sample iso 9001 quality manual - the quality seminar · pdf filemythical airlines mythical...

34
Mythical Airlines Mythical True Value Metrology a department of Mythical Airlines Legendary Safety, Service, Speed and Strength Around the World from Smallville, Kansas, USA BUSINESS OPERATING MANUAL (QUALITY MANUAL) Revision Date: 2010-06-14 Approved By: Director, Mythical True Value Metrology Date: 2010-06-14 This document is authenticated in whole by verification of the above digital signature, using the signer's public key. This is a complete re-issue of the manual with all previous changes incorporated, therefore there are no revision marks. This version replaces all prior issues. This manual is the property of Mythical True Value Metrology. It must not be reproduced in whole or in part or otherwise disclosed without prior written consent from Mythical True Value Metrology. The official controlled copy of this manual is the digitally signed PDF document on the Mythical True Value Metrology network server and visible to all authorized users. All printed copies, and all electronic copies and versions except the ones described above, are considered uncontrolled copies used for reference only. This document is controlled as a single entity, as any change – however slight, even a single character – to any part of the document by definition changes the entire document. For this reason, as well as the fact that the concept of “page” varies with the publication format, page-level revision is not practiced with this or any other Mythical True Value Metrology document. Sample Quality Manual (Service).odt

Upload: phungtruc

Post on 25-Mar-2018

214 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines

Mythical True Value Metrology

a department of

Mythical AirlinesLegendary Safety, Service, Speed and Strength Around the World from

Smallville, Kansas, USA

BUSINESS OPERATING MANUAL

(QUALITY MANUAL)

Revision Date: 2010-06-14

Approved By: Director, Mythical True Value Metrology Date: 2010-06-14This document is authenticated in whole by verification of the above digital signature, using the signer's public key.

This is a complete re-issue of the manual with all previous changes incorporated,

therefore there are no revision marks. This version replaces all prior issues.

This manual is the property of Mythical True Value Metrology. It must not be

reproduced in whole or in part or otherwise disclosed without prior written

consent from Mythical True Value Metrology.

The official controlled copy of this manual is the digitally signed PDF document

on the Mythical True Value Metrology network server and visible to all

authorized users. All printed copies, and all electronic copies and versions except

the ones described above, are considered uncontrolled copies used for reference

only.

This document is controlled as a single entity, as any change – however slight,

even a single character – to any part of the document by definition changes the

entire document. For this reason, as well as the fact that the concept of “page”

varies with the publication format, page-level revision is not practiced with this

or any other Mythical True Value Metrology document.

Sample Quality Manual (Service).odt

Page 2: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 2 of 34

2010-06-14

1. TABLE OF CONTENTS

Business Operating Manual: Table of Contents

1. TABLE OF CONTENTS.............................................................................................................2

2. INTRODUCTION.......................................................................................................................4

2.1 Conformance and Compliance Standards.............................................................................4

2.2 Other Relevant Standards .....................................................................................................4

2.3 Abbreviations, Acronyms and Definitions............................................................................5

2.4 Services Offered....................................................................................................................5

2.5 Parent Organization ..............................................................................................................6

2.6 Purpose of This Manual........................................................................................................6

2.7 Scope of the Business Management System and Exclusions................................................7

2.7.1 Business Operating Manual ..........................................................................................7

2.7.2 Subsidiary Level 2 Documents......................................................................................7

2.7.3 Laboratory Network......................................................................................................8

2.7.4 Permissible Exclusions and Mitigation ........................................................................8

3. DISTRIBUTION AND REVIEW................................................................................................9

3.1 Circulation List......................................................................................................................9

3.2 Procedures for Updating the Business Operating Manual....................................................9

4. QUALITY MANAGEMENT SYSTEM.....................................................................................9

4.1 General Requirements...........................................................................................................9

4.2 Documentation Requirements.............................................................................................10

4.2.1 General........................................................................................................................10

4.2.2 Business Operating Manual.........................................................................................12

4.2.3 Control of Documents ................................................................................................12

4.2.4 Control of Quality Records.........................................................................................14

5. MANAGEMENT RESPONSIBILITY......................................................................................14

5.1 Management Commitment..................................................................................................14

5.2 Customer Focus...................................................................................................................15

5.3 Quality Policy......................................................................................................................15

5.4 Planning...............................................................................................................................16

5.4.1 Quality Objectives ......................................................................................................16

5.4.2 Quality Management System Planning ......................................................................16

5.5 Responsibility, Authority and Communication...................................................................18

5.5.1 Responsibility and Authority.......................................................................................18

5.5.2 Management Representative.......................................................................................18

5.5.3 Internal Communications ...........................................................................................19

5.6 Management Review...........................................................................................................20

5.6.1 General .......................................................................................................................20

5.6.2 Review Input...............................................................................................................20

5.6.3 Review Output.............................................................................................................20

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 3: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 3 of 34

2010-06-14

6. RESOURCE MANAGEMENT.................................................................................................20

6.1 Provision of Resources........................................................................................................20

6.2 Human Resources................................................................................................................21

6.2.1 Assignment of Personnel.............................................................................................21

6.2.2 Competence, Awareness, and Training........................................................................21

6.3 Infrastructure.......................................................................................................................21

6.4 Work Environment .............................................................................................................22

7. SERVICE REALIZATION........................................................................................................22

7.1 Planning of Service Realization .........................................................................................22

7.2 Customer-Related Processes...............................................................................................23

7.2.1 Determination of Requirements Related to the Equipment.........................................23

7.2.2 Review of Requirements Related to the Product.........................................................23

7.2.3 Customer Communication...........................................................................................24

7.3 DESIGN AND DEVELOPMENT......................................................................................24

7.4 PURCHASING...................................................................................................................24

7.4.1 Purchasing Process......................................................................................................25

7.4.2 Purchasing Information...............................................................................................25

7.4.3 Verification of Purchased Product...............................................................................26

7.5 CALIBRATION AND SERVICE PROVISION.................................................................26

7.5.1 Control of Production and Service Provision..............................................................26

7.5.2 Validation of Processes for Calibration Provision.......................................................27

7.5.3 Identification and Traceability.....................................................................................28

7.5.4 Customer Property.......................................................................................................28

7.5.5 Preservation of Product...............................................................................................29

7.6 Control of Monitoring and Measuring Devices..................................................................29

7.6.1 Substitution of Test and Measurement Equipment Used as Measurement Standards.30

8. MEASUREMENT, ANALYSIS & IMPROVEMENT..............................................................30

8.1 General................................................................................................................................30

8.2 Monitoring and Measurement ............................................................................................30

8.2.1 Customer Satisfaction..................................................................................................30

8.2.2 Internal Audit...............................................................................................................30

8.2.3 Monitoring and Measurement of Processes................................................................31

8.2.4 Monitoring and Measurement of Product....................................................................31

8.3 Control of Nonconforming Product....................................................................................32

8.4 Analysis of Data .................................................................................................................33

8.5 Improvement.......................................................................................................................33

8.5.1 Continual Improvement...............................................................................................33

8.5.2 Corrective Action.........................................................................................................33

8.5.3 Preventive Action........................................................................................................33

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 4: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 4 of 34

2010-06-14

2. INTRODUCTION

This Quality Manual demonstrates and documents Mythical True Value Metrology’s

commitment to maintaining a high-level of quality and strong customer service within an

environment that has safety as a first priority, is focused on the customers, and fosters continual

improvement.

