ISO Standards Compliance Support with Remote Certification Solutions

Much has been written on the audit Process in the past. This article will break down the items which must be considered by an organization when engaging an auditor.
In a previous article, “Inside the mind of and auditor” we delved into how an auditor thinks.
This article will give the actual “nuts and bolts” of ISO Audit Process and how an ISO Auditor should navigate himself/herself through auditing .

The two major activities of an ISO Audit will consist of:

1. Review of an organizations current documents.
   This consists of verification of the organization’s documentation. The goal is to gage how the documentation adheres to the relevant tenets of the ISO Audit Standard.
2. Process Review:
   This is the main part of the physical audit. This is the activity whereby the ISO Auditor physically examines the organization’s adherence to the ISO Standard.
   An auditor will sample operations in an organization looking for evidence of conformity to relevant tenets of the ISO Standard. This is where preparation is an organization’s
   best friend. Having actual documentation showing the relevant connection between processes and how they support the organization’s Quality Management System, is a must.
   Keep in mind that an ISO Auditor is on a strict schedule. Because of time constraints, he/she only has enough time to audit one or two examples of each key process.

It’s not practical nor possible to audit and evaluate everything within the organization’ four walls.
Again being prepared is your first line of defense. Excessive fumbling tends to give an auditor the sense that the Company has problems or is simply not engaged enough
nor prepared for the auditor. This can have the effect of causing potential questions which could lead to a major or minor non-conformance. Poor documentation and preparedness
causes the auditor to rely on asking more in depth questions of the employees themselves. Auditors will ask the same questions of the same employee operating the
same equipment on either the same shift or multiple shifts. This line of questioning tends to give less consistent results and can lead to a major or minor non-conformance

Organizations which tend to fare well in ISO Audits are the ones which have definitive and planned internal audits on a weekly/monthly/Quarterly basis.
These audits should be done by competent and trained employees. It’s advisable that you put your designated internal auditors through a training course to give them
the essential tools to perform their own internal audits. ISO Certification Consultants Inc. through its partnership company can provide Internal Auditor training.
By following a standardized approach to internal auditing, a company can avoid many of the pitfalls which lesser prepared companies fall into.
A standardized approach which consists of an Audit Checklist and a standardized approach to questioning stakeholders is the methodology which helps Company’s
avoid embarrassing situations during the ISO Certification audit. A systematic approach provides ongoing feedback on weaknesses in a company’s Quality Management System.

For further information and questions regarding ISO Audit, training your internal auditors please contact ISO Certification Consultants.

There is a large number of searches on Google by people trying to understand the costs associated with performing an ISO audit and ISO Certification.

Firstly, its important to note that these are two separate costs.
Secondly, ISO Certification Costs or fees are typically based on the scope of work that needs to be performed. Many Certifying companies will request that the company wishing to be certified complete a questionnaire. The questionnaire is designed to determine a number of items about the subject Company’s business.

Some of the questions asked are:

Sites to be covered in the audit? (Some companies have multiple sites)
Is the company design responsible?
Does the company have any outsourced processes?
What is the current status of the company’s registration? Have they been registered before? Has it lapsed?
These are just a small sampling of the questions that would be asked by a Certifying company.

Finally ISO certification costs/fees can vary based on the organization providing the service. At ISO Certification Consultants we pride ourselves on being competitively priced. As of late, we have embraced technology to the greatest extent possible. We now offer a Technological approach to ISO compliance which helps a company maintain ISO compliance month after month and year after year. We are getting a lot of acceptance for our new approach.

As we are business owners ourselves we understand our clients’ need to be competitive also. Please feel free to contact us for a quick consultation. We will assess your requirements and provide you with a quote within 24 hours. Call us at 416-622-0022.

Having your organization audited can be daunting, stressful and a generally anxious event.
Whether this is your first audit or you’ve been part of many audits before, it’s still not something which generates excitement.(At least not the kind we look forward too)
Here’s some helpful tips to help you negotiate your next audit.

