National Seminar & Exhibition on Non-Destructive Evaluation, NDE 2014, Pune, December 4-6, 2014 (NDE-India 2014) Vol.20 No.6 (June 2015) - The e-Journal of Nondestructive Testing - ISSN 1435-4934 www.ndt.net/?id=17872

“ Road Map For Getting Accredited To ISO/IEC 17025 For NDT Service Organizations.” By Dr. Santosh Gupte – ICO Asiapacific Group- Singapore E-mail: [email protected] Affiliation of Author: ASNT Level III in RT,UT,MT,PT & VT (C.No. 86050) Member of ASME, ASQ, ASNT, IIW, etc. Reviewing & Contributing Member of TH HillUSA for DS1 Standards. ABSTRACT The new legislation in EU and Australia, demands that all NDT service providers should get certified to ISO/IEC 17025 – 2005 : General requirements for the competence of testing and calibration laboratories.

If you are implementing the requirements of ISO/IEC 17025:2005 This paper aims to explain the criteria in a simple and easy way, allowing you to facilitate a cost-effective system to help control your operations and achieve accreditation.

I have tried my best to put my efforts to explain in the most possible simple way, though the path is bit harder than it appears to be.

In short statement of abstract or this article will be : A clause-by-clause analysis of the ISO/IEC 17025 accreditation criteria, what they are and what they mean, for NDT Company and some guidance on their implementation. Key Words: ISO/IEC 17025 Accreditation Introduction: Background:

In the recent events of accidents all over the Globe in many segments of Industries, obvious necessity was realized with paramount need to have standardization among the Laboratories, which provide the services of Testing and Calibration of Testing, Monitoring & Measuring Equipment, including Non-destructive Testing. As per International Law of Industries, there are 5 parties, plays role in any major International Projects, Owner of the Equipment, Inspection/Testing Organization on behalf of owner, Third Party Inspection Organization, Insurance Organization & Purchaser or party at Risk; specifically in Oil & Gas, Shipping, Constructions, Aeronautics, & Infrastructure. However, in the event of any accident, there are 2 more parties (Government and Public or any other not listed), who get involved. It is generally agreed by the WTO that the biggest obstacle to trade is Non Tariff Technical Barriers i.e. (TBT’s). However, International recognition of accreditations awarded by national bodies is based on the conclusion of Mutual Recognition Agreements (MRAs) between national bodies. The mechanism is that the bodies seeking to agree to recognise each other’s accreditations will audit each other’s operations against ISO 17011: Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies. This is the international standard to which assessment bodies are expected to adhere. It is in the interest of all to overcome these and to develop a means of recognizing the technical infrastructure and output from one country in another country as being equivalent To protect this entire complex situation, and to have standardization among all Laboratories, ISO has evolved with accreditation as per Standard ISO/IEC 17025. (IEC: International Electrotechnical Commission) Organizations who provides services for NDT, comes under this Standard. The Standard defines the Organization as “Laboratory”.

What is Accreditation? Accreditation is independent and formal recognition of the competence a laboratory to perform specific tests etc. What does Accreditation to ISO/IEC 17025 mean? ISO/IEC 17025 is applicable to testing and calibration laboratories and covers the use of standard, non-standard and laboratory-developed methods.

Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have demonstrated they operate using sound management practices and are technically competent to perform specific tests, calibrations and/or measurements for which they hold accreditation. What are the key differences between accreditation and certification? Certification: -Means compliance with a standard or specification (e.g. systems or product standards). -Is assessed by management systems auditors who are certified by an independent body as meeting internationally agreed criteria. -Can cover more than the sections or tests that have been accredited through laboratory accreditation. -May be general in the scope of recognition. -Considers the total business including strategy and planning. Accreditation: -Is the recognition of a specific technical competence? -The scope of accreditation is normally highly specific. -Evaluates people skills and knowledge. -Is formal recognition that t attesting laboratory is competent to -carry out specific tests or specific types of tests. -Uses technical assessors who are recognized experts in their field. Process of Accreditation to ISO /IEC 17025 - 2005 Step 1: Decision making- The Scope of accreditation. Selecting the scope is very crucial, as there are many activities, methods and techniques that a NDT laboratory is adopting for their customers / in specific country and all these methods/techniques of NDT, may not need to accredit. The scope will also define the fee for assessment and annual subscription for accredit. In practice, any MDT laboratory will have only some of its NDT methods accredited and may not the major methods need to be accredited. An accreditation body will see a comprehensively operating quality system for all those NDT Methods / Techniques as stated in scope. In fact, any assessment will focus on the scope of NDT methods and on the equipment used to deliver them and take little interest outside this scope.