Since the philosophy of Mythical True Value Metrology is that Quality is an integral part of the

entire business operation, hereafter this Quality Manual will be referred to as the Business

Operating Manual. The organization is in the process of implementing that change. As part of

the implementation, the term “Quality Management System” is also being changed to Business

Management System.

2.1 Conformance and Compliance Standards

The Business Operating Manual is intended to demonstrate conformance to

ANSI/ISO/ASQ Q9001-2008 American National Standard: Quality management systems

— Requirements. This standard is the United States’ legal equivalent of the

ISO 9001:2008 international standard. These two reference numbers may be used

interchangeably in this manual and the quality management system. In all other

references to this conformance standard in this manual or quality management system

documents, the reference to the year of the current edition is not used. Reference to this

conformance standard also implies reference to all guidance standards contained therein.

In addition, because Mythical Airlines is a scheduled air carrier that performs its own

maintenance and is an FAA licensed Repair Station for maintenance work performed for other

airlines, this Business Operating Manual is intended to demonstrate compliance with relevant

regulatory issues from

Federal Aviation Regulations Part 121 (14 CFR 121) and Part 145 (14 CFR 145).

2.2 Other Relevant Standards

In addition to the conformance and compliance standards, Mythical True Value Metrology may

from time to time use other standards documents as guidance in its operations and Quality

Management System. These may include but are not limited to current editions of the following:

• ANSI/NCSL Z540.2 American National Standard — Guide to the expression of

uncertainty in measurement

• ANSI/NCSL Z540.3 American National Standard — Requirements for the calibration of

measuring and testing equipment

• ISO 10012 Measurement management systems — Requirements for measurement

processes and measuring equipment

• ISO/IEC 17025 General requirements for the competence of testing and calibration

laboratories

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 5: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 5 of 34

2010-06-14

With the exception of ISO/IEC 17025, these are not auditable standards and are used solely for

guidance. ISO/IEC 17025 is currently used only for guidance as it is part of the laboratory's

continual improvement process to become accredited to that standard at a future date.

2.3 Abbreviations, Acronyms and Definitions

ANSI American National Standards Institute

ASQ American Society for Quality

FAA Federal Aviation Administration (the USA regulatory agency for aviation and

aerospace operations.)

IEC International Electrotechnical Commission

ISO International Organization for Standardization

Metrology The science and practice of precision measurement, specifically the various

disciplines of calibration required by Mythical True Value Metrology

customers

NCSL National Conference of Standards Laboratories, now known as NCSL

International (NCSLI)

PDF Portable Document Format, a file system extension used to designate a

document that conforms to the requirements of international standard

ISO 32000-1, Document management – Portable document format – Part 1:

PDF 1.7

QMS Quality Management System. Mythical True Value Metrology is in the

process of changing this to BMS – Business Management System. The

change will be fully implemented in this document after all level 2

documents have been updated.

RSA An algorithm for public-key cryptography which is suitable for digital

signatures. This type of digital signature both authenticates the signer as the

only person who could have signed it, and authenticates that the document

has not been changed since it was signed. (RSA stands for Rivest, Shamir

and Adleman, authors of the Massachusetts Institute of Technology paper

that disclosed the method in 1978.)

2.4 Services Offered

Mythical True Value Metrology is a department of Mythical Airlines. The product of Mythical

True Value Metrology is the service of providing calibration of tools, precision measuring

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 6: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 6 of 34

2010-06-14

equipment and testing equipment. The department performs, or arranges for, the calibration of all

such equipment owned by or used by Mythical Airlines in all operating stations, as well as that of

other aviation customers as arranged by contract. The department was created in 1995 and has

been registered to ISO 9001 since August 2001. The department’s vision is to be the leading

metrology facility in the airline industry and provide strong support toward continually building

a superior Mythical Airlines team.

2.5 Parent Organization

Mythical Airlines, Incorporated, is an international airline which carries more passengers

annually than any other airline in the world. Based in Smallville, Kansas, USA, Mythical

Airlines has had from its earliest days a strong Midwestern reputation for legendary safety,

service, speed, and strength around the world. The company’s vision is to create the world’s most

trusted airline by becoming “Number One” in the eyes of our customers. The corporate strategies

to accomplish this are:

• Operate an airline network that takes passengers from anywhere to anywhere with

unmatched safety, quality of service, and speed;

• Excel in building a superior Mythical Airlines team;

• Leverage Mythical Airlines’ strengths for the good of our customers, employees and other

stakeholders;

• Achieve superior financial results while acting ethically and dealing fairly, consistent

with generally accepted superior values, and in conformance to all laws and regulations.

2.6 Purpose of This Manual

Mythical True Value Metrology’s overall commitment to quality in work practice and customer

service is defined through its Core and Support Business Processes. Through each of these

business processes, the Business Management System is aligned with the goals and strategic

direction of the organization. The Business Management System as described in this Business

Operating Manual defines the department’s commitment:

• by demonstrating its ability to consistently provide quality service that meets customer

and applicable regulatory requirements,

• by addressing customer satisfaction through the effective application of the system,

including processes for continual improvement and the prevention of nonconformity,

• through employee empowerment, especially for innovative action to improve the

department’s performance, and

• through orderly change management that will maintain a high level of service in

technologically complex and fast-paced environments, both to accommodate

technological change and for continual improvement of the technical skill and capability.

This Business Operating Manual provides an overview of the quality policies and key

requirements for the department. It is the source of reference for all matters dealing with quality.

It is available for inspection by our customers, potential customers, third party quality auditors,

and regulatory agencies.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 7: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 7 of 34

2010-06-14

2.7 Scope of the Business Management System and Exclusions

Scope: Calibration service for tools, precision measuring equipment and testing equipment

for Mythical Airlines and other customers.

The scope of the QMS is specifically defined as everything within the direct

control and authority of Mythical True Value Metrology only. Many functions are

performed by other departments of Mythical Airlines; these departments are

treated as customers and/or suppliers, as appropriate.

Exclusions: ISO 9001 clause 7.3 Design and Development.

Mitigated: ISO 9001 clause 7.4 Purchasing.

2.7.1 Business Operating Manual

This Level 1 Business Operating Manual and its subsidiary documents describe the Business

Management System of Mythical True Value Metrology, and complies with all applicable

requirements of the ISO 9001 International Standard. It addresses pertinent requirements of the

standard and includes references to documented quality procedures that apply to Mythical True

Value Metrology. Compliance is demonstrated through the formal ISO registration process.

IMPORTANT: The system described in this manual is in addition to the

quality and technical policies and procedures defined by Mythical Airlines or

mandated by FAA and other regulatory agencies. These other requirements are

followed and may be referenced in some documents for clarity. However, they

are outside the scope and control of this Department's own QMS. Nothing in this

manual should be interpreted to supersede or contradict these external

requirements.

2.7.2 Subsidiary Level 2 Documents

In addition, there are several subsidiary (Level 2) quality documents that include information on:

• Organizational structure

• Quality responsibilities and authorities, including Management Representative

appointment

• Mythical True Value Metrology’s business processes including core and support

processes

• Core Business Processes address the department’s calibration process — they

define the sequence of processes and sub-processes required to achieve contracted

requirements and address applicable requirements of clause 7 of ISO 9001, and

regulatory requirements.

• Support Business Processes address infrastructure requirements such as those

described by clauses 5, 6 and 8 of ISO 9001, and regulatory requirements.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 8: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 8 of 34

2010-06-14

Level 2 documents are referenced in this Business Operating Manual but are not part of it.

