Category Archives: ISO9001

Quality in Your Business Strategy

The position of Quality in the overall company strategy isn’t always clear. Yes, most companies claim that quality is their number one priority. This makes sense, as you can only deliver real value if you provide quality products and services. However, how this strategy is translated into the operation isn’t always clear. More often than not, it isn’t incorporated in the organization at all. Last week we talked with a couple of CEOs about how they try to accomplish this and what actions they take. We briefly touch upon the highlights of these discussions.

Empower Quality

Most companies we talked to have an internal quality department. The CEOs pointed out that in order to make quality deeply embedded in the organization, they need to change the role of the quality department. They want the quality department to support the operational departments with embedding quality within the processes. This way, it becomes part of the core processes and not a stand-alone thing. The CEOs also pointed out that it won’t be an easy transition, but it is crucial for the organization in order to execute the strategy. To accomplish this, they gave quality a seat at the table and involved it more in the strategic direction of the company.

Special Improvement Projects

Some of the organizations actually started some special projects to bring quality to the next level. One was a cross-department improvement board. Instead of keeping this main role with Quality, this particular organization made it a collaborative effort among different departments. It wasn’t always easy to coordinate, but it definitely changes the role of Quality within the organization. By bringing the knowledge of the departments together, they got a different point of view for these improvements, which led to some amazing solutions. There were a couple of points they learned during this process. The first is trying to include most opinions. When an organization starts something like this, there will always be certain people eager to help out, which is great. However, sometimes it makes a lot of sense to also hear people that might not be so vocal. It’s a good idea to change the configuration of the people that join the meetings or invite these people occasionally. The second point was about the follow-up. In the beginning, it is very important to keep momentum in these projects to make sure that everybody stays motivated. When momentum slows, certain people might tune out. And lastly was the support from upper management. It is very important that top management joins these meetings every now and then to support the project and show involvement.

Quality as a Department

Another great approach these companies clearly pointed out was the way they positioned quality within the organization. Quality was more like an internal audit and improvement department instead of a department that has to deal with the certificates. This way, quality really focuses on improvement and helping the business get to the next level. Another great result is that the organization is almost constantly ready to be audited by customers or certifying bodies.  

Changing an organization into this paradigm isn’t easy and will take time, but in the end, it will be good for the company. 

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Working from home as a Quality Manager

Working from home can become quite tiresome and repetitive but it also holds some great opportunities for you as a Quality Manager. Normally you are running around with little time left to make fundamental improvements. We all know that it is important, but lots of us are just too busy with the day-to-day business. The distraction from colleagues and accidents that need to be solved right away doesn’t help with the overall improvements.

Review Procedure

Not being interrupted by your colleagues is a blessing when it comes to cleaning up procedures. During busy times, colleagues drop in with all kinds of questions. Most Quality Managers are distracted a lot due to the role they have in the organization. They are in the middle of everything that is going on, so most departments go to the Quality Managers when they have business questions. You might not know the answer, but most of the time you know who does or where someone needs to look to find the answer.

Being forced to work from home allows you to fully concentrate on reviewing the documents and really making some progress on improving them. Of course, don’t do this in full isolation; include people in the team to review the improvements via any web conference solution, like Zoom or Microsoft Teams.

Analyze Data Thoroughly

A thorough analysis of data is another great activity you can do while working from home. We don’t mean creating a pie chart or a histogram. Great platforms will create these graphs for you. We are talking about real analysis and putting context to the data. Technology can visualize the data, but for years to come it won’t be able to make decisions for you on what to do. Yes, artificial intelligence will have a great impact here, but it will not be able to make these informed decisions for the coming years, if not decades, for now, it can only assist you. You know why certain deviations happened and maybe also what went wrong. Use these difficult times to advance and analyze the data you have.

Build Improvement Plans

In line with the analysis done in the previous step, use the analysis to create some great improvement plans that you can do when things come back to normal again. Lots of improvements fix the problem at hand but hardly the true root cause. Sitting at home gives you an excellent opportunity to have a deeper understanding of what went wrong and create improvement plans that solve the root cause. Also look back at the last couple of months. What things went right and what went wrong? Make a list of all these things and communicate this with the different departments in the company. Then they can look at this and make a plan for the next couple of months, what they want to improve in their work and what their goals are for the rest of the year. Now everybody has a goal to work for and they can look forward to get back to work and start working on completing these goals. Then everybody has new energy to get started again.

