Industry 4.0 and ISO 9001 Quality Management (Part 1)



quality-tablet.jpgThe concept of Industry 4.0 has been gradually introduced into manufacturing facilities in recent years, bringing with it operational improvements and countless other benefits. In a two-part blog series, we will explore how these exciting developments can support ISO 9001-based Quality Management Systems (QMS), as well as dive into their impact on the overall Quality department.

Before Industry 4.0, the previous three Industrial Revolutions were powered by single, so-called “disruptive” technologies:

  • Industry 1.0 – Mechanization (Steam Power)
  • Industry 2.0 – Mass Production (Electricity)
  • Industry 3.0 – Electronics (Computing)

Our current Fourth Industrial Revolution revolves around Digitization.

4-0-nodes.pngUnlike previous Industrial Revolutions, Industry 4.0 is represented by nine distinct but related technology trends shown in the figure to the right.

Adopting such technologies can bring substantial benefits when implemented effectively. For example, cobots can be used to perform tasks that are dull, dirty, or dangerous. Rapid prototyping of components and assemblies, accomplished with 3D printing, can generate massive savings in new product development. Placing low-cost sensors on production equipment can prevent failures through cost-effective predictive maintenance.

A quick review of these technologies and their application is likely to flag several questions for any Quality staff person, such as:

  • How will it affect the QMS?
  • How will we audit it?
  • Will it affect our certification audit?

One consideration is the interaction with a department not typically heavily involved in QMS maintenance: IT. Commonly, the IT department assists with the QMS by providing back-up and maintenance of the digital records (now known as “retained documented information”) or by maintaining the IT infrastructure, including ERP and CRM systems. The technology trends of Industry 4.0 largely rely on IT competencies beyond traditional interfaces and therefore require effective planning. Through technology adoption, an organization’s QMS processes are likely to look very different – and a clue on how Quality leaders should prepare comes from a verse in the Beatles song, “Revolution”:

“You say you got a real solution
Well, you know
We'd all love to see the plan
You ask me for a contribution
Well, you know
We're doing what we can”

In the requirements of ISO 9001:2015, there are a number of references to items which must be planned for and taken into consideration within the framework of the QMS. For example, in meeting the requirements of the section entitled “The Context of the Organization,” the impact of Industry 4.0 could be considered as an external issue affecting the QMS. If a SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis is performed, this might be categorized as either a threat or opportunity, both of which have associated risks.

Section 6 of the standard deals with planning to address risks and opportunities (6.1) and planning changes to the processes of the QMS (6.3). It stands to reason that the adoption of sensors to detect heat, vibration, noise, etc., on machines will change the manner in which maintenance is scheduled and necessitate a change to the maintenance process.

From a resources perspective, planning also should include the need for competencies to be developed (7.2), which is closely tied to the acquisition of organizational knowledge (7.1.6). In particular, how does an organization acquire the knowledge of these technologies being adopted? Where can they get help with 3D printing product design optimization?

Closely linked to this is the need to perform internal audits (9.2.2) on changes affecting the QMS, as well as Management Review (9.3.3) outputs, which include the need for changes to the QMS and identified improvements.

The adoption of Industry 4.0 into an ISO 9001:2015-certified company should not be overwhelming with the appropriate planning and the tools your QMS provides. As the Beatles song goes on…

“Don't you know it's gonna be 
All right, all right, all right”

For assistance with your Quality management and Industry 4.0 implementations, The Center can help. Visit to learn more or contact our experts at

Nichols_A.jpgAndy Nichols, Quality Program Manager

To The Center’s clients, Andy Nichols, CQP MCQI, brings 40 years of expertise in a wide variety of roles and industries, with a particular focus on quality management systems in manufacturing organizations. Prior to joining the Michigan Manufacturing Technology Center, he was the East Coast Regional Sales Manager for NQA, a “Top 5” Global Certification Body, responsible for significant sales growth in a highly competitive marketplace. He has authored two books, “Exploding the Myths Surrounding ISO 9000 – A Practical Implementation Guide” (published by ITG in April 2013) and “A Guide to Effective Internal Management Systems Audits" (published May 2014).


Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

Categories: Industry 4.0, Quality Management