2.7.3 Laboratory Network

The Laboratory computer network is an important piece of the Mythical True Value Metrology

QMS. This network contains the documents and applications that define the management

controls by which the department demonstrates conformance to its QMS. It also demonstrates the

effectiveness of the QMS towards attainment of the department’s management objectives.

This network contains at least the following documents and records:

• The Mythical True Value Metrology Business Operating Manual, Quality Procedures, and

other instructions that implement the policies in the Business Operating Manual.

• Internal Auditing Information: including audit schedule, audit checklists that detail the

department management controls, plus conformance criteria; conformance responsibility;

and objective evidence criteria for each control. These controls are further described in

the corresponding level II quality procedures.

• Audit findings that assess compliance and effectiveness and needs for improvement

• Corrective and preventive activities for continual improvement

• Summaries of Management Review meetings, including action items and their current

status of accomplishments.

• Other support documents as needed to supplement this information.

2.7.4 Permissible Exclusions and Mitigation

Mythical True Value Metrology does not design or develop the equipment or service used in the

calibration process, or the equipment that is calibrated. The equipment calibration is based on

published and verifiable performance specifications and requirements of the equipment

manufacturer and/or the customer. Therefore, clause 7.3 of the ISO 9001 standard is not

applicable.

Mythical True Value Metrology does not directly procure equipment, services or most supplies.

A procurement action must be initiated by the department and then be processed and handled by

other departments of Mythical Airlines. The only exception is permissible small purchases using

a corporate purchase card. Therefore the requirements of clause 7.4, Purchasing, are mitigated to

the extent that they are outside the scope of Mythical True Value Metrology's authority and

Business Management System.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 9: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 9 of 34

2010-06-14

3. DISTRIBUTION AND REVIEW

3.1 Circulation List

The Business Operating Manual is maintained on the Mythical True Value Metrology Laboratory

network as a read-only document and is available to all Department employees and to other

interested and authorized parties. All copies printed from the network are reference copies and

are uncontrolled. Electronic copies other than the one visible on the laboratory internal network

are reference copies and are uncontrolled.

3.2 Procedures for Updating the Business Operating Manual

The Business Operating Manual will be reviewed by Mythical True Value Metrology

management and revised as required. After management review, the Business Operating Manual

is updated (if needed) by incorporating all approved changes. The Management Representative

may approve minor changes and updates to the Business Management System. (Minor changes

include, for example, spelling corrections, punctuation corrections where the sense of the

sentence is not changed, or maintaining hyperlinks and references to other documents on the

network.) The revision date is updated, and the document is re-approved and released as a new

issue in its entirety. The revision data on the cover refers to the entire document. Procedures for

quality policies and procedures documents within the QMS are covered in section 4.2.3 Control

of Documents, and implemented by QP 4230.

4. QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

Mythical True Value (MTV) Metrology has established, documented and implements an

effective QMS as a means of ensuring that its calibration services conform to specified

requirements, to foster an environment of continual improvement with an eventual goal of

achieving laboratory accreditation to ISO/IEC 17025, and to identify its position as a leading

metrology laboratory in the aviation maintenance and repair organization community.

The department’s QMS is comprised of the Core and Support Business Processes that take

market opportunities and converts them into value added outputs to satisfy our customers’ needs

and expectations.

Core Processes:

The core processes describe all the processes that are necessary for the department to realize and

deliver the desired service to its customers. QP 4100 is an overview of the processes and their

interactions. The Core Processes for the department are listed below:

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 10: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 10 of 34

2010-06-14

Receiving Process (QP 4101)

Evaluation Process (QP 4102)

Calibration Process (QP 4103)

Repair Process (QP 4104)

Process for control of Outside Services (QP 4105)

Out-Processing Process (QP 4106)

Support Processes:

Mythical True Value Metrology Support Processes describe all other business requirements that

are necessary to manage and control resources, and to conduct business in an orderly manner.

The support processes are implemented and managed in accordance with the applicable

requirements of the International Standard. They include:

Quality Management (Business Operating Manual)

Document Management (QP 4230, QP 4240)

Facility and Equipment Management (QP 6300, QP 6400)

Information Technology Management (QP 6301)

Measurement Standards (QP 7600)

Human Resources (QP 6220)

The sequence and interaction of the Core and Support Business Processes are described in

section 5.4.2 QMS Planning and QP 4100.

The criteria and methods required to ensure the effective operation and control of these processes

are defined and documented.

The entire QMS documentation and other key information necessary to support the operation and

monitoring of the department business processes are available to all department employees, and

other parties requiring access, on the Laboratory network.

Appropriate levels and types of monitoring and measurement of core and supplemental processes

have been determined and are documented in relevant policies and procedures.

The QMS includes policies and procedures for implementation of actions required to achieved

planned results, and for continual improvement of the business processes.

4.2 Documentation Requirements

4.2.1 General

Mythical True Value Metrology has defined and documented quality procedures consistent with

the requirements of the standard. The quality procedures further describe criteria, methods, detail

activities, responsibilities and the quality assurance measures that are required to ensure the

effective operation and control of the department business processes. The department QMS also

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 11: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 11 of 34

2010-06-14

includes other documents and records required by the organization to ensure the effective

operation and control of the business processes. The degree of documentation is consistent with:

• the methods used,

• the complexity and interaction of the business processes, and

• skills needed and training required by the personnel involved in carrying out these

activities.

An outline of the department QMS documentation is shown in Figure 1.

The QMS is maintained, updated, and continually improved as the department seeks better

business practices. Mythical True Value Metrology employees have been trained on:

• which procedures apply to them,

• how to access those procedures,

• how to apply them to their job function, and

• how to report related results.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Figure 1: Quality management system documentation

Documentation Hierarchy

Level 3: Work Instructions

Level 2: Policies & Procedures

Level 1: Quality Manual

External CorporatePolicies/Procedures,

Laws,Regulations & etc.

External WorkInstructions

Boundary of QualityManagement System

Page 12: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 12 of 34

2010-06-14

4.2.2 Business Operating Manual

A Business Operating Manual (this document, also known as the quality manual) has been

established and maintained and includes:

• the scope of the QMS, including details of and justification for any exclusions;

• documented procedures or reference to them; and

• a description of the sequence and interaction of the processes included in the QMS.

The Business Operating Manual is a controlled document subject to the requirements of section

4.2.3 Control of Documents.

4.2.3 Control of Documents

Mythical True Value Metrology ensures that pertinent issues of documents and data that relate to

the requirements of the QMS are controlled. This control also extends to documents of external

origin that are maintained solely by Mythical True Value Metrology and not by other

departments of Mythical Airlines, such as customer drawings or requirements, performance

standards, and service specifications. This policy is implemented by QP 4230.

4.2.3.1 Document and Data Approval and Issue:

All documents and data that relate to the requirements of the Business Management System and

the Standard are reviewed and approved for suitability by authorized personnel prior to use or

release. Where use is made of computer-based documents and files, special attention is paid to

appropriate approval, access, distribution, and archiving procedures.

Currently Mythical True Value Metrology has a mixed media documentation system for

documents within its control:

• Levels 1 and 2 are computer based, and are available as read-only documents.

• Level 3 documents (such as work instructions, standard operating procedures, or

calibration procedures) are also in electronic format wherever possible.

• For the remaining Level 3 documents not in electronic format, authorized distribution to

points of use is in hard copy. This includes many documents of external origin.

All electronic QMS documents are stored in protected folders. Many are further protected from

unauthorized change by use of digital signatures that implement the RSA public key encryption

algorithm. Update access privileges to these folders are limited to the designated document

control administrator.

