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Beskæftigelsesudvalget 2015-16
BEU Alm.del Bilag 251
Offentligt

Number and

Classification

Requirement and Finding

4.4, 5.3, 5.4.1

The basic IT policy and the structure of

the IT system are not documented

Response from AB

Analysis of root cause and extent:

The IT policy and the IT system have only been

described at user level.

Remedial and corrective actions:

A Section 4.12 will be added to the QM:

4.12 IT system:

DANAK uses an IT system for communication, for

creating and filing documents, for managing and

registering cases, documents, non-conformities,

use of time, and financial affairs.

The external part of the IT system is used for

information and communication with customers and

others and consists of e-mail communication, a

website, a searchable database of accredited

companies, list of methods and calibration

measurement scheme as well as a password

protected customer portal and a database for

handling of non-compliances.

The internal part consists of file servers for case

related documents, a database containing

information on the accreditation cases, an interface

for managing the accreditation cases, a

report

generator for merging standard letters and

reports,

a timesheet system and a financial

management system.

Team Comments/Conclusions

Closed: Yes/no

NC = Non-conformity; CN = Concern; Cm = Comment

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Number and

Classification

Requirement and Finding

Response from AB

The IT system, its use and security is described in

IP (F) 42.

Objective evidence of implementation:

Revised QM and new IP (F) 42.

Team Comments/Conclusions

4.6.3

DANAK had a sectorial committee for

medical laboratories that was closed in

2013. In a letter sent to the committee

members, DANAK declared that it would

use the existing professional associations

when to further developing accreditation

of medical laboratories.

However, DANAK has not followed up this

and established a policy on how to

adopt/develop new technical fields.

Analysis of root cause and extent:

When the sectoral committee was closed 8

November 2013 the members of that committee

was informed in a letter where it was indicated

(with the support from the committee chairman)

that DANAK would increase cooperation with

medical societies, individual applicants and

interested parties (eg. the five national regions) in

the medical field in order to ensure proper

accreditation procedures. This policy has been

followed, but has not been described in DANAK’s

quality system.

Remedial and corrective actions:

IP 5 pkt. 1.6, 2.4 og 3.4 and QM 6.13.7 is updated

and this information is provided on the DANAK

homepage.

Objective evidence of implementation:

The ToR for sectoral co-operation in the medical

field according to the above mentioned procedures

is established.

Closed: Yes/no

5.4

DANAK uses a powerful electronic

Analysis of root cause and extent:

The principles in the IT system are not documented

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Number and

Classification

Requirement and Finding

Response from AB

Team Comments/Conclusions

database. However, the principles and the in the QM and there are no references to user

instructions for use are not documented

manuals for the databases.

or referred to in the QM procedures

Remedial and corrective actions:

A new IP (F) 42 The IT system, with a description

of the principles and safety of the IT system,

including references to user manuals will be

issued.

Closed: Yes/no

Objective evidence of implementation:

IP (F) 42

5.5, 7.8

The surveillance assessment report for an

office visit carried out on the 02/06/2015

does not exist.

NOTE: DANAK has opened the

noncompliance number 63 dated on

04/05/2016, this noncompliance identified

that other assessment reports were also

missing. Corrective actions are going to

be implemented

During the internal audit the auditor

discovered that a number of cases from

2012-2015 are not closed due to missing

assessment reports. DANAK performed a

root cause analysis and defined a

corrective action, which is not complete

and not yet implemented

Analysis of root cause and extent:

The missing reports are concentrated to a few lead

assessors who have unfortunately been

overloaded with too many tasks in a period.

Remedial and corrective actions:

A new section manager has been employed from 1

March 2016 who will secure a satisfactory

distribution of tasks between the employees of the

section and regularly follow-up on the performance. Closed: Yes/no

A list of missing assessment reports has been

elaborated, and decisions made whether the

reports should be elaborated or “closed” with

reference to an internal non-conformity. The last

one was the solution if:

a) An assessment has been done afterwards

b) There are no special decisions which

require an action

c) The accreditation has been cancelled

Assessments reports in other cases shall be

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Number and

Classification

Requirement and Finding

Response from AB

elaborated before 15. August 2016

Monthly the section manager will follow-up on data

from our database system SAGSYS with each lead

assessor regarding status of assessments reports

to secure they are delivered within a month. Lead

assessors whose record indicates one or more

missing reports follow-up will be performed with

shorter intervals.

Objective evidence of implementation:

List of all missing reports and the handling of them.

Team Comments/Conclusions

5.6

DANAK has not defined a policy on

preventive actions in an adequate way.

However, the principles are implemented

on several levels and in different

processes

Analysis of root cause and extent:

Preventive action are described in the quality

manual and in a procedure to be considered in

connection with internal audits and management

review.

