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ISO 13485: 2016

OPTION 1 – Training service (application for company that has ISO certificate or has document system)

  1. Awareness/ interpretation training  (2 man-days)
  2. Writing documents training (2 man-days)
  3. 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

Sq.

 

Items of ISO project

 

 

In charge

Progress with milestone (month/ week)

 

Total

Man-days

1st month

2nd month

3rd month

4th month

5th month

6th month

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

 

1

Factory tour & general documents & records survey

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

2

ISO 13485 awareness & interpretation training

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

 

3

Writing documents assignment for each of the Depts

ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

4

Writing/ modification the procedures/ documents

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

5

Issue documents

ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

 

6

Training general requirements to ISO team

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

7

ISO 13485 internal auditor training

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

 

8

Internal audit

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

 

9

Management review

BOD & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

 

10

Corrective action after internal audit

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

11

Pre-audit  by consultant

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

12

Certificating audit - 1st stage audit (*)

ISO team & auditors team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

 

13

Corrective action

Consultant & ISO team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

 

14

Certificating audit – 2nd stage audit (**)

ISO team & auditors team

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-

 

15

Total man-days

 

 

 

 

 

 

 

22


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

Sq.
Document’s name
ISO 13485 Clause
1
Quality policy
5.3
2
Quality objective
5.4.1
3
Quality manual
4.2.2
4
Control of Law & compliance relating to products procedure
1.0
5
Setting up medical equipment data & records procedure

4.2.3

6
Control of documents procedure
4.2.4
7
Control of records procedure
4.2.5
8
Job description
5.5.1
9
Communication procedure

5.5.3

10
Management review procedure
5.6
11
Provision of human resources procedure
6.1
12
Competence training and management procedure
6.2
13
Maintenance and repair procedure
6.3
14
Mold management procedure

6.3

15
Employees health care procedure
6.4
16
Control of pest procedure
6.4
17
Work environment management procedure
6.4
18
Control of contamination procedure

6.4.2

19
Hazard identification and risk assessment procedure
7.1
20
Technology procedure

7.1

21
Product standards

7.1

22
Material standards
7.1
23
Review of contracts procedure
7.2
24
Evaluation of suppliers procedure
7.4.1
25
Purchase procedure
7.4.2
26
Material check procedure
7.4.3
27
Control of  manufacture procedure
7.5.1
28
Control of 4M changes procedure
7.5.1
29
Delivery procedure
7.5.4
30
Validation of  the value of using production & using software procedure
7.5.6
31
Customer properties management procedure

7.5.10

32
Product traceability procedure

7.5.9

33
Samples of materials & finished products management procedure

7.5.11

34
Input – output control procedure
7.5.11
35
Control of measuring instrument procedure
7.6
36
Customer feedback and complaints solving procedure
8.2.2
37
Reporting to management agencies procedure

8.2.4

38
Internal audit procedure
8.2.4
39
In-process & final check procedures
8.2.6
40
Control of nonconforming product procedure
8.3
41
Statistic procedure (Data analysis)
8.4
42
Improvement procedure
8.5
43
Corrective action procedure
8.5.2
44
Preventive action procedure
8.5.3
45
Work instructions
7.5.1

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