Audits4U Blog

Critical Concerns of QMS

There are some critical concerns of QMS, especially when a business is transitioning from one specialist to another. Implementing and maintaining a Quality Management System can be a challenge. As a result, professionals experience numerous challenges. So, what are some issues that professionals face when using Quality Management Systems and why do you need to secure everything your current specialist has?

Challenges with QMS

A Quality Management System documents the policies, procedures, and controls necessary for an organization to create and deliver high-quality products or services to customers. As a result, there are many elements that need to be addressed in order to make a QMS function. After all, some QMS models will not work with certain companies. Your QMS specialist or team has to find a method to maintain your own system. While developing a system, specialists will face challenges such as:

Too Much Documentation
Too Many Details
Overly Rigid
Lack of Communication
Lack of Motivation
Not Focusing on Customer Satisfaction

When your specialist or team addresses all of these issues, your company will be left with a practical and effective Quality Management System. It is important to involve staff in the process and continue to change to improve the system over time. Once a company has a functioning QMS, the business will benefit from the proficiency that it provides. However, one of the critical concerns that you can face with QMS is what happens when your specialist leaves.

Risks of Losing Your QMS

Losing a QMS specialist can be a major blow. However, the impact can be worse if you lose your QMS as well. After all, your QMS specialist is the one responsible for implementing and maintaining your system. If you do not secure your management system, your company can face:

Disengaging the Workforce
Lack of Customer Satisfaction
Lack of Improvements
Losing Documents

Considering all of the challenges that people face with QMS, losing your own system would force you to start from square one. However, you don’t have to face these risks if you are working with QMS Bridge.

Solving Your Critical Concerns with QMS Bridge

QMS Bridge builds the foundation between the QMS employee leaving your company and your incoming QMS employee. Our company provides QMS support services to help your secure your current management system. After you hire your new employee, we will connect with them and give them all the required documents and records for your Quality Management System. You don’t have to worry about your QMS leaving with your former employee! Need to secure your management system?

QMS Support Services and Quality Management

QMS support services and quality management are becoming integral in a variety of industries. However, most people do not know what a QMS is and what benefits it can provide.

What is QMS?

QMS stands for Quality Management System. A quality management system is a system that documents the policies, procedures, and controls necessary for an organization to create and deliver high-quality products or services to customers. A QMS uses this information to continuously improve the efficiency and quality of customer and regulatory requirements. In addition, the system will help coordinate and direct the organization to meet these requirements.

There are different types of QMS (ISO 9001, AS9100, Six Sigma, CMMI) that are prominent in many industries. The type of QMS used will depend on the industry. In addition, the understanding of the particular QMS by employees and customers. However, what principles does QMS use to determine quality management?

Principles of QMS Support Services and Quality Management

Seven principles go into quality management. These principles are:

Engagement of People
Customer Focus
Leadership
Process Approach
Improvement
Evidence-Based Decision-Making
Relationship Management

These principles inform the different elements that need to be in a quality management system. While a QMS should address the specific and unique needs of a company, all systems address certain elements to achieve the overall goal. These elements include improvement opportunities, quality analysis, and other factors that can direct the organization in the right direction. Regardless of what type of QMS is being used, there are major benefits to using this type of system.

Benefits of a QMS

A quality management system provides major benefits for organizations. First of all, the support system that a QMS provides improves every aspect of an organization’s performance. The system provides support that affects the workflow of an organization. The support process will coordinate human resources, finance, document control, training, and facilities maintenance to help the delivery of high-quality products or services to customers. Other benefits include:

Improvement of Processes
Reduces Waste
Prevents Mistakes
Lowers Cost
Engaging Staff
Training Opportunities

However, maintaining a quality management system is important. Most companies have an employee that is in charge of the QMS, that handles all of the information and records. But what happens when the QMS employee leaves? Will you have all your records for the yearly audit?

