ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

ISO/IEC 17021 is an international standard that sets out the requirements for bodies providing audit and certification of management systems. Its primary objective is to ensure that these certification bodies operate in a competent, consistent, and impartial manner when conducting third-party auditing (TPA).

Key Aspects of ISO/IEC 17021 Accreditation for Third-Party Auditing:

Scope of the Standard:
- The standard applies to certification bodies that audit and certify management systems like ISO 9001 (Quality Management), ISO 14001 (Environmental Management), and other ISO standards.
- It provides the framework for ensuring that audits are conducted with the necessary competence, impartiality, and consistent processes.
Accreditation for Certification Bodies:
- Accreditation is a formal, independent recognition that a certification body meets the requirements of ISO/IEC 17021.
- Accreditation bodies, themselves typically complying with ISO/IEC 17011, assess certification bodies for their competence and processes.
Third-Party Auditing (TPA):
- TPA refers to independent audits conducted by a certification body (the “third party”) on organizations (the “first party”) to verify compliance with a management system standard (like ISO 9001).
- It involves the review of documents, interviews with employees, and observations of processes to ensure compliance.
Key Requirements:
- Competence: Certification bodies must demonstrate that they have the competence to perform audits across the range of management systems they certify.
- Impartiality: Bodies must maintain impartiality in the audit process, with procedures in place to manage potential conflicts of interest.
- Process Requirements: Certification bodies must adhere to defined processes for auditing, ensuring consistency across different audits and auditors.
- Confidentiality: Protection of client information is crucial.
Benefits of Accreditation:
- Trust: Accreditation under ISO/IEC 17021 ensures that certification bodies are trusted by organizations seeking certification and their stakeholders.
- Quality and Consistency: It promotes high standards for auditing quality and helps maintain consistency in audit outcomes.
- Global Recognition: Accreditation gives certification bodies credibility in international markets, as the ISO/IEC 17021 standard is recognized globally.
Continuous Monitoring:
- Certification bodies are subject to continuous monitoring and reassessments to ensure ongoing compliance with the ISO/IEC 17021 standard.

In summary, ISO/IEC 17021 accreditation ensures that third-party auditing of management systems is carried out competently, consistently, and impartially, making it a vital standard for certification bodies involved in management system certification.

What is ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

ISO/IEC 17021 accreditation refers to the formal recognition of certification bodies that perform third-party audits (TPA) for management systems. This standard ensures that the certification bodies are competent, consistent, and impartial in their auditing processes.

Overview of ISO/IEC 17021 for Third-Party Auditing:

ISO/IEC 17021:
- This international standard specifies requirements for certification bodies that audit and certify management systems (such as ISO 9001, ISO 14001, etc.).
- It establishes guidelines to ensure that audits are performed with high integrity and reliability.
Third-Party Auditing (TPA):
- TPA is when an independent body (the third party) conducts audits on an organization’s management system to verify its compliance with a specified standard.
- Certification bodies carry out these audits to certify that the management system meets the requirements of a given ISO standard.
Accreditation:
- Accreditation under ISO/IEC 17021 means that an independent accreditation body has assessed a certification body and confirmed that it meets the standards for competency, impartiality, and consistency in conducting audits.
- Accreditation bodies themselves follow guidelines under ISO/IEC 17011 to evaluate certification bodies.

Key Features of ISO/IEC 17021 Accreditation:

Competence: Certification bodies must demonstrate that their auditors are skilled, knowledgeable, and competent in the specific management systems they audit.
Impartiality: To avoid conflicts of interest, certification bodies must have mechanisms in place to ensure impartial and objective auditing.
Consistency: The audit processes need to be standardized and consistent across different certifications, ensuring the same level of scrutiny regardless of the location or organization size.
Transparency: Clear communication of audit results, certification decisions, and ongoing monitoring of certified organizations must be maintained.

Benefits of ISO/IEC 17021 Accreditation:

Credibility: Organizations certified by an accredited certification body are trusted by stakeholders, as the certification process meets rigorous international standards.
Global Recognition: Accredited certification bodies are recognized worldwide, making their certifications more valuable.
Quality Assurance: Accreditation ensures that certification bodies maintain high standards, providing confidence in the auditing and certification process.

In summary, ISO/IEC 17021 accreditation ensures that third-party auditing is carried out with the highest levels of integrity, competence, and impartiality, benefiting organizations seeking credible certifications for their management systems.

Who is required ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

ISO/IEC 17021 accreditation is specifically required for certification bodies that conduct third-party audits (TPA) for the certification of management systems. These certification bodies assess organizations’ compliance with various ISO standards such as ISO 9001 (Quality Management Systems), ISO 14001 (Environmental Management Systems), and many others.

