For many professionals and employees, an audit invokes feelings of being under the gaze of a policeman. This breeds compliance or conformance under duress, and is totally contrary to what an audit should be about.
Audits that Drive Conformance, Compliance, and Improvements by Collaboration
We encourage compliance/conformance via collaboration. The audits are conducted with an amiable approach, without compromising the integrity of the requirements identified in applicable standards and regulations. Examples of the standards / regulations we audit to include:
- ISO 9001, 13485, 14971, 27001, 22001, 14001, 45001
- ICH Q7, Q9, and other ICH guidelines
- MDSAP, MDR, MDDEV 2.7.1 Rev 4, En 62366, IEC 60601, 21 CFR 111, 210, 211, 820…
- FDA Mock Audits
- AS 9100 and associated standards
- IATF 16949
- Audits by topic / area such as: Risk Management, Process, Product, Complaints…
- … – the list keeps expanding – pls call / write to us if you have a particular need
Audits that Balance Stakeholder Interests and use Risk-based Approach
Our approach to auditing keeps your interests (auditee or audit client) in perspective at all times in addition to other stakeholders as applicable. A risk based approach is used that enables the right focus and delivers actionable information to the audit client and the auditee.
Reports are tight and crisp, with non-conformities documented in a way that make it easier to determine key causes of NCs and quick action to address them.
De-Risk Your Supply Chain with Supplier Audits from The KPI System
Supply Chain audits from us – provide you with an ACT Score that gives you metrics on Agility, Capability, and Tightness of the chain. This goes way beyond a typical QMS audit which leaves you desperately searching for how good, or risky a supplier might be when it comes to performance. Knowing the risk involved is so vital because it impacts your business and more importantly – customer satisfaction – which has a quick and direct impact on your cash flow. You can use the ACT Score to compare suppliers and optimize your supply chain across multiple tiers.
Our auditors have the right credentials, and bring wide and deep experience from a multitude of industries. Call today to discuss your specific needs: (512) 560 8326, or send us a message at info@thekpisystem.com
