CA QA QM 001 - ISO 9001 2015 QMS Manual

Download as pdf or txt
Download as pdf or txt
You are on page 1of 32

Our ISO 9001:2015 QMS drives increased

transparency and quantifiable objectivity to the


organizational decision making which results in
continual improvement, process control and risk
mitigation across the company.

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. 

  Name Signature Position Date

Prepared by Walter Amaya Elvir Quality Assurance Coordinator 11-Mar-2022

Reviewed by Lyle Whiteside Quality Manager 11-Mar-2022

Approved by Tracy Orellana Operations Manager 23-Apr-2022

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:

Page No. Context Revision Date


6 Revision 1 10-Apr-19
Table 1: Organizational Factors Update; Table 2: Interested Parties – Needs & Expectations Update
10 5.1.3.2.: Quality Policy Update Revision 1 10-Apr-19

15 Table 5: Quality Objectives Update Revision 1 10-Apr-19

24 9.11: Rearrange order and update of items Revision 1 10-Apr-19

25 Table 6: Key Performance Indicators Update Revision 1 10-Apr-19


A.1: Correlation Matrix - Removal of text; A.2: Sequence & Interaction of Processes Update; A.3:
29-32 Revision 1 10-Apr-19
Organizational Chart Update
Cover Added revision and date Revision 2 10-Jun-2020

15 Table 5: Quality Objectives Update Revision 2 10-Jun-2020

22 8.5.2: Updated procedure as Material Identification and Traceability Revision 2 10-Jun-2020

10 5.1.3.1: Removal of text in first paragraph Revision 3 08-Apr-2021

15 Table 5: Quality Objectives Update Revision 3 08-Apr-2021

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

26 9.3.1 General updated “meeting” to review. Revision 3 08-Apr-2021


Updated organizational
32 Revision 3 08-Apr-2021
chart
Cover Added revision and date Revision 4 23-Apr-2022

15 Table 5: Quality Objectives Update Revision 4 23-Apr-2022


A.3: Organizational Chart
31 Revision 4 23-Apr-2022
Update

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:

Document Ref.   Rev  


     
Uncontrolled Copy    Controlled Copy     Date  

CA-QA-QM-001 Rev. 4 Page 1 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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 

CA-QA-QM-001 Rev. 4 Page 2 of 31


Quality Manual
ISO 9001:2015 Quality Management System

8.3  DESIGN & DEVELOPMENT  19 


8.3.1  General  19 
8.4  CONTROL OF SUPPLIERS & EXTERNAL PROCESSES  20 
8.4.1  General  20 
8.5  PRODUCTION & SERVICE PROVISION  20 
8.5.1  Control of Production & Service Provision  20 
8.5.2  Identification & Traceability  22 
8.5.3  3rd Party Property  22 
8.5.4  Preservation  22 
8.5.5  Post‐delivery Activities  22 
8.5.6  Control of Changes  22 
8.6  RELEASE OF PRODUCTS & SERVICES  23 
8.7  CONTROL OF NON‐CONFORMING OUTPUTS  23 
9  PERFORMANCE EVALUATION  24 
9.1  MONITORING, MEASUREMENT, ANALYSIS & EVALUATION  24 
9.1.1  General  24 
9.1.2  Customer Satisfaction  24 
9.1.3  Analysis and Evaluation  24 
9.2  INTERNAL AUDIT  25 
9.3  MANAGEMENT REVIEW  25 
9.3.1  General  25 
10  IMPROVEMENT  26 
10.1  GENERAL  26 
10.2  NON‐CONFORMITY & CORRECTIVE ACTION  26 
10.3  CONTINUAL IMPROVEMENT  27 
APPENDICES  28 
A.1  CORRELATION MATRIX  28 
A.2  SEQUENCE & INTERACTION OF PROCESSES  30 
A.3  ORGANIZATIONAL CHART  31 

CA-QA-QM-001 Rev. 4 Page 3 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

Head Office & Manufacturing Facility is located at:

Canalta Controls Ltd.


6759-65 Avenue
Red Deer, Alberta
Canada T4P 1X5

www.canaltaflow.com

Phone: +1 (403) 342-4494


Fax: +1 (403) 346-7110

The official accreditation of the Quality Management System at Canalta Controls Ltd. is under the jurisdiction of
the following registrars (in alphabetical certification order):

1) ABSA - ABSA (Alberta Boilers Safety Association);


2) ISO 9001:2015 – Quasar, a division of CWB Group;
3) PED 2014/68/EU - BSI (British Standards Institution).

CA-QA-QM-001 Rev. 4 Page 4 of 31


Quality Manual
ISO 9001:2015 Quality Management System

2 References
In addition to ISO 9001:2015 we also make reference to other relevant local / international standards appropriate
to our products and market.

