QUALITY MANUAL with new times-1

Uncontrolled Copy if RAJ PHARMACEUTICAL INC. Logo NOT in BLUE
Issued By: QMR Approved By: CEO
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ISSUED BY
QUALITY MANAGEMENT REPRESNETATIVE
AUTHORIZED BY
RAJ PHARMACEUTICAL INC. MANAGEMENT

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TABLE OF CONENTS
Clause Description Page
QM 1.0 OVERVIEW AND SCOPE 03
QM 1.1 Overview 03
QM 1.2 Manual Distribution Record 03
QM 1.3 Manual Revision 03
QM 1.4 Scope 03
QM 1.5 Exclusion and Justifications 04
QM 2.0 REFERENCE 04
QM 3.0 TERMS AND DEFINITIONS 05
QM 4.0 QUALITY MANAGEMENT SYSTEM 05
QM 4.1 General Requirements 05
QM 4.2 Documentation Requirements 06
QM 4.3 Quality System Process Interactions 07
QM 5.0 MANAGEMENT RESPONSIBILITY 08
QM 5.1 Management Commitment 08
QM 5.2 Customer Focus 08
QM 5.3 Quality Policy 08
QM 5.4 Planning 09
QM 5.5 Organizational Chart 10
QM 5.6 Management Review 11
QM 6.0 RESOURCE MANAGEMENT 12
QM 6.1 General Requirements 12
QM 6.2 Human Resources 13
QM 6.3 Infrastructure 14
QM 6.4 Work Environment 14
QM 7.0 PRODUCT REALIZATION 15
QM 7.1 Planning Product Realization 15
QM 7.2 Customer-Related Process 15
QM 7.4 Purchasing 17
QM 7.5 Production Operation 18
QM 7.6 Control of Monitoring and Measuring Equipment 19
QM 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 21
QM 8.1 General 21
QM 8.2 Monitoring and Measurement 21
QM 8.3 Control of Nonconforming Product 22
QM 8.4 Analysis of Data 23
QM 8.5 Improvement 23

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QM 1.0 OVERVIEW AND SCOPE
QM 1.1- Overview:
This Quality Manual is a level 1 document that establishes the quality policies, and practices of
RAJ PHARMACEUTICAL INC. and its management to support a Quality Management System
based on the requirements of ISO 9001:2008
QM 1.2- Manual Distribution Record:
The master copy of this Quality Manual is saved on Quality Manager’s computer. Only one copy
has been printed and kept in Document center for reference.
Uncontrolled copies may be allowed for training employees and creating organization-wide
awareness of ISO 9001:2008 and also for customer reference.
QM 1.3- Manual Revision:
Revision Level: 00, Effective April 17 2014
This Quality Manual has been rewritten to conform to ISO 9001:2008; This Manual supersedes all
documents becomes effective as on date 17 April 2014
QM 1.4- Scope:
Company: RAJ PHARMACEUTICAL INC.
Business: Chemotherapeutics Drug Manufacturing
Client: Multinational Pharmaceutical Company, Hospitals, Pharmacy stores.
Address: 7 Copper Bays, Calgary, Alberta L6T 4W5, Canada
Phone No: - 647-763-2727
Fax No: - 647-713-1729

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A QMS enables a company to implement effective, efficient, transparent and simple processes and
structures to achieve continual compliance. In addition, this will benefit the company’s business
in terms of improved quality, optimized costs, inspection readiness and customer satisfaction. This
document gives detailed guidance for implementing a QMS. It provides a standard for API (Active
Pharmaceutical Ingredients) manufacturers and other parties involved, including official bodies.
QM 1.5- Exclusion and Justification(s):
The QMR has identified exclusion, from the scope of the quality system, to the requirements of
ISO 9001:2008, that do not apply to products and services provided by RPI. RPI Management
Team has evaluated and approved them.
a) Section 7.3 Designand Development – including all sub- sections-
Justifications RPI does not design or develop products. The customers or their consultants
provide and specify all principal product’s drawings, samples, etc.
b) Section 7.5.2 Validation of process for production and service provision- including
all sub-sections-
Justifications RPI verifies all subsequent monitoring or measurements for each successive
process output.
QM 2.0- REFERENCE
RAJ PHARMACEUTICAL INC has developed and implemented a Quality Management System
in accordance with-
ISO 10013:2001- Guidelines for Quality Management System Documentation
ISO 9000:2005- Quality Management System- Fundamentals and Vocabulary
ISO 9001: 2008- Quality Management System-Requirements
GMP- Good Manufacturing Practices.

