1. OPERATIONS
(Note: integration of para.’s 4.0, 5.0, 6.0 Philosophies)
Quality is Culture 1 November 2016

2. 2
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3. *
8.1 Operational planning and Control
(previously ISO 9001:2008, para. 7.1)
8.2 Requirements for products and services (7.2)
8.3 Design and Development of products and services (7.3)
8.4 Control of Externally provided products and Services (7.4)
8.5 Production and Service (7.5)
8.6 Release of products and Services (8.2.4)
8.7 Control of nonconforming outputs, products and services
(8.3)
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4. *
8.1 Operational Planning and Control
• Determine requirements
• Establish criteria for processes and acceptance
• Determine resources needed to achieve conformity
• Implement controls
• Documented information as necessary
Outsourced processes are controlled.
-New: Control planned changes and review the
consequences of unintended changes, taking actions to
mitigate any adverse effects (risk)
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5. *
8.2 Requirements for products and services (Sales)
(Similar to ISO 9001, para. 7.2 but reorganized to consider internet/
catalog orders that don’t require extensive review)
• Customer Communication
-New: specific requirements for contingency actions, when relevant
• Determine requirements
• Review of requirements, retained information, handling
changes
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6. *
8.3 Design and Development (Similar to ISO 9001, para. 7.3)
• Design and Development Planning
• Design and Development Inputs
• Design and Development Controls
• Design and Development Outputs
• Design and Development Changes
- emphasis on customer interaction
- added:
- (planning) 8.3.2.a Nature, duration, and complexity of the design
and development activities
- (input) 8.3.2.e the potential consequences of failure due to the
nature of the products and services.
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7. *
8.4 Externally provided processes, products, and services
(Purchasing, similar to ISO 9001, para. 7.4)
• Type and extent of control
• Information for External Providers
• Retained documentation
- 8.4.1 b. addresses “drop ship”
- 8.4.2.c.1. Take into consideration the potential impact to meet
all requirements
- 8.4.2.c.2 The effectiveness of controls applied by the external
provider
- Consider sister companies
v Terms suppliers and outsourcing are no longer used
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8. *
8.5 Production and Service Provision
(Similar to ISO 9001:2008, para. 7.5)
• Documented Information
• Suitable Monitoring and Measuring Resources
• Monitoring and Measuring Activities
• Infrastructure and Environment
• Competent persons
• Validation and revalidation of ‘Special Processes’
• Prevent Human Error
• Release, delivery, and post-delivery activities
• Identification and Traceability
• Property belonging to customers and external providers (expanded)
• Preservation of products and services
• Post Delivery Activities
• Control of Changes (documented information)
8.6 Release of Products and Services (documented information)
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8.7 Control of Nonconforming Outputs
(Similar to ISO 9001:2008, para. 8.3)
v Identified
v Controlled
v Prevent unintended use or delivery
v Take action (including on post delivery product and services)
- Correction
- segregation, containment, return or suspension of provision of
products and services.
- Informing the customer
- Obtaining authorization for acceptance under concession
- Upon correction, verification of conformity
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