Contact QMS Bridge for QMS Support Services

QMS Bridge builds the foundation that fills the gap between your old and new QMS employees by securing all the records from the QMS system. QMS Bridge has over 25 years of auditing experience which makes us experts in implementing and maintaining all types of quality management systems. Before your Quality Manager leaves, our company will help them secure all the records for the new manager for internal audits. Once your new Quality Manager starts, QMS Bridge will make sure all the documents are in their hands!

Maintain your quality management system with QMS Bridge by contacting us today!

Why doesn’t the auditor like our QMS?

My auditor does not like my Quality Management System (QMS)

Your company has been certified to ISO9001, AS9100, ISO13485, and IATF16949 for several years then you get a new auditor and they say you need to make changes. Don’t let any auditor tell you your system is wrong and you need to change it. If there is an issue with your QMS ask your auditor to write a nonconformance report with the section of the standard that is non-conforming. If they don’t write a nonconformance it is because there is NOT a nonconformance just their opinion. Don’t change your QMS because the auditor says there is an issue, challenge them but say it nicely.

Make your auditor understand your QMS

Here is a great example – you do a complete audit of your system once a year then an auditor tells you internal audits need to be done every 6 months. Immediately pick up a copy of your standard (ISO9001, AS9100, ISO13485, IATF16949) and ask them nicely “What section of the standard are they looking at?” Then say I am looking at section 9.2 (8.2 in ISO13485) Internal audit and it says ‘the organization shall conduct internal audits at planned intervals, Not every 6 months.

Now if you have several nonconformances during your internal audits the auditor might suggest you do your internal audits every 6 months but it is up to the company to decide how often you do your internal audits.

Get out a copy of your standard

Once you bring out a copy of your standard (ISO9001, AS9100, ISO13485, IATF16949), ask your auditor what section they are referring to, believe me, they will back down really quick. I have enough experience with auditors that every time I have a copy of a standard and ask them what section they are looking at their attitudes changes quickly. If you don’t have a copy of the standard your company is certified to buy a copy today. Finally, contact us today for all your QMS needs.

Is it okay to disagree with your auditor?

It is okay to disagree with an auditor.

ABSOLUTELY. Auditors are human beings and sometimes they don’t understand the way you are doing things so you need to make them understand your processes.

Here is a great example I was auditing a company they had job descriptions and group training records but I wasn’t seeing how they showed an employee was competent in the job they were doing. After a while and several employees later, they told me there was a training matrix which showed the level of competency each employee was at in their positions. But because I did not ask to see ‘the training matrix’ no one was showing it to me. Sometimes an auditor does not speak the same language as you but if you have a good auditor, they should keep asking you questions to hopefully get the answer they need.

Looking for you to be compliant

An auditor is looking for you to be compliant to the standard, sometimes they are asking for certain things, they aren’t sure what you have named the document so it might take a while. Don’t get nervous just keep showing the auditor what documents you have.

Tell your auditor to go ahead and write a nonconformance report

If your auditor says they are going to write a nonconformance ask your auditor, what section of the standard will they be writing the nonconformance against? Take the time to read that section of the standard then look at your internal audits also previous audit reports and see what the auditors wrote under that section. This might help you see what documents were looked at under this section of the standard. Then show your auditor what previous auditors accepted.

If you show your auditor proof and the auditor stills writes the nonconformance ask your registrar what their appeal process is, this means you do not agree with the nonconformance. Once your registrar has all the evidence, they need they will make a determination if the nonconformance is legitimate or not. Most of the time the registrar will withdraw the nonconformance.

Should you Invest in Training your Employees?

Should you Invest in Training your Employees to be ISO9001, AS9100, ISO13485 or IATF16949 Internal Auditors or Hire a 3rd Party Auditor?