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QM 3.0- TERMS AND DIFINITIONS
Terms and definitions adopted in this Manual are in accordance with those of ISO 9000:2005, ISO
9001:2008 and GMP (Good Manufacturing Practice ).
RAJ PHARMACEUTICAL INC specific terms and abbreviations:
Term For
CAR Corrective Action Request
C of C Certificate of Conformance
MT Management Team/ Company Management
PAR Preventive Action Report
PO Purchase Order
PM Preventive Maintenance
QM Quality Manual
QMR Quality Management Representative
QMS Quality Management System
QSP Quality System Procedure
RFQ Request for Quotation
WI Work Instruction
R.P.I Raj Pharmaceutical Inc.
GMP Good Manufacturing Practice
HVAC Heating Ventilation Air Conditioning
SOP Standard Operating Procedure
QM 4.0-QUALITY MANAGEMENT SYSTEM
QM 4.1- General Requirements:
Requirements
RPI has established documented, implemented, and maintains and continually improves a quality
management system in accordance with the requirements of ISO 9001:2008. The organization has-
 Identified the process needed for the QMS and their application throughout the
organization
 Determines the sequence and interaction of these processes
 Determines criteria and methods needed to ensure that both the operation and control of
these processes are effective

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 Ensured the availability of resources and information necessary to support the operation
and control of these processes
 Established a means of monitoring, measuring and analyzing these processes. Where
applicable
 Established the implementation of action necessary to achieve planned results and
continual improvement of these processes
RPI has monitored and controlled to the best of its ability, outsourced products also.
QM 4.2- Documentation Requirements:
General
RPI’s QMS documentation includes documented statements of a quality policy and quality
objectives, a quality manual, documented procedures and records required by ISO 9001:2008,
including records determined by the organization to be necessary to ensure the effective planning,
operation and control of processes.
Quality Manual
RPI’s Quality Manual includes:
 The scope of the QMS, including applicable exclusions and justifications
 The documented procedures established for the QMS or reference to them
 Description of the interaction between the processes of the QMS
 Organizational chart
Control of Documents
RPI has a procedure for establishing, maintain, and controlling all documentation required to
support the QMS and ensure its continued effectiveness.
Control of Records
RPI controls the records established to provide evidence of conformity to requirements and the
effective operation of the QMS. RPI has a procedure QSP-02(4.2.4)for controlling quality records
to ensure that they are:
 Identified and stored safely
 Legible and readily retrievable and have established retention times

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QM 4.3-Quality SystemProcess Interaction:
Customer
RFQ/PO
(QM 7.0)
Contract Review
(QM 7.2)
Planning Production
Realization
(QM 7.1)
Product Inspection
(QM 7.1)
Handling
Packaging
Shipping
(QM 7.5)
Delivery to
Customer
(QM 7.5)
Customer
Supplied Product
(QM 7.5)
Equipment
Calibration
(QM 7.6)
Quality Management System
Management Responsibility (QM 5.0)
Quality System (QM 4.0)
Document Control (QSP 01)
Nonconforming Product (QSP 04)
Corrective Action (QSP 05)
Control of Records (QSP 02)
Internal Quality Audit (QSP 03)
Training (QM 6.2)
)
Customer Satisfaction (QM 7.2)
Continual Improvement (QM 8.5)
Preventive Action (QSP 06)

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QM 5.0-MANAGEMENT RESPONSIBILITY
QM 5.1- Management Commitment:
General
RPI is committed to the development and implementation of the QMS and continual improvement
of the quality system by:
 Communicating the importance of meeting customer, statutory and regulatory
requirements throughout the organization.
 Established and documenting the quality policy and quality objectives as described in the
management review procedure.
 Conducting management reviews as described in the Management Review, Ensuring the
availability of necessary resources. This compromise in Management review form RQF
01
QM 5.2- Customer Focus:
General
RPI is committed towards identifying customer requirements and their fulfillment to ensure
customer satisfaction.
QM 5.3- Quality Policy:
General
The Quality policy provides a framework for establishing and reviewing quality objectives. The
following Quality Policy is communicated throughout the organization. The Quality Policy is
reviewed during management reviews to ensure its continuing suitability and effectiveness.
“RPI is committed to achieve and provide high quality precision products that are machined to
close tolerances for Hi-Tech pharmaceutical industry by continually improving its quality system
and processes in order to meet and exceed ever-changing customer requirements and enhancing
the satisfaction of customers and employees by delivering best Quality of Drug products.”

