Information & Training. | Quality Assurance. Quality Management.
ISO 9001 2015.
New requirements and changed emphasis under the 2015 revision.
ISO 9001 2015 was released on 15th September 2015. There was a three year transition period, therefore conformity to the previous ISO 9001 2008 revision was acceptable up to 14th September 2018, after this date in order to be compliant to the ISO 9001 standard, an organization must meet the requirements of the ISO 9001 2015 revision.
What are the changes to the ISO 9001 standard required under the 2015 revision?
In general, the major focus of the revision is as follows*:
i) Make the standard more compatible with services and non-manufacturing users.
ii) The “process” approach has been strengthened.
iii) The concept of preventive action is now addressed throughout the standard by risk identification and mitigation.
iv) The term “documented information” replaces the terms “document” and “record”.
v) The requirement for control of externally provided products and services replaces the concepts of “purchasing” and “outsourcing”.
vi) There is a greater emphasis on seeking opportunities for improvement.
*(reference ISO TC 176 SC 02 – International Organization for Standardization, Technical Committee 176, Sub-committee 02 with responsibility for Quality Systems).
The Principles of Quality Management
The Quality Manual
Quality Standards and Specifications
The Quality Management System
Revised requirements of ISO 9001: 2015
Design Quality – Products & Processes
Good Manufacturing Practice (GMP)
Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
Information & Training presentation >>>
The standard has been aligned with the Deming’s “Plan – Do – Check – Act”
Plan: Context, Leadership, Planning and Support (sections 4,5,6, 7)
Do: Operations (section 8)
Check: Performance and Evaluation (section 9)
Act: Improvement (section 10)
Sections of the ISO 9001 2015 standard aligned with “Plan-Do- Check-Act”:
1 Scope.
2 Normative reference.
3 Terms and definitions.
4 Context of the organization, this includes establishing an understanding of the organization and its context, understanding the needs and expectations of interested parties, determining the scope of the quality management system, describing the Quality Management System and its processes.
5 Leadership. Details expectations concerning organizational leadership and commitment, the development of a leadership policy, the defining of the roles, responsibilities and spans of authority for those in positions of leadership.
6 Planning. What are the quality objectives (KPI’s) for the organization, what is the plan to realize those objectives, how will change be managed, how are risks identified and managed, equally is there a plan for identifying and exploiting opportunities?
7 Support. How are the organizational quality resource needs identified and provided? How are the competence requirements for staff fulfilled? Staff need to be aware of the potential quality impacts of their roles. Processes need to be in place to ensure effective quality related communication. The appropriate “documented information” must be in place to span the quality impacting activities.
8 Operation. This section spans, operational planning and control, the customer requirements for products and services provided by the organization, the processes and practices covering the design and development of products and services. The control of externally provided processes, products and services, the production and service provision, the release of products and services and the control of nonconforming outputs.
9 Performance evaluation. Includes requirements on the monitoring, measurement, analysis and evaluation for organizational wide performances, including the implementation of an effective internal audit program and the holding of the Management Review.
10 Improvement. There is a strong focus on the need for ongoing improvement across all quality impacting activities. Specifically, the identification and investigation of non-conformances and the implementation of efficient and effective corrective action. There is a required emphasis for an ongoing focus on continuous improvement.
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>