Standard Title Description


ISO 9001:2015 Quality management systems Requirements
Directive 2014/68/EU of the European Parliament
PED 2014/68/EU Quality management systems
and the Council of 15 May 2014
ABSA Quality management systems Alberta Boilers Safety Association

3 Definitions
This document does not introduce any new definitions but rather relies on the following:

1. Definitions typically used by our customers, stakeholders or marketplace;


2. Terms typically used in standards and regulations as they relate to our QMS or products;
3. Standard business terminology;
4. Terms and vocabulary commonly used in quality and engineering practices.

4 About Our Organization


4.1 Organizational Context
Canalta Controls Ltd. is committed to defining Figure 1: Typical QMS Input Hierarchy
our position in the marketplace and
understanding how relevant factors arising from
legal, political, economic, social and Internal External Interested
Factors Factors Parties
technological issues influence our strategic
direction and our organizational context.

Canalta Controls Ltd. identifies, analyzes,


monitors and reviews factors that may affect our Organizational Strategy
ability to satisfy our customers and
stakeholders, as well as; factors that may
Business Planning
adversely affect the stability of our process, or
Resources Budgets
our management system’s integrity.

To ensure that our QMS is aligned with our


Quality Policy Managment System
strategy, while taking account of relevant
KPIs/
internal and external factors; we initially collate Objectives Context Scope
Metrics
and analyze pertinent information in order to
determine potential impact on our context and
subsequent business strategy.

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

CA-QA-QM-001 Rev. 4 Page 5 of 31


Quality Manual
ISO 9001:2015 Quality Management System

consider issues that influence our context during management review meetings and are conveyed via minutes and
business planning documents.

Table 1 – Organizational Factors


Internal Factors External Factors The output from this activity is evident as an input
Organizational Structure Geography to the consideration of risks and opportunities, and
Corporate Culture Industry the actions that we take to address them. Refer to
Workforce Capability Competitors
Section 6.1 for more information about our risk and
Infrastructure Technological Advancement
opportunity management framework.
Tooling & Machinery Customers
Employees Labour Accessibility Although we acknowledge that ISO 9001:2015
Values & Culture Supply Accessibility does not require our organizational context to be
Innovation & Knowledge Sub Contracted Skills Accessibility
maintained as documented information, we
Financial Standing Regulatory Environment
maintain and retain; in addition to this document,
Current Products Taxation
Fixed Costs & Overheads Local Infrastructure & Utilities the following documented information to describe
Strategic Direction Ethical Norms our organizational context:
Credit Environment
1. Analysis of business plans, strategies, and
Political Climate
statutory and regulatory commitments;
Currency Exchange
2. Analysis of technology and competitors;
3. Economic reports from relevant business sectors;
4. Technical reports from technical experts and consultants;
5. Minutes of meetings (Management and design review minutes), process maps and reports, etc.
4.2 Relevant Interested Parties
Canalta Controls Ltd. recognizes that we have a unique set of interested parties whose needs and expectations
change and develop over time, and furthermore; that only a limited set of their respective needs and expectations
are applicable to our operations or to our quality management system. Such needs and expectations broadly
include those shown in the table below.
Table 2 – Interested Parties - Needs & Expectations
Interested Parties Needs & Expectations To ensure that our products and processes
Employees Satisfaction, security, growth, safety, values continue to meet all relevant requirements,
Satisfaction, security, growth, safety, values,
Leadership/Management we identify and assess the potential impact
profitability, reduced stress & liability
Profitability, growth, reduced stress & of any relevant needs and expectations
Owners/Shareholders
liability that may be elicited from the interested
Satisfaction, service, price, quality, reliability,
parties.
Customers, Industry value, contract requirements, timely
deliveries Where appropriate, to ensure that our
Suppliers, Sub Contractors Commercial stability & reliability,
(External Providers) communications, capabilities
processes are aligned to deliver the
Competitors None requirements of our interested parties; we
Regulatory, Statutory,
Code adherence & reporting, resource use,
convert relevant needs and expectations
Utilities, Bylaws, Fire &
land use into requirements which become inputs to
Safety
Governing Authorities Regulation & protocols adherence our QMS and to our product and service
Code Compliance Standard adherence designs.
Community Support, respect

CA-QA-QM-001 Rev. 4 Page 6 of 31


Quality Manual
ISO 9001:2015 Quality Management System

4.3 Quality Management System


4.3.1 Management System Scope
Based on the analysis of the issues and requirements identified in Sections 4.1 and 4.2, Canalta Controls Ltd. has
established the scope of our quality management system in order the implement our objectives and our policies
that are relevant to our context, products and any interested parties.
4.3.1.1 SCOPE
Canalta Controls Ltd. has established our scope as follows:
Design, development, manufacturing, assembly, sales and service of industrial
measurement and process control equipment.

