CA QA QM 001 - ISO 9001 2015 QMS Manual
CA QA QM 001 - ISO 9001 2015 QMS Manual
CA QA QM 001 - ISO 9001 2015 QMS Manual
Quality
Manual
ISO 9001:2015 Quality Management
System
Revision 4
April 23, 2022
Quality Manual
ISO 9001:2015 Quality Management System
APPROVAL
The signatures below certify that this management system manual has been reviewed and accepted and
demonstrates that the signatories are aware of all the requirements contained herein and are committed to
ensuring their provision.
AMENDMENT RECORD
This quality manual is reviewed to ensure its continuing relevance to the systems and process that it describes. A
record of contextual additions or omissions is given below:
17 7.1.3 & 7.1.4: Updated title “Facilities Manager” to Millwright Revision 3 08-Apr-2021
25 Table 6: Key Performance Indicators. Removal of text in third paragraph Revision 3 08-Apr-2021
COMPANY PROPRIETARY INFORMATION
The electronic version of this document is the latest revision. It is the responsibility of the individual to ensure that
any paper material is the current revision. The printed version of this manual is uncontrolled, except when provided
with a document reference number and revision in the field below:
Table of Contents
TABLE OF CONTENTS 2
1 INTRODUCTION 4
2 REFERENCES 5
3 DEFINITIONS 5
4 ABOUT OUR ORGANIZATION 5
4.1 ORGANIZATIONAL CONTEXT 5
4.2 RELEVANT INTERESTED PARTIES 6
4.3 QUALITY MANAGEMENT SYSTEM 7
4.3.1 Management System Scope 7
4.3.2 Management System Processes 7
4.3.3 Outsourced Processes 8
4.3.4 Documented Information 8
5 LEADERSHIP & GOVERNANCE 9
5.1 LEADERSHIP AND COMMITMENT 9
5.1.1 Quality Management 9
5.1.2 Customer Focus 9
5.1.3 Quality Policy 10
5.2 ROLE, RESPONSIBILITIES AND AUTHORITIES 11
5.3 COMMUNICATION 11
5.3.1 Internal Communication 11
5.3.2 External Communication 12
6 MANAGEMENT SYSTEM PLANNING 13
6.1 ADDRESSING RISKS & OPPORTUNITIES 13
6.2 QUALITY OBJECTIVES 14
6.3 PLANNING FOR CHANGE 15
7 SUPPORT 15
7.1 RESOURCES 15
7.1.1 General 15
7.1.2 People 15
7.1.3 Infrastructure 16
7.1.4 Operational Environment 17
7.1.5 Monitoring & Measurement Tools 17
7.1.6 Organizational Knowledge 17
8 PRODUCT & SERVICE DEVELOPMENT 18
8.1 OPERATIONAL PLANNING & CONTROL 18
8.2 CUSTOMER REQUIREMENTS 18
8.2.1 Customer Communication 18
8.2.2 Determining Requirements 19
8.2.3 Review of Requirements 19
8.2.4 Changes in Requirements 19
1 Introduction
Canalta Controls Ltd. is a privately owned Canadian company and has been in business since 1986. The foundation
of Canalta is based on our core principles of Quality, Service, Value and Respect. Canalta has thoroughly developed
and implemented a quality management system (QMS), using ISO 9001:2015, ABSA and PED 2014/68/EU Quality
Standards as a framework that allows our organization to document and improve our practices in order to better
satisfy the needs and expectations of our customers, stakeholders and interested parties. Any reference to the
Standard in this manual implies ISO 9001:2015 unless stated otherwise.
This manual describes the quality management system, delineates authorities, inter relationships and
responsibilities of the personnel operating within the management system. The manual also provides references
to procedures and activities that also comprise our quality management system.
The manual is used to familiarise customers and other external organizations or individuals with the controls that
have been implemented and to assure them that the integrity of our quality management system is maintained
and is focused on customer satisfaction and continual improvement.