To conclude, please look at the bright site of things and use these exceptionally difficult times to your advantage. Start to improve the organization, but make sure to involve the rest of the team. This way, everybody is motivated to start working again after the Corona isolation is over. 

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How you can audit differently

This week we organized a great workshop together with the Team of Brown Paper Audit. They introduced their refreshing point of view to audits. Rather than the one-on-one talks with people in the company, they recommend having an interactive session with a group of colleagues. This is definitely not a solution to all the audit fallacies, but an excellent tool to use. During the workshop the main topics were around:

  • Audits in general
  • Context analysis
  • Management review

Audits in General

The overall feeling by the group was that lots of audits are still performed because the external auditor requires them. Regardless, lots of Quality/Safety Managers noted that they preferred a different take on this. An important fallacy they pointed out was a lack of defining a clear goal for the audit. When questioned, they noted there wasn’t always a clear goal defined on what to do with the outcome. The audit report with some NC was filled in but never really given enough attention. In general, the Quality/Safety professionals had the intention to make the audit results more important and create ownership with the audited person. Giving credit where credit is due can do this. When the audited person resolved the improvement, make the company aware of the effort done by the audited person. Next to the results, most Quality/Safety Managers had to admit that the one-on-one talks didn’t give a great insight into what is going on in the company. When tens or even hundreds of people perform a process, auditing one doesn’t give a good idea of how things are going. Having a group approach to an audit can help with this.

Context Analysis

Introduced already back in the 2015 edition, still a significant number of companies is still struggling with this. In most companies we see that the Quality/Safety department owns this document, while it should be a Management document. If you have a document of course, documentation of this isn’t required. The Quality/Safety managers admit they all do the exercise while the managers should pull more weight to it. On the contrary, there were also quite some professionals that were debating the high-level nature of the context analysis. They noticed the big gap between what is in the context analysis and how the people on the floor experience this. They proposed creating a context analysis for each department or per business unit. This could be a great solution, just don’t make it a heavily business-oriented document.

Management Review

Management Review is another topic where Top Management isn’t pulling their full weight according to most Quality/Safety Managers. The Quality/Safety department creates the document and sends it to Management for approval. We always propose to move to a more data-driven continual Management Review. Create a proper dashboard on which top Management can see the progress. The document can be as small as one A4 and highly actionable. Stop creating piles of paper just for the sake of it.

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Make sure you calibrate equipment

Having the right and best equipment for the job is crucial to guarantee the highest quality level. Monitoring and Measuring Resources is the clause in the ISO9001:2015 that focuses on this. Regardless of the standard you are certified for, having proper equipment is crucial to do a good job. Make sure you manage it properly and calibration is done on the equipment.


Before a company can even start managing the equipment effectively, it is important to have a clear description and list of tools that need to be monitored. Especially in the definition, there are endless debates on which tools should be part of this calibration and which don’t. A couple of tools that are always up for debate are the roller gauge and measuring tape. Some claim they should be calibrated, while others claim them to not be that critical. Whatever approach you take, make sure you have a clear definition on this, and of course, this definition can change over time.

Take Inventory

When the definition is clear, make sure all the tools within this definition are known and identified. A clear time interval for calibration should be set. Either based on time or usage is a great way to define this. The list should hold the important information for the organization to identify the different tools—and don’t forget to calibrate intervals. Most of the time, it also helps to list the brand of the equipment and the location where people can find it. Some common registrations we see are something like this:

Name Brand Location Supplier Serial nr. Comment Picture Next Inspection Date Time Interval Inspector


Most of the time, a third party performs calibrations or inspections. Make sure you find a reliable party relatively close by. Together with them, plan the calibrations based on your needs. Some companies have breaks during which they can calibrate most of the equipment. Other great approaches are during holiday seasons or, if possible, when production is in a low season. Make sure you create a schedule that fits the needs and characteristics of the company.


When the equipment is selected and added to the calibration plan, make sure this plan is monitored. It is important that the equipment/tools are calibrated and inspected within the intervals to keep the quality of the products they are used for high. To manage all the tools properly, notifications on when equipment needs to be calibrated will help a lot. These notifications allow the company only to act when this is required. Also, this way, no equipment falls through the cracks, which means that it is less likely that uncalibrated equipment is used.

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Quality Management, does a certificate help?

Previously we touched upon whether or not a certificate is worth it. This post led to quite some discussion, with strong opinions from both sides. However, looking at Quality Management in general you can ask the question, “Does a certificate add value, and if so, how?”