The NDT laboratory should select a scope of NDT methods; which includes those performed routinely and those where either commercial or legal issues make accreditation advantageous. Accreditation bodies differ in precisely how they define scope and some will allow a more generic definition in some areas of activity. In such instances they will assess the NDT laboratory for a particular application of a method plus a procedure to be followed when extending the method to other areas. For example, a NDT laboratory may have accreditation for Ultrasonic Testing by Shear Wave Method (Angle Beam); however, the assessment may also extend to Compressive Wave Method (Longitudinal Beam) may also be assessed if the Laboratory is performing it. Step 2: Decision making- Accreditation Body Selection of accreditation Body is very vital. The body should be well reputed and shall be recognized by the countries where the NDT Laboratory has Customers, meaning; importing country. To make the decision of selection of Accreditation Body, is solely depend on the need for business purpose. Step 3: Once the decision has been taken, the application is to be submitted along with the fee for initial assessment. In the application, legal entity has to be established. The legal aspects such as indemnity and liability associated with scope, need to be clearly defined. “Quality Manager” and “ASNT NDT Level III or equivalent”, are the only positions to be declared with the individual’s names, while filling the application. Accreditation Body has right to check the required technical knowledge of NDT Level III. Step 4: Quality System to be established and generally it is in line with ISO 9001 Standard and few additional requirements of ISO/IEC 17025. The QMS must have Quality Manual and Quality Management Procedures. The requirements are divided in 2 topics. 1. Management Requirements: Clause 4. - relates to the operation and effectiveness of the quality management system within a laboratory. 2. Technical Requirements: Clause 5. - addresses competence of staff, operators, methodology and test.

There after pay the fee to Accreditation Body and submit as follow: - Quality Manual - Operating Procedures - Non-Destructive Test Methods / Techniques including UOM. - CV for key personnel - Copy of Risk Assessments and Contingency plans - Organization chart (Key clauses are explained in this article) Step 5: Once the application is accepted by Accreditation Body, the date of assessment will be fixed on mutually agreed dates. There will be following type of assessments: 1. Adequacy Audit - A review of laboratory’s quality manual and associated documents 2. Pre-assessment - preliminary assessment of the NDT laboratory’s quality management system and operation to determine its readiness for the compliance assessment 3. Compliance - assessment to establish whether the laboratory can competently perform the test for which it seeks accreditation. Step 6: AccreditationGranting of accreditation upon satisfactory discharge of all non-compliances raised during the assessment. Certificate of Accreditation and Schedules of Accredited tests will be issued to NDT laboratory The Certificate of Accreditation is valid for 3 years (Renewal every 3 years)

Detailed interpretation of few major clauses:

1. Influences, confidentiality and independence [Clause No.: 4.1.4, 4.1.5] The NDT laboratory must be set up in such that all employees shall completely free to exercise their professional judgment. There must be no commercial or financial pressures, which might influence the quality of the work / NDT Evaluation. This does not mean that you cannot insist on a reasonable efficiency from NDT Technicians/Inspectors, but it would not be acceptable to pay them on the basis of the number of NDT or NDE being carried out. All employees shall be instructed to keep confidential anything which they may learn as a result of their work and any information which they are given in order to help them to carry out their duties. The quality manual should contain a statement to this effect. Some organizations require staff to sign a confidentiality agreement. This is not essential but is generally to be recommended. There should be instructions to staff on the course of action to be taken if they believe that an attempt has been made to subvert their judgement. The general

instruction should be that the staff member must inform the management as soon as possible and the management should arrange to have the work in question passed to another employee, wherever possible. It is emphasized that this is not done as a reflection on the integrity of the staff member concerned but is required in defense of the laboratory's reputation and to remove any possibility of a suggestion that the approach might have been successful.

