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How Much Does ISO 9001 Certification Cost?

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.

What Are The Logging Requirements In ISO 27001 Certification?

Logs act as digital diaries for effective information security. It allows organizations to follow meticulous recording steps and keep track of valuable interactions and events.

Additionally, logs are helpful when evaluating incidents. If anything goes wrong in your ISMS, you can use the recorded logs to find out precisely where things went wrong and who is responsible for it.

It is why ISO 27001 certification consultants, as well as the standard itself, encourage organizations to implement controls for effective logging.

In clause 8.15 of Annex A of ISO 27001, you will find the control requirement for producing, storing, protecting, and analyzing logs.

In today’s blog, we offer a breakdown of this requirement to help you comply with it.

So, if your company is pursuing the ISO 27001 certification, continue reading!

Logging Requirements In ISO 27001 Certification: Your ISO Audit Consultants

According to ISO 27001:2022, your ISMS logs should record activities, faults, exceptions, and other relevant events.

Overall, the control should focus on

•Recording events,

•Collecting evidence,

•Protecting information integrity,

•Securing log data against unauthorized access

•Identifying events and actions that can lead to data or security breaches,

•Acting as a tool in investigating internal and external matters.

What To Include In The Event Log?

ISO 27001 certification consultants explain that events are actions performed by a physical or logical presence on a computer system. For instance, it could be something like requesting data or deleting a file.

What you should include in the event log essentially depends on your operations. Yet, there are a few pointers that every event log should contain.

They are:

•User ID: Who or what account completed the event or performed the actions,

•System activity: What happened,

•Timestamps: Date and time of the actions or events,

•System and device identifiers and location: The system where the event occurred,

•Network address and protocols: IP information.

What Events Should You Record?

Logging every event may not be possible for your organization. In that case, ISO 27001 certification consultants and Control 8.15 highlight 10 critical events that you should definitely log in.

•System access attempts,

•Data or resource access attempts,

•System or OS configuration changes,

•Using elevated privileges,

•Using maintenance facilities or utility programs,

•File access, deletion, migration requests,

•Access control interruptions and alarms,

•Activation and deactivation of security systems,

•Identity administration work,

•Specific suspicious actions, such as data alterations,

How To Protect The Logs?

Logs play a vital role in establishing system and user behavior during investigation.

Therefore, it’s essential to protect their integrity and prevent users from deleting or modifying their own logs.

Reputed ISO 27001 certification consultants agree that each log should be complete, safeguarded, and accurate.

Experts recommend the following methods for protecting logs.

•Cryptographic hashing,

•Append-only recording,

•Read-only recording,

•Using public transparency files,

If your organization needs to send logs to suppliers to resolve incidents, you should de-identify the logs and mask the following information.

•Usernames,

•IP addresses,

•Hostnames.

Additionally, you shall take measures to secure personally identifiable information as per the organization’s data privacy protocols and applicable legislation.

What To Consider When Analyzing The Logs?

When you need to analyze the logs for identifying, resolving, and analyzing information security issues, you must consider the following factors.

•The competence of the person carrying out the analysis,

•The methods of analyzing the logs,

•The category, attributes, and type of each event that you need to analyze,

•Exceptions applied via network rules emerging from security platforms,

•The default network traffic flow compared to unexplainable patterns,

•Trends resulting from specialized data analysis,

•Threat intelligence.

What To Consider When Monitoring The Logs?

Along with log analyzing, ISO 27001 certification consultants recommend monitoring the logs to analyze key patterns and anomalous behavior.

For effective log monitoring, you should consider

•Reviewing attempts to access critical resources, such as web portals, file-sharing platforms, and domain servers,

•Scrutinize logs to keep an eye on outgoing traffic linked to dubious sources or dangerous server operations,

•Collect data usage reports to identify malicious activities,

•Collect logs from physical access points like fob logs, key cards, or room access information.

Additional Information

ISO 27001:2022 certification consultants recommend organizations consider utilizing specialized utility programs to search through vast amounts of information. It can help you save time and resources.

If your organization uses a cloud-based platform to carry out any operation related to logging, make log management a shared responsibility. Your organization, as well as the services provider, should take responsibility for the management system.

Furthermore, when implementing this control, you should check out the supporting controls of ISO 27001, including 5.34, 8.11, 8.17, and 8.18.