4.3.2 Management System Processes


Canalta Controls Ltd. has implemented a quality management system that exists as part of a larger strategy that
has established, documented and implemented our processes, quality policy and objectives, while satisfying the
requirements of ISO 9001:2015.

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:

Sales and Project Execution Process

The effectiveness of each process and its subsequent output is measured and evaluated through regular internal
audits, quality inspections and data analysis.

CA-QA-QM-001 Rev. 4 Page 7 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

4.3.3 Outsourced Processes


Where Canalta Controls Ltd. identifies the requirement to outsource any process, or part thereof, which affects
conformity with the stated requirements; Canalta Controls Ltd. identifies control criteria such as; the competence
of personnel, inspection regimes, the provision of product conformity certificates, adherence to specifications and
specific job files, etc. Refer to Section 8.4.

4.3.4 Documented Information


4.3.4.1 Management System Documents
Canalta Controls Ltd. ensures that our QMS includes the documented information that is required to be maintained
and retained by ISO 9001:2015, and additionally, any documented information identified by our organization that
demonstrates the effective operation of our QMS. For further details, refer to our 3 Tiered Approach to maintaining
quality management system documents and CA-QA-QSP-001_Control of Documented Information.

3 Tiered Approach to our Quality Management System Documentation

Level 1: Quality Management System Manual

Level 2: Quality System Procedures (QSP)

Level 3: Work Instructions, Forms, Drawings, Datasheets, Product


Diagrams, Industry Specifications

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

CA-QA-QM-001 Rev. 4 Page 8 of 31


Quality Manual
ISO 9001:2015 Quality Management System

5 Leadership & Governance


5.1 Leadership and Commitment
5.1.1 Quality Management System
Canalta’s leadership is also responsible for implementing the QMS, which includes the development and
deployment of the quality policy, the quality objectives, and product/project-specific plans that are customer
focused.

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:

1. Create and sustain shared values of fairness and ethical behavior;


2. Establish a culture of trust and integrity;
3. Encourage commitment to quality;
4. Provide people with the required resources, training and authority to act with accountability;
5. Inspire, encourage and recognize people’s contribution.
In addition, our policies, objectives and targets are communicated and deployed throughout the business via
individual performance objectives which are established and discussed during employee performance reviews.

5.1.2 Customer Focus


Canalta Controls Ltd. strives to identify current and future customer needs, to meet their requirements and to
exceed their expectations. Top Management ensures that the focus on improving customer satisfaction is
maintained by setting and reviewing objectives related to customer satisfaction at management review meetings.

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.

CA-QA-QM-001 Rev. 4 Page 9 of 31


Quality Manual
ISO 9001:2015 Quality Management System

5.1.3 Quality Policy


5.1.3.1 Establishing & Communicating
The quality policy acts as a compass by providing the direction and framework for establishing key corporate level
performance measures, as well as related objectives and targets. Top Management ensures that our corporate
policies are established and documented.

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.

5.1.3.2 Quality Policy Statement


Canalta is committed to an operating philosophy based on openness in communication, integrity in serving our
customers, fairness and concern for our employees and responsibility to the communities within which we operate.

QUALITY POLICY

Canalta Controls Ltd. strives to be the premiere supplier of industrial


measurement and process control equipment solutions worldwide by offering our
customers, our employees and our community an unparalleled commitment to
our core principles of Quality, Service, Value and Respect.

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.

CA-QA-QM-001 Rev. 4 Page 10 of 31


Quality Manual
ISO 9001:2015 Quality Management System

5.2 Role, Responsibilities and Authorities


Our organizational structure is defined in Appendix A.3. The organization chart shows the interrelation of personnel
within Canalta Controls Ltd., while job descriptions define the responsibilities and authorities of each role. Job
descriptions and the organizational structure are reviewed and approved by Top Management for adequacy as
determined by the changing needs and expectations of the interested parties identified in Section 4.2, and any risk
and opportunities presented through the risk management process, Section 6.1.

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:

1. Ensure that QMS processes are delivering their intended outcomes;


2. Report on the operation of the QMS and identifying any opportunities;
3. Ensure that improvement is taking place;
4. Ensure that customer focus is promoted throughout the organization;
5. Ensure that whenever changes to the QMS are planned and implemented;
6. Ensure the integrity of the system is maintained during changes;
7. Ensure that responsibilities and authorities relating to the QMS are communicated and understood.
All managers demonstrate their commitment to the development and improvement of the quality management
system through the provision of necessary resources, through their involvement in the internal audit process and
through their proactive involvement in continual improvement activities. Emphasis is placed on improving both
the effectiveness and efficiency of key system processes.

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.

