Copyright 20XX Insulating Glass Manufacturers Alliance. All rights reserved.
Disclaimer
The information and recommendations contained in these guidelines were developed by
representative members of IGMA as advisory information. However, it shall not be assumed that all
acceptable procedures are contained in these guidelines or that additional measures may not be
required under certain circumstances or conditions. Note that the various codes and regulations
referenced in this document may be amended from time to time and it shall not be assumed that
the versions referenced herein are the most current versions of such codes and regulations. Please
consult the appropriate regulatory authorities for the most up-to-date versions. Compliance with all
local governing building codes is also required.
The Insulating Glass Manufacturers Alliance (IGMA) makes no warranty or representation and
assumes no liability or responsibility in connection with any information contained in these
guidelines. IGMA assumes no liability or responsibility in connection with any modifications to or
adaptations of these guidelines by any user, purchaser or other party, or in connection with the use
or misuse of any information contained in these guidelines.
While IGMA recommends the use of and reference to these guidelines by private industry and
others, these guidelines are intended to be voluntary and not binding.
IGMA does not approve or endorse any products, services or methods mentioned herein. These
guidelines shall not be referenced in any way, which would imply such approval or endorsement.
Additional copies of this and other publications of the IGMA are available from:
Insulating Glass Manufacturers Alliance
Telephone: (613) 233-1510 / Fax: (613) 482-9436
or
Visit the IGMA website at: www.igmaonline.org
DRAFT WORKING DOCUMENT – Version 7, November 12, 2014
The information contained in this working document is the exclusive property of the Insulating Glass
Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
[Delete this page in your final Quality Manual]
Quality Manual instructions for use:
Attached is a Quality Manual that outlines the requirements for ISO 9001. To become ISO
certified your organization must establish company policies that will serve as general
requirements for your quality management system (QMS). By documenting these policies in a
Quality Manual, you will demonstrate compliance to the standard.
The text provided is generic in nature and must be tailored to support your company’s structure
and operations. The text in red must be edited by you with specific information regarding your
organization. The Comments in blue are for clarification purposes and should be deleted in your
final Quality Manual.
For smaller companies, you should use specific individual’s titles for your company (e.g.
President, Operations Manager, Sales Manager, etc.) instead of Department names.
Double click to enter the “header” section of this document on the title page (page 1) to insert
your company’s name and logo if you want it to appear on each page, or to delete the text.
We recommend you save an additional copy of this document for reference before you begin
editing.
One word of caution is that you must ensure that your finished Quality Manual expresses policies
that fully meet ISO 9001 requirements. After you have adjusted the documentation to meet your
needs, then you can implement the policies you have written.
DRAFT WORKING DOCUMENT – Version 7, November 12, 2014
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
[Insert Company Name / Location]
Quality Manual
Rev. 1 – MM/DD/YYYY
Authorized
Date:
By:
[Name-1], [Title-1]
[Name-2], [Title-2]
[Name-3], [Title-3]
This manual complies with the requirements of the ISO 9001:2008 International Standard.
Comments: You may add additional formatting, logos or company information to this title page
as needed.
DRAFT WORKING DOCUMENT – Version 7, November 12, 2014
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
Table of Contents
1.0 SCOPE:
1
1.1 GENERAL
1.2 APPLICATION / QUALITY MANUAL / EXCLUSIONS
1
1
2.0
NORMATIVE REFERENCES
2
3.0
TERMS AND DEFINITIONS
3
4.0
QUALITY MANAGEMENT SYSTEM
3
4.1
GENERAL REQUIREMENTS
PROCESS MAP
OUTSOURCED PROCESSES (SAMPLE)
4.2
DOCUMENTATION REQUIREMENTS
4.2.1
GENERAL
4.2.2
QUALITY MANUAL
4.2.3
DOCUMENT CONTROL
4.2.4
CONTROL OF RECORDS
3
6
6
6
6
7
7
8
5.0 MANAGEMENT RESPONSIBILITY
8
5.1
MANAGEMENT COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.4.1 QUALITY OBJECTIVES
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 RESPONSIBILITY AND AUTHORITY
5.5.2 MANAGEMENT REPRESENTATIVE
5.5.3 INTERNAL COMMUNICATION
5.6 MANAGEMENT REVIEW
5.6.1 GENERAL
5.6.2 REVIEW INPUT
5.6.3 REVIEW OUTPUT
8
9
9
9
9
10
10
10
10
11
11
11
12
12
6.0
RESOURCES MANAGEMENT
12
6.1
6.2
6.2.1
6.2.2
6.3
6.4
PROVISION OF RESOURCES
HUMAN RESOURCES
GENERAL
COMPETENCE, TRAINING AND AWARENESS
INFRASTRUCTURE
WORK ENVIRONMENT
12
12
12
13
13
14
7.0 PRODUCT REALIZATION
14
7.1
15
ADVANCED PLANNING
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
7.2
CUSTOMER INPUT AND FEEDBACK
7.3 DESIGN AND DEVELOPMENT
7.4
PURCHASING AND RECEIVING
7.4.1 PURCHASING PROCESS OVERVIEW
7.4.2 VENDORS & SUPPLIERS
7.4.3 PURCHASING INFORMATION
7.5
PRODUCTION AND SERVICE PROVISION
7.5.1
CONTROL OF PRODUCT AND SERVICE PROVISION
7.5.2
PROCESS CONTROL FOR INSULATING GLASS
7.5.3 IN-PROCESS QUALITY CHECKS
7.5.4 PROCEDURE (SECTION 2 - EXAMPLES OF SPECIFIC WORK INSTRUCTIONS)
7.5.6 IDENTIFICATION AND TRACEABILITY
7.5.7 CUSTOMER PROPERTY
7.5.8 PRESERVATION OF PRODUCT / SERVICE
7.5.9 PROCEDURES
7.5.10
OPERATOR INSTRUCTIONS
7.5.11 MANUFACTURING PROCESS INSTRUCTIONS
7.6 CONTROL OF MONITORING AND MEASURING DEVICES
15
17
19
19
20
20
21
21
21
22
23
ERROR! BOOKMARK NOT DEFINED.
ERROR! BOOKMARK NOT DEFINED.
ERROR! BOOKMARK NOT DEFINED.
24
25
25
26
8.0
MEASUREMENT, ANALYSIS AND IMPROVEMENT
27
8.1
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3
GENERAL
MONITORING AND MEASUREMENT
CUSTOMER SATISFACTION
INTERNAL AUDIT
MONITORING AND MEASUREMENT OF PROCESSES
MONITORING AND MEASUREMENT OF PRODUCT
CONTROL OF NONCONFORMING PRODUCT
ANALYSIS OF DATA
IMPROVEMENT
CONTINUOUS IMPROVEMENT
CORRECTIVE ACTION
PREVENTIVE ACTION
27
27
27
28
28
29
29
30
30
30
31
31
9.0 REFERENCE DOCUMENTS
32
10.0 CHANGE LOG
32
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
1.0
Scope:
1.1
General / Quality Policy
This document provides an outline for a quality management system for manufacturing
insulating glass units and associated services that:
(a) Demonstrates [Insert Company Name’s] ability to consistently provide product that meets
customer and applicable statutory and regulatory requirements, and
(b) Aims to enhance customer satisfaction through the effective application of the system,
including processes for continual improvement of the system and the assurance of
conformity to customer and applicable statutory and regulatory requirements.
Quality Policy:
[Insert Company Name’s] policy is to provide Quality Products and ensure the highest level of
Customer Satisfaction.
[The following section contains the an example company quality policy – insert your company’s
quality policy here]
[Insert Company Name] and its entities are committed to the following:
 Total Customer Satisfaction
 Open communication among all employees of [Insert Company Name]
 Implementing a Quality management System that demonstrates how each process of
[Insert Company name] manages, performs and verifies work affecting quality.
 Employee involvement in the success of the Quality management System.
 Continual Improvement of Process.
 Ensuring that the Quality Policy is understood, implemented and maintained among all
employees of [Insert Company Name].
1.2
Application / Quality Manual / Exclusions
Application
The scope of this document applies to the manufacturing of insulating glass units and
associated services. This document shall be tailored as needed to meet the needs of the
specific organization. The quality program will satisfy the requirements for IG certification
through the IGCC/IGMA and the IGMAC programs.