Remedial and corrective actions:

A policy on preventive actions has now been added

to section 2.3. of DANAK’s Quality Manual which

contains the overall

Closed: Yes/no

Section 4.7.5 is added to QM:

In connection with handling complaints, IP 13 (F),

new products IP 22(F), acceptance of application

for accreditations IP 7 (P) and IP 25 (C), and

decision on accreditation IP 32 (F) potential non-

conformities and the necessary

preventive

actions…determining and implementing

are

identified as part of the regular case work.

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Number and

Classification

Requirement and Finding

Response from AB

Objective evidence of implementation:

Revised QM

Team Comments/Conclusions

5.9 of 17011 + Art 61 of the A&V

Regulation

The EU ETS complaints from the

competent authority are not managed

according to art 61 of the A&V Regulation:

1. There is no evidence of the response to

the complainant for the complaint number

114, received on the 25th of November

2014 coming from the Danish EU ETS

Competent Authority.

2. There is no evidence of the actions

taken by DANAK about the complaint

number 114 (affecting a second CAB).

NOTE: DANAK informed the Danish

Competent Authority in November 2014

about the acceptance of this complaint

Analysis of root cause and extent:

The information from the CA was received and

then distributed internally as well as discussed by

telephone with the CA. Information was requested

and received from the concerned CAB.

The issue concerning another CAB relates to

verification activities which were performed by the

CAB in 2012. At that time the verifier was not

accredited by DANAK. This was also informed to

and discussed with the CA by telephone.

However the responsibility for follow up on the

complaint was not clearly defined.

Remedial and corrective actions:

Answer to the CA on the complaint to be sent and

filed in DANAK file registration SAGSYS.

DANAK procedure IP(C) 23, clause 3.7.4, will be

amended to define clearly that the appointed LA

responsible for receiving information from the CA is

responsible for follow up and responding to the CA:

“The appointed LA is responsible for follow up on

information and complaints received from the

competent authority and to respond to the

competent authority within the defined deadline.”

Objective evidence of implementation:

Closed: Yes/no

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Number and

Classification

Requirement and Finding

Response from AB

Answer to the CA on complaint no. 30-08-01-0114,

file no. 4 attached.

Revised DANAK procedure IP(c) 23

Team Comments/Conclusions

6.1.1

DANAK has accredited 2 CABs for FSMS

using ISO/TS 22003: 2007. According to

the IAF Resolution, three years transition

period for the new version of ISO/TS

22003 will end in December 2016.

However, one CAB has already applied

for the assessment according to the new

version; DANAK at the moment does not

have a trained LA in ISO/TS 22003: 2013

due to the unexpected departure of a

competent LA.

6.2.4

The LA assigned for the witnessed

assessment for FSMS has not

appropriate qualification for FSMS (no

experience in food sector, no knowledge

of HACCP, no training for ISO/TS 22003

….). The LA has not been approved either

by the head of section nor by the

accreditation committee in line with IP(C)

24.

7.9.1

In one case in 2014, the Accreditation

Committee decided on extension of

FSMS being composed by the Quality

Manager and one LA (without appropriate

qualification in FSMS).

Analysis of root cause and extent:

According to DANAK procedure IP(C) 25, the

assessment team consist of a lead assessor (LA)

and one or more technical expert(s) (TE).

DANAK had in the past two LA on ISO 22003. One

retired and the other has changed to work in other

fields of accreditation. The recent assessments on

ISO 22003 were therefore mainly based on the LA

who resigned unexpectedly shortly before the EA

evaluation. The committee deciding on

Closed: Yes/no

accreditation has consisted of persons with in

depth knowledge of accreditation on management

systems (ISO 17021), but without specific

competence on ISO 22003 and HACCP.

The LA in the team performing the assessment

during the EA evaluation was chosen to replace the

resigned LA based on his competence on ISO

17021, knowledge on the client’s quality system

and his participation in the previous assessment of

the client in 2015. However there was no formal

documented evaluation and approval of the LA for

ISO 22003 assessment. The LA was assisted by a

TE competent for the scope of accreditation on

food.

Remedial and corrective actions:

A training seminar has been planned to be carried

out the 25 August especially on ISO 22003 and

HACCP but also including information on schemes

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Number and

Classification

Requirement and Finding

Response from AB

for food and feed such as IFS and GMP+. Six

employees of DANAK and technical experts will

participate.

Following the seminar DANAK will evaluate trained

LA’s on ISO 22003 including witnessing on-site

according to the internal procedure IP 24. Based

on the result of the evaluation DANAK will decide

on approval of LA’s for assessment against the

standard or further training and evaluation.

