ISO 9001.2015 Transition (Sample)
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Transcript of ISO 9001.2015 Transition (Sample)
• ISO 9001:2015 / ISO 9001:2008 Standards Comparison
• Key Terminology Changes
• Major Differences between ISO 9001:2015 and ISO 9001:2008
• ISO 9001:2015 Changes & Additions – by Clause / Elements
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ISO 9001:2015 ISO 9001:2008 Clause 4: •Context of Organization – Internal & External • Needs & Expectations of Interested Parties • Scope of QMS & Processes – Risks & Opportunities / Documented Information
Clause 4: •QMS • Documentation Requirements; including Quality Manual, & Control of Documents / Records
Clause 5: •Leadership & Commitment – Customer Focus •Quality Policy •Organizational Roles, Responsibilities, & Authorities
Clause 5: •Management Commitment – Customer Focus •Quality Policy • Responsibility & Authority •Management Representative & Communication •Management Review
Clause 6: •Actions to Address Risks & Opportunities •Quality Objectives & Planning to Achieve
Clause 6: •Resource Management – Human Resources •Infrastructure • Work Environment
Clause 7: •Resources – People, Organizational Knowledge, Competence, Awareness, & Communication •Infrastructure •Environment for Operation of Processes •Monitoring & Measuring Resources
Clause 7: •Planning of Product Realization •Customer-Related Processes •Design & Development •Purchasing Process •Production & Service Provision •Control of Monitoring & Measuring Equipment
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ISO 9001:2015
ISO 9001:2008
Added “Risk-Based Thinking”
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Strategic Planning
• Context of Organization
• Needs / Expectations of Interested Parties
• Risks & Opportunities (Risk-Based Thinking)
• Internal & external issues, relevant to purpose and strategic direction, that affects ability of organization to achieve intended results of QMS (ex: technology, market, company culture, performance)
Context of Organization
• Individuals and/or groups that have a stake in or are affected by the QMS of an organization and its products or services (ex: customers, suppliers, end-users, regulatory bodies)
Interested Parties
•RIsks - effects of uncertainty; having a negative or positive result (ex: using single source supplier)
•Opportunities - situation favorable for achieving an intended result (ex: addressing new customers)
Risks & Opportunities (Risk-Based Thinking)
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Reduce / eliminate undesirable
Enhance desirable / Achieve
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Infrastructure & Environment
Buildings, Utilities,
Workspace / Environment Suitable to Operations (human & physical factors)
Monitoring & Measuring
Resources / Equipment
People & Communication
Competency Requirements
/ Needs
Communication & Awareness of
QMS
Organizational Knowledge
Company-specific information, product / trade relative, or tribal knowledge
which may result from lessons learned or previously
undocumented
Information necessary for operation of processes / achieving conformity of
products & services
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Control of Production &
Service Provision
Identification, Traceability, & Preservation
Property belonging to Customers or
External Providers
Post Delivery Activities
Control of Changes
Control of Nonconforming Outputs
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Control of Production & Service Provision
now includes:
•use of suitable infrastructure / environment
• appointment of competent / qualified persons
• implementation of actions to prevent human errors
Post Delivery Activities
include:
• statutory / regulatory requirements
•potential undesired consequences
•nature, use, & intended product / service lifetime
• customer requirements
• customer feedback
Control of Changes
include:
• review / control changes to extent necessary to ensure continuing conformity with requirements
• retain documented information describing results of change review, actions, & person(s) authorizing change
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Management Review
Internal Audit
Monitoring, Measurement,
Analysis, & Evaluation
QMS
PERFORMANCE
EVALUATION
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•React & take action to control / correct
•Evaluate need to eliminate cause / prevent recurrence
Nonconformity
• Implement any action needed
•Review effectiveness of Corrective Action taken
•Update Risks & Opportunities determined during planning
•Make changes to QMS, as necessary
Corrective Action
•Continually improve suitability, adequacy, and effectiveness of QMS
•Consider results of analysis, evaluation, and outputs from Management Review
Continual Improvement
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