Comments: If this manual pertains to multiple sites indicate that here.
Quality Manual
The [Insert Company Name] Quality Manual constitutes Tier 1 of our documentation system
and contains policies that have been implemented at the [Insert Company Name]
manufacturing site. It is supported by our Tier II plant procedures of our Quality System, and
Tier III, only as required, of the documentation system, consists of manufacturing work
instructions. Tier IV, only as required, consists of forms, records. [Insert Company Name] QMS
is designed around ISO9001:2008. This Quality Manual describes the [Insert Company Name]
organization’s policies and the procedures used to achieve our goals and objectives.
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The information contained in this working document is the exclusive property of the Insulating Glass
Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
Comments: Many companies choose to include their entire site, while some choose just a
portion of their business. E.g. “This manual pertains to processes relating to the Sale, Design,
Manufacturing and Distribution of aluminum parts for the Defense Industry.”
TIER I
QUALITY MANUAL
Defines approach and responsibility
TIER II
PROCEDURES
Defines who, what and when
TIER III
WORK INSTRUCTIONS
Answers how
TIER IV
OTHER DOCUMENTATION
Forms, records, labels
Exclusions
The organization has no permissible exclusions as they apply to ISO 9001 requirements.
Comments: Exclusions may be taken for portions of the ISO standard that don’t apply to your
organization. Exclusions may only be taken for items in section 7.0. For any exclusions
 1. list them here with a brief justification or reason you are excluding the requirement
(see examples above), and
 2. delete the text from the body of the manual, but keep the section title, simply stating,
“Exclusion – see 1.0 above.”
If you have no exclusions, use the first sentence above and delete the remainder of this section.
[Insert Company Name] has identified the following areas as exclusions, based on the
product currently produced for their customers:
Clause x.x.x – [Insert Clause Name]. This [insert reason for exclusion].
Clause x.x.x – [Insert Clause Name]. This [insert reason for exclusion].
Clause x.x.x – [Insert Clause Name]. This [insert reason for exclusion].
[Etc.]
2.0
Normative References
[Remove any which do not apply from the list below]
ANSI Z 97.1, Safety Glazing Materials Used in Buildings - Safety Performance Specifications
and Methods of Test
ASTM E 2188, Standard Test Method for Insulating Glass Unit Performance
ASTM E 2189, Standard Test Method for Testing Resistance to Fogging in Insulating Glass Units
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
ASTM E 2190, Standard Specification for Insulating Glass Unit Performance and Evaluation
ASTM E 2269, Standard Test Method for Determining Argon Concentration in Sealed
Insulating Glass Units using Gas Chromatography
CAN/CGSB 12.1, Tempered or Laminated Safety Glass
CAN/CGSB 12.8, Insulating Glass Units
ISO 9001:2008 Quality Management System
IGMA
TB-1201 – Sealant Manufacturers minimum sealant dimensions and placement survey
TB-1202: Definition of a Gas Filled Unit
TB-1205: Definition of a Failed Unit
TB-1400: Insulating Glass Manufacturing Guidelines: Important considerations
TB-1601: Guidelines for Use of Capillary Tubes
TB-2403: Guidelines for IG Manufacturers’ studies of Sealant Compatibility
TB-2701: Guidelines for the Testing of Moisture Vapor Transmission Rate (MVTR) and the
Presentation of the Results
TM-1300: Design Considerations for Multiple Cavity Insulating Glass Units
TM-1500: Guidelines to Reduce Instances of Thermal Stress
TM-2000: Voluntary Test Methods & Voluntary Performance Quality Assurance Criteria for
Spacers for Sealed Insulating Glass Units
TM-2100: Recommended Voluntary In-Plant Test Methods and Performance Criteria of
Desiccants for Sealed Insulating Glass Units
TM-2400: Test Methods of Insulating Glass Sealants
TM-2301: Voluntary Test Methods and Voluntary Performance Quality Assurance Criteria
for Two component Polysulfide Sealants Used in Manufacturing Sealed Insulating Glass
Units
TM-3100: Voluntary Guidelines for the Identification of Visual Obstructions in the Airspace
of the Insulating Glass Units
TM-3401: Preventing Glass Breakage During IG Design, Manufacture, Transport,
Installation and Use.
TM-4100: Preventing Insulating Glass Failures
TM-6000: Technical Manual for Acoustical Glass Design
IGCC-IGMA Certification Program Manual
IGMAC Certification Program Manual
3.0
Terms and Definitions
3.1
Refer to IGMA TR-1400, Language of Sealed Insulating Glass Units.
Comments: This section can also include terminology or abbreviations that are specific to
your company.
<May include other definitions>
4.0
Quality Management System
4.1
General requirements
Comments: 4.1 “General Requirements” refers to the overall structure of your quality
management system (QMS) and includes definition of the general processes of your business
necessary to deliver your product/service to your customers.
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
[Insert Company Name] has established, documented, implemented and currently maintains a
quality management system. We continually improve its effectiveness in accordance with the
requirements of ISO 9001:2008.
The organization:
 Has determined the processes needed for the quality management system and
their application throughout the organization,
 Determined the sequence and interaction of these processes,
 Determined criteria and methods needed to ensure that both the operation and
control of these processes are effective,
 Ensures the availability of resources and information necessary to support the
operation and monitoring of these processes,
 Monitors, measures where applicable, and analyzes these processes, and
 Implements actions necessary to achieve planned results and continual
improvement of these processes.
These processes are managed by [Insert Company name] in accordance with the requirements
of ISO 9001:2008.
The Key Business Processes of [Insert Company name] are:
 Quality Management
 Customer Service
 Purchasing and Receiving
 Order Fulfillment
The following page provides a Process Map showing the sequence and interactions of these
processes.
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
Review customer
order
Document and
Records Control
INPUTS:
Customer Orders,
Specs, or Raw
Materials
Order Fulfillment
INPUTS:
Purchasing Spec,
Approved
Supplier List,
Manufacturing
Request
Schedule / plan
manufacturing
Purchase order
issued based on
requirements
Purchasing and Receiving
INPUTS:
Customer call or
email
Customer Service
Define Key
Processes and
Quality Objectives
Quality Management
ACME Company
Manufacture/
assemble product
Materials received
and compared to
P.O.
Enter order
Manage Resources
Complete final
inspection
Incoming
materials logged
and inspected
If complaint,
initiate resolution
Data Analysis and
Improvement
If necessary
If necessary
Control nonconforming
product
If necessary
Contact vendor
with any
discrepancies
Internal Audit
Ship to customer
Corrective/Preventive Action
Management
Review
OUTPUTS:
Shipped products
OUTPUTS:
Received materials
Supplier POs
OUTPUTS:
Customer Orders
Resolved Customer
Complaints
OUTPUTS:
Internal Audits
CAPAs
Management Review
Controlled Docs & Records
Comments: Replace the above Process Map with your own Key Process Map here, and then
delete this text.
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
Process Map
[NOTE: Change as appropriate for the organization.]
Objective 3
Key Processes
Quality Management
Objective 2
Process Effectiveness Matrix
Objective 1
Quality Objectives
X
X
X
Customer Service
Purchasing
Order Fulfillment
[Insert flowchart of highest level flow chart here. Delete this box when done.]
Where [Insert Company name] chooses to outsource any process that affects product
conformity to requirements, [Insert Company name] ensures control over such processes. The
type and extent of control to be applied to these outsourced processes are defined within the
quality management system.
Outsourced Processes [Edit as Required]
Outsourced Process
Non-Destructive Testing
Provider
Various
Temporary Employees
Temp Agencies
Forklift Maintenance
Testing
xyz Maintenance Company
Various
Controls
Approved Supplier/Reports
from Supplier to confirm
Supervision, Management
Reports
Daily Inspection of Forklift
Approved
Supplier,
Inspection and test reports
Etc.
Etc.
4.2
Documentation Requirements
4.2.1
General
Comments: 4.2.1 “General-Documentation Requirements”
documentation of your quality management system.
refers
to
the
required
Comments: If your company provides service only, the procedure above will be titled “Control
of Nonconformances” rather than “Control of Nonconforming Product” and should be
modified here.
