Document No. Rev.

Date
ROWLAND PLASTICS QUALITY MANUAL QM-01 A 9/29/16
Owner: President

ISO 9001 QUALITY MANAGEMENT SYSTEM MANUAL

Rowland Plastics
9395 Henry Court
Zeeland, MI 49464

I hereby approve the Quality Management System (QMS) described in this Quality Manual (QM), in
support of our Quality Policy and Quality Objectives. I am committed to the ongoing development,
implementation, and continual improvement of our Quality Management System.

APPROVED BY: Tim Rowland

REVISION: A

DATE ISSUED: 9/28/16

(c) [Copyright 2016] [Rowland Plastics]; all rights reserved. This document may contain proprietary information and may only be released
to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject
to update notification.

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Table of Contents

Section Title

Quality Management Systems - Requirements

0 Revision History and Approvals
1 Scope
2 Normative References
3 Terms and Definitions

4 Context of the Organization

4.1 Understanding the Organization and Its Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System
4.4 Quality Management System and Its Processes

5 Leadership
5.1 Leadership and Commitment
5.2 Policy
5.3 Organizational Roles, Responsibilities, and Authorities

6 Quality Management System Monitoring, Measurement, Analysis, and Improvement

6.1 Actions to Address Risks and Opportunities
6.2 Quality Objectives and Planning to Achieve Them
6.3 Planning of Changes
6.4 Improvement
6.5 Management Review

7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information

8 Operation
8.1 Operations Planning and Control
8.2 Requirements for Products and Services
8.3 Design and Development of Products and Services
8.4 Control of Externally Provided Processes, Products and Services
8.5 Production and Service Provision
8.6 Release of Products and Services
8.7 Control of Nonconforming Outputs
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Table of Contents (continued)

Section Title

9 Performance Evaluation
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.2 Internal Audit
9.3 Management Review

10 Improvement
10.1 General
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement

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0. Revision History and Approval

Date of Revision Section Nature of Revision Revision

Revision Level Revised Approved by
9/28/16 A N/A Initial Issue T. Rowland

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1.0 Welcome to Rowland Plastics

Rowland Plastics is a provider of custom plastic injection molding to various industries.

1.1. A strategic decision has been made by senior management to establish a Quality Management System
based on ISO 9001:2015, with the aim to support consistent quality management performance
outcome, and to provide a sound basis for sustainable processes within our Company. The potential
benefits to our Company from implementing a Quality Management System based on ISO 9001:2015
are:

1.2. The ability to consistently provide products and services that meet or exceed our current and future
customer needs and applicable statutory and regulatory requirements;
a) facilitating opportunities to enhance customer satisfaction;
b) addressing risks and opportunities associated with our organizational context and objectives;
c) the ability to demonstrate conformity to all relevant Quality Management System requirements.

1.3. The policies established in this Quality Manual and its scope and purpose are written to conform to
the international ISO 9001:2015 standard as a working document that describes, as a minimum, the
Quality Management System to be deployed and at all time maintained at Rowland Plastics.

1.4. Rowland Plastics promotes the adoption of a process approach when developing, implementing and
improving the effectiveness of the Quality Management System, in order to ensure to enhance
customer satisfaction by meeting customer requirements.

1.5. Management of QMS processes as a whole will be achieved using the PDCA cycle with overall focus on
risk-based thinking, aiming to take advantage of opportunities and preventing undesirable results.

1.6. PDCA Closed Loop Cycle can be briefly described as follows:

a) Plan: Establish the Quality Objectives of the Quality Management System and its processes, and
plan the resources needed to deliver results in accordance with customers' requirements and
company’s policies, and also identify and address all business risks and opportunities.
b) Do: Implement what was planned
c) Check: Monitor and (where applicable) measure the QMS processes and the resulting products
and services against QMS policies, objectives, requirements and planned activities, and report the
results;
d) Act: Close the loop and take actions to improve our QMS performance, as necessary.

1.7. This PDCA application of the process approach in our Quality Management System enables us to:
a) understand and stay consistent in meeting customer requirements;
b) consider QMS processes in terms of added value;
c) achieve effective process performance;
d) improve QMS processes based on evaluation of data and information.
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1.8. Risk Based Thinking

a) Rowland Plastics applies the concept of risk-based thinking, as extension of the task known as
carrying out preventive action to eliminate potential nonconformities by analyzing any
nonconformities that do occur, and taking action to prevent recurrence. Risk-based thinking is
essential for achieving effective Quality Management System application, as the planning and
implementation of actions to address risks and opportunities increases the effectiveness of the
Quality Management System, supporting the prevention of negative effects, while leveraging
opportunities that can arise as a result of a risk mitigation situations favorable to achieving an
intended result within the context of the QMS.

2. Normative References
The following documents are normatively referenced in this document. Only edited content in its latest edition
applies including any amendments.

ISO 9000:2015, Quality Management Systems — Fundamentals and vocabulary

3. Terms and Definitions

For the purpose of this Quality Manual, the terms and definitions given in ISO 9000:2015 apply to this document.

4. Context of the Organization

4.1. Rowland Plastics has reviewed and analyzed key aspects of itself and its stakeholders to determine the
strategic direction of the company.

4.2. The Organizational Context involves:

a) Understanding our core products and services, and scope of management system (see 4.4 below).
b) Identifying “interested parties” (stakeholders) who receive our products, or who may be impacted
by them, or those parties who may otherwise have a significant interest in our company. These
parties are identified in the document QF-411 List of Interested Parties.
c) Understanding internal and external issues that are of concern to Rowland Plastics and its interested
parties; also identified in the document QF-410 SWOT Analysis. Many such issues are identified
through an analysis of risks facing either Rowland Plastics or the interested parties. Such issues are
monitored and updated as appropriate, and discussed as part of management reviews. Control of
the Context of the Organization is detailed in procedure QP-410 Content of the Organization.

This information is then used by senior management to determine the company’s strategic direction. This is
defined in records of management review, and periodically updated as conditions and situations change.