Entities That Require ISO/IEC 17021 Accreditation:

Certification Bodies (CBs):
- Organizations that provide third-party certification services for management systems must be accredited under ISO/IEC 17021 to ensure their audit and certification processes are consistent, impartial, and competent.
- These certification bodies offer certification across various sectors, including manufacturing, healthcare, IT, and environmental management.
Accreditation Bodies (Indirectly):
- Accreditation bodies assess and certify the competence of the certification bodies. While these accreditation bodies themselves do not seek ISO/IEC 17021 accreditation, they must comply with ISO/IEC 17011, a related standard that governs how they evaluate certification bodies.
- Accreditation bodies ensure certification bodies are following the correct procedures and maintaining standards for ISO/IEC 17021 compliance.

Organizations That Rely on ISO/IEC 17021 Accredited Audits:

Organizations Seeking Certification: Businesses or entities seeking certification for their management systems under ISO standards (e.g., ISO 9001, ISO 27001, ISO 45001) will require their management system to be audited by a certification body accredited to ISO/IEC 17021.
- Examples include manufacturing companies, service providers, government agencies, and non-profit organizations.

Reasons for ISO/IEC 17021 Accreditation Requirement:

International Standards Compliance: Accreditation ensures that the certification body complies with globally accepted practices for auditing management systems.
Market Confidence: Certification by an accredited body is trusted by customers, regulatory bodies, and stakeholders. This accreditation gives assurance that audits are performed competently and impartially.
Legal or Contractual Requirements: In some industries or regions, regulatory bodies or large customers require that certifications are issued by a certification body accredited under ISO/IEC 17021.

In conclusion, certification bodies are the primary entities required to obtain ISO/IEC 17021 accreditation to demonstrate competence, impartiality, and consistency in third-party auditing and certification of management systems.

When is required ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

ISO/IEC 17021 accreditation is required for third-party auditing (TPA) under specific circumstances, primarily when certification bodies provide management system certifications and need to demonstrate competence, impartiality, and consistency. Here are the situations when ISO/IEC 17021 accreditation is required:

1. To Issue Formal Management System Certifications:

Certification bodies that certify organizations to international standards like ISO 9001 (Quality Management Systems), ISO 14001 (Environmental Management Systems), ISO 45001 (Occupational Health and Safety), and other management system standards are required to be accredited under ISO/IEC 17021.
Without this accreditation, certifications issued by the certification body may not be recognized or trusted by industry regulators, customers, or other stakeholders.

2. When Contractual or Regulatory Requirements Mandate Accreditation:

Contracts with Clients: Many organizations seeking certification often require that the certification body they work with is accredited under ISO/IEC 17021. This ensures that the audit and certification process meets international standards.
Regulatory Compliance: In some industries or regions, regulatory authorities or government bodies mandate that certifications must come from an ISO/IEC 17021-accredited body. For example, health, safety, environmental, and security management certifications might have to be issued by accredited bodies to comply with national or international regulations.

3. When Operating in International Markets:

In global markets, ISO/IEC 17021 accreditation is essential for certification bodies to gain recognition. Many organizations, especially those exporting products or services internationally, require their management system certifications to be recognized globally, which can only be achieved by working with accredited certification bodies.
Without this accreditation, certifications issued by a certification body may not be accepted by foreign partners, clients, or governments.

4. When Demonstrating Impartiality and Competence Is Crucial:

If a certification body is involved in auditing high-risk industries (e.g., aerospace, pharmaceuticals, environmental management), impartiality and competence are critical for maintaining trust in the certification process.
ISO/IEC 17021 accreditation ensures that certification bodies operate with the necessary independence from clients, eliminating conflicts of interest that could undermine the credibility of the audit.

5. For Maintaining Trust in the Certification Process:

In sectors where trust and integrity are essential, such as financial services, healthcare, or food safety, accreditation under ISO/IEC 17021 is crucial. It demonstrates that the certification body adheres to strict standards, ensuring the audit process is robust and reliable.
This is important when certifications are required to meet stakeholder expectations, such as customers, investors, or regulatory bodies.

6. For Consistency Across Multiple Certifications:

When certification bodies provide certifications for a variety of standards (e.g., ISO 9001, ISO 14001, ISO 45001), ISO/IEC 17021 accreditation ensures that they follow consistent auditing processes across different management system standards.
Accreditation ensures that the certification body has the systems in place to manage multiple certifications with consistency, regardless of the sector or industry.

7. When Required for Membership in International Accreditation Forums:

Certification bodies wishing to be part of recognized international accreditation forums, such as the International Accreditation Forum (IAF), must be accredited under ISO/IEC 17021. These forums promote the mutual recognition of certifications across different countries and regions.

Summary:

ISO/IEC 17021 accreditation is required for certification bodies conducting third-party audits in various situations:

When issuing formal management system certifications (like ISO 9001, ISO 14001).
When contractual, regulatory, or legal requirements specify that certifications must come from accredited bodies.
For certification bodies operating in international markets where global recognition is essential.
When impartiality, competence, and consistency in the audit process are critical, especially in high-risk or regulated industries.
When a certification body aims to ensure trust in its certifications and consistency across multiple standards.

