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Making An ISO 27001 Checklist? Take A Final Look At The New Controls!

Is your organization preparing for the ISO 27001 certification? Are you on your way to make the perfect ISO 27001 stage 1 audit checklist? We can help!

Making a checklist is an effective way to keep track of your progress and ensure you don’t forget anything crucial during the demanding process. However, before making that checklist, it’ll be wise to take a final look at the new controls of ISO 27001:2022.

The recent Annex A update of ISO 27001 has left many scratching their heads.

Essentially, the update intended to simplify the implementation of controls while making them more relevant to the nature of modern-day cyber crimes. Yet, the modifications might have made things more complex for you rather than streamlining it if you have been following ISO 27001:2013.

Since the stage 1 ISO audit is about assessing documentation, clearing these doubts is critical!

Hence, in today’s blog, we present a straightforward outline of all the changes to ISO 27001 controls.

This outline will help ensure you’re indeed on the correct path and ready to jump into the ISO 27001 stage 1 audit checklist.

So, dive into the section below!

A Look At The Updated ISO 27001 Controls!

Annex A is a part of ISO 27001 that contains classified security controls. Companies are responsible for determining which of these controls apply to their organization and implementing them accordingly.

In ISO 27001, the controls take a risk-based approach associated with the Statement of Applicability.

ISO 27001:2013 contained a total of 114 controls separated into 14 categories. These controls covered a wide range of information security issues.

ISO 27001:2022 aligned the Annex A controls. It merged 24 controls and revised 58 of them. Currently, the standard has 93 controls divided into four categories, including 11 new ones.

Statement of Applicability

A must-include point in your ISO 27001 stage 1 audit checklist is the Statement of Applicability or SoA. This document outlines the Annex A control your organization has implemented.

Your auditors will refer to SoA to learn about what controls you have and have not executed at your organization.

The Updated ISO 27001:2022 Annex A Controls

The current version of ISO 27001 has 4 categories for its controls instead of 14. These categories are:

• Organizational (37 controls)

• People (8 controls)

• Physical (14 controls)

• Technological (34 controls)

Now, here’s an outline of all the current controls of ISO 27001:2022 that you might want to assess before making the ISO 27001 stage 1 audit checklist.

ISO 27001:2022, Organizational Controls

• Policies for Information Security

• Information Security Roles and Responsibilities

• Segregation of Duties

• Management Responsibilities

• Contact With Authorities

• Contact With Special Interest Groups

• Threat Intelligence

• Information Security in Project Management

• Inventory of Information and Other Associated Assets

• Acceptable Use of Information and Other Associated Assets

• Return of Assets

• Classification of Information

• Labeling of Information

• Information Transfer

• Access Control

• Identity Management

• Authentication Information

• Access Rights

• Information Security in Supplier Relationships

• Addressing Information Security Within Supplier Agreements

• Managing Information Security in the ICT Supply Chain

• Monitoring, Reviewing, and Change Management of Supplier Services

• Information Security for Use of Cloud Services

• Information Security Incident Management Planning and Preparation

• Assessment and Decision on Information Security Events

• Response to Information Security Incidents

• Learning From Information Security Incidents

• Collection of Evidence

• Information Security During Disruption

• ICT Readiness for Business Continuity

• Legal, Statutory, Regulatory and Contractual Requirements

• Intellectual Property Rights

• Protection of Records

• Privacy and Protection of PII

• Independent Review of Information Security

• Compliance With Policies, Rules, and Standards for Information Security

• Documented Operating Procedures

ISO 27001:2022, People Controls

• Screening

• Terms and Conditions of Employment

• Information Security Awareness, Education and Training

• Disciplinary Process

• Responsibilities After Termination or Change of Employment

• Confidentiality or Non-Disclosure Agreements

• Remote Working

• Information Security Event Reporting

ISO 27001:2022, Physical Controls

• Physical Security Perimeters

• Physical Entry

• Securing Offices, Rooms, and Facilities

• Physical Security Monitoring

• Protecting Against Physical and Environmental Threats

• Working In Secure Areas

• Clear Desk and Clear Screen

• Equipment Siting and Protection

• Security of Assets Off-Premises

• Storage Media

• Supporting Utilities

• Cabling Security

• Equipment Maintenance

• Secure Disposal or Reuse of Equipment

ISO 27001:2022, Technological Controls

It is the lengthiest category among the four control categories. Therefore, make it a top priority in your ISO 27001 stage 1 audit checklist.