2. Measurement of Uncertainty [Clause 5.6] This is a very important clause to be understood properly as most of the NDT Laboratories fail to understand this. For the uncertainty to be truly meaningful, it must address the entire measuring process, which may have uncertainties associated with factors such as equipment calibration, equipment resolution, operator skill, sample variation, and environmental factors. In many cases, sample variability and operator skill are the largest sources of uncertainty and they are often the only source considered when only the repeatability of a measurement is evaluated. However, a more thorough analysis will consider other sources of uncertainty. As a minimum, in addition to the repeatability evaluation, an uncertainty analysis should consider the instrumentation/standard calibration and the resolution of the instrumentation. Uncertainty classification: –Random uncertainty / variability – scatter in the measurements (v) –Systematic uncertainty / bias – systematic departure from the true value (b) Type of uncertainty: Type A Uncertainty: calculated by statistical methods (it is useful to explain the design of experiments and the number of samples involved), calculated by statistical methods. Type B Uncertainty: determined by other means, such as estimate from experience or manufacturers specifications. Difference: Error vs. Uncertainty: Error is the deviation from the true value and measured value (never known), which is estimated as uncertainty ISO Guide to the Expression of Uncertainty in Measurement (GUM) ISO GUM has described 2 principles to measure the uncertainties of tests. One is for Type A and another for Type B Uncertainties.

General a step by step process as follow as per GUM: 1. Sp ecify the measurement: Clearly specify the quantity to be determined and the method by which it is to be determined. This sp ecification must include all of the factors that could significantly affect the measurement result including but not limited to environmental conditions, samp ling p rocedures, samp le p rep aration p rocedures, as well as the test or calibration method to be used. 2.

Derive the mathematical model: Exp ress mathematically the relationship between the measured value and all of the inp ut quantities up on which the measurement dep ends. This mathematical model should contain every quantity , including all corrections that can contribute significantly to the uncertainty of the result of the measurement.

3.

Quantify the influence quantities: Estimate the value of each inp ut quantity either by the statistical analysis of rep eated observations or by other means such as taking the uncertainty of a reference standard from a calibration certificate, estimating temp erature effects on test or calibration results based on theoretical p redictions, estimating the uncertainty of p hy sical constants based on data in reference books and so on.

4.

Evaluate the standard uncertainty of each influence quantity : Evaluate the standard uncertainty of the estimates of the values for the inp ut quantities. For the uncertainty of an inp ut estimate based on the statistical analy sis of repeated observations, the estimate is made as described in above section (Ty pe A). For estimates obtained by other means, the standard uncertainty is evaluated as described in above section (Ty p e B).

5.

Evaluate sensitivity coefficients and covariance For non-correlated inp ut quantities, evaluate their resp ective sensitivity coefficients either directly by differentiation of the function used to model the measurement or indirectly by exp eriment. For correlated inp ut quantities, evaluate the associated covariance.

6.

Calculate the measurement result: Calculate the result of the measurement based on the mathematical model adop ted and the estimates of the inp ut quantities.

7

Determine the combined standard uncertainty : Determine the combined standard uncertainty of the measurement result from the standard uncertainties and covariance’s of the inp ut estimates.

8

Determine the expanded uncertainty : If it is necessary to p rovide an exp anded uncertainty , first estimate the effective degrees of freedom of the estimate of the combined standard uncertainty . Consulting a t-table,

multip ly the combined standard uncertainty by the coverage factor associated with the estimated degrees of freedom and desired level of confidence.

9

Rep ort the measurement result and associated uncertainty estimate: Rep ort the measurement result and either the combined standard uncertainty or the expanded uncertainty .

