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GE HEALTHCARE AS
Lindesnes Fabrikker
4521
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MSYS
PERS
TAVLER
LEKEPLASS
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Resertifisering
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MSYS
Process Flow Steps
Process flow step 1
Check whether one or more management systems are applicable and determine the applicable standards.
Process flow step 2
Evaluate whether the organization is eligible for multisite certification.
Process flow step 3
Evaluate whether the organization is eligible for multisite certification.
Process flow step 4
Determine the number of sampled sites.
Process flow step 5
Determine the Effective Number of Persons (ENP) for each management system at each site (when relevant)
Process flow step 6
Determine the complexity level for each management system at each site (when applicable)
Process flow step 7
Determine the audit time for each management system at each site (as applicable)
Process flow step 8
Determine the adjustment factors in reduction or increase for each management system at each site (when applicable)
Process flow step 9
In case of multi-site, determine further reduction in audit time for each site (when applicable)
Process flow step 10
In the case of multiple management systems, check whether there are conditions for conducting an integrated audit.
Process flow step 11
Determine the starting point for the total audit time of the integrated management system (IMS)
Process flow step 12
Adjust the starting point figure by considering factors that may increase or reduce the required audit time.
Tilbud prosess
50%
Process flow step 1
Level 5 Standards Applicable to Management Systems
Applicable documents & requirements
Check whether one or more management systems are applicable and determine the applicable standards.
Link: ISO 17021-1:2015 clause 9.1.4
QMS ISO 9001
IAF MD 5:2019 Determination of Audit Time of Quality Management System
EMS ISO 14001
IAF MD 5:2019 Determination of Audit Time of Environmental Management Systems
OH&SMS ISO 45001
IAF MD 5:2019 Determination of Audit Time of Occupational Health & Safety Management Systems
Process flow step 2
Multisite certification
Ingen avdelinger funnet
Applicable documents & requirements
Evaluate whether the organization is eligible for multisite certification.
QMS ISO 9001
Clause 5: Eligibility of a multi-site organization for certification.
Link: IAF MD1:2018
EMS ISO 14001
IAF MD 5:2019 Determination of Audit Time of Environmental Management Systems
OH&SMS ISO 45001
IAF MD 5:2019 Determination of Audit Time of Occupational Health & Safety Management Systems
Process flow step 3
Multisite site
Applicable documents & requirements
Evaluate whether site sampling is appropriate or not
QMS ISO 9001
Ref: IAF MD1:2018:
• clause 6.1: site sampling is appropriate.
• clause 6.2: site sampling is not appropriate.
• clause 6.3: combination of sites that can and cannot be sampled.
• clause 6.2: site sampling is not appropriate.
• clause 6.3: combination of sites that can and cannot be sampled.
EMS ISO 14001
Ref: IAF MD1:2018:
• clause 6.1: site sampling is appropriate.
• clause 6.2: site sampling is not appropriate.
• clause 6.3: combination of sites that can and cannot be sampled.
• clause 6.2: site sampling is not appropriate.
• clause 6.3: combination of sites that can and cannot be sampled.
OH&SMS ISO 45001
Ref: IAF MD1:2018:
• clause 6.1: site sampling is appropriate.
• clause 6.2: site sampling is not appropriate.
• clause 6.3: combination of sites that can and cannot be sampled.
Ref: IAF MD1:2019:
• Clause 9.1.4 • Clause 9.1.5
• clause 6.2: site sampling is not appropriate.
• clause 6.3: combination of sites that can and cannot be sampled.
Ref: IAF MD1:2019:
• Clause 9.1.4 • Clause 9.1.5
Process flow step 4
Multisite site
Applicable documents & requirements
Determine the number of sampled sites.
QMS ISO 9001
Ref: IAF MD1:2018:
• cl 6.1.2 “Sampling”
• cl 6.1.3: “Size of sampling”:
Initial audit: y=√x
Surveillance: y=0.6√x
Recertification: y=√x or y=0.8√x
where MS has proved to be effective.