A list of documents, identifying the current revision status of each, is established and is readily

available. Appropriate documents are available at all locations where operations essential to the

effective functioning of the Business Management System are performed, or they may be readily

obtained.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 13: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 13 of 34

2010-06-14

4.2.3.2 Document and Data Changes

All personnel are required to identify required changes in documents and are encouraged to

suggest improvements. Changes to documents and data are reviewed and approved by the same

function/organizations that performed the original review and approval, unless specifically

designated otherwise. Access to appropriate background information is provided. The nature of

the changes is recorded.

When practical, the changes are highlighted in the document and/or on attachments.

4.2.3.3 Obsolete Documents

Electronically maintained documents are promptly removed from active files when they become

obsolete. They may be maintained for the document retention period, in file areas not accessible

to general users.

After a revision issue, obsolete hard copy documents are promptly removed from points of issue

and use. The obsolete master document is archived and may be retained for legal and/or

knowledge preservation purposes. The obsolete point of use copy is destroyed.

NOTE: Due to the nature of work performed by Mythical True Value Metrology

(calibration and repair of precision tools, inspection, measuring and test

equipment) there may be multiple versions of Level 3 documents for a given

manufacturer/model of equipment. This is an acceptable situation because: it is

due to version changes during production by the manufacturer of the equipment

being calibrated and is outside the control of Mythical True Value Metrology;

and the metrology technicians are responsible for selecting the correct document

version based on the specific version or serial number of the item being

calibrated.

These documents are also exempt from the requirement to destroy old copies,

unless and until it can be demonstrated that there will never again be a

requirement to calibrate or repair that specific instrument from any current or

potential future customer. The primary reason for this exemption is that some of

the workload items may be several decades beyond their manufacturer's support

life and the data owned by Mythical True Value Metrology may well be the only

data available anywhere.

4.2.3.4 Documents of External Origin

Due to the nature of the organization as a department of a large corporation, there are a number

of documents of external origin that we must use and follow but which are controlled elsewhere.

Access to and use of these documents is in accordance with applicable Mythical Airlines

policies.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 14: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 14 of 34

2010-06-14

Mythical True Value Metrology is also subject to various government regulations. When there is

a need to refer to any of these regulations, access is gained through the Mythical Airlines system

or the regulatory agency system. Our presumption is that the link from that site goes to the most

current edition of the regulation. Any other copies of these regulations are not authorized for use.

These and other situations are further documented in QP 4230.

4.2.4 Control of Quality Records

Quality records are a special case of quality documents. For example, a blank form is a

document, a completed form is a record.

Mythical True Value Metrology maintains quality records to demonstrate conformance to

specified requirements and the effective operation of the Business Management System. Control

provides for the identification, collection, indexing, filing, access, storage, maintenance, and

disposition of quality records. Pertinent customer or supplier records are an element of these

data.

All quality records are legible and are stored and retained in such a manner that they are readily

retrievable. Storage facilities provide an environment that minimizes damage, deterioration and

prevents loss. Retention times of quality records are established and recorded. A records control

matrix is documented to aid control. QP 4240 is established to implement the above policies and

to control Business Management System records.

5. MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

The top management of Mythical True Value Metrology is committed to the development and

improvement of an effective Quality Management System. This commitment is demonstrated by:

• Communicating to the organization the importance of meeting all customer, regulatory,

and legal requirements. (Section 5.5.3 Internal Communications.)

• Establishing the Mythical True Value Metrology Quality Policy for total commitment to

excellence and the associated quality objectives. The Quality Policy and the Quality

Objectives are published and displayed on the Laboratory network sign-in page and the

office notice board. (Sections 5.3 Quality Policy and 5.4.1 Quality Objectives.)

• Conducting Management Reviews. (Section 5.6 Management Review.)

• Identifying and acquisition of controls, processes, equipment, fixtures, resources, and

skills need to achieve the required quality. The associated quality management activities

are described in Section 6 – Resource Management.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 15: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 15 of 34

2010-06-14

5.2 Customer Focus

Top management of Mythical True Value Metrology ensures that customer needs and

expectations are determined, converted into requirements, and fulfilled with the aim of meeting

or exceeding those expectations. The general needs of our customers are defined by the fact that

Mythical True Value Metrology was established by the parent company to perform the specific

service of metrology. The specific needs of our customers are determined through continual

verbal and written communications, as well as periodic visits to their facilities to better

understand their individual processes. It is the responsibility of all personnel that interface with

customers to access stated or implied needs and bring them to the attention of top management

so that they may be addressed. To continually improve, the department also monitors, measures,

and analyzes customer satisfaction throughout the business cycle.

The department also meets all of its other obligations including regulatory and legal

requirements. This is further described in Section 7.2.1 Determination of Requirements Related

to the Equipment.

5.3 Quality Policy

The top management of Mythical True Value Metrology has defined and documented its Quality

Policy. This policy includes the organization’s commitment for meeting customer requirements

and to continual improvement.

Quality Policy Statement:

• The Quality Policy of Mythical True Value Metrology is to provide high and

consistent quality in the calibration and servicing of precision tools, inspection,

and measuring and test equipment owned by Mythical Airlines and other

customers. We are always mindful of the fact that the items we calibrate and

repair are used in maintenance of aircraft and all of their systems, an

environment where safety is paramount.

• Our commitment is to the safety and accurate work of our customer's

professionals who use the items we have calibrated, thereby ensuring the safety

and comfort of aviation passengers and other customers.

• All work is done in conformance to Mythical True Value Metrology’s QMS, the

applicable technical and administrative operating policies and procedures of

Mythical Airlines, legal and regulatory requirements, and specific customer

requirements.

• Through front-line input and management leadership, we will continue to

improve our people and processes to anticipate, meet, and exceed the needs of

our customers.

• We support the continually improving quality of our customer's maintenance and

other technical operations through the the services we provide.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 16: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 16 of 34

2010-06-14

The quality policy and quality objectives are relevant to the department’s organizational goals

and the expectations and needs of its customers. These concepts have been communicated to all

employees within the scope of the QMS. Quality concepts have been integrated into Mythical

True Value Metrology’s culture.

The top management of Mythical True Value Metrology ensures that its Quality Policy is

understood. This is accomplished through training, communication, and displays. The Policy is

implemented by means of documentation, and training about the Business Management System

to meet the requirements of the Standard. The Policy is maintained through Business

Management Systems audits and corrective and preventive action, and reviewed for continuing

suitability through periodic Management Reviews. Further, this Quality Policy is supported by

the quality objectives listed in this Business Operating Manual. (Section 5.4.1 Quality

Objectives).

5.4 Planning

5.4.1 Quality Objectives

Top management of Mythical True Value Metrology establishes quality objectives at all relevant

functions and levels within the organization. The objectives are derived from Mythical True

Value Metrology’s Quality Policy and Mythical Airlines corporate policies. The quality

objectives are documented (Annual Quality Objectives) and are reviewed by top management.

The quality objectives are measurable and consistent with the quality policy, including

commitment to continual improvement. Quality objectives include those needed to meet all

contracted requirements. Inherent in the entire set of quality objectives is a focus on customer

satisfaction.

5.4.2 Quality Management System Planning

Top management of Mythical True Value Metrology has identified and planned the resources

needed to achieve its quality objectives. The results are documented in management reviews.

Quality planning addresses continual improvement of the QMS and assures that change is

conducted in a controlled manner so that the integrity of the QMS is maintained during this

change.