4.3. Scope of the Quality Management System

4.3.1 Scope Determination: Our Senior management determines the boundaries and applicability of our
Quality Management System to establish its scope by considering:
a) the external and internal issues referred to in clause 4.1 of the ISO 9001:2015 standard

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b) the requirements of relevant interested parties referred to in clause 4.2 of the ISO 9001:2015
standard
c) to establish consistency in the quality of the applicable products and services of our Company.
d) to enhance customer satisfaction through effective application of the QMS
e) all statutory, regulatory and/or legal requirements
f) establishment of suitable processes for improvement of the QMS
4.3.2 Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration
of its products and services, Rowland Plastics has determined the scope of the management system
as follows:

Custom injection molding of plastic parts

4.3.3 The scope of the Quality Management System and the understanding of our core products and
services must be also at all time based on our strategic business planning concept outlined within
the document.

4.3.4 Facilities Within the Scope

The quality system applies to all processes, activities and employees within the company. The
facility is located at:
9395 Henry Court
Zeeland, MI 49464
Phone: (616) 875-5400
www.rowlandmold.com

4.3.5 Permissible Exclusions

The following clauses of ISO 9001 were determined to be not applicable to Rowland Plastics:
 8.3 Design and Development – products are designed by customers

4.4 QMS Process Management: Rowland Plastics has established, implemented, is maintaining and continually
improving the Quality Management System, including the processes needed and their interactions, in
accordance with the requirements of the ISO 9001:2015 standard. The processes needed for the Quality
Management System have been determined and include business activities and their application
throughout the Company.

4.4.1 Process Identification

Rowland Plastics has adopted a process approach for its management system. By identifying the
top-level processes within the company, and then managing each of these discretely, this reduces
the potential for nonconforming products discovered during final processes or after delivery.
Instead, nonconformities and risks are identified in real time, by actions taken within each of the
top-level processes.

Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been
elevated to a higher level of control and management oversight. The controls indicated herein are applicable only to the
top-level processes identified.

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The following top-level processes have been identified for Rowland Plastics:

 Sales
 Manufacturing (Injection Molding)
 Purchasing
Each process may be supported by other activities, such as tasks or sub-processes. Monitoring and
control of top level processes ensures effective implementation and control of all subordinate
tasks or sub-processes.

Each top-level process has a Turtle Diagram document which defines:

 applicable inputs and outputs

 process owner(s)
 applicable responsibilities and authorities
 applicable risks and opportunities
 critical and supporting resources
 criteria and methods employed to ensure the effectiveness of the process
 Quality Objectives related to that process
The sequence of interaction of these processes is illustrated in Appendix A.
Note: Appendix A represents the typical sequence of processes, and may be altered depending on customer or regulatory
requirements at the job or contract level, as needed.

4.4.2 Process Controls & Objectives

Each process has at least one objective established for it; this is a statement of the intent of the
process. Each objective is then supported by at least one “metric” or key performance indicator
(KPI) which is then measured to determine the process’ ability to meet the quality objective.

Note: some processes have multiple objectives and multiple metrics. This is determined by the nature of the process, it’s
impact on products, and associated risks.
Note: Whereas ISO 9001 discusses process measurements and “Quality Objectives” as separate concepts, Rowland
Plastics combines them; i.e., Quality Objectives are used to control the processes. Additional objectives for products may
be assigned, but these will also be used to measure process effectiveness.

Throughout the year, metrics data is measured and gathered by process owners or other assigned
managers, in order to present the data to the management team. The data is then analyzed by the
management team in order that the management team may set goals and make adjustments for
the purposes of long-term continual improvement.
The specific Quality Objectives for each process are defined in the applicable Turtle Diagram.

Metrics, along with current standings and goals for each objective, are recorded in records of
management review.

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When a process does not meet a goal, or an unexpected problem is encountered with a process,
the corrective and preventive action process is implemented to research and resolve the issue. In
addition, opportunities for improvement are sought and implemented, for the identified
processes.

4.3.3. QMS Process Deployment

4.3.3.1 To establish QMS processes, Rowland Plastics has created and maintains the Turtle
Diagrams that provide the following:

a. determine the inputs required and the outputs expected from each process

b. determine the sequence and interaction of our QMS processes

c. determine and apply the criteria and methods (including monitoring, measurements
and related performance indicators) needed to ensure the effective operation and
control of each process

d. determine the resources needed for each process and ensure their availability

e. assign the responsibilities and authorities for each process

f. address the risks and opportunities for each process as determined in accordance with
the requirements of clause 6.1 of the ISO 9001:2015 standard

g. evaluate each process on effectivity on a regular basis and implement any changes
needed to ensure that these processes achieve their intended results, and

h. try to constantly improve all processes and the Quality Management System.

4.3.3.2 Rowland Plastics will maintain documented information to support the operation of all
QMS processes within the Turtle Diagrams to gain confidence that all QMS processes
including its businesses activities are being carried out as planned.

5. Leadership Responsibility

5.1. Quality Commitments: Rowland Plastics’ management must be committed at all time to developing and
maintaining an efficient and effective Quality Management System with focus on the following quality
management principles.

5.1.1. Customer Focus: Our customers determine the expectations, standards and requirements. Our
senior management must strive at all time to understand, meet & exceed all of our existing
customer requirements, inclusive focus on predicted future customer expectations. Our
customers determine the expectations, standards and requirements of our QMS. Rowland Plastics
strives to understand, meet and exceed these requirements. This requires us to apply continuous
customer satisfaction research and measurement. This balanced approach between satisfying
current and future customer needs and managing needs of all interested parties must include also

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tracking of internal customer’s satisfaction. (Regular internal customer surveys, employee training
feedback, etc.)

5.1.1.2 Customers are defined as:

a) External Customers as product and service end users.
b) Internal Customers which are all people in our organization.
c) The public that can be affected by our product and services.

