Quality System, Consulting and Auditing Services
Strategic Link is competent to provide a full suite of consulting services. We can support multiple consulting activities, individual topics, or a hybrid of the two. We can also perform internal (1st party), vendor and supplier (2nd party), and Gap (3rd party) audits. Our services span a variety of standards, customer flowdown of Quality Notes and requirements, and industry best practices. We can serve as a one-stop shop for clients.
Strategic Link has a strong working knowledge of business, process, product, and supply related risks, and integrates this knowledge into our approach. Whether your company is large or small, high or low tech, manufacturing or service, for profit or not, our risk and compliance-based approaches will meet your company needs.
Strategic Link has a strong working knowledge of business, process, product, and supply related risks, and integrates this knowledge into our approach. Whether your company is large or small, high or low tech, manufacturing or service, for profit or not, our risk and compliance-based approaches will meet your company needs.
Industry Standards that we consult and audit to:
- ISO 9001 - AS 9100 (Aerospace)
- AS 9120 (Aerospace)
- AS 9102 (Aerospace First Article)
- ISO 13485 (Medical Device)
- ISO 10007 (Configuration Management)
- GMP – 21 CFR 820 (FDA)
- ISO 14001 (Environmental Management System)
- ISO 31000 (Risk)
- ESD 20.20 (Electro-Static Discharge)
- NIST 800 (Cyber)
Our clients are from General Manufacturing (electronics, electro-mechanical, machining, sheet metal, etc.), foods, medical, chemical, mechanical assemblies, engineering, software and technology, high or low volume assembly, etc.
Through our relationship with national and international 3rd party Registrars, attending auditor conferences and webinars, and participating in industry action groups through the Internal Aerospace Quality Group (IAQG) and ISO 9001 Technical Committee (TC 176), we know what is trending in industry and factor this information into our highly effective auditing processes.
The Strategic Link team has performed over 5,000 ISO 9001, AS 9100, AS 9120, risk assessments, ISO 13485, and ISO 14001 (environment) related audits. Our approach is based on those used by 3rd party accredited organizations and our auditors are Exemplar Global and United Kingdom Accreditation Service (UKAS) certified. Whether your company desires a single or integrated certification audit, we can provide credible reporting to meet your business, customer compliance, or industry needs. We also conduct risk-based assessments compliant with ISO 31000 and gap audits that provide senior management with awareness of the health of various segments of their business.
The Strategic Link team has performed over 5,000 ISO 9001, AS 9100, AS 9120, risk assessments, ISO 13485, and ISO 14001 (environment) related audits. Our approach is based on those used by 3rd party accredited organizations and our auditors are Exemplar Global and United Kingdom Accreditation Service (UKAS) certified. Whether your company desires a single or integrated certification audit, we can provide credible reporting to meet your business, customer compliance, or industry needs. We also conduct risk-based assessments compliant with ISO 31000 and gap audits that provide senior management with awareness of the health of various segments of their business.
Your company will start to understand and implement requirements at the earliest point possible based on our auditor knowledge, allowing your company sufficient time to implement and prepare for your registrar assessment. Our consultants can assist with establishing a business or quality manual, standard operating procedures, required risk assessments, or necessary forms and templates needed for standardization and compliance with ISO or Aerospace related requirements.
Our Lean Manufacturing programs can include a hybrid of value stream mapping, single piece flow, lean standardization, goal and metric systems, time studies, and Kaizen Events with the focus on identifying and eliminating process waste. We work with our clients to determine the best lean manufacturing plan of attack and remain with your company throughout the lean journey.
Our Lean Manufacturing programs can include a hybrid of value stream mapping, single piece flow, lean standardization, goal and metric systems, time studies, and Kaizen Events with the focus on identifying and eliminating process waste. We work with our clients to determine the best lean manufacturing plan of attack and remain with your company throughout the lean journey.