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QM 5.4- Quality Planning:
Quality Objectives
RPI has established Quality Objectives, particularly those concerning product requirements.
Quality Objectives are measurable and consistent with the Quality Policy.
QMS Planning
RPI has developed its QMS with the following priorities in mind:
 The requirements given in QMS 4.1 and those mentioned in Quality Objectives are
satisfied
 Any plans for changes will consider their impact on the QMS, and will ensure the integrity
of the QMS is maintained
QM 5.5- Responsibility, Authority, and Communication:
Responsibility and Authority
Job descriptions for all personnel in accordance with the RPI are prepared by Administration
affairs manager cooperating with other managers and after being approved by managing director,
job descriptions are submitted to all personnel in all organizational levels. Administration affairs
manager has ensured that responsibilities and authorities are defined in all organizational levels
and are available for all personnel.

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RPI’s Organizational Chart:

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Management Representative
RPI management has appointed Quality Manager as its Quality Management Representative. Who,
irrespective of other responsibilities, has responsibilities that include:
 Ensuring that process of the quality system are established, implemented and maintained
 Reporting to top management on the performance of the quality system, including any
needs for improvement.
 Ensuring promotion of awareness of customer requirements throughout the organization
 Acting as liaison with external parties on matters relating to the quality system.
The person named below has full responsibility and authority for the implementation and
maintenance of Quality Management System as defined in this Quality Manual and promoting the
awareness of customer requirements throughout the organization.
RONAK PATEL
QUALITY MANAGER (ASQ-CQE)
M/s RAJ PHARMACEUTICAL INC.
Phone : 647-763-2727
Internal Communication
RPI recognizes that all employees and their work activities affect product quality and RPI’s ability
to satisfy customer requirements. Information communication and transfer methods are different
according to the type of information and it includes using computer systems, designed quality
system documents and conducting internal meetings at different organizational levels. The type of
these communicating methods is defined in quality management system.
QM 5.6- Management Review:
RPI management reviews the organization’s QMS, at least once in a year, to ensure its continuing
suitability, adequacy and effectiveness. This review includes assessing opportunities for
improvement and the need for changes to the QMS, including the quality policy and quality
objectives.
The QMR chairs the Management Review meetings and records are maintained on form RQF 01

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Review Input
Inputs to management review include but are not limited to current performance and improvement
opportunities related to the following:
 Audit results
 Customer feedback
 Process performance and product conformity
 Preventive and corrective action reports
 Follow up actions from previous management reviews
 Changes that may affect QMS
 Recommendations for improvement
 Quality policy and objectives
 Supplier information
 Resource requirements
Review Output
The outputs from the management review include but are not limited to decisions and actions
related to:
 Improvement of the effectiveness of the QMS and its processes
 Improvement of product related to customer requirements
 Resource needs
Results of management reviews are recorded.
QM 6.0- RESOURCCE MANAGEMENT
QM 6.1-General Requirements:
Requirements
Top management of RPI 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.

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These resources are assessed and reviewed on a periodic basis consistent with annual and strategic
business planning activities.
QM 6.2- Human Resources:
General
RPI ensures that personnel who are assigned responsibilities directly or indirectly affecting
conformity to product (Quality) requirements are determined to be qualified and competent based
on education, training, observed skills, and experience .
Competence, Awareness and Training
RPI 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 on the
appropriate education, training, observed skills, and experience, as required. All Tablets and
Capsules manufacturing machine operators must be evaluated as fully competent in a discipline of
manufacturing of drug product before being allowed to work independently in that discipline.
A training plan is prepared and scheduled annually with periodic updates. This comprise of training
skills in form RQF 02
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.
Personnel in all levels shall be aware of:
 Quality policy
 Quality management system requirements
 The importance of conformance with customer requirements, regulatory bodies,
organization commercial partners and organizational requirements
 How they contribute to the achievement of the quality objectives
 The impact of their work in quality
 The potential consequences of departure from the specified procedures
The signatures of employees on a quality document are sufficient as evidence of relevant training.