Our quality management system meets the requirements of ISO 9001:2015 and uses the Plan, Do, Check and Act
approach to process planning. Our QMS addresses and supports our strategies for the design, development,
manufacturing, assembly, sales and service of industrial measurement and process control equipment.
www.canaltaflow.com
The official accreditation of the Quality Management System at Canalta Controls Ltd. is under the jurisdiction of
the following registrars (in alphabetical certification order):
2 References
In addition to ISO 9001:2015 we also make reference to other relevant local / international standards appropriate
to our products and market.
3 Definitions
This document does not introduce any new definitions but rather relies on the following:
Canalta Controls Ltd. then monitors and reviews this information to ensure that a continual understanding of each
group’s requirements is derived and maintained. To facilitate the understanding of our context, we regularly
consider issues that influence our context during management review meetings and are conveyed via minutes and
business planning documents.
To achieve this, Canalta Controls Ltd. has adopted the process approach advocated by ISO 9001:2015. Top
Management has determined the processes required for achieving the intended outputs. By defining our key
processes and by managing their inputs, activities, controls, outputs and interfaces; we ensure that system
effectiveness is established maintained. These processes are supported using tools such as documented
procedures, process maps, flow diagrams, matrices, schedules, and charts, etc. Refer to the Sequence & Interaction
of Processes in Appendix A.2 which shows the sequence and interaction of the processes within our management
system.
A key process outlining our Sales and Project Execution Process in its entirety is highlighted as follows:
The effectiveness of each process and its subsequent output is measured and evaluated through regular internal
audits, quality inspections and data analysis.
We use key performance indicators (KPIs) that are linked to our objectives to control and monitor our processes,
as well as assessments to determine the risks and opportunities inherent to each process. We use trends and
indicators relating to nonconformities, objectives and corrective action, as well as, monitoring and measurement
results, audit results and customer satisfaction data, process performance and the conformity of our products.
Although we recognize that ISO 9001:2015 does not require a quality manual, we have decided to retain and
update our quality manual, as our employees, customers, suppliers and other stakeholders perceive it to add value
to our operations. This document also demonstrates the relationship between our quality management system
and the sequence and interaction of our key processes. Conformance to ISO 9001 is verified utilizing a formal
assessment and review process by Quasar, A Division of the CWB Group, www.cwbgroup.org.
Supporting documentation:
Ref. Title & Description
01 CA-QA-QSP-001_Control of Documented Information
Top Management provides the leadership and governance to all activities related to the lifecycle processes
including defining the strategic direction, responsibility, authority, and communication to assure the safe and
effective performance.
Canalta’s governance structure provides necessary support for creating and establishing appropriate processes
that are important for maintaining and achieving our quality objectives and policies.
In addition, governance activities include systematic verification of the effectiveness our QMS by undertaking
internal audits and analyzing performance data.
Regular management reviews ensure that our quality management system is adequate and effective, and that any
necessary adjustments are made as a result.
Top Management is committed to implementing and developing the quality management system and this
commitment is defined by our corporate policies and objectives. Canalta Controls Ltd. ensures that our policies are
understood, implemented and maintained throughout at all levels of the organization through printed distribution
of our policy statements and through periodic management review of the policy statements and corporate level
improvement objectives. Canalta Controls Ltd. communicates our mission, vision, strategy, policies and processes
to all employees in order to:
Top Management also ensures that customer requirements are understood and met. Customer requirements are
understood, converted into internal requirements and communicated to appropriate personnel within the
organization. Customer complaints and other customer feedback are continually monitored and measured to
identify opportunities for improvement. We continually look for ways to interact directly with our customers to
ensure that we focus on their unique needs and expectations.
The Quality Manager has overall responsibility for defining, documenting, implementing and reviewing our quality
policy in consultation with the management teams and other personnel, or their representatives. The policy is
reviewed at least annually, as part of the management review program or at a frequency determined by:
1. The changing needs and expectations of relevant interested parties, Section 4.2.
2. The risks and opportunities that are presented through the risk management process, Section 6.1.
The quality policy is communicated to all employees at all levels throughout our organization via training, internal
communications and as displayed via company bulletin boards. Employee understanding of our policies and
objectives is determined during internal audits and other methods deemed appropriate.
QUALITY POLICY
Canalta is dedicated to creating a profitable business culture that is based on the following foundational principles:
QUALITY
The prerequisite requirement in gaining and maintaining Canalta customer's confidence and trust.
