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White Paper:
ISO 9001:2000 Standards:
Automating Quality Systems
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Using MasterControl for ISO Compliance
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ISO 9001:2000 Standards: Automating Quality Systems
PLEASE NOTE: MasterControl has another white paper that covers the latest standards, ISO 9001:2008. If you would
like to know more, please download the following white paper:
Meeting ISO 9001:2008 - Standards with Automated Tools

Introduction
Adhering to ISO 9000 quality standards have helped companies improve product quality and production effciency. Will
your electronic quality management system capabilities meet the challenge?
If you are using MasterControl, the worlds leading quality management solution, there is no worry about nonconformance.
Be assured, you will not only meet, but will exceed the new standards. The following describes how MasterControl helps
with ISO9001:2000 requirements specifc to document control:

Requirement How MasterControl helps with
4.1 GENERAL REQUIREMENTS
4.1.1 Establishes a document control system that stores and manages documents relating to
implementing, maintaining and continually improving a Quality Management System in
accordance with ISO 9001:2000.
Requirement How MasterControl helps with
4.2 GENERAL DOCUMENTATION REQUIREMENTS
4.2.1 Stores and manages documented procedures for:
Control of documents;
Control of quality records;
Internal Audit;
Control of non-conformity;
Corrective action;
Preventive action.
4.2.2 Helps the organization identify and control documents particularly those needed to ensure
effective operation and control of its processes.
Note: MasterControl is capable of storing documented procedures in virtually any medium
(fle format) type.
Requirement How MasterControl helps with
5.1 MANAGEMENT COMMITMENT
5.1.1 Provides evidence of commitment by top management towards development and improvement
of the Quality Management System by:
Helping maintain awareness of regulatory and legal requirements. 1.
Helping maintain documentation of top managements communications regarding meeting 2.
customer requirements.
Helping maintain top management reviews of resource requirements and storage of quality 3.
data collection. Also helps demonstrate timely resources are provided to achieve quality
objectives.
Helping maintain documentation of Management Review of the Quality Management 4.
System.
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ISO 9001:2000 Standards: Automating Quality Systems
Requirement How MasterControl helps with
5.2 CUSTOMER FOCUS
5.2.1
5.2.2
Helps top management store and manage documented methodologies to ensure that: Customer
needs and expectations are determined, converted into requirements, and fulflled with the aim of
achieving customer satisfaction.
Helps maintain documentation including legal and regulatory requirements.
Requirement How MasterControl helps with
5.3 QUALITY POLICY
5.3.1 a-g) Helps top management store, communicate, and control a Quality Policy. The Quality
Policy can be made accessible to appropriate levels in the organization.
Requirement How MasterControl helps with
5.4 PLANNING
5.4.1.1
5.4.1.2
5.4.1.3
Stores, maintains, and communicates quality objectives to relevant functions and levels within
the organization. Info Cards with objectives can be linked to the Quality Policy Info Card.
5.4.2.1
5.4.2.2
5.4.2.3
5.4.2.4
Helps an organization store and manage quality planning
Documentation.
Ensures changes to quality planning are managed in a controlled manner.
Ensures the integrity of Quality Management System is maintained during the change process.
Requirement How MasterControl helps with
5.5 ADMINISTRATION
5.5.2.1
5.5.2.2
5.5.2.3
5.5.2.4
Manages interface information (i.e. organizational charts, documentation) including routing and
approval interrelationships, responsibilities, and authorities.
5.5.3.1
5.5.3.2
Helps the Management Representative by:
Maintaining process documentation. 1.
Assisting with management reports on the performance of the Quality Management System. 2.
Promoting awareness of customer requirements throughout the organization. 3.
5.5.4.1 Helps the organization with communication at various levels and functions regarding the
processes of Quality Management System and improves effectiveness by providing access to
documents and through the routing and approval processes.
5.5.5.1
5.5.5.2
5.5.5.3
Maintains and provides secure access to the Quality Manual.
Maintains relationships and references to documented procedures through the Vault structure,
Organizer, Linking, etc.
Helps ensure the Quality Manual is controlled.
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ISO 9001:2000 Standards: Automating Quality Systems
5.5.6.1
5.5.6.2
Establishes a system for controlling documents (including documents defned as Quality
Records) required for the Quality Management System.
Helps to ensure documents are:
Approved for adequacy prior to issue; 1.
Reviewed, updated, as necessary and re-approved; 2.
Identifed with current revision status; 3.
Available at points of use; 4.
Legible, readily identifable and retrievable; 5.
Identifed and their distribution controlled if they are external documents; 6.
Prevented from unintended use if they are obsolete documents, and have suitable 7.
identifcation if they are retained for any purpose.
5.5.7.1
5.5.7.2
5.5.7.3
5.5.7.4
5.5.7.5
Establishes a system for the identifcation, storage, retrieval, protection, retention time and
disposition of quality records.
Guarantees quality records are subjected to control.
