iso 13485 remote audit

How to get started: ISO 9001 Certification simplified

When speaking with clients these are some of the things I hear:

1. It would be a great idea to get ISO 9001 Certified
2. We would like for our company to be ISO certified but we don’t know where to start
3. We need ISO certification but don’t know what’s involved
4. Where do we begin?
5. How much does it cost?
6. How quickly can this be done?
7. What are the steps?
8. When can I get audited?
9. What do we need to do?

And any combination of these.

It’s interesting to find that there are a number of companies out there who are geared to providing the auditing and certifying for any business. You place a phone call and book an appointment. This in my estimation is the easiest transaction available. An auditor comes to your facility or provides a remote audit and provides you an assessment of your company’s conformance to the ISO 9001:2015 standard. Easy enough. Then they go away and wait 90 days for you to provide evidence that you’ve corrected the minor non-conformances. If major non-conformances exist, they want to book another follow up review of your facility to validate your compliance. This is one cost of getting certified.

I’ve discovered what’s really missing. Many smaller companies have heard of the benefits of ISO 9001 certification but don’t really understand how to navigate this complex world. When potential clients call me, I take the time to make them understand what’s involved. Invariably I get thanks and accolades for taking the time to explain the steps. I’ve even heard, “it’s so nice to actually speak with a real live person”.

What’s typically missing are the competent and qualified consultants who get the small or medium size business’s ready for ISO Audit. These are the unsung heroes of the business. Company’s like ISO Certification Consultants are few and far between. They understand what’s involved and how to get a company ready for it’s first ISO 9001 audit.

Our approach is simple. We provide a consulting service which walks a company through the steps needed to get ready for it’s first ISO 9001 Audit. We understand the needs of business. Most auditors are not business people. They are pure practitioners and are therefore well suited to the Audit and Certification side of the business. Although Auditing is a very intense and often tiring activity it pales in comparison to the energy and time required to prepare for the audit. As business people we know the value of time and money, therefore we’ve streamlined the approach. We can even provide our consulting remotely, depending on the company.

I advise my clients to take the “border-crossing” approach to start. This means only answer the most necessary questions which need to be answered. If portions of the standard don’t apply, don’t look for reasons or find ways to make it apply. The standard and its clauses must be tailored to your unique business. No more, no less.

1. Breakdown the business into the fundamental core process’s
2. Develop High level Process diagrams and steps for each process
3. Develop next level standardized work instructions
4. Document the steps. Start with a system for documentation and storage.
5. Develop the recording and reporting process’s
6. KEEP IT SIMPLE

Now, it’s important to note that Clause 10 of the ISO 9001:2015 standard talks about continuous improvement activity. What most company’s miss is that the standard is a more than just a Quality Management system. When properly implemented it forms the framework for a complete Business Management System. The ISO 9001:2015 standard is the basis for the integration of a company’s systems in a way which provides a value-added approach to doing business. Many company’s fail to remember that their company’s operational stance should be built around a very basic premise. That is, is the company activity value added and is it something that the customer is willing to pay for. If the answer to one of both of these questions is NO, then you should stop doing it.

ISO 9001:2015, when properly implemented, can help a company put in place the methodology to help address these questions. It’s also the basis for other integrated systems such as ISO 14001 (Environmental), ISO 45001 (Occupational Health and Safety) and a number of other ISO standard which are commensurate with the type of business vertical your company occupies.

Another common statement amongst company’s is, ‘just get me my certificate so that I can continue with my business.’ This attitude and approach contravenes the reason for getting ISO Certification in the first place. Once you put a basic system in place, the goal should be to continuously improve everything about your business. Many company’s neglect this most important point. Depending on the type of business this can be a recipe for poor performance in many areas and sometimes disaster. History is full of examples of company’s that went out of business because they simply did not improve or change. Meanwhile the competitors who continued in business made it a regular exercise to improve and where required re-invent themselves.

ISO Certification Consultants provides a one-stop consulting service for your ISO certification needs. We provide the consultation, our partner accredited group provides the auditing and certification.

