Graphical QMS, documented information, and the audit process

Graphical QMS

A gQMS will help with internal and external auditing requirements - leading to ISO certification in less time and at a lower cost!

When the auditor says: 'Show me where it says that' in reference to your business processes, wouldn't it be great if you were just a few clicks from the relevant pages and able to summon up the documented information on the spot? The graphical QMS (gQMS) approach makes this possible because it is so much easier to navigate through your processes.

You will then be challenged to 'Prove that this is what happened'. How? Simple: you select the process that is being audited from the flowcharts and menu items and drill down to the evidence in the form of documents and records in your "controlled and maintained" documented information.

Documented information in a ISO 9001:2015 quality system can be in any format and media and from any source. The term as defined (3.11) in the DIS can refer to:

  1. The quality management system (3.33), including related processes (3.12);
  2. Information (3.50) created in order for the organization (3.01) to operate (documentation);
  3. Evidence of results achieved (records).

An interactive gQMS will take you straight to the data that the auditor requires to establish compliance with the ISO 9001:2015 requirements, and show that your processes are effective in achieving quality objectives. The latter involves making detailed judgements, which will be aided by appropriate evidence being made available when and where it is needed.

These days, ISO 9001 auditors are expected to focus issues of "risk, status, and importance". They also need to ask if the particular process that you are showing them is a good one, or if there is a way to improve upon it. Therefore, it is important that the documented information keeps pace with this continual process of review and assessment. With on-screen access to the QMS data, both internal and external auditors will be able to verify that your system is working properly; to find out where it can improve; and to correct or prevent any problems that are identified during the audit. The CogniDox gQMS helps you to highlight the issues affecting quality and takes the auditor, via relevant hyperlinks, to the evidence that shows you are addressing the problems. They can then be confident from your documented information that you have considered the risks and opportunities when defining the rigour and degree of formality needed to plan and control the quality management system, as well as its component processes and activities.

One of the myths about the new version of the standard is that fewer documents will be required. It is important to grasp from the outset that ISO 9001:2015 requires that organizations retain documented information " the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements. [8.1 Operational Planning and Control, e)].

Even outsourced processes must be controlled in accordance with 8.4 and the results of the evaluations, monitoring of the performance and re-evaluations of the external providers retained as documented information.

How to Build a QMS Your Team Will Actually want to Use

Documented information describing the results of any review of customer requirements, including any new or changed requirements for the products and services, must also be retained; and where there are changes, the organization has to ensure that relevant documented information is amended and that relevant personnel are made aware of the changed requirements. Documented information from the design and development process must also be retained, again including any changes that are made. When you search for the use of the words "documented information" in the DIS, you find 34 instances in Clauses 4 through 10. The number of occurrences in Clause 8 alone makes for interesting reading and will dispel any notions that ISO 9001:2015 will significantly reduce the total amount of data required to operate a quality system:

8.5.1 Control of production and service provision states that controlled conditions shall include the availability of documented information that defines (a) the characteristics of the products and services; and (b), the availability of documented information that defines the activities to be performed and the results to be achieved. In fact, the requirements set out under Clause 8, including 8.5.2 Identification and traceability, 8.5.6 Control of changes, 8.6 Release of products and services, and 8.7 Control of nonconforming process outputs, products and services will be reassuringly familiar territory for quality professionals, as will the need for what were called "documents and records" in ISO 9001:2008. And as before, the problem of managing all this information in a controlled way and keeping it up to date will still represent a major undertaking. Hence, it could be time to review your options to implement modern document management system technology?

One thing is for sure: an intranet-friendly, web-based based solution with graphical representations of processes and data is more likely to be used than a massive library of documents that no one trusts to be up to date!

Next time: How a gQMS can also help you to sail through your 9001 audit by providing instant access to procedures and evidence from records.

This post was written by Michael Shuff

Tags: ISO 9001:2015, Quality Management System, Document Management and Control, New Product Development

Paul Walsh

Written by Paul Walsh

Paul Walsh was one of the founders of Cognidox. After a period as an academic working in user experience (UX) research, Paul started a 25-year career in software development. He's worked for multinational telecom companies (Nortel), two $1B Cambridge companies (Ionica, Virata), and co-founded a couple of startup companies. His experience includes network management software, embedded software on silicon, enterprise software, and cloud computing.

Related Posts

8 tips for documenting your SOPs (Standard Operating Procedures)

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in ...

Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar ...

Document Control requirements in ISO 9001:2015; what you need to know

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement ...

A short guide to non-conformance reports; what, why and how

How do you log and deal with non-conformities so that faulty products don't end up in the hands of ...

What does it take to make your TMF an eTMF?

A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of ...

Data integrity in life sciences: the vital role of ALCOA principles

Data integrity is central to the safe development and manufacturing of every life-science product ...

Why not just use Google Drive as a Document Management System?

Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. ...

Why not just use SharePoint for your Medical Device QMS?

A Quality Management System (QMS) is a requirement for medical device developers across the globe. ...

Why not just use Dropbox as a document management system?

Dropbox is an easy to use cloud storage and sync application that is increasingly used in work ...

8 tips for documenting your SOPs (Standard Operating Procedures)

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in ...

Pros and cons of a phase gate process in new product development

Will a phase gate process hold back or enhance your new product development? What are the pros and ...

The evolution of a Quality Management System

A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an ...