![]() ![]() (Device Master Record) quality assurance procedures and specifications including control plans, inspection equipment and procedures, acceptance criteria, etc. (Device Master Record) production process specifications including equipment, production methods and procedures, operator (work) instructions, production environment specifications, etc. BSI, together with its Group Companies, also offers a broad portfolio of business solutions other than NSB activity that help businesses worldwide to improve results through Standards-based best practice (such as certification, self-assessment tool, software, product testing, information products and training).INTERNAL AUDIT CHECKLIST Issued by: QA ISO13485 Requirements 4 Quality Management System 4.1 General requirements Date: What to look for and how 4.1 Is the quality management system documented, implemented and maintained in accordance with requirements of ISO 13485? Are processes needed for the quality management system identified and established (process map)? Is the sequence and interaction between these processes determined (process map)? Are criteria and methods for the operation and control of quality system processes established (operational procedures)? Are required resources available? Are quality system processes monitored and measured (internal audit, customer feedback, manufacturing process performance, etc.)? 4.1 Are outsourced processes adequately controlled? How are outsourced processes controlled? Are outputs of outsourced processes verified? Are subcontractors and suppliers required to operate and maintain quality management systems (ISO 9001, for example)? 4.2 4.2.1 4.2.1 Documentation requirements General Are the following types of documents established, maintained and controlled: quality policy and quality objectives quality manual operational procedures device specifications including drawings, composition, formulation, components, software etc. The British Standards Institution (BSI, a company incorporated by Royal Charter), performs the National Standards Body (NSB) activity in the UK. ![]() Likewise, we do not offer consultancy to clients when they also seek certification to the same management system. It means decisions are made free from any engagements of influences which could affect the objectivity of decision making.Īs an accredited certification body, BSI Assurance cannot offer certification to clients where they have also received consultancy from another part of the BSI Group for the same management system. Impartiality means acting fairly and equitably in its dealings with people and in all business operations. Impartiality is the governing principle of how BSI provides its services.
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