5.1.1.3 Expectations include:

a) Product Safety & Product Liability
b) Availability of Products and Services
c) Packaging, Delivery and Shipping
d) Conformity

5.1.1.4 Standards shall include:

a) Customer established written requirements (If provided)
b) Government or Industry specifications (If provided)
c) Regulatory specifications (If provided)

5.1.1.5 Requirements shall include:

a) Key product and service characteristics
b) Internal product and process specifications
c) Internal process procedures
d) Purchase material and service specifications
e) Key supplier selection

5.1.2. Leadership: Senior management establishes the quality management vision, goals, measurable
objectives and quality related direction for the QMS. At all times the needs of all the applicable
interested parties are considered. Management must apply “Risk Based Thinking” when planning
QMS activities and lead by example and involve all employees proactively in reaching quality goals
and objectives. Management provides freedom to act with responsibility and accountability.
Company leaders encourage and recognize people contributions.

5.1.3. People Engagement: Quality is seen as the responsibility of all employees and must be intrinsic in
the products and services provided, as we can only achieve our vision, goals and measurable QMS
objectives by including all employees. Employees must be competent and experience a blend of
job satisfaction, organizational commitment, job involvement and feelings of empowerment, in
order to deliver value. This shall include a well communicated perception of job importance, clarity
of job expectation, regular feedback and dialog with supervisors and the active participation of
employees in generating improvement opportunities.

5.1.4. Process Approach: Senior management must at all time recognize, identify, understand,
document and manage processes that determine final outcome of the quality management
related activities. Senior management must ensure that at all time customer requirements and

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other requirements (Statutory/regulatory/industry requirements) are built in the QMS processes.

We identify these as input – process – output and connect these as a series of interrelated
processes. All employees must be trained and understand the QMS core process map, which must
be defined within an ongoing continuous PDCA process loop.

5.1.5. Continuous Improvement: Continuous improvement is the core of the Quality Policy. All
employees must be trained in the Quality Policy, and in the methods and tools of improvement
management. Management must make the commitment to improve efficiency and effectiveness
of the products and processes as QMS performance objective, with the aim to improve the entire
Company.

5.1.6. Evidence Based Approach to Decision-Making: Management must make effective and efficient
decisions based on evidence rich data and information and is at all time responsible for collecting
evidence by performing observations, measurements, tests, or by using any other suitable
methods to produce data or information that is sufficiently accurate and reliable. QMS related
data and information should include determination, measurement and monitoring of key
indicators to manage the performance of all processes.

5.1.7. Relationship Management: Management must see all external and internal interested parties as
“suppliers” to the Company as integral important part of meeting our customer needs and
expectations. Improving the internal and external “supplier” performance benefits our customers
and the Company. Management must at all time establish relationships that balance short-term
considerations with long term focus; including pooling of expertise and resources with partners,
identification and selection of key suppliers and creating open dialog with all our stakeholders for
improvement purposes and to communicate shared achievements.

5.1.8. Rowland Plastics has established a Quality Policy that provides an overall framework for
establishing specific Quality Objectives, and provides direction for the goal of continual
improvement and is determined by the following factors:

a) Senior management shall assure that the quality policy is appropriate to Rowland Plastics

b) The Quality Policy shall provide a commitment for product and services to meet the highest
quality standards.

c) Continuous improvement is the core of Rowland Plastics Quality Policy.

d) Review of the Quality Policy will form part of the Quality Management Reviews.

e) The Quality Policy must be communicated to all employees within Rowland Plastics

5.1.9. Rowland Plastics Quality Policy:

“Rowland Plastics will consistently provide products and services that meet or exceed the
requirements and expectations of our customers. We will actively pursue quality improvements
through programs that enable each employee to do their job right the first time and every time.”

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5.1.10. Quality Policy Deployment: The Quality Policy is deployed by senior management establishing,
implementing and maintaining well connected quality plans, standard operating procedures and
training plans to execute on quality improvement.

5.2. Roles & Responsibilities: Senior Management is overall responsible for effective deployment,
communication and improvement of all matters regarding our QMS, which can be managed by one or
more Managers who report directly to the President.

5.2.1. The Molding Manager, Office Manager, and President form the senior management staff. They
are the key personnel jointly responsible for achieving product and service quality, compliant to
the quality system processes and the operating guidelines within this manual.

5.2.2. The management team is jointly responsible for:

a) Supporting the Quality Policy of Continuous Improvement.

b) Creation, implementation and review of quality plans and Quality Objectives.

c) Initiation of corrective action to prevent product, service or any other operational non-
conformance within our QMS processes.

d) Identification and recording of product, service or systemic quality problems.

e) Initiation, recommendation and development of risk mitigating preventive measures and

solutions.

f) Verification of such preventive measures and solutions.

g) Control of further processing and delivery of non-conforming product until appropriate

corrective action of the deficiency.

5.2.3. Personnel who are in charge of inspection, review and testing of products and servicing are
responsible for:

a) Identifying and segregating any non-conforming products,

b) Monitoring the production and servicing process on a scheduled basis, and

c) Maintaining manufacturing and inspection plans for all significant process characteristics and
parameters (where appropriate).

5.2.4 QMS Management Representative

a) The Office Manager is designated by the company as the management representative for the
quality system.
b) Although senior management is responsible for ensuring that the necessary processes needed
for the Quality Management System are established, implemented, and maintained, the Office

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Manager has the authority and responsibility to ensure that the daily operation of the quality
system is maintained in compliance with ISO 9001 requirements.
c) The Office Manager is responsible on a daily basis for reporting to senior management on any
deviation to this compliance and the performance of the Quality Management System and any
needed necessary improvements.
d) Senior management is responsible for ensuring the promotion of awareness of customer
requirements throughout Rowland Plastics, while the Office Manager is supporting this task
on a daily basis.

6. Planning

6.1. Risks and Opportunities Management

6.1.1. Quality planning must focus on effectively meeting Quality Objectives and customer and legal
requirements, as well as try to mitigate all potential operational risks, which includes product risk,
service risk, but also all other operational risk, based on the context of the organization. Rowland
Plastics considers risks and opportunities when taking actions within the Quality Management
System, as well as when implementing or improving the Quality Management System; likewise,
these risk considerations have to be updated within the regular management reviews.