The Quality Plan identifies the core and support business processes of the QMS, and is

documented in the form of references to associated Quality Procedures. The Core Business

Processes represent how we turn opportunity into profitable outcomes. Its effectiveness is

maintained and enhanced by Support Processes. The identified Core and Support business

processes are indicated in Figure 2.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 17: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 17 of 34

2010-06-14

Each core and support business process has a process owner who has the prime responsibility for

ensuring that the process:

• achieves its objectives, and

• is under continual review for improvement.

The business processes, their associated procedures, and the business process owners are shown

in the Business Process and Responsibility Matrix. Each of the core business processes and

support processes is linked to a specific Level 2 quality procedure.

The Quality Plan describes the overall plan for quality assurance. The quality plan consists of

• the core business processes and their interactions,

• the support processes and their interactions,

• the Business Process and Responsibility matrix, and

• appropriate outputs of management review, such as supporting resources.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Figure 2: Core & Support Business Processes

Core Processes

Support Processes

Customer

Receiving Evaluation Calibration

Adjustmentor Repair

OutsideServices

Out-Processing

As needed

QualityManagement

DocumentManagement

MeasurementStandards

Facilities &Equipment

Management

InformationTechnology

Management

HumanResources

Page 18: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 18 of 34

2010-06-14

The Quality Plan is assessed for on-going suitability and effectiveness during management

review meetings.

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

Top management of Mythical True Value Metrology has defined business functions and their

interrelations within the organization, including responsibilities and authorities; and those are

communicated in order to facilitate effective quality management. For the purpose of this

Business Operating Manual and the quality management system, top management of Mythical

True Value Metrology is the Vice-President — Quality of Mythical Airlines.

Mythical True Value Metrology ensures the responsibility, authority and interrelationship of

personnel who manage, perform, and verify work affecting quality is defined and documented,

particularly for personnel who need the organizational freedom and authority to:

• Initiate action to prevent the occurrence of any nonconformance relating to service,

process, and Business Management Systems,

• Identify and record any problems relating to the service, process, and Business

Management System,

• Initiate, recommend, or provide solutions through designated channels,

• Verify the implementation of solutions,

• Control further processing, delivery or installation of nonconforming product until the

deficiency or unsatisfactory condition has been corrected.

The Mythical True Value Metrology organization chart (Figure 3) shows the organization of the

department and the relationships to the Mythical Airlines corporate management. Relationships

to other parts of the Mythical Airlines corporate structure are documented by Mythical Airlines

and are available on the Mythical Airlines network. In the organization chart, the portion

INCLUDED in this quality management system is shaded in blue. The rest of the company is

treated as customers or suppliers, as appropriate.

5.5.2 Management Representative

The top management of Mythical True Value Metrology has appointed the Mythical Airlines

Director – Metrology as its Management Representative. This individual, irrespective of other

responsibilities, has the defined authority to:

• Ensure that the business processes of the QMS are defined.

• Ensure that the Business Management System requirements are established, implemented

and maintained in accordance with the Standard.

• Report to top management on the performance of the QMS, including needs for

improvement.

• Promote awareness of customer requirements throughout the organization.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 19: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 19 of 34

2010-06-14

The Management Representative also acts as the liaison between the department and other third

parties on matters concerning the department Business Management System.

The Metrology Engineering and Support Manager is the Deputy Management Representative.

5.5.3 Internal Communications

Top management of Mythical True Value Metrology ensures that communication is maintained

between its various levels and functions regarding the processes of the QMS and their

effectiveness. This is accomplished via the Laboratory network, various quality meetings, and

other internal publications.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Figure 3: Organization & Top Management

Mythical Airlines' Organization

CorporateOfficers

VP:Corporate

Support Depts.

VP:Customer Service

Operations

VP:Flight Operations

VP:Quality Assurance

VP:Maintenance &

Repair Operations

VP:Training

Operations

Director:Metrology

Director:Corporate-Level QA &

Regulatory Compliance

Director:Quality of Customer

Service

Director:Quality of Flight

Operations

Director:MRO Quality

Director:Quality of Training

Manager:Electrical - ElectronicMetrology

Manager:Physical -

DimensionalMetrology

Manager:Metrology

Engineering &Support Svcs.

Blue shading indicates the part of the company included in the MTV Metrology quality system.Bold black lettering indicates the direct linkage to Mythical Airlines corporate officers.

Gray italic lettering indicates parts of the company that are excluded from the MTV Metrology quality system; these parts of the company are described in other Mythical Airlines documents.

Page 20: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 20 of 34

2010-06-14

5.6 Management Review

5.6.1 General

Top management of Mythical True Value Metrology reviews the QMS at planned intervals to

ensure its continuing suitability, adequacy and effectiveness. The review evaluates the need for

changes to the organization's QMS, including its quality policy and quality objectives.

5.6.2 Review Input

Inputs to management review include but are not limited to current performance and

improvement opportunities related to the following:

• results of audits;

• customer feedback;

• process performance and product conformance;

• status of preventive and corrective actions;

• follow-up actions from earlier management reviews;

• changes that could effect the QMS; and

• recommendations for improvement of the system.

5.6.3 Review Output

The outputs from the management review include but are not limited to decisions and actions

related to:

• improvement of effectiveness of the QMS and its processes;

• improvement of product related to customer requirements; and

• resource needs.

Results of management reviews are recorded.

6. RESOURCE MANAGEMENT

6.1 Provision of Resources

Top management of Mythical True Value Metrology determines and provides, in a timely

manner, the resources needed:

• to implement, maintain and improve the effective operations of the QMS processes, and

• to enhance customer satisfaction by meeting requirements.

These resources are assessed and reviewed on a periodic basis consistent with annual and

strategic business planning activities.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 21: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 21 of 34

2010-06-14

6.2 Human Resources

6.2.1 Assignment of Personnel

Personnel who are assigned responsibilities directly or indirectly affecting conformity to service

(product) requirements are determined to be qualified and competent based on education,

training, observed skills, and experience.

6.2.2 Competence, Awareness, and Training

Mythical True Value Metrology identifies training needs and provides for the training of all

personnel performing activities affecting quality. Personnel performing specific assigned tasks

are qualified on the basis of appropriate education, training, observed skills, and experience, as

required. All metrology technicians must be evaluated as fully competent in a discipline of

metrology before being allowed to work independently in that discipline.

A training plan is prepared and scheduled annually with periodic updates.

Training is provided either on or off the job, internally or externally, as appropriate. The ongoing

effectiveness of training is periodically assessed by observation, proficiency testing or other

appropriate means.

Mythical True Value Metrology ensures that its personnel are aware of the relevance and

importance of their jobs and how they contribute to the achievement of the quality objectives.

Mythical True Value Metrology securely retains duplicate copies of training records in the form

of attendance sheets, certificates of proficiency and/or completion for all employees. Original

copies of these records are maintained by Mythical Airlines Human Resources Department,

which is outside the scope of this quality management system.

Quality Procedure QP 6220 implements the above policies.

6.3 Infrastructure

Top management of Mythical True Value Metrology identifies, provides and maintains the

facilities and infrastructure it needs to achieve service quality, including:

• workspace and associated facilities, including utilities;

• process equipment, hardware and software;

• supporting services such as telephone, computer networks, etc.

QP 6300 and QP 6301 have been established to further describe and implement the above

policies.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 22: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 22 of 34

2010-06-14

6.4 Work Environment

Top management of Mythical True Value Metrology identifies and manages the human and

physical factors of the work environment needed to achieve conformity of service quality.

QP 6400 has been established to further describe and manage the above policies, and to define

the physical environmental requirements for each metrology discipline.

