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Office of Energy Efficiency & Renewable Energy

Operated by the Alliance for Sustainable Energy, LLC

This report is available at no cost from the National Renewable Energy

Laboratory (NREL) at www.nrel.gov/publications.

Contract No. DE-AC36-08GO28308

Proposal for a Guide for Quality 

Management Systems for PV 

Manufacturing: Supplemental 

Requirements to ISO 9001-2008

Paul Norum

Amonix

Ivan Sinicco

Tokyo Electron

Yoshihito Eguchi

Japan Electrical Safety and 

Environment Technology 

Laboratories (JET) 

Sumanth Lokanath

First Solar

Wei Zhou

Trina Solar

Gunnar Brueggemann

Tokyo Electron

Alex Mikonowicz

Powermark

Masaaki Yamamichi

National Institute of Advanced 

Industrial Science and 

Technology (AIST)

Sarah Kurtz

National Renewable Energy 

Laboratory

Technical Report 

NREL/TP-5200-58940

June 2013
NREL is a national laboratory of the U.S. Department of Energy

Office of Energy Efficiency & Renewable Energy

Operated by the Alliance for Sustainable Energy, LLC

This report is available at no cost from the National Renewable Energy

Laboratory (NREL) at www.nrel.gov/publications.

Contract No. DE-AC36-08GO28308

National Renewable Energy Laboratory

15013 Denver West Parkway

Golden, CO 80401

303-275-3000 • www.nrel.gov

Proposal for a Guide for Quality 

Management Systems for PV 

Manufacturing: Supplemental 

Requirements to ISO 9001-2008

 

Paul Norum

Amonix

Ivan Sinicco

Tokyo Electron

Yoshihito Eguchi

Japan Electrical Safety and 

Environment Technology 

Laboratories (JET) 

Sumanth Lokanath

First Solar

Wei Zhou

Trina Solar

Gunnar Brueggemann

Tokyo Electron

Alex Mikonowicz

Powermark

Masaaki Yamamichi

National Institute of Advanced 

Industrial Science and 

Technology (AIST)

Sarah Kurtz

National Renewable Energy 

Laboratory

Prepared under Task No. SS13.5510

Technical Report 

NREL/TP-5200-58940

June 2013
NOTICE

This report was prepared as an account of work sponsored by an agency of the United States government. 

Neither the United States government nor any agency thereof, nor any of their employees, makes any warranty, 

express or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of 

any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately 

owned rights. Reference herein to any specific commercial product, process, or service by trade name, 

trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, 

or favoring by the United States government or any agency thereof. The views and opinions of authors 

expressed herein do not necessarily state or reflect those of the United States government or any agency thereof.

This report is available at no cost from the National Renewable Energy

Laboratory (NREL) at www.nrel.gov/publications.

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Cover Photos: (left to right) photo by Pat Corkery, NREL 16416, photo from SunEdison, NREL 17423, photo by Pat Corkery, NREL 

16560, photo by Dennis Schroeder, NREL 17613, photo by Dean Armstrong, NREL 17436, photo by Pat Corkery, NREL 17721.

 Printed on paper containing at least 50% wastepaper, including 10% post consumer waste. 
iii

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Executive Summary

The goal of this Technical Specification is to provide a guideline for manufacturers of 

photovoltaic (PV) modules to produce modules that, once the design is proven to meet the 

quality and reliability requirements, replicate the design on an industrial scale without 

compromising its consistency with the requirements. 

From 1996 to 2011, the PV industry grew by a factor of almost 400, resulting in annual PV 

module production greater than 30 gigawatts (GW). With an annual investment in PV around 

$100 billion, the industry has become highly motivated to ensure quality of that investment, with 

special emphasis on the quality of the PV modules, as these are the most expensive part of the 

system to replace and the extent of their power output degradation in the field significantly 

impacts the return on investment. 

The International PV Module Quality Assurance Task Force was formed in 2011 to develop 

standards that can help customers quickly assess a PV product’s ability to withstand regional 

stresses and to gain confidence that purchased PV products will be of consistent quality. 

Reliability is neither defined, nor covered, by the existing International Electrotechnical 

Commission (IEC) standards. Module design qualification to those standards does not imply the 

PV module’s reliability. Therefore, the Task Force set the goal to establish guidelines dealing 

with all relevant influences on the module such as raw materials and components, process 

parameter sets and their control, reasonable test sequences, training of the staff, etc. 

Task Group #1 of this Task Force has focused on the requirements of a quality program used to 

guide the manufacture of PV modules in maintaining module consistency. While ISO 9001 is 

used as an industry standard for documenting quality programs, it addresses generic elements of 

a quality management system and does not cover specific details of interest to the PV industry. 

