NABL 218

NABL

NATIONAL ACCREDITATION BOARD FOR

TESTING AND CALIBRATION
LABORATORIES

Desktop Surveillance

Issue No. 02
Issue date: 29.05.2013

Amendment No.02
Amendment date: 15.01.2015

AMENDMENT SHEET
Sl

Page

Clause

Date of

No.

No.

Amendment

2/4

ii/4

2 (k) & 3.2

Preface

11.03.2014

15.01.2015

Amendment made

Reasons

QO
Summary of NCs of last internal audit & CPAIC
Minutes of MRM

recommendations

Reference to ISO 15189:2012 added

New edition : ISO

15189:2012

4/4

12.2

15.01.2015

Signature Signature

Reference to ISO 15189:2012 added

New edition : ISO

15189:2012

4
5
6
7
8
9
10

PREFACE

Director

For an accredited laboratory to maintain its accreditation status, it is mandatory that the laboratory continues to comply
with the requirements of ISO/IEC 17025: 2005 or ISO: 15189: 2007/ ISO: 15189: 2012 (whichever is relevant) and
NABL policies. Once a laboratory has been accredited for the first time, NABL conducts onsite surveillance visit within
the first year of accreditation to verify the continued compliance. In the subsequent accreditation cycles of 2 years,
instead of onsite surveillance visits, NABL has evolved a monitoring system for verifying the continued compliance of
the laboratory by conducting desktop surveillance.
For this purpose the laboratory should provide the information as per this document and the same will be considered
to verify the continued compliance for maintaining accreditation. The information provided by the laboratory is
evaluated at NABL secretariat and if the information is conforming to the requirements; the laboratory is allowed to
continue its accreditation status based on desktop surveillance. However; if the information provided is insufficient to
establish the continued compliance; an onsite surveillance visit may be conducted or NABL may call for further
additional evidences to fulfil the requirements for continuation of accreditation.
The laboratories are therefore advised to provide the desired information accurately as per the format. The information
provided is subject to verification at onsite surveillance (if conducted) or in subsequent reassessment visit. Any wrong
information provided may lead to adverse decision by NABL.

INFORMATION TO BE FURNISHED BY LABORATORY FOR DESKTOP SURVEILLANCE

Laboratory's name, address & ID:

Field:

Testing/ Calibration/ Medical

Discipline(s):
Accreditation validity period:
Period of the report:
1. Status of implementation and monitoring the effectiveness of corrective actions(s) taken on non-conformities raised
during last re-assessment: (please provide details in tabular format)
Non-conformities raised during last

Brief Summary of corrective actions

Evidence of continued compliance

assessment

taken

of corrective actions (as on date)

2. Summary of last internal audit findings and corrective actions taken on non-conformities raised during the audit
a)

Availability of audit scope and plan/schedule

b)

Frequency of internal audit as per procedure for internal audit._____________________________________

c)

Dates of last two internal audit conducted _____________________________________________________

d)

Particulars of persons who have conducted last internal audit

Name(s)

ofQualification

auditors(s) &
designation

Affiliation
(Internal/ External)

Yes/No

Training status

Details of training organization & duration

(whether trained as of training

per ISO/IEC 17025
/ ISO 15189)

e) Comment on independence of activities audited_________________________________________________

f) Whether all the activities (as required by standard) were covered in the audit
Yes / No
g) Whether various locations (including site testing / calibration, mobile, collection centres etc) were covered in
the audit
Yes / No
h) Whether the all the requirements of ISO/IEC 17025 (or) ISO 15189 were covered in audit
i) Number of NCs raised...........
j) Whether NCs are monitored for its closure as agreed time frame
Yes / No
k)

Yes/ No

l)

m)

Non-conformities

Brief Summary of corrective

Sl.

raised during last Internal audit

actions taken

r)

s)

n)

(Closed/

t)

v) 3.
Management Review Meeting
w) 3.1 Summary of last Management Review
x) a)
Date
y)

Status

Open)

No
.
q)
u)

o)
p)

of

last

Management

Review____________________________________________________________
b)
Whether all the agenda points as required by the relevant standard (ISO/IEC 17025 / ISO 15189)

were discussed including quality policy and objectives

Yes/ No
z) c)
Whether minutes of the meeting and with actions points thereon were recorded
aa) d)
Whether the action plan implemented as targeted
Yes/ No
ab) 3.2 Minutes of last Management Review Meeting
(Annexure......)
ac)
ad) 4. Summary of complaints received and status of their resolutions
ae)

af) Complain

S.

ag) Complaint

t No. &

ah) Investigation

details

ai) Corrective

findings

action taken

date
al)

am)

an)

ao)

ap)

Yes/No

aj) Status
settled/
ak) unsettled
aq)

ar)
as)
at) 5. Details of internal quality control (IQC) checks practiced by the laboratory
au) a)
Which of the following quality control measures are used by the laboratory, please tick appropriate
column(s).
i.
av) Use of Certified reference material/reference material.
aw) ax)
ii.
az) Use of internal quality control material
ba) bb)
iii.
bd) Replicate testing using same or different method.
be) bf)
iv.
bh) Retesting of retained item
bi) bj)
v.
bl) Replicate calibration using same or different method
bm) bn)
vi.
bp) Recalibration of retained items.
bq) br)
vii.
bt) Use of control charts using control samples
bu) bv)
viii.
bx) Use of control charts using check standards
by) bz)
ix.
cb) Correlation of results for different characteristics of an item
cc) cd)
x.
cf) Any other technique(s); Please specify......
cg) ch)
cj)
b) Details of IQC plans of the laboratory as per accredited scope mentioning frequency of IQC checks
ck)
(Annexure: _______________)
c) Whether the compliance criterion is defined, met and corrective actions taken if required
Yes/ No
cl) 6. Details of participation in EQAS/ PT/ ILC and initiation of ILC by the laboratory
cm) a)
cn) b)
co) c)