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
The quality management system documentation includes:
 Documented statements of a quality policy and quality objectives,
 A quality manual,
 Documented procedures and records required for operation of the business, and
by such external organizations as IGCC/IGMA, IGMAC, AAMA and NFRC. Such
procedures may include Document Control, Record Control, Internal Audit,
Control of Nonconforming Product, Corrective and Preventive Action
procedures.
 Documents, including records, determined by [Insert Company name] to be
necessary to ensure the effective planning, operation and control of its
processes.
4.2.2
Quality Manual
Comments: 4.2.2 “Quality Manual” refers to the requirements for this document. Your quality
manual serves two purposes: (1) It defines how your company meets the ISO 9001 requirements
in general terms, and (2) it defines responsibilities for each element of the quality management
system.
Comments: This individual is responsible for updating and revising the document, as needed.
The same is true for other controlled documents referenced elsewhere in this Manual.
[Insert Company name] has established and currently maintains a quality manual that
includes:
 The scope of the quality management system, including details of and
justification for any exclusions,
 The documented procedures established for the quality management system, or
reference to them,
 A description of the interaction between the processes of the quality
management system.
The [Insert person/title or position responsible] is responsible for maintaining the quality
manual.
4.2.3
Document Control
Comments: 4.2.3 “Document Control” refers to your formal process for controlling revisions,
approvals, distribution, etc. of the formal quality system documentation. There is a documented
procedure required for Document Control and is referenced within this section below.
Comments: This last requirement for the Management Representative to approve all documents
(in RED) may be modified or deleted based on your company policy.
Documents required by the quality management system are controlled. Records are a
special type of document and are controlled according to the requirements given in
section 4.2.4.
A documented procedure has been established (see Control of Documents Procedure)
to define the controls needed:
 To approve documents for adequacy prior to issue,
 To review and update as necessary and re-approve documents,
 To ensure that changes and the current revision status of documents are
identified,
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.




To ensure that relevant versions of applicable documents are available at points
of use,
To ensure that documents remain legible and readily identifiable,
To ensure that documents of external origin determined by [insert company
name] to be necessary for the planning and operation of the quality
management system are identified and their distribution controlled, and
To prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
The [Insert person/title or position responsible] is responsible to maintain the Document
Control Procedure, to ensure that relevant versions are available at points of use, to
remove obsolete documents, and to control external documents. Documents are
reviewed and approved, including re-approval as required, by the appropriate
functional manager along with the appropriate Management Representative.
4.2.4
Control of Records
Comments: 4.2.4 “Control of Records” refers to your formal process for controlling filing, storage,
maintenance, etc. of the formal quality system records. There is a documented procedure
required for Control of Records and is referenced within this section below.
Records are established to provide evidence of conformity to requirements and of the
effective operation of the quality management system shall be controlled.
A documented procedure has been established (see Control of Records Procedure) to
define the controls needed for the identification, storage, protection, retrieval, retention
and disposition of records.
Records are legible, readily identifiable and retrievable [Insert Location for Document
Control]
The [Insert person/title or position responsible] is responsible to maintain the Records
Control Procedure.
5.0 Management Responsibility
5.1
Management Commitment
Comments: 5.1 “Management Commitment” refers to the responsibility of your senior executive
team to actively guide the development and implementation of your quality management
system through personal involvement. This commitment is essential during the initial setup of your
QMS as well as to support the process on an ongoing basis.
Comments: The term “top management” from the ISO 9001 standard requires that the top
executive of your organization and other senior manager who directly report to the top
executive are active participants in your quality management system and must be included in
the list above.
[Insert person/title or position responsible] must provide evidence of its commitment to the
development and implementation of the quality management system and continually
improving its effectiveness by
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.





5.2
Communicating to the organization that [insert company name / entity] is
meeting stakeholder as well as statutory and regulatory requirements, and is the
responsibility of all employees.
Establishing a mission, values and quality policy (including commitments to meet
stakeholder requirements and continuous improvement objectives),
Ensuring that quality objectives are established and followed,
Conducting management quality system reviews and
Ensuring the availability of resources necessary to meet all quality objectives.
Customer Focus
[Insert person/title or position responsible] shall ensure that customer requirements are
determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)
5.3
Quality Policy
Comments: 5.3 “Quality Policy” refers to the responsibility of your senior executive team to
develop and communicate a formal policy statement regarding your company’s commitment
to meeting customer requirements consistently and to continual improvement. This commitment
is measured through achievement specific quality objectives defined in the next section –
therefore the measure of the effectiveness of the quality policy are the results indicated through
your quality objectives.
[Insert person/title or position responsible] management shall define a mission, value and quality
policy statements that:
 Is appropriate to the purpose of the organization,
 Includes a commitment to comply with requirements and continually improve the
effectiveness of the quality management system,
 Provides a framework for establishing and reviewing quality objectives.
 Is communicated throughout the organization,
 Is reviewed annually for continuing suitability.
[Alternatively - Insert Quality Policy Here]
5.4
Planning
5.4.1
Quality Objectives
Comments: 5.4.1 “Quality Objectives” refers to the responsibility of your senior executive team to
establish and maintain formal measures of the quality of your company’s performance for your
customers. These measures provide formal, objective indication of improvement of your overall
quality management system.
Comments: List 3 – 5 quality objectives (measures) below that demonstrate the effectiveness of
your quality management system. Data collection processes must be established for each
quality objective, current data must be maintained, and targets listed must be specific and
measurable
[Insert Company Name] management shall define quality objectives, including those
needed to meet the requirements for a quality product / service, and ensures that they
are established at relevant functions and levels within the organization. The quality
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.
objectives shall be measurable and consistent with the mission, value and quality policy
statements.
Specific Quality Objectives for [insert company name] are as follows:
 Zero Scrap / Zero Non-conformance(s)
 Zero Customer Returns
 100% on-time Delivery
5.4.2
Quality Management System Planning
Comments: 5.4.2 “Quality Management System Planning” refers to the responsibility of your
senior executive team to guide the setup and maintenance of your company’s QMS, including
making necessary changes as the need arises.
[Insert person/title or position responsible] shall ensure that:
 The planning of the quality management system is carried out in order to meet
the requirements given in 4.1, as well as the quality objectives, and
 The integrity of the quality management system is maintained when changes to
the quality management system are planned and implemented.
5.5
Responsibility, Authority and Communication
5.5.1
Responsibility and Authority
Comments: 5.5.1 “Responsibility and Authority” refers to the responsibility of your senior executive
team to formally define job responsibilities and decision-making authority for all managers and
employees within your organization in order to effectively and consistently meet customer
requirements.
Comments: Examples may include an organization chart, job descriptions, procedures and
instructions, etc.
[Insert person/title or position responsible] shall ensure that the responsibilities, authorities
and their interrelation are defined and communicated within the organization.
Top Management shall establish the interrelation of all personnel who manage, perform
and verify work affecting quality, and shall ensure the independence and authority
necessary to perform these tasks.
5.5.2
Management Representative
Comments: 5.5.2 “Management Representative” refers to the responsibility of your senior
executive team to assign one of the company managers to oversee the quality management
system.
Comments: The Management Representative should also be indicated on the Organizational
Chart in section 2.0 above
[Insert Company name] management shall appoint a member of the organization's
management who, irrespective other responsibilities, shall have the responsibility and
authority that includes:
 Ensuring that processes needed for the quality management system are
established, implemented and maintained,
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Manufacturers Alliance. Distribution and / or reproduction of any part of this document is strictly prohibited.


Reporting to senior management on the performance of the quality
management system and any need for improvement, and
Ensuring the promotion of awareness of stakeholder requirements throughout the
organization.
[Insert person/title or position responsible] shall be responsible for carrying out the actions
listed above.
5.5.3
Internal Communication
Comments: 5.5.3 “Internal Communication” refers to the responsibility of your senior executive
team to provide regular communication to all employees to ensure that everyone understands
how company quality objectives are being achieved and their role in making regular
improvements to enable higher levels of company performance.