As we only have 2 accreditations on ISO 22003 it is

presently planed that 2 LA’s after training and on-

site witnessing will be approved as LA for

assessment against ISO 22003. The on-site

witnessing before approval of the 2 LA’s will be

performed at the first possible ordinary

assessment.

DANAK will also decide on approval of LA’s for

being qualified to decide on accreditation to ISO

22003 based on participation in above mentioned

training seminar. According to DANAK procedure

IP(F) 32 the decision committee consist of 2

persons, where one needs to be qualified for the

specific field.

Decisions taken by the committee in the present

accreditation cycle for the concerned 2

accreditations will be reviewed after the approval of

LA’s as mentioned above.

Objective evidence of implementation:

Attached is the training program.

Team Comments/Conclusions

6.2.1

DANAK has not specified competence

criteria for an assessment team in the

Analysis of root cause and extent:

DANAK’s requirements for qualification of lead

assessors and experts in the area of certification,

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Number and

Classification

Requirement and Finding

field of FSMS and has not yet

implemented IAF MD 16 (version 2014

and 2015)

Response from AB

inspection and verification are elaborated in

internal procedure IP(C) 24. The requirements of

IAF MD 16 were not included.

Team Comments/Conclusions

Remedial and corrective actions:

IP(C) 24 has been updated to cover the

requirements in IAF MD 16:2015. It is now explicitly

Closed: Yes/no

mentioned that competence shall be present for

document review, for assessment, and for the

accreditation decision on HACCP, food safety

management and legal framework.

Objective evidence of implementation:

Attached is an updated procedure IP(C) 24.

6.3.2

DANAK does not meet its own policy on

on-site monitoring (once in 3 years) of LA

in some cases.

Analysis of root cause and extent:

During the EA-audit the requirement was not

fulfilled for 1 LA, as the other LA discussed during

the evaluation (DANAK’s managing director) had

stopped acting as LA in 2014 and was before this

monitored in 2012.

Remedial and corrective actions:

The missing on-site monitoring is planned to

August 2016. It is stated clearly if the LA has

stopped as LA in the monitoring plan.

A new form (Monitoring plan) is elaborated to give

an overview of performed and planned on-site

monitoring.

IP 20 (F) is revised and reference to the form is

Closed: Yes/no

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Number and

Classification

Requirement and Finding

Response from AB

given. Cl. 3.1 is revised to:

Team Comments/Conclusions

“3.1

SLs plans the evaluation of LAs through

periodic monitoring of the assessment activities.

Once a year SL defines which activities shall be

monitored based on the experience with LA and

which on-site monitoring of the LA that has been

done before. The result is recorded in the spreadsheet

Monitoring plan “

Objective evidence of implementation:

Filled in Monitoring Plan

Revised IP 20 (F)

7.5.6

The policy for sampling for product

certification (AMC 15) does not ensure

that all necessary scopes and activities

are covered during the accreditation

cycle.

The procedure describes the necessary

witnessing and files review activities for

specific schemes; however, this is not

translated into forward planning for each

accredited CB (audit Plan). (note that

there are some recent examples using the

portal system where such information is

included – this is a new process being

developed).

In the inspection area, it is not ensured

that the witness activities cover the whole

accreditation scope within the 4-year

accreditation cycle, since it was observed

Analysis of root cause and extent:

The lack of an AMI regarding witness activities for

inspection and an in-complete AMC regarding

witness activities for certification and verification

combined with a new system for using SAGSYS for

planning witness audits is the root.

Regarding the forensic activities witness

assessments are done in the autopsy room at the

hospitals normally when an on-site assessment is

done. Witness assessment has not yet been done

Closed: Yes/no

at the place of finding, as the police only allow a

few people to be there and inspection of places of

findings are done unannounced within a very short

time limit.

Remedial and corrective actions:

As a supplement to the plan for on-site assessment

(office) there shall be a plan for all witness

BEU, Alm.del - 2015-16 - Bilag 251: Orientering om redegørelser fra Det Norske Veritas og DANAK om tilsyn og arbejdsmiljøcertificering af Siemens Wind Power og Vestas, fra beskæftigelsesministeren

Number and

Classification

Requirement and Finding

that in certain cases (forensic activities)

witness activities have not been

performed at all.

At least in one case DANAK has not

conducted witnessing of all required

categories (FSMS) and has no plan how

to fulfil the requirements on witnessing

during the accreditation cycle

Response from AB

assessments in SAGSYS for the accreditation

period. It shall be stated which parts of the scope/

accreditation shall be covered at each witness

assessment.

AMC 15 will be revised and cover FSSC 22000 etc.

An AMI 1 for Inspection corresponding to AMC 15

for certification and verification shall be issued.