Starting in fall of 2011, Task Group #1 began to write a PV-specific version of ISO 9001 that 

would strengthen the quality program by incorporating known requirements for PV. This 

revision of ISO 9001 will be submitted to IEC/ISO for formal adoption and, once revised by the 

standards process, will become a standard that can be fully used by the community. 

In the meantime, this report summarizes the revisions identified by Task Group #1 and provides 

the community with a way to begin benefitting from the more robust quality programs, even 

before the standards process is completed. Community experience in implementing this draft 

standard will also provide essential feedback for the standardization process to help ensure that 

the adopted standard is optimally useful. In that context, the community is encouraged to use the 

contents of this report and to provide feedback to the International PV Module QA Task Force 

and the IEC/ISO standards organizations. We are interested in positive and negative experiences 

with the application of the recommendations herein. 

Key requirements in the proposed standard include: 

• Focus on the organization’s control of the PV module’s design to align the expected 

lifetime with its relationship to the organization’s warranty. Warranty claims must be 

addressed by product and process design or by financial means.
iv

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• Requirement to obtain IEC product certification and implement an ongoing reliability test 

program that monitors PV modules’ performance for compliance with standards and the 

stated design lifetime.

• Requirement to improve product traceability through the entire supply chain to enact 

positive control of the product for recalls and warranty claims.

• Design of a manufacturing process that will ensure conformance to the design intent for 

power, lifetime, and warranty.

• Special processes such as control of solderability, electro-static design (ESD) control, and 

assignment of PV module power rating. 
v 

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Table of Contents

Executive Summary...................................................................................................................iii

Acknowledgements ...................................................................................................................vi

Acronyms ...................................................................................................................................vi

Introduction: Motivation............................................................................................................. 1

Methodology................................................................................................................................ 2

Proposed Additions to ISO 9001-2008 ...................................................................................... 3

Goal of This Technical Specification ....................................................................................................... 3

3 Terms and Definitions........................................................................................................................... 3

3.1 Terms and Definitions for the PV Industry .................................................................................. 3

6 Resource Management .......................................................................................................................... 4

6.1 Provision of Resources................................................................................................................. 4

7 Product Realization ............................................................................................................................... 4

7.1 Planning of Product Realization................................................................................................... 4

7.2 Customer-Related Processes......................................................................................................... 4

7.3 Design and Development ............................................................................................................. 5

7.4 Purchasing Process....................................................................................................................... 7

7.5 Production and Service Provision................................................................................................. 8

7.6 Control of Monitoring and Measuring Equipment ..................................................................... 10

8 Measurement, Analysis, and Improvement ......................................................................................... 10

8.2 Monitoring and Measurement .................................................................................................... 10

8.3 Control of Nonconforming Product............................................................................................ 11

8.5 Improvement............................................................................................................................... 11

Proposed Implementation........................................................................................................12

References................................................................................................................................. 13

About the Authors ....................................................................................................................13
vi 

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Acknowledgements

The international efforts that contributed to this work were primarily provided by volunteers 

from the companies and national laboratories. This support is deeply appreciated. The portion of 

this work completed at the National Renewable Energy Laboratory was supported by the U.S. 

Department of Energy under Contract No. DE-AC36-08GO28308. 

Acronyms

AIST National Institute of Advanced Industrial Science and Technology 

ESD electro-static design

FMEA failure modes and effects analysis

IEC International Electrotechnical Commission

ISO International Organization for Standardization

JRC Joint Research Centre

NREL National Renewable Energy Laboratory 

PFMEA process failure modes and effects analysis 

PV photovoltaic 

QA quality assurance

STC standard test conditions 
1 

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Introduction: Motivation

From 1996 to 2011 the photovoltaic (PV) industry grew by a factor of almost 400, resulting in 

annual PV module production greater than 30 gigawatts (GW). With an annual investment in PV 

of about $100 billion, the PV community has become highly motivated to ensure quality of that 

investment. Because PV module prices fell by a factor of about three between 2009 and 2012, 

manufacturers have been universally pressured to cut costs. There is some concern within the 

community that some manufacturers may be reducing costs by paying less attention to quality 

issues. Even for those who are conscientious, it is difficult to determine whether a PV module 

will have a lifetime that will meet the warranty (typically 25 years). For those who are less 

conscientious, the possibility of premature failure can be considered an unacceptable risk.