Comments: Examples of communication methods may include scheduled meetings,
newsletters, intranet site, email announcements, training, etc. Be prepared to show evidence of
method(s) used during the audit
[Insert person/title or position responsible] shall ensure that appropriate communication
processes are established within [Insert Company name] and that communication takes
place regarding the effectiveness of the quality management system.
At a minimum, [insert responsible manager] holds quarterly meetings to discuss specifics
of the company.
Additionally, based on the Quality Objectives (see 5.4.1) monthly measures/metrics are
updated and displayed for the month prior, which includes the following information:
 Total scrap for the month/Non-conformance(s)
 Customer issues for the month
 On-time delivery percentage for the month
[Insert responsible manager] and/or its designees are responsible for updating and
displaying this information.
5.6
Management Review
Comments: 5.6 “Management Review” refers to the responsibility of your senior executive team
to meet regularly to assess the status and results of your quality management system and to
determine actions needed to improve performance.
Comments: Management reviews must be completed a minimum of annually, but may be
scheduled more frequently. We recommend monthly or quarterly for most organizations.
Modify the frequency above based on your company’s policy.
5.6.1
General
[Insert person/title or position responsible] shall review the organization's quality
management system, at planned intervals, to ensure its continuing suitability, adequacy
and effectiveness. This review includes assessing opportunities for improvement and the
need for changes to the quality management system, including the mission, values, and
quality policy and quality objectives. Records from management reviews are maintained
in the designated repository.
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5.6.2
Review input
The input to management review includes information on
 Results of audits,
 Stakeholder / customer feedback,
 Process performance and product / service conformity,
 Status of preventive and corrective actions,
 Follow-up actions from previous management reviews,
 Planned changes that could affect the quality management system, and
 Recommendations for improvement.
5.6.3
Review Output
The output from the management review includes decisions and actions related to:
 Improvement of the effectiveness of the quality management system and its
processes,
 Improvement of product / service related to stakeholder requirements, and
 Resource needs.
6.0
Resources Management
6.1
Provision of Resources
Comments: 6.1 “Provision of Resources” refers to the need for a process to identify and provide
for resource needs throughout the organization in order to improve results.
[Insert Company name] determines and provides the physical (including building, equipment,
furniture and fixtures) and human resources needed to implement and maintain the quality
management system and continually improve its effectiveness and to enhance customer
satisfaction by meeting necessary customer requirements. Resource needs are discussed during
management review.
6.2
Human Resources
Comments: 6.2.1 “General-Human Resources” refers to your company’s hiring process and the
method(s) you use to define job requirements (competencies, experience, education, skills, etc.)
in order to select qualified job candidates.
Comments: Examples of methods for defining competencies include job descriptions, job
postings, etc.
6.2.1
General
Personnel performing work affecting conformity to product requirements are deemed
competent on the basis of appropriate education, training, skills and experience.
Human Resource Representative, with the assistance of the appropriate functional
group, is responsible for assessing competence. Competency requirements are defined
in individual job descriptions developed by the appropriate functional group, and are
maintained by the Human Resources representative.
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6.2.2
Competence, training and awareness
Comments: 6.2.2 “Competence, Training and Awareness” refers to the training and employee
development processes of your company, including follow-up to ensure effectiveness of
training.
Comments: Examples of methods to define training requirements can include training plans, a
training matrix, employee evaluations, management review, etc.
[Insert HR Position/HR Group Responsible]:
 Determines the necessary competence for personnel performing work affecting
conformity to product requirements,
 Where applicable, provides training or takes other actions to achieve the
necessary competence,
 Evaluates the effectiveness of the actions taken,
 Ensures that personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives
and
 Maintains appropriate records of education, training, skills and experience.
[Insert HR Position/HR Group Responsible] is responsible for:
 Maintaining the competency requirements as determined by the appropriate
functional group.
 Ensuring that the appropriate functional group leadership oversees the training
process.
 Training requirements are defined in the functional departments’ Standard
Operating Procedures documents.
The [insert appropriate group] maintain appropriate records of education, training, skills,
and experience.
As of the initial release of this document, all current employees are considered to be
competent, or are in the process of being trained.
Comments: The last statement above is referred to as a “grandfather clause” that states the
qualification of current employees. Do not modify or delete this statement.
6.3
Infrastructure
Comments: 6.3 “Infrastructure” refers to maintenance activities relating to facilities, equipment,
vehicles and systems that can have an impact on your company’s ability to consistently meet
customer requirements.
Comments: List types of equipment, facilities, computer systems, shipping/service vehicles, etc.
that have a schedule of maintenance. You do not need to list individual pieces of equipment,
just the general categories. Be sure to include maintenance/data backup of your computer
systems.
[Insert Company Name] determines, provides and maintains the infrastructure needed to
achieve conformity to product requirements.
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Infrastructure includes, as applicable:
 Buildings, workspace and associated utilities,
 Production equipment (both hardware and software), and
 Supporting services (including, but not limited to, procurement, sales, shipping
and receiving, communication or information systems).
Scheduled maintenance, including data backup, is performed on the following:
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6.4
Manufacturing equipment
Data collection equipment
Data servers for all departments
Computer workstations and laptops
Gauges, equipment and tools required for measurements in production
Work Environment
Comments: 6.4 “Work Environment” refers to specific controls required to protect the quality of
your product in the work environment.
Comments: List in the table above any special controls needed in your production process that
are necessary to protect your product from work environment factors that affect quality.
Delete/modify the list as appropriate. If your company provides only service, or has not special
work environment controls required, this may not apply. In that case, delete the entire table
and the sentence preceding it.
[Insert Company name] determines and manages the work environment needed to achieve
conformity to product requirements. Production management [or Insert Appropriate Group]
and Environmental Health and Safety [or Insert Appropriate Group] are responsible to identify
and control work environment requirements. Work environment controls include the following:
[Edit Chart as Required]
Condition
Temperature
Air particulates
Electro-static Discharge (ESD)
Humidity
7.0
Control
Thermostat
Cleanroom Controls
Grounded ESD Controls
De-humidifier
Product Realization
Product Realization includes product planning development (customer input, design, change
control, etc.), production operations and quality systems to ensure product meets customer
expectations and specifications.
Comments: The term “Product Realization” refers to the processes used to provide your
product/service to your customers. If your company provides services only, you may replace
the terms “Product Realization” and “Production” with “Service” or “Service Delivery” (or similar)
throughout section 7.0.
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Also, if any subsection below (7.1 – 7.6) do not apply to your business, this can be taken as an
“Exclusion”. See the note in section 1.0 above for instructions regarding the proper way to
document exclusions in this manual.
7.1
Advanced Planning
Comments: 7.1 “Planning of Product Realization” refers to the process used to plan for new
customer orders, contracts, product lines, services, etc.
Comments: Examples of planning methods may include
documentation, travelers, contracts, scope of work, etc.
production
schedules
and
[Insert Company name] shall define how it will achieve customer satisfaction and meets quality
requirements when designing a new product or process. This includes refining an existing
product as well as introducing a new product.
Changes to products may be required due to changes including, but not limited to:
Federal building codes, supplier product changes, customer specifications, and changes in
component availability.
Planning for new or changed product or processes (advanced planning) includes, but is not
limited to, such items as:
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Customer surveys and focus groups
Review of Specifications
Quality inspection plans
Process and test equipment needs
Review of documentation (change) needs
Review of measuring capabilities
Employee training needs
Process Flow Diagrams
FMEA’s
Control Plans
[Insert Company name] shall ensure that all departments are appropriately involved, including
personnel from the quality department, engineering and production.
7.2
Customer Input and Feedback
7.2.1 Determination of requirements related to the product
Comments: 7.2.1 “Determination of Requirements Related to the Product” refers to the
process(es) used to gather and review the necessary information pertaining to products/services
provided to customers in order to understand their requirements.
When [Insert Company name] is designing or re-designing a new product, the customer
requirements shall be clearly defined. These may include but are not limited to:
 Customer purchase order(s);
 Customer provided specifications;
 Standards documents;
 Customer memos;
 Customer feedback including complaints; and
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Field performance reports on products to be re-designed.
