McAllister Consulting offers a wide range of services designed to meet the unique needs and specific operating environment of our clients.
We work with all of our clients to address their specific needs, below are some brief descriptions of ways in which we help our clients:
Turn Key Project:
Many ISO 14001 requirements duplicate the same or very similar requirements in ISO 9001 or TS 16949. There is no need (in fact, it is not advisable) to set up separate systems for addressing the common requirements. McAllister Consulting can help you blend the two Standards simply and effectively. In many cases, we have set up compliant Environmental Management Systems with only two additional procedures.
Health, and Safety Assessment Series OHSAS 18001:2007
Occupational Health and Safety Management System – Requirements
McAllister Consulting assists businesses of all types in achieving compliance to the OHSAS 18001:2007 requirements. You may choose to get registered to OHSAS 18001 or “self-declare” your compliance.
OSHAS 18001 is due to be re-issued as ISO 45001 in 2016.
A Safety Management System assists a business in achieving compliance to health and safety regulations, and in identifying hazards, assessing the related risks, and taking actions to reduce the risk of injury or ill health. We can assist you in all phases: design, development, implementation, and maintenance (including training your internal auditors or performing your internal audits for you) of your safety management system.
Your Safety Management System can be designed to be:
organizations want to do the "right thing" and ISO 26000 offers
guidance on a variety of social responsibilities subjects: corporate
governance, human rights, labor practices, the natural environment,
fair operating practices, consumer issues, and community involvement
and development. These subjects have varying degrees of applicability
and appropriateness for an organization.
McAllister can assist in defining priorities and specific programs to accomplish your CSR goals. One of our structured approaches offers a numerical assessment of criticality, frequency, and probability of success in helping to define these. Importantly, we emphasize integrating these programs with existing business practices, in areas like:
These areas of focus link seemlessly to your existing ISO practices. This avoids duplication and "layering on" and helps enforce the culture and values that support CSR.
QS 9000 just a bad memory, ISO/TS 16949 offers a more flexible,
performance-based approach to compliance in the automotive supply
chain. McAllister can help the QS survivors to jettison the excess
documentation, and can assist those just embarking on TS to achieve a
leaner, more focused quality management system.
Our ISO-SIZEsm process is specifically designed to unclog the documentation drain so that the worthwhile, value-added procedures and work instructions are retained and the rest hit the circular file. Many former QS 9000 companies find this helpful.
ISO/TS 16949, like its’ parent ISO 9001, is process-based. As with ISO 9001, McAllister helps our clients define their processes and performance metrics so that the “critical few” drive quality system activities. Our ISO/TS internal audit approach then aligns ISO/TS requirements with the relevant process(es). The net effect is process based internal auditing that pays serious attention to performance metrics like scrap and rework costs, along with the customer line-of-sight indicators like on-time delivery and order cycle time.
Please also visit our ISO 9001 section for additional details on the many customized ways in which McAllister can help your organization achieve and maintain ISO/TS 16949 compliance.
McAllister Consulting assists medical device manufacturers in meeting ISO 13485 21 CFR 820 requirements and preparing for ISO registration. Those involved in the medical device supply chain, including component manufacturers, can move directly to ISO 13485 registration, or can add ISO 13485 21 CFR 820 requirements to their existing ISO 9001 registration. We assist clients in both types of projects but encourages “blending” ISO 9001 and 13485 quality systems to achieve maximum integration, while avoiding costly duplication of procedures and practices. ISO 13485 21 CFR 820 systems can include relevant FDA requirements, thus satisfying the needs of American medical industry customers. Requirements for the CE Mark, a designation often required on product headed for the European Union, also can be rolled-into ISO 13485 21 CFR 820 efforts.
with FDA and other regulations is a serious matter. While most
companies are conscientious and proactive in compliance, many want some
level of “comfort” that CGMP compliance practices are up to par.
Discovering and addressing a deficiency before an FDA or a customer
visit is preferable to the alternative. That’s where McAllister can
We offer an array of customized services to help you achieve and maintain compliance, while helping to identify and capture efficiencies that are more visible to an outsider. Typically, we provide an internal audit to the targeted CFR and render an internal audit report. The nature of this audit and report are aligned with the organization’s objectives – addressing a previous or suspected nonconformance, meeting a specific customer requirement for third party auditing, or simply developing a new source of input for improvement and effectiveness.