The International PV Module Quality Assurance Forum was held in July of 2011 in San 

Francisco, organized and sponsored by the National Institute of Advanced Industrial Science and 

Technology (AIST), the National Renewable Energy Laboratory (NREL), the European 

Commission Joint Research Centre (JRC), and the SEMI PV Group. About 160 individuals 

representing PV manufacturers, PV customers, test laboratories, and government organizations 

attended the Forum. The participants agreed that improved standards are needed to differentiate 

PV module durability in different climate zones and in various mounting configurations. In 

addition to the need for accelerated tests that match the intended use conditions, the participants 

highlighted the need to be able to communicate the strength of the quality management program 

used by the factory. Although factories use quality programs, there has been no simple way to 

differentiate a strong quality program from a weak program. The International PV Module 

Quality Assurance Task Force was formed at the Forum to develop standards that can help 

customers quickly assess a PV product’s ability to withstand regional stresses and to gain 

confidence that purchased PV products will be of consistent quality. Five task groups were 

formed to address the manufacturing consistency (Task Group #1) issues and need for 

accelerated tests (Task Groups #2–5). Since then, four additional task groups have been formed 

to help discuss the communication of the testing results, as well as address other issues including 

those related to thin-film and concentrator PV modules. 

Task Group #1 of this Task Force has focused on the requirements of a quality program used to 

guide manufacture of PV modules. While ISO 9001 is used as an industry standard for 

documenting quality programs, it addresses generic elements of a quality management system

and does not touch on specific details of interest to the PV industry. Starting in the fall of 2011, 

Task Group #1 began to write a PV-specific version of ISO 9001 that would strengthen the 

quality program by incorporating known requirements for PV. This revision of ISO 9001 will be 

submitted to IEC/ISO for formal adoption and, once revised by the standards process, will 

become a standard that can be fully used by the community. 

In the meantime, this report summarizes the revisions identified by Task Group #1 and provides 

the community with a mechanism to begin benefitting from the more robust quality programs, 

even before the standards process is completed. Community experience gained by implementing 

this draft will also provide essential input into the standards process to help ensure that the 

adopted standard is optimally useful. In that context, the community is encouraged to use the 

contents of this report and to provide feedback to the International PV Module QA Task Force 
2 

This report is available at no cost from the 

National Renewable Energy Laboratory (NREL) 

at www.nrel.gov/publications.

and the IEC/ISO standards organizations. We are interested in the positive and negative 

experiences with application of the recommendations herein. 

Methodology

There have been a large number of participants in Task Group #1 (as of June, 2013 there are 

more than 190). The participants have represented different continents, requiring optimization of 

the working method. So, a task leader was set as coordinator, and four regional task groups were 

formed in Europe, the Americas, Japan, and China. International participation was encouraged, 

but the formation of regional teams allowed more convenient scheduling of meetings and, in 

some cases, aided in communication by allowing participants to speak in their native language. 

The four regional groups separated the various chapters and began to develop a set of suggested 

revisions. The graph below indicates an example of activities by regional groups when drafting 

the new proposal (the y-axis represents the percentage while the x-axis represents the paragraph 

considered). 

Example of contribution of regions on chapters of the proposal

The four drafts were then merged to identify and resolve the differences. Each regional group 

leader was asked to participate, via online teleconference, in an alignment meeting by the 

coordinator. Moreover, worldwide phone calls and periodic face-to-face meetings facilitated the 

alignment of the multiple drafts to the draft that is presented here (finalized during the Feb. 26-

27, 2013 PV Module Reliability Workshop in Colorado). 

The method for implementing the proposed quality program was discussed at length by both 

Task Group #1 and representatives of ISO and IEC to identify the “smoothest” way to introduce 

it into the community. According to the authors, the best way will be a joint document 

(ISO/IEC).
3 

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Proposed Additions to ISO 9001-2008

Goal of This Technical Specification

The goal of this Technical Specification is to provide a guideline for manufacturers of PV

modules to produce modules that, once the design has proven to meet the quality and reliability 

requirements, replicate such design in an industrial scale without compromising its consistency 

with the requirements. 

This Technical Specification is meant to be used in assessment audits of the PV module 

manufacturer’s Quality Management System (QMS), and to form a common basis for audits by 

various certifying bodies. 

Such assessments should audit the entire set of materials, components, and processing. 

The larger the diversity of products from a manufacturer, the more materials and material 

combinations must be controlled. All changes in the design and/or materials and processes 

applied must be considered. 

For the convenience of the reader, the relevant paragraph numbers from ISO 9001-2008 are 

indicated. Note that no changes are proposed for many of the paragraphs. 

