ISO consulting

What I Offer

ISO 9001/ISO 14001/ISO 45001/IATF 16949 Management Systems

 

Registration of a management system may be a customer requirement or an opportunity to expand business.  But the main benefit is to develop a structured approach to manage your business to achieve its overall objectives.

 

The latest revisions of each standard put focus on understanding the full context of your business, risk and opportunity-based thinking (especially during planning and change management), leadership commitment, and a comprehensive process approach to system management, all of which I have long considered an untapped benefit of management systems.

 

I have been a management representative for safety, quality, and environmental management systems.

 

I led or participated in dozens of management system developments, registrations, and upgrades. 

 

I have incorporated existing documentation into a new management system, and have built management systems from scratch, with my documentation used as templates for sister sites around the world.

 

My services range from coaching and training to hands-on development and implementation.

  • Executive overview

 

Providing an executive summary of the management system standards, general process to implement or upgrade, and expected benefits.

 

  • Gap analysis

 

Assessing your company’s current systems and compliance with a management system standard to develop a better understanding of the work necessary to achieve compliance.

 

  • Documentation (review/development/control)

 

Creating new documentation, helping to revise existing documentation, or developing a system and training for control and distribution of policies, procedures, instructions, forms, or records.

  • Internal auditing

 

Conducting most internal audits (as the internal audit program needs itself to be audited), or training your company’s team to develop an audit schedule, conduct internal audits, prepare reports, and conduct follow-up activities where nonconformances are found.

  • Training (auditing/management review/corrective action)

 

Training and guidance for management to develop an appropriate management system scope and policy, and for activities to measure and improve the system.

 

  • Registrar selection

 

Advising on selection of the organization who has the authority to register your management system based on your company’s criteria.

 

  • Pre-assessment

 

Assessing readiness for management system readiness prior to Stage 1 review by a registrar and assisting in filling in any gaps identified.

 

  • On-site support for registration audit

 

Availability to support your team through the duration of the audit.

 

  • Post-registration ongoing support

 

Providing continued assistance with training, auditing, preparation for future surveillance audits, or management reviews, or assistance in your corrective action or change management processes.

 

 

  • Advantages of Management System Integration

 

Providing a summary of the advantages of an Integrated Management System.

 

ISO 9001, ISO 14001, and ISO 45001 have adopted similar format to be better aligned, and IATF 16949 provides additional automotive specific requirements beyond the base of ISO 9001.  There are synergies to be gained, particularly with setting policies and objectives, change management, internal audit, corrective action, management review, and document control.

 

  • Automotive core tools (Advanced Product Quality Planning and Control Plan, Production Part Approval Process, Failure Modes and Effects Analysis, Statistical Process Control, Measurement Systems Analysis)

 

Training or development of documentation according to the AIAG guidelines which are typically part of an automotive quality management system but add value to any management system.

Regulatory Compliance

 

  • Extensive experience with the following agencies

    • BATF

    • EPA

    • PHMSA

    • NHTSA

    • CBP

    • DHS

    • BIS

 

While I do not consider myself a compliance expert, I can offer my experience in communicating with Federal and State regulatory agencies on several compliance topics, or provide guidance on a system to monitor regulatory changes that may affect your company as part of your management system.

 

Quality Management

 

  • Planning

  • Assurance

  • Control

  • Improvement

 

Assisting or guiding the establishment or improvement of specific aspects of your quality management processes, including receiving inspection, sampling, instrumentation and calibration, change management, inspection standards, or shipping approvals in support of your Quality Management System.

Problem Solving and Data Analysis

 

  • Root cause analysis techniques

  • Data analysis

    • Designed experiments

    • ANOVA

    • Capability Analysis

    • Basic statistics

 

Training or guidance in various problem solving techniques such as brainstorming, 8D, A3, or PDCA to ensure problem definition, planning, root cause analysis, change effectiveness, implementation of permanent system changes, and identification of similar opportunities elsewhere.  Problem solving can be used in response to corrective action requests or identified improvement opportunities.

 

Likewise training or guidance in various root cause analysis techniques such as 5-why, fault tree analysis, FMEA, or fishbone, along with simple analytical techniques such as scatter diagrams, histograms, run charts, or pareto diagrams.  Or if required, more detailed analytical techniques such as designed experiments, capability analysis, or hypothesis testing.

 

Supply Chain

 

  • Supplier development and auditing

  • Customs-Trade Partnership Against Terrorism program development

Conducting or training on audits of your supply chain.  My experience in supplier audits is extensive, including stamping, welding, machining, injection molding, heading and forging, drawing, winding, and heat treating.  If you’re importing some materials, I can assist in the development of a C-TPAT system for your company to help expedite the customs process.