CA-QA-QM-001 Rev. 4 Page 11 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

5.3.2 External Communication


Canalta Controls Ltd. determines the need to communicate information externally to our interested parties, as
defined in Section 4.2, regarding the effectives of our QMS. In most instances, external interested parties (such as
consumers, stockholders, neighboring communities, etc.) are the main driving force for our organization to
implement our QMS. The various processes or means of external communication may include as appropriate:

Table 3: Modes of Communication


Interested Parties Possible Modes of Communication
Website, Marketing Publications, Tradeshows, Lunch &
Customers, Industry Learns, Technical Training Sessions, Email, In-Person,
Telephone, Fax
Meetings, Questionnaires, Email, Documented Procedures,
Suppliers, Sub Contractors (External Providers)
In-Person, Telephone, Fax
Competitors Customer Feedback, Public Information, Trade Shows
Regulatory, Statutory, Utilities, Bylaws, Fire & Safety Regulatory Compliance Submissions, Audits, Inspections
Regulatory Compliance submissions, Audits, Inspections,
Governing Authorities
Email
Code Compliance Audits, Inspections, Email
Community Meetings, Email, In-Person, Telephone

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

CA-QA-QM-001 Rev. 4 Page 12 of 31


Quality Manual
ISO 9001:2015 Quality Management System

are transmitted by email or letter. In each case the response is retained and controlled in accordance with the
requirements for documented information.

6 Management System Planning


6.1 Addressing Risks & Opportunities Figure 2: Risk & Opportunities PDCA

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 & .

effective implementation of risk and opportunity management Opportunitie


principles and activities by:
s Check -
Monitor risk
management
1. Providing sufficient resources to carry out risk and plans using
opportunity management activities; Act - measurement
Implement s and audits.
2. Assigning responsibilities and authorities for risk and
changes to
opportunity management activities; the QMS and
3. Reviewing information and results from audits and risk and continually
review.
opportunity management activities.
The scope of Canalta Controls Ltd. risk and opportunity management process includes the assessment of the
internal and external issues identified in Section 4.1, and the assessment of the needs and expectations of any
interested parties identified in Section 4.2. Risk and opportunity management is undertaken as part of Canalta’s
day-to-day operations and is captured at the following hierarchy:

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:

Table 4: Hierarchy of Risks & Opportunities


Business Hierarchy Risk/Opportunity
Canalta Controls Ltd. uses a risk register to help record,
Strategic level Budgets and profitability
assess, respond, review, report, monitor and plan for the
Program level Performance and efficiency
risks and opportunities that we perceive to be relevant. The
Department level Resources and targets
register allows our organization to methodically assess
Process level Evaluation and assurance
each risk and to study each opportunity associated with our
organizational context, and the needs and expectations of our interested parties. The register records the controls
and treatments of risks and opportunities and preserves this knowledge as documented information.

CA-QA-QM-001 Rev. 4 Page 13 of 31


Quality Manual
ISO 9001:2015 Quality Management System

Supporting documentation:
Ref. Title & Description
02 CA-QA-QSP-002_Control of Risks & Opportunities

6.2 Quality Objectives


Canalta Controls Ltd. sets out its objectives and targets annually using the quality policy and the company business
plan as a guide. They will be monitored on a regular basis within the management review minutes where details
of program dates and responsibilities are defined. Improvements in quality and performance are incremental and
are in keeping with the size and complexity of our organization.

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:

1. Turnover & profitability;


2. Sales targets & production efficiency targets:
3. Reject and rework & cost of quality targets;
4. Staffing performance.
On the basis of the quality policy and in connection with the application of the ISO 9001 quality management
principles, Canalta Controls Ltd. sets quality objectives as stated below.

Table 5: Quality Objectives


Quality Objective Target Measure
 Job Descriptions and Training
 All job descriptions updated and Records available for all
Complete & Maintain a Transparent Work Hub system fully employees and Competency
Employee Skills Matrix implemented by end of Q3 2022 Matrices completed for all
departments
 Reduce annual customer  Number of customer warranties
Improve Customer Satisfaction
warranties by 15% from end of 2021 to end of 2022
 Reduction of received non-
conforming product from  Tracking reworks requirements
foundries by 50% on incoming crate summaries
compared to previous years’
Improve Product Quality  Rework initiative to reduce
levels
volume of in stock non-
 Track monthly rework stats of
conforming product by 40 fittings
stockkeeping units
per month

 Develop and implement


 Implementation of automated
automated fitting inspection
Improve Calibration Program process using CMM technology fitting inspection process by end
of Q2 2023
by end of Q2 2023

CA-QA-QM-001 Rev. 4 Page 14 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

6.3 Planning for Change


The quality management system is planned and implemented in order to meet our corporate objectives and the
requirements of ISO 9001:2015. The planning process involves establishing and communicating our policies,
objectives and associated operational procedures.

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.

CA-QA-QM-001 Rev. 4 Page 15 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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. Transportation and material handling equipment management, maintenance and repair;


2. Process and production equipment management, maintenance and repair;
3. Facilities management, maintenance and repair.