• User Endpoint Devices

• Privileged Access Rights

• Information Access Restriction

• Access to Source Code

• Secure Authentication

• Capacity Management

• Protection Against Malware

• Management of Technical Vulnerabilities

• Configuration Management

• Information Deletion

• Data Masking

• Data Leakage Prevention

• Information Backup

• Redundancy of Information Processing Facilities

• Logging

• Monitoring Activities

• Clock Synchronization

• Use of Privileged Utility Programs

• Installation of Software on Operational Systems

• Networks Security

• Security of Network Services

• Segregation of Networks

• Web filtering

• Use of Cryptography

• Secure Development Life Cycle

• Application Security Requirements

• Secure System Architecture and Engineering Principles

• Secure Coding

• Security Testing in Development and Acceptance

• Outsourced Development

• Separation of Development, Test, and Production Environments

• Change Management

• Test Information

• Protection of Information Systems During Audit Testing

What Annex A Controls Should You Include?

Now, you are prepared to create an ISO 27001 stage 1 audit checklist and carry out a thorough assessment!

Still, if you have doubts about what controls you should execute, evaluate your company’s operations, legal requirements, business goals, and information security risks.

Do any of the above controls apply to those aspects? If yes, then you should consider executing it.

Remember, if a control does not apply to your organization, you should not feel obliged to implement it. However, during the ISO 27001 stage 1 audit, your auditor will inquire about the controls you didn’t execute. At that moment, you should be prepared to justify your decision. Hopefully, this blog will help achieve your audit goal.

14 Key Criteria You Must Meet To Pass The ISO 14001 Audit!

Is your organization on a mission to improve its sustainability efforts? Are you planning to register for ISO 14001 certification? Then, you have reached the correct place!

The ISO 14001 environmental management system standard has helped over 500,000 organizations across 180 countries implement an effective EMS till now.

The standard puts forward an easy-to-follow framework consisting of 10 clauses that act as the audit criteria in ISO 14001. To obtain the ISO 14001 certification, you shall ensure your organization adheres to all the applicable requirements and create documentation and records as evidence.

In today’s blog, we list the most critical requirements of ISO 14001 to help you understand its criteria and what you should do to obtain the certification.

So, delve into the below section now!

The Most Vital Audit Criteria In ISO 14001

ISO 14001 environmental management system standard has 10 clauses. The first three clauses describe the standard, while the rest of the seven clauses lay out its requirements.

Hence, when creating an ISO 14001 audit checklist, you shall focus on the seven requirements.

Here are the must-know audit criteria in ISO 14001.

Scope of the Environmental Management System

The scope of your environmental management system sets out the type of operations the system will cover and its boundaries.

Establishing the boundary will also help you understand which parts of your organization will come under the EMS and your ISO 14001 audit checklist. It may include processes, departments, divisions, and sites.

In most cases, EMS covers the entire organization. Yet, there are circumstances where specific requirements of the EMS may not apply to your organization or are impossible to implement in a particular department.

Environmental Policy

The environmental policy should describe your company’s responsibilities and commitments towards the EMS and other legal requirements. It should include your commitment to continually improve the environmental management system and prevent pollution.

Evaluation of Environmental Risk and Opportunity 

Audit criteria in ISO 14001 certification require you to identify the environmental risks and opportunities your organization faces and establish strategies to address them.

Although the standard does not specify a particular methodology or process for risk management, you must demonstrate that you are following a risk-based approach.

Your team should be able to explain the methodology you are using to address the risk and document evidence during the ISO 14001 audit questions and answers.

Also, the documented evidence should align with the clauses of ISO 14001.

Analysis of Environmental Aspects

Environmental aspects refer to the organizational activities that impact the environment, such as using resources like gas or water, generating waste, emitting air pollution, and disposing of effluents.

Audit criteria in ISO 14001 ask organizations to identify their environmental aspects and determine their impact on the environment. Experts suggest using a risk-scoring system to find out the significance of the aspects.

Also, you shall review and modify your environmental aspects, their impacts, and the scoring system as required.

Environmental Objectives and Plans For Achieving Them

One of the first clauses of ISO 14001 focuses on setting straightforward environmental objectives and establishing strategies to achieve them. You can use the outcome of your risk assessment to identify your company’s environmental goals and prioritize them.

Ensure the objectives are specific, measurable, attainable, relevant, and time-bound, such as reducing waste production within the next six months.

Along with the objectives, you shall determine who has ownership of each objective, how you will monitor their progress, a timeline to achieve those objectives, and the specialized equipment used in the process.

When assessing your compliance with the audit criteria of ISO 14001, auditors will check how the objectives relate to each other and your environmental policy.

