Philip F. Scott
September 11, 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.
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful ISMS.
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.
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Company-wide training program for employees and senior management to comply with Article 20 of the NIS 2 cybersecurity directive.
Compliance and training products for personal data protection according to the European Union’s General Data Protection Regulation.
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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, training, and knowledge products for Environmental Management Systems (EMS) according to the ISO 14001 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.
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.
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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), and NIS 2 (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.
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).
Accredited courses for individuals and professionals who want the highest-quality training and certification.
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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).
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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.
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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 (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 ISO 27001 (cybersecurity), ISO 22301 (business continuity), GDPR (privacy), and NIS 2 (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, 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 (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), and GDPR (privacy).
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), and GDPR (privacy).
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).
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).
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) and ISO 9001 (quality).
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.
The AS9100 Quality Management System (QMS) standard anticipated that organizations would make customer satisfaction and continual improvement cornerstones of their business strategy. Elements of the standard implicitly supported this. However, some organizations achieved certification without integrating the QMS into the business, and it had no measurably positive impact on the quality of their products or services.
Well, industry has taken action. The release of AS9100 Rev D clearly insists that organizations implement a QMS woven into the fabric of their business systems. This article describes a few of the most visible requirements that make this apparent.
One of the principles of change management is that for an idea to move from the abstract to everyday practice, top management commitment must be open and active. The late Philip Crosby, a well-known quality guru, developed 14 steps of quality improvement. The first of these is management commitment. Likewise, the AS9100 standard begins with the following requirements of an organization’s top management:
1) Section 4 Context of the Organization – This new term in the lexicon of the QMS consists of the four clauses listed below. A summary of the wording from AS9100 that integrates the QMS with the business systems is in bold.
Clause | Summary |
4.1 Understanding the Organization and Its Context | Determine the issues relevant to the organization’s purpose and strategic direction and affecting its ability to achieve the intended results of the QMS. |
4.2 Understanding the Needs and Expectations of Interested Parties | Determine the effect the interests of other parties (e.g., customers, regulatory agencies, employees, stockholders, competitors) may have on the organization’s ability to meet customer, statutory, and regulatory requirements. |
4.3 Determining the Scope of the Quality Management System | Determine the boundaries of the QMS that apply to external and internal issues in 4.1 above. |
4.4 Quality Management System and Its Processes | Determine the processes and interactions required to adequately address customer, statutory, and regulatory requirements. |
Table 1 – Context of the Organization
Clause | Summary |
5.1 Leadership and Commitment | Sub-clause 5.1.1b requires the organization to ensure that the quality policy and objectives are compatible with the context and strategic direction of the organization. Note this a responsibility of organizational leadership. |
Sub-clause 5.1.2 Customer Focus once again emphasizes top management’s responsibility to ensure that customer, statutory, and regulatory requirements are determined, understood, and consistently met. |
Table 2 – Leadership
3) Section 6 Planning – Clause 6.1 Actions to Address Risks and Opportunities, sub-clause 6.1.1, requires organizations to again look back at the issues referenced in clauses 4.1 and 4.2 (see Table 1 above) when identifying the risks and opportunities that need to be addressed. Through careful analysis and planning by top management, it’s clear that implementation of the QMS must be tied to and partnered with the strategic business goals and plans, and take into account the risks to those goals and opportunities. Although not within the scope of this article, the requirements of that planning and ongoing analysis, as illustrated in the Plan-Do-Check-Act (PDCA) cycle, are detailed in other sections of AS9100D.
One might ask: “How do I make this happen?” The answer begins with a crucial change in focus.
The change is from “Our organization seeks to achieve certification because our customers require it,” to “Our organization chooses to implement a certified QMS to provide a framework on which we can profitably build customer satisfaction and continual improvement.”
One way to integrate quality management into business processes is for top management to evaluate the organization’s Strengths, Weaknesses, Opportunities, and Threats (S.W.O.T.) in light of its strategic goals. From this point, organizational leadership can then craft a quality policy and objectives that are unmistakably tied to the S.W.O.T. analysis.
Metrics such as on-time delivery, warranty repairs/replacements, and market share help management understand whether the S.W.O.T. analysis and risk management are on the right track.
It occurred to me a few years ago that an organization that chooses to implement an AS9100-compliant management system, and then chooses not to integrate that management system with its business system, is analogous to deciding to make a cup of tea without putting the teabag in the hot water.
The hard work to implement the QMS is undermined by top management’s hollow-sounding words of commitment amid the flurry to get ready for an impending audit. The QMS “teabag” sits alongside the business system “cup of hot water.” As the water cools, the opportunity to make a cup of hot tea slips away. Likewise, what may have started as an energetic commitment to improve business on the foundation of an effective Quality Management System rapidly becomes a distant memory.
It takes hard work and genuine commitment, but put the teabag in the hot water, allow the two to become one, and the integration will be far more rewarding and forever indivisible.
Use this free Clause-by-clause explanation of AS9100 Rev D to more easily integrate an AS9100-based QMS with existing business activities.
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