IAF MD1 clause 6.1.3.4:
“The central function … shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.”
IAF MD1:
y = number of sites to be sampled;
x = total number of sites.
• cl 6.1.2 “Sampling”
• cl 6.1.3: “Size of sampling”:
Initial audit: y=√x
Surveillance: y=0.6√x
Recertification: y=√x or y=0.8√x
where MS has proved to be effective.
IAF MD1 clause 6.1.3.4:
“The central function … shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.”
IAF MD1:
y = number of sites to be sampled;
x = total number of sites.
EMS ISO 14001
Ref: IAF MD1:2018:
• cl 6.1.2 “Sampling”
• cl 6.1.3: “Size of sampling”:
Initial audit: y=√x
Surveillance: y=0.6√x
Recertification: y=√x or y=0.8√x
where MS has proved to be effective.
IAF MD1 clause 6.1.3.4:
“The central function … shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.”
IAF MD1:
y = number of sites to be sampled;
x = total number of sites.
• cl 6.1.2 “Sampling”
• cl 6.1.3: “Size of sampling”:
Initial audit: y=√x
Surveillance: y=0.6√x
Recertification: y=√x or y=0.8√x
where MS has proved to be effective.
IAF MD1 clause 6.1.3.4:
“The central function … shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.”
IAF MD1:
y = number of sites to be sampled;
x = total number of sites.
OH&SMS ISO 45001
Ref: IAF MD1:2018:
• cl 6.1.2 “Sampling”
• cl 6.1.3: “Size of sampling”:
Initial audit: y=√x
Surveillance: y=0.6√x
Recertification: y=√x or y=0.8√x
where MS has proved to be effective.
IAF MD1 clause 6.1.3.4:
“The central function … shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.”
IAF MD1:
y = number of sites to be sampled;
x = total number of sites.
• cl 6.1.2 “Sampling”
• cl 6.1.3: “Size of sampling”:
Initial audit: y=√x
Surveillance: y=0.6√x
Recertification: y=√x or y=0.8√x
where MS has proved to be effective.
IAF MD1 clause 6.1.3.4:
“The central function … shall be audited during the initial certification and every recertification audit and at least once a calendar year as part of surveillance.”
IAF MD1:
y = number of sites to be sampled;
x = total number of sites.
Process flow step 5
Multisite site
Applicable documents & requirements
Determine the Effective Number of Persons (ENP) for each management system at each site (when relevant)
QMS ISO 9001
Ref: AF MD5:2019:
• cl.1.9 (definition of ENP)
• cl. 2.3 (calculation of ENP)
• cl.1.9 (definition of ENP)
• cl. 2.3 (calculation of ENP)
EMS ISO 14001
Ref: AF MD5:2019:
• cl.1.9 (definition of ENP)
• cl. 2.3 (calculation of ENP)
• cl.1.9 (definition of ENP)
• cl. 2.3 (calculation of ENP)
OH&SMS ISO 45001
Ref: AF MD5:2019:
• cl.1.9 (definition of ENP)
• cl. 2.3 (calculation of ENP)
• cl.1.9 (definition of ENP)
• cl. 2.3 (calculation of ENP)
Process flow step 6
Multisite site
QMS table
| Effective number of personnel | Audit time |
|---|---|
| 1-5 | 1.5 hours |
| 6-10 | 2 hours |
| 11-15 | 2.5 hours |