As you might know, we believe Quality Management is important for everybody in the company. Every person has an influence on the Quality of the product or service the company produces. But to do this, is a certificate required other than a customer requirement? Lots of companies deliver high-quality products, but most of them are not certified.


Of course, a certificate is not required to produce high-quality products. Every company that has a great focus on Quality will be able to produce high-quality products and services regardless. The people in the organisation mainly determine quality, not by the certificate. However, the certificate can give a certain kind of guidance and structure that can help a lot. There are certain things that need to be formalized, such as continuous improvement. Having the Management System audited on a regular basis puts back the focus on it. In the end, it all depends on how the management system is set up and how the employees use it. Nevertheless, there are always industries where you simply cannot operate without the certificates.


A standard forces a certain structure in the Management System. Yes, with most standards, you have quite some freedom on how to set up the Management System, but there are certain requirements for a company to work accordingly. A great example is the focus on continuous improvement. These can feel rigid in a way but they also give a great framework when you are trying to get some kind of structure in the organization. This structure can also work great as a playbook for expansion when the company wants to keep a certain level of Quality throughout different branches in different parts of the world.

Force for Change

In every company, there is room for improvement. However, convincing people to move and change the way they work isn’t easy. An advantage of having an auditor coming in every year is that as a Quality Manager, you can leverage them to force internal change. When speaking with hundreds of Quality Managers, we hear over and over again that they do this. However, when you use this tactic, never tell the people that the auditor is forcing this change, as this will not go very well. Not being certified makes it harder or even impossible to use this practice.


At the end of the day, a certificate isn’t really required, but it can help the company quite a lot in structuring the Quality Management within the company. Also, the external audits can be some kind of leverage to create change.

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Quality can sometimes feel ungrabbable

Quality can feel immeasurable sometimes. By immeasurable, we don’t mean all the KPIs we defined within our management system. We have great KPIs to measure company performance, which include things like:

  • Customer satisfaction
  • Production fail rates
  • Recalls
  • Costs of Quality

We say Quality is immeasurable more in the sense of soft output—things like how Quality culture is and how our employees see their work in relation to Quality.

Measuring Quality

Quality Controls in production environments are crystal clear, it either falls within range or doesn’t. If the product doesn’t fall within acceptable levels, it will be rejected. However, Quality Control in more interpersonal activities is much harder to measure. How do you rate the support of a company, for example? Not picking up the phone is a clear bad sign, but the tone of voice of the employee can also have a big impact. Especially the service departments of companies face these interpersonal complexities. Companies and business gurus came up with all kinds of measuring tools to get a good feeling about this, but the fallacy is still embedded in it. What if the person on the other end of the phone is just having a bad day? We cannot easily compensate for this other than in a statistical way. Also, most of these methodologies are making use of the average from lots of data, which is great, but doesn’t say anything on individual cases. Just measure the things that are important and acknowledge that there is bias in the data. And always check for the biggest impact, not only the average of all the data.

Outside Process

To make it even more complex, there are certain outsourced processes that also have a significant impact on the quality perception of the customer. A great example is the delivery guy/girl that delivers the packages for your company. He or she just drops the package over the fence without much care or wasn’t able to deliver it. The customer would get annoyed at the company while you weren’t able to complete control the process. Yes, again, there are ways to measure suppliers, but there is no way for the company to control this process because there are no internal resources for this. In order to have a good feeling of control, make sure critical suppliers are regularly audited and allow customers to easily file a complaint on your website. Use this data to manage and control the outsourced processes. This gives at least some form of control.


Get comfortable with having these immeasurable and hard to define KPIs within the company. There will always be certain outputs that are hard to measure; just make sure there is clear guidance within top management, as well as within the workforce, on how to perceive them. Getting the Quality mindset adopted throughout the company will ensure a much better feeling on the Quality within the company. Create measurable KPIs where possible to back things up with data.

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Buying an ISO Certificate: Is It Worth It?

After interviewing a couple dozen auditors, we heard the expression “Buying Certificates” quite a lot. It basically comes down to companies only caring about the certificate and not about the management system. In general, it happens more often with smaller companies than bigger ones—but it happens everywhere.

Most of the time, ISO certification is simply forced upon by a new customer that requires an ISO certificate. The real question is, is it worth it? It depends on the industry you are in, of course, because some industries you simply cannot do anything without. In general, it isn’t really worth all the things you are required to do if you really only care about the certificate.