Clause 3.9 in IP 25 (C) is revised. A plan for the

witness assessments for the accreditation period

shall be delivered to the accreditation committee

and when accreditation is granted/renewed it shall

be put in to SAGSYS.

Clause 3.1.2 in IP 26 C is revised. A plan for the

witness assessments for the rest of the

accreditation period shall be elaborated and put in

to SAGSSYS.

Team Comments/Conclusions

Objective evidence of implementation:

Revised AMC 15, IP 25 ( C ) , IP 26(c ) and a new

AMI 1.

7.5.6

DANAK does not establish a specific plan

for sampling tests. It uses a competence

matrix in which it registers the main

technical fields and the activities that are

assessed (IP(P)7 point 3.1.3 f). In some

Analysis of root cause and extent:

Although the procedure is in place for establishing

competence matrices and in a number of cases

request for revision of competence matrices have

been made at renewal of accreditation (decisions),

a number of competence matrices are not

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Number and

Classification

Requirement and Finding

cases not all accredited technical fields

have been checked during an

accreditation cycle

7.5.8

Procedure IP (P) 7 does not define a

policy for:

-Planning sites in case of multi-site

laboratories: CAB 1 all the sites where

verified during one accreditation cycle but

in CAB 2 not

In case of multisite testing laboratories,

DANAK does not document the scope of

accreditation for the different sites.

It produces only one list of tests without

specification where the single test is

accredited.

Response from AB

appropriate in the field of testing. This is not the

case in the medical field or in calibration.

Team Comments/Conclusions

Closed: Yes/no

Remedial and corrective actions:

The following remedial actions are made:

1. All testing competence matrices are

reviewed systematically and changed

accordingly.

2. A process for ensuring that requests made

in the visit note (supporting the decision for

accreditation is made) are implemented is

installed in IP7 cl. 3.1.3 f) to ensure that an

alarm is established by the decision

makers in the electronic system.

3. For sampling among sites the policy is

clarified in IP 7 cl. 3.1.3 d) and f). Those

clauses for sampling are collected in a

separate clause and a form is created to

support a uniform approach in sampling

among sites.

4. Laboratories are requested to include

location in the list of methods. AB 3 is

revised accordingly and this will be

followed up at future surveillance and .

Objective evidence of implementation:

1. A table with indications of the changes

made to competence matrices of all testing

labs is included.

2. One example of change to competence

matrix is included

IP 7 is included, see cl. 3.1.3.

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Number and

Classification

Requirement and Finding

7.7.2

DANAK reaccredited a CAB although

there is little evidence that chapter 4 of

ISO/IEC 17043 has been assessed

properly.

At the previous surveillance visit there is

also little evidence that chapter 4 of

ISO/IEC 17043 has been assessed.

DANAK did not realise this gap in the

report.

At the decision-making DANAK waived

the requirement.

Response from AB

Team Comments/Conclusions

Analysis of root cause and extent:

When DANAK established accreditation of PT

providers this activity was a part of ISO 17025

accreditation. When separate accreditation

according to ISO 17043 was developed in June

2010 DANAK issued a first edition of IP 8 which

allowed combined reporting with laboratory

accreditation to ISO 17025. During accreditation

committees in the years 2010 - 2014 it was

discovered that this approach did not satisfy

Closed: Yes/no

decision makers and IP 8 was consequently

changed in both 2011 and 2012 where the

requirements to separate filing on laboratory case

and PT case and to separate reporting was

required. Due to the low number of PT providers (in

total 4) experience is gathered at very low speed.

The 4

version of IP 8 from September 2014 is

however considered appropriate.

For one case in march 2015 the decision makers

discovered that reporting as required by IP 8 was

not very good and the technical assessor reported

all of chapter 4 in a vertical audit which however

covered all activities that year (The PTP only

organized one PT that year). For that reason the

decision makers decided to renew the accreditation

despite the poor reporting and required that

reporting at the next assessment shall cover all

requirements in chapter 4 and that this shall be

clear from the reporting.

All lead assessors dealing with PT were at the

same time made aware that reports need to be

better and all other newer reports show adequate

reporting.

Remedial and corrective actions:

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Number and

Classification

Requirement and Finding

Response from AB

There is not considered any need for changes to IP

8 and therefore the following two actions are made:

- A dummy report is made displaying proper

reporting similar to what is found in all

other areas (ISO 17025 and ISO 15189) in

the laboratory section.

- The team for the CAB in question is

informed of the need for better reporting

and the outcome of the next surveillance

will be monitored by the manager of

section.

Objective evidence of implementation:

The dummy report and the report from the

surveillance June 2016 are included.