| 16-25 | 3 hours |
| 26-45 | 4 hours |
| 46-65 | 5 hours |
| 66-85 | 6 hours |
| 66-85 | 6 hours |
| 86-125 | 7 hours |
| 126-175 | 8 hours |
| 176-275 | 9 hours |
| 276-425 | 10 hours |
| 426-625 | 11 hours |
| 626-875 | 12 hours |
| 876-1175 | 13 hours |
| 1176-1550 | 14 hours |
| 1551-2025 | 15 hours |
| 2026-2675 | 16 hours |
| 2676-3450 | 17 hours |
| 3451-4350 | 18 hours |
| 4351-5450 | 19 hours |
| 5451-6800 | 20 hours |
| 6801-8500 | 21 hours |
| 8501-10700 | 22 hours |
| >10700 | 23 hours |
EMS table
| Effective number of personnel | High | Medium | Low | Limit |
|---|---|---|---|---|
| 1-5 | 3 | 2.5 | 2.5 | 2.5 |
| 6-10 | 3.5 | 3 | 3 | 3 |
| 11-15 | 4.5 | 3.5 | 3 | 3 |
| 15-25 | 5.5 | 4.5 | 3.5 | 3 |
| 26-45 | 7 | 5.5 | 4 | 3 |
| 46-65 | 8 | 6 | 4.5 | 3.5 |
| 66-85 | 9 | 7 | 5 | 3.5 |
| 86-125 | 12 | 9 | 6 | 4.5 |
| 126-175 | 12 | 9 | 6 | 4.5 |
| 176-275 | 13 | 10 | 7 | 5 |
| 276-425 | 15 | 11 | 8 | 5.5 |
| 426-625 | 16 | 12 | 9 | 6 |
| 626-875 | 17 | 13 | 10 | 6.5 |
| 876-1175 | 19 | 15 | 11 | 7 |
| 1176-1550 | 20 | 16 | 12 | 7.5 |
| 1551-2025 | 21 | 17 | 12 | 8 |
| 2026-2675 | 23 | 18 | 13 | 8.5 |
| 2676-3450 | 25 | 19 | 14 | 9 |
| 3451-4350 | 28 | 21 | 16 | 11 |
| 4351-5450 | 28 | 21 | 16 | 11 |
| 5451-6800 | 30 | 23 | 17 | 12 |
| 6801-8500 | 32 | 25 | 19 | 13 |
| 8501-10700 | 34 | 27 | 20 | 14 |
OH&SMS table
| Effective number of personnel | High | Medium | Low |
|---|---|---|---|
| 1-5 | 3 | 2.5 | 2.5 |
| 6-10 | 3.5 | 3 | 3 |
| 11-15 | 4.5 | 3.5 | 3 |
| 16-25 | 5.5 | 4.5 | 3.5 |
| 26-45 | 7 | 5.5 | 4 |
| 46-65 | 8 | 6 | 4.5 |
| 66-85 | 9 | 7 | 5 |
| 86-125 | 11 | 8 | 5.5 |
| 126-175 | 12 | 9 | 6 |
| 176-275 | 13 | 10 | 7 |
| 276-425 | 15 | 11 | 8 |
| 426-625 | 16 | 12 | 9 |
| 626-875 | 17 | 13 | 10 |
| 876-1175 | 19 | 15 | 11 |
| 1176-1550 | 20 | 16 | 12 |
| 1551-2025 | 21 | 17 | 12 |
| 2026-2675 | 23 | 18 | 13 |
| 2676-3450 | 25 | 19 | 14 |
| 3451-4350 | 27 | 20 | 15 |
| 4351-5450 | 28 | 21 | 16 |
| 5451-6800 | 30 | 25 | 19 |
| 6801-8500 | 32 | 25 | 19 |
| 8501-10700 | 34 | 27 | 20 |
Applicable documents & requirements
Determine the complexity level for each management system at each site (when applicable)
QMS ISO 9001
Ref: IAF MD5:2019:
• table QMS2: complexity level based on the business sector of the organization)
• table QMS2: complexity level based on the business sector of the organization)
EMS ISO 14001
Ref: IAF MD5:2019:
• table EMS2: complexity level based on the business sector of the organization)
• table EMS2: complexity level based on the business sector of the organization)
OH&SMS ISO 45001
Ref: IAF MD5:2019:
• table OH&SMS2: complexity level based on the business sector of the organization)
• table OH&SMS2: complexity level based on the business sector of the organization)
Process flow step 7
Multisite site
QMS table
Template is not defined.