7. SERVICE REALIZATION

NOTE: The product of Mythical True Value Metrology is the service of

providing calibration of tools, precision measuring equipment, and testing

equipment.

7.1 Planning of Service Realization

Upon receipt of new service requirements, or significant changes (modify, add, remove) to

existing requirements, Mythical True Value Metrology management plans the sequence of

processes required to realize the specified requirements. Planning the processes for the

realization of service quality includes but is not limited to the functions listed below.

• Prepare documentation and data that describes how the processes of the QMS are applied

to a specific service. These are referred to as calibration procedures or calibration

documents. Such documents describe the quality objectives and requirements, the

sequence of processes and sub-processes required to achieve the contracted services

including specified performance objectives. Quality plans are consistent with the other

requirements of the organization's QMS and are documented in a form suitable for the

department’s method of operation.

• Identify and document suitable verification, validation, monitoring, process

measurement, inspection, and testing at appropriate stages of the calibration service

realization.

• Identify and acquire controls, processes, equipment, fixtures, total calibration resources,

and skills that are needed to achieve the required quality.

• Address for compatibility the delivery of service, calibration process, installation,

servicing, inspection and test procedures, and the applicable documentation.

• Address the need to develop and implement new techniques, and the criteria for

acceptance, as necessary.

• Address measurement requirements involving capability that exceeds the known state of

the art.

• Clarify standards of acceptability, including those that contain a subjective element.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 23: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 23 of 34

2010-06-14

• Identify quality records that are necessary to provide confidence of conformity of the

processes and results, and the records are maintained as described in documented

procedures.

Quality Procedure QP 7100 describes the planning for service delivery and refers to other

Mythical True Value Metrology quality procedures involved in the process.

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Equipment

Mythical True Value Metrology determines customer requirements including service and/or

product requirements specified by the customer. These customer requirements include, but are

not limited to:

• specific calibration requirements;

• the requirements for availability, and delivery, with associated costs;

• contract requirements not specified by the customer but necessary for intended or

specified use; and

• obligations related to the contract, including regulatory and legal requirements.

NOTE: Mythical True Value Metrology is established by Mythical Airlines (its

principal customer) to provide calibration and related services. Contract review

or other customer determination processes are not an on-going requirement with

respect to the calibration service that we provide to Mythical Airlines. If

equipment is delivered to us using Mythical Airlines’ processes and no

exceptions are noted, the customer and we expect that routine calibration service

will be provided with no need for further determination or review.

Quality Procedure QP 7200 is established to implement and provide further guidance regarding

customer-related processes.

7.2.2 Review of Requirements Related to the Product

If equipment is delivered to us using Mythical Airlines’ processes and no exceptions are noted,

the customer and we expect that routine calibration service will be provided with no need for

further determination or review. Should that expectation change due to a change in Mythical

Airlines policy, it will be reviewed and documented at management review.

Mythical True Value Metrology ensures that customer requirements are fully understood and the

department has the capability to meet them. Before acceptance of a non-routine customer

requirement, including work from customers other than Mythical Airlines, the request is

reviewed by the department to ensure that:

• Requirements are adequately defined and documented.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 24: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 24 of 34

2010-06-14

• Differences between the standard requirements and those in the request are resolved.

• Mythical True Value Metrology has the capability and capacity to meet these

requirements.

If a change to the standard requirements is identified by the laboratory or requested by the

customer, the department documents such statements of or changes to requirements. The

department ensures that relevant documentation is amended and relevant personnel are made

aware of the changed requirements.

7.2.3 Customer Communication

Mythical True Value Metrology identifies and implements arrangements for communication with

customers relating to:

• calibration information;

• inquiries, or order handling, including amendments;

• customer feedback, including customer complaints.

7.3 DESIGN AND DEVELOPMENT

Mythical True Value Metrology is not currently engaged in the design or development of

product. Mythical True Value Metrology does not design or develop the equipment or service

used in the calibration process, or the equipment that is calibrated. The equipment calibration is

based on verifiable performance specifications and requirements of the equipment manufacturer

and/or the customer. Work instructions (calibration procedures) are either publicly available

methods or methods written by the metrology engineering staff based on publicly available

methods. In either case, the methods are verified and validated according to generally acceptable

metrology principles before being accepted for use. Therefore, clause 7.3 of the ISO 9001

standard is not currently applicable. Should the department become involved in product design,

then it will define and document suitable controls to ensure conformance to specified

requirements.

7.4 PURCHASING

Purchasing of outside materials, supplies, and services is not a burdensome requirement for

Mythical True Value Metrology. In most cases, Mythical Airlines is considered the supplier of all

purchasing services.

• All purchases of capital items, high volume consumables, items or services requiring a

purchase order, contracted services, and so on are largely handled by other Mythical

Airlines departments and are under the control of Mythical Airlines’ policies and

procedures and therefore outside the scope of this QMS.

• Much of the purchasing process uses Mythical Airlines requirements, controls and staff,

which are outside the scope and controls of the Mythical True Value Metrology QMS.

• Suppliers that may be used with a purchase order or through the electronic business-to-

business system are controlled by the Mythical Airlines corporate purchasing and

accounting departments, which are outside the scope of this QMS.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 25: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 25 of 34

2010-06-14

• Some materials and supplies are obtained from the Mythical Airlines stock system.

• Support processes are supplied and controlled by other Mythical Airlines departments.

Mythical True Value Metrology directly purchases some materials, supplies, and services from

other companies by using Mythical Airlines’ corporate purchase card. Almost all such purchases

are infrequent or non-recurring retail purchases of very small quantities of cataloged or other

commercial off-the-shelf products. All purchases must follow the policies and procedures of

Mythical Airlines, which are outside the scope of this QMS.

Mythical True Value Metrology maintains a local list of active outside (non-Mythical Airlines)

suppliers and the materials or services they provide, but suppliers are primarily managed at the

corporate level and must be listed in the corporate enterprise management system database.

Mythical Airlines provides for the inspection and auditing of suppliers, when a need is

determined, according to Mythical Airlines policy. In this respect Mythical Airlines is a supplier

of this service to Mythical True Value Metrology.

Mythical True Value Metrology, where practical, verifies purchased material, supplies, and

services before use or redistribution.

7.4.1 Purchasing Process

Mythical True Value Metrology ensures that purchased products and services conform to

specification and are purchased from approved sources. Purchasing control is dependent on the

type of product, on the effect on subsequent service realization processes and their output, and

where applicable, on the quality audit reports and/or quality records of suppliers’ previously

demonstrated capability and performance. In all cases, incoming product is not used until it is

inspected or otherwise verified against specified requirements.

Mythical True Value Metrology has established and maintains local records of acceptable

suppliers. An approved supplier list (ASL) is maintained. A critical supplier list is also

maintained.

QP 7400 defines the Mythical True Value Metrology process for purchasing controls over its

suppliers. Separate procedures detail the processes for purchasing and materials, supplies and

services other than calibration (QP 7410.1), and subcontracted calibration services (QP 7410.2).

7.4.2 Purchasing Information

Mythical True Value Metrology requires that purchasing documents contain data clearly

describing the product ordered including, where appropriate, requirements for approval or

qualification of

• product and/or services,

• procedures,

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 26: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 26 of 34

2010-06-14

• processes,

• equipment, and

• personnel

All appropriate and relevant contract clauses have been supplied to Mythical Airlines purchasing

department, and all requests for external services or supplies identify the relevant clauses to be

used. All purchasing documents are reviewed and approved to ensure the adequacy of specified

requirements contained in the purchasing documents prior to their release.

