Professional Documents
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Definitions of Risk
Combination of the probability of an event and its consequence (ISO DGUIDE 73)
The chance of something happening that will have an impact upon objectives. It is measured in terms of consequences and likelihood. (AS/NZS 4360)
Risk Management
Acceptance/Tolerance: With or without planning of contingency.
Reduce likelihood or consequence: By establishing processes and controls
Analysis, evaluation and assessment of risk and its rational control in helping to promote the objectives and targets of the business
Auditing
QMS
Risk
Conformance Score
Clause Score Sub Clause Score
Risk Classification
7
7.1 7.2
7.2.1 Determination of requirements related to product 7.2.2 Review of the requirements related to the product 7.2.3 Customer communication 7.3 Design and Development (Title) 7.3.1 Design and Development Planning 7.3.2 Design and Development Input 7.3.3 Design and Development Output 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Design and Development Changes 7.4 Purchasing (Title) 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Validation of Purchase Information 7.5 Product and Service Provision (Title) 7.5.1 Control of product and service provision
Validation of processes for production and service
7.5.2 provision Information 7.5.3 Identification and traceability 7.5.4 Customer Property 7.5.5 Preservation of product 7.6 Control of monitoring and measuring equipment
ACT
PLAN
CHECK
Indicators & Measurement. Audit
DO
Implementation of planned actions