3 Terms and Definitions

3.1 Terms and Definitions for the PV Industry

For the purposes of this document, the terms and definitions in ISO 9000:2008, IEC/TS 61836, 

and the following apply. 

Control plan

Documented description of the systems and processes required for controlling the product. 

Design lifetime

Design target period during which PV modules are expected to satisfy the specified performance 

under the specified conditions. 

Note: Specified conditions include application of use, installation environment 

configurations, and operation conditions of the PV module in use. The design 

target period is set considering changes in performance of PV modules due to 

aging degradation of parts and materials used in the stated environment. 

FMEA

Stands for "failure modes and effects analysis." A document that defines the new process or 

solution with requirements and includes potential causes and effects of failure, along with a 

prediction of the likelihood of their occurrence and ease of detection. The FMEA provides a 

mechanism to articulate the risks and take appropriate mitigation steps. 

Performance warranty

A warranty provided by the party ensuring product liability to guarantee the specified 

performance of PV modules over the specified period and under the specified conditions. 
4 

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6 Resource Management

6.1 Provision of Resources

Provision of resources – supplemental

The organization shall determine and provide the resources needed to maintain the product 

warranty system through product reliability measurements or provision of after-sales service.

7 Product Realization

7.1 Planning of Product Realization

Planning of product realization – supplemental

In planning product realization, the organization shall also determine the following, as 

appropriate: 

a) Product certification requirements,

b) Design lifetime aligned with the stated warranty under specific conditions and a documented 

method to ensure compliance to stated warranty by a combination of product reliability and 

after-sales services,

c) Recycling requirements at the end of the modules’ lifetime, and 

d) Quality assurance and control measures to be applied to production to meet requirements of 

the applicable PV standards. 

Customer requirements and references to related technical specifications, as applicable, shall be 

included in the planning of product realization as a component of the quality plan. 

NOTE 1: “Organization” means an entity that takes primary responsibility for 

production, quality assurance, and warranty of the PV module. 

NOTE 2: “Design lifetime” is one of the key design parameters, defined as a 

period of time throughout which PV modules are expected to generate designed 

power output under pre-specified conditions. 

NOTE 3: With changing requirements from the market place and with emerging 

new technology in the PV Industry, the development and launch of new products 

should meet requirements of the product warranty as well as customers’ needs. 

Therefore, a completed product life cycle plan is required.

7.2 Customer-Related Processes

Determination of requirements related to the product – supplemental

The organization shall determine product warranty workmanship and power degradation and its 

relationship to the expected design lifetime under specified or intended use conditions. 

The organization shall incorporate requirements arising from previous failure information, 

competitive analysis, supplier feedback, and other internal inputs. 

Review of requirements related to the product – supplemental 

The organization shall ensure that all modified product, not covered by the retest guidelines, is 

qualified to all related type designations and that the modified product is evaluated for impact on 

the warranty.
5 

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The organization shall identify and document all limitations on product application.

The organization shall identify critical areas for ESD control.

NOTE: Retest guidelines are being developed.

Organization manufacturing feasibility

The organization shall investigate, confirm, and document the manufacturing feasibility of the 

proposed products in the contract review process, including risk analysis. 

Customer communication – supplemental

The organization shall also determine and implement effective arrangements for communicating 

with customers in relation to: 

a) Safety, workmanship warranty, output power warranty, and installation guidelines including 

electrical and mechanical installation instruction,

b) Application notes detailing specific attention and/or care needed to secure expected design 

lifetime of installed modules, and 

c) The definition of a warrantable defect or safety-critical defect and the rules and/or process to 

manage stated defects.

NOTE 1: “Information” includes but is not limited to specifications, drawings, 

and other material, including “installation” manuals. 

NOTE 2: “Suitable Equipment” includes software. 

NOTE 3: “Implementation of product post-delivery activities” includes “aftersales service.” 

7.3 Design and Development

Design and development planning – supplemental

The organization shall include production processes in the design and development planning. 

The organization shall also determine: 

a) The responsibilities and authorities for a cross-functional project design and development 

team, 

b) the process to conduct design FMEAs or equivalent, reliability verification, expected design 

lifetime and product specification generation, and 

c) The requirements for process FMEAs or equivalent, specifications, layouts, and work 

instructions.

Design and development inputs – supplemental

The inputs shall also include: 

a) Functional, performance, and safety requirements including expected design lifetime, power, 

maintainability, durability, transportation, timing, and costs, 

b) Identification of the product, traceability, and packaging requirements, and 

c) Requirements for proper handling of product and components for ESD. 
6 

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Manufacturing process design input

The organization shall identify, document, and review the manufacturing process design input 

requirements, including: 

a) Product design output data, 

b) Targets for productivity, process capability, and cost,

c) Customers’ requirements, if any, and 

d) Experience from previous developments. 