A lot of people ask how long they should retain the logs. Truthfully, ISO 27001 does not dictate a specific retention period. Therefore, it comes down to your needs. Your organization should specify the log retention period in its policy. If you are still confused, a good rule of thumb is to retain logs for at least three years.

Wrapping Up

So, are you ready to implement the log requirements of ISO 27001? Hopefully, this guide from ISO 27001 certification consultants has helped you understand the control. If you have any further queries, check out the Annex A control list of ISO 27001. Also, make sure you choose skilled and competent experts to oversee the controls and measure their effectiveness periodically.

Nail Your QMS Audit With This ISO 9001 Audit Criteria Guide

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,

Improve Your Competitive Strength with ISO 14001 Standard – Learn How!

ISO 14001 standard is the globally recognized standard for the environmental management system. The primary goal of the standard is to set the policies and procedures for a robust eco-friendly system that will control different elements for reducing the yearly carbon footprint. Today’s business organizations need this management protocol to understand the requirements for improving their operations to maintain the environmental sustainability.

The increasing need for waste management and proper mobilization of resources, forces companies to take prompt initiatives so that their operational impact does not disrupt nature and the community. ISO 14001 is often considered a competitive mechanism that works for a company’s CSR (corporate social responsibility) program.

There is no need to implement a completely new system if you already have one. However, ISO 14001 is an excellent tool for monitoring and evaluating the functions and productive efficiency of your existing program. You need professional assistance to carry out the necessary analyses, reviews, and audits to ensure your system is performing as per the expectation.

The following post has discussed the key elements of the standard and the prime benefits a company can enjoy.

What is the aim of the ISO 14001 Standard?

The fundamental purpose is to help companies proactively improve their operational efficiency for minimizing waste production, controlling energy usage, and finding proper resources.            It helps to set SMART objectives and suggest strategic moves for eco-friendly methods. Today, every company needs to show concern for community welfare and environmental sustainability. The standard allows the stakeholders to clear their rudimentary concepts, which further encourages them to contribute to the final goal.

What are the five elements of the ISO 14001 Standard?

•The environmental policies

•Planning

•Implementation and operations

•Review and evaluation

•Corrective actions for continual improvement

The three pillars of a successful implementation are –

•The enhancement of environmental performances

•Timely fulfillment of the compliance

•The ultimate achievement of the objectives

What are some of the major advantages of getting the ISO 14001 Standard?

1.Legal compliance

In India, companies have to pay lakhs and spend approximately 5 years in jail for violating environmental laws. Legal compliance has become stricter and more mandatory. ISO 14001 is the fastest and easiest option to meet regulatory demands and avoid parliamentary intervention. As per one of the main clauses of ISO 14001, a company should determine the organizational context and scope of the program first before modifying or implementing a system. Further, they should design proper planning and find resources to meet the goals. While setting the policies and objectives, a company has to consider the legislative terms and conditions. This way, both the governmental criteria and organizational goals for reducing pollution are achieved.

2.Brand Reputation

Impressing customers and earning their loyalty is necessary to build a sustainable empire. Today, most customers are concerned about greenhouse gas emissions and carbon footprint. More than 50% of Indian customers are eager to buy products/services from a company that has an eco-friendly approach. By achieving the ISO 14001 certification, a company can successfully improve its brand reputation. Customers start to rely more on the company as they come to know about the effective practices. With a loyal customer base, a company achieves a high-profit margin.

3.Competitive advantages

The international standard is known for being an exclusive mechanism for increasing competitive strength. By performing as per the customers’ expectations in reducing greenhouse gas emissions and other degradable ingredients, a company makes a permanent impression. As per market research, the new generation of customers goes through the ingredient list and manufacturing process first before purchasing something. They are conscious buyers who do not invest in services that directly or indirectly harm nature. ISO 14001 is the wisest tool for ensuring the target segment that your actions have been carefully planned and executed. Your company achieves a competitive edge as you accomplish an almost niche customer base.

If a company meets legal compliance for waste reduction, it automatically reduces insurance costs and the overall cost of manufacturing and supply. ISO 14001 is a comprehensive measure for earning more than just competitive advantages.

