What’s got us talking

Story
SouthWestSensor ISO 9001 and ISO 14001 for tech start-up
Story
Elgin Energy UK solar energy developer and asset manager
Story
Eseye ISO 27001: 2022 Transition for IoT Services Provider

Make an enquiry

To find out more about how Qfactorial can help your business, please get in touch using the enquiry form below or, if you prefer, call us on +44 (0)1256 814111 or email kevin@qfactorial.co.uk to speak to our principal consultant.

AS9100 Consultancy

 AS9100 Quality Management Systems – for Aviation, Space and Defence Organisations

AS9100 is a quality management standard which is widely adopted by the aerospace, space and defence industry worldwide. It’s latest issue – revision D – was released in 2016 and is based around ISO 9001: 2015. It adds industry-specific quality management requirements applicable throughout the aerospace supply chain for organisations that design, develop or provide products or services. AS9100 was prepared by the International Aerospace Quality Group (IAQG) and is recognised throughout the industry in challenging and highly regulated sectors.

In addition to the general aerospace standard AS9100 the IAQG created AS9120 specifically for the quality management of stockist distributors.

We can help you to establish, implement and improve an effective quality management system compliant with AS9100. Many aerospace manufacturers and supply chain members will only work with partners who hold certification. Whether you are establishing an AS9100 compliant system for the first time, or you just want to make your existing system work more effectively, we can help you through the complete process.

Answering your FAQ on AS9100:

This aerospace standard was released at revision D in 2016 and aligns the specific quality management requirements for the aerospace, space and defence sectors to the latest structure of ISO9001: 2015. AS9100 was first adopted in 1999 and built on input and requirements of major commercial aerospace companies and other customers including NASA. Rather than each customer organisation having their own supplementary requirements built around ISO 9001 as was previously the case, AS9100 was implemented in recognition of the globalisation of the industry and the need for standardisation, and has further developed to incorporate key requirements in the industry and best practices.

While aligning with the requirements of ISO 9001: 2015 AS9100D incorporates further specific requirements such as those for Risk Management with particular emphasis for operational processes, Product Safety during the entire life cycle, and for Counterfeit Parts Prevention. The standard also incorporates areas such as consideration of human factors and the identification of root causes in nonconformity management. It also draws on concepts introduced in earlier revisions – such as risks and measures around delivery performance and implementing a proven product development process.

Applying the requirements of AS9100 will ensure that you plan and implement an effective aerospace management system, whether you are involved in design, manufacture, installations, maintenance or distribution. Whether you are setting out for the first time with the standard or are looking to develop and get more from your existing system, we can help you. We can support you through all the detailed requirements and help you to maximise the effectiveness of your system, supporting you through to certification if required.

If you operate in the aerospace, defence or space sectors, then the answer is definitely “yes”.  AS9100 is the world’s most recognised and accepted standard specifically for these industries wherever you sit in the supply chain - whether your business is in design and manufacture or is support-related such as manufacture and installation. Following the same structure as the current issue of ISO 9001 it builds on the standard requirements with specific elements to address the specific needs of the industry, including regulatory, safety and reliability needs.

There are some significant benefits from implementing a quality management system compliant with AS 9100 and achieving certification. Fundamentally it helps you to become a recognised and accepted member of the supply chains for aviation, defence and space. For example, it provides the route for entry onto OASIS, the Online Aerospace Supplier Information System which lists suppliers certified under the IAQG rules who comply with the AS9100 series of standards. OASIS is a searchable database which includes information about every certified supplier and is a key tool for attracting new business opportunities.

Incorporating core principles such as risk management and the process approach as well as the specific industry requirements for aspects such as product safety and counterfeit parts AS9100 brings together the key factors central to effective quality management in the aerospace, defence, and space sectors. You may be looking for help to implement an effective system for the first time, maybe to develop beyond an existing ISO 9001 system, and to work towards certification. You may also be driven by your customers or potential business that you are targeting. You might need to take better control of your supply chain or to improve your own internal processes. Whatever your reason we can help you and support you to use AS9100 to maximise the benefit to your own organisation.