SERVICE
Working hard for Canalta's customers means being there when needed for support, products or services.
VALUE
Bringing forth good value by providing cost effective and timely solutions allows Canalta and all of its partners to
remain competitive.
RESPECT
Maintaining a culture of respect and honesty in all of our interactions (internal and external) is how we maintain a
business which other companies choose to deal with and our employees prefer to work for.
Additionally, Canalta Controls Ltd. hereby states that we shall not change an approved quality system significantly
until approval is granted by the assessment body. Nor shall we supply CE marked product into the EU that does
not fully satisfy compliance with the Essential Safety Requirements (ESRs) of PED 2014/68/EU.
Members of Top Management are ultimately responsible for the quality of Canalta’s products and services since
they control the resources, systems and processes by which conforming work is accomplished. Top Management
are responsible for business planning, development and the communication of our policies, quality management
system planning, the establishment and deployment of objectives, the provision of resources needed to implement
and improve the quality management system and for undertaking management reviews. Top Management has
assigned the responsibility and authority to the management teams and departments to:
All managers are responsible for execution of the business plan and the implementation of the policies, processes
and systems described in this manual. All managers are responsible for planning and controlling the management
system processes within their area of responsibility, including the establishment and deployment of operational
level objectives and the provision of resources needed to implement and improve these processes.
All employees are responsible for the quality of their work and implementation of the policies and procedures
applicable to processes they perform. Personnel responsible for product quality have the authority to stop
production to correct quality problems. Employees are motivated and empowered to identify and report any
known or potential problems and to recommend related solutions aid the corrective and preventive action process.
5.3 Communication
5.3.1 Internal Communication
Canalta Controls Ltd. communicates information internally regarding our QMS and its effectiveness, through
documented training, internal audit reports and continual improvement processes. All managers and supervisors
are responsible for establishing regular formal and informal communications as needed to convey to their
employees the relevance and importance of their activities; typically this information is conveyed through team
meetings and cross-functional improvement projects.
Communications regarding how employees contribute to the achievement of objectives are also conveyed and
reinforced during employee performance reviews. Issues pertaining to our QMS that may be communicated
internally include:
1. Day-to-day operations and general awareness;
2. Quality policy;
3. Information on achieving objectives and targets;
4. Risk and opportunities.
Top Management and their direct reports are responsible for communicating the corporate policies as well as the
importance of meeting customer, statutory and regulatory requirements to employees within their respective
departments. They ensure the quality policy is understood and applied to the daily work of the organization
through the establishment of measurable goals and objectives. Internal communication occurs on an on-going
basis and is achieved through various mechanisms as appropriate:
1. Regular meetings and briefings;
2. Training sessions and training material;
3. Display boards, memorandums, letters;
4. Website, intranet, internal e-mails;
5. Product and process performance data analysis and audit results;
6. Targets, objectives, scorecards, KPIs, management system manual and procedures;
7. Corrective action and non-conformance reports;
8. Minutes of ad-hoc and scheduled meetings.
Canalta Controls Ltd. ensures that all external communications are authorized prior to release when applicable.
Where required, advice appropriate to the context of the communication may be sought concerning the content
and dissemination of certain external communications. Responses to external communications are recorded if they
are transmitted by email or letter. In each case the response is retained and controlled in accordance with the
requirements for documented information.
The overall aim of risk and opportunity management within Canalta Plan - Create
plans to
Controls Ltd. is to ensure that organizational capabilities and address risk
resources are employed in an efficient and effective manner to take and
opportunities Do -
advantage of opportunities and to mitigate risks. . Implement
plans to
Top Management is responsible for incorporating risk based mitigate risks
or to adopt
thinking in to our organization's culture. This includes the opportunities
establishment of risk management policies and targets to ensure Risks & .
1. Strategic level;
2. Program level;
3. Department level;
4. Process level;
Establishing such a hierarchy for capturing risk and opportunity ensures that each is managed at the most
appropriate level within our organization. Typically, the following categories are assigned to each level in the
hierarchy as shown in the table below:
Supporting documentation:
Ref. Title & Description
02 CA-QA-QSP-002_Control of Risks & Opportunities
When setting objectives and targets, our organization ensures that they are consistent with the needs and
expectations of our interested parties, as defined in Section 4.2, and to our corporate policies. In addition,
technological options, financial, operational and business requirements are considered.
