ISO 2001 Requirements - Eastern Illinois University

ISO 2001 Requirements - Eastern Illinois University

Quality Management Systems Anurag Sharma Alfred Borget Anoye Introduction Why develop quality standard?

To increase quality oriented customers To generalize norms of quality To prepare credible benchmarking Most prevalent standards

ISO 9000: specifies necessary components of a quality management system ISO 14001: manages environment processes and impacts QS 9000: supplement of IS0 9000:1994 for continuous improvement, prevention of nonconformance, and scrap and rework reduction ISO/TS 16949: specific to the Automotive industry Most prevalent standards (contd)

AS 9100: specific to aerospace industry TL 9000: specific to telecommunications industry ISO 13485 & 88: specific to medical devices TE Supplement: specific to US

automotive suppliers History of ISO Found in 1946 International standards for quality systems published in 1987 Republished and updated version in 1994

Benefits of ISO regulation Significant improvement on: Internal quality Production reliability External quality Time performance Cost of poor quality ISO 9000 series of Standards

ISO 9000: 2000 focus on fundamentals and vocabulary ISO 9001: 2000focus on requirements ISO 9004: 2000focus on guidelines for performance improvement ISO 2001 Requirements

It is the standard used for registration by acquiring conformity of the quality management system More details of IS0 9001 found in Implementing ISO

Management Interest Management representation Awareness and communication Assigning a team Training and practices Time Frame Element ownership Implementing ISO (contd)

Revision of the current system Documentation Identifying flaws Installing new system Auditing Management assessment Registration Documentation (why is it needed?)

Records or proofs Future references Planning and updating Traceability Cascading documentation Policy Procedure

Work Instructions Document Development Document development

Policies, procedures and work instruction brought together Revision Discarding irrelevant documents Changes and amendments Updating Reader friendly format Documentation

Simplicity Brevity and Conciseness Attractive format Good fonts and designs Relevant information Traceability Underscoring important issues Creating Manuals

Statement of purpose Companys policy Making controlled copies Inclusion of ISO 9001 Flow diagrams and figures instead of verbiage Procedure manuals (refer to flow diagram in text)

Auditing One of the key elements of ISO standard, audit is performed in order to make sure if the system is being followed and the expected results are obtained. It is done by the qualified individuals who are trained in auditing principles and procedures. Objectives of Auditing

Conformance of actual performance Identifying deficiencies and implementing corrective actions Improvising the system Inculcating flawless process to employees Auditing techniques

Examining documentation Observing activities Listening to employees Identifying significant issues from trivial Generating appropriate questionnaire Auditing procedure

Auditing procedure comprises of making audit plan and checklist first. The plan should contain department, its activity, list of procedures and regulatory requirement. The checklist on the other hand is a form of questions based on procedures, records and work instruction to ensure the well running of system. Registration Quality systems registration is an assessment and audit of a quality system by a third party; a registrar. Selecting a registrar is based upon

the qualifications, recognition, process of registration and time limits. Registration process Application Review

Preassessment Assessment Registration Follow-up surveillance Questions What is more important, implementation of an ISO or its registration? Case study

Company A has an ISO 9001 registration, all its processes are well governed and follow ISO regulations. It delivers excellent products to customers. Company B does not have ISO registration, but it still manufactures products as good as Company A. How can we prove company A superior to company B?

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