Operational Control Procedures

As per the ISO 14001 EMS requirements, your organization must define and execute its operational controls based on its industry. The standard doesn’t specify how you should implement these controls. However, it’s essential to keep evidence of your operational controls to meet the audit criteria of ISO 14001.

Procedure For Emergency Preparedness And Response

Environmental emergencies are the situations within your company that influence the environment or the environmental events that impact your company.

Your emergency plan should demonstrate your ability to address both. The plan should be able to identify emergencies and address them.

Also, you should have records on testing the proceeds and providing training to relevant parties.

List of Interested Parties and Applicable Regulations

Interested parties are essentially the stakeholders your organization cannot operate without.

The audit criteria in ISO 14001 EMS want organizations to determine the needs and expectations of their interested parties. Considering them when building the EMS will help you ensure its appropriateness.

Furthermore, you shall record the requirements of all interested parties and upgrade them as necessary. Additionally, you shall determine all the environmental regulations applicable to your organization and list them.

Competence Record

Record the skills of every relevant stakeholder at your company. Also, document how you help improve their skills with training. Make sure employee training records are easily accessible.

Communication Evidence

According to the ISO 14001 audit requirements, it’s your top management’s responsibility to communicate the environmental management system to relevant stakeholders. They should be aware of your obligations and their role in the system.

Monitoring Performance

To facilitate continual improvement of the ISO 14001 environmental management system, you must establish a monitoring process to measure performance. Keeping records of these evaluations will help auditors determine your commitment to the standard.

Compliance Obligation Record

You shall obtain records of everyone working at your organization. Experts suggest performing a competence evaluation to establish legal requirements and regular reviews to keep the records up-to-date.

Internal Audit Program and Management Reviews

The internal audit criteria in ISO 14001 require you to perform planned audits to check your company’s overall environmental performance and maintain records of the audit outcomes as evidence of compliance.

Furthermore, your top management shall take the responsibility to review the EMS to maintain its effectiveness and record its outcome.

Non-Conformities and Corrective Actions

Document the non-conformities of your environmental processes and operations and the actions you took to address them. To prove the effectiveness of your corrective actions, consider performing a root cause analysis.

Final Thoughts

Not all audit criteria in ISO 14001 may apply to your organizations. However, following these 14 requirements is a must. These clauses build the foundation of ISO 14001. Complying with them will help demonstrate your commitment to the standard and achieve the ISO 14001 certification.

What Is ISO 21001 Certification? How Much Does It Cost?

Do you know that even though 91% of children attend primary education globally, most are not learning enough?

UNESCO says that over 617 million children are not learning although they attend school. Their reports also indicate that the number of students dropping out has significantly increased from 2021.

Unqualified or lack of teachers and economic issues are among the most common reasons behind this issue.

So, as an owner of an educational institute, how should you deal with this issue?

You can implement an educational organization management system, like ISO 21001. It will help you maintain structured processes throughout your organization, improving the quality of education and making students a top priority.

In today’s blog, we will look at the principles and requirements of the standard, the ISO 21001 certification cost, and other factors.

Hence, if you are looking for an effective way to manage your educational institute, keep reading!

What Is The ISO 21001 Certification?

The ISO 21001 standard offers a framework to establish an educational organization management system. Following the framework can help create and maintain transparency, inclusivity, and flexibility across your EOMS.

It will allow you to implement the best practices, provide personalized training, improve the quality of education, train educators, and take a learner-centric approach.

ISO published the standard in 2018 to help educational institutions provide high-quality services. Also, the certification promotes equitable and accessible education for learners with special needs and distance learners.

What Is The ISO 21001 Certification Cost?

Your ISO 21001 certification cost depends extensively on the size and complexity of your organization, the scope of the EOMS, and the certification body you hire. To give you an estimation, a company with around 25 employees may pay approximately 4000 USD for their ISO 21001 certification.

On the other hand, an organization with 250 employees pays maybe 12000 USD for the ISO EOMS certification. Also, the cost can vary based on your location and the time it takes to audit the EOMS.

If you want a realistic figure, speak to your nearest third-party auditor. Remember to ensure the auditor has certification and works with accredited certification bodies.

Can Your Educational Institute Apply For The ISO 21001 Certification?

The ISO 21001 standard applies to all organizations operating in the educational sector. Regardless of the size, nature, and location of the company, you can apply for the certification if you can bear the ISO 21001 certification cost.

Following are a few examples of educational institutions that can apply for the ISO 21001 certification:

• Pre-schools,

• Colleges,

• Adult education centers,

• Vocational education centers,

• Tutoring or coaching centers,

• Special education schools,

• Universities,

• Training institutes,

• K-12 schools.