Firstly, there’s no guarantee of a flawless audit where the ISO auditor finds no non-conformances. It’s not uncommon that he/she will find at least one or more minor non-conformances or one or more major non-conformances. In fact it’s typically normal that an organization has non-conformances after an audit or at least some OFI’s (opportunity for improvement).

Preparation is key:

The more prepared you are the better. An internal pre-audit should be performed many weeks before the audit date. This can be done with your own staff
or you can contact a third party certification group such as ISO Certification Consultants Inc. In any case, its advisable to assess your readiness by honestly answering
and providing objective evidence which answers each clause of ISO 9001:2015 (Clauses 4 through 10). If you can do this, then you will have a better chance of being ready to answer the same questions asked by the ISO Auditor. Also note that the ISO Auditor will provide an ISO Audit plan well in advance of the audit. He/she will be identifying the clauses of the ISO 9001:2015 standard that he/she will be reviewing at your facility. Preparation also means knowing where the objective evidence is stored in your company’s database or documented storage system. Fumbling or showing uncertainty during an audit provides warning flags to the ISO Auditor which may lead to additional questions and discovery. An in depth internal audit of your systems can also help you to find your own potential non conformances or OFI’s. Many don’t realize the importance of this statement. When you find your own problems and launch non conformity reports and CAR’s within your Quality Management system, the External auditor cannot also cite you for the same issue when they perform their audit. The caveat to this statement is that you must now demonstrate to the External auditor that you also have a firm corrective action plan in place which is comprised of who owns the problem and what is the expected date for completing the corrective actions.

Think like an ISO Auditor:

The ISO Auditor follows the trails. Here’s an example: An auditor could review The standardized work of an operation in your company in advance of going onto the floor to observe the employee performing the work. He/she can ask questions of the employee to assess their knowledge of their operation. The employee could be asked where their work instructions are. (They could be at the work station or somewhere else). The auditor can also ask to see the training records for the employee. The auditor can make note of the gages being used. He/she will look for a current certification tag. The Auditor could then want to look at the calibration records for the gage.
The auditor could then repeat this procedure on the other shifts too to assess the off-shift operators. This is an example of following the trail. During this whole
process, other items may be uncovered which may cause the ISO Auditor to ask other question and request more documents to review. The more you can think like an auditor the better is your chance that you will be prepared. Keep in mind, if you do not have all of this documentation completed and available you are subjecting yourself to non-conformances. If you try to put this documentation together a few days before the audit, you will most likely fail.

The Human aspect:

Remember that the ISO Auditor is human. They are doing their job. This means that they make mistakes. Also it means that you can challenge them if you feel that they’ve made the wrong conclusions.
But make sure you are backing up your argument with evidence. Arguing for the sake of arguing will only alienate the Auditor.

Provide a decent workspace for the ISO Auditor:

Make sure you provide a nice office environment/boardroom for the ISO Auditor while he/she is at your facility. Nothing is more off-putting then forcing the Auditor to
occupy a space not fit for a human being or put them in a boardroom and kick them out so that another meeting can occur. Always provide lunch too. Provide a decent meal.
Ensure that the entrance way and walk area/restroom facilities are clean and well kept. Eliminate clutter or evidence of disorder. Good auditor’s also live by the adage,
“you never get a second chance at a first impression”. The impression you provide of your facility is important and helps set the tone of the audit.

Use the same Auditor for every audit:

Good auditors are not in great abundance. If you find an auditor that you can work with and who is fair, it typically serves you to continue using his/her services for subsequent audits
Remember, even though the ISO 9001:2015 standard is clearly written, interpretation is in the hands of your auditor. If you find someone you can work with, Keep them.

If you would like to understand more about ISO Auditing, or find out how we can help you get ready for and Audit, please contact us at ISO Certification Consultants Inc. Call us for immediate action at 416-622-0022