7.2.2
Review of requirements related to the product
Comments: 7.2.2 “Review of Requirements Related to the Product” refers to the process(es) used
to assess customer orders and/or contracts prior to acceptance/approval.
Comments: Examples of methods for reviewing customer orders and/or contracts can include
RFQ review, contract/ specification review, order review during order entry, etc.
Comments: Examples of verifying verbal orders can include repeating orders back to customer,
confirmation sent to the customer, fax/email, etc.
Whenever practical, the customer shall be involved in product change reviews to ensure
that the new or re-designed product will conform to specifications. (See also 7.1.2) This
review is conducted prior to the organization’s commitment to supply a product to the
customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of
changes to contracts or orders) and ensures that:
 Product requirements are defined and documented,
 Contract or order requirements differing from those previously expressed are
resolved, and
 The organization has the ability to meet the defined requirements.
 Records of the review and actions arising from the review are maintained.
 Where the customer provides no documented statement of requirement, the
customer requirements shall be confirmed by the organization before
acceptance.
Where product requirements are changed, [Insert Company name] ensures that
relevant documents are amended and that relevant personnel are made aware of the
changed requirements.
Note: In some situations, such as internet sales, a formal review is impractical for each
order. Instead the review can cover relevant product information such as catalogues or
advertising material.
7.2.3
Customer Communication
Comments: 7.2.3 “Customer Communication” refers to the process(es) used to ensure effective
communications with customers at all times throughout your process and to take appropriate
actions when needed.
Comments: Examples of such customer service processes can include phone, email, fax,
website form, etc.
Comments: Examples of methods for handling customer feedback and complaints can include
customer surveys, emails from customers, forms, phone calls, meetings, etc.
As deemed necessary by [Insert Company name] management, amendments to the
contract or order will be reviewed with the appropriate departments including, but not
limited to, equipment operators and assembly personnel, quality personnel and all other
appropriate plant personnel.
[Insert Company name] shall make effective arrangements for communicating to the
customer;
 Product information, change control;
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7.3
Queries, contracts or order handling (including amendments); and
Customer input and feedback (including customer complaints).
Design and Development
Comments: 7.3 “Design and Development” refers to the process(es) to design products you sell
to customers. If your company does not design its own products, this section can be taken as an
“Exclusion”. See the note in section 1.0 above for instructions regarding the proper way to
document exclusions
7.3.1
Design and Development Planning
Comments: 7.3.1 “Design and Development Planning” refers to the development and
maintenance of a written project plan for your design activities.
Comments: Examples of methods for design planning can include project schedules, Gantt
charts, forms, flowcharts, meeting minutes, etc.
[Insert Company name] shall ensure that appropriate design and development activities
are planned, documented, and carried out for new and revised product. These include:
 Designated, qualified individual(s) that are responsibilities for each phase;
 Product requirements;
 Description of objective(s), tasks and activities to achieve the objective(s); and
 Resource requirements.
7.3.2
Design and Development Inputs
Comments: 7.3.2 “Design and Development Inputs” refers to the process(es) used to gather and
review the necessary technical information from customers, industry standards, previous designs,
product research, etc. needed to design your products. Design inputs should be specified on
your design plan (see 7.3.1 above).
Comments: Examples of design inputs can include specifications, application requirements,
marketing data, etc.
It is critical to have clear communications defined between the different groups of
employees that will have input for the design process. Consideration shall be given to
appropriate measures and documentation, which may include:
 Project Manager, or designated person responsible for execution of defined
activities.
 Meeting agendas and minutes.
 Design plans.
 Customer specifications and other communications.
 Standards, specifications, statutory and regulatory requirements.
 Results of design and contract reviews.
 Record management and retention.
 Safety standards and specifications.
 Blueprints, test requirements, specifications, test procedures, work instructions,
control plans, FMEA’s, flow charts, etc., documented and expressed in order to
be verified and validated against design input requirements.
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7.3.3 Design and Development Outputs
Comments: 7.3.3 “Design and Development Outputs” refers to the documentation and other
information needed to manufacture/provide your product that are produced as a result of your
design process. Design outputs should be specified on your design plan (see 7.3.1 above).
Comments: Examples of design outputs can include drawings, specifications, bills-of-materials,
production documentation, purchasing information, quality/test plans, etc
The outputs of design and development are in a form suitable for verification against the
design and development input and are approved prior to release.
Design and development outputs shall:

Meet input requirements for design and development,
 Provide appropriate information for purchasing, production and service,
 Contain and/or reference product acceptance criteria, and
 Specify the characteristics of the product that are necessary for its safe and
proper use.
Information for production and service provision can also include details for the
preservation of product.
7.3.4 Design and Development Review
Comments: 7.3.4 “Design and Development Review” refers to scheduled project status checks in
order to ensure design requirements are being met at critical stages of the project. One or more
design reviews should be scheduled and recorded on your design plan (see 7.3.1 above)
At suitable stages, systematic reviews of design and development are performed in
accordance with planned arrangements (see 7.3.1)
 To evaluate the ability of the results of design and development to meet
requirements, and
 To identify any problems and propose necessary actions.
Participants in such reviews include representatives of functions concerned with the
design and development stage(s) being reviewed.
Records of the results of the reviews and any necessary actions shall be maintained (see
4.2.4).
7.3.5 Design Verification
Comments: 7.3.5 “Design and Development Verification” refers to formal technical assessments
of design outputs (see 7.3.3 above) to determine if design input requirements (see 7.3.2 above)
are met by the resulting design. One or more design verifications should be scheduled and
recorded on your design plan (see 7.3.1 above).
[Insert Company name] shall verify the design through document review, testing and/or
comparison with similar proven designs. These reviews shall be performed at appropriate
defined stages to ensure that the designed product meets all design requirements and
specifications as determined.
7.3.6 Design Validation
Comments: 7.3.6 “Design and Development Validation” refers to formal assessments of the
performance of your product in the customer’s application, if known, and should be completed
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prior to shipment or installation, if possible. Design validation should be scheduled and recorded
on your design plan (see 7.3.1 above).
Comments: Examples of design validation methods can include field testing, customer first-piece
approvals, prototypes, lifecycle testing, etc.
[Insert Company name] shall perform such tests as required by federal regulation,
specification, certification and safety requirements to ensure that the final product
conforms to defined requirements. All design changes and modifications shall be
identified, documented, reviewed, verified and validated, as appropriate, and
approved by authorized personnel before implementation. Records of the results of the
reviews and any necessary actions shall be maintained. Wherever practical, validation is
completed prior to the delivery or implementation of the product. Records of the results
of validation and any necessary action shall be maintained (see 4.2.4).
7.3.7 Control of Design and Development Changes
Comments: 7.3.7 “Design and Development Changes” refers to methods used to document and
implement changes to product designs during or subsequent to the initial design project. Some
design changes can initiate a new design plan (see 7.3.1 above).
Design and development changes are identified and records maintained. The changes
are reviewed, verified and validated, as appropriate, and approved before
implementation. The review of design and development changes includes evaluation of
the effect of the changes on constituent parts and product already delivered. Records
of the results of the review of changes and any necessary actions are be maintained.
7.4
Purchasing and Receiving
7.4.1
Purchasing Process Overview
Comments: 7.4.1 “Purchasing Process” refers to formal activities for selection/approval of
suppliers and monitoring of their performance.
Comments: List criteria below used for supplier selection, evaluation and re-evaluation. Delete
those that do not apply and add additional criteria if needed.
Comments: Examples of methods for recording supplier approvals can include approved
vendor list, accounts payable system records, etc.
[Insert Company name] shall meet the following purchasing process requirements:
 Define Criteria for Suppliers – Determine the basis on which to choose Suppliers
including establishing minimum requirements for each supplier
 Evaluate Current Suppliers – Determine which current Suppliers meet the
minimum requirements. Determine which Suppliers might need to improve to
remain qualified and / or which may need to be replaced.
 Establish Qualification Process for New Suppliers – Identify, evaluate and qualify
new Suppliers and determine how these qualifications will be recorded and
archived.
 Set up Suppliers Performance Monitoring Process – Determine the processes or
procedures and frequency to best track vendor performance including
identification of responsible personnel to review the data and circumstances
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under which action may be required.