Accreditation under ISO/IEC 17021 is vital for ensuring the credibility and global acceptance of management system certifications.

Where is required ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

ISO/IEC 17021 accreditation is required in various geographical regions, industries, and contexts where organizations rely on third-party auditing for management system certifications. The need for ISO/IEC 17021 accreditation is driven by regulatory requirements, contractual obligations, and international standards for certification bodies. Here’s where ISO/IEC 17021 accreditation is required:

1. Globally (International Markets)

International Trade: Companies operating in global markets often require certifications issued by certification bodies accredited under ISO/IEC 17021 to meet international standards. Accreditation ensures that their management system certifications (e.g., ISO 9001 for quality management, ISO 14001 for environmental management) are recognized and trusted across borders.
Multinational Organizations: Large multinational companies typically require ISO/IEC 17021-accredited certification for their facilities across various countries to ensure consistency and compliance with global standards.

2. In Countries with National Accreditation Bodies

National Regulations: In many countries, national accreditation bodies (such as UKAS in the UK, ANAB in the US, DAkkS in Germany, and JAB in Japan) require certification bodies to be accredited under ISO/IEC 17021 in order to operate. These accreditation bodies work under the guidelines of ISO/IEC 17011 and evaluate certification bodies to ensure compliance with international standards.
For example, in Europe, accreditation for third-party auditing is overseen by national accreditation bodies within the framework of EA (European Cooperation for Accreditation).

3. Specific Sectors or Industries:

ISO/IEC 17021 accreditation is essential in various industries where management system certifications are critical for compliance, safety, quality, and risk management:

Healthcare: Accreditation may be required for certification bodies offering audits related to ISO 13485 (Medical Devices Quality Management Systems) and ISO 9001 (Quality Management Systems) in healthcare organizations.
Food Safety: Certification bodies conducting audits for food safety management systems like ISO 22000 (Food Safety Management Systems) or HACCP certifications are often required to have ISO/IEC 17021 accreditation.
Environmental Management: In industries related to environmental conservation and energy management, certification bodies need ISO/IEC 17021 accreditation to conduct audits for standards like ISO 14001 (Environmental Management) and ISO 50001 (Energy Management).
Occupational Health and Safety: Certification bodies auditing for ISO 45001 (Occupational Health and Safety Management Systems) must often be accredited to ISO/IEC 17021 to ensure the validity and trustworthiness of their certifications.
Automotive, Aerospace, and Defense: In high-risk industries, such as automotive (IATF 16949), aerospace (AS9100), and defense sectors, ISO/IEC 17021 accreditation is often required for certification bodies conducting third-party audits.

4. Regulated Markets

Government Contracts: Many government contracts require suppliers to be certified by ISO/IEC 17021-accredited certification bodies. This ensures that the suppliers’ management systems meet recognized international standards for quality, safety, and efficiency.
Public Sector: In public sector procurement processes, organizations may be required to obtain certification from an ISO/IEC 17021-accredited body, especially for standards like ISO 9001 or ISO 27001 (Information Security Management Systems).

5. Organizations Seeking International Recognition

Organizations with Global Clients: Businesses seeking to serve global clients or operate in multiple regions often require certifications from ISO/IEC 17021-accredited bodies to demonstrate compliance with widely recognized standards.
Exporting Businesses: Exporters often need certifications from ISO/IEC 17021-accredited bodies to meet import regulations and market access requirements in other countries, ensuring that their management systems conform to global standards.

6. Industry-Specific Accreditation Schemes

International Accreditation Forum (IAF): Certification bodies that are part of the IAF Multilateral Recognition Arrangement (MLA) must be accredited to ISO/IEC 17021. The IAF MLA ensures that certifications issued by accredited bodies are accepted globally.
Sector-specific Schemes: Some industries have their own schemes that require certification bodies to be accredited to ISO/IEC 17021. For example:
- Automotive: Certification to IATF 16949 (automotive quality management) requires ISO/IEC 17021-accredited certification bodies.
- Information Security: Certification to ISO/IEC 27001 (information security management) is typically carried out by ISO/IEC 17021-accredited bodies.

7. Where Legal or Regulatory Requirements Exist

Regional Regulations: In some regions, certain management system certifications (such as those related to environmental or safety management) must be conducted by ISO/IEC 17021-accredited certification bodies to meet legal or regulatory requirements. For instance:
- Environmental Auditing: In regions with strict environmental regulations (like the EU or California), certification bodies conducting ISO 14001 audits must often be accredited under ISO/IEC 17021.
- Data Protection: In sectors with high data protection requirements (such as finance or healthcare), certification bodies conducting audits for ISO/IEC 27001 may need ISO/IEC 17021 accreditation to ensure compliance with privacy laws (such as GDPR).