CA-QA-QM-001 Rev. 4 Page 16 of 31


Quality Manual
ISO 9001:2015 Quality Management System

7.1.4 Operational Environment


Canalta Controls Ltd. ensures that our factory, warehouse and offices comply with relevant health and safety
regulations. The Millwright carries out regular inspections to ensure that appropriate standards are maintained.
Top Management is committed to providing:

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

7.1.6 Organizational Knowledge


Canalta Controls Ltd. recognizes that organizational knowledge is a valuable resource that supports our quality
management activities and ensures continual product and service conformity. There is a strong link between
organizational knowledge and the competence of our people, the latter being peoples’ ability to apply knowledge
to their work.

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;

CA-QA-QM-001 Rev. 4 Page 17 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

8 Product & Service Development


8.1 Operational Planning & Control
Canalta Controls Ltd. establishes and implements documented plans and procedures that describe the processes
(Refer to Section 4.3.2) and the controls required for the provision of products and services in cognizance to the
objectives, the potential for planned or unintended change, and the risks and opportunities identified in Section
6.1. During this planning phase, management or other responsible personnel identify the following parameters:

 Objectives and requirements for the product or service;


 Verification, validation, monitoring, inspection and test requirements;
 Documented information to demonstrate conformity;
 Document information to demonstrate process effectiveness;
 Necessary resources; or outsourced processes and their controls;
 Criteria for process performance and product/service acceptance;
 Potential consequences and mitigation to change affecting input requirements;
 Resources necessary to support the ongoing operation and maintenance of the product.
The output of planning activity includes documented plans, resource schedules, processes, equipment
requirements, procedures and design outputs.

8.2 Customer Requirements


8.2.1 Customer Communication
In accordance with our commitment to exceed our customer’s expectations, Canalta Controls Ltd. highlights
effective customer communication as an essential element of delivering customer satisfaction. Appropriate
handling of customer communication helps to reduce customer dissatisfaction and in many cases turn a
dissatisfying scenario into a satisfying experience. Customer communication occurs through the following formats,
events and processes:

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.

CA-QA-QM-001 Rev. 4 Page 18 of 31


Quality Manual
ISO 9001:2015 Quality Management System

8.2.2 Determining Requirements


Canalta Controls Ltd. develops appropriate requirements to ensure that we satisfy the needs and expectations
across the socio-technical environment including those of our customers, stakeholders or relevant interested
parties. Canalta Controls Ltd. ensures that customer requirements are clearly articulated and that their
requirements are captured and understood before the acceptance of an order. Customer requirements include the
following:

1. Previous customer requirements which pertain to current parts being ordered;


2. Statutory and regulatory requirements related to the product;
3. Other non-customer specified performance requirements;
4. Any additional requirements determined by Canalta Controls Ltd.;
5. Requirements not stated by the customer but which are necessary for specified or intended use.
This is customer-driven process requires clear, and often repeated, customer interaction to understand the
customer’s needs.

8.2.3 Review of Requirements


Prior to committing to the customer, Canalta Controls Ltd. ensures and confirms our capacity to supply the required
product or service. Pre-acceptance reviews are conducted to ensure that:

1. Product requirements are defined and are appropriate;


2. Requirements are defined for delivery and post-delivery activities such as product or service support;
3. Requirements not stated by the customer but which are necessary for intended use are appropriate;
4. Any additional requirements determined by Canalta Controls Ltd. are appropriate;
5. Contract or order requirements differing from those previously expressed are resolved;
6. Canalta Controls Ltd. has the ability to meet the defined requirements;
7. Documented information is retained and maintained showing the results of the review.
Customer requirements are confirmed before acceptance by the exchange of contracts, purchase orders via
appropriate electronic or hard copy formats.

8.2.4 Changes in Requirements


Canalta Controls Ltd. ensures that all relevant documented information; relating to changes in product or service
requirements, is authorized and amended where necessary, and that all relevant personnel are made aware of the
documented requirement changes.

8.3 Design & Development


8.3.1 General
The design and development activity transforms the inputs requirements into conforming product or service
outputs. Canalta Controls Ltd. has implemented a design and development process to allow for effective product
or service provision as outlined in the procedure: CA-QA-QSP-006_Control of Design & Development.

CA-QA-QM-001 Rev. 4 Page 19 of 31


Quality Manual
ISO 9001:2015 Quality Management System

Supporting documentation:
Ref. Title & Description
06 CA-QA-QSP-006_Control of Design & Development

8.4 Control of Suppliers & External Processes


8.4.1 General
The purchasing process is essential to our organization’s ability to provide our customers with products and
services that meet their requirements. Canalta Controls Ltd. ensures that all purchased products or services that
are incorporated in to our final products; conform to our specified requirements. This procedure is outlined in CA-
QA-QSP-007_Control of Purchasing & Procurement.