Purchasing Communication Process – Establish a process or procedure to
document the requirements for each vendor, including how to ensure accurate,
clear and detailed enough communication of product requirements.
Purchased Product Verification Process – Establish procedure to confirm that
incoming material received is what has been ordered, including establishing
criteria to determine when a visit to a supplier's facility is needed to verify a
shipment, quality procedures or other specified requirements of the vendor.
As of the initial release of this document, all current suppliers in good standing are
considered to be approved.
Comments: The last statement above is referred to as a “grandfather clause” that states the
qualification of current suppliers. Do not modify or delete this statement
7.4.2
Purchasing Information
Comments: 7.4.2 “Purchasing Information” refers to your process(es) for documenting,
approving and communicating purchase requirements to suppliers.
Comments: Examples of methods for communicating purchase requirements to suppliers can
include the use of purchase orders, drawings/specifications, contracts, etc.
[Insert Company name] shall maintain a master list of approved Suppliers identified by
date to ensure that only Suppliers on the approved list are used. All Suppliers are to be
evaluated and selected based on their ability to supply product in accordance with
established requirements.
[Insert Company name] shall establish procedures, and designates [Insert responsible
group or individual] to:
 Approve new Suppliers,
 Establish and maintain quality records,
 Maintain a master list of approved Suppliers; and
 Delete obsolete Suppliers from master list.
Approval of Suppliers:
 Component Suppliers shall provide current copies of the Material Data Sheets for
products provided;
 Component Suppliers shall provide current copies of all relevant test data to
substantiate performance claims.
 Reports and pertinent documents shall be provided annually or when a change is
made to any product or document.
 Equipment Suppliers shall provide a current operating and maintenance manual,
safety requirements documents, and all other documentation necessary for
equipment operation and maintenance.
7.4.3
Verification of Purchased Product
Comments: 7.4.3 “Verification of Purchased Product” refers to your process(es) for checking
received products/services to ensure requirements have been met.
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Comments: Examples of methods for verifying purchased products/services can include
receiving inspection, review of supplier documentation, count/quality verification, monitoring of
services, etc.
[Insert Company name] purchasing documents sent to Suppliers shall require clear
descriptions of the product ordered:
 Type, class, grade, etc.
 Name of product
 Product identification number or code
 Any other pertinent information necessary to properly specify the product and /
or service.
Verification of Purchased Product
 As required, materials shall be accompanied by a Certificate of Analysis (COA) or
Certificate of Compliance (COC).
7.5
Production and Service Provision
Comments: 7.5.1 “Control of Production and Service Provision” refers to your methods of
controlling your manufacturing or service provision processes.
7.5.1
Control of Product and Service Provision
[Insert Company name] shall plan and carry out product and/or service provisions under
controlled conditions, and provide detailed guidelines and work instructions for the
individual tasks necessary for the assembly of insulating glass units, [Insert other products
here] in a production setting. The goal is to standardize the manufacturing and assembly
procedures such that all operators perform tasks in the same manner insuring consistent
product quality in manufacturing.
 Information shall be made available describing the characteristics of the product
/ service. Such information may include statements of work, specifications and
contracts.
 The availability of work instructions where required.
 The use of suitable, calibrated and maintained equipment,
 The implementation of monitoring and measurement to ensure product part
compliance to specification, and
 The implementation of product release, delivery and post-delivery activities.
7.5.2
Validation of Processes for Production and Service Provision
Comments: 7.5.2 “Validation of Processes for Production and Service Provision” refers to special
controls needed in your manufacturing or service provision processes in the event that
product/service quality cannot be verified through inspection or testing. Testing that harms your
product (“destructive testing”) would be such an example.
If your company does not have processes requiring validation of special processes this section
can be taken as an “Exclusion”. See the note in section 1.0 above for instructions regarding the
proper way to document exclusions.
Comments: List below any processes that must be specially controlled due to inability to inspect
or test the product quality prior to delivery to the customer or installation. Also indicate your
method(s) for controlling each process to ensure quality. Delete those that do not apply and
add additional processes if needed.
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[Insert Company name] validates processes for production and service provision where
the resulting output cannot be verified by subsequent monitoring or measurement and,
as a consequence, deficiencies become apparent only after the product is in use or the
service has been delivered.
[Insert Company name] has established arrangements for these processes including, as
applicable:
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Defined criteria for review and approval of the processes,
Approval of equipment and qualification of personnel,
Use of specific methods and procedures,
Requirements for records (see 4.2.4), and
Revalidation
Validation shall demonstrate the ability of these processes to achieve planned results.
7.5.3
Identification and Traceability
Comments: 7.5.3 “Identification and Traceability” refers to the methods used to maintain clear
identification of product throughout your process through delivery to your customer and (if
applicable) how you record unique identification of individual products and associated records
of production, component materials, inspections and testing to maintain traceability.
Comments: Examples of methods for identifying products can include tags, labels, marked
containers, travelers or other documentation, packaging, etc.
Comments: Examples of methods for maintaining traceability of product records can include
batch or serial numbers, date and time of production, recording of raw materials, components
or processes used in manufacturing, etc.
Where appropriate, [Insert Company name] shall identify the product by suitable means
throughout product realization. Traceability is twofold. Internal traceability is used for
vendor products and for in-house production traceability. External traceability is used for
manufacturer to customers who may be, but not be limited to glazing contractors,
homeowners, retail outlets, other distribution centers and regulatory agencies.
Some level of traceability is recommended and will assist in determining root cause
analysis for non-conforming products, corrective action and for continuous improvement.
[Insert Company name] shall identify the product status with respect to monitoring and
measurement requirements throughout product realization.
Where traceability is a requirement, [Insert Company name] shall control the unique
identification of the product and maintain records. [Insert Company name] shall
establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records. Records shall remain
legible, readily identifiable and retrievable.
Where required, [Insert Company name] will identify the product / service by suitable
means throughout product / service realization, and identify the product / service status
with respect to monitoring and measurement requirements throughout product / service
realization.
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7.5.4
Customer Property
Comments: 7.5.4 “Customer Property” refers to the process(es) needed to protect customer
physical or intellectual property that you may handle in the course of providing your product or
service. If your company does not handle customer property, this section can be taken as an
“Exclusion”. See the note in section 1.0 above for instructions regarding the proper way to
document exclusions.
Comments: Examples of methods for proper handling of customer property can include
segregation, specialized employee training, equipment logs, data backup, etc.
Note: Customer property can include intellectual property and personal data.
[Insert Company name] and its designees are responsible for controlling and recording
customer property. The [insert person responsible] is responsible for all communication
with the customer regarding their property.
[Insert Company name] will care for any of their customer’s property (intellectual or
physical) as if it were their own. [Insert Company name] will report to the customer any
property that is lost, damaged or otherwise found to be unsuitable for use. Records of
this report to the customer will be maintained.
7.5.5 Preservation of Product
Comments: 7.5.5 “Preservation of Product” refers to the methods used to protect product
throughout your process.
This includes proper usage of products with limited shelf-life
(expiration) and handling techniques for products requiring protection from electrostatic
discharge (ESD controls).
Comments: Examples of methods for proper protection of product can include use of gloves,
storage/transportation methods, packaging or equipment, electrostatic mats, double bagging,
shelf-life controls, etc.
[Insert Company name] preserves the product during internal processing and delivery to
the intended destination in order to maintain conformity to requirements.
This
preservation shall include identification, handling, packaging, storage and protection.
Preservation shall also apply to the constituent parts of a product.
[Insert Company name] will preserve the product / service during internal processing and
delivery to the intended destination in order to maintain conformity to requirements. As
applicable, preservation includes identification, handling, packaging, storage and
protection.
Preservation also applies to the constituent parts of a product / service.
A storage facility shall be designated to store products available for distribution.
The purpose of this section is:
 To control the handling of products and materials from the point of receipt
through storage, manufacturing and inventory, until they are sent to their final
destination.
 To ensure material is moved or handled in a safe manner that prevents damage
or deterioration.
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To provide secure storage areas to prevent damage or deterioration of product
pending use or delivery.
To preserve product integrity and product identification during handling and
storage.
To ensure that the product is protected after final inspection and test and, where
required, to protect the product through delivery to the customer.
