Flashcards
3er parcial
Cards in this deck (23)
- 1How many norms integrate the ISO 9000?4 Norms:
*9000:Foundation and vocabulary
*9001 (2015): Requirements (industries)
*9004 (2009): Managing for the sustained success of an org.
*10911 (2018): Guidelines for auditing MS (for all ISO) - 2Describe the 5 Strategies1. A clear understanding of the role of quality
2. Minimize the # norms inside ISO 9000
3. Minimize the # norms developed outside ISO
4. Assure the integrity of ISO 9000
5. Maximize the usefulness and implementation. - 3How many sections does the ISO 9000 have?1. Scope
2. Normative Ref
3. Terms and definitions
GENERAL TERMS (1-3)
4. About the org
5. Leadership and Governance
6. QMS Planning
7. Support
8. Operation
9. Follow Up
10. Improvement - 4What contains the scope?*Can be applied to any org
*Benefits include enhanced customer satisfaction, process standardization. - 5Name the important points of section 4 "About the organization"4.1. Understand the org. and context.
4.2. Identify interested parties and requirements of QMS.
4.3. Establish the scope of the (documented).
4.4. QMS and ist process:
4.4.1 QMS established.
4.4.2. Info documented - 6Name the important points of section 5 "Leadership and Governance"5.1 Leadership and Governance
5.1.1 Top management and leadership demonstration.
5.1.2 Customer Focus.
5.2 Policy
5.2.1 Quality Policy Development
5.2.2 Communicate, understand and application
5.3 Responsibilities and roles need to be assigned. - 7Name the important points of section 6 "QMS Planning"6.1 Actions to address the risk and opportunities.
6.1.1 Assure to reach the committed results.
6.1.2. The org. plans the actions to improve the system
6.2 Quality objectives and planning
6.2.1 Establish the quality objectives
6.2.2 During plannification consider resource availability - 8Name the important points of section 7 "Support"7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documentation - 9Name the important points of section 8 "Operation"8.1 Planning implementation and control of all required process
8.2 Communication with customer
8.3 Establish services, implement and maintain the design and development process to assure the supply of the product and services
8.4 Assure that all products and services supplied externally to comply with the requirements.
8.5 Production and provision of the service.
8.6 Product and service release
8.7 Control on the non-conforming product. - 10Name the important points of section 9 "Follow up"9.1 Follow up measurement, analysis and evaluation
9.2 Internal Audits - 11Name the important points of section 10 "Improvement"10.1 Generalities
10.2 Non-conformance and corrective actions should be documented and closed
10.3 Continuous improvement - 12Steps to write a procedure1. Decide the process limits (detail the requirements for each step)
2.Gather the info (understand the whole process)
3. Allign with other document/process
4. Define the document structure (also exists the standard document structure).
5. Write the document.
6. Get approval for the document
7. Train the relevant employees. - 13Name the different types of audits1. First Party Audits (inside the company)
2. Second Party Audits (made by subcontract)
3. Third-Party Audits (independent org./ Certifying body) - 14What is the purpose of an audit*To verify adequacy, compliance, and effectiveness of the management system
*It is about finding facts, not fault. - 15Name the principles related to auditors*Integrity (professionalism)
*Fair presentation (Truthfully)
*Due Professional Care (Judgment)
*Confidentiality (not using the info for personal gain)
*Independence (Impartiality)
*Evidence-based-approach (Based on appropriate samples - 16People involved in an audit*Lead Auditor (manages the audit)
*Auditor (The one that audits)
*Auditee (the one being audited)
*Audit Client (the one that requests the audit) - 17How many phases have an audit?5:
1. Initiation (Initial contact, to program the schedule, plan or request)
2. Preparation (Define the objectives, include details)
3. Execution
4. Reporting
5. Follow up
6. Closure - 18What does the lead auditor define in step 2 "preparation"?*Competence or training of auditors (knowledge on standards, skills in MS discipline and Education.
*Preparation of working documents
*Auditors should study the process, policies, guidelines, and Records of the auditee
*Toolkit (Itinerary, Report forms, the standard) - 19What happens in the 3rd step "Execution"?*Is an open meeting between the lead auditors and auditees. (Introduction of the audit team, procedure of the audit and relevant safety procedures).
*Obtaining info (Observations, asking, check facts, review records) - 20What happens in the Reporting phase?*The non-conformances are written down in a report
*Consolidate the findings and summarize them
*Conduct the closing meeting
*Discuss the results
*Agree on posible action plan - 21Name the types of audit findings*Major findings (absence or total breakdown of a system to meet the requirements)
*Minor findings (failure to conform a requirement, minimal risk of non-conforming products)
*Observations (Not complying a guideline, doesn't jeopardize the quality, doesn't need corrective actions) - 22What happens in the follow up step?*Auditor evaluates the adequacy of actions and time to close the findings.
*Follow up to the dates committed.
*Searching for continuous improvement - 23Name the performance audit types*Supplier audit (By purchases of their suppliers)
*Certification (Used to maintain certification)
*Award audits
*Consultant audits (Performed by a consultant to determine the maturity of a company)
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- Quality Integrated Systems Flashcards on 3er parcial, created by Mayte Bm on 31/10/2019.
- Created by
- Mayte Bm · Oct 2019
- Updated
- Nov 1, 2019
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