Principles Of ISO 21001 Certification

The ISO 21001 EOMS certification has 11 principles, including the following.

• Focus on learners and other beneficiaries,

• Visionary leadership,

• Engagement of people,

• Process approach,

• Improvement,

• Evidence-based decisions,

• Relationship management,

• Social responsibility,

• Accessibility and equity,

• Ethical conduct in education,

• Data security and protection.

Is ISO 21001 Certification Worth It?

After seeing the ISO 21001 certification cost, you may wonder whether achieving the certification is worth it.

Well, if you consider the statistics above, ISO 21001 can be valuable for many education institutes.

The education sector across the world is facing many hurdles, from unqualified stakeholders and corrupt management to a lack of resources. About 72 million children don’t even get the chance to get an education. If you listen to experts, only six out of ten kids will finish school in 2030.

ISO 21001 can play a critical role in improving the situation.

When followed religiously, the standard can help you

• Align organizational policies with objectives and enhance the credibility and reliability of the institute,

• Execute personalized learning processes to make education more accessible,

• Promote inclusivity and meet learner’s expectations,

• Demonstrate your commitment to quality and comprehensive education,

• Harmonize legal regulations and other requirements into a single framework,

• Enhance your social responsibility.

The Requirements Of ISO 21001 Certification

Do you think the above benefits justify the ISO 21001 certification cost? If you do, here are the requirements you have to meet to comply with the ISO 21001 standards.

ISO 21001 follows the same high-level structure as ISO 9001. It contains 10 clauses, three of them being introductory.

These are the seven clauses you have to follow to achieve the certification.

Context of the organization:

Your organization shall define the internal and external issues affecting its educational organization management system. Furthermore, you should form strategies to obtain the EOMS objectives that include its purpose and social responsibilities.

Leadership: 

The top management of your company should take accountability and responsibility for maintaining the effectiveness of the EOMS. Along with helping you make a plan to cover ISO 21001 certification costs, they shall assist with integrating the management system across the company.

Planning:

You should make plans to address risks and opportunities, meet the objectives of the EOMS, and manage changes.

Support:

You will spend a significant percentage of your total ISO 21001 certification cost to meet this clause. It requires you to determine what resources are needed to implement and maintain the EOMS and gather them.

Operation: 

It is one of the lengthiest clauses of the standard. It operates with clause 6 of ISO 21001. You can use this clause to develop controls for developing and designing educational products and services, control externally provided resources, and more.

Performance evaluation: 

Your organization shall adopt methods to monitor, measure, evaluate, and analyze performance.

Improvement: 

To maintain the EOMS, your organization shall identify and address nonconformity, continual improvement, and requirements of corrective actions.

Summing Up

The benefits of the EOMS certification surely outweigh the ISO 21001 certification cost here. However, remember, that achieving ISO certification is not a one-time thing. It’s a recognition that you will have to continuously maintain, which means going through paid annual third-party audits. So, before jumping into the process, consider creating a realistic budget and consulting with multiple auditors and certification bodies to get a good deal.

Enjoy The Benefits Of ISO 27001 Certification: Avoid These 10 Errors!

With a cyber attack happening every 39 seconds on average, information security is no longer an afterthought. It’s a necessity.

Consequently, information security standards and regulations, such as ISO 27001, have become the cornerstone of building a resilient and thriving information security management system. In fact, many companies these days demand their partners to provide an information security certification to protect their operations from cyber attacks.

That said, the ISO 27001 certification benefits go beyond healthy partnerships. It can help you protect the most critical assets of your organization and avoid legal issues related to cyber crimes.

However, obtaining the ISO 27001 certification is not a walk in the park. It’s a lengthy, detailed, and demanding process that requires continuous maintenance. As a result, mistakes happen. Moreover, if you don’t take appropriate action to address those blunders, you might lose the certification.

Through today’s blog, we are here to give you an advance alert so you don’t make the same errors as others when pursuing the ISO 27001 certification.

So, let’s get started!

Terrifying Mistakes That Can Prevent You From Enjoying The ISO 27001 Certification Benefits

1.Neglecting Top Management Involvement 

Top management has critical responsibilities in developing, implementing, analyzing, and maintaining ISO 27001 certification. Their commitment, support, and role in communicating the ISO 27001 certification benefits are critical for the organization-wide success of the system.

It’s nearly impossible to comply with the ISO 27001 requirements without dedication from top management. It can lead to poor resource management, direction, authority, and ineffective implementation.

2.Overcomplicated Policies

Another grave error organizations make when pursuing ISO 27001 certification is creating complex and convoluted policies. If your ISMS policies are not comprehensible to auditors or staff, you can’t expect them to follow the rules.