Supporting documentation:
Ref. Title & Description
07 CA-QA-QSP-007_Control of Purchasing & Procurement

8.5 Production & Service Provision


8.5.1 Control of Production & Service Provision
The Operations Manager is responsible for and has the authority to ensure production and service procedures are
implemented. The process control activities are systematically controlled and verified at regular quality control
checkpoints as per the Material Realization & Quality Control Points process flow below:

CA-QA-QM-001 Rev. 4 Page 20 of 31


Quality Manual
ISO 9001:2015 Quality Management System

Material Realization & Quality Control Points

The following controlled conditions are applied where applicable:

 Quality control checks are performed using appropriate measuring equipment;


 Handling, storage and transportation;
 Evidence of completed inspections;
 Detailed process work instructions and specifications for all products;
 Criteria for workmanship, competence and plant maintenance.
In cases where special processes are employed where the results of which cannot be easily checked, including any
processes where deficiencies become apparent only after the product is in use, validation demonstrates the ability
of these processes to achieve planned results by:

 Defining qualification criteria and approval of special processes prior to use;


 Defining criteria for review and approval of the processes;

CA-QA-QM-001 Rev. 4 Page 21 of 31


Quality Manual
ISO 9001:2015 Quality Management System

 Approval of equipment and qualification of personnel;


 Use of specific methods and procedures;
 Requirements for records;
 Revalidation.
8.5.2 Identification & Traceability
In order to preserve the conformance of products to customer requirements during internal processing and
delivery, Canalta Controls Ltd. identifies the product throughout the product realization process in accordance with
the Material Identification and Traceability Procedure.

 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

CA-QA-QM-001 Rev. 4 Page 22 of 31


Quality Manual
ISO 9001:2015 Quality Management System

adequate review of the QMS requirements. Changes to the scope of the QMS may require re-certification of the
affected quality management system.

8.6 Release of Products & Services


The Quality Manager has overall responsibility for planning and implementing the inspection and test activities
needed to verify that product requirements are met at appropriate stages of the product realization process.

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.

8.7 Control of Non-Conforming Outputs


It is our organization’s policy to detect, control and rectify any aspect of an output that does not conform as quickly
and efficiently as possible. Where necessary, any product or service output that does not conform to requirements
is properly identified and controlled to prevent unintended use or delivery. The non-conformity is analyzed and
the cause(s) are investigated.

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.

CA-QA-QM-001 Rev. 4 Page 23 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

Canalta’s Strategic Priorities:

1. Improve Customer Satisfaction


2. Ensure Regulatory Compliance
3. Improve Product Quality
4. Improve Operational Efficiency
5. Increase Flexibility & Innovation
6. Waste Reduction
7. Increase Profitability & Revenue Growth
8. Improve Employee Satisfaction
9. Increase Positive Community Contribution

9.1.2 Customer Satisfaction


Canalta monitors information and trends relating to customer perception as to whether the organization has
fulfilled the customers’ requirements. Customer Satisfaction Surveys, complaints and other feedback are monitored
as outlined in the following procedure: CA-QA-QSP-009_Control of Customer Satisfaction.

Supporting documentation:
Ref. Title & Description
09 CA-QA-QSP-009_Control of Customer Satisfaction

9.1.3 Analysis and Evaluation


Top Management and other managers and supervisors collect and analyze data using appropriate techniques to
determine the suitability and effectiveness of key quality management system processes applicable to their area(s)
of responsibility and to identify opportunities for improvement.
9.1.3.1 Key Performance Indicators
A process is effective if the desired results are measurably achieved. Their effectiveness is measured in terms of
achieving targets based on metrics. The following Key Performance Indicators are monitored quarterly and/or
yearly to ensure Canalta is achieving its desired goals and objectives.

CA-QA-QM-001 Rev. 4 Page 24 of 31


Quality Manual
ISO 9001:2015 Quality Management System

Table 6: Key Performance Indicators


Improve Customer Ensure Regulatory
Improve Product Quality
Satisfaction Compliance
 Regulatory Non-  Non-Conformance
 Customer Feedback Compliances (OH&S, Fire, Reports / Production
Bylaw) Volume
 Warranty Related Sales
 Customer Complaints  WCB Injury Reports
Returns
 External Providers Audit
 Customer Audit Results  Regulatory Audit Results
Results
Improve Operational Increase Flexibility &
Waste Reduction
Efficiency Innovation
 Revenue / Profit per Man  New Items Under
 Inventory Rework Levels
Hour Construction
 Write-Off as a % of
 Inventory Turnover Rate  R & D Expenditures
Revenues
Increase Profitability & Improve Employee Increase Positive Community
Revenue Growth Satisfaction Contribution
 Booked Orders in CDN &
 Employee Turnover Rate  Expenditures (Donations)
(USA) USD
 Total Revenue CDN &
 Safety Rating (TRF)
USA (USD)

9.2 Internal Audit


Internal audit results are critical inputs that help to assess the effectiveness of our quality management system.
Canalta’s internal audit program is based upon a strategy that investigates each area and process to determine
whether the quality management system conforms to our organization’s planned arrangements and to the
requirements of the applicable quality standards.