The standard was issued in 2016 at its current revision D and provides a stable and accepted set of QMS expectations for organisations operating in the aerospace, space, and defence sectors. Your use of the standard will be driven by your business and your goals and expectations - wherever you sit in the supply chain, and irrespective of the size of your organisation. Your decision to move towards adopting the standard and working towards certification will be influenced by the needs and expectations that you have identified for yourselves, and those of your customers – whether new or existing, based in the UK or abroad. You might be planning to move into the sector for the first time and need certification to demonstrate your credibility. Or you may be an established and already certified supplier, but you have recognised that you have opportunities for meeting the requirements more effectively and for improving your quality, cost, and delivery performance.

Whatever your focus we can help you. We can work with you to incorporate your applicable industry regulatory requirements, and to bring your policies, procedures and processes together effectively under the requirements of AS9100.  We can help you to operate in a more structured and effective way, to improve your business processes and to benefit from efficiency improvements and good practice. With our extensive experience in this sector QFactorial can work closely with you to fully understand your business needs, support you to establish an effective and compliant system and to maximise the benefit to your organisation.

We are, first and foremost, a quality management consultancy. And we are really keen on the consulting part. By engaging with us you can be assured we will listen carefully to your story and understand the details of what you want, and what you need (which are not always the same thing!). Our consultants can then offer you a uniquely tailored solution. We're Quality People, and we understand how to bend and shape the ISO framework to add value to your business.

As a worldwide and highly regulated sector the aerospace industry recognises the need for the highest quality and reductions in cost throughout the supply chain. This standard has been prepared by the IAQG to standardise QMS requirements specifically applicable to aviation, space and defence using ISO 9001 as the basis, and without removing any of the core requirements.

The good news is that AS9100 is specifically designed for all levels of the supply chain in your industry and is recognised globally. It incorporates the thinking – such as risk management and the process approach – that integrates with the latest ISO management system standards while aligning with the aerospace industry-specific requirements and regulatory aspects. AS9100 can be applied to any organisation that works in the aerospace industry whether designing or manufacturing components and assemblies, or supporting through installation, maintenance, and other associated activities. For Stockist Distributors there is an associated standard AS 9120 which adds requirements for sourcing aerospace components and materials.

You may operate a QMS, perhaps already aligned with ISO 9001. You might be entering the aerospace sector for the first time, perhaps with new business dependent on your achieving certification. Or perhaps you already have an AS9100 system but need help to make it work for you more effectively, to drive improvements and gain more recognition for your business. Whatever your starting point, QFactorial can help your business with your AS9100 needs, to work towards certification and get the most out of a robust and effective system.

AS9100 is applicable at all levels of the supply chain by organisations operating in the aviation, space, and defence sectors. It reduces reliance on the requirements of individual customers regarding quality management system requirements and implemented effectively it is aimed at improving quality and delivery performance and reducing costs. Based around ISO 9001: 2015 the specific additional aerospace requirements are shown in bold italic text in the standard and are intended to complement customer and regulatory requirements.

The standard sets out additional terms and definitions such as counterfeit parts, critical items, key characteristics, product safety and special requirements. It incorporates the need to address customer and applicable regulatory requirements in setting up the quality management system and adds requirements regarding documented information and the processes required for the QMS which can be incorporated into a Quality Manual.

Management considerations are expanded to incorporate the specific measurement of product and service conformity and on-time delivery performance and action on the results. Additionally, the role of management representative is required – appointed by top management - for oversight of the quality management system and resolution of issues arising.

Support-related requirements include additional safeguards regarding monitoring and measurement equipment – including test hardware and software - such as a recall process for equipment requiring calibration, maintaining a register, and carrying out calibration under suitable environmental conditions. Other considerations include extra points relating to the competence and awareness of personnel, such as awareness of  their contribution to product safety. Documented information control is also strengthened to require prevention of unintended use of obsolete materials, and to implement defined data protection processes when the documented information is managed electronically.