EMS table
Template is not defined.
OH&SMS table
Template is not defined.
Applicable documents & requirements
Determine the audit time for each management system at each site (as applicable)
QMS ISO 9001
Ref: IAF MD5:2019:
• table QMS 1
Note: Table output is “audit time”
• table QMS 1
Note: Table output is “audit time”
EMS ISO 14001
Ref: IAF MD5:2019:
• table EMS 1
Note: Table output is “audit time”
• table EMS 1
Note: Table output is “audit time”
OH&SMS ISO 45001
Ref: IAF MD5:2019:
• table OH&SMS 1
Note: Table output is “audit time”
• table OH&SMS 1
Note: Table output is “audit time”
Process flow step 8
Multisite site
Applicable documents & requirements
Determine the adjustment factors in reduction or increase for each management system at each site (when applicable)
QMS ISO 9001
Ref: IAF MD5:2019:
• clause 8 “Factors for adjustment of audit time”:
reduction: 30% max
increase not quantified
• clause 8 “Factors for adjustment of audit time”:
reduction: 30% max
increase not quantified
EMS ISO 14001
Ref: IAF MD5:2019:
• clause 8 “Factors for adjustment of audit time”:
reduction: 30% max
increase not quantified
• clause 8 “Factors for adjustment of audit time”:
reduction: 30% max
increase not quantified
OH&SMS ISO 45001
Ref: IAF MD5:2019:
• clause 8 “Factors for adjustment of audit time”:
reduction: 30% max
increase not quantified
• clause 8 “Factors for adjustment of audit time”:
reduction: 30% max
increase not quantified
Process flow step 9
Multisite site
Applicable documents & requirements
In case of multi-site, determine further reduction in audit time for each site (when applicable)
QMS ISO 9001
Ref: IAF MD1:2019:
• clause 7.3 “Calculation of audit time”: unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.
• clause 7.3 “Calculation of audit time”: unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.
EMS ISO 14001
Ref: IAF MD1:2019:
• clause 7.3 “Calculation of audit time”: unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.
• clause 7.3 “Calculation of audit time”: unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.
OH&SMS ISO 45001
Ref: IAF MD1:2019:
• clause 7.3 “Calculation of audit time”: unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.
• clause 7.3 “Calculation of audit time”: unless precluded by specific schemes, the reduction of audit time per sampled site shall not be greater than 50%.
Process flow step 10
Multisite site
Applicable documents & requirements
In case of multiple management systems check whether there are the conditions for conducting an integrated audit
QMS ISO 9001
Ref: IAF MD11:2013:
• clause 2 “Application”
• clause 2 “Application”
EMS ISO 14001
Ref: IAF MD11:2013:
• clause 2 “Application”
• clause 2 “Application”
OH&SMS ISO 45001
Ref: IAF MD11:2013:
• clause 2 “Application”
• clause 2 “Application”
Process flow step 11
Multisite site
Applicable documents & requirements
Determine the starting point for the total audit time of the integrated management system (IMS)
QMS ISO 9001
Ref: IAF MD11:2013:
• clause 2.1.5.1b: determine the starting point for calculating the total audit time of an IMS by adding the audit times calculated for each management system that is part of it.
• clause 2.1.5.1b: determine the starting point for calculating the total audit time of an IMS by adding the audit times calculated for each management system that is part of it.
EMS ISO 14001
Ref: IAF MD11:2013:
• clause 2.1.5.1b: determine the starting point for calculating the total audit time of an IMS by adding the audit times calculated for each management system that is part of it.
• clause 2.1.5.1b: determine the starting point for calculating the total audit time of an IMS by adding the audit times calculated for each management system that is part of it.
