FAQs
Frequently Asked Questions
Find quick answers to common questions
ISO Certification signifies that a company's management system, process, service, or documentation procedure has all the requirements for standardization and quality assurance as published by the International Organization for Standardization (ISO). The most common standard is ISO 9001:2015 (Quality Management System).
An ISO audit is a systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. It is how certification bodies verify that an organization meets the requirements of a specific ISO standard.
Standardization brings numerous benefits, including increased efficiency and productivity, improved customer satisfaction, enhanced credibility and reputation, better internal management and control, and easier compliance with regulatory requirements.
ISO 9001:2015 is the international standard for Quality Management Systems (QMS). It is the most popular standard and provides a framework for organizations to manage their business processes to ensure customer satisfaction and consistent quality.
ISO 13485 is the international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in one or more stages of the life cycle of a medical device. It is essential for compliance in the medical device industry and focuses heavily on risk management, regulatory requirements, and traceability.
Certification is the process where a third-party body (like ACCREDIX) audits an organization and issues a certificate confirming its compliance with a specific ISO standard (e.g., ISO 9001). Accreditation is the process where a higher authority (an Accreditation Body like UKAS, ANAB, or NABCB) assesses the competence and impartiality of the Certification Body (ACCREDIX). In short: Organizations get Certified; Certification Bodies get Accredited.
Yes, they are different. Accreditation is a formal recognition that a Certification Body (like ACCREDIX) is competent to perform certification tasks. It ensures the trustworthiness of the certifications issued. Certification is for the organization; Accreditation is for the Certifier.
IAF stands for the International Accreditation Forum. It is a worldwide association of accreditation bodies and other bodies interested in conformity assessment in fields like management systems. Its primary role is to ensure that accredited certificates are accepted globally through multilateral recognition arrangements.
Accreditation Bodies (e.g., UKAS, ANAB, NABCB, etc.) operate under IAF guidelines. While the ISO standard is the same, they differ based on the country or region they represent and the specific accreditations they grant to Certification Bodies. Choosing an accredited Certification Body ensures your certificate holds international recognition due to the IAF framework.
The general process involves these steps: 1. Preparation (Developing and documenting your management system), 2. Implementation (Putting the system into practice), 3. Internal Audit, 4. Management Review, 5. Certification Audit (Stage 1 and Stage 2 audit by a Certification Body like ACCREDIX), and 6. Certification Issuance.
The time varies greatly depending on the standard, the size of your organization, and the current maturity of your processes. Typically, it takes 3 to 12 months from the start of implementation to the final certificate. ACCREDIX can help streamline the audit portion of this timeline.
After the final (Stage 2) audit, the final certificate is typically issued within 2 to 6 weeks, provided all non-conformities (if any) have been closed and verified by the audit team.
The cost is not fixed. It is determined by factors such as: 1. Standard scope (e.g., ISO 9001 vs. multiple standards), 2. Company size (number of employees), 3. Complexity of processes, and 4. Number of sites. We provide a customized quote based on an initial scope assessment.
ISO certificates are typically valid for three years. During this three-year cycle, the Certification Body will conduct annual Surveillance Audits to ensure continued compliance.
Maintenance is an ongoing process integrated into your daily operations. The time dedicated varies but includes annual activities like Internal Audits, Management Reviews, and closing non-conformities from surveillance audits.
Key maintenance activities include: 1. Performing annual Internal Audits, 2. Conducting an annual Management Review, 3. Monitoring and measuring performance, 4. Continually improving the system, and 5. Passing the annual Surveillance Audits.
While one person often acts as the Management Representative or system coordinator, the standard requires that the entire organization is responsible for the management system's effectiveness. The commitment must come from top management, and responsibilities should be distributed across relevant functions.
A remote audit is an audit conducted off-site using technology (e.g., video conferencing, screen sharing, secure document transfer) to review documentation, interview personnel, and observe processes. You can expect the same rigorous review as an on-site audit, with a focus on preparation, clear communication, and ensuring all necessary documents and personnel are accessible via the chosen technology.