The Top 6 Barriers to ISO 9001 Certification and How to Remove Them

This article, by Jim Lee, focuses on the top barriers to ISO 9001 certification and provides some guidance on how to deal with those obstacles. “When we understand the real roadblocks holding us back, we can set our expectations and strategies to remove those roadblocks and move forward.”

The Top ISO 9001 Challenges

The most common ISO implementation challenges for companies center on:

1. Case for ISO certification is not compelling
2. Resistance to change due to fear and misperceptions of ISO
3. Inadequate team support or management sponsorship
4. Perceived added costs and resources to implement and maintain ISO
5. Poor project management or change management
6. Unrealistic expectations

1.  The case for ISO certification is not compelling

This could be due to existing customers not demanding or requiring ISO certification.  It might be that some existing customers are now asking their suppliers to be ISO certified, but aren’t applying pressure to do so.  Some of these customers may perform their own audits to manage their risks and try to develop their suppliers to improve their quality systems, without mandating ISO 9001 certification.  There is a risk to the long-term relationship by not getting ISO certified when a customer is asking.  For some companies, the perceived risk may not be compelling enough to push the case to become ISO certified.

Making The Case

To tackle this obstacle, you might take a different approach. Find out from Sales what business opportunities were quoted and lost, and if the customer asked whether your company is ISO 9001 certified. That may not be the only reason a business opportunity was lost, but it can be a contributing factor.  These lost opportunities exist, and it’s possible to show the cost benefits to compel management to support the change to grow business opportunities.  Even if only 10% of the lost business opportunities over the last year or two might have been due to not being ISO certified, you may gain an ally from Sales to help justify and push for ISO 9001 certification.

2.  Resistance to change due to fear and misperceptions of ISO

Another challenge may be that management and the company are resistant to change.   Find out about management’s fears and perceptions about ISO 9001. 

• Do they think the company is too small for ISO?
• Do they fear excessive documentation?
• Do they fear losing flexibility and innovation?
• Do they feel that ISO 9001 doesn’t benefit the business, or distracts the company from its core business activities?
• Do they fear that ISO 9001 “operates” the business, not management?
• Does management lack an understanding of ISO 9001’s purpose and benefits?

Overcoming Fears and Resistance

While these perceptions are real, there are common sense ways to implement practical quality management systems (QMS), and it may start with improving the awareness of ISO 9001 requirements, or an executive overview to improve management’s perception and understanding of ISO’s purpose and benefits.  ISO 9001 done poorly can result in the fears listed.  ISO 9001 done right should not be a detriment to the business. It is an irrational fear that a quality system will take over the business because there are examples or poorly implemented or executed quality systems. Benchmark other companies that are ISO certified where the concerns have been addressed and learn how they were successful.  Ask this question at a local ASQ meeting to see what others are doing when networking with other quality managers and consultants. You may get some good free advice.  Hire a good consultant for guidance.  (Most of simpleQuE’s clients have between 1 and 25 employees.)

3.  Inadequate team support or management sponsorship

Sometimes a business owner may delegate and assign ISO 9001 certification to the quality manager, with the expectation they can accomplish the task alone. Or, they don’t want to be bothered with the QMS and don’t understand why an auditor would want to talk with top management.  It would be beneficial to have an executive overview and awareness of the elements of ISO 9001 that impact the leadership team and the expectations of ISO – setting the strategic direction, company objectives and quality policy, communicating expectations, etc.  It may be helpful if the management team sees the results of a gap analysis to see where they already comply with ISO and where gaps exist. 

Process Approach

Critical to ISO is the process approach, and clearly defining the value stream (from sales, purchasing, receipt of materials, engineering, production, to delivery of the product or service to the customer).  When done properly, the interaction of process map helps integrate the quality system with the business system, and there are no differences between the two. When the core business processes match what you do as a business, and it is understood that ISO wants to see this as the core quality system process, then it is easier to get buy-in and support from other departments.  If we ask the company who is responsible for the sales process, or purchasing process, or production process, or engineering process, it isn’t quality.  Those process owners will quickly step up and take responsibility for their processes and don’t want quality to own their process. 

Process Owners

It will be important that process owners understand those ISO 9001 requirements that will apply to them, and how their business process will be evaluated for performance and effectiveness.