Summary:

ISO/IEC 17021 accreditation is required in several contexts:

Globally: For certification bodies working in international markets to ensure their certifications are recognized and trusted worldwide.
Nationally: In countries where accreditation bodies oversee and regulate certification processes under ISO/IEC 17021.
Industry-Specific: In high-risk or regulated industries (e.g., healthcare, food safety, automotive, aerospace, environmental management), where certification bodies need accreditation to demonstrate competency and impartiality.
Public Sector and Government Contracts: Where certifications must come from accredited bodies to meet contractual or regulatory requirements.

In essence, ISO/IEC 17021 accreditation is required whenever certification bodies need to demonstrate their ability to conduct third-party audits that meet international standards, ensuring global recognition, trust, and regulatory compliance.

How is required ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

ISO/IEC 17021 accreditation for Third Party Auditing (TPA) requires a structured process that certification bodies must follow to demonstrate compliance with the standard’s requirements. The accreditation process is carried out by an accreditation body (such as UKAS, ANAB, or DAkkS), which evaluates the certification body against the ISO/IEC 17021 standard to ensure it can competently and impartially conduct management system audits.

Here is a step-by-step outline of how ISO/IEC 17021 accreditation is required for third-party auditing:

1. Understand ISO/IEC 17021 Requirements

Certification bodies must familiarize themselves with the ISO/IEC 17021-1: Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems. This includes understanding the principles of competence, impartiality, consistency, and confidentiality that underpin the auditing process.
ISO/IEC 17021 also includes specific requirements for the management of audit teams, the certification process, decision-making, and ongoing monitoring of certified clients.

2. Develop and Implement Management Systems

Certification bodies must establish internal management systems that comply with ISO/IEC 17021 standards. This includes:
- Documented Procedures: Certification bodies need to document procedures for conducting audits, managing audit teams, making certification decisions, and ensuring impartiality.
- Competence of Auditors: The certification body must ensure that its auditors have the required qualifications, training, and experience to audit management systems (e.g., ISO 9001, ISO 14001).
- Impartiality Safeguards: Certification bodies must demonstrate that they have processes in place to manage any conflicts of interest, ensuring that audits are independent and objective.
- Risk Management: They should also have risk management procedures to ensure the quality and reliability of their audit and certification services.

3. Prepare for Application

Eligibility: The certification body must confirm that it meets the eligibility requirements to apply for ISO/IEC 17021 accreditation with an appropriate accreditation body (such as UKAS, ANAB, or others).
Application Submission: Once the certification body is ready, it must submit an application for accreditation to the accreditation body. The application typically includes:
- Detailed documentation of internal management systems.
- Evidence of impartiality and auditor competence.
- Procedures for handling complaints and appeals related to the certification process.

4. Initial Assessment by the Accreditation Body

The accreditation body conducts an initial assessment of the certification body. This includes:
- Document Review: The accreditation body reviews the certification body’s documented processes to ensure they align with ISO/IEC 17021 requirements.
- On-Site Audit: The accreditation body performs an on-site assessment of the certification body’s operations to evaluate how they implement the standard in practice. This includes observing audits conducted by the certification body to verify their competence and impartiality.

5. Corrective Actions (if necessary)

After the assessment, the accreditation body provides feedback. If any non-conformities are identified, the certification body must take corrective actions. These may include:
- Modifying internal procedures.
- Providing additional training to auditors.
- Strengthening impartiality mechanisms.
The certification body must then submit evidence of corrective actions to the accreditation body for review.

6. Granting of Accreditation

Once the certification body has successfully demonstrated compliance with all the requirements of ISO/IEC 17021, the accreditation body will grant formal accreditation.
The certification body can now issue certifications for management systems (such as ISO 9001, ISO 14001, ISO 45001) under the scope of its accreditation, and these certifications will be internationally recognized.

7. Ongoing Surveillance and Reassessment

Accreditation is not a one-time process. Certification bodies are subject to ongoing surveillance by the accreditation body to ensure continued compliance. This includes:
- Regular audits by the accreditation body to verify that the certification body’s processes and performance remain in line with ISO/IEC 17021 standards.
- Periodic Reassessments: Full reassessments are conducted at regular intervals (often every few years) to maintain accreditation.
- Monitoring of Certified Clients: Certification bodies must also monitor their certified clients to ensure that certified management systems continue to meet the relevant standards.

8. Maintaining Competence and Impartiality

To maintain accreditation, certification bodies must:
- Continuously develop their auditors’ competence.
- Monitor and mitigate any potential conflicts of interest.
- Maintain impartiality in all auditing and certification activities.
- Ensure compliance with changes in standards, regulations, and accreditation requirements.