My experience has been if you train your employees to be internal auditors usually, they take the experience and run. They stay at your company a year or two then start looking elsewhere for more money and/or better benefits. When your trained internal auditors, your employees are auditing their friends and find their friend aren’t following the process your internal auditor doesn’t state the process is not being followed in their internal audit report. Your internal auditor does not write a corrective action so no one knows there is an issue. Therefore, your internal audits are not effective.

Do you struggle to keep your internal auditors after they are trained?

If your employee goes through Lead Auditor training, they even more valuable to your company and other companies out there looking to hire someone to lead their Quality Management System (QMS). Chances are you probably don’t want to send your employee to a Lead Auditor course.

Hire a 3^rd party auditor to do your internal audits.

Your employees get the experience of internal auditing then after a year or two they leave your company. Now you are faced with are you going to pay for someone else to be trained or is it cheaper to hire a 3^rd party auditing firm like Audits4u.com then continue to train employees to audit your system. Also, when you hire a 3^rd party to do your internal audit, you hire a fresh pair of eyes that are not friends with anyone.

Regardless if your company is ISO9001, AS9100, ISO13485 or IATF16949 every standard requires you to perform internal audits. Who does your internal audits are up to you. Will you choose to continue training employees or go out and look for a 3rd party auditor?

Beware if Your Consultant Wants You to Sign a Contract

So, if you need help implementing or updating your Quality Management System (QMS) who are you going to call? Well, before you call anyone, do some research. Even if you receive a referral from a customer, supplier, or registrar, beware of signing a contract, especially with a large consulting firm. Regardless if you find them from a Google search for ‘ISO9001 consultant’, social media site, or get a referral there are things you need to know before you commit.

Know Your Payment Terms

Once you sign a contract you are legally bound. If you don’t receive the services the company promised you or you just do not get along with the consultant you will be STUCK. When you interview your consulting candidates let them know your payment terms – once they have performed the service, they will be paid 15 or 30 days later, do NOT agree to 50% upfront then the balance after the service is complete. Not every consultant is greedy, but there are a lot of them that take retainers and then generously bill for their time.

In that regard, if you are certified to ISO9001, AS9100, ISO13485, or IATF16949 – BEWARE of the consultant that comes in and needs to change everything because it is wrong. If you are already certified then your system only needs to be tweaked. Many consulting firms like to change documents so they can charge you more money. A good independent consultant with years of experience and good references will be clear and concise when it comes to billing their services.

Consultant Referrals and References

One way to hire a consultant is to get a referral. Even if one of your customers refers a consultant to your company you should call and interview the consultant over the phone. After you speak with them and think you feel comfortable with them invite them to come to your facility. Be sure to ask them for references from companies that they have worked with, then call those companies and find out if the consultant helped them.

Getting a referral may not be convenient and not the only way to go. Just do a little homework, and get references, then you won’t be sorry later.

Welcome To QMS Bridge

No matter where your company is located QMS Bridge will work virtually with your Quality Management System person to secure the required documents / records required by ISO9001, AS9100, ISO13485 and/or IATF16949. QMS Bridge was created to help companies get the documents / records needed to maintain their certification.

QMS Bridge will meet with your current Quality Manager / Management Representative to get the required records for ISO9001, AS9100, ISO13845, and/or IATF16949. Once we have all the required records, we will store them until you are able to find a replacement for your current Quality Manager / Management Representative.

QMS Bridge is the link between the employee leaving your company to your new employee. Even if you appoint an interim person to handle your Quality Management System (QMS) they don’t have the experience to know what documents / records are required to be maintained.

Once you have your Quality Manager / Management Representative hired then contact QMS Bridge to meet with your new employee to give them the required ISO9001, AS9100, ISO13845, and/or IATF16949 records, it is that easy.

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AS9100 Audits

AS9100 is the aerospace standard. AS9100 was first released in 2004. It took ISO 9001 as the base of the standard then added the additional aerospace requirements. The AS9100 standard is not government-related. Also, it has developed standards to ensure the quality, safety, and efficiency of products, services and processes are in place.

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