Supporting documentation:
Ref. Title & Description
10 CA-QA-QSP-010_Control of Internal Audits

9.3 Management Review


9.3.1 General
To ensure the continuing suitability, adequacy and effectiveness of our quality management system in meeting
our organization’s strategies, Top Management conducts management reviews at planned internals. The primary
inputs that are reviewed comprise data from target areas and key performance indicators that are gathered at key
quality data points from various processes. Subsequent recommendations for improvement are based on the
evaluation of such measurements.

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.

CA-QA-QM-001 Rev. 4 Page 25 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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:

1. Risk and opportunity evaluations;


2. Assessment of the changing needs and expectations of interested parties;
3. The conformity of existing products and services;
4. The effectiveness of our QMS;
5. Supplier performance;
6. Levels of customer satisfaction, including complaints and feedback;
7. Internal and external audit results;
8. Corrective action and non-conformance rates;
9. Data from process and product characteristics and their trends.
Canalta Controls Ltd. also ensures that opportunities for improvement from daily feedback on operational
performance are evaluated by the Quality Manager which are typically implemented through the corrective action
system. Opportunities for improvement from analysis of longer-term data and trends are evaluated and
implemented through the management review process and are prioritized with respect to their relevance for
achieving our quality objectives.

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.

10.2 Non-Conformity & Corrective Action


Evidence of non-conformance, customer dissatisfaction or process weakness is used to drive our continual
improvement system. Since problems may already exist, they will require immediate correction and possible
additional action aimed at eliminating or reducing the likelihood of its recurrence.

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.

CA-QA-QM-001 Rev. 4 Page 26 of 31


Quality Manual
ISO 9001:2015 Quality Management System

Supporting documentation:
Ref. Title & Description
08 CA-QA-QSP-008_Control of Non-Conformity & Corrective Action

10.3 Continual Improvement


Canalta Controls Ltd. continually improves the effectiveness of its quality
management system through the effective application of the corporate
policies, objectives, auditing and data analysis, corrective and preventive
actions and management reviews.

The continual improvement process begins with the establishment of our


corporate policies and objectives for improvement, based on objectives
contained in our business plan and customer targets and goals. Customer
satisfaction, internal audit data, process and product performance data, and
the cost of poor quality or risk control are then compared against objectives
or KPIs to identify additional opportunities for improvement.

Canalta’s continuous improvement program assesses, validates,


implements and subsequently re-assesses activities towards improving the
strategic, operational and quality goals of the organization, while reducing
the associated risks.

Achieved through periodic reviews of:

1. Internal and External Organizational Factors


2. Strategic Priorities
3. Critical Success Factors & Risks
4. Policies / Objectives
5. Key Performance Indicators
The overall effectiveness of continual improvement program, including corrective actions taken, as well as the
overall progress towards achieving corporate level improvement objectives, are assessed through our
management review process.

CA-QA-QM-001 Rev. 4 Page 27 of 31


Quality Manual
ISO 9001:2015 Quality Management System

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.

ISO 9001:2015 This Document


4.0 Context of the Organization 4.0 About our Organization
4.1 Understanding the Organization and its Context 4.1 Organizational Context
4.2 Needs and Expectations of Interested Parties 4.2 Relevant Interested Parties
4.3 Scope of the Quality Management System 4.3.1 Management System Scope
4.4 Quality Management System and its Processes 4.3.2 Management System Processes
5.0 Leadership 5.0 Leadership & Governance
5.1 Leadership and Commitment 5.1 Leadership and Commitment
5.1.1 Quality Management System 5.1.1 Quality Management System
5.1.2 Customer Focus 5.1.2 Customer Focus
5.2 Quality Policy 5.1.3 Quality Policy
5.2.1 Establishing the Quality Policy 5.1.3.1 Establishing & Communicating
5.2.2 Communicating the Quality Policy 5.1.3.2 Quality Policy Statement
5.3 Roles, Responsibilities and Authorities 5.2 Roles, Responsibilities and Authorities
6.0 Planning for the Quality Management System 6.0 Management System Planning
6.1 Actions To Address Risks and Opportunities 6.1 Addressing Risk & Opportunities
6.2 Quality Objectives & Planning To Achieve Them 6.2 Quality Objectives
6.3 Planning of Changes 6.3 Planning for Change
7.0 Support 7 Support
7.1 Resources 7.1 Resources
7.1.1 General 7.1.1 General
7.1.2 People 7.1.2 People
7.1.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the Operation Of Processes 7.1.4 Operational Environment
7.1.5 Monitoring and Measuring Resources 7.1.5 Monitoring and Measuring Tools
7.1.6 Organizational Knowledge 7.1.6 Organizational Knowledge
7.2 Competence 7.1.2.1 Competence
7.3 Awareness 7.1.2.2 Awareness
7.4 Communication 5.3 Communication
7.5 Documented Information 4.3.4 Documented Information
7.5.1 General 4.3.4.1 Management System Documents
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
8.0 Operation 8.0 Product & Service Development
8.1 Operational Planning and Control 8.1 Operational Planning and Control
8.2 Requirements for Products and Services 8.2 Customer Requirements
8.2.1 Customer Communication 8.2.1 Customer Communication
8.2.2 Determining Requirements Related to Products 8.2.2 Determining Requirements