The Situation

A new project or customer requires ISO certification, and the company starts to look into the requirements. A consultant gets contacted and a plan is created. Most companies have some form of Quality and Safety controls, so these are extended and adjusted to fit more into the requirements of the standard. A responsible person is appointed internally and he/she is working together with the consultant to get the management system in place.

The Pain

Because of the lack of support and awareness of the importance of the Quality and Safety management, it will start to feel like a big burden on the company. During the audit there should be some sort of proof that the team follows the procedures and processes described and that they are somehow involved in the stakeholder analysis and risk management. This can be quite challenging and lead to lots of irritation, with the most common phrase:

“We have to do it for ISO”

This of course is nonsense because the standard doesn’t write your procedures.

The Numbers

If you only do it to get a project/customer, which we don’t recommend, then it should at least make economical sense. Getting certified isn’t really hard, the real pain lies in maintaining the management system. Let’s make a small calculation. (These figures highly fluctuate among sectors and countries and therefore you should always make your own.) Just make sure you not only include the certification and the auditor but also the internal resources.

We expect 3 months of consulting by an in-house consultant.

  Year 1 Year 2 Year 3
Consultant € 10000 ,- € 4000,- € 4000,-
Internal Resources 200 hours 1 year (100 hours year 2 & 3) € 9000,- € 4500,- € 4500,-
External Audits (3 years) € 2000 € 2000 € 2000
Grand Total €42000,- For 3 years  

This is just a simple, relatively small company but it already turns out to be some significant costs.

The Real Implications

Because the management system isn’t really part of the company and not integrated into the operation, the audits will be a real pain every year. Things will be forgotten or aren’t up to date and control measures aren’t checked on effectiveness or simply don’t exist. This will lead to very frustrating situations during the audits.

A Good Thing

To finish with a positive note, we do see lots of companies that start to see and embrace the value of the management system when they have to implement it. They start to use it as a vehicle to improve Quality and Safety and structure their organization. If this is what you plan for, ISO is most definitely a good framework to do this and the ROI on the certificate will be great. So even if a company starts off as a Certification Buyer, it can still become a company that really leverages the standard to improve the business.

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Why Digitize our QHSE Management System

A QHSE management system gets built over the years and is mostly done with existing tools. However, a scattered QHSE system does more harm than good. A combination of an inspection app, with some Word and Excel docs and an ERP, is how most QHSE Management systems are running. Bring your QHSE to the next level by leveraging one seamless Digitize QHSE platform,.

Why Digitize a Quality Management System?

Why should we digitize our QHSE Management System on one platform? This is a valid question and one we get asked quite a lot. Well, the efficiency improvements are huge. Search time for documents and forms go down by hours, more data is gathered, errors are reduced. These advantages and much more allow companies to have an ROI on platforms of months every single year.

Current Situation

Over the years, companies have built their QMS within the solutions and tools they have been provided. Documents are stored as Word or PDF on the company server. Production issues might be filed in the ERP system, some basic quality checks are built in the ERP. Due to the rise of the mobile phone usage, there might even be an app to perform some basic checks.

This setup is acceptable for staying compliant, but the company will never utilize the full potential of the QMS, namely as a vehicle to improve Quality. This scattered landscape makes it hard for the employees to find relevant information or data, while the Quality department can’t start effective improvement plans. The system also gets very rigid and hard to align with the changes in the company and its environment.


The QMS becomes very rigid because changes to existing ERP or other solutions aren’t easy to realize or are simply out of budget. The Excel documents are pretty easy to change; however, with these documents it gets hard to enforce the use of the latest version. Getting actionable data out of these Excel sheets is even harder, let alone getting proper visualization. In the end, maintaining a fractured management system is undoable.

One QHSE Platform

Bringing all QHSE documents and data into one platform allows connecting the different parts of the QHSE system seamlessly. Employees know where they need to be for their documents and forms. No need to search for ages, the QHSE system is tailored to the role they hold in the organization.

Having all the QHSE data in one place and enriching it with other company data allows for finding the real root causes and implementing a data-driven continuous improvement process.

User Engagement

Having one clear platform for QHSE allows for much more user engagement. Mobile apps increase the number of NCRs by hundreds of percentage, data that is crucial for improving the company. Users know where to go to for their procedures and documents and can find them within a couple of clicks. Clear activity logs show who did what when and what are the next required actions.


Scattered QHSE management systems are harming the company. Digitzing the QHSE management on a single solution will allow the company to improve and maybe even go for Operational Excellence.