In order to determine whether or not our objectives and targets are being met, they are measured and reported
as a set of key performance indicators (KPI). This allows progress to be monitored as metrics are gathered and data
is analyzed. KPIs and objectives for our organization include the following aspects:
Managers of all departments are accountable for converting departmental goals into objectives as applicable to
their departments and employees. All employees are responsible for fulfillment of the quality policy and
subsequent objectives.
This document constitutes our overall plan for establishing, maintaining and improving the quality management
system. For each instance of management system planning, the output is documented and retained accordingly
and changes are conducted in a controlled manner. The management review and the internal audit processes
ensure that the integrity of the QMS is maintained when significant changes are planned which may affect key
processes.
Whenever quality management system changes are planned, Top Management ensures that all personnel are
made aware of any changes which affect their process, and that subsequent monitoring is undertaken to ensure
that QMS changes are effectively implemented.
7 Support
7.1 Resources
7.1.1 General
Resources at Canalta Controls Ltd. include human resources and specialized skills, infrastructure, technology, work
environment and financial resources. The resource requirements for the implementation, management, control
and continual improvement of the quality management system, and activities necessary to enhance customer
satisfaction, are defined in our operational procedures, processes, work instructions and as per CA-QA-QSP-
003_Control of Resources.
7.1.2 People
To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications,
experience and responsibilities that are required for each position that affects product and system conformity.
Qualifications include desired requirements for education, skills and experience. Appropriate qualifications, along
with the provision of any required training, provide the competence required for each position.
Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position
change. Human Resources maintains records of employee qualifications. If any differences between the employee’s
qualifications and the requirements for the job are found, training or other action is taken to provide the employee
with the necessary competence. The results of training are then evaluated to determine if it was effective.
All employees are made aware of the relevance and importance of their activities and how they contribute to the
achievement of our policies and objectives. The company ensures that all employees within the organization are
adequately trained to enable them to perform their assigned duties.
Staff training records are maintained to demonstrate competency and experience. Human Resources maintains
and reviews the training records to ensure completeness and to identify possible future training needs. Training
records are maintained and include as a minimum; resumes, copies of certificates for any training undertaken to
date and current job description.
7.1.2.1 Competence
Top Management identifies emerging competency needs during management reviews. Emergent competency
needs are converted into job descriptions for the type and number of positions that need to be filled through
internal or external recruitment.
Where required; competency training and monitoring is conducted in-house, although for more specialist skills,
external seminars or courses are utilized. The effectiveness of training is evaluated and recorded. The company
induction includes an introduction to our policies and objectives. Future competency training needs are identified
as part of the Management Review process.
7.1.2.2 Awareness
All employees are trained on the relevance and importance of their activities and how they contribute to the
achievement of our policies and objectives. The company ensures that all employees within the organization are
adequately trained to enable them to perform their assigned duties.
Where required; awareness training and monitoring is conducted in-house. The effectiveness of awareness training
is evaluated and recorded as part of both the competency and training evaluations. The company induction
includes an introduction to our organization’s policy statement and objectives. Future training needs are identified
as part of the management review process.
Supporting documentation:
Ref. Title & Description
03 CA-QA-QSP-003_Control of Resources
04 CA-QA-QSP-005_Control of Competence & Awareness
7.1.3 Infrastructure
Canalta Controls Ltd. is responsible for planning, providing and maintaining the resources needed to achieve
product and process conformance, including buildings, workspace and associated utilities; process equipment
(hardware and software); and supporting services (such as internal transportation and material handling systems
and communications systems). The Millwright has overall responsibility for managing our facilities and equipment
maintenance programs which include:
1. A place of work that is safe, including all equipment and methods of work;
2. Training, instruction, information and supervision for employees;
3. A means of safe handling, storage, use and transportation of equipment, materials and chemicals;
4. Safe working environment with good lighting, ventilation, safe passageways, stairs and corridors.
7.1.5 Monitoring & Measurement Tools
Canalta Controls Ltd. has determined the monitoring and measurement activities to be undertaken, and the devices
needed to provide evidence of validation to specified tolerances and measurement ranges. This procedure is
outlined in CA-QA-QSP-004_Control of Calibrated Equipment.