7.4.3 Verification of Purchased Product

Mythical True Value Metrology identifies and implements the activities necessary for verification

of purchased products and/or services to ensure that purchase specifications are met.

Mythical True Value Metrology ensures that incoming material is not used or processed until it

has been inspected or otherwise verified to specified requirements. Verification of conformance

is in accordance with the quality plan and/or documented procedures.

Mythical True Value Metrology has determined the amount and nature of receiving verification,

based on the extent of control exercised at the supplier premises and the recorded evidence of

conformance provided.

Verification of purchased product or service by Mythical True Value Metrology at the supplier’s

premises is not required at this time. If it ever does become a requirement, this process will be re-

evaluated.

Verification of purchased product or service by the Customer is not required at this time. Such

verification would required recalibration of the instrument, and the customer does not have the

facilities, measurement standards, or qualified personnel to perform the verification. If it ever

does become a requirement, this process will be re-evaluated. However, this does not absolve

Mythical True Value Metrology of the responsibility to provide acceptable product, nor will it

preclude subsequent rejection by the customer.

7.5 CALIBRATION AND SERVICE PROVISION

7.5.1 Control of Production and Service Provision

Mythical True Value Metrology identifies and plans calibration processes that directly affect

quality to ensure that these processes are carried out under controlled conditions. The plan is

modified, if necessary, based on review of new customer requirements.

These plans are executed under controlled conditions. Controlled conditions include the

following:

• The availability of information that specifies the product/calibration characteristics.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 27: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 27 of 34

2010-06-14

• Use of documented work instructions defining the manner of calibration, where the

absence of such instructions could adversely affect quality.

• Use of suitable calibration equipment in a suitable work environment.

• Compliance with reference standards, codes, control plans, and/or documented

procedures and work instructions. Calibration personnel have access to appropriate

product specifications information and control measures at each stage of the process.

• Monitoring and control of suitable product characteristics and process parameters, and

the availability and use of measuring and monitoring devices.

• The approval of process and equipment as required.

• Criteria for workmanship are stipulated in the clearest practical terms using written

standards, representative samples, or illustrations, as appropriate.

• Suitable maintenance of equipment to ensure continuing process capability.

• The implementation of defined processes for release, delivery, and any applicable post-

delivery activities.

7.5.2 Validation of Processes for Calibration Provision

Work processes (calibration procedures) are validated before first use and periodically as

necessary as determined by Metrology Engineering, proficiency test results, observed

deficiencies, or measurement system changes. The nature of a calibration service is that all of the

customer's product is either verified to be in good working order before release, or rejected as

unusable.

The need for special processes is confirmed or ruled out during product planning. See Quality

Procedure QP 7100.

If applicable, Mythical True Value Metrology will validate any calibration and service processes

where the resulting output cannot be verified by subsequent measuring or monitoring. This

includes any processes where deficiencies may become apparent only after the equipment is in

use or the service has been delivered. Currently there are no special processes in use by Mythical

True Value Metrology where the results cannot be fully verified by subsequent inspection or

testing.

Validation demonstrates the ability of the processes to achieve planned results. Mythical True

Value Metrology defines arrangements for validation, including the following, as applicable:

• qualification of processes;

• qualification of equipment and personnel;

• use of defined methodologies and procedures;

• requirements for records;

• re-validation.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 28: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 28 of 34

2010-06-14

7.5.3 Identification and Traceability

Mythical True Value Metrology ensures that equipment in a work process is adequately identified

by suitable means throughout the process. The department also provides for physical traceability

(identification of location and step in the process).

Identification

Equipment is adequately identified through all stages by means of a Mythical Airlines property

ID number, or the property ID number provided by an external customer, as applicable.

Traceability

When and to the extent that physical traceability is a specified requirement, Mythical True Value

Metrology will establish and maintain documented procedures for the unique identification of

product.

NOTE: Traceability in this sense refers to physically tracking a product through

the service provision process and not to metrological traceability of

measurement results.

Inspection and Test Status

Mythical True Value Metrology identifies the status of the equipment with respect to

measurement and monitoring requirements specified. The identification of inspection and test

status is maintained throughout the process to ensure that only equipment that has passed

required inspections, tests, and calibration are dispatched or used as serviceable items.

• Suitable means of identification are in place throughout the calibration process.

• Computer records are the primary means of identification of status.

• Job numbers, tags, labels, inspection logs, traveler sheets, and so forth may also be used

when appropriate.

• Since all operations are performed on unique single items, any method relating to a lot of

more than one item is by definition not appropriate.

7.5.4 Customer Property

Mythical True Value Metrology exercises care with customer property while it is under our

control or being used by the organization. The department identifies, verifies, protects, and

maintains customer property provided for service. Any occurrence of customer property that is

lost, damaged, or otherwise found to be unsuitable for use is recorded and reported to the

customer for disposition.

Customer property includes intellectual property (information provided in confidence) and

proprietary information. All personnel are responsible for following Mythical Airlines' general

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 29: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 29 of 34

2010-06-14

corporate policies on confidentiality. These policies apply equally to intellectual property of

external customers.

7.5.5 Preservation of Product

Mythical True Value Metrology preserves conformity of equipment with customer requirements

during internal processing and delivery to the intended destination. This includes identification,

handling, packaging, storage, and protection. This also applies to the constituent parts of and

accessories for a product.

Quality Procedure QP 7550 provides for the preservation of equipment quality through all stages.

7.6 Control of Monitoring and Measuring Devices

NOTE 1: This section applies to the calibration and maintenance of Mythical

True Value Metrology’s own equipment used to provide its calibration services.

NOTE 2: In this respect, Measuring and Monitoring Devices may also be

referred to as measurement standards, calibration standards, or laboratory

standards. All of these terms are equivalent.

Mythical True Value Metrology identifies the measurements to be made and selects the

measuring and monitoring devices required to assure conformity of calibration to specified

requirements.

Adequately calibrated measuring and monitoring devices (measurement standards) are used and

controlled to provide assurance that measurement capability is consistent with the measurement

requirements, and that measurement results are traceable to the International System of Units.

Where applicable, Mythical True Value Metrology ensures that measuring and monitoring

devices:

• are calibrated on a defined periodic basis and adjusted when the need is indicated, against

devices traceable to nationally recognized standards. Where no such standards exist, the

basis used for calibration is agreed upon and recorded;

• are safeguarded from adjustments that would invalidate the calibration;

• are protected from damage and deterioration during handling, maintenance, and storage;

• calibration results are recorded;

• have the validity of previous results re-assessed if measuring and monitoring devices are

subsequently found to be out of calibration, and corrective action taken.

Where software is used to control measuring and monitoring of specified requirements, it is

validated prior to initial use. Once the software has been verified to function as intended (as part

of the receiving inspection process), then no further tests are required unless a version upgrade is

installed or a skilled operator has reason to suspect a problem.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 30: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 30 of 34

2010-06-14

Quality Procedure QP 7600 provides additional guidance on control of measurement standards

and implements this policy.

7.6.1 Substitution of Test and Measurement Equipment Used as Measurement Standards

When the measurement standard called for in the calibration procedure does not exist or is not

available on a more or less permanent basis, a substitution may be required. The substitute

equipment may also be referred to as “equivalent” or “alternate” equipment.

When the calibration procedure used is documented in an aircraft, engine or component

maintenance document controlled by the controlled maintenance manual procedures of Mythical

Airlines, or an Airworthiness Directive, any substitute for the measurement standard must be

requested and approved through Mythical Airlines' corporate Tooling Equivalency process. The

work cannot be accomplished until approval is documented and received.