To modify your current system as per the terms and conditions of ISO 14001 standard, hire expert audit specialists from Blue Wolf Certifications. It is India’s premium ISO consultancy website providing solutions for internal audits. To get complete guidance for conducting an effective audit assessment, contact here now!

What to Include in ISO 22301 Audit Checklist?

The business continuity management system provides the most effective asset protection plan. ISO 22301 is designed to provide a concrete protocol that helps a company prevent and recover from potential hazards. Since a disaster can arrive anytime, all types of resources should be given the ultimate security so that they can perform as per their ability even after going through the disruptions.

The ISO 22301 certification procedure needs to be streamlined and the trickiest part is the internal audit. ISO 22301 audit is the second most significant evaluation after a gap analysis. It helps to check the progress and compare the financial outcome of the implemented system.

The process can take more than the usual time if the checklist is not ready properly. The audit checklist plays a crucial role in determining the final outcome of the assessment. Therefore, the content of the checklist should be designed carefully. Companies often make grave mistakes while choosing the right questionnaire for the checklist. Lack of experience and proper knowledge can turn the entire process exhausting and unprofitable.

The following post has briefly discussed what should be in the audit checklist for ISO 22301.

What is a checklist for an audit?

The audit checklist is considered a tool to facilitate the entire process. An audit checklist primarily adds information on the following –

• Scope of the audit

• Evidence collection

• Tests

• Each method for the test

• Analysis of the test results

The main areas of an audit checklist are – the standard, the procedure, performance monitoring, reporting, and system development. The checklist often includes follow-up actions for further modifications and improvements.

What are the main benefits of keeping an audit checklist ready?

• The audit checklist is an excellent mechanism for planning and maintaining time

• It acts as a database for contingency audit planning

• It ensures a flawless and productive process

• A checklist helps ensures that all the necessary evidence has been collected

• It ensures that the proper audit scope has been followed

What are the testing methods of the ISO 22301 audit?

Before understanding what should be incorporated into the audit checklist, it is necessary to understand the five fundamental methods for testing. There are five processes for audit testing. They are as follows –

• Observation

• Re-performance

• Observation

• Inspect all the evidence

• CAAT (Computer-Assisted Audit Tecnique

The ISO 22301 Audit Checklist

The checklist should be designed as per the main clauses of the ISO standard.

Clause  – Organizational context

Understanding the organizational context both internal and external is necessary when performing the audit. For an effective business continuity management plan, you need to define the organization first. A company is influenced by several factors, which must be enlisted while defining the context. The continuity plan should be made considering the values, interests, and opinions of each stakeholder. Accordingly, the following three things should be on the checklist

• All the internal and external problems, which influence the need for a robust continuity plan should be listed.

• The individual requirements of each stakeholder department should be listed.

• All the relevant laws should be enlisted

Clause – Limitation of the BCMS

As per clause 4, the business continuity management system should have a clearly defined boundary. Accordingly, the checklist should have the following –

• All those aspects, which are related to the scope

• Outputs, which are incorporated in the scope

• Explanation of the exclusions in a document

Clause – Management proactiveness/leadership

To effectively utilize all the necessary resources, a company needs proactive management. A strong sense of leadership and an understanding of the fundamentals are required. The management should be fully committed to the plan. To check that, the list should have –

• A clearly states business continuity plan and policy

• If the policy has been communicated to the internal and external stakeholders

• Leadership responsibilities

Clause  – Objectives & Resources

• Risks and opportunities

• Plan to work on the risk factors

• Objectives

• Determining the ideal resources

• Confirmation of resource acquisition

• A communication plan

Clause – Business Impact Analysis

• Key factors that influence product and service

• Identifying the resources to deliver the service

• Identifying and determining the business impact

• Setting a time frame for the recovery

Clause – Risk Assessment

• Risk identification

• Risk aggregation

• Prevention strategies

Clause – Procedures and plan

• Procedures for risk detection, aggregation and aversion

• Plan for acquiring resources and investing them for the ultimate execution

Clause – Continual Improvement

• Risk Control

• Plans for removing gaps

• Determining areas of improvement

• The corrective measures

To design an effective ISO 22301 audit checklist, you can hire expert consultants from Blue Wolf Certifications. It is India’s premium ISO consultancy website providing solutions for conducting internal audits before system registration.