I’ve had this question raised by people in the past.
What is the difference between getting certified by an accredited vs. non-accredited Certification body?

To be clear, a non-accredited body is not necessarily an incompetent organization.
There can be some very good organizations within those ranks.
The problem is, to be a non-accredited organization is easy. Anyone can self declare themselves as a competent certifying body.
As a consumer how does one gauge or rate their services? A company wishing to become ISO 9001 certified will be paying money to achieve this certification. They need to spend their money wisely.
It’s important to note that many organizations including Governments are making it mandatory now that certifications are from accredited certifying bodies. So the choice becomes very clear when confronted by these type of mandatory requirements.

When a certifying body states that it’s accredited by an organization such as the IAF (International Accreditation Forum), it’s stating that it’s been independently audited and certified by IAF as meeting the minimum requirements of being a qualified certifying body to ISO/IEC 17021: (Requirements for bodies providing audit and certification of management systems). To put this in perspective: When an organization is being audited for compliance to ISO 9001 or ISO 14001 or any number of ISO standards, who audits the auditors? This is the crux of the argument for using accredited vs. non-accredited auditors.

When using an accredited auditor you are being provided assurance that the Certifying body is considered competent to an internationally recognized level of competency as stated by the internationally acclaimed certification body:IAF. Moreover from a price perspective, quite often there is no difference in price between an accredited and non-accredited organization. With this point in mind, why would a company choose non-accredited for their ISO needs?

An IAF accredited auditing/certifying body is also capable of competing Internationally for business. This is a strong business consideration for the Certifying body.
Also to remain IAF Accredited, the ISO certifying body must be continually audited on a schedule to ensure that compliance is being maintained rigorously. This is a very serious undertaking. Note that there are a number of companies shown as delisted on the IAF member directory. This is a clear indication that IAF takes their business seriously. They don’t rubber stamp organizations if they pay their fee. Also, on that note, their is a fee which is paid to the IAF. This is why some companies choose not to be accredited. It’s an obvious cost savings to them.

ISO Certification Consultants, is partnered with an IAF certified organization which is operating Internationally. Not only do you benefit from our competence as consultants but you benefit from the competence of an internationally IAF certified company for your ISO auditing and ISO Certifying needs. We welcome any inquiries from companies needing help in navigating the ISO world.

Many people enroll in ISO Auditor Training worldwide.
With Covid 19 here, classroom courses have disappeared and have been replaced by the video conferencing era.

Of important note is that the majority of people who become an ISO Lead Auditor never embark on the course of becoming a full time auditor. There are a number of reasons for this:

Firstly, being a good auditor requires practice, perseverance and constant application. ISO auditing cannot be a part time job unless the auditor is a retiree. Even then, the auditor needs to keep current in his/her qualifications.

Secondly, when you are a highly qualified ISO auditor you are typically in high demand and hence very busy. What this means is that you will have a very rigid schedule of audits which can quite often be back to back or week to week. A typical audit can last anywhere from 1 to 5 days depending on the requirements. This means that a typical auditor will always be travelling and living in a hotel and eating at restaurants all the time. Now for some people this sounds like a lot of fun but I can assure you it’s not for the faint of heart. Travelling for work is totally different than travelling while on vacation. If you travel for a long time, it makes for a lonely existence. Most people typically don’t fare well over a long term “living out of a suitcase”.

Thirdly, ISO auditing is hard work. If you take it seriously it’s mentally tiring. Auditing an organization is serious business. The reputation of the Certifying body is in jeopardy if the ISO auditor is not competent. Moreover the livelihood of an organization is at stake if an auditor does not exercise good common sense or discretion while auditing. This is because some companies are required to have ISO 9001:2015 certification in good standing in order to continue doing business with their customers. This not only means current business but future business. Many customers do not allow a company to bid on new business if they’re not ISO 9001:2015 certified.

ISO Auditing is a very serious and respectable profession. ISO Certification Consultants Inc. is one such professional organization.
We have the experience and competency that a client requires and deserves. Feel free to contact us to get a better understanding of who we are and how we can help you.