ISO 9001:2015 (RISKs Element) By KAMARRUDIN ALI 18

Transcript:ISO 9001:2015 (RISKs Element) By KAMARRUDIN ALI 18:
ISO 9001:2015 (RISKs Element) By KAMARRUDIN ALI 18 April 2018 ISO 9001:2015 Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise ISO 9001:2015 REQUIREMENTS ISO 9001:2015 requires for the organization to determine the risks and opportunities based on the knowledge of the organization’s context (4.1 & 4.2) EXTERNAL ANALYSIS (PESTEL) (including issues from interested parties) 4 Template A INTERNAL ANALYSIS (SWOT) 5 Note: As a guide to do a thorough analysis for each of the above quadrants, a normal tool used is FITCOW which is Financial, Infrastructure, Technology, Competency, Operation (Process) and work environment) Template A 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) enhance desirable effects; c) prevent, or reduce, undesired effects; d) achieve improvement. ISO 9001:2015 REQUIREMENTS Identifying Risks Risks are determined to prevent or reduce undesired effects, and to give assurance that quality management system can achieve its intended results. ISO 9001 does not define specific types of risks that need to be determined and addressed Types and categories of risks are commonly used: Processes: risks of nonconforming output, process breakdown, process inefficiency, excessive variability, etc. Quality: risk of defects and non-attainment of specified requirements Suppliers: risk of defects and non-attainment of specified requirements Operation: risks to business continuity, data loss, public relations, etc.; What about Opportunity? Apart from the risks, the organization has to also identify the opportunities that may come in its way. Opportunities can be in form of adoption of new practices, launching of new products or services, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs. Why Risks are considered? Risk : Effect of uncertainties Risk Level: Likelihood x consequences Risks and opportunities can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed Managing Risks Step 1: Identify the Risk. ... Step 2: Analyze the risk. ... Step 3: Evaluate