OH&SMS ISO 45001
Ref: IAF MD11:2013:
• clause 2.1.5.1b: determine the starting point for calculating the total audit time of an IMS by adding the audit times calculated for each management system that is part of it.
• clause 2.1.5.1b: determine the starting point for calculating the total audit time of an IMS by adding the audit times calculated for each management system that is part of it.
Process flow step 12
Multisite site
Applicable documents & requirements
Adjust the starting point figure by considering factors that may increase or reduce the required audit time.
QMS ISO 9001
Ref: IAF MD11:2013:
• clause 2.1.5.1c: take into account factors that may increase or reduce the time required for the audit
• clause 2.1.5.2: reduction ranges from 0% to 20% based on the integration level of the organization MS and of the competence of the CB audit team
• Annex 1 “Reduction of audit time”
• clause 2.1.5.1c: take into account factors that may increase or reduce the time required for the audit
• clause 2.1.5.2: reduction ranges from 0% to 20% based on the integration level of the organization MS and of the competence of the CB audit team
• Annex 1 “Reduction of audit time”
EMS ISO 14001
Ref: IAF MD11:2013:
• clause 2.1.5.1c: take into account factors that may increase or reduce the time required for the audit
• clause 2.1.5.2: reduction ranges from 0% to 20% based on the integration level of the organization MS and of the competence of the CB audit team
• Annex 1 “Reduction of audit time”
• clause 2.1.5.1c: take into account factors that may increase or reduce the time required for the audit
• clause 2.1.5.2: reduction ranges from 0% to 20% based on the integration level of the organization MS and of the competence of the CB audit team
• Annex 1 “Reduction of audit time”
OH&SMS ISO 45001
Ref: IAF MD11:2013:
• clause 2.1.5.1c: take into account factors that may increase or reduce the time required for the audit
• clause 2.1.5.2: reduction ranges from 0% to 20% based on the integration level of the organization MS and of the competence of the CB audit team
• Annex 1 “Reduction of audit time”
• clause 2.1.5.1c: take into account factors that may increase or reduce the time required for the audit
• clause 2.1.5.2: reduction ranges from 0% to 20% based on the integration level of the organization MS and of the competence of the CB audit team
• Annex 1 “Reduction of audit time”
Process flow step 13
Multisite site
Applicable documents & requirements
Calculate the onsite audit duration.
QMS ISO 9001
Ref: IAF MD5:2019:
• clause 4.1: should not be less than 80% of the audit time
• clause 4.1: should not be less than 80% of the audit time
EMS ISO 14001
Ref: IAF MD5:2019:
• clause 4.1: should not be less than 80% of the audit time
• clause 4.1: should not be less than 80% of the audit time
OH&SMS ISO 45001
Ref: IAF MD5:2019:
• clause 4.1: should not be less than 80% of the audit time
• clause 4.1: should not be less than 80% of the audit time
Process flow step 14
Multisite site
Applicable documents & requirements
Consider how to split the audit time between Stage 1 and Stage 2.
For a multisite, Stage 1 could normally be limited to the central function and possibly some other site(s)s as deemed useful.
For a multisite, Stage 1 could normally be limited to the central function and possibly some other site(s)s as deemed useful.
QMS ISO 9001
Ref: IAF MD5:2019:
• clause 3.1, Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1
• clause 3.1, Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1
EMS ISO 14001
Ref: IAF MD5:2019:
• clause 3.1, Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1
• clause 3.1, Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1
OH&SMS ISO 45001
Ref: IAF MD5:2019:
• clause 3.1, Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1
• clause 3.1, Note: Normal practice is that time spent for Stage 2 exceeds time spent for Stage 1
Process flow step 15
Multisite site
Applicable documents & requirements
Determine the audit time for surveillance and recertification audits.