6.1.2. All operational risks and opportunities are managed in accordance with procedure QP-610 Risk
Assessment and based on results from risk assessments performed and evaluated in QF-610 Risk
Assessment Worksheet.

6.1.3. The Contingency Plan, form QF-611 identifies risk and provide mitigation or back-up plans based
upon the risk assessments.

6.2 Quality Objectives and Planning

6.2.1 Senior Management is responsible for quality planning throughout our Company. Inputs of the
Quality planning must include:
a) Organization strategies
b) Organization QMS objectives
c) Customer and Regulatory requirements
d) Product and service performance data
e) Risk and Opportunities mitigation strategies
f) Process performance data
g) Lessons learned, Knowledge and Change management
h) Quality Management Review

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Outputs Needs of Quality planning shall include:

i) Process improvement plans
j) Necessary skills, resources and knowledge capture
k) Performance metrics
l) Documentation

6.2.2 Quality Objectives, Key Performance Indicators

a) Senior Management determines the Quality Objectives. These objectives must meet the
Quality Policy. The Quality Objectives must be at all time established, implemented and
maintained as goals to be achieved at relevant functions and levels within the
Company/organization.

b) Senior Management ensures that also QMS objectives are established:

c) Quality Objectives must at all time be defined and documented.
d) Quality Objectives will be periodically reviewed on a schedule basis during management
review meetings.
e) QMS objectives will be specific, measurable, applicable, reliable and defined within a
scheduled achievement time/date.
f) QMS objectives will be tracked.
g) Improvement actions to achieve the Quality Objectives will be implemented based on results
of measurements.
6.2.3 The Quality Objectives can include but are not limited to:
a) Customer Satisfaction
b) Process Performance
c) Product Performance
d) On Time Delivery
e) Supplier Performance
f) Overall QMS Performance

6.2.4 Quality Objectives are identified within QF-630 Quality Objectives. The Quality Objectives are
reviewed by management and approved by the President.

6.2.5 The specific Quality Objectives for each process are defined in the applicable process activities of
each core process, and further described in the Turtle Diagrams. Metrics, along with current
standings and goals for each quality objective, are recorded in records of management reviews.
When a process does not meet a goal, or an unexpected problem is encountered within a QMS
core process, the corrective action process is implemented to research and resolve the issue. In
addition, opportunities for improvement are sought and implemented, for the identified
processes.
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6.3. QMS Change Management

6.3.1. When the Company determines the need for changes to the Quality Management System and its
processes, these changes must be at all times planned, implemented, and then verified for
effectiveness; according to the QF-641 Change Request Form. QMS documents are changed also
in accordance with the Change Request Form.

7. Support

7.1. Resource Management

7.1.1. Senior management determines and provides the resources necessary to implement, maintain
and improve the quality management system, including both internal requirements and resources
required from external sources.

7.1.2. Senior management determines and provides resources needed to implement and maintain the
Quality Management System. Resource allocation is done with consideration of the capability and
constraints on existing internal resources, as well as needs related to supplier expectations.
Resources and resource allocation are assessed during management reviews.

7.1.2.1 Resources include:

a) People
b) Facilities
c) Suppliers and supplies
d) Infrastructure
e) Work environment
f) Operational Knowledge capture
g) Natural resources
h) Equipment

7.1.2.2 Senior Management shall at all time ensure the availability of resources. This includes but
are not limited to:
a) Adequate staffing
b) Adequate equipment
c) Adequate facilities
d) Adequate tooling
e) Adequate supplies

Note: the management system does not include other aspects of Human Resources management, such as payroll, benefits, insurance,
labor relations or disciplinary actions.

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7.1.3. Infrastructure: Rowland Plastics determines, analyzes, provides and maintains the infrastructure
to maintain and continuously improve this quality system and ensure that customer requirements
are met. This includes the following:
a) Targeted plans for new equipment or new services
b) Product specific requirements
c) Scheduled Preventive Maintenance of equipment
d) Supplier scores\initial and continual supplier performance evaluations

7.1.4. Work Environment: Rowland Plastics determines, analyses, provides and maintains the work
environment to maintain and continuously improve this quality system and ensure that customer
requirements are met. This includes the following:
a) Safety training
b) Statutory and regulatory environmental training (as needed)
c) Feedback from employees
d) Environmental controls needed, such as lighting, heat, humidity, noise

Human factors are considered to the extent that they directly impact on the quality of products.

Note: Social, psychological and safety aspects of the work environment are managed through activities outside of the
scope of the management system. Only work environment aspects which can directly affect process efficiency or product
and service quality are managed through the management system.

7.1.5 Monitoring and Measuring of Resources

7.1.5.1 Rowland Plastics determines and provides the resources needed to ensure valid and
reliable results when monitoring or measuring is used to verify the conformity of
products and services to requirements.
Rowland Plastics ensures that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being
undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
Rowland Plastics retains appropriate documented information as evidence of fitness for purpose
of the monitoring and measurement resources.
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to
be an essential part of providing confidence in the validity of measurement results,
measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement
standards; when no such standards exist, the basis used for calibration or verification
shall be retained as documented information. A master list of calibrated equipment is
maintained on form QF-715 Calibration Control Log.

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b) identified in order to determine their status;

c) safeguarded from adjustments, damage or deterioration that would invalidate the
calibration status and subsequent measurement results.
Rowland Plastics determines if the validity of previous measurement results has been
adversely affected when measuring equipment is found to be unfit for its intended
purpose, and shall take appropriate action as necessary.

7.1.6 Organizational Knowledge

Rowland Plastics determines the knowledge necessary for the operation of its processes and to
achieve conformity of products and services. This may include knowledge and information
obtained from:

a) internal sources, such as lessons learned, feedback from subject matter experts, and/or
intellectual property;
b) external sources such as standards, academia, conferences, and/or information gathered from
customers or suppliers.
This knowledge shall be maintained, and made available to the extent necessary.

When addressing changing needs and trends, Rowland Plastics considers its current knowledge
and determine how to acquire or access the necessary additional knowledge.

7.2 Competency and Training

Senior management ensures that it provides sufficient staffing for the effective operation of the
management system, as well its identified processes.