Ensures the following records are maintained:
Results of management review (5.6);
Records of education, experience, training and qualifcation (6.2.2);
Results of review of product requirements and subsequent follow-up actions (7.2.2);
Results of design and / or development review and subsequent follow-up actions (7.3.4);
Results of design and / or development verifcation and subsequent follow-up actions (7.3.5);
Results of design and / or development validation and subsequent follow-up actions (7.3.6);
Results of design and / or development changes and subsequent follow-up actions (7.3.7);
Results of supplier evaluations and follow-up actions (7.4.1);
Unique identifcation of the product, when traceability is requirement (7.5.2).
Results of calibration for measurement and monitoring devices (7.6).
Authority responsible for release of the product (8.2.4).
Stores records for the following, as applicable:
Customer property that is lost, damaged or otherwise unsuitable for use reported to the
customer;
Process validation records;
Basis of calibration in the absence of traceable national or international standards;
Results of corrective action taken;
Results of preventive action taken.
Requirement How MasterControl helps with
5.6 MANAGEMENT REVIEW
5.6.1 Maintains records of top management review of the Quality Management System.
5.6.2.1 Stores and manage records that include:
Results of audits; 1.
Customer feedback; 2.
Process performance and product conformance; 3.
Status of corrective and preventive actions; 4.
Follow-up action from earlier management reviews; 5.
Changes that could affect Quality Management System 6.
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ISO 9001:2000 Standards: Automating Quality Systems
5.6.3 Stores and manages records related to:
Improvement of the Quality Management System and its processes; 1.
Improvement of product related to customer requirements; 2.
Resource needs. 3.
5.6.4 Helps ensure results of management review recorded (5.5.7)
Requirement How MasterControl helps with
6.2 HUMAN RESOURCES
6.2.1.1
6.2.2.1
6.2.2.2
6.2.2.3
6.2.2.4
6.2.2.5
Identifes competency needs and maintains training records for personnel performing activities
affecting quality.
Provides training records through email notifcation and requiring review by affected employees
and/or training personnel when documents are changed.
Training documents can be routed and signed off after review and/or completion of competency
verifcation.
Helps ensure employees are aware of the relevance and importance of their activities and how
they contribute to the achievement of quality objectives by involvement in document change and
post-approval notifcation, review, and training.
Maintains records of education, experience, training and qualifcations. (5.5.7)
Requirement How MasterControl helps with
6.4 WORK ENVIRONMENT
6.4.1
6.4.2
Maintains a suitable work environment by providing controlled access to process operating
instructions.
Requirement How MasterControl helps with
7.1 PLANNING OF REALIZATION PROCESSES
7.1.1 Stores and manages documents that include:
Quality objectives;
Resources and facilities specifc to the product;
Verifcation and validation activities and the criteria for acceptability;
Records that are necessary to provide confdence of Conformity of the processes and
resulting product.
Requirement How MasterControl helps with
7.2 CUSTOMER RELATED PROCESSES
7.2.1.1 Establishes the organizations document control system to manage customer requirements
including product requirements specifed by the customer, product requirements not specifed
by the customer but necessary for intended or specifed use, and obligations related to product,
including regulatory and legal requirements.
7.2.2.1
7.2.2.2
7.2.2.3
7.2.2.4
7.2.2.5
7.2.2.6
Provides a system for routing documents for review including review of customer requirements
and other requirements determined by the organization prior to commitment to supply a product.
Routes documents during all stages of review and approval processes.
Ensures that product change requirements are made aware to relevant personnel in the
organization.
Guarantees amendments made to relevant documentation are controlled and that the results of
review and subsequent follow-up actions recorded.
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ISO 9001:2000 Standards: Automating Quality Systems
7.2.3.1 Stores and manages communications relating to:
Product information;
Inquiries, contract or order handling, including amendments;
Customer feedback, including customer complaints.
Requirement How MasterControl helps with
7.3 DESIGN AND/OR DEVELOPMENT
7.3.1.1
7.3.1.2
7.3.1.3
7.3.1.4
Provides a system for managing and controlling the organizations design and / or development
of product.
Defnes the organizations interfaces between different groups involved in design and / or
development through routing and approval.
Stores and Update documents relating to design and / or development planning as the design and
/ or development progresses.
7.3.2.1
7.3.2.2
7.3.2.3
Provides a process for defning, documenting and reviewing design and/or development input for
adequacy.
Offers a review process that ensures all incomplete, ambiguous or conficting requirements
identifed during review and resolved.
7.3.3.1
7.3.3.2
7.3.3.3
Provides a system for managing document design output in a manner that enables verifcation
against the design and / or development inputs.
Ensures all design and / or development output documents are approved prior to release.
7.3.4.3 Provides a system for managing and storing records of reviews of design and / or development.
(5.5.7)
7.3.5.1
7.3.5.2
Stores and manage documents related to design and / or development verifcation.
Provides a system for storing records of the results of verifcation and subsequent follow-up
actions. (5.5.7)
7.3.6.1
7.3.6.2
7.3.6.3
Store and manages documents related to design and / or development validation.
Helps store manage records of validation and subsequent follow-up actions. (5.5.7)
7.3.7.1
7.3.7.2
7.3.7.3
7.3.7.4
Establishes a system to identify, document and control design changes.
