphasis on the sequence of steps to be taken, the
tools and methods to be used, and the accuracy requirements. They can also include provisions for
any risk related to the activity, how to mitigate it, and its potential impact on safety, performance,
and compliance with regulatory requirements if not managed properly.

The use of competent personnel, and adequate staff training, will eliminate the need for highly
detailed work instructions. You can learn more on this topic in the article Using Competence,
Training and Awareness to Replace Documentation in your QMS.

Records. These are the low-level documents that provide evidence that a process is in place and
performed according to the procedure or work instruction. For example, inspection records show
that an inspection was performed, along with some specific findings.

Good QMS documentation is essential for an effective Quality


Management System
Planning the size and scope of your QMS documentation based on your organizational needs is
essential for a functional and efficient Quality Management System. Moreover, properly structured
documentation will make your operations much easier, while sloppy documentation will bring you
nothing but trouble.

Click here to download a free white paper Checklist of Mandatory Documentation Required by
ISO 13485:2016.

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