Staff members performing work affecting product quality are competent on the basis of appropriate
education, training, skills and experience, as defined on Job Descriptions. The Skills Matrix, form QF-720
defines these activities in detail.

7.2.1. Rowland Plastics shall determine the required competence for personnel performing work
affecting product and service quality. Consideration will be given to:

a) Future demands

b) Cross training

c) Audit results

d) Statutory and regulatory requirements

e) Promotion of importance of awareness for potential failure of non-active participation within

our QMS processes

7.2.2. Rowland Plastics shall provide training or take other action to satisfy these needs. The objective is
to provide people with skills, knowledge and experience that will improve their competence.
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7.2.3. Rowland Plastics shall evaluate the effectiveness of the actions/training taken.

7.2.4. Rowland Plastics shall ensure its personnel are aware of the relevance and importance of their
activities and how they contribute to the quality objectives.

7.2.5. Records of education, training, skills and experience will be maintained.

7.3 Personnel Awareness

7.3.1 Rowland Plastics shall select personnel based on appropriate education, training, skills and
experience to perform work that affects product quality.

7.3.2 Rowland Plastics encourages the involvement and development of its people by:

a) Ongoing training (Training Record, QF-720.01)

b) Establishing responsibilities and authorities

c) Involving them in objective setting and decision making

d) Operator certification (Employee Competency Certification, form QF-720.02)

e) Establishing Training needs (Job Descriptions, Skills Matrix)

7.4 Management of Communication

7.4.1 Senior Management ensures that appropriate communication systems are established within the
organization.

7.4.2 Senior Management must define and implement an effective and efficient communication of our
quality management system matters.

7.4.3 Communication parameters of the quality management system include:

a) Quality Policy and promotion of Risk Based Thinking
b) QMS Objectives and request for detailed support
c) Results of objective measurements
d) Ongoing improvement projects
e) All QMS Requirements
f) Convey the importance of our applicable Standards
g) All employee accountability for the QMS and Accomplishments

7.4.4 Senior management must also be at all time committed to communicating and meeting all internal
and external customer requirements as well as statutory and regulatory requirements by:

a) Continuous training of employees on QMS compliance

b) Detailed documentation of customer and legal requirements

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c) Understanding external customer needs and expectations and transferring this information to
employees through pertinent disclosure

d) Encouraging all employees to contribute to Risk Based Thinking on all operational processes
during regular meetings

e) Understanding and communicating internal customer needs and expectations and

transferring this information into documented activities to satisfy these needs

f) Encouraging employees to strive for continuous improvement of customer satisfaction

7.4.5. Methods of communication include:

a) Schedule quality reviews

b) Meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS

c) Performance Boards
d) use of corrective and preventive action processes to report nonconformities or suggestions
for improvement
e) use of the results of analysis of data
f) use of the results of the internal audit process
g) regular company meetings with all employees
h) internal emails
i) memos to employees
j) President’s “open door” policy which allows any employee access to President for discussions
on improving the quality system

7.5. Management of Documented Information

7.5.1. Documented and controlled information comprising the QMS includes:

a) Documented statements of the Quality Policy and Quality Objectives.
b) The documented Scope of the QMS and justification of any exclusions.
c) This Quality Manual.
d) Documented procedures relevant to the QMS.
e) All documented information needed to ensure the effective planning, operation and control
of the internal and external QMS processes.
f) Records required by ISO 9001 as being documented information needed to be retained by
Rowland Plastics for the purpose of providing evidence of result achieved

7.5.2. Controlled documented information of Quality Planning can include:

a) Product, Equipment and Process Control documentation
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b) Procedures
c) Quality System Documentation
d) Quality Records in hardcopy or any kind of electronic format
e) Documents containing QMS relevant internal communications
f) Any other kind of Test and Inspection Plan, Quality Plan, Risk Plan, Quality Manual, Strategic
Plan, Records, or Forms.

7.5.3. Control of Documented Information

7.5.3.1 Rowland Plastics ensures that all QMS controlled documents are under change and
revision control and are maintained on QF-753 Master Documents List. All other
documented information necessary to manage the QMS must be kept accessible and
preserved at all time during day to day work. Records are controlled per section 7.5.4.
Rowland Plastics has established a documented procedure QP-753 Control of Documents
which defines the controls in place to:
a) Approve documents for adequacy prior to use.
b) Review and update as necessary and re-approve documents
c) Ensure that changes and the current revision of documents is identified.
d) Ensure that relevant versions of documents are available at point of use.
e) Ensure that controlled documents remain legible and readily identifiable.
f) Ensure that documents of external origin and their internal distribution are identifiable and
controlled by our QMS within documented filing.
g) Prevent unintended use of obsolete documents and apply suitable identification to them if
they are retained for any purpose.

7.5.4. Control of Records

a) Rowland Plastics establishes and maintains records to provide evidence of conformity to all
our legal and customer requirements and establish measurable evidence for effective
operations of our quality management system.

b) These records will at all time remain legible, easily identifiable and retrievable either in
hardcopy or electronic format. The documented procedure QP-754 Control of Records defines
the controls needed for identification, storage, protection, retrieval, retention time and
disposition of our QMS related records, which shall be (P) planned in forms, (Do) taken
regularly, (C) measured and (A) acted on the evidence based results of the records. Record
control is maintained on form QF-754 Quality Records Log.

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8. Operation

8.1 Operational Planning and Control

Rowland Plastics plans and develops the processes needed for product realization. Planning of product
realization is consistent with the requirements of the other processes of the management system. Such
planning considers the information related to the context of the organization (see section 4.0 above),
current resources and capabilities, as well as product and service requirements.

Changes to operational processes are done in accordance with form QF-641 Change Request Form.

8.2 Requirements for Products and Services

8.2.1 Customer Communication
Rowland Plastics has implemented effective communication with customers in relation to:
a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to products and services, including customer complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency actions, when relevant

8.2.2 Determining the Requirements for Products and Services

Once requirements are identified, Rowland Plastics reviews the requirements prior to its
commitment to supply the product. This review ensures that:

a) product requirements are defined,

b) contract or order requirements differing from those previously expressed are resolved,
c) the organization has the ability to meet the defined requirements, and/or the claims for the
products and services it offers, and
d) risks have been identified and considered.
These activities are documented on form QF-822 Requirements Review Form.

