
September 6, 2017
Implementation, maintenance, training, and knowledge products for Information Security Management Systems (ISMS) according to the ISO 27001 standard.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
All required policies, procedures, and forms to implement an ISMS according to ISO 27001.
Train your key people about ISO 27001 requirements and provide cybersecurity awareness training to all of your employees.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
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Compliance and training products for critical infrastructure organizations for the European Union’s Network and Information Systems cybersecurity directive.
All required policies, procedures, and forms to comply with the NIS 2 cybersecurity directive.
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Compliance and training products for financial entities for the European Union’s DORA regulation.
All required policies, procedures, and forms to comply with the DORA regulation.
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Compliance and training products for personal data protection according to the European Union’s General Data Protection Regulation.
All required policies, procedures, and forms to comply with the EU GDPR privacy regulation.
Accredited courses for individuals and privacy professionals who want the highest-quality training and certification.
Implementation, training, and knowledge products for Quality Management Systems (QMS) according to the ISO 9001 standard.
All required policies, procedures, and forms to implement a QMS according to ISO 9001.
Accredited courses for individuals and quality professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 and the QMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for Environmental Management Systems (EMS) according to the ISO 14001 standard.
All required policies, procedures, and forms to implement an EMS according to ISO 14001.
Accredited courses for individuals and environmental professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 14001 and the EMS using Advisera’s proprietary AI-powered knowledge base.
Implementation and training products for Occupational Health & Safety Management Systems (OHSMS) according to the ISO 45001 standard.
All required policies, procedures, and forms to implement an OHSMS according to ISO 45001.
Accredited courses for individuals and health & safety professionals who want the highest-quality training and certification.
Implementation and training products for medical device Quality Management Systems (QMS) according to the ISO 13485 standard.
All required policies, procedures, and forms to implement a medical device QMS according to ISO 13485.
Accredited courses for individuals and medical device professionals who want the highest-quality training and certification.
Compliance products for the European Union’s Medical Device Regulation.
All required policies, procedures, and forms to comply with the EU MDR.
Implementation products for Information Technology Service Management Systems (ITSMS) according to the ISO 20000 standard.
All required policies, procedures, and forms to implement an ITSMS according to ISO 20000.
Implementation products for Business Continuity Management Systems (BCMS) according to the ISO 22301 standard.
All required policies, procedures, and forms to implement a BCMS according to ISO 22301.
Implementation products for testing and calibration laboratories according to the ISO 17025 standard.
All required policies, procedures, and forms to implement ISO 17025 in a laboratory.
Implementation products for automotive Quality Management Systems (QMS) according to the IATF 16949 standard.
All required policies, procedures, and forms to implement an automotive QMS according to IATF 16949.
Implementation products for aerospace Quality Management Systems (QMS) according to the AS9100 standard.
All required policies, procedures, and forms to implement an aerospace QMS according to AS9100.
Implementation, maintenance, training, and knowledge products for consultancies.
Handle multiple ISO 27001 projects by automating repetitive tasks during ISMS implementation.
All required policies, procedures, and forms to implement various standards and regulations for your clients.
Organize company-wide cybersecurity awareness program for your client’s employees and support a successful cybersecurity program.
Accredited ISO 27001, 9001, 14001, 45001, and 13485 courses for professionals who want the highest-quality training and recognized certification.
Get instant answers to any questions related to ISO 27001 (ISMS), ISO 9001 (QMS), and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Find new clients, potential partners, and collaborators and meet a community of like-minded professionals locally and globally.
Implementation, maintenance, training, and knowledge products for the IT industry.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
Documentation to comply with ISO 27001 (cybersecurity), ISO 22301 (business continuity), ISO 20000 (IT service management), GDPR (privacy), NIS 2 (critical infrastructure cybersecurity), and DORA (cybersecurity for financial sector).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Compliance, training, and knowledge products for essential and important organizations.
Documentation to comply with NIS 2 (cybersecurity), GDPR (privacy), ISO 27001 (cybersecurity), and ISO 22301 (business continuity).
Company-wide training program for employees and senior management to comply with Article 20 of the NIS 2 cybersecurity directive.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for manufacturing companies.
Documentation to comply with ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for transportation & distribution companies.
Documentation to comply with ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for schools, universities, and other educational organizations.
Documentation to comply with ISO 27001 (cybersecurity), ISO 9001 (quality), and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS) and ISO 9001 (QMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, maintenance, training, and knowledge products for telecoms.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
Documentation to comply with ISO 27001 (cybersecurity), ISO 22301 (business continuity), ISO 20000 (IT service management), GDPR (privacy), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, maintenance, training, and knowledge products for banks, insurance companies, and other financial organizations.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
Documentation to comply with DORA (cybersecurity for financial sector), ISO 27001 (cybersecurity), ISO 22301 (business continuity), and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for local, regional, and national government entities.
Documentation to comply with ISO 27001 (cybersecurity), ISO 9001 (quality), GDPR (privacy), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS) and ISO 9001 (QMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for hospitals and other health organizations.