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QM 6.3- Infrastructure:
Requirements
RPI’s infrastructure needed to achieve conformity to product requirements has been determined
and provided and maintained according to the repairs and maintenance procedure. These
infrastructures may include, but not be limited to:
 Buildings, workspace and associated utilities (such as cleanrooms, HVAC system, water
systems, etc)
 Process equipment, (including production and laboratory equipment, reference standards
used for calibration, the software used to production and laboratory , etc)
 Supporting services (such as computers, computer networks, lift trucks, etc)
QM 6.4-Work Environment:
Requirements
RPI’s Work environmental conditions at different working areas including temperature, humidity,
differential pressure, other relevant parameters and also safety relevant issues that affect product
quality (such as personnel clothes, entering into and exiting from cleanrooms, etc) have been
determined in production and laboratory environments according to the regulatory requirements
related to the products as follows:
 Requirements related to health, cleanliness and clothing of personnel if contact between
such personnel and the product or work environment could adversely affect the quality of
the products.
 Requirements of environment conditions when these conditions can have an adverse effect
on product quality.
 Providing special trainings for all personnel who are required to work temporarily under
special environmental conditions.
 Special arrangements for the control of cross contamination
All above requirements have been established in production SOPs and test methods.

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QM 7.0- PRODUCT REALIZATION
QM 7.1-Planning Product Realization:
RPI has established and maintains a documented Product Realization Planning Procedure to ensure
that processes and sub-processes are conducted under controlled conditions. The processes needed
for product realization are planned and developed, and the interaction between these processes and
other processes of the quality management system is also defined. In planning product realization,
the following has been taken into consideration:
 Determination of required documents, sub-processes and resources needed to realize
these processes
 Verification, inspection and test activities of row materials, packaging material, semi-
finished and finished products and their conformance to products acceptance criteria
 Records needed to provide evidence that the realization processes and resulting product
meet requirements
QM 7.2 –Customer-Related Processes:
Determination of Requirements Related to the Product
RPI determines requirements related to the product have been determined by the organization,
including:
Requirements related to the product have been determined by the organization, including:
 Requirements specified by customers (distribution companies), including the
requirements for products type and quantity and delivery time
 Requirements not stated by the customer but necessary for intended use of the products
such as requirements for packaging and information accompanying product
 Regulatory requirements related to the product including the requirement stated in
pharmacopeias or determined by Ministry of Health
 Organizational requirements and requirements stated by commercial partners

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Review of Requirements Related to the Product
Requirements related to the product are reviewed. This review is conducted prior to committing to
supply a product to customers. These reviews are conducted annually by sales manager according
to received information from production planning, marketing and statistics about sales
Quantity in a year, production lines capacity and other constraints. Review output is reported to
Ministry of Health by managing director. The intent of these reviews is to ensure that:
 Product requirements (including requirements related to delivery and post-delivery
activities) are defined
 Records of the results of review and actions arising from this review are maintained
 When product requirements are changed, relevant documents are amended and the
relevant personnel are made aware of the changed requirements.
Customer Communication
Required arrangements for communication with customers relating to the followings are
determined and implemented:
 Product information according to the customer communication procedure
 Enquiries, contracts or order handling, according to the sales procedure
 Customer feedback, according to the customer communication procedure and when
receiving complaints from customer according to the complaints follow-up procedure and
when product recall is necessary, this process will be handled according to the product
recall procedure
RPI encourages its customer to send their enquiry in writing. The necessary information from
the written enquiries is transferred to Contract Review form RQF 18. In case of verbal
enquiries the information is confirmed by repeated statement and recorded onto form RQF
24. For assembly orders, the necessary information is transferred onto Assembly Contract
review from RQF 18
In case of customer’s verbal or telephonic proposal for modification in specifications/
requirements, formal approval is initiated using form RQF 24
QM 7.3-Designand Development:
Out of scope and excluded