Ensures that the effect of changes are evaluated on constituent parts and delivered products.
Guarantees that all design and / or development changes are verifed and validated, as
appropriate and approved before implementation.
Stores records of the results of review of changes and subsequent follow-up actions. (5.5.7)
NOTE: MasterContol can be used manage the Engineering Change process from electronic
redlining to fnal approval. Ask MasterControl for the Engineering Change White Paper.
Requirement How MasterControl helps with
7.4 PURCHASING
7.4.1.1
7.4.1.2
7.4.1.4
7.4.1.5
Provides a system for controlling purchasing processes to ensure purchased product conforms to
requirements.
Maintains procedures and records of supplier evaluation and periodic evaluation of suppliers.
(5.5.7)
7.4.2.1
7.4.2.2
7.4.2.3
Stores what the organization has defned as a purchasing document.
Performs a review of purchasing documents to ensure the adequacy of specifed requirements
prior to their release.
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ISO 9001:2000 Standards: Automating Quality Systems
Requirement How MasterControl helps with
7.5 PRODUCTION AND SERVICE OPERATIONS
7.5.1.1 Provides documentation on how the organization controls production and service operations by
making information available including work instructions.
7.5.5.1 Stores and manages documents relating to production and service processes that require
validation.
NOTE: MasterControl and MasterControl Collaboration can be used to manage validation
reports by providing controlled access to related documents.
Requirement How MasterControl helps with
7.6 CONTROL OF MEASURING AND MONITORING DEVICES
7.6.1
7.6.2
7.6.3
Stores and manages documents relating to the calibration including calibration records.
NOTE: MasterControl can be used to track calibration status of measuring and monitoring
devices including expiration date with email notifcation prior to expiration and at expiration.
Requirement How MasterControl helps with
8.1 MEASUREMENT, ANALYSIS AND IMPROVEMENT PLANNING
8.1.1
8.1.2
Stores and manages documents relating to measurement and monitoring activities.
8.2.1.1
8.2.1.2
Stores and manages documents relating to customer satisfaction and/or dissatisfaction.
8.2.2.1 Stores and manages documents relating to internal audits.
8.2.2.4 Allows internal audit plans are reviewed at periodic intervals.
8.2.2.5 Ensures the internal audit process has been effectively implemented and maintained.
8.2.2.6 Ensures management takes timely corrective action on defciencies found during the audit.
8.2.2.7 Helps to ensure follow-up actions are part of the audit process including verifcation of the
implementation of corrective action and reporting of verifcation results.
NOTE: MasterControl and MasterControl Forms can be used to manage Internal Audit reports
from initial fnding, to assignment, to verifcation and closure.
8.2.4.1
8.2.4.2
8.2.4.3
8.2.4.4
8.2.4.5
Helps store and manage documents relating to verifcation of product.
Stores records of the measurement and monitoring of product including the authority responsible
for release of the product. (5.5.7).
Requirement How MasterControl helps with
8.3 CONTROL OF NON-CONFORMITY
8.3.1
8.3.2
8.3.3
8.3.4
8.3.5
Stores and manages documents involved in the control of nonconformity.
Helps store records relating to nonconforming product, re-verifcation, corrective actions,
concessions, and customer reports.
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ISO 9001:2000 Standards: Automating Quality Systems
Requirement How MasterControl helps with
8.4 ANALYSIS OF DATA
8.4.1
8.4.2
8.4.3
Helps store records related to appropriate data to determine the suitability and effectiveness of
the Quality Management System and Identifes improvements that can be made including data
from:
Customer satisfaction and/or dissatisfaction;
Conformance to customer requirements;
Characteristics of process, product and their trends;
Suppliers.
Requirement How MasterControl helps with
8.5 IMPROVEMENT
8.5.1.1
8.5.1.2
8.5.1.3
Stores and manages documents related to continual improvement of the Quality Management
System.
Facilitates continual improvement of the Quality Management System by routing and review of:
Quality Policy
Quality Objectives
Audit Results
Analysis of Data
Corrective & Preventive Action
Management Review
Helps store records of continual improvement with involvement of top management.
8.5.2.1 Stores and Manages documents related to corrective action.
8.5.3.1 Manages and stores documents related to preventive action.
NOTE: MasterControl CAPA can be used to manage the Corrective Action and Preventive
Action process from initial fnding, to assignment, to verifcation, closure and complete reporting
and trending. (Ask MasterControl for the white paper on automating CAPA processes.)


















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About MasterControl Inc.
MasterControl produces software solutions that enable regulated companies to get their products to market faster,
while reducing overall costs and increasing internal effciency. MasterControl securely manages a companys critical
information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate
and easy to use. MasterControl QMS and QEM solutions include quality management, document management/document
control, product lifecycle management, audit management, training management, bill of materials, supplier management,
submissions management, and more. Supported by a comprehensive array of services based on industry best practices,
MasterControl provides our customers with a complete information management solution across the entire enterprise. For
more information about MasterControl, visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.); +44 (0) 1256 325
949 (Europe); or +81 (03) 6801 6147 (Japan).
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