8.2.3 Review of the Requirements for Products and Services

During the review of new customer requirements, Rowland Plastics ensures they have the ability to
meet the customer requirements and shall review the requirements prior to committing to take the
order and also review:

a) requirements specified by the customer, including the requirements for delivery and post-
delivery activities;
b) requirements not stated by the customer but necessary for specified or intended use, where
known

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c) statutory and regulatory requirements related to the product;

d) any additional requirements determined by Rowland Plastics.
e) order requirements that differ from those supplied by the customer or previously identified
These activities are defined in form QF-822 Requirements Review Form.

8.2.4 Changes to Requirements for Products and Services

8.3. Design and Development

Rowland Plastics is not a product design-responsible supplier. Due to the nature of Rowland Plastics and
its product, Rowland Plastics is excluded from compliance to the design and development requirements
of ISO 9001, clause 8.3.

This exclusion does not affect the ability or responsibility of Rowland Plastics to provide product that
meets customer and applicable statutory/regulatory requirements.

8.4. Control of Externally Provided Processes, Products, and Services

8.4.1. Outsourcing: If Rowland Plastics decides to outsource any process that affects product and service
conformance with related requirements, Rowland Plastics shall ensure control over such
processes. These processes must be clearly identified within the QMS, to ensure that the QMS is
not adversely affected. Processes, products, and services includes:
a) Products and services from external sources that are intended for use into Rowland Plastics’
own products and services

b) Products and services provided directly to the customer by an external source on behalf of
Rowland Plastics

c) A process or part of a process is provided by an external source as a result of a decision by

Rowland Plastics

Rowland Plastics determines the criteria for the evaluation, selection, monitoring of performance,
and re-evaluation of external providers based on the criticality of the product/service and their
ability to provide processes, products, or service that meet requirements. Procedure QP-841
Control of Externally Provided Processes, Products, and Services defines the controls in place for
approvals and monitoring of vendors. Vendors approvals are documented on form QF-841.01
Vendor Evaluation Report.

8.4.2 Type and Extent of Control

Rowland Plastics ensures that externally provided processes, products and services are controlled
to the aspect that they do not adversely affect the ability to consistently deliver conforming
products and services to customer requirements. Rowland Plastics will:

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a) Ensure that externally provided processes remain within the control of the QMS
b) Define the controls that it will apply to an external provider and those it intends to apply to
the resulting product or service
c) Take into consideration:
1) The potential impact of the externally provided processes, products and services on the
ability to consistently meet customer and any applicable statutory and regulatory
requirements
2) The effectiveness of the controls applied by the external provider
d) Determine the verification or other activities necessary to ensure that the externally provided
processes, products and services meet requirements

8.4.3. Information for External Providers

a) The purchasing person shall ensure that all supplies and services procured from suppliers
conform to specified requirements.

a) The type and extent of control is dependent upon the effect of the purchased product on the
subsequent product realization or the final product, considering all potential risk factors
involved with suppliers.

b) The company shall select suppliers on the basis of their ability to meet and exceed
requirements within initial documented supplier evaluation analysis, following annual supplier
performance evaluation.

c) A controlled list of approved critical material suppliers is maintained on form QF-841

Approved Vendors List. Critical is defined as material that has been deemed to affect product
quality.
d) Records of the results of the evaluations and any necessary actions arising from the evaluation
are maintained on the Vendor Performance Worksheet.
8.4.4. Purchasing Information

All company purchase orders shall contain data clearly describing the product ordered and where
appropriate, the following information:
a) The type, class, style, grade, quality code or other precise identification.
b) The title, document number, and revision level of all relevant technical data or standards.
c) The title number and issue of any quality system standard to be applied.
d) All requirements for approval of the purchased item
e) All requirements for qualification of personnel
f) Quality management system requirements
g) Rowland Plastics shall ensure the purchase requirements are adequate and correct prior to
placing the order with the supplier.

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8.4.5. Verification of Purchase Products & Services

Rowland Plastics has established and implemented inspection procedures with acceptance criteria
for purchase products and services to assure product and services meets purchase requirements.
This includes the following:
a) Acquisition of objective evidence of the quality of the product or service from subcontractors
(e.g., accompanying documentation, certificate of conformity, test reports, statistical records,
process control)
b) Inspection and audit at the source. If inspection is required at source, the verification
arrangements and product and service release information will form part of the purchase
order.
c) Review of the required documentation
d) Inspection of products and service at delivery points

8.5. Production and Service Provision

8.5.1. Control of Production and Service

Rowland Plastics management plans and carries out production and service under controlled
conditions within planned control points. This includes but is not limited to:
a) Availability of specifications and information that describe the characteristics of the product
and process requirements, including Work Orders and customer drawings
b) Availability of procedures and work instructions for all manufacturing processes and
inspections covering all operational relevant risks
c) The use of suitable equipment including its maintenance and repairs.
d) The availability of monitoring and measuring devices
e) The implementation of measurement and monitoring at control points
f) The implementation of release, delivery and post-delivery activities
g) Product or critical materials liable to deterioration shall be identified and assessed or tested
at defined intervals. Critical materials with limited shelf life shall be identified on receipt to
stock or stores at the time it is produced. Final stocked product subject to deterioration shall
be identified, and inspected in accordance with the Work Order.

h) Rowland Plastics will validate any process change where the resulting output cannot be
verified by subsequent monitoring or measurement. This includes any process where
deficiencies become known only after the product has been delivered.

i) Validation will demonstrate the ability of these processes to achieved planned results.
Rowland Plastics has established validation processes for appropriate applications using the
following:
1) Defined criteria for review and approval of the process

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2) Approval of equipment, process and qualification of personnel

3) Use of specific methods and procedures
4) Requirements for records
5) Revalidation