NOTE: The manufacturing process design includes the use of error-proofing 

methods to a degree appropriate to the magnitude of the problems and 

commensurate with the risks encountered.

Design and development outputs – supplemental

Design and development outputs shall also: 

a) Specify an instruction manual for the end user and an installation manual for proper and safe 

use, 

b) Include design FMEAs, or equivalent, which are to be updated during design reviews, and 

c) Define product special characteristics that will require unique controls.

Manufacturing process design output

The manufacturing process design output shall be expressed in terms that can be verified against 

manufacturing process design input requirements and that can be validated. The manufacturing 

process design output shall include: 

a) Specifications and drawings,

b) Manufacturing process flow chart/layout,

c) Manufacturing process FMEAs or equivalent,

d) Control plan (see Section 7.5.1.1 of ISO 9001-2008), 

e) Work instructions,

f) Process approval acceptance criteria,

g) Data for quality, reliability, maintainability and measurability,

h) An ESD protection plan 

i) Results of error-proofing activities, as appropriate, and 

j) Methods of rapid detection and feedback of product/manufacturing process conformities. 

NOTE: PFMEA shall cover the process from material receipt to product delivery, 

installation and maintenance.

Design and development validation – supplemental

The organization shall include standard requirements from applicable IEC and national standards 

for validation of the design. 

All performance testing activities including durability of first batch modules shall be monitored 

for timely completion and conformance to requirements. Performance testing shall conform to a 

product and process approval procedure including a reliability test plan similar to applicable 

standards. Prototyped PV modules can be tested according to IEC standards.
7 

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While services may be outsourced, the organization shall be responsible for the subcontracted 

services, including technical leadership.

Note: Product approval should be subsequent to the verification of the 

manufacturing process. This product and manufacturing process approval 

procedure shall also be applied to suppliers.

Control of design and development changes – supplemental

The organization shall implement a change management system for materials and processes and 

ensure all changes adhere to product and defined internal/external qualifications and certification 

requirements.

All design and development changes shall be documented in the appropriate FMEA. 

Qualification and reliability tests shall be documented. Changes shall not be released before tests 

are verified. If the change has impact to form, fit, and performance of the product, notification to 

the appropriate customer is required.

NOTE: All changes should be reviewed and qualified by reference to retest 

guidelines. 

7.4 Purchasing Process

Purchasing process – supplemental

Materials components and sub-assemblies that have a safety implication on the finished product 

and that are purchased from or prepared by a supplier require a higher level of control. 

The organization shall define a process for the supplier’s notification of changes. It is the 

responsibility of the organization to ensure that subassemblies and assemblies completed by 

subcontractors meet the quality plans and relevant safety requirements.

The organization should ensure that the supplier can meet product requirements by doing the 

following: 

a) Evaluate the quality performance of key materials and audit the supplier of key materials on 

a regular basis

b) Ensure that materials used in the product conform with related regulations in the PV industry 

c) Optionally, carry out onsite audits to check that: 

• The material produced is conformal with PV industry regulations; 

• The supplier has the capability to deliver the goods on time; 

• The supplier has the capability to maintain product quality consistently, and will notify 

customers when there is any change of products or interruption of production, 

d) Urge the supplier to improve its quality performance, and 

e) Apply methods for incoming inspections and preparation of raw materials. 
8 

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Purchasing information – supplemental

Purchasing information shall also describe the requirements for materials/component traceability.

Verification of purchased process – supplemental

The organization shall have a process to ensure the quality of the purchased product by utilizing 

one or more of the following methods: 

a) Receipt of certificate of conformance or analysis,

b) Evaluation of statistical data by the organization,

c) Conducting a receiving inspection and/or testing such as sampling based on performance, 

d) Have product evaluation or material analysis performed by an independent laboratory or 

testing facility, and/or 

e) Require evidence of supplier inspections when the supplier has been delegated the inspection 

authority based on the supplier’s history of product conformance to requirements. 

7.5 Production and Service Provision

Control of production and service provision – supplemental

The organization shall devise methods to monitor the performance and accuracy of the 

equipment utilized in the product realization process. 

The organization shall create definitions of serious product problems and determine rules and/or 

processes to minimize the impact of the problem.

The organization shall provide technical support to help customers use the product properly, help 

customers in trouble-shooting, and help prevent any safety risks.