Graphical representation we can show as follow:

Please note that : Random Uncertainty (Variability) is the scatter in the measurement (v ) v x = sx =

sx N

& Systematic Uncertainty (Bias) is the systematic departure from value b.

b =

B 2

In case NDT Level II is unable to establish the statement of compliance due to the error in measurement of uncertainness for any reason, he shall contact NDT Level III. There after NDT Level III shall go though with NDT Level II to find out the error source and will eliminate the issue. In above case, one or more NDT Level IIIs of NDT Laboratory, may be contacted for better decision making.

In case of such errors affecting the statement of compliance, the report shall be with the note : “ error has been calculated with Measurement Uncertainty and found to be as ….”

To understand for readers, please refer the table as follow:

1. Magnetic Particle (Magnetic Flow) Measurement Uncertainty Estimate Error source component

Include Y/N

Pa i nt on Surface of Inspection

N

Contrast coating too thin

N

Contrast coating too thick

Y

Poles of magnet too far apart Edge only of magnet poles applied to test area Insufficient/excessive particle concentration in case of mixture to be prepared.

Estimated 99% confidence range (mm) [Note 2]

Assumed Compone distributi nt on standard Uncertain ty

Squared Standard Uncertain ty

See notes

1& 3 3 Normal

0.03

0.009

Y

+/- 0.10 (+/0.0001Inch) +/- 1.0

Normal

0.3

0.09

Y

+/-2.0

Normal

0.7

0.49

Y

+/- 0.10

Normal

0.03

0.009

Normal

0.3

0.09

+/-100

Mi crowa tts/15I nch Di s tance

UV Light for Fluorescent MPI (Black light method)

Y

Amp=Turn, in case of DC Coil

Y

+/- 10 Amp-Turn

Normal

0.3

0.09

Ruler- 1/64 Inch graduations Ruler- parallax error

Y Y

+/- 1/64 Inch +/-1/64

Normal Normal

0.3 0.15

0.09 0.0225

Level of experience of technician

N

Very/fine/tight/short crack

Y

+/-1.0

Normal

0.7

0.49

Defect not at 90 to magnetic field

Y

+/-1.0

Normal

0.3

0.09

Magnetization time too short/too long

N

Location/geometry of defect eg, crack along weld toe(difficult to see location)

Y

4

o

5& 3 +/-2.0

Normal

Confined space/hard to access N test area Surface contamination N Inadequate lighting Y +/-2.0 Normal A. Sum of squares of component values B. Estimated combined std uncertainty (square root ofA) C. Estimated expanded uncertainty 95% range (multiply B by 2) ie, MU at 95% confidence Notes and reasons for the points not considered for MU calculations.:

0.7

0.49

6 3 0.7

0.49 2.4055 1.565 3.13 ie,+/3.1mm

1. Paint on surface of Magnetic Particle Testing is not acceptable. Mandatory to remove it before starting MPI Test. 2. Normal distribution as shown in procedure covering 99% uncertainty of results . 3. Covered in Level II training programs 4. All NDT inspectors are trained and certified.Trainees (NDT Level 1 ) shall work underNDT Level 2. MU will be eliminated with the proper training and experie nce. 5. NDT Inspectors are well trained to allow proper magnetic field and proper timing to allow the required magnetic flux at the surface of inspection. 6. Confined space and hard to access / areas shall be an isolated case, and shall be dealt with case to case basis.

3. Test Methods and Method Validations [Clause No. 5.4] - select appropriate methods to meet customers’ requirement - ensure methods give valid results - Method validation encompasses: Selectivity, Linearity, Limit of detection, Precision, Reproducibility, Accuracy, Robustness, Ruggedness 4. Personnel Competency [Clause No 5.4] The Staff performing tasks need to be competent and records of the authorization and competence confirmed to be made available. Competency means: qualification + training/certification + experience + skills + capability. In my opinion, all other clauses are similar to ISO 9001- 2008 and understood through out industry quiet well. Conclusion: The road for getting accredited for ISO –IEC 17025 is not that easy, it is a challenge. However, if the steps are followed as stated in this article the probability of getting accredited is high for NDT service providers. References: ISO/IEC 17025-2005 NATA Guide ICO’s IOPs