8.5.2. Identification and Traceability

All products, including raw material shall be identified with a part number, lot number, or move
order number. All final product shall be traceable to all raw material sources for the purposes of
investigation. This traceability is documented from receiving to final product and defined in
appropriate procedures. According to the level of traceability required by contract, regulatory, or
other established requirement, the quality system shall provide for the following:
a) identification to be maintained throughout the product and service life
b) all the products manufactured from the same batch of raw material or from the same
manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products
of the same batch
c) for a given product, a sequential record of its production to be retrieved
d) identification of the product or service status with regards to monitoring and measurement
requirement
e) Maintaining the identification of the configuration - via the lot traveler of the product - in
order to identify any differences between the actual configuration and the agreed
configuration
f) Incoming defect products or services must be at all time placed in quarantine areas, to avoid
infusion into our conforming product and services and must be processed under formulized
quality control.
g) Adequate bins, containers, pallets, trays, or bags shall be used to move production in-house
under safety and operational risk considerations.
h) Cleaning, Prevention, detection and removal of foreign objects

8.5.3. Property Belonging to Customers or External Providers: Rowland Plastics shall exercise care with
customer or external provider’s property while it is under Rowland Plastics’ control or being used
by Rowland Plastics. Rowland Plastics shall identify, verify, protect and safeguard customer or
external provider’s property provided for use or incorporation into the product. If any customer
or external provider’s property is lost, damaged or otherwise found unsuitable for use, it shall be
reported to the customer or external provider and records maintained.

8.5.4. Preservation

All product, at whatever stage of production or delivery shall be handled in a manner such as to
prevent damage or deterioration to the product. The proper handling method will be documented
in the appropriate Work Order.

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The use and configuration of packaging and labeling material shall be defined in the Work Order
or in accordance with customer requirements. The Work Order covers the specific requirements
for:
a) Special handling for sensitive products
b) Marking and labeling including safety warnings
c) Shelf-life control and stock rotation
d) Hazardous materials
e) Where applicable, product specifications must always be under regulations
f) Shipping documentation shall exist to identify product, customer and destination.
g) Product shipped from stock shall be processed to a “First In- First Out” policy.
h) The company shall ensure that the accompanying documents for the product are present at
delivery as specified in the contract/order and are protected against loss and deterioration.

8.5.5 Post-Delivery Activities

8.5.5.1 As applicable, Rowland Plastics conducts the following activities which are
considered “post-delivery activities”:
 No post-delivery activities

8.5.5.2 In determining the extent of post-delivery activities, Rowland Plastics considers:

a) Statutory and regulatory requirements
b) Any potential undesired consequences associated with products and services
c) Nature, use and intended lifetime of products and services
d) Customer requirements
e) Customer feedback

Note: Post-delivery activities can include installation, warranty activities, maintenance services, or other services such as
recycling or disposal of product.

8.5.6 Control of Changes

Rowland Plastics reviews and controls both planned and unplanned changes to processes to the
extent necessary to ensure continuing conformity with all requirements. Process change
management is defined in the document QF-641 Change Request.

8.6. Release of Products and Services

Rowland Plastics ensures release of product to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority
and, where applicable, by the customer. Product and service activities are verified at various stages to
ensure all requirements have been met.

Records shall be maintained to enable identification of the individual releasing the product.

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8.7. Control of Nonconforming Output

8.7.1. Rowland Plastics ensures that product and services that does not meet requirements are identified
and controlled to prevent use or delivery of the product or service. Nonconforming product is
documented on form QF-870 Corrective/Preventive Action Request and control of the
nonconforming product/service process is identified in procedure QP-870 Nonconforming
Product.

8.7.2. All nonconforming material is reviewed by the Molding Manager. Review and disposition
guidelines are defined in procedure QP-870 Nonconforming Product.

8.7.3. The nonconforming material review is established to provide a means for evaluating discrepant
material and initiating corrective action. The review can be performed by the Molding Manager,
Office Manager, or the President. The disposition decision authority performed on final
manufactured product rests solely with the Molding Manager or designated representative within
the Quality department. Only the President can override this decision.

8.7.4. Nonconforming product reviews are conducted to determine the status of non-conforming
material which may include: Rework, Use-As-Is, Regraded, Scrapped, or Return to Vendor.

8.7.5. A description of nonconforming product or lots and its condition shall be recorded on the CPAR
form.

8.7.6. The Nonconforming product decision shall be recorded on the CPAR and the material processed
accordingly.

8.7.7. Established procedures shall take into account process nonconformity that may result in product
or service nonconformity. Parties requiring notification of nonconforming product may include
subcontractors, internal organizations, customers, distributors and regulatory authorities

8.7.8. The company shall not use dispositions of use-as-is or repair, unless specifically authorized by the
customer, if (1) the product or service is produced to customer design, or (2) the nonconformity
results in a departure from the contract requirements. Unless otherwise restricted in the contract,
company-designed product or service which is controlled via a customer specification may be
dispositioned by the company as use-as-is or repair, provided the nonconformity does not result
in departure from customer-specified requirement.

8.7.9. Product dispositioned for regrade requires a change in product identification to preclude the
product’s original use. Adequate test reports and certifications shall reflect the regrading. The
same process must be applied for servicing programs.

8.7.10. Product and services that have been reworked shall be subject to re-verification to demonstrate
conformity to requirements.

8.7.11. When nonconforming product, services or processes are detected after delivery or use has started,
the organization shall take action appropriate to the effects or potential effects of the
nonconformity. The nonconformity is documented on the CPAR form and the customer may need
to be notified.
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9. QMS Performance Evaluation

9.1.1 Monitoring, Measurement, Analysis, and Evaluation: Rowland Plastics determines:

a) what information or processes need to be monitored or measured

b) what methods will be used to ensure valid results
c) when monitoring and measuring will be performed and when the results will be analyzed and
evaluated
The performance of the Quality Management System will be evaluated and records maintained on form
QF-911 Process Measurement Chart.