Employees might have previously worked in companies that were ISO certified, but might never have been responsible for implementing ISO 9001 from scratch.  There is a difference between being trained on the standard and being competent and knowledgeable enough to understand the flexibility of the standard. That competency gives confidence in making the standard fit your company’s unique culture, as opposed to doing something extra and wasteful because you think ISO requires you to do it.  Just attending a training course on the standard will not make you competent.  Just like taking a drivers’ education course, doing the practice driving, taking the driving test and written test, and getting a drivers’ license – That doesn’t make the new driver competent. 

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4.  Perceived added costs and resources to implement and maintain ISO

Sometimes there isn’t a budget to implement ISO 9001. It is intended that you will get it done with existing resources and the goal is to become ISO or IATF or AS certified.  No one wants to work 10%+ more hours to add a new task to their workload.  There is a common fear that resources will need to be added to handle document control, or change control, or more quality resources to manage and sustain the QMS. 

Realizing True Cost Savings

What management may not see are the reactive, firefighting costs to deal with quality problems and escaped nonconforming product that reaches the customer, versus the proactive costs to try to avoid just 50% of the problems.  Implementing an ISO 9001 quality management system will not make all your problems go away, but it will reduce the occurrences of problems. 

Work with accounting to see what costs have been spent fighting fires with customers and quality problems with suppliers.  Even if it is an estimation, you’re getting a better sense of the costs associated with poor-quality systems.  If you could reduce those costs in the future by 25% or 50%, what is that savings?  Can the company proactively invest in the QMS to try to offset those future firefighting costs?  You might gain an ally in accounting to help push ISO certification.  Accounting might even help in adjusting the company budgets to assign more funding for quality versus other departments. 

Get Quotes

Also, obtain quotes for getting certified. Reach out to certification bodies to see what it would cost year over year to get and maintain certification. If you think you’ll need consulting guidance and support, get a quote from a consultant too.  Know what costs you’re looking at, versus guessing and thinking that you can’t afford it.  Maybe it’s a matter of waiting a year or two to work it into the budget and whittling away on what you can do in the interim.

5.  Poor project management or change management

Larger companies understand the importance of project management. Some have program or project managers to help coordinate the planning, management, and execution of multiple tasks across departments to achieve the company’s objectives. Smaller companies should have clear action items, with responsibilities assigned, and due dates – a simple action item list for tracking and monitoring progress.  When assignments start to slip, management should be made aware so that resources may be reallocated, or conflicting priorities may be realigned.

Cross-Functional Coordination

 This is related to poor change management control within companies. When change is needed, cross-functional coordination is required to successfully plan, implement, and communicate changes.

6.  Unrealistic expectations

Management expects certification within an unreasonably short time.  This is made worse when the quality manager is expected to get the company certified on their own, with little or no cross-functional support, and external consulting support isn’t permitted.  

Setting Realistic Expectations

Rely on the certification body to help set management expectations.  With just their timing for initial certification audits, conducted in two stages, certification could take months.  There are ways to condense the timing, but it will require more resources (internal and external).

Custom vs Canned Options

Some companies or management think you can purchase a documentation package to get certified.  There may be variations of consulting support options, but ultimately the QMS must be adopted and maintained by each of the business process owners. You can’t take a canned document package (quality manual, procedures, forms), put your company name on it, and expect it to be implemented and followed week-after-week, month-after-month.  The other option is to hire a consultant that does a 100% turnkey quality management system with little or no involvement or buy-in and gets it done fast.  These extreme scenarios are when the management fears can come true with cumbersome, complex quality systems that don’t make sense for the business, and mountains of paperwork.  You might be able to achieve certification with the new, rarely used quality system, but on the first annual surveillance, the quality system falls apart because it isn’t practical or sustainable.

Setting Priorities

Be careful when there is no deadline to achieve ISO 9001 certification.  Achieving certification is never a high priority and always gets pushed aside when the next business priority gets dropped on the company.  This may be fine, as long as you have the cross-functional support and involvement and there is clarity on the steps that need to be taken.  It is a good idea to periodically monitor and report on the progress.

ISO 9001 Consulting

In conclusion, understanding what barriers to ISO 9001 certification exist in your company is the first step in determining how you can remove those obstacles.  If you struggle and can’t make the progress you need, consider outside help.  A good consultant can help you achieve your ISO 9001 certification objective.

SimpleQuE is a leader in AS, IATF^® and ISO consulting, auditing and training.  Whether you are just beginning the certification process or looking for a partner for ongoing gap analysis and internal audit assistance, simpleQuE makes the process easier and more efficient. Contact our ISO 9001 consultants and see the difference that simpleQuE can bring to your quality management process.