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QM 7.4- Purchasing:
Purchasing Process
RPI ensures that purchasing processes are controlled to ensure purchased product conforms to
specified purchase requirements. This control is applied to purchased items, goods, equipment and
services that affect product quality, 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.
RPI has established and maintain local records of acceptable suppliers. A critical supplier list also
maintained.
Purchasing Information
RPI requires purchasing information describes the product to be purchased, including where
appropriate:
 Requirements for approval of product, procedures, processes and equipment,
 requirements for qualification of personnel, and
 Quality management system requirements.
Purchasing information adequacy is reviewed prior to stating the specified requirements to contain
in the purchasing documents. Purchasing information including relevant documents and records
are maintained in order to provide product traceability.
Verification of Purchased Product
RPI identifies and implements inspection and testing activities are performed according to Quality
Assurance department on raw materials and packaging to ensure that purchased products meet
specified requirements. For other items and equipment which affect the quality, inspection and
testing activities are performed.
Where verification of purchased product is intended at suppliers’ premises, verification includes
comparing products with specified specifications via testing and inspection at supplier’s premises
or supervision on testing process and examining results and measuring equipment accuracy.

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QM 7.5 – Production Operations:
Controls of production provision
RPI ensures that products production process is planned. Production and material planning is
performed by using Manufacturing Report form RQF 04 and the production tracking sheet form
RQF 12
The following activities are carried out by RPI to control production process:
 The availability of documented procedures (to describe production processes and
equipment usage), documented requirements, work instructions, reference materials and
reference measurement procedures
 The use of suitable equipment according to the world latest technologies
 The availability and use of monitoring and measuring devices (such as balances,
thermometers and humidity meters)
 The implementation of monitoring and measurement by control laboratories at different
stages of production process such as raw materials, semi-finished products and final
products
 The implementation of release, delivery, and post-delivery activities
 The implementation of defined operations for labeling an packaging
RPI establishes and maintains a record for each batch of its products (batch record) to provide
traceability and identify amount manufactured and amount approved for distribution. Batch record
is verified and approved by quality assurance manager.
Identification and Traceability
RPI’s all products of are identified according to identification and traceability procedure form RQF
12 the primary stages of production to packaging. Recalled products are also identified according
to product recall procedure and conforming products are segregated from the non-conforming
ones. The records of all product components (including test results), materials and work
environment conditions are considered in batch record to demonstrate the tractability.
Products status is identified with respect to monitoring and measurement requirements by sticking
labels defined in quality control procedures

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Customer Property
RPI takes care of all customer-supplied materials and/or products under its control. RPI identifies,
verifies, and protects customer property provided for use or incorporation into the product.
Receipts of customer supplied samples/parts are recorded in the Customer Material Log form RQF
13 and stored safely.
Customer supplied products / materials are identified by the Receiver appropriately and handled
carefully. Customer supplied drawings are stored in separate folders of concerned jobs with
identification by unique drawing/ part numbers. Copies of these drawings are made for production
and inspections. Normally, the Office Coordinator handles the drawings but any member of the
Management Team or the Quality Manager can also handle the drawings if the office coordinator
is not present.
Any nonconformity or damage to the customer property is brought to the attention of any member
of Management Team who then advises the customer of the situation. The decision about
disposition is taken after discussion with customer.
Preservation of Product
Preservation includes identification, handling, packaging, storage and protection. Preservation is
also applied to the constituent parts of a product. Handling and preservation of products throughout
internal processing is performed according to production procedures. Packaging of products is
carried out according to packaging procedures. Storage of products is carried out according to
storage procedure.
QM 7.6 – Control of Monitoring and Measuring Equipment:
RPI ensures the accuracy and the validity of product characteristics by using controlled monitoring
and measuring equipment calibrated periodically to master traceable to recognized standards. In
the event of non-availability of such standard, the basis used for calibration or verification and
criteria for acceptable schedule is maintained on form RQF 16

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All measuring and monitoring devices in RPI are:
 Calibrated at specified intervals, or prior to use, against measurement standards traceable
to international or national measurement standards; where no such standards exist, the basis
used for calibration is recorded
 Adjusted or re-adjusted as necessary
 Safeguarded from adjustments that would invalidate the measurement result; and,
 Protected from damage and deterioration during handling, maintenance and storage
according to equipment technical instructions
 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.
The equipment is sent for calibration before the specified time when it is found not to conform to
requirements. If necessary, the parameters measured by the nonconforming device are measured
again according to calibration process. The computer software used for measurement and
monitoring are validated according to computer systems validation protocol and their ability to
meet the requirements is confirmed