QMS ISO 9001
Ref: IAF MD5:2019:
• clause 5 “Surveillance”: about 1/3 of the audit time spent on the initial certification audit (should not be less than 1 md)
• clause 6: “Recertification”: about 2/3 of the audit time that would be required for an initial certification audit, if such an initial audit were to be carried out at the time of recertification (should not be less than 1 md)
• clause 5 “Surveillance”: about 1/3 of the audit time spent on the initial certification audit (should not be less than 1 md)
• clause 6: “Recertification”: about 2/3 of the audit time that would be required for an initial certification audit, if such an initial audit were to be carried out at the time of recertification (should not be less than 1 md)
EMS ISO 14001
Ref: IAF MD5:2019:
• clause 5 “Surveillance”: about 1/3 of the audit time spent on the initial certification audit (should not be less than 1 md)
• clause 6: “Recertification”: about 2/3 of the audit time that would be required for an initial certification audit, if such an initial audit were to be carried out at the time of recertification (should not be less than 1 md)
• clause 5 “Surveillance”: about 1/3 of the audit time spent on the initial certification audit (should not be less than 1 md)
• clause 6: “Recertification”: about 2/3 of the audit time that would be required for an initial certification audit, if such an initial audit were to be carried out at the time of recertification (should not be less than 1 md)
OH&SMS ISO 45001
Ref: IAF MD5:2019:
• clause 5 “Surveillance”: about 1/3 of the audit time spent on the initial certification audit (should not be less than 1 md)
• clause 6: “Recertification”: about 2/3 of the audit time that would be required for an initial certification audit, if such an initial audit were to be carried out at the time of recertification (should not be less than 1 md)
• clause 5 “Surveillance”: about 1/3 of the audit time spent on the initial certification audit (should not be less than 1 md)
• clause 6: “Recertification”: about 2/3 of the audit time that would be required for an initial certification audit, if such an initial audit were to be carried out at the time of recertification (should not be less than 1 md)
Process flow step 16
Multisite site
Applicable documents & requirements
Confirm audit time or make adjustments as needed during the certification cycle.
QMS ISO 9001
The audit time can be furtherly adapted considering the results of any prior audit
• clause 9.1.4.2 of ISO/IEC 17021-1:2015
• clause 5 and 6 of IAF MD5:2019
• clause 4 of IAF MD11:2013
• clause 9.1.4.2 of ISO/IEC 17021-1:2015
• clause 5 and 6 of IAF MD5:2019
• clause 4 of IAF MD11:2013
EMS ISO 14001
The audit time can be furtherly adapted considering the results of any prior audit
• clause 9.1.4.2 of ISO/IEC 17021-1:2015
• clause 5 and 6 of IAF MD5:2019
• clause 4 of IAF MD11:2013
• clause 9.1.4.2 of ISO/IEC 17021-1:2015
• clause 5 and 6 of IAF MD5:2019
• clause 4 of IAF MD11:2013
OH&SMS ISO 45001
The audit time can be furtherly adapted considering the results of any prior audit
• clause 9.1.4.2 of ISO/IEC 17021-1:2015
• clause 5 and 6 of IAF MD5:2019
• clause 4 of IAF MD11:2013
• clause 9.1.4.2 of ISO/IEC 17021-1:2015
• clause 5 and 6 of IAF MD5:2019
• clause 4 of IAF MD11:2013
Avtaler
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GE HEALTHCARE AS
Orgno: 914 829 674
Kundenr:
Hovedkontor
Type: Selskap
Stiftelsesdato September 7, 1981
2100
Private aksjeselskaper mv.
Lindesnes Fabrikker, Lindesnesveien 208
4521
Lindesnes
Kommune 4205
Lindesnes
NACE kode: 21.100
Produksjon av farmasøytiske råvarer
NACE kode 21.200
Produksjon av farmasøytiske preparater
Konkurs: Nei
Under avvikling: Nei
Under tvangsavvikling: Nei
Kunde
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Kontaktpersoner
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