McAllister Consulting is management’s eyes and hears…….and provides an independent voice to assist management in making and implementing compliance decisions.
McAllister consulting supports companies throughout the aerospace supply chain. OEM and component-supplier experience in the aerospace and military sectors gives McAllister a practical knowledge of meeting FAA and various flowdown requirements.
The AS family of standards (for manufacturers, repair depots, and distributors, respectively) is a registration path for the capable aerospace supplier. The AS standards are based on the ISO 9001 standard but with many additional requirements that are appropriate to the risks and margins of aerospace business.The "trick" is to provide the required services to aerospace customers (e.g., first article inspections, traceability systems, and/or foreign objects' controls) without imposing the associated overhead on customers without these requirements.
Our proportioned approach allows for a customized quality management system that fits the breadth of the customer base in the most cost-effective manner.
If your organization can "Right Size", then so too can your ISO systems.
This approach focuses on deleting and/or
documents that have out-lived their usefulness. Often, these have
become the source of nonconformance because they are too long,
confusing, cumbersome, or just plain annoying for people to actually
Wherever sensible, narratives are replaced by visuals, digital photos, flowcharts, or self-explanatory templates. Important where your workforce is not comfortable with written English.
The structured ISO-sizesm optimizes the number, length, and simplicity of your ISO documentation so that it focuses on what matters most......customer-responsiveness, product quality, profitability. Your ISO docs become truly relevant to your business.
McAllister Consulting practice includes assisting firms in meeting the
the Sarbanes-Oxley (ISOxsm) requirements from an ISO platform:
Sarbanes-Oxley legislation of 2002 has raised the bar on management and auditor accountability of many aspects of corporate governance. Several of its requirements relate directly to the systems and procedures that support accurate data recording and reporting. While the focus is on financial data, anything of material impact to the business is subject to reporting requirements. In particular, management must assess the "control environment" and have evidence to support its attestations about its systems.
Compliance to ISO 9000 and ISO 14001 requirements can help management achieve the systems and procedural integrity necessary to substantiate its assessment of adequate internal controls. Many aspects of ISO support this:
The McAllister Consulting practice includes extensive experience in a variety of materials management topics:
Often, clients face situations where external or internal pressures drive a change in how they plan, schedule, move and stock their products. Customers expect everything from vendor-scheduling, to fully automated Advance Shipment Notification, to same day delivery. McAllister Consulting helps our clients to understand the systemic impacts of there requirements, then assists in the planning and roll-out of these changes. The key is in understanding the linkages, bottlenecks and "pinch points" before implementation. No systemic change is easy, but we can help ease the transition.
global food chain is long and disjointed. Consumers and governments
alike fear the possible outcomes of tainted food. Bio-terrorism threats
aside, there are many possible ways to contaminate the food supply.
With most food commodities and many processed foods crossing
international boundaries, governmental regulators and private
organizations are seeking assurances.
McAllister Consulting can help your organization comply with the mandates of your regulators and/or customers. In some cases, registration to an international scheme, like BRC Global Standard Version 5, the SQF 2000 Level 2, or IFS Version 5 makes sense. In other cases, an organization must demonstrate compliance to FDA and/or state-based regulations through third-party assistance or internal auditing. Some customers demand independent verification of compliance to their customer-specific requirements.
McAllister offers preparation services and internal auditing to help achieve, demonstrate, and maintain compliance to the appropriate food-related scheme, regulation, or requirement. As with our approach in other topical areas, we offer customized consulting and support that will meet your needs……no more, no less.
Organizations, public and private, are becoming more aware of the importance of sustainability. For some it is just the latest buzzword, driven by customer or end-user demand. For others, it represents a commitment to the future economic and social viability of their products.
Whatever the motivation, McAllister Consulting can help achieve the benefit of certification without the administrative burden of yet another set of requirements and controls. In most cases, organization who already have a Quality or an Environmental Management System in place……ones like ISO 9001 or ISO 14001….can achieve certification with few if any additional procedures, and only incremental recordkeeping – mostly focused on sourcing, traceability, and customer communication controls.
Allow McAllister to simplify this certification process and fully integrate your FSC/SFI certification controls.