Scribd
Upload
28 views

Is Your QMS Documentation Fit For Purpose?

A quality management system (QMS) requires formal documentation of processes, procedures, and responsibilities to achieve quality policies and objectives and consistently deliver quality products and services to customers. Good QMS documentation ensures quality standards are met, minimizes errors, allows quick access to relevant data, and facilitates monitoring processes for improvement. However, documentation must be "fit for purpose" - lean, understandable, and support effective implementation. Realizing fit documentation follows a PDCA cycle and includes identifying documentation needs, structuring documentation, generating documents clearly describing processes, implementing the documentation system, and maintaining/improving documentation through the product or service lifecycle.

Uploaded by

Puneet Parashar
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
28 views

Is Your QMS Documentation Fit For Purpose?

A quality management system (QMS) requires formal documentation of processes, procedures, and responsibilities to achieve quality policies and objectives and consistently deliver quality products and services to customers. Good QMS documentation ensures quality standards are met, minimizes errors, allows quick access to relevant data, and facilitates monitoring processes for improvement. However, documentation must be "fit for purpose" - lean, understandable, and support effective implementation. Realizing fit documentation follows a PDCA cycle and includes identifying documentation needs, structuring documentation, generating documents clearly describing processes, implementing the documentation system, and maintaining/improving documentation through the product or service lifecycle.

Uploaded by

Puneet Parashar
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

A quality management system (QMS) is a formalized system that documents

processes, procedures, and responsibilities for achieving quality policies and


objectives and thus consistently delivering a quality product or service to the
customer. A QMS helps to coordinate and direct an organization’s activities
to meet customer and regulatory requirements and continually improve its
effectiveness and efficiency. The QMS documentation must accurately and
succinctly document the organisation’s structure, procedures, processes and
resources.

A well designed documented system has many benefits, it ensures quality


standards are routinely met, minimizes the potential for error, reduces
downtime when deviations occur due to being able to quickly access relevant
data, and allows for easy monitoring of the processes such that process
outputs are analysed and appropriate adjustments are made. QMS
documentation fulfills many functions such as communication of information,
providing evidence of conformity and sharing knowledge and as such many
different types and levels of documents are needed, for example a quality
manual, quality policy, documented procedures and work instructions.

A one size fits all approach won’t work, each document type must be fit for
purpose such that it is readily understood by relevant personnel and can be
effectively implemented. Documentation must also be lean, as too many
documents will result in the processes and respective QMS being harder to
both use and maintain while also being bureaucratic. Documentation is also
required for regulatory purposes and must demonstrate the effective
planning, operation and control of the organisation’s processes and the
implementation and continual improvement of the effectiveness of its
QMS. It is evident that good documentation is critical to a functioning QMS,
in fact it forms the foundation of the organisation’s QMS as it gives effect to
the QMS for the life-cycle of the product/service being delivered.

Is your QMS documentation fit for purpose?

Fit for purpose QMS documentation ensures that all processes are
understood and consistently executed by employees such that a quality
product/service is delivered to the customer each and every time. If your
organisation’s documentation doesn’t meet this standard it will result in
regulatory non-compliance, significant costs to your organisation in terms of
resources to rectify issues, and may impact your organisation’s reputation
for example as a result of delays in processing customer orders or failing to
deliver a quality product or service to your customer.

RRL can help your organisation achieve fit for purpose QMS documentation
whether you are a start-up company embarking on designing a QMS and
documentation of same and need to get it right first time or QMS
documentation in place isn’t fit for purpose and is thereby hindering effective
and efficient operation of the QMS.

What does fit for purpose QMS documentation look like and how can
you achieve it?

Realisation of fit for purpose documentation is based on PDCA (Plan-do-


Check-Act) cycle and can be achieved in 5 steps which are detailed
below. Fit for purpose documentation must be lean to facilitate
implementation and maintenance while the documents must clearly describe
all QMS processes using simple, concise unambiguous language to ensure
that processes are understood and can be easily implemented.

To achieve fit for purpose documentation you must first identify the
documentation that your organisation needs for implementation of its QMS
and the medium you want to use either hard copy or electronic media. The
amount of documentation needed depends on the size of the organisation
and its business, the complexity of the processes and their interactions and
the competence of the personnel. Many organisations find it useful to use a
process map to document the processes and their interactions and use this
as a tool to decide on what documents are needed, good planning at this
stage will save time and effort later.

The next step is to decide on the structure of the QMS documentation, which
usually follows the organisation’s processes or the structure of the applicable
quality standard or a combination of both. The structure or hierarchy of the
documentation facilitates distribution, maintenance and understanding of the
documentation. Following the identification and structure of the documents
needed Step 3 is where you generate the required documents, this is the
most difficult part of the realisation process as the documents themselves
will determine employees understanding of the processes such that they can
implement and document them accordingly as quality
records. Implementation of the documentation system is the next phase and
is documented in the document control procedure which must be robust and
stringently followed.

The final step is maintenance and improvement of the QMS documentation


throughout the lifecycle of the product or service. Maintenance is performed
by ensuring that QMS documents are controlled as per document control
procedure and improvement is achieved via analysis of QMS outputs and
taking appropriate action to continuously improve effectiveness and
efficiency of the QMS.

Step 1: Identify documentation


Identify all your processes and the interaction between them using a Process
Map, analysis of the processes should then be used to determine the amount
of documentation needed for the QMS. QMS standards will determine
mandatory documents, for example ISO13485:2016 lists Quality Manual,
Quality Policy, Quality Objectives, Quality Records and six procedures as
listed below as mandatory documentation:

1. Control of Documents
2. Control of Records
3. Internal Audit
4. Control of Nonconforming Product
5. Corrective Action
6. Preventive Action
Thereafter you only require procedures to cover each section of the standard
that applies to your business and the complexity of the business will dictate
the amount of documentation and level of detail needed.

You might also like