Mark Hammar
April 24, 2019
Implementation, maintenance, training, and knowledge products for Information Security Management Systems (ISMS) according to the ISO 27001 standard.
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Implementation, training, and knowledge products for Quality Management Systems (QMS) according to the ISO 9001 standard.
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Implementation and training products for Occupational Health & Safety Management Systems (OHSMS) according to the ISO 45001 standard.
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Implementation and training products for medical device Quality Management Systems (QMS) according to the ISO 13485 standard.
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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.
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Implementation products for Business Continuity Management Systems (BCMS) according to the ISO 22301 standard.
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Implementation products for testing and calibration laboratories according to the ISO 17025 standard.
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Implementation products for automotive Quality Management Systems (QMS) according to the IATF 16949 standard.
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Implementation products for aerospace Quality Management Systems (QMS) according to the AS9100 standard.
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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), and NIS 2 (critical infrastructure cybersecurity).
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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).
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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).
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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.
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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 ISO 27001 (cybersecurity), ISO 22301 (business continuity), 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.
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Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
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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.
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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.
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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.
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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.
Implementing an aerospace quality management system (QMS) using the requirements of AS9100 Rev D will help you to create a world-recognized management system that focuses on improvement and customer satisfaction. While the standard includes the requirements of what is needed for a company to successfully achieve the aims of customer satisfaction and improvement, these requirements do not identify how to perform specific tasks. As such, companies may have additional requirements from customers that need to be incorporated into their process instructions, and one such requirement is the use of PEAR forms.
PEAR is an acronym that is used to help remember human factors that need to be assessed and mitigated as part of aircraft maintenance. The letters stand for People who do the job, Environment the work is done in, Actions that need to be performed, and Resources needed to do the job. This is particularly important for developing aviation maintenance activities. These factors can be assessed on a form that becomes part of the design process for the maintenance activities.
When defining the activities that need to happen for aviation maintenance, the physical, physiological, psychological and psychosocial factors of the people involved need to be assessed and any risks mitigated. Additionally, the physical and organizational factors of the environment as well as the actions to be performed and the resources to be used must also be considered for risk. By doing so, the maintenance activities can be defined in such a way that the human factor risks associated with the activities do not cause the maintenance to be unsafe or hazardous to the aircraft products being maintained.
It is important to note that AS9100 Rev D is used throughout the aerospace industry, and not just for aviation. The standard is used to create a QMS for aviation, space and defense organizations, and as such it does not include customer-explicit requirements for specific industries within the aerospace community. As such, AS9100 Rev D does not use the acronym PEAR within the requirements.
For more information on how human factors relate to the AS9100 Rev D standard, see the article: 12 most important human factors to consider according to AS9100 Rev D.
While the AS9100 Rev D standard does not use the acronym PEAR, it does talk about human factors and human error. So, while not a requirement, the PEAR philosophy can be used as a way of thinking of human factors where it is required in the standard. This concept of assessing human factors appears in three clauses of AS9100 Rev D:
Clause 7.1.4, Environment for the operation of processes. Here the standard highlights that a suitable environment can be a combination of human and physical factors. So, when you are defining the environment in which your employees perform their processes, how do you mitigate against the risks posed by the people involved so that mistakes are not made? Can you simplify the actions required or the resources needed to make the job easier and reduce risks? Are there physical or organizational factors that affect the ability of employees to do the job correctly and if so, what can you do about these factors?
Clause 8.5.1f, Production and service provision. AS9100 Rev D mentions that one controlled condition that should be included are actions to prevent human error. When you are specifically defining the processes for creation of your products and services, how do you assess the risks of people, environment, actions and resources so that you can mitigate against damage to the products and services?
Clause 10.2.1b, Nonconformities and corrective action. The requirements include the human element when determining the causes of process nonconformities during investigation and corrective action. Even if you planned well, sometimes problems happen and process nonconformities require you to understand the root cause of the problem. If the problem has stemmed from a human error, then re-assessing the process using the PEAR model could be a good way to make sure you look at all the different ways that risk could have entered your process. If you need help with defining non-conformities and corrective actions, these templates can be helpful: Non-Conformity Record and Corrective Action Record.
As with many processes in the AS9100 QMS, it is important to ensure that you not only incorporate the requirements of the standard and customers, but also requirements that make the process work best for your company. If the PEAR model is a helpful way for your employees to assess the human factors that could affect your ability to provide products and service, use it even if there is no hard requirement for the model or PEAR forms.
To learn more about AS9100 clauses that describe human factors download this free whitepaper: Clause-by-clause explanation of AS9100 Rev D.
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