Team Comments/Conclusions

7.8 of 17011 + art 47 of the Regulation

A&V

During the GHG witnessing the LA

assessed as satisfactory an onsite

monitoring plan for EU ETS auditors of a

6 years period claiming that there was no

requirement for this monitoring. The EA

06/03 includes that the maximum

frequency for on-site monitoring shall not

be more than 3 years.

Analysis of root cause and extent:

The 6-year period monitoring plan was given as an

observation to the verifier in 2015. In praxis the

monitoring of LAs are done within 3 years.

During the on-site assessment LA did not

remember the requirement.

Remedial and corrective actions:

It has been required to the verifier to adjust the

monitoring plan to 3-years periods. The

implementation of this will be assessed on next

office visit.

The requirement will be stated in the checklist

Objective evidence of implementation:

Closed: Yes/no

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Number and

Classification

Requirement and Finding

Response from AB

Copy of revised checklist

DANAK has required the VB to implement a 3 year

monitoring plan as stated in the report.

Copy of report to the VB, page 4, in which it is

stated (translated):

“Competences in “Skills” demonstrated. The date

of expiry was 6 years, but EA -6/ 03 6.2.1 indicates

max 3 years. Given that observation in 2015.

DANAK will at the next office visit follow up on

monitoring planned with 3-year interval.”

Team Comments/Conclusions

7.9.5

The accreditation certificate of inspection

bodies in the forensic area does not

include the specific requirements against

which the inspection body was assessed

Analysis of root cause and extent:

DANAK was not aware of the need for the details

during the original accreditation, probably because

it is a rather regulated area.

Remedial and corrective actions:

As mentioned during the interview of the LA at the

EA-evaluation, the 3 forensic pathology

departments accredited by DANAK, had already

been requested to define a list of specific

requirements for the scope of accreditation.

This is documented in the reports for the

assessments 2015-09-25, 2015-09-28 and 2016-

01-22: “The

scope of accreditation shall be

described more specific, to include the standards

and / or references which are the basis for the

methods and procedures for the performance of

the activities.

The time for implementing the specific

requirements has been agreed to be before the 16

Closed: Yes/no

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Number and

Classification

Requirement and Finding

Response from AB

September 2016 considering the need for

discussion and coordination.

Objective evidence of implementation:

Copy of the reports from the 3 forensic

departments.

Team Comments/Conclusions

7.15

In the AB 3 cl.3.9 DANAK requests from

the laboratory to elaborate a plan for

participating in PT that shall be worked

out in a way that makes it possible to

evaluate whether the extent adequately

covers the scope of the accreditation.

In some cases in testing, no evidence for

the assessment of the plan was found.

During the visits TA register in the check

list if laboratories have participated in PT.

In some cases there is no information in

the report on the existence of a PT policy

nor if PT is not available or just no

participation.

Analysis of root cause and extent:

All AB’s and IP 7 are considered to be sufficient.

Further dummy reports exist to support proper

reporting in all areas of testing and calibration.

The root cause is therefore considered to be lack of

awareness among assessors to assess the plan

and especially when PT is not available or

impossible.

Remedial and corrective actions:

All LA and TA will be informed in writing about the

need for addressing PT plans specifically at every

assessment and also awareness of difference

between a PT policy and a plan for PT. Further PT

activities will be marked to be addressed at every

assessment.

Objective evidence of implementation:

Communication to TA about how to address PT in

reports and during assessment.

Closed: Yes/no

4.3.2

The process of identifying and analysing

of potential conflicts of interests and the

involvement of the interested parties is

not transparently described

Analysis of root cause and extent:

Potential conflicts have been handled by the Board

of Directors, however not in a systematic and

transparent way.

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Number and

Classification

Requirement and Finding

Response from AB

Corrective action plan:

The agenda for management review as listed in IP

2 (F) will be extended with an item regarding

identifying and analysing potential conflicts of

interest.

The outcome of management review is addressed

annually by the Board of Directors, where

stakeholders are represented.

Revised IP 2 (F) is attached.

Team Comments/Conclusions

Closed: Yes/no

5.3

In the quality manual a reference to the

procedure IP(P)8 for accreditation

according to ISO/IEC 17043 is missing in

section 6.5.2 (paragraph 6)

Document RL 16 in both versions (Danish

and English) refers to an obsolete

standard (EN 16001)

Analysis of root cause and extent:

IP 8 refers to IP 7 for decision making so it has

been understood that the same procedure applied

to labs shall be utilized for PTP’s. In all cases the

same process is applied.

