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 · A Standard Operating Procedure (SOP) is a standardized process that outlines a set of detailed instructions to help workers perform complex tasks properly and safely. The main objective of standard operating procedures is to develop an effective quality system and comply with industry-specific regulations and standards.

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 · (2) A risk assessment must take into consideration the nature of the workplace, the type of work, the conditions of work at that workplace and the conditions of work common at similar workplaces. O. Reg. 167/16, s. 3. (3) The results of an assessment must be provided, in writing, to the joint health and safety committee or the health and safety representative, if any. …

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 · ISO 9001, CAN3-Z299.2-1985, Z299.3-1985, Z299.4-1985, USFDA GMP, Health Canada, European Medical Device Directive 93/42/EEC and EN 46001. The Management fully endorses the Quality Assurance program as detailed in this manual.

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 · The ISO 22400 reports have presented a set of KPIs to evaluate the performance for manufacturing and processing operations using five basic elements of measurements (ISO, 2014a, ISO, 2014b, ISO, 2017, ISO, 2018). The basic elements for a manufacturing system as identified by ISO 22400 standard are related to planned and real-time measurements ...

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