All functional areas that have some responsibility for the movement, labeling or storage
of materials throughout the manufacturing process shall be addressed in this procedure.
Documented procedures and work instructions shall be established and maintained for
handling, labeling, storage, packaging, preservation and delivery of product. These
procedures and work instructions shall be developed to ensure compliance with
customer requirements or accepted commercial practice.
7.5.6
Procedures
Training: Employees are to be trained how to handle and transport products as part of
the job introduction by their supervisor.
Handling: Materials are to be protected to prevent damage or deterioration. Products
including incoming materials, in-process and finished goods are handled in a way that
ensures against damage or degradation of physical characteristics. Materials and
products are to be moved with care to prevent damage that may result from handling.
Labeling: Materials and finished products are to be properly labeled as to identity,
source and date. Labels are to be of a consistent format to allow convenient use by all
departments that may handle the materials. They shall be affixed in a manner that will
not come off during the expected storage time or in normal transit.
Storage: Material and products shall be stored in a manner that ensures that material
and product integrity will be maintained. Material and product are held in designated
storage areas. Bins, racks and shelves are used to protect product, reduce damage and
to improve identification and location of materials. Procedures and work instructions
shall be documented and maintained for documenting receipt and issue of material or
product from storage areas. Periodic inspections are made on product held in storage
areas to detect any damage or deterioration. These inspections will be performed at a
minimum with each physical inventory.
Packaging: Packaging procedures and work instructions shall be established and
maintained in accordance with contractual and internal requirements. Products shall be
packaged to protect against physical damage during storage and shipment.
Packaging materials are used to protect products from handling damage and protect
from normal transportation shock and to ensure the integrity of the product.
Preservation: Materials and products shall be segregated and preserved against
damage and deterioration as determined by internal or customer requirements.
Rotation of inventory shall be controlled to ensure that materials are used within the
appropriate shelf-life.
Delivery: Delivery methods and carriers are selected to optimize for safe shipment and
on-time delivery. The transportation mode is based on customer requirements or best
way based on other distribution requirements (requested delivery date, transportation
lead-time, size and weight). The specific carriers and delivery instructions are in
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accordance with the customer requirements or selected from carriers who have proven
they can deliver on time and without damage due to mishandling. Where specified, the
product protection is extended to receipt by the customer.
Work Instruction documents (selected examples or areas to be included)
 Raw material receipt and storage
 Finished product labeling and storage
 Warehouse organization
 In-plant handling and operation of fork-lift equipment
 Proper loading and unloading of trucks
 Traffic planning and shipping
Example document - Raw material receipt and storage
 Inspect for material conformance, quality, damage, etc. according to
established Quality Control procedures.
 Label as required.
 Add material to inventory as required.
 Move to assigned storage area following established handling and safety
procedures.
 Assure that racks, shelving, etc. are in compliance to receive materials to prevent
damage. Example: Proper durometer rubber pads are in place and have
proper thickness remaining to receive and protect glass.
7.5.7
Operator Instructions
There shall be documented operator instructions where applicable for:
 Manufacturing process set-up and monitoring;
 Manufacturing process assembly; and
 Other subjects where the absence of instructions could have a negative effect on
quality.
7.5.8
Manufacturing process instructions
Shall include as applicable:
 Process parameters with tolerances;
 Criteria for workmanship;
 Maintenance of equipment; and
 Responsibilities and steps.
 will establish arrangements for these processes including, as applicable
o Defined criteria for review and approval of the processes,
o Approval of equipment and qualification of employees or volunteers,
o Use of specific methods and procedures,
o Requirements for records, and
o Revalidation.
Appropriate regulations, standards and customer requirements shall be taken into
consideration when preparing manufacturing instructions
Manufacturing documents including instructions shall be available at the workplace and
operator personnel must be trained to these instructions. All training shall be recorded
and documented. All staff will have their individual training records.
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In the case of processes where the resulting outcome can’t be verified by subsequent
monitoring or measurement of the product, the processes shall be qualified, process
parameters defined and monitored, and the personnel qualified as evidenced by
training records.
Where customers supply product, activities and responsibilities are to be defined for the
inspection, storage, and maintenance of customer-supplied product such as consigned
materials, customer tools, customer gauges, and returnable packaging. Customer
supplied products shall be treated as if they were [Insert Company name]’s own
product.
Customer-supplied product that is lost, damaged or otherwise unsuitable for use shall be
recorded as such and reported to the customer.
There shall be instructions available for:
 Storage of raw materials, in-process and final product;
 Use of proper palettes and containers; and

Material preservation.
Proper methods of handling shall be defined and used to ensure prevention of damage
and deterioration of components, equipment, company products and customersupplied product.
Appropriate storage areas shall be designated to prevent supplier and company
product damage during:
 Receipt of product;
 Material storage; and

Final product storage.
[Insert Company name] shall establish proper packaging and labeling activities including
defined procedures and responsibilities for:
 Clear identification of packed product;
 Transport instructions;
 Inspection of packaging material;
 Identification and correct disposal of shelf life items; and

That only approved products are shipped.
7.6 Control of Monitoring and Measuring Devices
Comments: 7.6 “Control of Monitoring and Measuring Equipment” refers to the calibration of
inspection and test equipment. If your company does not use equipment that requires
calibration, this section can be taken as an “Exclusion”. See the note in section 1.0 above for
instructions regarding the proper way to document exclusions.
Comments: Examples of equipment requiring calibration can include calipers, micrometers, test
equipment, scales, etc.
Where necessary to ensure valid results, measuring equipment is:


Shall be verified and/or calibrated on a regular basis (gauge calibration
program).
Shall be identified as to calibration status (gauge calibration sticker).
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Applicable test hardware and software used for inspection and testing shall be part of the
verification and calibration.
Measuring and test equipment inspection records shall show:
 Identification number;
 Measurement range/accuracy;
 Verification interval;
 Verification instruction;
 Calibration instruction or reference;
 Inspection results (before and after calibration if applicable); and
 Verifications and calibrations traceable to national standards.
Control procedures shall be defined for inspection equipment that does not have a relation to
national standards.
When measuring equipment is found out of calibration, the applicable inspection data (back to
date of last calibration) shall be reviewed and if appropriate the suspect material shall be
placed on hold.
8.0
Measurement, Analysis and Improvement
Comments: 8.1 “General – Measurement, Analysis and Improvement” refers to the methods
used to measure product/process quality, analyze results and initiate appropriate improvement
actions.
8.1
General
[Insert Company name] plans and implements the monitoring, measurement, analysis and
improvement processes needed:
 To demonstrate conformity to product requirements,
 To ensure conformity of the quality management system, and
 To continually improve the effectiveness of the quality management system.
This includes determination of applicable methods, including statistical techniques, and the
extent of their use. [Name of Management Representative] is responsible for systems related to
monitoring, measurement, analysis and improvement.
8.2
Monitoring and measurement
8.2.1
Customer satisfaction
Comments: 8.2.1 “Customer Satisfaction” refers to the methods used to gather, review and
analyze data, feedback and other information regarding your customers’ level of satisfaction
with the quality of products and services you provide.
Comments: Examples of methods for measuring customer satisfaction can include
written/electronic surveys, customer interviews, satisfaction rating cards, measuring repeat sales,
measuring rates of returned products, market research, etc.).
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As one of the measurements of the performance of the quality management system,
[Insert Company name] monitors information relating to customer perception as to
whether [Insert Company name] has met customer requirements.
Customer satisfaction is monitored by means of market research; post-install and postservice visit surveys; service ticket analysis; and repeat business. (Edit as required)
The methods for obtaining and using this information are determined by Sales, Marketing,
and Quality teams.
8.2.2
Internal audit
Comments: 8.2.2 “Internal Audit” refers to your formal process for auditing your quality
management system. There is a documented procedure required for Internal Auditing and is
referenced within this section below.
[Insert Company name] conducts internal audits at planned intervals to determine
whether the quality management system:


Conforms to the planned arrangements, to the requirements of TM-4000 and to
the quality management system requirements established by the organization,
and
Is effectively implemented and maintained.