Supporting documentation:
Ref. Title & Description
05 CA-QA-QSP-004_Control of Calibrated Equipment
To ensure that organizational knowledge is retained and transferred, organizational knowledge is recorded in
documented information, and is embedded in our processes, products and services. Examples of organizational
knowledge include:
1. Documented information regarding a process, product or service;
2. Previous specifications and work instructions;
3. The experience of skilled people and their processes and operations;
4. Knowledge of technologies and infrastructure relevant to our organization, etc.
Sources of internal knowledge also include our intellectual property; knowledge gained from experience and
coaching; lessons learnt from failures and successes; capturing and sharing undocumented knowledge and
experience; the results of improvements in processes, products and services.
Sources of external knowledge often include other ISO standards; research papers; webinars from conferences; or
knowledge gathered from customers, stakeholders or other external parties. Canalta Controls Ltd. determines and
reviews internal and external sources of knowledge, such as:
1. Lessons learnt from non-conformities, corrective actions, and the results of improvement;
2. Gathering knowledge from customers, suppliers and partners, benchmarking against competitors;
3. Capturing knowledge existing within the organization, e.g. through mentoring/succession planning;
4. Sharing knowledge with relevant interested parties to ensure sustainability of the organization;
5. Knowledge from conferences, attending trade fairs, networking seminars, or other external events.
1. Brochures, specifications or technical data sheets relating to our products and services;
2. Enquiries, quotations and order forms, invoices and credit notes;
3. Confirmation of authorized orders and amended orders;
4. Delivery notes and certificates of conformity;
5. E-mails, letters and general correspondence;
6. When customer property is handled or controlled;
7. Customer feedback and complaints management process;
The Sales Administration team is responsible for establishing methods of communication with our customers to
ensure enquiries, contracts or order handling; including amendments, customer feedback and complaints are
handled expeditiously and professionally.
Supporting documentation:
Ref. Title & Description
06 CA-QA-QSP-006_Control of Design & Development
Supporting documentation:
Ref. Title & Description
07 CA-QA-QSP-007_Control of Purchasing & Procurement
Stored equipment and materials are identified as to type, description and inspection status;
Unacceptable items are identified as such and are removed from the normal work flow;
All enquiries are identified with a unique estimate number, allocated on receipt;
Subsequent orders are identified by contract number.
8.5.3 3rd Party Property
We identify, verify, protect and maintain customer property provided for use. The Quality Manager ensures that
lost, damaged or unsuitable customer property is recorded and immediately reported to the customer.
In cases where the customer provides drawings, specifications, etc. they are reviewed and stored in the respective
customer job file. Customer property can also include customer-owned materials, tools (including packaging),
tooling (including test/inspection tooling and equipment), and intellectual property.
8.5.4 Preservation
Canalta Controls Ltd. ensures that all products and materials are handled and stored appropriately at all stages of
the development cycle to prevent damage or deterioration:
Components and products are handled and stored in a manner that prevents damage or deterioration,
pending use or delivery;
Each department ensures controls are implemented to prevent mixing conforming and non-conforming
materials;
Packing ensures specified or original manufacturing packaging is utilized;
All products are suitably packed to prevent deterioration or damage during storage and delivery.
8.5.5 Post-Delivery Activities
Canalta Controls Ltd. determines customer requirements before acceptance of an order. Customer requirements
include the following:
Previous customer requirements which pertain to current part numbers being ordered;
Requirements not stated by the customer but necessary for specified use or intended use;
Statutory and regulatory requirements related to the product;
Requirements required for delivery and post-delivery activities such as replacement parts.
Any additional requirements determined by Canalta Controls Ltd.
8.5.6 Control of Changes
Top Management ensures the integrity of the Quality Management System is maintained when changes to the
QMS are planned and implemented. Planning for changes must involve the Top Management and include an
adequate review of the QMS requirements. Changes to the scope of the QMS may require re-certification of the
affected quality management system.