9.1.2 Monitoring and Measurement of Customer Satisfaction

Rowland Plastics shall monitor information relating to customer perception as to whether the
organization has met customer satisfaction. Our Customer Satisfaction System includes methods for
obtaining and using this information. Methods include:
a) Internal and External Customer complaints
b) Delivery data
c) Growth data
d) Customer feedback through analysis of internal customer contact and customer feedback

Customer Satisfaction results and analysis are documented on the Data Analysis Reports and the Quality
Score Card and discussed during Management Review Meetings.

9.1.3 Rowland Plastics realizes that measurement data is important for making evidence-based decisions.
To ensure Rowland Plastics performance and customer satisfaction, effective and efficient
measurement, collection and validation of data is necessary. Examples of process performance
measurables include:
a) Conformity of products, services and processes
b) Customer Satisfaction
c) Performance and effectiveness of the Quality Management System
d) Planning effectiveness
e) Effectiveness of actions taken to address risks and opportunities
f) Performance of external providers
g) Need for improvements to the Quality Management System

A broad range of data is collected and acted upon. This measurement data is converted to information
and knowledge that benefits Rowland Plastics. Data collection and analysis is documented on the Data
Analysis Reports and reviewed with the management.

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9.2. Internal Audit

9.2.1. Internal Audits, performed as identified in procedure QP-920 Internal Audits, are conducted at
planned intervals to determine whether the quality management system conforms and is
effectively implemented and maintained to:
a) Planned arrangements
b) Requirements of the ISO 9001:2015 standard
c) Requirements established by this Quality Manual

9.2.2. The audit program is planned under the focus and purpose of finding opportunities for
improvement in all QMS areas, based on process improvement, not “People” improvement, and
shall take into consideration the status, importance, and previous audits of processes and areas
by creating appropriate sampling plans for targeted process audit areas.

9.2.3. The audit program defines the following:

a) Criteria
b) Scope
c) Frequency
d) Methods
e) Responsibilities
f) Planning
g) Reporting results
h) Maintaining records

9.2.4. The Management responsible for the audited area shall ensure actions are taken to eliminate
deficiencies with undue delay. Follow up activities shall include verification of the actions and
reporting of verification results.

9.3. Management Review

9.3.1 Senior Management reviews the quality management system every year to ensure its suitability,
adequacy, effectiveness and alignment with Rowland Plastics’ strategic direction. The review will
include review of the quality objectives, quality policy, and necessary changes and improvement
to the quality management system.

9.3.2. The Management Review shall be planned and documented on form QF-930 Management
Review Template. These reviews must include these inputs but not limited to:
a) Results from previous QMS management review meetings and follow up actions
b) Changes in external and internal issues that are relevant to the QMS
c) Information on the performance and effectiveness of the QMS, including trends in:
1) Customer satisfaction and feedback from interested parties
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2) Extent to which Quality Objectives have been met

3) Process performance and conformity of products and services
4) Nonconformities and corrective action
5) Monitoring and measurement results
6) Audit results
7) Performance of external providers
d) Adequacy of resources
e) Effectiveness of actions taken to address risks and opportunities
f) Opportunities for improvement

9.3.3. Management Review Outputs: The output from the quality management review shall include any
decisions and actions made by our senior management related to:
a) Opportunities for improvement
b) Any need for changes to the QMS
c) Resource needs
Records from quality management reviews are maintained on form QF-930 Management Review
Template.

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10. QMS Improvement

10.1. QMS Improvement Plan: Rather than waiting for problems to reveal opportunities for improvement,
Rowland Plastics management continually seeks to improve the effectiveness and efficiency of the
processes. Rowland Plastics has a process in place to identify and manage improvement activities. This
process is partially based of results from the following:
a) Quality Policy implementation
b) Quality Objectives
c) Audit results
d) Analysis of data
e) Corrective actions
f) Risk and opportunity considerations
g) Preventive actions
h) Management Review

There is also opportunity to document continual improvement activities on form QF-1010 Continual
Improvement Project Log or on form QF-870 CPAR to identify QMS improvement activities.

10.2. Nonconformity and Corrective Action

10.2.1. When a nonconformity occurs, including that from customer complaints, Rowland Plastics:
a) Reacts to the nonconformity and performs the following actions:
1) Takes action to control and correct the nonconformity
2) Deals with any consequences arising from the nonconformity
b) Evaluates the need for action to eliminate the cause of the nonconformity to prevent
recurrence by:
1) Reviewing and analyzing the nonconformity
2) Determining the root cause of the nonconformity
3) Determining if similar nonconformities exist or could occur
c) Implement any action needed
d) Review the effectiveness of any corrective action taken
e) Update risks and opportunities determined during planning, if needed
f) Make changes to the Quality Management System, if needed
Determination of the need for corrective action is determined by management, based on the
effect of the nonconformity.
10.2.2 The Corrective Action process is identified and controlled in accordance with procedure QP-
1020 Corrective and Preventive Action and Nonconformances and Corrective Actions are
documented on form QF-870 Corrective/Preventive Action Request (CPAR).
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10.3 Continual Improvement

Rowland Plastics continually improves the suitability, adequacy and effectiveness of the QMS by
reviewing the results of data analysis, process evaluations, internal audit results, corrective and
preventive action, and management review meetings.

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Appendix A: Overall Process Sequence & Interaction

Quality Management System (4)

Resources
Plant, Facility and Equipment
Environment
Monitoring and Measuring Resources
Measuring Devices
Organizational Knowledge CUSTOMERS
Competency and Awareness REQUIREMENTS
Communication
Document Control
Operational Planning
Requirements for Products
Control of External Processes/Product Change Management
Production and Service
Content of the Product Release
Organization (4) Control of Nonconformances
Customer
Satisfaction

Support (7)
Results of the QMS
Operation (8)
Products and
Services

Risk Assessment Performance Monitoring, measuring, analysis

Quality Objectives Planning (6) Leadership (5) Internal Audit
Planning of Changes Evaluation (9) Management Review

Improvement
(10)

Improvement
Nonconformity and
Needs and Corrective Actions
expectations of Continual Improvement
interested parties
(4)

NOTE: Numbers in parenthesis refer to clauses in ISO 9001:2015

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