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ISO 9001:2015 Quality Management System

Context of Organization
1. Define the context of organization by establishing aim of organization, nature of
business, benefits of business and also establish strength, weakness, threat and
opportunity for your business.
2. Define the different external issues like competitive, cultural and economic etc. how it
affects your organization and also list out the risks associated with each external
issues.
3. Define the different internal issues like competence, cultural, values etc. how it affects
your organization and also list out the risks associated with each internal issues.
4. Define the stakeholder/interested parties names and give detail what you expect/ need
from them, how it impact your organization and also list out risks associated with
stakeholder/interested parties
5. Risk associated with internal, external and interested parties will be captured in risk
and opportunity module where you can take action to control the risks.
6. Define the scope of QMS for which your organization getting certified and list out the
clauses that are excluded.
7. Give justification for excluded clauses.
8. Flowcharts, procedures and forms related to context can be captured in documented
information module.
Risk and Opportunity
1. Define the risk and opportunity type whether it is captured from context, process and
products/ services
2. Define the activity/ source from where risk/opportunity may occur.
3. Define to which category risk falls from predefined list of categories.
4. Describe the risk in detailed manner.
5. Define how much it impact and probability of occurrence.
6. Define how you are going to treat the risk from predefined list of treatment.
7. Define the suitable action to treat the risk.
8. Define the opportunity and describe proposed action.
9. Procedure and forms related risk and opportunity can be captured in documented
information module.
HR
1. Define organization structure, create employees, departments, roles, designations.
2. Define role, responsibility and authority.
3. define ideal competence
4. Map existing competence with ideal competence and identify competence gaps
through competence evaluation.
5. Identify training needs and create training calendar.
6. Capture training records
7. Carry out training effectiveness evaluation.
8. Manage HR related policies and procedures using documented information control
module.
9. Define, plan and track HR objectives.
Marketing
1. Capture customer enquiry and contact details.
2. Capture follow up for each enquiry
3. Define internal proposal and send to technical teams for reviewing.
4. Update the status of enquiry.
5. Rise work order when status of enquiry changed to won.
6. Send predefined customer feedback to customers.
7. Update the response once you get feedback answers from customer.
8. Define plan and track marketing objectives.
9. Procedures. Forms, flowcharts can be captured in documented information module.
Purchase
1. Create supplier registration by capturing contact details and product/service details.
2. List of approved suppliers are available in read only version.
3. Capture the Re-evaluation details of each supplier by providing value to predefined
parameter.
4. Define the criteria for outsourced process.
5. Update the purchase order details from original purchase order.
6. Define, plan and track purchase objectives.
7. Procedures and forms related to purchase can be captured in documented information
module.
Design and development
1. Identify the design and development project.
2. Define the planning for identified design & development project.
3. Define inputs for identified design & development project
4. Define outputs for identified design & development project
5. Capture review and verification details for identified design & development project.
6. Define validation for identified design & development project
7. Define what changes to be done for identified design & development project
8. Define, plan and track design and development objectives.
9. Procedures and forms related design and development module can be captured in
documented information module.
Quality
1. Establish quality policy.
2. Define quality objectives for each department.
3. Define objective achievement plan for each objective.
4. Define objective tracking for each objective.
5. Define incoming inspection quality plan for raw materials/purchased product-service
6. Capture the incoming inspection quality record for all purchased products/purchase
order.
7. Define in-process inspection quality plan for processes.
8. Capture the in-process inspection quality plan for processes/work order.
9. Define final inspection quality plan for final products/services
10. Capture the final inspection quality record for final product/work order
11. Define the improvement activity.
12. Procedures and forms related to quality can be captured in documented information
module.
Operations
1. Define the raw materials
2. Define the product/services
3. Raise the work order by providing details of work order and responsible person for
work order.
4. Establish operation planning for each product by defining processes and resources
required.
5. Determine the process by defining input, working, output, process effectiveness and
risks associated.
6. Risk associated with process will be captured in Risk and Opportunity module and
action taken can be addressed in risk and opportunity module.
7. Establish process validation where output of process cannot be measured.
8. Prepare the execution plan for work order.
9. Define the equipment’s.
10. Schedule the equipment for calibration.
11. Update the calibration details of equipment after calibration.
12. Schedule the equipment for preventive maintenance
13. Update the preventive maintenance of equipment details after preventive
maintenance.
14. Capture the breakdown details
15. Capture the customer owned property.
16. Define what to monitor and when to monitor.
17. Procedures and forms related to Operation can be captured in documented
information module.
Non conformance
1. Define the non-conformance.
2. Define non-conformance type.
3. Define correction.
4. Define root cause analysis.
5. Define proposed corrective action.
6. Define actual corrective action.
7. Define verification taken.
8. Define effectiveness of corrective action.
Internal audit
1. Define master schedule for each department to conduct internal audit.
2. Define internal audit schedule.
3. Define internal audit report.
4. Non-conformance captured here will be reflected in non-conformance module where
you can take action.
5. Procedure and forms related to internal audit can be captured in documented
information module.
MRM
1. Define the MRM agendas and send mail to attendees.
2. Define the discussion/minutes against each agenda.
3. Capture the action planned during meeting.
4. Procedures and forms related to MRM can be captured in documented information
module.
Documented information
1. Define the department, document type, document name and attach related files.
2. Define retention and disposal mechanism only for forms and checklist type.
3. Able to Raise change request for any document.
4. Define external document by providing details like document name, department,
revision number, revision date.