[Insert Company Name]’s audit program takes into consideration the status and
importance of the processes and areas to be audited, as well as the results of previous
audits. The audit criteria, scope, frequency and methods are defined. This selection of
auditors and conduct of audits ensures objectivity and impartiality of the audit process.
Auditors do not audit their own work.
A documented Internal Audit Procedure has been established (see Internal Audit
Procedure) to define the responsibilities and requirements for planning and conducting
audits, establishing records and for reporting results. Records of the audits and their
results are maintained. The [Insert Internal Audit Coordinator Name] is responsible to
oversee the internal auditing system and for maintaining appropriate records.
The [Insert Company Name] manager responsible for the area being audited ensures
that any necessary corrections and corrective actions are taken without undue delay to
eliminate detected nonconformities and their causes. Follow-up activities include the
verification of the actions taken and the reporting of verification results.
8.2.3
Monitoring and measurement of processes
Comments: 8.2.3 “Monitoring and Measurement of Processes” refers to your methods of
monitoring process performance for key processes. In many organizations, this requirement is
met through the implementation of your quality objectives (see 5.4.1 above).
Comments: Examples of methods for measuring process quality can include internal audits,
quality performance data, quality objectives (see 5.4.1 above.), etc.
[Insert Company Name] applies suitable methods for monitoring and, where applicable,
measurement of the quality management system processes.
These methods
demonstrate the ability of the processes to achieve planned results. When planned
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results are not achieved, correction and corrective action is taken by assigned
personnel, to ensure conformity of the product.
Methods for monitoring and measuring of processes include internal audits, quality
performance data, and quality objective metrics.
8.2.4
Monitoring and measurement of product
Comments: 8.2.4 “Monitoring and Measurement of Product” refers to your methods of
monitoring product/service quality throughout your process.
Comments: Examples of methods for measuring product quality can include product audits,
inspection results, testing, etc. See 5.4.1 above.).
Comments: Examples of methods for documenting approval for shipment (release) can include
approvals on appropriate documents, marking or labeling the released products, work order
sign-offs, etc. If your company provides services only, this requirement may be met through
approval of customer contracts or final project reviews.
[Edit as Required]
[Insert Company name] monitors and measures the characteristics of the product to
verify that product requirements have been met. This is carried out at appropriate
stages of the manufacturing process in accordance with planned arrangements.
Methods for monitoring and measuring of products include inline process inspections,
final assembly assessments, random product testing, and internal audits.
Evidence of conformity with the acceptance criteria is maintained. Records indicate the
person(s) authorizing release of product for delivery to the customer. Product and
service release is indicated by appropriate labeling.
The release of product and delivery of service to the customer does not proceed until
the planned arrangements have been satisfactorily completed, unless otherwise
approved by a relevant authority and, where applicable, by the customer.
8.3
Control of nonconforming product
Comments: 8.3 “Control of Nonconforming Product” refers to your formal process for controlling
and correcting defective or discrepant products and materials. This includes defective product
from internal processing, suppliers and customer returns. There is a documented procedure
required for Control of Nonconforming Product and is referenced within this section below.
If your company provides service only, this section should be titled “Control of
Nonconformances” rather than “Control of Nonconforming Product”. Both the title above and
the procedure name below should be modified here.
[Insert Company Name] ensures that product which does not conform to product requirements
is identified and controlled to prevent its unintended use or delivery. A documented procedure
has been established (see Control of Nonconforming Product Procedure) to define the controls
and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, [Insert Company name] deals with nonconforming product by one or more
of the following ways:
 By taking action to eliminate the detected nonconformity;
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


By authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer;
By taking action to preclude its original intended use or application;
By taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started.
When nonconforming product is corrected, it is subject to re-verification to demonstrate
conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including
concessions obtained, are maintained.
8.4
Analysis of data
Comments: 8.4 “Analysis of Data” refers to your formal process for reviewing data from quality
objectives (5.4.1 above), process monitoring (8.2.3 above) and product inspections, tests and
returns (8.2.4 above) to determine whether stated requirements or targets have been met.
Comments: Examples of methods for data analysis can include management review, team
meetings, summary reports, etc.
[Insert Company name] determines, collects and analyzes appropriate data to demonstrate the
suitability and effectiveness of the quality management system and to evaluate where continual
improvement of the effectiveness of the quality management system can be made. This
includes data generated as a result of monitoring and measurement and from other relevant
sources.
The analysis of data provides information relating to:
 Customer satisfaction,
 Conformity to product requirements,
 Characteristics and trends of processes and products including opportunities for
preventive action, and
 Suppliers.
Data analysis is conducted by means of management review, team meetings, summary reports,
and performance metrics.
The Management Representative is responsible for determining the data requirements and for
coordinating with other departments to collect and subsequently analyze the data in order to
make improvements.
8.5
Improvement
Comments: 8.5.1 “Continual Improvement” refers to the overall impact and effectiveness of your
quality management system as demonstrated by results from quality objectives, audits,
management review, etc. This requirement is generally met through effective implementation
of your QMS.
8.5.1
Continuous improvement
Comments: 8.5.2 “Corrective Action” refers to your formal process for making changes to
company processes in response to a reported problem. This can be from nonconforming
product, customer complaints, management review, suppliers, audits and other sources. There
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is a documented procedure required for Corrective Action and is referenced within this section
below. Most often, this procedure is combined into a “Corrective and Preventive Action
Procedure” to address both types of improvement action.
[Insert Company name] continually improves the effectiveness of the quality
management system using the quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management review.
8.5.2
Corrective Action
Comments: 8.5.2 “Corrective Action” refers to your formal process for making changes to
company processes in response to a reported problem. This can be from nonconforming
product, customer complaints, management review, suppliers, audits and other sources. There
is a documented procedure required for Corrective Action and is referenced within this section
below. Most often, this procedure is combined into a “Corrective and Preventive Action
Procedure” to address both types of improvement action.
[Insert Company name] takes action to eliminate the cause of nonconformities in order
to prevent their recurrence.
Corrective actions are appropriate to the effects of the nonconformities encountered.
A documented procedure has been established (see Corrective and Preventive Action
Procedure) that defines requirements for:






Reviewing nonconformities (including customer complaints),
Determining the causes of nonconformities,
Evaluating the need for action to ensure that nonconformities do not recur,
Determining and implementing action needed,
Recording and maintaining records of the results of action taken, and
Reviewing the effectiveness of the corrective action taken.
[Insert Corrective Action Manager]is responsible for maintaining the procedure and the
associated records.
8.5.3
Preventive Action
Comments: 8.5.3 “Preventive Action” refers to your formal process for making changes to
company processes in anticipation of a likely problem. This can be from data analysis,
employee observations, data analysis, customer complaints, management review, audits and
other sources. There is a documented procedure required for Preventive Action and is
referenced within this section below. Most often, this procedure is combined into a “Corrective
and Preventive Action Procedure” to address both types of improvement action.
[Insert Company name] determines action to eliminate the causes of potential
nonconformities in order to prevent their occurrence.
Preventive actions are appropriate to the effects of the potential problems
A documented procedure has been established (see Corrective and Preventive Action
Procedure) to define requirements for:


Determining potential nonconformities and their causes,
Evaluating the need for action to prevent occurrence of nonconformities,
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


Determining and implementing action needed,
Recording and maintaining the results of action taken, and
Reviewing the effectiveness of the preventive action taken.
[Insert Corrective Action Manager] is responsible for maintaining the procedure and the
associated records.
9.0 Reference Documents
Comments: Listed below are required procedures as reference documents. This section should
list other documents that are either specifically referenced in this document, or that provide
more detail to a process that is referenced in this document.
Procedures
QP-001 - Control of Documents Procedure
QP-002 - Control of Records Procedure
QP-003 - Control of Nonconforming Product Procedure
QP-004 - Corrective/Preventive Action Procedure
QP-005 - Internal Audit Procedure
Work Instructions
Forms
Logs
10.0 Change Log
Comments: If you have another means of tracking changes to documents, such as an
electronic document control system, you may delete this section.
Revision #
Rev. 001
Document
Revision Date
xx/xx/xxxx
Description of Change
Approval(s)
Initial Release
xxxxxxxxxxxx
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