Setting the bar higher for quality – is ISO9001 still relevant in manufacturing today?

Quality leader in the Additive Manufacturing sector and former external auditor Andrew Milner provides his insights into how standards could better serve the needs of industry, and how “big data” may play a part in this in the near future.

ISO9001 has long been the most widely applied Quality Management System standard worldwide.

However, does it still remain relevant at the sharp end of advanced manufacturing?

In this article I will be putting forward the case for setting the bar higher by implementing industry specific standards, and greater collaboration on the development of harmonised standards that are tailored to the manufacture of a particular product family.

We will also explore some of the benefits from a commercial and supply chain management perspective, and I hope that for some of you reading this I can change your perception of standards and make them something you can get excited about!

Standards and why they matter

Standards are recognised methods, norms and best practices that provide a reliable basis for people to share the same expectations about a product or service. This is vital for ensuring interoperability throughout the supply chain, and in the context of manufacturing, provides buyers with a reasonable level of confidence in the organisation they are sourcing from. A certification scheme is a method for independent third party assessment of whether an organisation complies with these standards, and therefore provides even greater confidence and assurance.

For several decades, ISO9001 has been the leading certifiable standard for manufacturing organisations around the world – often a pre-requisite to being included on tenders and becoming an approved supplier. ISO9001 has no doubt been the basis for driving improved product quality and customer satisfaction for many. However, as the standard has to be applied to almost every type of organisation it can sometimes be too general and non-prescriptive in terms of defining requirements.

An industry specific standard is a standard developed to meet the needs of a specific industry or product group. Some well known examples include:

  • AS9100 (Aerospace, Space and Defence)
  • IATF16949 (Automotive)
  • ISO13485 (Medical Devices)

I often describe some of these standards as “ISO9001 on steroids” as they incorporate additional requirements and terminology that is relevant to that specific industry. For example, in the operational clauses of AS9100 additional requirements such as configuration management, product safety, production process verification (commonly known as First Article Inspection) and prevention of counterfeit parts are introduced – considerations that are a common practice within Aerospace circles but would not be relevant to many other sectors. 

If you are an organisation pursuing increased work with a more specialist sector such as Aerospace or Medical Devices, I would highly recommend having a plan to become certified to the relevant QMS standard for this industry to demonstrate alignment with industry norms and best practices relating to Quality. Many organisations also see a general increase effectiveness of their Quality System from following a more focussed set of requirements.

These industries will also likely have product related standards and codes that need to be complied with, so it is essential to get a good understanding of them to.

Photo by ThisisEngineering RAEng on Unsplash

Potential issues

Whilst I am an advocate for industry specific Quality Management System standards and more product standards, they are not without potential risks and challenges. For example:

  1. Some standards have more significant requirements around documentation and record keeping, incurring greater expense (and investment in time) for smaller companies. This could be a burden for some, especially if the standard is being adopted only for the potential of more work with a certain customer.
  2. Certification body / Standards body resourcing – due to the specialist nature, there are naturally fewer certification bodies accredited for these schemes. Therefore, choice of local provider, availability of audit dates and personnel may be more limited if you are in a smaller country or remote region. A lot of product technical standards are developed by committees, and the publishing process can also be time consuming due to the time it can take to get consensus of opinion.
  3. Even after becoming certified there may be further variation in the practices adopted by different customers and flowed down to their suppliers; especially if they are manufacturing parts that are a significant component of the aircraft, vehicle or device that they destined for – requiring further adjustments to your quality management system to be compliant, and potentially having to accept numerous customer audits on top of certification body surveillance.

Point number 3 is particularly relevant and forms a key focus of today’s article. For example, customer expectations for manufacturing aircraft engine components would be significantly different to manufacturing cabin fittings, and then on top of that there may also be special requirements applied by different customers based on their own interpretation of what is necessary to maintain quality in the supply chain.

Having to apply different rules and practices depending on the customer creates additional complexity (and, therefore, potential for error) and costs associated with compliance – whether this be using a certain document for one customer but not the other, or fronting audits from several different customers throughout the year.

Photo by ThisisEngineering RAEng on Unsplash

Harmony in Industry – The role of Supplemental Standards

In my view the most effective way to address this would be through greater collaboration across different OEMs and the development of harmonized supplemental standards that sit a tier below Management System Standards such as AS9100. 

One of the most interesting examples I have seen of this in recent years is the Aerospace Engine Supplier Quality Strategy Group (AESQ) and their development of the AS13100 standard (Quality Management System Requirements for Aero Engine Design and Production Organizations). 