Control plan

The organization shall establish control plans for all appropriate processes, subassemblies, 

components, and materials for the final product. Control plans shall: 

a) Be based on a risk analysis such as design or process FMEA outputs, or equivalent,

b) List the controls used for the manufacturing process control, 

c) Include methods for monitoring of control exercised over special characteristics (see Section 

7.5.2 of ISO 9001-2008) defined by the organization, 

d) Include customer required information, if any, and 

e) Initiate a specific out-of-control action plan when a process becomes unstable or not 

statistically capable.

The organization shall review and update control plans when any change occurs that affects the 

product manufacturing process. 

The organization shall define and manage a process to disposition the affected product impacted 

by an out-of-specification process.

The organization shall maintain data records in a manner that allows detection of possible 

tendencies.

Validation of processes for production and services provisions – supplemental

The organization shall also validate all software utilized in the production and services provision. 
9 

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The organization shall define a recertification process for qualified personnel.

The organization shall determine parameter sets for the acceptance tolerance for the module.

The organization shall validate the effectiveness of its ESD program, as required. 

NOTE: Use of statistical process control is recommended for these processes.

Identification and traceability – supplemental

The organization shall document traceability of changes to the product and the impact from those 

changes for previous and future product deliveries. 

The organization shall ensure traceability of the product by: 

a) Tracking product construction to the constituent raw materials and the components used to 

the lot/batch level that are traceable back to suppliers, dates and locations of manufacture, 

b) Tracking the product through each process step to the specific machine and time of 

processing. 

The organization shall inspect the product in process and at the final inspection to ensure that the 

requirements of the product specification are met. Repaired/reworked products must be subject 

to and meet all in-process and final inspection requirements. 

The processing, storing, and back tracing of test and process data must be documented in an 

adequate way. The recording of the data should allow a monitoring that shows possible 

tendencies.

Customer property – supplemental

NOTE: If required, the control methods of customer property shall be approved 

by the customer.

Preservation of product – supplemental

The packaging method of the PV module needs to be tested and validated to meet customer 

requirements and ensure that the product can be transported to customer sites properly. Product 

traceability information should be easily identified from outside packaging. 

The organization shall use an inventory management system to optimize inventory turns over 

time and ensure stock rotation, such as “first-in-first-out.” Obsolete product shall be controlled in 

a similar manner to that for nonconforming product. 

Ongoing product monitoring

The organization shall define an ongoing/periodic reliability-monitoring/production-monitoring 

program that uses accelerated stresses for the known failure mechanisms of the product. The 

tests shall be conducted on random samples from normal production. 

Discovery of failures from these activities shall follow Sections 8.5.2 and 8.5.3 of ISO 9001-

2008. Corrective, root cause action shall be taken and documented for any failures. 
10 

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Records of the results of any ongoing/periodic reliability testing/production monitoring program 

activities and any necessary actions arising from such activities shall be maintained (see Section 

4.2.4 of ISO 9001-2008). 

7.6 Control of Monitoring and Measuring Equipment

Control of monitoring and measuring equipment – supplemental

Monitoring and measurement equipment shall be characterized by measurement system analysis 

to understand gauge capabilities (tolerance and precision).

Software shall be considered an integral part of monitoring and measuring equipment, and shall 

be appropriately controlled and validated. 

For monitoring and measurement equipment found to be out of tolerance at the time of 

calibration, corrective actions must be taken to determine the impact to the product and 

documented per Section 4.2.4 of ISO 9001-2008. 

Performance rating (IV) measurement equipment

The accuracy of measurement should be shown on the label and this should be verified (ISO/IEC 

Guide 98-3:2008: Uncertainty of measurement – Part 3: Guide to the expression of uncertainty in 

measurement) during factory inspection regardless of simulator class.

The organization shall include a statement on the accuracy of power measurement on the label of 

the produced module and, if applicable, refer to the name of the PV institute that issued the 

reference device calibration certificate.

8 Measurement, Analysis, and Improvement

8.2 Monitoring and Measurement

Customer complaints

The organization shall manage customer complaints in a controlled fashion and log the issues 

and the corrective and preventive actions taken to satisfy the complaint.

Complaints must be dealt with in a timely and effective manner.

Monitoring and measurement of a manufacturing process

The organization shall perform process studies on all new manufacturing processes (including 

assembly or sequencing) to verify process capability and to provide additional input for process 

control. The results of process studies shall be documented with specifications, as applicable, for 

means of production, measurement and test, and maintenance instructions. These documents 

shall include objectives for manufacturing process capability, reliability, maintainability and 

availability, as well as acceptance criteria.