Overcomplicated policies also lead to confusion, misinterpretations, misdiagnosis of security issues, and, eventually, non-compliance.

Hence, keep your ISO 27001 policies straightforward, jargon-free, and accessible to relevant parties.

3.Failing To Align Business Objectives With ISO 27001 Policies

To truly enjoy the countless ISO 27001 certification benefits, you must align the organization’s overall objectives with the ISMS policies. Failing to establish this alignment will create a disconnection between your company’s aims and priorities.

Hence, when developing the ISO 27001 policies, involve key stakeholders and utilize the policies to address business risks, objectives, and compliance requirements.

4.Neglecting the Risk Assessment

The significance of risk assessments in ISO 27001 cannot be emphasized enough. It’s the best way for you to detect the risks threatening your ISMS and address them swiftly.

Yet, many organizations neglect their risk assessment performance, leading to overlooked threats, impacts, and inefficient controls.

If you don’t want to make the same error, regularly review and update your organization’s risk assessment process.

5.Not Reviewing The Policies

A prominent ISO 27001 certification benefit is that it mandates the periodic review of policies, procedures, and processes. It encourages organizations to keep their priorities in check and constantly make improvements to their system.

The routine reviews also aid with staying relevant and compliant with applicable regulations.

However, when you neglect to review and update the ISMS policies, it appears as a red flag to third-party auditors. It can lead to major non-conformations and even legal issues.

6.Inadequate Incident Response Planning

An adequate incident response plan is critical for minimizing the impact of potential security incidents and ensuring timely response.

Still, many organizations make the mistake of poorly developing their incident response plans.

As a result, they struggle to detect, respond to, and receive security issues. Instead of repeating the same mistake, ISO 27001 experts suggest periodically testing the incident plans and improving its effectiveness.

7.Failure To Monitor And Measure The ISMS Processes And Compliance

Monitoring and measuring is one of the most significant clauses you have to meet to enjoy the ISO 27001 certification benefits. ISO 27001 requires establishing a proper process for measuring and monitoring the ISMS policies and procedures.

Naturally, if you fail to satisfy this requirement, it will become a major nonconformity.

Also, you will miss out on the gaps and flaws of your system, leading to inaccurate outcomes.

8.Ignoring Third-Party Risks

Do you know 95% of data breaches are a result of human error? Many of these incidents are caused by third-party vendors or partners.

ISO 27001 requirements specifically ask organizations to carry out third-party risk management and conduct due diligence before establishing relationships.

Failing to comply will prevent you from obtaining the ISO 27001 certification.

9.Lack Of Continual Improvement Evidence

ISO standards encourage organizations to embrace a culture of continual improvement to stay compliant and relevant.

Unfortunately, organizations often see policy executions as a one-time job. They don’t put much effort into improving the policies and recording the improvement actions. To auditors, this appears as a sign of a lack of commitment.

Hence, if you want to obtain the ISO 27001 certification seamlessly, regularly review your policies, seek feedback, and identify gaps and opportunities for improvement.

10.Noncompliance With Legal And Regulatory Requirements

When you implement the requirements of ISO 27001, you not only commit to following its 10 clauses but all the legal and regulatory requirements that apply to your organization. It may include the data protection laws of your country and contractual obligations in your industry. Not complying with these laws can lead to major nonconformities.

Concluding Thoughts

Committing any of these mistakes can cost you the ISMS certification and prevent you from enjoying the ISO 27001 certification benefits. So, take notes and ensure to involve your top management in the process, create straightforward policies, and comply with each clause of the standard carefully.

A Comprehensive Audit Checklist For ISO 13485 Clause 4!

As expert auditors with sufficient industry experience, it’s understandable when business owners get anxious before a third-party audit.

One of the most effective ways to deal with this unease and ensure you are following the correct path is creating a comprehensive ISO 13485 audit checklist and evaluating your medical device quality management system.

It can help you understand the additional requirements you have to meet, the potential room for improvements, and identify the flaws in the system.

To help you get started, we present a sample audit questionnaire or checklist for clause 4 of ISO 13485.

So, if you are seeking effective ways to evaluate your company’s environmental management system, delve into the below section now!

An Expert-Approved Audit Checklist For ISO 13485 Clause 4!

Clause 4 presents the first set of requirements of ISO 13485. It focuses on establishing a medical device QMS, documenting it and related roles and responsibilities, creating quality manuals and policies, and controlling documents as well.

Here’s an ISO 13485 audit checklist solely designed to help you ensure compliance with the Clause 4 quality management system.

So, let’s get started!