How Beneficial Is ISO 22000 Audit? Audit Facts 101

As a food safety management standard, ISO 22000 is globally recognized for setting ideal requirements and relevant procedures. The increasing competition in the food chain industry pushes the quality and safety boundaries every day. Supporting an international safety management system is more than just a set of guidelines. From basic safety barriers to increasing customers to establishing a competitive edge, ISO 22000 is an all-inclusive program for sustainability.

The implementation procedure is rather rigorous and often exhausting. It starts with acquiring a basic understanding of the safety requirements, then moves on with gap analysis, gap filling, audits, and reviews subsequently. The ISO 22000 audit is one of the crucial elements of the process that determines the efficacy rate of the system.

As a system goes through different inspections and modifications, an internal audit is necessary to evaluate the financial outcome as well. It is a process that is incomplete without stakeholder engagement. The inclusive nature of the program is often overlooked. The following post has discussed the beneficial aspect of the audit in brief.

What is an ISO 22000 audit?

It is an objective-driven and independent analysis, which helps to add value to the operations and increase the efficiency level of the system. It is categorically divided into four types –

• Compliance Audit

• Information Technology audits

• Operational audits

• Financial audit

For ISO 22000, mainly compliance audit type is considered. The focus of this category is checking whether the system successfully complies with the regulatory conditions of the standard or not. The fundamental elements of ISO 22000 include the following –

• System management

• Leadership

• Interactive communication

• Critical control point (HACCP)

• Principles of hazard analysis

• Prerequisite programs

To accomplish each of the aforementioned elements, a company needs to acquire the right resources, mobilize them properly through robust planning, and monitor the progress followed by improvement. The overall program is generally streamlined with the help of certified ISO consultants who have same-industry experience and global knowledge. Understandably, the audit program is the key to measuring whether modification and implementation through hazard analysis prove fruitful or not. The significant benefits are –

• Cost efficiency – One of the fundamental aims of ISO 22000 is improving food quality with increased safety measures. It automatically reduces the amount of daily waste caused by inappropriate techniques of manufacturing and reserving perishable items. The audit helps to check if the major object is accomplished. Inspecting the system, interviewing employees, and allowing for further improvement, helps a company to save a substantial amount of money.

• Time-saving – By reducing the chances of producing wastage, the audit process helps the stakeholders to save time as well. As the process needs opinions from both management and employees, it augments the recovery process. Often, small and medium-sized companies do not consider including stakeholders in the decision-making process. After encountering repeated losses, once in a while team meeting is arranged. That eats time and leaves no solution. The internal audit is the easiest procedure for saving time by allowing each department to share valuable feedback. Decisions are taken easily and fast with multiple suggestions and perspectives.

• Document validation – It is necessary to establish an effective food safety management system. Through the audit, reports are submitted and evaluated. Professional auditors perform analyses and engage the management in documenting everything. Document validation is necessary to organize future meetings and build contingency plans as well.

• Policy development – The common reason for conducting an internal audit is probably because it helps to determine the best policies for increasing safety boundaries. Stakeholders and other interested parties get a better view regarding the ISO 22000 clauses and comprehend what is required to be done for damage control. Through a detailed risk management, top authorities decide on strategies, resources, and leadership so that disruptive events can be promptly avoided.

The audit, therefore, has a wholesome approach that promotes organizational sustainability. Professional conduct is necessary as the analyses and reviews are critical in form. Investing time in searching for expert auditors is essential.

Final words

To design an effective ISO 22000 audit checklist or to clear your fundamental grounds, hire expert consultants from Blue Wolf Certifications. It is India’s premium ISO consultancy website providing customer-friendly audit solutions for easy certification. To get comprehensive guidance for the quality management auidts, contact here now!

The Essential Steps To Conduct ISO 9001 Audits

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!

3 Types Of ISO 45001 Audits – Which One Should You Choose?

The objective of the ISO 45001 audit is to evaluate the scope of your OHSMS system, its policies and objectives, and other supporting documents, and determine if it has been implemented well. The audit aims to investigate all the incidents related to occupational health and safety and to find nonconformities and opportunities for improvement. Audits help to identify plans for corrective actions to optimize your outcomes.

There are two main categories of audit, internal and external. To get recognized worldwide as compliant to ISO 45001, a company needs to go through a certification audit that verifies the documentation, actions and records against the clauses of the occupational health and safety management system standard. The certification audit is part of the external audit, which is conducted in two phases, simply called stage 1 and stage 2.