 Operational considerations include specific criteria for determining the requirements for products and services to be controlled - such as safety, reliability and maintainability, embedded software, and product obsolescence. In establishing the criteria for acceptance of products and services the use of statistical techniques is added. There are various other additional requirements, incorporating planning and documentation, such as regarding the resources to meet on-time delivery, and for determining processes and controls for critical items and maintenance, prevention of shipping nonconforming products and for temporary or permanent transfer for work. Additional Operational arrangements include detailed requirements for operational risk management, configuration management, product safety and the prevention of counterfeit parts.    

The processes around design and development activities are extended and strengthened and include considerations such as the potential consequences of obsolescence, the representatives required for design and development reviews, the planning and control of testing activities and the inclusion of critical items and key characteristics in the process. Additionally specific requirements are defined around the definition, use and control of the data required throughout all stages from design and manufacture through to handling, packaging, and operating and maintaining the product. Change management includes requiring a process for changes that affect customer requirements. Further controls are required for ensuring the conformity of externally provided product, processes and services and extend through the supply chain, incorporating additional controls for the relationships with external providers such as verification activities, design and development control and other detailed requirements. The controlled conditions listed for the provision of goods and services is extensively expanded and incorporates such additional aspects as methods to measure variable data, detection and removal of foreign objects, and appropriate control of utilities and supplies. Required controls extend to equipment, tools and software and there are additional requirements for controlling special processes and conducting verification of production processes. Traceability aspects are extended along with greater consideration of preservation requirements such as special controls for sensitive products and hazardous materials. Post-delivery activities are also extended, particularly regarding analysis of in-service data, control of technical documentation and other product or customer support. Additional controls are included regarding the process and requirements for nonconformity control, and these are further extended regarding the disposition of nonconforming product, with specific focus on prevention of use of counterfeit parts.

The performance evaluation requirements are enhanced in various areas. For example the information to be monitored for evaluation of customer satisfaction is stipulated and specific plans are required for improvement activities, addressing deficiencies and reviewing effectiveness. Internal audit considerations are also extended to include customer and regulatory QMS requirements and the use of performance indicators to evaluate effectiveness. Management review criteria are also extended to include on-time delivery performance and decisions and actions related to risks identified. Improvement actions include a requirement to consider human factors when determining the cause of nonconformity, the need to flow corrective action requirements out to responsible external sources of nonconformance and to take action when timely and effective corrective actions are not achieved. Continual improvement requirements are extended to ensure the ongoing monitoring of improvements and evaluation of effectiveness. The standard also includes useful informative Annexes which help to clarify the terminology and concepts used and explain the relationship of other ISO and IAQG management system standards.

Overall, if you are planning to operate in the aerospace sector AS9100 provides the basis for implementing an effective management system which can be recognised through certification. With our extensive knowledge of the standard, an eye to your specific needs and understanding the real benefits for your business we can support you to build and maintain a robust, effective, and compliant system for your aerospace related business.

Whether you are completely new to working towards a certified quality management system, you already have knowledge of ISO 9001, or even if you are certified to AS9100 and need to get more from your system we can help you.

The first step towards setting up an AS9100 compliant QMS is to work with you to identify any gaps between the policies, processes, and procedures you already have in place compared to the requirements of the standard. We can fully support you with an effective action plan for implementing any new aspects or for amending what you may already have in place. By getting under the skin of what you really need and using our extensive knowledge and experience we can help you to develop and improve your processes and train your team.  We can support you through the certification process and beyond.

Certification to AS9100 is not a requirement of the standard itself and you can reap many benefits from implementing it effectively without undergoing the certification process. However, to supply into the aviation, space and defence sectors third-party certification is a key criterion to demonstrate to regulators, customers and other interested parties that you meet the requirements of the standard.

As an industry-specific standard the International. Aerospace Quality Group (IAQG) owns the management certification scheme for AS9100 and other associated aerospace standards such as AS9120. The IAQG operates a portal-based system, the Online Aerospace Supplier Information System (OASIS) which incorporates all information regarding certification, auditors and audit results. The certification scheme operates with industry-approved and accredited certification bodies and enables all organisations that purchase goods and services to recognise the audits and certifications issued within their supply chain management processes. The accredited certification bodies applicable in the UK can be found once you have an OASIS login.