The group are a collective of Aerospace Engine OEMs and Tier 1 suppliers – whilst some of these companies may be direct competitors on the commercial field, their technical teams have worked together to develop a set of standards that integrate with the higher level framework of the AS9100 standard, yet detailed enough to address the more stringent customer and regulatory requirements expected in the Aerospace Engines product segment. This initiative has helped to simplify the supplier quality requirements that are cascaded down to the sub-tier suppliers and adopt a common set of methods and terminology for those working in the Aerospace Engine segment.

All of this can only be a good thing for players in the supply chain, as it sets clearer expectations for all interested parties and would likely reduce the costs of compliance due to less variation between customer specific requirements when buying the same product – freeing up more internal resources for innovation, and making entry into the market appear less risky and more transparent for newcomers. Both of which benefits the OEMs.

Whilst AS13100 is not currently a certifiable standard, it can be flowed down as a contractual requirement and verified as part of AS9100 audits, so naturally there would also be less of a need for customers to audit suppliers on an individual basis and more efficiency from this perspective.

Standards and Big Data – The Future?

Earlier in the article I referred to certification body resourcing as a potential challenge to implementing specialist standards, as certification still depends primarily on personnel attending site to conduct an audit or inspection.

On the product certification side of things, it can take a long time to get consensus due to the number of stakeholders that need to be involved and the evidence that needs to be gathered from across industry to ratify the content of any new standard.

In the near future I believe that there is a significant opportunity for big data to simplify these processes. For anyone unfamiliar with the term, big data is the computational analysis of extremely large data sets to reveal patterns, trends and associations.

Here are some examples of how it could be applied to the world of Quality Standards:

  1. Quality Management System certification – keywords and customer sentiment are collected across a variety of publicly available platforms (i.e. social media posts, online reviews, media coverage). This is then used to establish a trend on the aspects of the product or service that are the biggest cause of customer dissatisfaction, resulting in a more targeted approach to surveillance audits by external bodies, and helping standard writing groups identify areas of weakness in the industry as a whole that need to be addressed in future updates the standard.
  2. Product certification – data points gathered from complex and costly inspection techniques (e.g. industrial CT scanning, destructive load / pressure / environmental testing) are analysed to identify critical elements of the design or production that influence the integrity of the product. Through use of software and predictive analytics, a trend is established and the process for formal agreement of design rules and best practices is sped up considerably. This would support the adoption of novel manufacturing techniques in examples where industry has been hesitant to move away from traditional methods due to lack of known standards. A common example of this is the hesitancy by many to adopt additive manufactured parts over cast parts – additive manufacturing may have significant technical benefits in many applications, but can often be seen as a risk due to the current lack of established standards in comparison to other methods such as casting.

These are just two use cases and I’m sure there are many, many more. The opportunities to apply big data and predictive analytics in the world of standards and certifications are immense, and I am very excited about what the future holds.

Photo by Scott Graham on Unsplash

Competitive Advantage and Market Leadership through Standards

So that was just a short example of how harmonised QMS standards are beneficial, using the case study of the AESQ’s work within the Aerospace Engine sector, and how big data may play a part in influencing future QMS certification and product certification in the future. Standards are more than just the “red tape” that many think they are, and can help drive broader commercial benefits as well as enhancing delivered product quality.

So back to my original question. Do I think ISO9001 is still relevant in high-tech manufacturing?

Yes, absolutely. As a blueprint for setting up a Quality Management System it is a necessary part of the process. Especially for start-up companies that want to get a seat at the table for large tenders.

However, as an organisation begins to seek greater participation in a complex industry such as Aerospace, Automotive or Medical, there are clear advantages for becoming certified to a more specialist standard and arguably more credibility. Some often dismiss these standards as only for big corporates, but that is far from the truth – during my time as a Lead Auditor I worked with start-up companies that had fewer than 4 employees that had implemented AS9100 series certification and were successful in winning work with major primes. 

If you are in a niche segment of a market, the next opportunity beyond this is to explore supplemental standards specific to a type of product that could be applied in tandem with the Quality Management System. For some companies operating in new and disruptive segments of the market, there may even be an opportunity to even lead the development of new standards if none exist yet – providing potential customers with more confidence in your methods / products, and in turn creating opportunities to sell into new market verticals.

Have you ever needed to implement a certain standard to win a tender? 

Do you see a need for more standards your industry or segment?  

Do you think big data will have a positive influence on audits and certification? 

Please do let me know your thoughts on this. Use the hashtag #AssuranceWithAndrew on social media to reach me, or feel free to ping me a message on LinkedIn!

Connect with Andrew Milner on LinkedIn and find out more about Conflux Technology, the pioneering additive manufacturing and thermal technology company that he works for, by visiting their website: www.confluxtechnology.com

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