The organization shall maintain manufacturing process capability or performance as specified by 

the customer part approval process requirements or organization-targeted level. The organization 

shall ensure that the control plan and process flow diagram are implemented, including 

adherence to the specified: 
11 

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at www.nrel.gov/publications.

a) Measurement techniques,

b) Sampling plans, 

c) Acceptance criteria, and

d) Reaction plans when acceptance criteria are not met.

Significant process events, such as a tool change or machine repair, shall be recorded. 

The organization shall initiate a reaction plan from the control plan for characteristics that are 

either not statistically capable or are unstable. These reaction plans shall include the containment 

of product and 100% inspection as appropriate. A corrective action plan shall then be completed 

by the organization, indicating specific timing and assigned responsibilities to ensure that the 

process becomes stable and capable. The plans shall be reviewed with and approved by the 

customer when so required. 

The organization shall maintain records of effective dates of process changes.

Monitoring and measurement of product – supplemental

Monitoring and measurement of product shall include studies of the performance during the 

expected design lifetime of the product. 

8.3 Control of Nonconforming Product

Control of nonconforming product – supplemental

Product with unidentified or suspect status shall be classified as nonconforming product (see 

Section 7.5.3 of ISO 9001-2008). 

Customers shall be informed promptly in the event that nonconforming product has been 

shipped. 

The organization shall obtain a customer concession or a deviation permit prior to further 

processing whenever the product or manufacturing process is different from that which is 

currently approved. 

Instructions for rework, including re-inspection requirements shall be defined and validated to 

the same requirements as new product.

8.5 Improvement

Continual improvement – supplemental

Note: The organization should identify measure and report quality metrics to 

drive continuous improvement. 

Corrective action – supplemental

Records of customer notifications, where appropriate, shall be maintained (see Section 4.2.4 of 

ISO 9001-2008). 
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at www.nrel.gov/publications.

Proposed Implementation

For an interim period of time until this proposed program is standardized to IEC/ISO, the 

program can be used in internal audits of the PV manufacturer to assess robustness of its quality 

management system. The program may also be used in factory inspections by test labs for IEC 

61215/61646 certification of the modules as an alternative to ISO 9001-2008. We encourage 

organizations to provide feedback to the IEC standards process to reflect their experiences.

When this program is published as an IEC/ISO standard, it will substitute for ISO 9001-2008 in 

factory inspections by test labs for IEC 61215/61646 certification of the modules, to provide 

better assurance of quality management for the clients. Test labs are requested to prepare their 

factory inspection guide for this program and release it to the customers so that module 

manufacturers may be well prepared for the inspection. We anticipate that this will be issued by 

the IEC/ISO as a Technical Specification some time in 2015.

These criteria may be implemented in a pass-fail evaluation, or it may be beneficial to 

differentiate excellent quality programs from inferior programs, as judged by how well they 

address all aspects of these criteria.
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National Renewable Energy Laboratory (NREL) 

at www.nrel.gov/publications.

References

IEC 61215 Crystalline silicon terrestrial photovoltaic (PV) modules – Design qualification and 

type approval 

IEC 61646 Thin-film terrestrial photovoltaic (PV) modules – Design qualification and type 

approval 

ISO 9001-2008 Quality management systems – Requirements 

JIS Q8901-2012 Terrestrial photovoltaic (PV) modules – Requirement for reliability assurance 

system (design, production, and product warranty) 

ISO/TS16949 Quality management systems – Particular requirements for the application of ISO 

9001:2008 for automotive production and relevant service part organizations

IEC/TS 61836 ed.2 Solar photovoltaic energy systems – Terms, definitions and symbols 

ISO/IEC Guide 98-3:2008: Uncertainty of measurement – Part 3: Guide to the expression of 

uncertainty in measurement

About the Authors

Paul Norum

Amonix 

Head of Global Regulatory Compliance for Amonix. 

Thirteen years of experience in Photovoltaics. Previously worked for SolarWorld and 

Siemens/Shell Solar in various positions. Twenty-eight years of experience in Quality 

Systems and ISO 9001 implementation. B.S. in Chemical Engineering from the University of 

North Dakota. 

Ivan Sinicco

Tokyo Electron

Vice President at TEL Solar. Head of Development.

Has worked with PV technology for 20+ years and has occupied several positions from 

Development Scientist to Technical Director, and managed technologies ranging from 

crystalline silicon technologies (mono and polycrystalline) to thin-film silicon (amorphous 

and micromorph), including dye sensitized solar cells. Ph.D. in Physics – University of 

Trieste. 