4.1 General Requirements

• Has your organization established, documented, implemented, and maintained an effective medical device quality management system? Have you improved the existing system according to the requirements of ISO 13485?

• Has your organization identified the processes required for the quality management system? Have you planned their application through your organization?

• Have you taken a risk-based approach to the control of the quality management system processes?

• Have you determined the interaction and sequence between the quality management system processes?

• What criteria and methods does your organization use to ensure the effectiveness of the control of quality management system processes and operations? Include them in your ISO 13485 audit checklist for a thorough review.

• Has your organization provided all the resources required to support the operation and monitoring of the medical device quality management system processes?

• How does your company monitor, measure, and analyze the ISO medical device quality management system processes?

• How has your company implemented the actions needed to achieve the QMS objectives and maintain its effectiveness?

• Are the processes of your medical device QMS managed according to the requirements of the ISO 13485 medical device quality management system?

• Does your organization outsource any processes that affect its products, services, or compliance? If yes, then how do you plan to control those processes?

• Where is the control of outsourced processes affecting product conformity in regard to the requirements of the ISO 13485 medical device QMS?

• Do you have a plan for validating software before using them? Include your processes for evaluating the plans in the ISO 13485 audit checklist.

4.2 Documentation Requirements

• Have you documented the statements of quality objectives and quality policy?

• Have you established a quality manual?

• Does your company have documented procedures required by ISO 13485?

• Do you have the appropriate documents to ensure effective planning, control, and operation of the organization’s processes?

• Have you considered the required records when creating the documentation?

• Are there any other documents required by laws and regulations?

• Can you show your auditors the medical file for each model of medical device, including documents with product specifications and meeting other ISO 13485 requirements?

• Does the quality manual include the scope of the QMS, including details of justification for excluding requirements that apply to your QMS?

• Where does the quality manual reference the documented procedures established for the QMS?

• Where does the quality manual contain a description of interactions between the processes of the QMS?

• Where does the QM outline the documentation structure of the quality management system?

• Have you established controls to prevent the deterioration and loss of documents as well as identify and distribute the documents? Then, be sure to include them in the ISO 13485 audit checklist!

A Few Details To Remember When Complying With ISO 13485 Clause 4!

Document control is a major feature of ISO 13485. Hence, ensure you make no mistake when complying with it. Note down these details to prevent errors when structuring the audit checklist.

Document Control Specifications In ISO 13485

• ISO 13485 recommends developing document control processes and procedures to

• Review and approve documents for appropriateness before using,

• Update and re-approve the documents as necessary,

• Identify the current revision status and changes made to the documents,

• Ensure the availability of relevant versions of the applicable documents,

• Ensure the accessibility, readability, and legibility of the documents,

• Identify and control the distribution of external origin documents,

• Prevent loss and unintended use of outdated documentation.

The Most Commonly Made Mistakes Regarding Documentation Control!

When crafting your ISO 13485 audit checklist, make sure to check on these three mistakes most organizations make when documenting control.

• Using obsolete documents or documents without prior approval or review,

• No defined controls to prevent the use of outdated documents or loss of documents,

• No procedure for tracking the revisions and changes in documentation.

Ensure to assign the ownership of key documents to named individuals to prevent their loss. Also, communicate the contents of the documents properly to your employees. Make sure they are able to answer queries from auditors.

Endnote

The extensivity of ISO 13485 can make it a challenging standard to meet. Hopefully, this ISO 13485 audit checklist will help you stimulate this process. Also, you can use this checklist to create similar lists for other clauses. Additionally, you can use it as a tool for readiness review or a pre-audit analysis.

Hack-Proof Your Business: The Many Benefits Of ISO 27001 Certification

Information is the most critical asset of any growing organization. Yet, most fail to protect it, leading to costly IT disasters.

According to reports, the average cost of data breaches was an astounding $4.45 million last year. If that’s not bad enough, reports also suggest that most organizations can’t even detect data breaches when it occurs. On average, organizations take around 207 days to identify a data violation.

These statistics clearly show the dire need for a robust information security management system. It is where ISO 27001 comes in. The ISMS standard has controls and procedures for every type of cybersecurity issue, from malware attacks to data theft. Plus, it’s applicable to all organizations and industries.

Considering the growing cyber security issues, today’s blog sheds light on some of the best perks of ISO 27001.

Even if the scary numbers haven’t convinced you to adopt an ISMS yet, these ISO 27001 certification benefits will.

So, continue reading!

What Is ISO 27001 Certification?

Before jumping into the benefits, let’s learn what ISO 27001 means.