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QM 8.0-MEASUREMENT, ANALYSIS, AND IMPROVEMENT
QM 8.1-General:
RPI plans and implements required processes for monitoring, measurement, analysis and
improvement in order to demonstrate product conformity, ensure quality management system
compliance and continual improvement of quality management system effectiveness. In this
regard, specific methods are defined for use of statistical techniques including control charts,
analysis using histograms, Pareto, cause and effect diagrams and other statistical tools.
QM 8.2-Monitoring and Measurement:
Customer Satisfaction
RPI Company monitors and measures information related to customers (doctors, distributing
companies and patients) perception at defined intervals as to whether the organization has met
customers’ needs and expectations according to customer communication process.
Internal Audit
Periodic internal audits are conducted at planned intervals according to internal audit procedure in
order to:
 Conforms to the requirements of the standard.
 Evaluate the effectiveness and deployment of quality management system
Audit plan is prepared with respect to the status and importance of quality management system
processes, according to internal audit procedure. This plan includes audit schedule, audit criteria,
scope and audit team. In selecting audit team members it is noted that auditors should be qualified.
Auditors should be independent from the process being audited and do not audit their own work.
The responsibilities and requirements for planning and conducting audits, audit report preparation,
records maintenance and nonconformities follow-up are described in internal audit procedure.

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Monitoring and Measurement of Processes
RPI applies suitable methods for measurement and monitoring of the realization processes
necessary to meet customer requirement. These methods confirm the continuing ability of each
process to satisfy its intended purpose. Suitable methods are determined by Quality Assurance
department and may include various quality control tests with its efficiency and effectiveness.
Monitoring and Measurement of product
RPI ensures that the characteristics of the product are monitored and measured at different stages
of production according to quality control procedures and testing instructions through physical,
chemical, microbial and biological tests to verify that product requirements are fulfilled.
Evidence of conformity with the acceptance criteria (test results) is maintained. These records
compose part of the batch record. Product release does not proceed until the batch records are
checked by quality assurance manager.
QM 8.3- Control of Nonconforming Product:
RPI ensures that nonconforming products are not used unintentionally; these products are
segregated from other products according to control of nonconforming product procedure QSP 03
(8.3).Controls, related responsibilities and authorities for dealing with nonconforming product and
disposition of these products are defined in control of nonconforming product procedure.
Nonconforming product is managed by one or more of the following methods:
 Taking action to eliminate the detected nonconformity and performing required corrections
 Authorizing its use, release or acceptance under concession where regulatory requirements
are met.
 Taking action to preclude product use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, are maintained according to control of nonconforming product procedure. When
nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to
the requirements.

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QM 8.4- Analysis of Data:
RPI ensures that determination, collection, and analysis of appropriate data to demonstrate the
suitability and effectiveness of the quality management system, and to evaluate where continual
improvement of the quality management system can be made.
This includes data generated as a result of monitoring and measurement (customer feedback,
monitoring sand measurement of processes, monitoring and measurement of product, etc) and
from other relevant sources.
The analysis of data provides information relating to:
 Customer feedback
 Conformance to product requirements
 Characteristics and trends of processes and products including opportunities for
preventive action
 Suppliers.
QM 8.5- Improvement:
Continual Improvement
RPI continually improves its quality management system efficiency through the use of quality
policy, quality objectives, audit results, analysis of data, corrective and preventive actions and
management review according to continual improvement procedure and defining improvement
projects.
Corrective Action
RPI identifies corrective actions are taken to eliminate the cause of nonconformities in order to
prevent recurrence according to corrective action procedure-QSP 05(8.5). Determining and
implementing of corrective action includes the following stages:
 Reviewing nonconformities
 Determining the causes of nonconformities
 Evaluating the need for action to ensure that nonconformities do not reoccur
 Determining and implementing action needed
 Records of the results of actions taken

QUALITY MANUAL
Model
ISO 9001:2008
Effective Date
17 April 2014
Revision Level
0
Page
24 of 24
 Reviewing corrective action taken.
Preventive Action
RPI identifies preventive actions are determined to eliminate the causes of potential
nonconformities in order to prevent occurrence according to preventive action procedure QSP
06(8.5). Determining and implementing preventive action includes the following stages:
 Determining potential nonconformities and their causes
 Evaluating the need for action to prevent occurrence of nonconformities
 Determining and implementing action needed
 Records of results of action taken; and
 Reviewing preventive action taken.

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