Category: ISO 9001

Do you want to gain ISO 9001 certification for your organization? Is the ISO 9001 certification cost holding you from jumping into the process? Then, this blog is for you!

Although the cost of ISO 9001 certification can be high, multiple factors play a central role in influencing it. Fortunately, most of those influential factors are in your control.

In today’s blog, we will evaluate those factors and give you ballpark figures for ISO 9001 QMS certification cost.

So, let’s get started!

What Factors Influence the ISO 9001 Certification Cost?

Predicting ISO 9001 certification costs can be difficult because it largely depends on the size of your organization and the scope of the QMS. Also, it can increase or decrease based on the assistance you hire for the certification.

Here are the most critical factors influencing the cost of ISO 9001 registration.

• Your location: The cost of the certification process can go up or down based on the location of your organization. For instance, the registration cost of ISO 9001 can range between $2,000 and $4,000 in the US, while it can increase in other countries.

• Size and complexity of your organization: Similarly, if you have a larger workforce, operations across multiple locations, or a relatively complex quality management system, it may cost you more to achieve ISO 9001 certification.

• Hiring consultants: Consultants can essentially help speed up the QMS development, analysis, documentation, and improvement process. However, hiring them will surely increase the cost of the entire process. The expenses of hiring multiple experienced consultants can double your ISO 9001 certification cost.

• The volume of ISO documentation: ISO 9001 requires organizations to create, maintain, modify, and review documentation related to the QMS. The more documents your auditors will review, the more they may charge.

How To Keep Your ISO 9001 Certification Cost Within Budget?

ISO 9001 certification is an investment. And it ultimately depends on you how you want to implement the standard and influence its cost.

Here are a few easy ways to keep the ISO 13485 9001 cost within your expected budget.

• DIY the implementation process: If you have a competent in-office team and dedicated managers, you may not need assistance from professional ISO consultants. Alternatively, you can utilize software or hire consultants who allow you to customize their service packages. This way, you can pick and choose what you need help with and pay for that service only.

• Utilize training programs and documentation templates: Providing training to employees and documenting hundreds of processes can seem overwhelming. Luckily, there are lots of consultants and websites that offer affordable training programs and documentation templates to help you out. This way, you don’t have to spend additional expenses on consultants.

• Gap analysis: Carrying out a gap analysis will give you a good idea about what you need to do to comply with ISO 9001 certification requirements. It will reduce your chances of having nonconformities, saving money and time.

• Integrated management system: If you have plans to implement multiple management system standards, it’s a clever idea to integrate them together. Since many of the ISO management standards share similar policy and procedure requirements, an integrated management system will save you from the repeated hassle and cost of each system.

The Average ISO 9001 Certification Cost

Giving an accurate estimation of the ISO 9001 certification cost without assessing your QMS is nearly impossible.

Yet, these figures should help you estimate what the bill may look like.

• For small companies (1-25 employees) with no quality system, the consultation cost can be between $1000 and $10000. The cost will increase when you add the expenses involved in the registration audit. However, if your small company already has an established quality management system, the expenses can be lower

For certification audits:

• companies with 1-25 employees, the cost of ISO 9001 certification can be from $2000 to $5000 or more

• For companies with 26 to 100 employees, the ISO 9001 certification cost can increase to roughly $5,000-$11,250.

• If your company has more than 100 to 250 employees, it will raise the certification cost to $11,250-$13,000. These expenses can go up based on the quotation of your hired auditors.

• The cost of ISO 9001 certification can increase even more if you have 251-500 employees. You may expect to pay $15,000 or more for the certification audit.

• Lastly, if your organization has over 1000 employees, you can expect to spend around $18,000 or more.

Multiple locations, multiple shifts, a complex ISO 9001 quality management system, a complex scope and many other factors will add to the cost.

Certification bodies also have different rates. Some may charge twice the rate of another certification body or more.

Don’t Let The Numbers Discourage You!

As mentioned previously, implementing a robust quality management system is an investment. While ISO 9001 certification cost may appear a lot initially, once you start receiving the return on investment, it will be worth it.

Also, you can avoid spending a significant amount of the mentioned budgets by implementing the system yourself. If you have a small company with a few employees, executing a QMS will be relatively easy.

However, although you can compromise on hiring a consultant, you cannot prioritize the budget when hiring third-party auditors. To receive credible certifications, you must employ trusted and certified lead auditors and accredited certification bodies. Otherwise, you may end up with inauthentic ISO 9001 registration, wasting all your time, effort, and money.

Maintaining a compliant quality management system requires a ton of effort and resources. So, it’s only natural to want to know whether your efforts are bringing worthy outcomes.

The audit criteria in ISO 9001 allow you to achieve this through periodic audits. The standard makes it mandatory for organizations to perform audits following the requirements of clause 9.2.

Implementing this clause can enable your organization to assess the effectiveness of the system, products, services, and processes.

Also, the outcomes of the audits will act as evidence of your efforts toward improving the QMS.

So, if your organization is planning to achieve the ISO 9001 certification, continue reading to find out the standard’s criteria for audits.

