Rockford ASQ,

Sep 20, 2012

Presenter:

Ken Berger

EVERYTHING YOU EVER

NEEDED TO KNOW

ABOUT ISO 17025 AND

MORE…..

purpose of the Standard

an overview

a comparison to ISO 9001

common errors

auditing tips

AGENDA

TITLE: General requirements for the competence of

testing & calibration laboratories

laboratories who “…wish to demonstrate that

they

operate a management system,

are technically competent,

and are able to generate technically valid results.”

PURPOSE OF THE STANDARD

Taken from ISO17025“Introduction”

AN OVERVIEW (1 OF 3)

Clause 4

•requirements for sound management

Clause 5

•requirements for technical competence

17025 at-a-glance, Technical (2 0F 3)

Testing (5.4) Sample

Handling (5.8)

Personnel

(5.2)

Environment

(5.3)

Report

(5.10)

Results Quality

(5.9)

Equipment

(5.5)

Traceability

(5.6)

Sampling

(5.7)

Consumables

(4.6)

Co

ntr

ol o

f N

/C

(4.9

)

17025 at-a-glance, Management (3 0F 3)

Management

System (4.2)

Review of

Contracts (4.4)

Org

an

iza

tio

n (4

.1)

Service to

Customers (4.7)

Improvement

(4.10)

Control of N/C

(4.9)

Complaints

(4.8)

Mgmnt Review (4.15)

Corrective

Action (4.11)

Preventive

Action (4.12)

Records Control

(4.13)

Internal Audits

(4.14)

Document

Control (4.3)

ISO9001 VS. ISO17025 (2 OF 5)

Management

System (4.2)

Document

Control (4.3)

Organization

(4.1)

Mgmnt

Review (4.15)

ISO9001 VS. ISO17025 (3 OF 5)

Management

System (4.2)

Review of

Contracts (4.4)

Organization

(4.1)

Mgmnt

Review (4.15)

Corrective

Action (4.11)

ISO9001 VS. ISO17025 (4 OF 5)

Management

System (4.2)

Review of

Contracts (4.4)

Organization

(4.1)

Mgmnt

Review (4.15)

Corrective

Action (4.11)

Report

(5.10)

Testing Method

(5.4)

Improvement

(4.10)

Personnel

(5.2)

Preventive

Action (4.12)

Environment

(5.3)

General

(5.1)

Assurance of

Qlty (5.9)

ISO9001 VS. ISO17025 (5 OF 5)

Management

System (4.2)

Review of

Contracts (4.4)

Organization

(4.1)

Mgmnt

Review (4.15)

Corrective

Action (4.11)

Report

(5.10)

Testing Method

(5.4)

Improvement

(4.10)

Personnel

(5.2)

Preventive

Action (4.12)

Environment

(5.3)

General

(5.1)

Assurance of

Qlty (5.9)

Subcontracting

(4.5)

Service

(4.7)

Complaints

(4.8)

Test Eqmnt

(5.5, 5.6 )

Handling T&CI

(5.8)

Purchasing

(4.6) Internal Audits

(4.14)

Incorporates all ISO 9001 requirements relevant to the scope

of testing and calibration … will therefore operate in

accordance with ISO 9001.

ISO9001 ≠ ISO17025

(… does not of itself demonstrate the competence of the laboratory to

produce technically valid data and results.)

ISO17025 ≠ISO9001

Nor does demonstrated conformity (of).. all the requirements of ISO

9001.

ISO9001 VS. ISO17025 (1 OF 5)

Testing or Calibration, or both

Policy vs. procedure

Handling test items, 5.8 &

handling test equipment, 5.5.6

Equipment meets specification 5.5.5

Including test/cal activities in Internal Audits

Purchasing records – PO, Inspection, Suppliers

NC Work procedure scope

COMMON ERRORS

what to look at first –

Start with 5.2 – easy

Do 4.9 before 5.5, so you know the NC

procedure

Do 4.9 with 4.11 Corrective Action

Save doc & records control for last

Repeated requirements:

procedure to protect client info in 4.1.5, also

in 4.13 & 5.4.7

Section 5.1 refers to all following section 5

items

AUDITING TIPS/EXPECTATIONS (1 OF 2)

Top Management:

Continually Improve - 4.2.3/4.10

communication of syst. effectiveness &

importance of meeting requirements -

4.1.6 & 4.2.4

how changes won't affect integrity -

4.2.7

review to ensure suit/effect, changes &

improve - 4.15

AUDITING TIPS/EXPECTATIONS (2 OF 2)

AUDITING APPROACH

Section Procedure* Record**

4.1 Organization Yes (ref)

4.2 Top Mngmt Yes (ref)

4.3 Document Control, Yes

4.4 Review of …Contracts Yes Yes

4.5 Subcontracting Yes

4.6 - Purchasing Services & Supplies yes Yes

4.7 Service to Customer Yes

4.8 Complaints Yes Yes

4.9 Control of N/C Test Work Yes

4.10 Improvement Yes

*term used 79 times, **used 53 times

AUDITING APPROACH

Section Procedure Record

4.10 Improvement Yes

4.11 Corrective Action Yes Yes

4.11 Preventive Action Yes Yes

4.13 Control of Records Yes

4.14 Internal Audits Yes Yes

4.15 - Top Mngmt Yes Yes

AUDITING APPROACH

Section Procedure Record

5.1 Technical Requirements Yes (ref)

5.2 Personnel Yes

5.3 Accommodation & Environmental

Conditions

Yes

(special)

5.4 Test & Calibration Methods &

Method Validation

Yes

5.5 Equipment Yes Yes

5.6 Measuring Traceability Yes Yes

5.7 Sampling Yes Yes

5.8 Handling of Test Items Yes

5.9 QC Yes Yes

5.10 Reporting the Results Yes

purpose of the Standard

an overview

a comparison to ISO 9001

common errors

auditing tips

RECAP