If you own a small business and are looking into gain ISO 9001 certification, one of the first things you may ask yourself is what kind of requirements you need to follow. One such condition that you may have heard of is First Article Inspection compliance.
Does ISO 9001 Require First Article Inspection? If you own a company that manufactures machinery for aviation or aerospace, you will need First Article Inspection (FAI) documentation.
To learn more about FAI, ISO 9001 certification requirements, and who is qualified for certification, continue reading.
No, however if you are a company that manufactures aviation or aerospace machinery, and you are applying for ISO 9001 certification or have IOS 9001 certification, you are required to provide a First Article Inspection.
As part of their quality assurance standards, you need to submit paperwork showing the specifications of the product being sold. This is to ensure that industry standards in both safety and quality are being maintained.
First Article Inspection, or FAI, is an aviation and aerospace specific standard. When a company is commissioned to make a part or product for a customer, they are required to submit paperwork detailing the specifications of the piece.
The customer upon receipt of their purchase will fill out an accompanying FAI. Just as with the company, they will detail the specification of the parts, such as measurement, shape, materials it is made from, etc.
This inspection serves a two-fold purpose — namely safety and quality.
The FAI's purpose in safety is because aviation parts and machinery are particularly sensitive to unexpected alterations or changes. If a piece of machinery is faulty because of a manufacturing error, the results could be catastrophic.
By making sure that the specifications match what was expected and sent, accidents are less likely to occur.
The FAI's purpose in quality is also related to safety. Poorly made materials or materials that passed the initial inspection due to human oversight are considered poor quality. The machine parts of inferior quality may fit the desired measurements but are still not appropriate for you.
ISO 9001 requirements refer to the necessary changes needed to be made in your company to be considered ISO 9001 certified.
There are five mandatory requirements for ISO 9001 certification. Today, we will focus on the five necessary conditions, which are: Quality Management System; Management Responsibility; Resource Management; Measurement, Analysis, and Improvement; and Product Realization.
The titles are fairly self-explanatory, but we will go more in depth below.
Quality management systems focus on the day to day aspects of your business once it has received ISO 9001 certification.
Within this area, you will look into how you're going first to enact implementation procedures and then follow up on them. You will show how you are complying to this requirement through the application procedure, internal audits, and certification audits.
In the application, you will be required to submit your proposed quality manual and your perspective plan for control of documents and control of records.
The submission of these materials through your application will show readiness to adhere to the standards set by ISO 9001 in your industry.
The internal audits will be how you train your employees to ensure quality control in both the product or service they provide and the environment they work in.
The annual certification audits will be how you confirm that you have been following the standards set and have been applying your proposed guidelines for your company.
Management responsibility is the requirement that looks into the role of yourself as the owner of your company, the duties assigned to those in managerial positions, and at the commitment and focus on your customers.
This is an essential requirement to meet. It doesn't matter if all your employees are complying with the standards and expectations made towards them with ISO 9001 certification. If their employer doesn’t follow suit standards will wane and disappear.
In fact, as the individuals in charge of your responsibility towards compliance is more important than your employees in a way, simply because the most effective approach is to lead by example.
Customers are also included in this requirement because the opinion your current and potential customers have towards your company and employees reflects more on you and your role in the creating quality standards to be met.
This requirement is done through having a written document detailing your’s and your management’s responsibilities and duties. This is kept in check through a review process that will be conducted by both customers and employees.
Having a form of review or feedback will ensure that the quality of work you as the employer provide will be held to the same standard you expect of your employees.
Resource management focuses on the infrastructure of the company, the work environment, and human resources. The requirement focuses on what is being provided to your employees to ensure that their needs are being met.
This is an integral part of the ISO 9001 certification. If your employees are unhappy, either because benefits aren't being met, the work environment is unhealthy and straining, or employer is uncommunicative, your company will falter.
It could be through apparent ways such as you suddenly have a massive drop in employees or more subtle ways like the quality of the product swiftly lessen.
This requirement is met through writing your plan of action and implanting it. You also provide training to your employees to improve their understanding of the standards you are reaching for in this company what much help with meeting this requirement is to meet the management responsibility requirement that came before.
Measurement, analysis, and improvement are vital whether you want to be ISO 9001 certified or not. Having any kind of standard that you have to try to meet every quarter or every year ensures that you are always trying to maintain quality.
In my opinion, the essential part of this is the analysis. It doesn't matter if you know you didn't meet the standard if you don't also understand why you didn't meet the standard. You have to be able to look at the reasons and say this is where we faltered.
Once the analysis is complete, you can move on to coming up with a solution or improving. The goal with this requirement is that you're always going to need to improve. If you follow that mentality, your approach to standards won't stagnate, and you will continue to have certification.
This requirement is met through your customer's feedback, your employees’ feedback (internal audits), and your observations. If you pay attention to what is losing traction and what is going strong, you will be able to pick up which areas need fixing before they become too big.
The final requirement, product realization, is unique in that depending on what your company does, or what service and provides and what products it makes you may not need to follow all of the requirements.
First Article Inspection is an excellent example of this. FAIs are an element of product realization but are only necessary if you are making aviation or aerospace parts and machinery.
In general, with product realization, you would provide paperwork establishing how you offered a customer or customers with a product or service.
If it is a product that you can physically touch you need to provide documentation showing the exact specifications, what the products intended use is for, and what type of machinery was used in the making of this product.
If it is a service, you don't need to include information such as measurements or other physical specifications or machinery used.
There are some international and national laws requiring ISO 9001 certification. Most do not, however. That being said, it is in your best interest to acquire this certification for your company.
As a certification that ensures the quality of service and product for your customers, this can drastically improve your reputation and customer base.
Not only does this improve your business through your customers, but the focus on safety will also improve the overall work of your employees.
Again, ISO 9001 isn’t required by any industry. However, it is strongly encouraged that it's principles are taught, whether you are a part of the five previously mentioned sectors or not. The reason simply being it will reflect well on your company if you have it.
Regarding ISO's approach to safety, it is becoming an increasingly popular choice for companies to gain certification that need to ensure safety for their customers, employees, and themselves.
ISO 9001 & Other Standards
Written: 24th July 2019
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard