ISO 9001:2016 Support. Created by RAMP Enterprises LLC - Quality is Culture

1. SUPPORT
Quality is Culture 1 November 2016

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3. *
* 7.1 Resources
* 7.2 Competence
* 7.3 Awareness
* 7.4 Communication
* 7.5 Documented information
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4. *
7.1 Resources (Similar to ISO 9001:2008,para. 6.0, but added)
1. General
• The capabilities of, and constraints on, existing resources
<related to meeting lead times>
• What needs to be obtained from external providers <make/
buy decision>
2. People
3. Infrastructure - added information and communication
technology (IT)
4. Environment – Note includes human and physical factors
(social, psychological, physical)
5. Monitoring and Measuring Resources <Calibration
requirement!>
6. Organizational Knowledge<new>
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5. *
* Organizational Knowledge –
1. Determine the knowledge necessary for the operation of its
processes and to achieve conformity of products and
services.
2. This knowledge shall be maintained, and made available to
the extent necessary.
3. When addressing changing needs and trends, the
organization shall consider its current knowledge and
determine how to acquire or access the necessary additional
knowledge.
- Ex: intellectual property, lessons learned, “tribal knowledge”
- See Annex A
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6. *
7.2 Competence (Similar to ISO 9001:2008)
Removed reference to skills
• Determine necessary competence
• Ensure competence based on education, training,
experience
• Take actions to acquire competence, and evaluate
the effectiveness of actions
• Retain documented information
- Note: Actions can include mentoring, reassignment,
hiring contracting competent persons.
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7. *
7.3 Awareness
- Quality policy
- Objectives
- Contribution to the effectiveness of the QMS
- The implications of not conforming with the QMS
7.4 Internal and External Communication, determine:
- What will be communicated
- When to communicate
- With whom
- How
- Who communicates
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7.5 Documented information (Similar to ISO 9001:2008, para. 4.2.3, 4.2.4)
1. Look for referenced requirements within this standard
2. Creating & updating (identification, description, format, media, review
and approval)
* <format can be software, graphics, etc.>
* <media can be paper or electronic>
3. Control of documented information
1. available, suitable
2. protected (apply risk)
* Distribution, access, retrieval, use
* Storage, preservation, legibility
* Control of changes
* Retention and disposition
Information of External origin controlled
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