In all other cases, a substitute standard request must be submitted to the metrology engineering

staff for approval and documentation.

8. MEASUREMENT, ANALYSIS & IMPROVEMENT

8.1 General

Mythical True Value Metrology defines, plans, and implements the measurement and monitoring

activities needed to ensure conformity and achieve improvement. This includes the determination

of the need for, and use of, applicable methodologies including statistical techniques.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

Mythical True Value Metrology monitors information on customer satisfaction and/or

dissatisfaction as one of the measurements of performance of the QMS. The quality manager

determines the methods for obtaining and using this information.

8.2.2 Internal Audit

Mythical True Value Metrology conducts periodic internal audits, or schedules equivalent audits

by other Mythical Airlines departments or by external contractors. The purpose of the internal

audit is to determine whether the department's QMS:

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 31: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 31 of 34

2010-06-14

• conforms to the requirements of the Standard;

• is being effectively implemented and maintained.

Internal quality audits are planned and scheduled on the basis of the status and importance of the

activity to be audited. Trained personnel independent of those having direct responsibility for the

activity being audited carry out the audits, thus ensuring that auditors do not audit their own

work. Since Mythical True Value Metrology is so small that independence cannot always be fully

assured, the department may arrange for the internal audit function to be performed by other

qualified parties. Examples of other qualified parties include but are not limited to:

• Agents of the customer, such as Mythical Airlines' own internal quality audit department.

• Independent third-party organizations, such as a qualified consultant or consulting firm.

• Qualified internal auditors from other departments of Mythical Airlines.

Mythical True Value Metrology currently schedules internal audits that are performed by

Mythical Airlines' own internal quality audit department.

The results of the internal audits are documented and brought to the attention of the personnel

having responsibility for the area audited. Management personnel responsible for the area take

timely corrective action on the deficiencies found during the audit.

Follow-up activities verify and record the implementation of the corrective action, report the

verification results, and close out the audit. Subsequent audits verify the effectiveness of the

corrective actions taken.

Results of internal audits and the corrective action are submitted for management review.

QP 8220 implements this policy.

8.2.3 Monitoring and Measurement of Processes

Mythical True Value Metrology applies suitable methods for measurement and monitoring of the

realization processes necessary to meet customer requirements. These methods confirm the

continuing ability of each process to satisfy its intended purpose. Suitable methods are

determined by Metrology Engineering and may include process control checks, proficiency tests,

and other methods.

8.2.4 Monitoring and Measurement of Product

The purpose of Mythical True Value Metrology is to measure and monitor the characteristics of

the equipment being calibrated to verify that requirements are met. This is carried out at

appropriate stages by the calibration process and may include equipment testing and/or

inspection as required by the quality plan and/or documented work instructions.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 32: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 32 of 34

2010-06-14

Evidence of conformity with the acceptance criteria is documented. Records indicate the

authority responsible for release of product.

Mythical True Value Metrology carries out final inspection in accordance with the quality plan

and/or documented procedures to complete the evidence of conformance of the finished

product/service to specified requirements. See QP 4106.

The quality plan and/or documented procedures require that all specified inspections and tests

and calibrations, including those specified on receipt or in process, have been carried out and that

the results meet specified requirements.

Equipment release and service delivery does not proceed until all the specified activities have

been completed and the associated data and documentation are available and authorized unless

otherwise approved by the customer.

Mythical True Value Metrology has established and maintains records that provide evidence that

equipment has been inspected and/or tested and calibrated. These records show clearly whether

the equipment has passed or failed according to defined acceptance criteria. Where the

equipment fails to pass any inspection, the process defined in the applicable Mythical Airlines

policy (outside the scope of this Business Management System) is followed. In the case of

equipment owned by an external customer, the customer is notified and the item is returned as

rejected with the specific deficiencies noted.

Records identify the calibration authority responsible for the release of the equipment.

8.3 Control of Nonconforming Product

NOTE: As noted in sections 2.2 and 7 of this Business Operating Manual, the "product" of this

organization is the service of performing calibration of precision electronic test and measuring

instruments.

Mythical True Value Metrology ensures that service provided which does not meet requirements

is identified, controlled where possible to prevent unintended use or delivery to the customer,

and corrected if it has been delivered. This policy is implemented in QP 8300. This procedure

includes provisions for:

• identification, documentation, evaluation, segregation (where practical), disposition of

nonconforming service, and for notification of the functions concerned;

• assigning responsibility for the review and the authority for disposition of nonconforming

service;

• correction of nonconforming service and re-verification/calibration of the affected

equipment after correction to demonstrate conformity (if necessary);

• handling of nonconforming service when it is detected after delivery to the customer.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 33: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 33 of 34

2010-06-14

8.4 Analysis of Data

Mythical True Value Metrology collects and analyzes appropriate data to determine the

suitability and effectiveness of the QMS and to identify improvements that can be made. This

includes data generated by measuring and monitoring activities and other relevant sources.

The data are analyzed to provide information on:

• customer satisfaction and/or dissatisfaction;

• conformance to customer requirements;

• characteristics of processes, product and their trends;

• performance of suppliers.

8.5 Improvement

8.5.1 Continual Improvement

Mythical True Value Metrology plans and manages the processes necessary for the continual

improvement of the QMS.

Mythical True Value Metrology facilitates the continual improvement of the QMS through the

use of the quality policy, objectives, audit results, analysis of data, corrective and preventive

action and management review.

8.5.2 Corrective Action

Mythical True Value Metrology takes corrective action to eliminate the cause of identified

nonconformities in order to prevent recurrence. Corrective actions are appropriate to the impact

of the problems encountered.

QP 8520 defines requirements for:

• identifying nonconformities (including customer complaints);

• determining the causes of nonconformity;

• evaluating of the need for actions to ensure that nonconformities do not recur;

• determining and implementing the corrective actions needed;

• recording results of action taken;

• review and evaluation of corrective action taken to assess its effectiveness.

8.5.3 Preventive Action

Mythical True Value Metrology identifies preventive actions to eliminate the causes of identified

potential nonconformities to prevent initial occurrence. Appropriate sources of information such

as processes and work operations results which affect product quality, concessions, audit results,

quality records, service reports, and customer complaints are analyzed (see 8.4 above) to detect

preventive action possibilities. Preventive actions taken are appropriate to the impact of the

potential problems.

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

Page 34: Sample ISO 9001 Quality Manual - The Quality Seminar · PDF fileMythical Airlines Mythical True Value Metrology Business Operating Manual Page 3 of 34 2010-06-14 6. RESOURCE MANAGEMENT

Mythical Airlines Mythical True Value Metrology

Business Operating Manual

Page 34 of 34

2010-06-14

QP 8530 defines requirements for:

• identification of potential nonconformities and their causes;

• determination of the steps needed to eliminate identified causes and completion of the

preventive action implementation;

• recording results of action taken;

• review and evaluation of preventive action taken to assess its effectiveness;

• ensuring that relevant information on actions taken, including changes to procedures, is

subject to management review.

- - - [END] - - -

All printed copies, and all electronic copies and versions except the one accessible on the

Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.

This EXAMPLE quality manual was created for ASQ by:

Graeme C. PayneASQ Senior Member, CQA, CCT, CQE, CQT

GK Systems, Inc.

4440 Weston Drive SW, Suite B

Lilburn GA 30047-3181

USA

http://www.gksystems.biz

This EXAMPLE manual is a representative item for use as

a training aid only. Any resemblance to any real

corporation, organization, policies or procedures is not

intentional and is purely coincidental.