Availability of EQAS/ PT/ ILC plan as per requirements of NABL163

Yes/ No
Whether the ILC/PT activities complied as per the plan submitted
Yes/ No
Please
provide
clarifications
of
lapses
in
implementation
(if

____________________________________
cp) Results of EQAS/ PT/ ILC participation

ay)
bc)
bg)
bk)
bo)
bs)
bw)
ca)
ce)
ci)

any)

cq)

EQA

cr) PT

S/ PT

programme

providers (or)

No.

cs) Paramete

ct) Z Score/

cu) Details of root cause

En Value /

analysis in case of

SDI

unsatisfactory

ILC/

performance

coordinating
laboratory
cv)

cx)

cy)

cz)

da)

cw)
db)

dc) 7. Please furnish detail of the reference standards, CRM, equipments, held by the laboratory
dd)

de)

reference standard/ CRM/

S.

equipments (Make & Model No. if applicable)

No.
dh)
dm)

di)
dj)

df)

Date of calibration

dg)

Metrological

(reference standard/

traceability/ calibration

equipments)/ Date of validity

agency

(CRM)
dk)

dl)

Note: Equipments, CRM, Reference standards details shall be given separately wherever applicable

dn)

do) 8. Details of Training provided to laboratory personnel since last assessment

dp) a)

Does the laboratory identify training needs of its employees and prepare an annual training plan

Yes/No
dq) b)
Whether the training plan implemented
dr) c)
Please
provide
clarifications

of

Yes/ No
lapses

in

implementation

__________________________________
ds) d)
Whether the effectiveness of training is evaluated and records are maintained

(if

any)

Yes/ No

dt)

du) 9. Has there been a change in the following aspects of the laboratory operations since last assessment?
dv) a)
Legal Status
: Yes/No (If yes, give details thereof)
dw) b)
Ownership
: Yes/No (If yes, give details thereof)
dx) c)
Top Management
: Yes/No (If yes, give details thereof)
dy) d)
Key Laboratory Personnel
: Yes/No (If yes, give details thereof)
dz) e)
Policies
: Yes/No (If yes, give details thereof)
ea) f)
Resources
: Yes/No (If yes, give details thereof)
eb) g)
Laboratory Premises
: Yes/No (If yes, give details thereof)
ec) h)
Major Test/ Calibration equipment
: Yes/ No (If yes, give details thereof)
ed) i)
Authorised signatories
: Yes/ No (If yes, give details thereof)
ee) Note: For any of above stated changes; laboratory should have informed NABL within 15 days of its change as defined
in NABL 131. The above declarations cannot be considered as an application for change
ef) 10. Does the laboratory want a change/ addition in authorised signatories? If yes please furnish bio data of
proposed authorised signatories along with signatures in NABL Form 71
eg) Note: Approval of authorised signatories is subject to verification of competence by NABL

eh)
ei) 11. Desktop surveillance fee details: __________________________________________________________
ej) Note: Provide the DD number/ bank details along with the amount paid. All payments shall be payable at New Delhi

ek)

el) 12. Self declarations

em) 12.1 (a) Please give a self declaration confirming the valid calibration status of various equipments and reference
standards held by the laboratory. The declaration should also focus on compliance to metrological traceability
policy as given in NABL 142. Annexure.....
en) (b) In case the laboratory has enhanced the periodicity of calibration of any equipment(s), please give
detailed technical justification for the same. Annexure....
eo) Note: The self declaration to be given by a competent authority on laboratorys letter head

ep) 12.2 Please furnish a self declaration by the head of the laboratory/ laboratory director for continued compliance
of the laboratory to ISO/IEC 17025: 2005 or ISO 15189:2007 / ISO: 15189: 2012 (whichever is applicable) and
relevant NABL specific criteria (s) (to be specified) since last on site assessment. Annexure...
eq) Note: The self declaration to be given on laboratorys letter head
er)

es) 13.

All information provided above is true and I am aware that any wrong information / declaration given therein

may lead to adverse actions by NABL

et)
eu)

Signature

of

Laboratory

Head/

Laboratory

Director__________________________________________________________
ev) Name

&

Designation

_________________________________________________________________________________

ew) Date

&

_______________________________________________________________________________________
ex)
ey)
ez)
fa)
fb)
fc)
fd)
fe)
ff)
fg)
fh)
fi)

Place

fj)
fk)
fl)
fm)
fn)
fo)
fp)
fq)
fr)

ga)

fs)
ft)
fu)
fv)
fw)
fx)
fy)
fz)
National Accreditation Board for Testing and Calibration Laboratories
NABL House
Plot No. 45, Sector 44,
Gurgaon - 122002, Haryana, India
Tel. no.: 91-124-4679700 (30 lines)
Fax: 91-124-4679799
Website: www.nabl-india.org