9. Expanding Scope of Accreditation (if necessary)

If a certification body wants to expand the scope of its accreditation (e.g., to include auditing for additional standards like ISO 27001 or ISO 50001), it must apply to the accreditation body for a scope extension. This will involve further assessments and possibly additional on-site audits.

Summary of Steps to Achieve and Maintain ISO/IEC 17021 Accreditation:

Understand and implement ISO/IEC 17021 requirements.
Develop internal management systems and processes for audits and certification.
Submit application for accreditation to an accreditation body.
Undergo an initial assessment, including document review and on-site audits.
Address corrective actions for any non-conformities.
Once compliant, the certification body is granted accreditation.
Engage in ongoing surveillance and periodic reassessment to maintain accreditation.
Maintain auditor competence, impartiality, and compliance with the standard.

In conclusion, ISO/IEC 17021 accreditation is a rigorous, structured process that requires certification bodies to demonstrate ongoing competence, impartiality, and consistency in conducting third-party audits for management systems.

Case study on ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

Case Study: Achieving ISO/IEC 17021 Accreditation for Third-Party Auditing

Background

ABC Certification Services is a medium-sized certification body operating in multiple regions, providing auditing and certification services for management systems such as ISO 9001 (Quality Management Systems), ISO 14001 (Environmental Management Systems), and ISO 45001 (Occupational Health and Safety Management Systems). Although ABC Certification had been providing these services for several years, its certifications were not globally recognized because it lacked ISO/IEC 17021 accreditation. In an increasingly competitive market, the company realized the need to gain accreditation to enhance its credibility, expand its market presence, and meet client demands for internationally recognized certifications.

Objective

The objective of this case study is to examine how ABC Certification achieved ISO/IEC 17021 accreditation to demonstrate its competence, impartiality, and consistency in conducting third-party audits and how this accreditation transformed its business.

Steps Taken to Achieve ISO/IEC 17021 Accreditation

1. Gap Analysis and Planning

ABC Certification’s first step was to conduct a gap analysis to assess its current systems against the requirements of ISO/IEC 17021:2015. The analysis identified several key areas that required improvement:

Documented Procedures: The company’s audit procedures needed to be formalized and aligned with ISO/IEC 17021 standards.
Impartiality Mechanisms: There was a lack of clear safeguards to ensure impartiality in the audit process.
Competence of Auditors: While ABC had experienced auditors, there was no formal process to assess and maintain auditor competence over time.
Consistency in Certification Decisions: The certification decision-making process was not clearly separated from the audit process, raising potential concerns about conflicts of interest.

A project team was formed to address these gaps, with a 12-month timeline to achieve accreditation.

2. Developing and Implementing a Conformity Assessment System

To meet the requirements of ISO/IEC 17021, ABC Certification implemented several changes:

Formalizing Procedures: ABC developed a comprehensive audit manual outlining the end-to-end process of third-party audits, from client onboarding to final certification. The procedures ensured transparency and traceability at every stage.
Ensuring Impartiality: A dedicated impartiality committee was established to oversee potential conflicts of interest. The committee included independent members who were not involved in daily operations, and it conducted regular reviews of audit assignments and certification decisions.
Competence Framework: ABC introduced a formal auditor qualification and training program. This framework included regular evaluations, continued professional development, and specific technical training aligned with the sectors they audited (e.g., manufacturing, healthcare, and IT services).
Separation of Audit and Certification Decisions: ABC Certification ensured that the personnel making final certification decisions were independent of the audit team to guarantee objectivity. Certification decisions were made by a separate department within the organization.

3. Submitting the Application for Accreditation

After the conformity assessment system was implemented, ABC Certification applied for ISO/IEC 17021 accreditation through the national accreditation body, UKAS (United Kingdom Accreditation Service). The application included detailed documentation of their audit procedures, impartiality mechanisms, and competence management systems.

4. Initial Assessment by the Accreditation Body

UKAS conducted an initial document review to ensure that ABC’s procedures aligned with ISO/IEC 17021 requirements. This was followed by an on-site assessment where UKAS auditors observed ABC Certification’s internal operations and witnessed an actual audit conducted by ABC.

During the assessment, UKAS noted the following:

Strengths: The impartiality committee was well-structured, and the competence framework for auditors was rigorous.
Non-Conformities: UKAS identified minor non-conformities, such as inconsistent documentation of client complaints and appeals.

5. Corrective Actions

ABC Certification quickly addressed the non-conformities by:

Updating their complaint and appeal logs to ensure they were consistently documented.
Introducing a more formalized review process for client feedback and incorporating it into regular audit performance reviews.

Once the corrective actions were implemented and verified by UKAS, ABC Certification was recommended for ISO/IEC 17021 accreditation.

Outcome of ISO/IEC 17021 Accreditation

1. Accreditation Achieved

After completing the initial assessment and corrective actions, ABC Certification successfully achieved ISO/IEC 17021 accreditation. This accreditation allowed ABC to offer internationally recognized certifications, increasing their credibility and marketability.

