How to Audit the Process Based QMS, Second Edition

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The fact that the audit process casts auditors on one side and the people being audited on the opposite side has createda general impression that auditing is adversarial. While there may, indeed, exist a point-and-blame atmosphere in some cases, more and more organizations recognize that an audit does not have to be a negative experience or a dreaded event.


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When implemented properly, it can be one of the most effective means for improvement. From financial institutions to manufacturers to hospitals, audit is being utilized as an important management, compliance, and quality tool.

ISO/TS 16949 Implementation Guide

Considering the type of products that the FDA regulates and the diversity of the industries where ISO quality standards are applicable, auditingfor the purpose of maintaining high quality standards directly impacts public health and safety. In these environments, the audit process is closely associated with quality and directly related to regulatory compliance.

This article is related to the toolkit: Audit Toolkit from MasterControl. To get the full details, please download your free Toolkit. The International Organization for Standardization ISO , the world's leading developer of international standards, is instrumental in boosting interest in quality audits among manufacturers and other types of businesses when it published the ISO standards in Under these standards, audit serves as a mechanism for evaluating and improving quality.

The same principle is reflected in a number of regulations enforced by the Food and Drug Administration. Under the Quality System Regulation 21 CFR Part , medical device manufacturers are required to conduct audits to ensure that the quality system is compliant Sec. Guidances for the pharmaceutical industry and blood establishments also emphasize the importance of audits. The "Guidelines for Quality Assurance in Blood Establishments" call for comprehensive audit of the quality assurance program.

In general, there must be a basis specific requirements for an audit and a systematic method for gathering facts or evidence. An auditor compares the evidence with the requirements and comes up with observations, which can be either positive or negative. Up to this point, the process is similar to inspection. But an audit entails much more. The auditor analyzes his or her observations for patterns - also called findings - in order to draw conclusions.

The auditor then presents the observations, findings, and conclusions in a report to all parties involved.

ISO Definitions in Plain English

Going back to the example of the mystery shopper, the focus was customer service in just one store. For example, clause 8. This violates clause 4.

Every human activity is a process: eating, breathing, walking, etc. This also means that everything — everything! Which makes things insanely difficult to manage, obviously. Knowing that the process approach is defined in clause 4. Just ensure that even if ISO is confused about how to use the word, in your QMS including the documentation you only use the word to describe activities you intend to manage per 4.

And remember, the second sentence of 4. So what are those requirements?

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What is ISO 9001?

So we can better understand them if we look at them logically, rather than in exact sequence:. So every company will be different. My experience tells me most small to medium sized companies employees or less have under a dozen activities they label as core QMS processes. For example, a typical small manufacturing shop usually has the following processes:.

For example, some companies separate Purchasing and Receiving into two processes, while other smaller companies keep them together as one. Others putting Shipping and Receiving together. Again, that depends on their size and complexity, and what they want to measure. This will make sense in a minute, but for now trust me; make a table of each of your processes and assign the ISO clauses that are applicable to that process, until all the clauses are assigned somewhere.

This is why you have to develop a few additional QMS oversight processes.

Again, even with a few QMS management related processes added, most companies have a set of about a dozen processes when done. Again, each of these QMS management processes would need be measured, too.

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In such a case, the process list from the example I made above might grow a bit, to look like this when done:. Here is an example of what your process listing vs. ISO clauses might look like for a company that conducts both design and field service, alongside manufacturing click here for a PDF version.

Via interactive communication means: — conducting interviews; — completing checklists and questionnaires; — conducting document review with auditee participation. Conducting document review e.

Risk based Thinking ISO 9001:2015 QMS Requirements

Observation of work performed. Conducting on-site visit. Completing checklists. Sampling e. Observing work performed via surveillance means, considering social and legal requirements.

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