Corrective action plan:

QM cl. 6.5.2 is updated to include IP 8 specifially in

dot, so that this clause takes the form: “

prepare

Closed: Yes/no

the appropriate assessment documentation for the

review by the accreditation committee as specified in

IP(P) 7,

IP(P) 8,

IP(C) 25 or IP(C) 26;

”

5.5 e

The DANAK electronic database is a

good tool to show open non-compliances

and their nature. However, the existing

process does not guarantee that open

findings are closed within reasonable time

Analysis of root cause and extent:

There has not been installed a mechanism in the

database to alert the Quality Manager and the

receiver of a NC when deadlines have been

passed.

Corrective action plan:

Closed: Yes/no

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Number and

Classification

Requirement and Finding

Response from AB

Alarms have been created so that receivers of

NC’s and QM are made aware when a deadline is

passed. The alarms are communicated

electronically by email to receiver and QM every

week.

Team Comments/Conclusions

5.9

IP(F) 13 is not clear on the fact who is

taking decisions on the final answer to the

complainant. The head of section and a

LA are involved. The records do not give

clear evidence who has taken a decision

Analysis of root cause and extent:

The procedure is not clear.

Corrective action plan:

IP(F) 13 is corrected to clarify that the head of

section (SL) takes the decision unless the

Closed: Yes/no

complaint concerns the SL. In that case the director

takes the decision.

Analysis of root cause and extent:

The competences in the Qualification form GHG

(form 48a) was by mistake not updated after the

training and by that formally qualifying the

specialist.

Corrective action plan:

Training and registration of specialist’s

competences will be updated according to IP(C)24,

formally qualifying the specialist.

Analysis of root cause and extent:

By mistake documentation of justification for

competence related to activity group 3 of the AVR

was not ensured to have a specific reference.

Closed: Yes/no

6.2

DANAK has not formally qualified

specialists in activity group 12 “aviation”

(Regulation A&V)

DANAK has delivered trainings in March

2014 and in 2012, for Lead Assessors

and

Specialists

including

the

requirements for this activity group.

DANAK has one accredited body in this

field. A witnessing in this field was made

on the 2nd and 3rd of March in 2015

6.2

There are no evidences in the DANAK´s

management system to support the

justification about the competence

evaluation carried out in the case of the

specialist in the field of production of pig

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Number and

Classification

Requirement and Finding

iron or steel (activity group 3 of the

Regulation A&V):

In form 48a the competence evaluation

for the activity group 3 of the RA&V is

based on a previous job carried out for

DANAK in a company. No information to

support this justification has been found in

the DANAK record systems. The form 48a

for this person was signed on the

19/03/2013.

Response from AB

Corrective action plan:

Justification for the concerned person will be

acquired and documented in form 48a and the

evaluated and approved by the SL.

IP(C) 24 to be amended to ensure that justification

is recorded.

Team Comments/Conclusions

Closed: Yes/no

6.2.1

The Annex to IP(P)19 contains the

“competence profile” of a LA. However,

this are the criteria for hiring new staff.

(same for technical assessors in IP(P)

18).

The competence criteria for assessors are

not properly defined.

Analysis of root cause and extent:

The competence profiles in IP 18 and 19 were

understood to clarify profiles for applicants to be

employed as LA and TA which means that the

competence for LA and TA shall be supplemented

with the competences acquired through training.

Closed: Yes/no

Corrective action plan:

IP 18 and 19 are updated to clarify the competence

requirements for LA and TA and to align with ILAC

G3.

Analysis of root cause and extent:

For the scope area of product certification it is

required for each lead assessor to search

knowledge by studying the scheme documents and

product requirements. DANAK has also made a

competence matrix where it appears who are

competent for specific areas and who are the key

Closed: Yes/no

persons for these areas responsible to obtain any

information and share this.

Corrective action plan:

Above description is added in IP(C) 24.

6.2.1

For product certification Lead Assessors,

the competence requirements as stated in

IP24 do not include any required

knowledge for the general scope area

concerned.

6.2.3

In the certification section DANAK has not

defined technical areas (areas of scope)

for the different accreditation activities in a

consistent way

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Number and

Classification

Requirement and Finding

Response from AB

Team Comments/Conclusions

.4.1

Records on assessors’ qualifications and

competence are not kept in a systematic

way. The competence matrix is used for

assessors (although not regularly

updated) but not for technical experts.

TEs are sometimes trained in specific

scheme requirements as “on the job”

training, but this is not recorded in

competence records

Training certificates of assessors do not

distinguish between participation of the

assessor as a trainer or as a trainee

Analysis of root cause and extent:

Lead assessors approved competence to a specific

standard (e.g. ISO 17065) is registered in the case

management system and in the competence matrix

mentioned in CN 8. The competence matrix refers

to the documents for approval for a specific

standard. The competence matrix is a new tool that Closed: Yes/no

still had a few errors at the evaluation.