2. Expansion of Services and Client Base

Post-accreditation, ABC Certification expanded its services to offer certifications across additional standards, including ISO 27001 (Information Security Management Systems) and ISO 50001 (Energy Management Systems). Their accredited status enabled them to:

Enter new markets: ABC secured contracts with multinational companies that required certifications from accredited bodies.
Increase client trust: Clients, especially in regulated industries like healthcare and manufacturing, were more willing to partner with ABC due to the rigorous standards ensured by ISO/IEC 17021 accreditation.

3. Global Recognition

ABC became a member of the International Accreditation Forum (IAF), allowing their certifications to be recognized globally. This led to more international clients seeking certification from ABC, knowing that their certifications would be accepted in multiple regions without the need for re-certification.

4. Improved Internal Efficiency and Consistency

Accreditation helped ABC Certification streamline its internal processes, ensuring a consistent and repeatable audit process. The company reported:

Improved auditor performance: The competence framework and ongoing training programs resulted in more effective audits and fewer client disputes over audit outcomes.
Higher client satisfaction: ABC saw an increase in client satisfaction scores due to the more structured and transparent audit process, and fewer complaints or appeals were lodged after audits.

5. Enhanced Reputation and Competitive Advantage

Achieving ISO/IEC 17021 accreditation gave ABC Certification a competitive edge over non-accredited bodies. Many clients switched to ABC because of their accredited status, allowing the company to grow its revenue by 20% in the year following accreditation.

Conclusion

Achieving ISO/IEC 17021 accreditation was a transformative step for ABC Certification Services. The accreditation process helped the company improve internal processes, strengthen impartiality mechanisms, and enhance auditor competence. As a result, ABC was able to expand into new markets, increase client trust, and achieve global recognition for its certifications. This case study illustrates the importance of ISO/IEC 17021 accreditation for certification bodies aiming to provide credible and internationally recognized third-party audits.

Key Takeaways:

ISO/IEC 17021 accreditation is essential for certification bodies that want to provide credible and globally recognized third-party auditing services.
The process requires a strong focus on impartiality, competence, and consistency in auditing practices.
Accreditation can open up new business opportunities and enhance a certification body’s reputation and trustworthiness in the marketplace.

White paper on ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

White Paper: ISO/IEC 17021 Accreditation for Third-Party Auditing (TPA)

Executive Summary

ISO/IEC 17021 is the international standard that specifies requirements for bodies providing audit and certification of management systems. The accreditation ensures that third-party auditing organizations, also known as certification bodies, are competent, impartial, and consistent in their audit activities. Achieving this accreditation is critical for certification bodies aiming to issue globally recognized management system certifications (e.g., ISO 9001, ISO 14001, and ISO 45001). This white paper discusses the requirements, process, benefits, and challenges involved in obtaining ISO/IEC 17021 accreditation, and its significance for stakeholders including organizations, clients, and regulators.

Introduction

The demand for third-party audits has grown significantly in recent years as industries seek to align with globally recognized standards for quality, environmental, information security, and other management systems. To ensure trust and global acceptance, certification bodies must operate under international standards for competence, impartiality, and consistency. The ISO/IEC 17021 standard governs the processes and practices of certification bodies, ensuring that they meet the highest levels of integrity in certifying management systems.

This white paper provides an overview of ISO/IEC 17021, focusing on its role in enhancing the credibility of third-party auditing for management systems, the process for achieving accreditation, and the broader impact on organizations and global markets.

What is ISO/IEC 17021?

ISO/IEC 17021, titled “Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems”, is a framework that establishes guidelines for how certification bodies must operate to ensure fair, consistent, and competent auditing practices. The standard is broken down into several parts, each focusing on specific requirements for third-party auditing bodies.

Key Requirements of ISO/IEC 17021

Competence: Certification bodies must demonstrate that their auditors are skilled, trained, and competent in conducting audits for specific management systems (e.g., quality, environment, health, and safety).
Impartiality: The standard emphasizes the need for third-party auditors to remain free of conflicts of interest, ensuring an unbiased and objective assessment.
Consistency: Certification bodies must ensure uniformity in audit procedures and decision-making, providing consistent and repeatable results for all clients.
Confidentiality: The standard requires that certification bodies protect the confidentiality of information obtained during audits.
Independence: There must be clear separation between auditing and decision-making processes to prevent conflicts of interest.

Why is ISO/IEC 17021 Accreditation Important?

The value of third-party certification lies in the credibility and trust that certified organizations can achieve, which is crucial for entering international markets, securing contracts, and meeting regulatory compliance. ISO/IEC 17021 accreditation ensures that certification bodies can provide this value by offering credible, impartial certifications that are globally recognized. Without accreditation, certifications may lack international acceptance, limiting their usefulness to certified organizations.