Systematic, Independent And Documented

ISO 9001 quality management standard defines the audit as an independent, documented, and systematic process for obtaining evidence and evaluating fulfillment of audit criteria in ISO 9001.

ISO 9001 QMS requires organizations to conduct audits at planned intervals. The audit should aim to provide information on whether the QMS conforms to the requirements of the company and the standard. Also, it shall indicate whether you have effectively implemented and maintained the QMS.

Systematic: Your audits should be planned and scheduled. It shall have support from the top management and necessary resources for execution.

Independent: Your organization must carry out the audit in an impartial manner. To achieve this, consider appointing an auditor not responsible for the systems and products you are auditing. It will help eliminate biases and conflicts of interest.

Documented: Lastly, you shall document evidence of compliance through the audit. There are several methods for doing this, such as tests, observations, and measurements. Then, you must communicate the outcomes of the audit to the management to perform corrective actions without delay per the audit criteria in ISO 9001.

Fundamental Audit Criteria In ISO 9001

Clause 9.2.2 in ISO 9001 highlights the essential requirements for performing a quality management system audit.

1.Plan, implement, establish, and maintain an audit program

According to the standard’s criteria, you shall plan, implement, establish, and maintain an audit program. This program should consider the frequency, methods, responsibilities, reporting, and planning requirements of the audit. Additionally, it should take into account the significance of the processes you are auditing, changes that affect the organization, and the results of the previous audits.

2.Define the criteria and scope of the audit

Ensure uniformity when defining your audit criteria. It will help you assess progress and implement recommendations without additional hassles. At the same time, make sure the criteria are flexible enough for you to change as necessary and relevant to the organization’s objectives.

3.Select impartial auditors

You can choose an auditor from a third-party consultancy or from inside your company, according to the audit criteria in ISO 9001. Regardless, make sure the professional is unbiased and not involved in any activities they are responsible for auditing. It will help you avoid conflicts of interest.

4.Report to relevant management

You will need the results of the audit to determine whether the QMS complies with the ISO 9001 requirements and if you need to make any improvements in the system.

According to the standard, relevant management departments are responsible for analyzing the audit results. Hence, you must communicate the results with them.

5.Implement corrective actions without delay

If you find nonconformance in the audit results, remember to plan and take corrective measures without undue delay. Then, you must assess the effectiveness of the corrective actions in a subsequent audit.

6.Retain documentation as evidence

Ensure that your management records the audit process, its outcomes, and corrective actions and makes it easily accessible for relevant parties and events, such as external audits.

Create A Checklist For The Audit Criteria In ISO 9001

Your checklist for the audit criteria in ISO 9001 should include questions related to all the requirements of the standard, including

Context of the organization

•Understanding the organization and its context,

•Understanding the needs and expectations of interested parties,

•The scope of the quality management,

•Quality management system and its processes,

Leadership

•Leadership and commitment to the quality management system,

•Customer focus,

•Quality policy,

•Organizational roles, responsibilities, and authorities,

Planning for the quality management system

•Actions to address risks and opportunities,

•Product design skills,

•Quality objectives and planning to achieve them,

•Planning of changes,

Support

•Resources,

•People,

•Infrastructure,

•Environment for the operation of processes,

•Monitoring and measuring resources,

•Organizational knowledge,

•Competence,

•Awareness,

•Communication,

•Documentation,

Operation

•Operational planning and control,

•Determination of requirements for customer communication products and services,

•Determining requirements for products and services for audit criteria in ISO 9001,

•Review of requirements related to services and products,

•Design and development of products and services,

•Design and development planning,

•Design and development inputs,

•Design and development controls,

•Design and development outputs,

•Design and development changes,

•Control of externally provided services and products,

•Type and extent of control for external provision,

•Information for external providers,

•Productional and service provision,

•Identification and traceability,

•Property of customers or external providers,

•Preservation,

•Post-delivery activities,

•Control of changes,

•Release of products and services,

•Control of nonconforming products and services.

Performance evaluation in audit criteria in ISO 9001

•Monitoring, measurement, analysis, and evaluation,

•Customer satisfaction,

•Analysis and evaluation,

•Audit,

•Management review,

Improvement

•General improvement requirements,

•Nonconformity and corrective actions,

•Continual improvement.

Wrapping Up

The official audit criteria in ISO 9001 do not clarify how frequently you should perform the audit, along with a few other pointers. Hence, when planning the audit process, make sure to tailor it to your company’s needs. Also, ensure your audit process is completely unbiased, accurate, and documented,

The ISO 9001 audit is an independent process conducted for gathering facts to determine compliance with the standard. The aim of this objective-oriented, systematic, and documented procedure is to detect areas of improvement in compliance and activity and help management to implement the most relevant corrective actions.

An ISO 9001 audit is a very effective tool for evaluating compliance with your current quality management system and with the standard itself. Auditing is a crucial part of the checking process in the PDCA (Plan, Do, Check, Act) cycle that is embedded into all ISO management system standards.  Audits are not the only form of checking, there are also many other versions such as inspections where relevant, management, supervisors, examinations, etc.  Amongst the other forms of checking, auditing has a special role in that it is planned, performed by competent individuals, and is effective at meeting its purpose which is to get a snapshot of compliance from a records point of view.