Some training activities have been performed as

workshops where some of the participant

presented some of the sessions

Corrective action plan:

The competence matrix has been reviewed and

updated. It is referred in the QMS and will be

maintained.

Records of training for TE’s will be maintained to

also include DANAK training.

For future workshops there will not be issued

certificates but a document showing the items

presented and discussed.

Analysis of root cause and extent:

Training has been performed in group of LA and

also with meetings of the TA and in newsletter

2014. TA hired after 2013 (check year) have not

received this training.

Corrective action plan:

The following steps are taken:

- All LA and TA in the medical field shall be

Closed: Yes/no

6.4.2

Personnel files of internal LAs for medical

laboratories:

Training activities for ISO 15189:2012 and

ISO 22870:2006 are not documented

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Number and

Classification

Requirement and Finding

Response from AB

trained to ISO 22870 in combination with

ISO 15189.

- ISO 22870:2006 is included in the training

courses for TA starting 2017 as the training

2016 has been made.

- All TA not receiving this training shall

receive that through circulation of the

information in the newsletter 2014.

Qualification of all LA to ISO 22870:2006 is

documented on personnel files based on received

training….. included in CV….

Team Comments/Conclusions

Document AMC 03, 2015/09/02 refers to

IAF MD16 and specifies the rules for

witnessing in the field of FSMS according

to this. IAF MD 16 was developed taking

into account ISO/TS 22003:2013. Since

DANAK still uses ISO/TS 22003:2007 for

the accreditation in field of FSMS, the

rules for witnessing are misleading from

the point of view of the specific marking of

the food chains categories which is

different in the old and the new version of

ISO/TS 22003.

7.1.1

DANAK policy on traceability does not

include ILAC P10 option 3a and 3b.

By doing so there is a risk that not all

measurement quantities are

metrologically traceable.

(DANAK document AB 3 cl. 4)

Analysis of root cause and extent:

DANAK has by mistake not considered the

differences in the two versions of the standards.

Corrective action plan:

A new AMC has been published to address the

requirements in ISO 22003:2007.

Closed: Yes/no

Analysis of root cause and extent:

The AB 3 in Danish is understood to not exclude

option 3a and 3b of ILAC P10 and such is the

tradition. Since all NMI’s in Denmark are accredited

for all services they offer in the KCDB DANAK is

not aware of any lack of service that can only be

achieved through 3a and 3b

Closed: Yes/no

Corrective action plan:

Option 3a and 3b are now included in DANAK AB3

chapter 4 as a separate clause.

BEU, Alm.del - 2015-16 - Bilag 251: Orientering om redegørelser fra Det Norske Veritas og DANAK om tilsyn og arbejdsmiljøcertificering af Siemens Wind Power og Vestas, fra beskæftigelsesministeren

Number and

Classification

Requirement and Finding

Response from AB

Team Comments/Conclusions

7.5.5

It has been observed that when the

assessment team comprises more than

one member, the tasks of each member

are not always clearly defined in the

assessment plan

Analysis of root cause and extent:

For certification bodies with several areas of

accreditations the areas are often assessed

simultaneously. The team can therefore consist of

more lead assessors, each responsible for an area

of accreditation. The tasks for each team member

have not always been clearly defined but based on

dialog between them.

Corrective action plan:

An IP 43 (C) on assessment of certification bodies

with several accreditations will be issued.

A team leader will be appointed for certification

bodies with several accreditations.

This person will be responsible for communication

with the management, drafting assessment plan,

determination of each team members tasks,

assessment of the customers

main

QMS.

IP 43 (C) is attached.

Closed: Yes/no

7.9.4

Accreditation scopes medical

laboratories:

Locations on the front page

and in the method list are not always

explicitly given, examples:



CAB 1 – Abbreviations used in the

method list are not identifiable on the

front page.

CAB 2 -– two locations are listed in

Analysis of root cause and extent:

It has never occurred to us at DANAK that the

location codes in lists of methods are not self-

explaining. CAB 2 is closed at the end of 2015.

Corrective action plan:

Closed: Yes/no

In all cases where a code is provided for location

DANAK will make this code clear from the overview

BEU, Alm.del - 2015-16 - Bilag 251: Orientering om redegørelser fra Det Norske Veritas og DANAK om tilsyn og arbejdsmiljøcertificering af Siemens Wind Power og Vestas, fra beskæftigelsesministeren

Number and

Classification

Requirement and Finding

Response from AB

Team Comments/Conclusions

the method list and nine locations are on the list of sites. See LINK XXXXX.

given on the front page. Names of the

locations in the method list are not

identifiable on the front page.

