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AS ISO 18385:2017 pdf free

AS ISO 18385:2017 pdf free.Minimizing the risk of human DNA contamination in products used to collect
Manufacturers shall document and implement a policy for the collection of relevant voluntary reference samples from personnel involved in the production of products.
NOTE 1 Refer to legislative or regulatory restrictions or preclusion in your jurisdiction regarding the collection of voluntary reference samples from staff.
A voluntary reference sample should be collected, with written permission, from personnel who have the potential to introduce DNA into the product. Personnel included in the staff contamination detection system should be determined based on risk. If a sample is provided, a relevant DNA profile (see Annex C) shall be generated and recorded for quality assurance purposes. Information on the staff contamination detection system shall be documented.
NOTE 2 Humans are constantly shedding DNA and the inadvertent contamination of product is a constant and unavoidable risk regardless of control measures implemented. When staff contamination of a product occurs,it can lead them to being erroneously linked by police to a crime or a series of crimes. A staff contamination detection system is used to detect the occurrence of contamination and protect against an erroneous linkage.
NOTE 3 The International Commission on Missing Persons provides a secure platform as a repository for DNA profiles of employees of manufacturing companies (www.ic-mp.org).
Risk management occurs across the product lifecycle. For the purposes of this International Standard,the scope of risk management is limited to risks that can introduce human DNA contamination into products used to collect, store, and analyze biological material for forensic purposes. The manufacturer shall establish, document, and maintain an on-going process for identifying, estimating, and evaluating the risks (see 6.2), controlling these risks (see 6.3 and 6.4), and monitoring the effectiveness of controls (see Clauses 7 and 9). The manufacturer shall collect and periodically review relevant product and process information (e.g. analysis of data, customer complaints, and corrective and preventive actions) to evaluate if any previously unrecognized risks are present or if a previously  dentified risk is no longer acceptable. If either of these occurs, the impact on previously implemented risk assessment and control measures shall be evaluated and the risk control measures updated as necessary. The results of the periodic reviews shall be recorded.AS ISO 18385 pdf download.

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