We can help you through the entire process, working with you to establish and implement an effective compliant system, and supporting you through your certification and beyond.

Becoming certified to AS9100 requires significant planning, commitment, and resources, even if you are already familiar with ISO 9001. How much work is involved will depend on your current stage of development, the size of your organisation and number of people involved. We will work closely with you to identify gaps and synergies against the requirements of the aerospace standard, and to implement a workable action plan to achieve your objectives – including certification - in the most efficient way. Our effective project management and extensive know-how will support your schedule and budget, with the right resources to help you at every stage such as preparing documentation, training and mentoring, reviewing and auditing. Beyond certification we can continue to work with you as your business goes forward so that you continue to maintain and develop your system.

As the standard is specifically oriented towards the aerospace industry and with a variety of additional specific processes and regulatory requirements to meet, AS9100 does require a significant amount of documentation. Whether relating to the policies, procedures and processes required, the workflows in your systems and the records generated the key is for you to be able to demonstrate that the processes are being effectively followed. We can help you to establish the systems you need, that support your business and meet the requirements of the standard.

We recognise that every business is different and there is not a “one size fits all” approach to developing your system. We can work with you to establish a quality system that really works for you in meeting the requirements of AS9100 and importantly is live and effective for your business needs - not just a dusty set of folders consigned to the shelf. In practice our aim is to look at how you actually do things, what processes you use, who is involved and how you record your results – and to design and describe your system that really works for your business and meets the requirements of the standard. For certification you will need to show that it is effective in planning, operation, and control of your processes and people to meet the needs of AS9100. Whether you are just starting to develop an aerospace oriented QMS, you need help to get ready for certification, or you already have a system that you know needs to develop to work better, we can help.

How long is a piece of string?

You’re not a cookie-cutter company, so we don’t deal with cookie-cutter prices. But let’s talk about what makes up the cost of ISO certification:

  • Finding out where you’re starting from, where you need to be and how to get there. (GSAAP).
  • In house resources to manage and deliver the work plan.
  • External consultants to help with parts of the plan that are outside your skills and experience (or time).
  • Certification Body.
  • Maintenance of your certification. Not just polishing the frame.

Depending on the size, scale and complexity of your organisation, you may need more or less consultancy time. We can work with you based on a specific number of days at an agreed rate, carefully scoped, fixed price work packages, or a combination of both to suit your budget.

There is a difference between certification and accreditation. In the UK there is only one government approved accreditation body (UKAS). When your customers are asking to see your ISO certification, they expect to see the UKAS logo alongside the certification body’s logo. Without this, your customer may reject the certificate and you may find you've a costly exercise to undo the commercial damage, upgrade your system and put yourself through the certification process all over again. We can help you choose a UKAS accredited certification body to make sure you aren’t going to get any awkward questions later.

We’ve been in this game a long time now and have developed a proven system of tackling the requirements of ISO certification with you. We begin with our Gap & Synergy Assessment with Action Plan (GSAAP for those acronym lovers) which shows us how close you already are to the standard requirements. We find, usually, that there are many more synergies than you’d expect - you’re running a successful business after all, aren’t you?

This gives us a head-start when creating the ISMS and gives you the opportunity to get to know your consultant and confirm you enjoy working with us before embarking on the good ship certification. At this point you’re able to take the GSAAP and run, but of course we’d like to think you’d want to keep working with us to help you with the documentation (Stage 1) and implementation (Stage 2).

At this point you’re able to take your new ISO Certificate, pat yourselves on the back for a job well done and send us on our merry way, happiness all round. However, we recommend you stick with us for this first year. Why? So we can help establish quarterly health checks to keep things ticking over. No one wants to be thrown into a full-blown panic 11 months down the line as the surveillance visit looms and you realise things have gotten a little wobbly. With us on board that little while longer, you can be sure that the gears are turning and the processes are followed so when the auditor returns, you’re armed and, if not dangerous, at least prepared.

Interested in gaining AS 9100 certification?

Speak with a QFactorial expert

Make an enquiry
Thank you

We have recieved your enquiry and one of our specialists will be in contact with you shortly.