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At first glance, it may seem appropriate to conduct more audits to identify compliance gaps and then While the audit-fix cycle can achieve results, it is a brute force approach to improvement. The output from audits tend to create action items and sometimes quite a few. So many go back to fixing potholes only to repeat the process after the next audit. and not able to make required transformations from prescriptive-based compliance evidenced by audits

If we didn’t focus on such things as certification, audits, and enforcement. properties that define what is really “essential” not for the purpose of certification, or to pass an audit First, it is not a prescriptive standard, intended to be audited. The shall statements afford some measure of support for an audit function , but not the safety performance These are more difficult to audit or to certify against.

their systems learn and evolve, while engineered design provides verifiable compliance and defensible audit

to be the case for Compliance 1 which thinks of compliance in terms of passing a boundary (e.g. an audit compliance requires educating stakeholders who are assumed to have a “bounded-set” mindset which creates additional In addition, without structure and discipline these initiatives are often poorly managed which also contributes

Answer : We passed our last audit. Quality Manager, We Make Things, Inc.

Government regulations provide a legal framework for manufacturers, however, self-regulation acts as an additional Algorithmic systems should also be regularly peer-reviewed or audited to ensure that unwanted biases In addition to clear roles related to accountability, it is also important to promote an organizational are affected by it ensures that the outcomes do not cause adverse effects in the process of creating additional While governmental regulations provide a legal framework, self-regulation acts as an additional layer

What it did expose was that Inspections and audits were insufficient to drive down defects or improve

We might still believe that if we double down on audits we might get back to having an operational system

compliance for the most has lagged behind and still functions using the old factory model using an audit-fix

Additionally, if the primary goal is to pass an audit then it makes sense to choose the path that is activities tend to focus on the collection of evidentiary artifacts through the use of inspections, audits prescriptive obligations reinforced by reactive management behaviors where improvement is done using an audit environmental, and other compliance objectives improves outcomes while at the same time avoids excessive audits

products across the following 15 categories: Reporting and Recording Incident Investigation and Analysis Auditing

The establishment of ISO 42001 as an audit standard signals the maturing governance landscape.