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articles:classifying_nonconformities [2022/07/20 08:08] – created rrandall | articles:classifying_nonconformities [2023/05/16 09:13] (current) – [Definitions...] rrandall | ||
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- | ====== | + | ====== |
+ | {{keywords> | ||
+ | ===== Why should you care? ===== | ||
- | Before we can classify | + | When undergoing an ISO 9001 or AS91xx audit by a Certification Body (CB), if the auditor incorrectly classifies a " |
- | < | + | Similarly, if an auditor incorrectly classifies an " |
+ | |||
+ | If your company is certified to one of the AS91xx standards, minor nonconformances must be included in the [[articles: | ||
+ | |||
+ | You should be aware of the below " | ||
+ | * nonconformity as a " | ||
+ | * " | ||
+ | |||
+ | Where you disagree over the classification, | ||
+ | |||
+ | ===== Definitions... ===== | ||
+ | {{ : | ||
+ | Before classifying a nonconformity as a minor or major, the auditor must have a clear understanding of their definitions. | ||
+ | |||
+ | Nonconformity classifications are defined in [[https:// | ||
+ | |||
+ | Due to the ambiguous/ | ||
+ | |||
+ | ISO 9001 & AS9100, " | ||
+ | < | ||
+ | ==== Minor Nonconformities ==== | ||
+ | |||
+ | < | ||
nonconformity that does not affectthe capability of the management system to achievethe intended results.</ | nonconformity that does not affectthe capability of the management system to achievethe intended results.</ | ||
+ | |||
+ | And | ||
+ | < | ||
+ | The requirements of ISO/IEC 17021-1 clause 3.13 apply. \\ | ||
+ | In addition a minor nonconformity can be a single system failure or lapse in conformity to meet a 9100-series standard requirement, | ||
+ | |||
In other words, a nonconformity that is NOT likely to result in the delivery of a nonconforming product or service. Examples of minor nonconformities may include: administrative errors in non-deliverable records or procedures, a lapse in following a procedure that did not impact the deliverable product or service, etc. | In other words, a nonconformity that is NOT likely to result in the delivery of a nonconforming product or service. Examples of minor nonconformities may include: administrative errors in non-deliverable records or procedures, a lapse in following a procedure that did not impact the deliverable product or service, etc. | ||
- | < | + | ==== Major Nonconformities ==== |
+ | |||
+ | < | ||
nonconformity that affects the capability of the management system to achieve the intended results. \\ | nonconformity that affects the capability of the management system to achieve the intended results. \\ | ||
//Note 1 to entry: Nonconformities could be classified as major in the following circumstances: | //Note 1 to entry: Nonconformities could be classified as major in the following circumstances: | ||
• if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements; | • if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements; | ||
- | • a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity.//</ | + | • a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus |
+ | constitute a major nonconformity.// | ||
+ | |||
+ | And | ||
+ | < | ||
+ | The requirements of ISO/IEC 17021-1 clause 3.12 apply. \\ | ||
+ | In addition, a major nonconformity can be one or more of the following situations: \\ | ||
+ | • a nonconformity where the effect is judged to be detrimental to the integrity of the product or service; \\ | ||
+ | • the absence of or total breakdown of a system to meet a 9100-series standard requirement, | ||
+ | • any nonconformity that can result in the probable delivery of nonconforming product or service; and \\ | ||
+ | • a condition that can result in the failure or reduce the usability of the product or service and its intended purpose.</ | ||
- | For greater clarity, a major nonconformity exists in the following situations: | + | As you can see, the threshold for a Major Nonconformance |
- | * a nonconformity where the effect | + | |
- | * the absence of or total breakdown of a system | + | |
- | * any nonconformity that can result in the probable delivery of a nonconforming product or service | + | |
+ | {{page> |