ISO 9001 does not require organizations to determine the financial viability of ISO 9001, therefore internal audits do not include an assessment of financial benefit.

Conducting the audit can be tricky for those who lack industry experience and knowledge of quality management systems. The following post discusses the essential elements and steps for performing a great ISO 9001 system audit.

What is ISO 9001?

ISO 9001 is the international and industry generic standard for quality management systems. The aim of the certification is to support companies in ensuring their product/services meet the industry guidelines and customer expectations. The standard can be a most effective marketing tool that adds competitive advantage by strengthening brand loyalty. With consistent performance, ISO 9001 compliance helps organizations to retain their customers. Therefore, it acts as a powerful tool for business sustainability and establishment as well.

Steps For Conducting ISO 9001 Audit

Internal audit – The internal audit, or in other words a “first party audit” is a requirement within ISO 9001. Therefore, you cannot comply with ISO 9001 unless you perform internal audits. Internal audits can be performed by a competent individual within the organization or external to the organization. The internal auditor will need to be trained and competent, but does not need to have lead auditor training, as lead auditor training is only a requirement for certification audits.  Internal audits will have to be planned and executed according to ISO 9001. Internal audits will be performed regularly at frequencies determined by your organization, usually annually at least.

2nd party audits – 2nd party audits are usually performed by your customer or a representative of the customer. The customer will normally pay for the 2nd party audit, unless agreed otherwise. 2nd party audits are not a requirement of ISO 9001; however, some customers will insist on 2nd party audits as part of their own purchasing requirements, or when you are not ISO 9001 certified.

Precertification audits – Precertification audits are performed by a certification body if requested by your organization. Precertification audits are not a requirement of ISO 9001.  Precertification audits are more like a readiness review for management that are not confident they are ready for certification.  Precertification audits can be offered by the certification body at a price and there are no particular rules that must be followed for these audits in ISO 9001 or ISO 17021.  Normally the auditor will provide an audit report at the end of their audit.

Stage 1 Audit – The stage 1 audit is the primary process that prepares an organization for the final round of evaluation which is the stage 2 audit. Through stage 1, management and the certification body confirm the scope of the activity, and whether the management review and internal audit have been effectively performed. Through the process, the certification body checks if the quality management system has been documented, and if there will be a high likelihood of a major corrective action in the stage 2 audit. The auditor will provide a report at the end of the stage 1 audit that emphasizes non-compliances and opportunities for improvement if there are any.

Stage 2 Audit – At stage 2, the auditor checks any corrections or changes from the stage 1 audit. The focus of this audit is whether you have implemented the quality management system. A checklist and questionnaire are prepared for the audit.  During the audit, selected personnel in your organization will be asked about their understanding of the quality management system and performance. Records will also be checked. At this stage, management needs to show evidence of compliance. Inability to prove compliance through records and discussions can lead to major or minor corrective actions.  Major corrective actions must be corrected before the ISO 9001 certificate is issued. Minor corrective actions must have a plan in place before the certificate is issued.  Implementation of the plan for minor corrective actions will be checked at the next annual audit. The auditor will provide a report at the end of the stage 2 audit.

Certification – If both stages 1 and 2 show an adequate level of compliance to the standards and your company’s quality management system, your company will be recommended for certification, and the certification body will therefore issue your ISO 9001 certificate. Congratulations!! Typically, the certification body will also add your organization name and certification details to their own list of clients on their website, and potentially also to the accreditation body and to the International Accreditation Forum (IAF) website.  Typically, your organization will also receive certification logos or marks for use within your organization such as on marketing materials.

Surveillance Audit – This is done to check the progress and performance of the implemented or modified quality management system. Certification is valid for three years, and within this time period, the audit is performed at least twice to ensure that your organization continues to comply with ISO 9001. It also helps to identify possible areas of improvement.  These audits also help companies prepare for future audits.

Recertification audit – Like most other ISO management system certifications, ISO 9001 lasts for three consecutive years. While the surveillance audit determines consistent performance, the recertification audit is performed to recertify your organization for an additional three years. Alongside the basic audit process, the recertification audit concentrates on new quality objectives and plans for upcoming years. If the recertification audit is successful, a brand-new ISO 9001 certificate is issued by the certification body.

The entire process can be exhausting and difficult. To streamline the process, you might consider engaging support from expert ISO consultants.

Blue Wolf Certifications is a business partner to various accredited certification bodies. To put it another way, we are one of their auditors, a regional office.

Our auditors have been described as transparent, open, fair and supportive. And even easy to talk to and helpful.

Our audits have been described as nonthreatening, relaxing, straightforward, orderly, professional and painless.

Take the advice of our clients, we will make your ISO certification journey easier and less stressful.

We can audit and provide accredited certifications for ISO 9001, ISO 14001, ISO 27001, ISO 37001, ISO 45001 and other certifications.

Contact us here now!