SMQS5103 QUALITY STANDARD AND SYSTEM

Contents
Part I............................................................................................................................................................1
Introduction.................................................................................................................................................1
Definition of quality based on core business product.............................................................................1
Preparation towards achieving ISO9001:2015.........................................................................................2
1. Prepare for the Audit...................................................................................................................2
2. Analyze gaps................................................................................................................................2
3. Make a plan.................................................................................................................................2
4. Train employees..........................................................................................................................3
5. Hold an internal audit..................................................................................................................3
6. Transparency with Documentation.............................................................................................3
7. Maintain an Audit Mindset..........................................................................................................3
8. Employ Risk-Based Thinking........................................................................................................4
9. Begin Remediation during the Audit............................................................................................4
Part 2...........................................................................................................................................................5
Audit process and appointment of a Certification Body (CB)..................................................................5
Principles of Internal Auditing.................................................................................................................5
1. Selection of Auditors....................................................................................................................5
2. Preparing for the Audit................................................................................................................5
3. The Human Aspect of Auditing....................................................................................................6
4. System Audits..............................................................................................................................6
5. Process Audits..............................................................................................................................6
6. Product Audits.............................................................................................................................7
7. Preparing the Audit Report..........................................................................................................7
Audit check sheet....................................................................................................................................7
Sr. No...........................................................................................................................................................8
ISO 9001:2015 clauses.................................................................................................................................8
Audit Question............................................................................................................................................8
1. Context of the Organization.........................................................................................................8
Five possible findings from internal and external issues.......................................................................14
1. Control of production and service:............................................................................................14
2. Measuring resources.................................................................................................................14
3. Operational planning.................................................................................................................15
 4. Infrastructure.............................................................................................................................15
5. Corrective action........................................................................................................................15
References.................................................................................................................................................16
Part I

Introduction

This document is meant to serve as a proposal to the company's management, in an effort to

persuade them to pursue ISO 9001: 2015 registration, as requested by the assignment. The first
section of this report will define quality in terms of the company's primary product. Next, it will
outline the steps that must be taken in order to become ISO 9001:2015 compliant. Part two will
focus on defining the audit process and outlining how the CB will be chosen. Additionally, the
report will include an audit check sheet that the company (Solid Waste Management Company)
may use to systematically carry out the audit. The audit's potential findings are included at the
conclusion of the report.

Definition of quality based on core business product

Quality, as defined by ISO 9000, is the extent to which an object's defining qualities meet
specified criteria. Please take into account that the word "degree" suggests that quality might
vary. Having "a set of" suggests that excellence is not a singular trait. According to ISO, a
feature that stands out from the others is a characteristic (Demir et al., 2021). Because of this, the
concept of quality excludes characteristics that are not distinguishing. A characteristic that sets
something apart from others of its kind is what the Longman dictionary calls a "distinguished
feature." The quantity of wheels on a vehicle can not be very noteworthy. This means that the
number of wheels does not necessarily indicate the superiority of a vehicle. Therefore, the
quantity of wheels is not a factor in quality control. Inherent qualities are traits that are a natural
component of anything and cannot be removed from it, as defined by both ISO standards and the
standards and core business product of the corporation (Demir et al., 2021). According to ISO,
inherent is defined as existing in anything, especially as a permanent trait, and is hence opposed
to assigned. Nonexistent or transient qualities are not included in this definition. Quality is linked
to specifications in ISO. This assumes there are standards; without standards, there can be no
quality (Siltori et al., 2021).
Preparation towards achieving ISO9001:2015

The organization will need to put in effort, spend money, and make adjustments to its operations
in order to get ISO 9001:2015 certified for quality management (Siltori et al., 2021). Due to this,
getting a head start is crucial. Companies can use ISO standards as a guide to develop a strategy
for reaching and maintaining the goals of that standard. The standards offer methods for firms to
pursue continuous improvement in addition to assuring consistent delivery of safe and quality
products and services. All the measures a quality manager would recommend to the organization
for passing the ISO 9001 audit are laid out here (Ikram, Zhang, and Sroufe, 2021).

1. Prepare for the Audit

The importance of being ready for an audit cannot be overstated. The company should always be
in a situation where its systems and procedures are audit-ready (Chiarini, 2019). However,
conducting an internal audit is a good approach to get ready for a customer or regulatory
inspection. Rather of waiting for an external audit to reveal problems, it is preferable to discover
them and document how you dealt with them. Several important aspects of audit readiness are
outlined below.