Documentation to comply with ISO 27001 (cybersecurity), ISO 9001 (quality), ISO 14001 (environmental), ISO 45001 (health & safety), NIS 2 (critical infrastructure cybersecurity) and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS), ISO 9001 (QMS), and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for the medical device industry.
Documentation to comply with MDR and ISO 13485 (medical device), ISO 27001 (cybersecurity), ISO 9001 (quality), ISO 14001 (environmental), ISO 45001 (health & safety), NIS 2 (critical infrastructure cybersecurity) and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS), ISO 9001 (QMS), and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for the aerospace industry.
Documentation to comply with AS9100 (aerospace), ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for the automotive industry.
Documentation to comply with IATF 16949 (automotive), ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for laboratories.
Documentation to comply with ISO 17025 (testing and calibration laboratories), ISO 9001 (quality), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and quality professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 and the QMS using Advisera’s proprietary AI-powered knowledge base.
Every year we hear news about some big recall in the automotive industry. The main purpose of FMEA (Failure Mode and Effect Analysis) is to help us foresee those failures and take actions to prevent them, although it is not always possible. Results of FMEA provide valuable inputs for many requirements of IATF 16949. How some requirements of the standard will be implemented depends directly on the FMEA results, from product safety, to design and development, to production, to monitoring and measuring, and improvement. FMEA has proven itself very useful in implementation and maintenance of the QMS (Quality Management System) based on IATF 16949, so special attention should be given to adopting and applying it in your QMS.
FMEA was one of the first highly structured, systematic methodologies for analysis of failures that occur in design and production processes, and it is one of the core tools in IATF 16949. (For more information, see: What are the five core tools of IATF 16949?) It is also called potential failure mode effect analysis, or failure modes or effect and criticality analysis (FMECA). During the 1950s, reliability engineers developed the methodology to analyze problems in military systems in the U.S., and then it spread to the automotive and aerospace industries. In later years, it also become popular in other industries, such as the medical device industry.
FMEA is a step-by-step approach to identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure mode” represents ways or modes that some element of the system can fail. Failures can be any kind of defects or errors, particularly ones that affect the customer, and can be potential or actual. “Effect analysis” means studying or analyzing the consequence of the failure.
There are different types of FMEA analysis, with the most common being:
There are several cases when it makes sense to perform a Failure Mode and Effects Analysis:
Furthermore, it can be beneficial to conduct FMEA from time to time throughout the lifetime of the process. Performing it regularly will ensure quality and reliability, as well as improvement for optimal results.
FMEA is performed through the following steps, with key activities at each step. The steps are separated to ensure that only the relevant team members for each step are present, in order to avoid wasting human resources during the analysis. Keep in mind that this is a general procedure. Specific details may vary according to the standards of your organization or industry.
The first step in the application of FMEA is to identify all potential failure modes of various parts of the system. In order to perform this step correctly, you need information about the elements of the system in sufficient detail for meaningful analysis. Information may include drawings or flowcharts of the system being analyzed and its components, or the steps of a process. Historical information on failures can be very useful if available. While identifying all failure modes, you should also determine the level of detection, or how easy it is to detect the failure; for example, leakage of the underground tank can be very hard to detect.
The next step is to determine the severity of consequences caused by the failure mode. This step requires full understanding of the system or process being analyzed, or engagement of people with sufficient knowledge about it. The effect of the failure mode should be expressed though the severity level.
The third step is to determine the cause of each failure mode. For each component or activity identified, you need to determine how each part could conceivably fail, and what mechanisms might produce these modes of failure. Just like in determining the cause of a nonconformity, you need to discover the root cause of each failure mode. Depending on the probability of this root cause occurring, you need to define the occurrence level.
Once you have identified failure modes, their severity, and occurrence levels, you can multiply them and discover the risk priority number, or RPN. The risk priority number is a semi-quantitative measure used most often in quality assurance applications. Depending on the scale for acceptance of risk levels, your risk will be either acceptable or unacceptable. All unacceptable risks must be mitigated and decreased to acceptable levels. Mitigation is usually conducted through corrective actions. At the end of the analysis, you will create a documented report that contains details of the system that was analyzed, the way the analysis was carried out, assumptions made during the analysis, sources of data, and the results, including the completed worksheets.
Once the actions are carried out, there should be follow-up to ensure that the actions were effective, which can be done by reassessing the whole system with FMEA.
Figure: Workflow for FMEA
FMEA is widely applicable to human, equipment, and system failure modes, as well as hardware, software, and procedures. It can help you to avoid the need for costly equipment modification by identifying problems during the design phase, identifying single point of failure modes and requirements for redundancy or safety systems, and providing input to the development monitoring programs by highlighting key features to be monitored.
The problem is, it can only be used to identify single failure modes, not combinations of failure modes. Unless adequately controlled and focused, the studies can be time-consuming and costly. It can also be tedious for complex, multi-layered systems.
To implement IATF 16949 easily and efficiently, use our IATF 16949 Documentation Toolkit that provides step-by-step guidance and all documents for full IATF 16949 compliance.
Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.
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