CA-QA-QM-001 Rev. 4 Page 28 of 31


Quality Manual
ISO 9001:2015 Quality Management System

ISO 9001:2015 This Document


8.2.3 Review of Requirements Related to the Products 8.2.3 Review of Requirements
8.2.4 Changes to Requirements for Products/Services 8.2.4 Changes in Requirements
8.3 Design and Development of Products 8.3 Design and Development of Products
8.3.1 General 8.3.1 General
8.3.2 Design and Development Planning
8.3.3 Design and Development Inputs
8.3.4 Design and Development Controls
8.3.5 Design and Development Outputs
8.3.6 Design and Development Changes
8.4 Externally Provided Products & Services 8.4 Control of Suppliers & External Processes
8.4.1 General 8.4.1 General
8.4.2 Type & Extent of Control of External Provision
8.4.3 Information for External Providers
8.5 Production and Service Provision 8.5 Production & Service Provision
8.5.1 Control of Production and Service Provision 8.5.1 Control of Production & Service Provision
8.5.2 Identification and Traceability 8.5.2 Identification & Traceability
8.5.3 Customer or External Provider’s Property 8.5.3 3rd Party Property
8.5.4 Preservation 8.5.4 Preservation
8.5.5 Post-Delivery Activities 8.5.5 Post-Delivery Activities
8.5.6 Control of Changes 8.5.6 Control of Changes
8.6 Release of Products and Services 8.6 Release of Products and Services
8.7 Non-conforming Process Outputs and Products 8.7 Control of Non-Conforming Outputs
9.0 Performance Evaluation 9.0 Performance Evaluation
9.1 Monitoring, Measurement, Analysis & Evaluation 9.1 Monitoring, Measurement, Analysis & Evaluation
9.1.1 General 9.1.1 General
9.1.2 Customer Satisfaction 9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation 9.1.3 Analysis and Evaluation
9.2 Internal Audit 9.2 Internal Audit
9.3 Management Review 9.3 Management Review
9.3.1 General 9.3.1 General
9.3.2 Management Review Inputs
9.3.3 Management Review Outputs
10.0 Improvement 10.0 Improvement
10.1 General 10.1 General
10.2 Non-Conformity and Corrective Action 10.2 Non-Conformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement

CA-QA-QM-001 Rev. 4 Page 29 of 31


Quality Manual
ISO 9001:2015 Quality Management System

A.2 Sequence & Interaction of Processes

MANAGEMENT Customer Related SUPPORT PROCESSES


PROCESSES
Processes
Quality Management 
Communication
System Customer, Market,
Stakeholder & Legal
Set Objectives &  Requirements Competence &
Targets Awareness

Provide Resources &  Opportunity & Maintain Facilities


Infrastructure Customer Quote & Equipment
Qualification Process

Identify Risks &  Calibrate
Opportunities Equipment

Identify Legal &  Order Contract Review Mitigate Risks &


Other Requirements Impacts

Determine Roles &  Document & Data


Responsibilties Control
Product & Process Design &
Planning Development
Domain
Quality Planning
Knowledge

Supplier Selection & Incoming Inspection,


ASSESSMENT Evaluation Handling & Storage ASSESSMENT
PROCESSES PROCESSES

Evaluation of Continual
Compliance Improvement
Storage, Dispatch &
Operations Processes
Delivery

Internal Auditing Corrective Action

Non-conformities Evaluate Risks &


Accounting & After Sales Service &
& Corrective Action Opportunities
Invoicing Processes Support

Customer Management
Feedback & Review
Satisfaction
Customer, Market &
Product & Process
Analyze QMS
Process Data
Stakeholder Feedback Monitoring

CA-QA-QM-001 Rev. 4 Page 30 of 31


Quality Manual
ISO 9001:2015 Quality Management System

A.3 Organizational Chart

CA-QA-QM-001 Rev. 4 Page 31 of 31

You might also like