7.11.4

DANAK collected information according to

IAF MD 12, but there are no written rules

or guidance for LA describing how to use

the collected data for assessment

planning

Analysis of root cause and extent:

The collected information has been used by the

LA’s for planning in an informal way.

Corrective action plan:

The collected data shall be used in the plan for

witness and on-site assessments. IP 25 (c ) and IP

26 (c ) are revised, and now includes a description

that the plan shall be evaluated each year when

the information about foreign activities is received.

A note shall be in SAGSYS of the result of the

evaluation of the information and if the plan needs

to be revised.

Analysis of root cause and extent:

It was a mistake by the lead assessor to tick the

suspension box in the electronic system. This is

seen as a single incident.

Corrective action plan:

The laboratory has been informed about the

closure of the file and all electronic information is

adjusted to reveal that this accreditation was

closed by the end of 2015.

Letter for termination is included.

Closed: Yes/no

8.2.1

A CAB has notified DANAK that they were

closing the lab by end of December 2015.

However, DANAK suspended the lab and

did still not update the website to state

that the lab is closed down.

Closed: Yes/no

8.3.3

Analysis of root cause and extent:

Incorrect use of DANAK’s logo on a list of The issuing organisation is part of the legal identity

orders was not noticed by the LA and was holding the accreditation.

BEU, Alm.del - 2015-16 - Bilag 251: Orientering om redegørelser fra Det Norske Veritas og DANAK om tilsyn og arbejdsmiljøcertificering af Siemens Wind Power og Vestas, fra beskæftigelsesministeren

Number and

Classification

Requirement and Finding

not discussed with the IB representatives

during a witnessed assessment. (the

issuing organisation is not accredited)

Response from AB

Team Comments/Conclusions

Corrective action plan:

The use of DANAK’s symbol by departments of an

accredited legal identity will be discussed at

Closed: Yes/no

DANAK for clarification to secure that it cannot give

reason for any misunderstanding as to what the

accreditation is covering.

The QM 6.10 as well as IP8 are reviewed to clarify

the team composition in PT (and RM which is also

covered by IP 8). QM 6.10 was revised for

consistency with IP 8 cl. 3.2 and with the change to

6.10 the need for change in IP 8 is unnecessary.

5.3

In section 6.9.1 of the quality manual

about the technical assessors procedure

IP(P)8 is mentioned. However, a team of

a lead assessor and technical experts

performs assessments. This is also not

clarified in IP(P)8.

6.4.2

The summary records for a technical

expert for product certification identify for

which overall area they are considered

competent but not the specific scheme or

scope, although this information can be

found by further searching it is not easily

accessible.

7.5.5

The Program refers to document AMC 09

dealing with scheme FSSC that is not

included in the scope of accreditation.

Reference to IAF MD 1 and MD 5 are also

misleading (applicable rules for multisite

certification and audit time for FSMS are

in ISO/TS 22003).

Technical experts on certification, inspection and

verification are registered in the case management

system but there is not a search engine for their

technical area of expertise.

DANAK will define a list of competences for

certification, inspection and verification and allocate

the experts to the relevant categories as done for

the experts used for laboratory accreditation.

The problems is seen as a single incident and arise

from our merging of information from the SAGSYS

and the standard program. Due to an human error

the FSSC has been marked as a part of the

accreditation scope.

The references to IAF MD 1 and MD5 are relevant

for the accreditation with the same number, but not

for FSMS. Normally on-site assessments are done

together during several days for several scopes as

quality, food etc.; but due to the EA-evaluation

BEU, Alm.del - 2015-16 - Bilag 251: Orientering om redegørelser fra Det Norske Veritas og DANAK om tilsyn og arbejdsmiljøcertificering af Siemens Wind Power og Vestas, fra beskæftigelsesministeren

Number and

Classification

Requirement and Finding

Response from AB

FSMS was done separate, and the lead assessor

did not evaluate the merge program properly

enough.

The “check mark” of FSSC is removed from the

database.

The process of merging documents and quality

control will be discussed at intern meetings.

Team Comments/Conclusions

7.7.3

Information on the number of inspectors

in each IB is not consistently obtained in

order to allow for a representative number

of staff of the IB to be witnessed

This information is often listed in DANAK’s

assessment reports to be used for the next

assessment. It has now been stressed at the

section meeting in May 2016 to include the number

of inspectors in reports.

For further actions DANAK awaits any

requirements from EA or ILAC.

BEU, Alm.del - 2015-16 - Bilag 251: Orientering om redegørelser fra Det Norske Veritas og DANAK om tilsyn og arbejdsmiljøcertificering af Siemens Wind Power og Vestas, fra beskæftigelsesministeren

Emma Alconero and Martin Czaske finished their visit before the final meeting.