Global Recognition and Trust

ISO/IEC 17021-accredited certifications are globally recognized, thanks to agreements like the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA). Certification bodies accredited under ISO/IEC 17021 can issue certifications that are accepted worldwide, reducing the need for re-certification across different markets.

Enhanced Credibility and Market Access

Accredited certification bodies are trusted by clients and regulators alike. For organizations seeking management system certifications, working with an ISO/IEC 17021-accredited certification body guarantees that their certification will be respected in global markets and among regulatory authorities.

Quality Assurance and Regulatory Compliance

In sectors like healthcare, food safety, and environmental management, regulatory bodies often require certification to standards like ISO 9001, ISO 13485, or ISO 14001. Accredited certification ensures that these standards are met, enhancing compliance with legal and regulatory requirements.

The Accreditation Process for Certification Bodies

Achieving ISO/IEC 17021 accreditation requires certification bodies to undergo a rigorous evaluation process by an accreditation body, such as UKAS (United Kingdom Accreditation Service), ANAB (ANSI National Accreditation Board), or JAB (Japan Accreditation Board). This process is designed to ensure that certification bodies are capable of conducting management system audits competently and impartially.

Step-by-Step Process

Preparation and Gap Analysis: The certification body conducts an internal gap analysis to assess its current operations against the requirements of ISO/IEC 17021. This step helps identify areas that need improvement before applying for accreditation.
Development of Internal Management Systems: Certification bodies must develop and document policies and procedures to ensure compliance with the standard. This includes formalizing audit procedures, creating competence management programs for auditors, and establishing impartiality committees.
Application to the Accreditation Body: Once internal systems are in place, the certification body submits an application to an accreditation body. The application includes documented procedures, records of audits, and evidence of auditor competence.
Initial Assessment by the Accreditation Body: The accreditation body conducts a thorough review of the certification body’s documentation, followed by an on-site assessment. During the on-site audit, the accreditation body observes actual audits conducted by the certification body to verify compliance with ISO/IEC 17021.
Corrective Actions: If non-conformities are identified during the assessment, the certification body must take corrective actions. The accreditation body will verify the effectiveness of these actions before accreditation is granted.
Ongoing Surveillance and Reassessment: Even after accreditation is granted, certification bodies must undergo periodic surveillance audits to ensure ongoing compliance with ISO/IEC 17021. Full reassessments are also conducted at regular intervals (typically every three to five years).

Challenges in Achieving and Maintaining ISO/IEC 17021 Accreditation

1. Managing Impartiality

Certification bodies often face challenges in ensuring complete impartiality. For instance, organizations that also provide consulting services may face conflicts of interest if they are auditing systems they helped to develop. Managing these conflicts effectively requires strong governance structures, such as an independent impartiality committee.

2. Ensuring Auditor Competence

Maintaining a pool of qualified auditors across multiple management systems can be resource-intensive. Certification bodies must invest in continuous training and professional development to ensure that their auditors remain competent and up to date with the latest standards and auditing techniques.

3. Maintaining Consistency

As certification bodies expand their operations, maintaining consistency in auditing practices across different regions and sectors can be challenging. Ensuring that all auditors follow uniform procedures and make consistent certification decisions is critical to maintaining the credibility of accredited certifications.

4. Regulatory Compliance

Certification bodies operating in regulated industries may need to comply with additional sector-specific regulations. For example, certification bodies auditing food safety systems (ISO 22000) may need to comply with local food safety regulations, adding complexity to the accreditation process.

Benefits of ISO/IEC 17021 Accreditation for Stakeholders

For Certification Bodies

Competitive Advantage: Certification bodies with ISO/IEC 17021 accreditation can offer certifications that are globally recognized, giving them an edge over non-accredited competitors.
Improved Processes: The requirements of ISO/IEC 17021 drive certification bodies to adopt more rigorous and structured internal processes, improving the quality of their audit services.
Global Market Access: Accreditation opens doors to international markets, as certifications issued by accredited bodies are accepted globally under the IAF MLA.

For Organizations Seeking Certification

International Acceptance: Organizations that receive certification from ISO/IEC 17021-accredited bodies can operate confidently across international markets, knowing that their certification will be accepted globally.
Increased Trust: Working with accredited certification bodies enhances the credibility of the organization’s management system, increasing customer and stakeholder trust.
Regulatory Compliance: Organizations in regulated sectors benefit from knowing that their certifications are backed by impartial and competent audits, helping them meet legal and regulatory requirements.

For Regulators and Government Agencies

Confidence in Compliance: Accreditation ensures that certification bodies are competent and impartial, providing regulators with confidence that organizations have met the required standards.
Reducing Duplicative Audits: Globally recognized certifications reduce the need for multiple audits, streamlining regulatory oversight and reducing the burden on businesses.

