ISO 9001:2015 Standard Control of Nonconforming Output Requirements
As soon as nonconforming outputs are detected within the organization, they must be identified, recorded, and controlled; and most importantly, they must be treated. The objective is to prevent the release, delivery, or use of nonconformed products or services by the customers. Treating and managing nonconformities is one of the basic objectives of the ISO 9001 Standard. Nonconforming outputs refer to the outputs of processes that do not fulfill a requirement that is a need or an expectation of one of the interested parties of the organization that is stated, implied, or obligated. Controlling the nonconforming outputs is planning activities for detecting nonconforming outputs and deciding what is to be done with them. And the ISO 9001 Standard specifically mentions what options one has.
When planning the process for handling nonconforming products, the next issues are expected:
- The organization shall maintain a documented procedure that describes the method of detecting and controlling non conforming products. The documentation of the procedure must be controlled and introduced to the documents control process in the organization as required in paragraph 4.2.4 – control of documents
- As soon as a non conforming product was detected and must be segregated from other products in. The organization must initiate an action in order to identify and eliminate the use of non conforming product
- Releasing a non conforming product must be approved by a prior authorized function. The release would be under concession. Concession can be made by an authorized person or by the customer but anyway documented
- The organization is required to maintain records that describe the nonconformities detected and the actions that were taken to eliminate them. The records are to be introduced to the records control process as required in paragraph 4.2.5– control of records
- When nonconformity is detected after delivering the product, actions must be taken relevant to the nature of the nonconformities
- When a nonconforming product was re-processed, it must be re-validated in order to ensure that it meets the requirements (customer’s or regulatory).
Detecting the Nonconforming Outputs
First thing is first. I want to make sure that we are talking about the same thing when we are referring to nonconforming output. A Nonconforming output: a product or process result that does not conform to its specified requirements:
- Customer’s requirements: Functionality or intended use requirements
- Regulatory requirements
We may look at it in another way: nonconformity is where a result was not achieved according to a specific requirement. The requirement refers to both products that were detected in house and products that were already delivered to the customer.
Controlling the nonconforming outputs will allow the organization to minimize their effect. Nonconformance can occur in raw materials, components, in goods that are in process or finished goods, or service operations. When nonconforming outputs are detected, the first step is to identify them. In order to effectively identify nonconforming outputs, one must understand which quality tools will indicate that a process output is nonconforming. The ISO 9001 Standard requires quite a few controls that may be of use:
- Verification activities
- Monitoring, measurement, analysis, and evaluation activities
- Controls of external providers
- Release activities
Reaction to Nonconformity
As soon as nonconforming outputs are detected, the organization must react to them. The ISO 9001 Standard expects several basic actions for managing nonconformity.
Identifying the Nonconforming Outputs
After spotting the nonconforming outputs, one must identify them as a means of classifying them. The standards specifically demand the identification of nonconforming outputs in an injective manner. This means that each nonconforming product or service will be identified independently (physically as well as logically). The objective of the classification is to prevent the use of those outputs before it is decidedwhat is to be done with them.
Control of Nonconforming Output Responsibilities and Authorities
The organization is required to determine the authorities and responsible parties to handle nonconforming products. The definition shall refer to all stages of the process; from the detection of the nonconforming product until the closure of the case. The definition shall be documented on the required procedure mentioned above.
Procedure for Control of Nonconforming Output
The ISO 9001 Standard does not requires defining and maintaining a documented procedure describing precisely how a nonconforming output or any other component of the product shall be handled when one is detected – but you may keep the existing procedure (required by the ISO 9001:2008 Standard). The process will specify steps tools, actions and required records while handling a nonconforming product. Of course, as any other procedurs of the QMS, the process of controlling nonconforming product shall be controlled under the documents control process within the organization. In other words, this process is under the quality management system, required to be controlled and would appear on the list of the controlled procedures in your quality manual guide.
Control of Nonconforming Output – Determination of disposition
Clause 8.7 refers to the immediate necessary action regarding the nonconforming product:
- Segregation of the nonconforming product
- Notification to the customer
- Notifications to the relevant parties; organizational, internal, external, or governmental
- Short term corrective action
You may determine the method according to the nature of your product or processes but you must document it. Everybody must know what they are required to do when a nonconforming product is detected; service call center, the logistics, salesmen, production manager, quality manager – everybody who is related and has a part in the realization of the product.
This webpage contains only a fragment of the chapter 8 Operation from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
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