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ISO 13485: 2016
OPTION 1 – Training service (application for company that has ISO certificate or has document system)
- Awareness/ interpretation training (2 man-days)
- Writing documents training (2 man-days)
- Internal auditor training (2 man-days)
OPTION 2 - Training and consulting service (application for the 1st time you have set up ISO 13485 system)
ISO 13485: 2016 TRAINING & CONSULTING PLAN
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Sq. |
Items of ISO project |
In charge |
Progress with milestone (month/ week)
|
Total Man-days |
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1st month
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2nd month |
3rd month
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4th month
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5th month
|
6th month
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1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
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1 |
Factory tour & general documents & records survey |
Consultant & ISO team |
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1 |
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2 |
ISO 13485 awareness & interpretation training |
Consultant & ISO team |
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2 |
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3 |
Writing documents assignment for each of the Depts |
ISO team |
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1 |
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4 |
Writing/ modification the procedures/ documents |
Consultant & ISO team |
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8 |
|
5 |
Issue documents |
ISO team |
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- |
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6 |
Training general requirements to ISO team |
Consultant & ISO team |
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1 |
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7 |
ISO 13485 internal auditor training |
Consultant & ISO team |
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2 |
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8 |
Internal audit |
Consultant & ISO team |
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5 |
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9 |
Management review |
BOD & ISO team |
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- |
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10 |
Corrective action after internal audit |
Consultant & ISO team |
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1 |
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11 |
Pre-audit by consultant |
Consultant & ISO team |
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1 |
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12 |
Certificating audit - 1st stage audit (*) |
ISO team & auditors team |
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- |
|
13 |
Corrective action |
Consultant & ISO team |
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- |
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14 |
Certificating audit – 2nd stage audit (**) |
ISO team & auditors team |
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- |
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15 |
Total man-days |
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22 |
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Notes: Certification audit is carried out by the independent Certification Body (Ex: SGS, TUV, QUACERT…)
(*) & (**) Certification Body will make the certification audit plan with man-days properly.
LIST OF DOCUMENTS NEED TO BE WRITTEN ACCORDING TO ISO 13485: 2016 4.2.3 5.5.3 6.3 6.4.2 7.1 7.1 7.5.10 7.5.9 7.5.11 8.2.4
Quality policy
Quality objective
Quality manual
Control of Law & compliance relating to products procedure
Control of documents procedure
Control of records procedure
Job description
Management review procedure
Provision of human resources procedure
Competence training and management procedure
Maintenance and repair procedure
Employees health care procedure
Control of pest procedure
Work environment management procedure
Hazard identification and risk assessment procedure
Material standards
Review of contracts procedure
Evaluation of suppliers procedure
Purchase procedure
Material check procedure
Control of manufacture procedure
Control of 4M changes procedure
Delivery procedure
Validation of the value of using production & using software procedure
Input – output control procedure
Control of measuring instrument procedure
Customer feedback and complaints solving procedure
Internal audit procedure
In-process & final check procedures
Control of nonconforming product procedure
Statistic procedure (Data analysis)
Improvement procedure
Corrective action procedure
Preventive action procedure
Work instructions
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