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You are responsible for poor Quality

Last week part of the roof of a big soccer stadium in Holland collapsed due to a heavy storm. Luckily no one was injured because there was no game at the time. The media storm that came after was almost as heavy as the natural one. Everybody started to blame each other, and no one takes responsibility for it. As with so many of these things, everyone hides behind policies and documents. This really shows the impact of poor quality products.

However, this disaster clearly showed that you don’t want to be the company that delivers a product that has poor quality—for whatever reason.

Manufacturers Are Responsible

The statement was that additional solar panels were installed and the construction wasn’t designed for that, but still the construction company gets lots of negative press. As the company that built the stadium, they are seen as the responsible party.

Most of the time, the company that manufactures a product is responsible for the product when something goes wrong. This might not be legally so, but in the media the company is. Therefore, it is important to find out how customers want to use the product. If the product is wrongly used, try to correct the customer and guide them in how to use the product properly. Alternatively, the company can even deny delivering the product if they don’t trust that it will be used appropriately. No sale can make up for the negative media that can happen. Yes, this is all covered with legal documents but it is still your name in the newspaper. In the end, you as the manufacturer are responsible. The example in Holland proves this.

Customer Demands

Sometimes customers can request solutions that your company is not comfortable with. This can be a lower price, faster delivery, or particular design choices. Whatever it may be, most of the time it impacts the quality of the product. Make sure the customer is well informed about the implication of their demands and explain what the impact can be. In the end, you need to be comfortable with the product you deliver because you are responsible for the poor quality. However, as a company it is essential to establish a baseline with what isn’t acceptable anymore and align this with the company vision and mission statement.

Don’t be afraid to walk away from a customer

Traceability Documentation

When things actually go wrong, make sure you have all the traceability documentation in place. This is of course after the damage has occurred, but it will help a lot when this is in place. Be able to show how materials were bought and that they have been sourced at reliable companies. Also show how the product was built and tested and have all the test results at hand and verified by trustworthy third parties. This will make it a lot easier in court when things go south.

Regardless if the judge eventually releases the company of any blame, most of the harm has already been done. The company is in every newspaper, which will have a long-term impact. The impact of poor quality lasts forever.

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Multicultural impact on your Quality and Safety management

­­The world is getting smaller, which means a more diverse company culture and multicultural organisation with multiple languages. Lots of companies work with people from different countries. Whether it is a trucker, a specialist engineer, or a welder from around the world.

Demand and supply are filled from every corner of the globe. It is amazing we live in a world where this is possible, but it introduces some challenges related to quality and safety management. When we want to keep this on the highest standard possible, we need to make sure that most of the critical information is well understood by everybody. Making all the documents and ways of working understandable for everybody and in every language isn’t always easy. Mistakes in aligning the cultural differences goes way back. However, with a more globalized economy, not just the big enterprises need to mitigate them.

Language Differences

With all those different kinds of people, there are language differences. People might speak English but they could be having difficulties really understanding it. When English isn’t your native language it can be hard really expressing yourself in it. In such a case, make sure all the important instructions are available in the employee’s native language. The risk of mistakes caused by employees not understanding what to do is just too high. Translating the different information and checklists can be hard—especially when you want to keep analyzing all the information regardless of the language. However, not providing the information in the native language introduces risks which are simply unacceptable.

A common solution for a lot of companies is to have a team leader who speaks English and communicates with the team. This works fine, but it also introduces communication problems. Having the important work instructions, safety guides, and procedures in the native language of the employees is the best way forward. This way you give them the option to really understand how to operate in the best possible way.

Managing all the documents in different languages requires a proper document management solution otherwise you will go crazy. However, when you have a significant number of employees with different native languages it is important to do this.

Cultural Differences

Apart from the language differences there are also quite some cultural differences when you work with people from different countries. They have been trained in a different way from a very young age and are used to doing things a certain way. This might not always align with the way the company does these things.

These cultural differences are something that needs to be taking care of the moment the new employee steps into the company. Make sure the person is trained on how the company handles certain things and colleagues should behave. A great example is the handling of NCRs. In some countries this isn’t really accepted because making mistakes is penalized. While maybe in your company you want more NCRs be filed because it helps you to improve the company. When you hire someone from a culture where this isn’t very straightforward, you need to train this new employee on that mindset.


Yes, having multiple cultures in your company introduces additional work and costs but being aware of the risks of not dealing with it is simply too high. Therefore it is essential that crucial information is available in the native language of the employee.

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