ISO 27001 is a globally accepted information security management system standard. It helps organizations maintain the quality of their information security management by establishing controls and addressing operations, technologies, and people.

The standard provides organizations with a straightforward ISMS framework. It also enables them to demonstrate compliance with cyber security regulations and laws.

Furthermore, ISO 27001 requires organizations to follow its ten clauses and implement the applicable controls to obtain the ISO 27001 certification. As a part of this requirement, you will create policies, procedures, and processes and routinely assess your ISMS.

The proactive and risk-based approach of the standard will allow you to detect information security issues before they cause severe damage.

The Best ISO 27001 Certification Benefits For Your Company

The ISO 27001 certification benefits are countless. And the best part is that any company can enjoy them.

• Improved company credibility and cyber resilience:

When an organization earns the ISO 27001 certification, it shows its commitment and dedication toward information security. For consumers and other stakeholders, it’s a sign that their personal data is safe with the organization.

It can help boost stakeholders’ trust, retain consumers, and win business deals. The ISMS certification can be especially beneficial for companies expanding overseas due to its international recognition.

• Avoid extra costs associated with cybersecurity: 

Data breaches and cyber-attacks cost organizations millions of dollars every year. Unfortunately, with more access to IT, the frequency of cyber attacks is increasing. Around 236.1 million ransomware attacks occurred only in 2022.

One of the best ISO 27001 certification benefits is that its clauses help you build a robust ISMS to prevent these attacks, eliminating the extra costs. Also, following the standard can help you avoid regulatory fines.

• Improve structure and focus:

Many organizations start with a resolution to take sufficient steps toward information security management. However, as their resources and market expand, cyber security management often takes a setback.

You will never face this issue with ISO 27001. The standard requires organizations to continuously monitor, assess, and improve their ISMS. It will help you improve the overall structure of your information security management system.

• Reduce human errors:

According to reports, human errors cause around 74% of all cybersecurity breaches. One of the ISO 27001 certification benefits is that it encourages organizations to train their human resources and relevant stakeholders to avoid this issue. It also requires companies to implement specific controls to monitor and control information access.

• Tested processes:

Following the ISMS framework of ISO 27001 certification can simplify audits and reviews. You can use the standard clauses to develop a written process for internal audits. It will allow you to clearly outline the necessary protocols, procedures, and timelines for completing them, eliminating the guessing game.

Furthermore, the regular audit will help you detect processes that bring visible results and the ones that are unnecessary. It can lead to consistent and effective workflow and better output.

• Get independent opinions on your ISMS:

One of the ISO 27001 certification benefits that people often overlook is the unbiased opinions of external auditors. To obtain the ISO 27001 certification, your organization will have to go through third-party audits. These audits are excellent for finding out the flaws in information security management systems. It can also help you detect improvement opportunities in the system, preparing you for emergencies.

• Reduce security loopholes:

From risk management to gap analysis, ISO 27001 requires organizations to frequently test their ISMS for security flaws. When you incorporate the standard into your organization, you will adhere to the industry’s best practices and stay up to date with the latest data-safeguarding methods.

• Improved security awareness:

ISO 27001 certification suggests organizations establish, follow, monitor, and evaluate their security policies, improving security awareness. Also, it includes clauses for evaluating suppliers and partners for security measures.

Concluding Thoughts

The ISO 27001 certification benefits can help you establish a structured process to maintain your company’s ISMS. You will be able to protect the confidentiality, availability, and integrity of your stakeholders’ data, eliminate the risk of cyber security issues and associated costs, and comply with applicable regulations. Furthermore, since continual improvement is a critical clause of ISO 27001, your ISMS will never be overlooked ever again.

A Checklist To Nail The ISO 14001 Internal Audit (From Clause 4 To 6)

External and internal audits are essential parts of ISO 14001. Both of them are mandatory for earning the ISO 14001 certification.

Performing them following the internal audit criteria in ISO 14001 can help check the effectiveness of your implementation process, evaluate compliance, and point out improvement opportunities.

But do you know what to check during the internal audit? If your response is no, then this blog is for you!

To help you get the most out of your internal audits, today’s blog presents a thorough checklist for assessing your compliance through clauses 4 to 6.

This checklist of questionnaires will allow you to take a deep dive into your environmental management system to gather critical facts.

So, let’s get started!

A Checklist To Meet The Internal Audit Criteria Of ISO 14001

The requirements clauses of ISO 14001 span from clauses 4 to 10. Your internal audit criteria shall depend on the requirements of these clauses.

Here’s an internal audit checklist to plan and meet the audit criteria of ISO 14001 for the requirements through clauses 4 to 6.

