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Chapter-04 SOPs and Policy Manual Writing: Why are they Important and How to Implement in Your Laboratory?

BOOK TITLE: ISARCON 2017 Manual of Data Management and Quality Control, March to Perfection Complete Hands of IVF

Author
1. Padgaonkar Shreyas
ISBN
9789352700790
DOI
10.5005/jp/books/14173_5
Edition
1/e
Publishing Year
2018
Pages
5
Author Affiliations
1. Shreyas Infertility and IVF Centre, Mumbai, Shreyas Infertility and IVF Centre, Mulund, Mumbai, India
Chapter keywords
Quality policy, standard operating procedure, SOP, quality assurance, quality assurance procedure, in vitro fertilization, IVF, IVF laboratory

Abstract

A quality policy is a predetermined course of action established as a guide toward accepted objectives and strategies of the organization. The policies should be a reflection of organization’s mission and objectives. A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. The procedure of writing, revising, approving of SOPs and control of distribution of SOPs is an important quality assurance procedure. For in vitro fertilization (IVF) laboratory, SOPs are based on ISO 15189:2012 section 5.5. IVF lab director is responsible for the SOP preparation, implementation and review. The chapter also covers steps of writing SOPs, elements, aims, format of SOPs, etc.

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