Companies can be audited in three ways – remote audit, on-site audit, and self-audits. The self-audit is not categorically an internal audit as it is performed by your company when they are requested by a customer. The on-site audit is seen as more advantageous than the remote audit because of face-to-face value. Remote audits have many advantages over on-site audits, especially reduced cost and greater flexibility. Audits are performed by trained and competent individuals as per various audit standards provided by the International Organization for Standardization (ISO) and the International Accreditation Forum (IAF).

Remote audits are by auditors using videoconference software.

The following post discusses 3 categories of OHSMS audits and when to apply them.

The Types Of ISO 45001 Audits

The Internal Audits

An OHS internal audit is an audit of your organization that is performed to examine occupational health and safety policies, systems, and performance. It is kind of a self-examination audit that prepares a company for an external audit, and yet it is a requirement of ISO 45001, in other words you cannot get ISO certified without performing an internal audit. The audit is performed by trained and competent auditors, or under the supervision of a competent auditor. Companies can hire multiple auditors from within their organization or from an external source. Having multiple auditors can help with mentoring and can provide a more diverse point of view. The objective of this type of audit is to check compliance with the standards and your organization’s Occupational Health & Safety management system and determine any opportunities for improvement where able. To achieve this, internal auditors question personnel and interested parties and view required documents and records.  Information sighted or discussed will be recorded as objective evidence. Internal auditors will provide an audit report which is reviewed by senior management, usually as part of the Management Review meeting. The requirements for an internal audit are documented in ISO 45001 in section 9.2.

The external audit

When the internal audit has been performed properly and all the non-conformities are corrected, companies are ready for external audits.  These audits can be performed via web meetings and / or on-site evaluations. External audits can be performed as a 2nd party audit or third-party audit. Normally a 2nd party audit is performed by a customer or other interested party. Customers will choose 2nd party audits if your organization is not ISO certified by a third-party auditor, or where your customer wants to perform their own validation of compliance. 2nd party audits usually have no cost to your organization. Where possible, organizations should be audited by a third party auditor which usually negates the need for a 2nd party auditor. Another term for a third-party audit is a certification audit. For certification audits, a certification body hires lead auditors, who are trained and competent/experienced to perform a third-party audit. Lead auditors can be trained through a 5 day course that is accredited by one of the various training certification bodies such as Exemplar Global or PECB. Certification bodies are accredited by an accreditation body. Although various regions worldwide have a regional accreditation body, all certification bodies that are accredited by a member of the International Accreditation Forum (IAF) have equal status worldwide, in other words it doesn’t matter who accredits your certification body as long as they are IAF members. You can check accreditation status on the IAF website. The third-party audit is normally paid for by your organization. External audits are performed after your organization has performed their internal audit, and when your organization feels ready.

Certification audit

To perform a certification audit on your OHSMS, a two-stage audit is done prior to issuing certification. For the stage 1 audit, the organizational policies and objectives for OHSMS are reviewed. The fundamental organizational documents and records are reviewed, and necessary information is shared by management. An audit report for stage 1 is prepared and issued for review and approval. Any areas of noncompliance or improvement are implemented by your organization if needed before you can move on to the stage 2 audit. In stage 2, certified auditors visit your organization and likewise conduct interviews with management and employees, and documentation / records are reviewed. All the necessary information sighted and discussed is documented on an audit report. Only after performing a complete audit of the documented data against ISO 45001 will the certification auditor be able to recommend your organization for certification.  Once the audit report is completed and accepted by your organization, and any major or minor nonconformities have been addressed (major nonconformances must be corrected prior to issuance of certification), the external certification body will issue your organization’s certification for compliance to ISO 45001. Depending on the certification body’s policy, your organization and certification information will be recorded in the public domain including on their website, the accreditation body website, and / or the IAF website.  Furthermore, the certification body may issue certification marks or logos to your organization for use in marketing.

If you have already completed the internal audit, you can directly register your system for an external audit, including the certification audit if you choose.

Final words

Not all certification auditors are equal. There are over a thousand certification bodies in the world you can choose. Your choice of certification body is likely to significantly impact your experience for better or for worse. 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. Contact us here now!

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