Products are not used until they are inspected or verified as conforming to requirements, except when the product
is released under positive-recall procedures pending completion of all required measurement and monitoring
activities.
When the organization uses sampling inspection as a means of product acceptance, the plan is statistically valid
and appropriate for use. The plan precludes the acceptance of lots whose samples have known nonconformities.
When required, the plan is submitted for customer approval.
Documented information is retained to indicate the person authorizing the release of the product. Product release
and service delivery does not proceed until all the planned arrangements have been satisfactorily completed,
unless otherwise approved by a relevant authority, and where applicable by the customer.
Measurement and acceptance criteria that are necessary for product acceptance are retained as documented
information; subsequent acceptance records form the production documentation evidence which includes the
following information:
Criteria for acceptance and rejection;
Locations in the process sequence where measurement and testing operations were performed;
Types of measurement instruments used, including any instructions associated with their use;
Test records showing actual test results where required by the specification or acceptance test plan.
Improvement actions are implemented to ensure the non-conformance does not reoccur. Once the non-
conforming outputs are corrected, the outputs are then verified for conformity against requirements. Documented
information concerning the nature of any non-conformances, the resolving authority, and the resulting corrective
actions is retained. Where necessary, details concerning any authorized concessions are documented as evidence
of acceptance.
Products are not released or delivered until all planned inspections and tests have been completed and that
documented information exists to provide evidence of conformity with acceptance criteria and identifying the
person(s) authorizing release.
Supporting documentation:
Ref. Title & Description
08 CA-QA-QSP-008_Control of Non-Conformity & Corrective Action
9 Performance Evaluation
9.1 Monitoring, Measurement, Analysis & Evaluation
9.1.1 General
Canalta Controls Ltd. applies suitable methods for determining which aspects of the quality management system
and its processes are to be monitored, measured and evaluated.
Data is analyzed to assess achievement of the organization’s strategic priorities and customer requirements.
Supporting documentation:
Ref. Title & Description
09 CA-QA-QSP-009_Control of Customer Satisfaction
Supporting documentation:
Ref. Title & Description
10 CA-QA-QSP-010_Control of Internal Audits
Conformance is primarily assured through internal audits and demonstrated through a review of both internal and
external audit results and our demonstrated ability to detect, correct and to prevent problems.
The primary outputs of management reviews are the decisions and actions necessary to make changes or
improvements to our quality management system and the provision of resources needed for implementation.
Responsibilities for required actions are assigned to the management team. Any decisions made during the review,
assigned actions and their due dates are recorded in the management review.
Supporting documentation:
Ref. Title & Description
11 CA-QA-QSP-011_Control of Management Reviews
10 Improvement
10.1 General
In order to determine and select opportunities for improvement or to implement any necessary actions to meet
the requirements of customers and relevant interested parties, or to enhance customer satisfaction, Canalta
Controls Ltd. drives improvement via the analysis of relevant data. The data inputs for the improvement process
include:
The overall effectiveness of continual improvement program (including corrective actions taken as well as the
overall progress towards achieving corporate level improvement objectives) is assessed through our management
review process.
The Quality Manager, who has responsibility and authority for implementing corrective actions, is notified promptly
of product or process non-conformities. Investigating and eliminating the root cause of these failures is a critical
part of our continual improvement process.
Canalta Controls Ltd. takes action to eliminate the cause of non-conformities in order to prevent their recurrence
as outlined in the following procedure: CA-QA-QSP-008_Control of Non-Conformity & Corrective Action.
Supporting documentation:
Ref. Title & Description
08 CA-QA-QSP-008_Control of Non-Conformity & Corrective Action
Appendices
A.1 Correlation Matrix
This section provides a matrix to correlate the requirements of ISO 9001:2015 against the relevant sections in this
document and should be used to determine where the new and amended clauses are located.
Identify Risks & Calibrate
Opportunities Equipment
Evaluation of Continual
Compliance Improvement
Storage, Dispatch &
Operations Processes
Delivery
Customer Management
Feedback & Review
Satisfaction
Customer, Market &
Product & Process
Analyze QMS
Process Data
Stakeholder Feedback Monitoring