Conclusion

ISO/IEC 17021 accreditation plays a critical role in maintaining the integrity and trustworthiness of management system certifications. For certification bodies, achieving accreditation is essential to providing credible, consistent, and internationally recognized audit services. The accreditation process is rigorous, but the benefits of enhanced credibility, global recognition, and market access far outweigh the challenges. For organizations seeking certification, working with ISO/IEC 17021-accredited bodies ensures that their management systems meet global standards, positioning them for success in a competitive international marketplace.

References:

ISO/IEC 17021-1:2015, “Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements.”
International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA).
United Kingdom Accreditation Service (UKAS). “Guide to Accreditation and Certification.”

Industrial application of ISO/IEC 17021 Accreditation For Third Party Auditing (TPA)

Industrial Application of ISO/IEC 17021 Accreditation for Third-Party Auditing (TPA)

ISO/IEC 17021 accreditation is crucial for organizations in various industries that require third-party auditing and certification of their management systems. The standard ensures that certification bodies operate in accordance with international best practices, providing reliable and impartial audits. This document outlines the industrial applications of ISO/IEC 17021 accreditation, highlighting its significance across different sectors.

1. Manufacturing Industry

Application:

Quality Management Systems (QMS): Many manufacturing companies seek certification to ISO 9001 to improve product quality and customer satisfaction. ISO/IEC 17021 accreditation ensures that the certification bodies auditing these systems are competent and impartial.

Benefits:

Enhanced Operational Efficiency: Accredited certification bodies conduct rigorous audits that help identify inefficiencies and areas for improvement in manufacturing processes.
Market Access: Manufacturers with ISO 9001 certification from accredited bodies can demonstrate compliance with international quality standards, facilitating access to global markets.

2. Automotive Industry

Application:

IATF 16949 Certification: This standard specifies the requirements for a quality management system in the automotive sector. Third-party auditors play a critical role in evaluating compliance with IATF 16949.

Benefits:

Supplier Qualification: Automotive manufacturers often require their suppliers to be certified by accredited bodies to ensure that components meet industry standards, thereby reducing risks in the supply chain.
Continuous Improvement: Accredited auditors provide valuable insights into best practices, fostering a culture of continuous improvement in automotive production.

3. Aerospace Industry

Application:

AS9100 Certification: The aerospace sector is governed by stringent safety and quality standards. ISO/IEC 17021 accreditation is vital for certification bodies assessing compliance with AS9100.

Benefits:

Regulatory Compliance: Accredited certification ensures that aerospace companies meet safety and quality regulations, which is crucial for maintaining certifications required by aviation authorities.
Enhanced Safety: Regular audits by accredited bodies help identify potential safety hazards, promoting safer manufacturing practices.

4. Information Technology (IT) Sector

Application:

ISO/IEC 27001 Certification: This standard focuses on information security management systems (ISMS). Certification bodies accredited under ISO/IEC 17021 evaluate compliance with security controls and practices.

Benefits:

Risk Management: Accredited auditors assess the effectiveness of information security measures, helping organizations mitigate risks associated with data breaches and cyber threats.
Client Confidence: Companies certified under ISO/IEC 27001 can demonstrate their commitment to information security, enhancing trust among clients and stakeholders.

5. Healthcare Sector

Application:

ISO 13485 Certification: This standard is essential for organizations involved in the design and manufacture of medical devices. Certification bodies must be accredited to ensure compliance with regulatory requirements.

Benefits:

Patient Safety: Accredited audits help healthcare organizations improve their processes, leading to higher-quality medical devices and increased patient safety.
Regulatory Approval: Accreditation provides a pathway to regulatory approvals, facilitating market entry for new medical devices.

6. Environmental Management

Application:

ISO 14001 Certification: Organizations seek ISO 14001 certification to demonstrate their commitment to environmental management. ISO/IEC 17021 accreditation ensures that certification bodies can effectively evaluate compliance.

Benefits:

Sustainable Practices: Accredited audits promote the adoption of sustainable practices, helping organizations minimize their environmental impact.
Stakeholder Trust: Certification from accredited bodies enhances credibility among stakeholders, including customers, investors, and regulatory authorities.

7. Food Safety Industry

Application:

ISO 22000 Certification: This standard specifies requirements for food safety management systems. Third-party certification ensures compliance with food safety regulations and best practices.

Benefits:

Consumer Confidence: Certification from accredited bodies helps food manufacturers assure consumers of the safety and quality of their products.
Regulatory Compliance: Accredited auditors ensure that food safety management systems comply with local and international food safety regulations.

Conclusion

ISO/IEC 17021 accreditation is essential for third-party auditing across various industries. It enhances the credibility and reliability of certification bodies, ensuring that organizations meet international standards for quality, safety, and environmental management. By obtaining ISO/IEC 17021 accreditation, certification bodies can significantly contribute to the continuous improvement and competitiveness of industries globally, promoting trust and transparency in management system certifications.