Yoshihito Eguchi

Japan Electrical Safety and Environment Technology Laboratories (JET)

Manager of Research & Business Development Center since 2013. Worked for Sharp 

Corporation for 16 years on its technical staff and as a manager, and has 13 years of PV 

module experience as design engineer and reliability and quality assurance engineer. B.S. in 

Biological Engineering and MS in Electrochemical Engineering from Tokyo Institute of 

Technology. 
14 

This report is available at no cost from the 

National Renewable Energy Laboratory (NREL) 

at www.nrel.gov/publications.

Sumanth V. Lokanath

First Solar

Systems Reliability Manager at First Solar, responsible for reliability optimization of PV power 

plants and associated components. Has 13 years of PV-related experience at First Solar and 

ASU-PTL, with roles as Senior Reliability Engineer, Test Laboratory Leader, and Field Test 

Engineer positions. B.S. in Electronics & Telecommunications from Bangalore University; M.S. 

in Computer Technology from Arizona State University. 

Wei Zhou

Trina Solar 

Quality Vice President of Trina Solar Inc. since August 2011.Worked as principal consultant 

in CLSS consulting company from 2009 to August 2011, and was Asia Pacific Quality 

Director in a variety of companies including Delphi (automotive), Motorola (automotive), 

Carrier (air conditioning), and Schindler (elevator and escalator) from 2001 to 2009. Worked 

in GE Medical Systems from 1991 to 2001 in multiple positions including plant manager, Six 

Sigma MBB/BB, quality department manager, and electrical engineer. Also, was Six Sigma 

MBB certified in GE and was appointed as a working group member in SEMI China PV 

Standard Committee in Oct. 2011. B.S. and M.S. in Electric Physics from Tsinghua 

University. 

Gunnar Brueggemann

Tokyo Electron

Manages PV thin-film raw materials sourcing and related certification projects within the 

development department at TEL Solar. Module manufacturers premiere contact for type 

designations through accredited institutes. Ph.D. in electronic and material engineering. 

Alex Mikonowicz

Powermark

Executive Director of PowerMark Inc. 

Was the "Head of Quality" of SolarWorld USA and was the Senior Director of Quality 

Management for Siemens & Shell Solar Industries USA. Worked for Control Data Corporation’s 

Aerospace, Large Computer and Small Systems divisions in a variety of quality and test 

engineering management positions. He was appointed as an examiner for the U.S. “Malcolm 

Baldrige National Quality Award” 5 times, is active on the standards committees of the IEC, 

IEEE, and ASTM, and is the present USA TAG Technical Advisor (TA) for the IEC-TC 82, 

voting on the behalf of the United States for the IEC, TC-82, Photovoltaics. He holds degrees in 

Business and Engineering. 

Masaaki Yamamichi

National Institute of Advanced Industrial Science and Technology (AIST) 

Adviser to Research Center for Photovoltaic Technologies of AIST since 2009 to support AISTindustry collaboration. Worked for Nippon Steel for 19 years as a technical staff and a manager. 

In 1985, moved to Nippon Steel Electron as a technical manager and Sales & Marketing 

director until 2005. After that, joined SEMI Japan to supervise the SEMI Standards program and 
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National Renewable Energy Laboratory (NREL) 

at www.nrel.gov/publications.

PV Japan event. B.S. and M.S. in Mechanical Engineering from The University of Tokyo, M.S. 

in Industrial Engineering from Stanford University. 

Sarah Kurtz

National Renewable Energy Laboratory 

Principal scientist and group manager at the National Renewable Energy Laboratory. 

Has worked at NREL since 1985 in a variety of roles including support of the International PV 

Module Quality Assurance Task Force. Ph.D. in Chemical Physics from Harvard University. 

Additional contributors include: 

Chao (Raymond) An, Keizo Asaoka, Qiang Han, Jiacai Jin, Masaaki Kameda, Kenji Kawai, 

Joseph Kopp, Soichiro Kori, Yaohua Mai, Hiroshi Matsuki, Linda Merritt, Osami Mizuno, 

Masashi Nakamura, Nobuhisa Ohta, Hiroko Saito, Katsuaki Shibata, Masayoshi Takani, 

Kazufumi Tanaka, Mayuki Tsunoda, Mitsuro Uchida, Kiyoshi Ueno, John Wohlgemuth, 

Pengjun Xiao, Tingting Xu, Yasuaki Yamamoto, Toshiharu Yamazaki, Guolin Yang, Hideki 

Yoshikawa, and Hideki Yoshioka, Bo Yu, Zhulin Zhang, Gary Zhou, Jingbing Zhu.