4.1 Understanding the organization and its context

• Has your organization determined the external and internal issues relevant to your purpose? Do the issues affect your organization’s ability to achieve the intended EMS outcome?

• How does your organization monitor and review the internal and external issues?

4.2 Understanding the needs and expectations of interested parties

• Has your organization determined the interested parties relevant to its environment management system?

• Has your organization determined the requirements of those interested parties relevant to the EMS?

• Has your organization determined which of these needs fall under compliance obligation as per audit criteria in ISO 14001?

4.3 Determining the scope of your EMS

• Has your organization established the applicability and boundary of the EMS for its scope?

• Have you considered compliance obligations and external and internal issues when deciding the EMS scope?

• Have you considered the organizational units, physical boundaries, functions, activities, products, services, authority, and ability to exercise control when determining the scope?

• Have you included all activities, products, and services in the scope?

• Are you maintaining documented information on the scope?

• Have you made the scope available to interested parties?

4.4 Environment management system

• Has your company established and implemented the EMS as per the audit criteria in ISO 14001?

• Do you have the system to continually improve and maintain the EMS, including various processes and their interactions?

• Have you considered the requirements of clauses 4.1 and 4.2 when establishing and maintaining the EMS?

5.1 Leadership and Commitment

• Does your top management take accountability for the effectiveness of the EMS, demonstrating commitment and leadership?

• Has your top management ensured the establishment of EMS policy and objectives?

• Are the EMS policy and objectives compatible with the organization’s context and strategic direction?

• Have you integrated the EMS requirements into business processes?

• Has your top management ensured the availability of resources for the EMS?

• Have you communicated the importance of the EMS conformance and effectiveness?

• Does your top management ensure the EMS archives its intended goals according to the audit criteria in ISO 14001?

• Do they direct and support stakeholders to contribute to the EMS?

• Does top management promote continual improvement?

• Does top management support relevant management roles?

5.2 Policy

• Has your top management established an environmental policy appropriate to the context and purpose of the organization?

• Does the policy provide a framework for setting the objectives?

• Does the policy include an affirmation to protect the environment?

• Does the policy contain a commitment to meet compliance obligations and make continual improvements?

• Are you communicating the environmental policy, maintaining it as documented information, and making it available to interested parties?

5.3 Organizational roles, responsibilities, and authorities

• Have you assigned the authorities and responsibilities of relevant roles as mentioned in the audit criteria in ISO 14001?

• Have you communicated the roles within your company?

• Has your top management assigned roles and responsibilities for ensuring ISO 14001 EMS compliance and reporting on the performance of the EMS?

6.1 Actions to address risks and opportunities

• Has your organization considered all the requirements of clause 4 when planning the EMS?

• Has your organization considered reducing or preventing undesired effects impacting the EMS?

• Has your organization considered emergencies impacting the environment and included them in the EMS scope?

• Has your organization established documented information on its risks, opportunities, and processes to address them?

6.1.2 Environmental aspects

• Has your organization determined its environmental aspects as guided by audit criteria in ISO 14001?

• Have you considered new or modified activities, products, or services when determining environmental aspects?

• Have you considered emergency and abnormal conditions when determining the aspects?

• What criteria have you used to determine the aspects? Have you communicated the aspects across the organization?

• Are you maintaining documented information on the aspects and impacts?

6.1.3 Compliance obligation

• Has your organization determined the compliance obligations related to the environmental aspects and how they apply to the company?

• Have you considered the obligation when implementing the EMS?

• Are you maintaining the obligation as documented information?

6.1.4 Planning action

• Have you addressed the environmental aspects, compliance obligations, risks, and opportunities?

• How do you plan to integrate the actions into the EMS and business processes?

• How do you plan to evaluate the effectiveness of the action as required in audit criteria in ISO 14001?

6.2.1 Environmental objectives

• Have you established the environmental objectives, considering compliance obligations, aspects, risks, and opportunities?

• Are the objectives consistent with the environmental policy?

• Are the objectives measurable and monitored?

• Have you communicated and updated the objectives as needed?

• Are you maintaining documented information on the objectives?

6.2.2 Planning actions to reach the environmental objectives

• How does your organization plan to achieve its environmental objectives?

• Do you have sufficient resources to achieve the goals?

• Who will be responsible for this task?

• Have you set a timeline for achieving the objectives?

• How do you plan to evaluate the results?

Endnote

The audit criteria in ISO 14001 are quite extensive. However, you can tailor the requirements depending on the services and products of your organization. Hopefully, this questionnaire will help you evaluate parts of the EMS. For the checklist on the rest of the clauses, keep an eye on this space!

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,