Quality, the assurance of improvement. Quality, the assurance of improvement. Using ISO in AQU Catalunya Núria Comet, Barcelona, 14th April 2008

Quality, the assurance of improvement. ISO requirements ISO and European Standards Using ISO in AQU Catalunya Index

Quality, the assurance of improvement. What is ISO 9001? ISO 9001 is an international consensus on good quality management practices. It provides a set of requirements for a quality management system, regardless of : what the organization does, its size, whether it is in the private, or public sector. Iso survey, 2006

Quality, the assurance of improvement. Number of certified universities by ISO (Spain)

Quality, the assurance of improvement. ISO has a bad reputation; it is considered to be a formal system with many requirements. ISO 9001:2000 Has significantly reduced the documental requirements Less preceptive than the 1994 version More flexibility ISO 9001 What are the real requirements of ISO 9001?

Quality, the assurance of improvement Control of documents Control of records Internal audit 8.3 Control of nonconforming product Corrective action Preventive action Combine in one document ISO 9001:2000 requires to have documented procedures for the following six activities Requirements

Quality, the assurance of improvement. Quality policy Quality objectives Quality manual Requirements Only three documents are specially mentioned in ISO 9001:2000 (clause 4.2.1)

Quality, the assurance of improvement. For example: Process map Process flow chart Work instructions Documents containing internal communications The entities could increase the number of documents to add value to the Quality management system to save knowledge Requirements

Quality, the assurance of improvement. Is an international system to assure the management of the quality system. Gives a lot of flexibility the formal aspects depends on your organisation. Asks for measurement and evaluation of the activities. Internal revision is mandatory. Yearly external certification. Strong points

Quality, the assurance of improvement. ISO requirements ISO and European Standards Using ISO in our Agency Index

Quality, the assurance of improvement. ESG and ISO 9001 ESG FOR EXTERNAL QUALITY ASSURANCE AGENCIES WHAT ABOUT ISO 9001? Product = Assessment activities 3.2 OFFICIAL STATUSIt doesnt mention legal aspects 3.3 ACTIVITIES - evaluation, review, audit, assessment, accreditation 7. Product realization 3.4 RESOURCES - human and financial 6. Resources management (not financial) 3.5 MISSION STATEMENT: goals, objectives, policy, management plan 5. Management responsibility: Q policy, Q objectives, Q management system 3.6 INDEPENDENCEIt doesnt mention legal aspects 3.7 EXTERNAL QUALITY ASSURANCE CRITERIA AND PROCESSES 4. Quality management system: processes, criteria, methods, improvements 3.8 ACCOUNTABILITY PROCEDURES: policy, experts, sub-contractors, feedback 5.3 Quality Policy 7.4 Purchased (evaluate and select suppliers) 8. Measurement, analysis and improvement

Quality, the assurance of improvement. ISO requirements ISO and European Standards Using ISO in AQU Catalunya Index

Quality, the assurance of improvement. Objective: To implant a system that assures quality and the improvement of our activities To fulfil ISO 9001 and ESG requirements To share knowledge A simplified system focused on the day-to-day work Complex systems Very formally systems Full of templates or internal requirements Internal Quality System in AQU DISASTER !!!

Quality, the assurance of improvement. ISO in AQU Catalunya Process map Flow charts We have two work tools Framework that defines the activities Application Project work

Quality, the assurance of improvement. Process map

Quality, the assurance of improvement. Flow charts

Quality, the assurance of improvement. Each project contains: Planning ISO 7.1 Responsibilities ISO Target figures ISO 8 Satisfaction ISO 8 Project work The information is gathered in a single document/file Evidence ISO 4.2 At regular times Project meetings Annually Management review ISO 5.6 Follow-up and analysis of results

Quality, the assurance of improvement. Planning of product realization ISO 7.1 Annual planning Detailed planning for each activity

Quality, the assurance of improvement. Who is in charge? Name When? How often? What to do? Activity details Result: what really happened? Product realization ISO 7 Persons in charge Start Time planned End Actual situa- tion Requirements / Observations Dossier revision Revision of documentation Gloria-Rocio- Marta 12 Nov 3 weeks 3 Dec ok Distribution by dossier number – each person is in charge of the file for the entire process Activity started 7/11/2007 Enter files into G Gloria-Rocio- Marta 12 Nov 3 weeks 3 Dec ok Activity started 7/11/2007 Enter files into GESTA Gloria-Rocio- Marta 12 Nov 3 weeks 3 Dec ok N.B. Change of place!! Planned for 15 Nov ==>< + 1 week/Activity started 7/11/2007

Quality, the assurance of improvement. Objective Result Analysis Mesurament, analysis and improvement ISO 8 Analysis Objective Result Objective Result

Quality, the assurance of improvement. Mesurament, analysis and improvement ISO 8 External and Internal non conforming Result Target

Quality, the assurance of improvement. Conclusions ISO is an approach or a tool to think and reflect on your processes. It helps to ensure the implementation of the ESG

Quality, the assurance of improvement. Conclusions BUT to success is important: Reduce the number of templates and documents. Forget to do things only for ISO. (You will do the day before the external audit). Reduce the number of targets. Introduce the requirements in the daily work. Although all the staff must be trained, it is good to have one internal quality expert in each department.

Quality, the assurance of improvement. Thanks for your attention AQU CATALUNYA