 Staff members should get ready for an audit. Everyone needs to be coached on what to
say and not to say if an auditor approaches them.
 Make sure workers don't leave sensitive materials out in the open on their desks while
they're away.
 Prior to sharing any paperwork with auditors, make sure it's comprehensive and accurate.
 Subject matter experts (SMEs) should be briefed on how they should communicate with
the auditor before the audit begins. This includes providing only the information required
and avoiding offering any extraneous details.

2. Analyze gaps

The team must assess the discrepancies between current practices and the new standards once the
quality manager has evaluated the new standard. That's where the company's weak spots will be
exposed (Fonseca, Cardoso, and Novoa, 2021).

3. Make a plan
The company's quality management strategy will need the creation and documentation of new
processes. The quality manager will develop a strategy that specifies what has to be done and by
when. To get ready, you'll need to map out a comprehensive strategy for gathering data and
define key performance metrics (Astrini, 2021).

4. Train employees

It is imperative that those who will be implementing the update receive training on the new
processes and how to effectively manage the transition.

5. Hold an internal audit

To ensure the organization is prepared for certification under the new standard, an audit team,
either internal or external, will conduct a quality audit.

6. Transparency with Documentation

The company's documentation processes should indicate how reviews, approvals, and re-
approvals are carried out. Documents must be tracked for modifications and revisions, and the
usage of outdated versions must be avoided (Astrini, 2021). Furthermore, upper management
should be ready to provide relevant records in advance of the audit. Preliminary requirements for
documentation may include:

 Key business information

 Quality manual
 Document management procedures
 Training procedures
 Physical and logical security procedures
 High level organization chart

7. Maintain an Audit Mindset

Audits are more of a discussion than a questioning. Since they are essential to ongoing attempts
to improve, they can also be used for no cost in this capacity. To ace an audit, you need to know
the rules as they are right now (Fonseca, Cardoso, and Novoa, 2021). Learn to distinguish
between what is required by law and what is considered to be best practice in the sector. The
regulations may or may not require a certain standard, in which case meeting that level is
voluntary.

8. Employ Risk-Based Thinking

The more prepared a business is for an audit, the more hazards the quality manager may
anticipate and record in advance. Instead of waiting for costly delays, rework, or product recalls
to occur, risk-based thinking proactively monitors trends and identifies and mitigates risks
(Fonseca, Cardoso, and Novoa, 2021). If many audits have shown the same problem, for
instance, you should formulate a plan to address it. Creating a formal reason for the choice is
necessary if the organization cannot or will not execute a change management procedure.

9. Begin Remediation during the Audit

To ensure that all audit findings and expectations are discussed and documented before the
auditor leaves, schedule a closing meeting. When the audit report finally arrives, you'll be better
prepared to respond to its conclusions (Latan et al., 2020). Make careful to record the methods
and rationales for addressing problems. The company's ability to identify and address the causes
of non-conformances hinges on its level of openness. There is no requirement for audits to be
time-consuming and nerve-wracking. In order to keep the firm audit-ready, it is best if these are
used to better understand the company's strengths and shortcomings. To better prepare for audits
and assure compliance with ISO 9001 requirements, it has adopted a digital, platform-based
QMS (Da Fonseca et al., 2019; Aamer, Al-Awlaqi, and Mandahawi, 2020).
Part 2

Audit process and appointment of a Certification Body (CB)

An internal ISO audit is conducted to evaluate the efficiency of the company's quality
management system and its overall performance. Audits conducted internally show that the
Quality Management System (QMS) is being used and maintained as intended (Aamer, Al-
Awlaqi, and Mandahawi, 2020).

Principles of Internal Auditing

An audit is only as good as the information it provides, and auditors rely on a set of principles
designed to provide them the information they need to be impartial and dependable in their work.

1. Selection of Auditors

A person's degree of competence may be evaluated based on their education, number of audits
conducted, and length of time in the field. Anyone, whether inside or outside the company, can
serve as an auditor, but they must be able to maintain objectivity and (Barbosa et al., 2021).
When relying on in-house workers to carry out an audit, some mechanism must be put in place to
guarantee objectivity, such as assigning a member of another department to do the inspection.
Auditing is a challenging task that calls for a wide range of knowledge and experience. The
scope, size, and complexity of an audit all play a role in determining the optimal number of
auditors to be assigned to the job (Latan et al., 2020).

2. Preparing for the Audit

The business should be ready for the audit in great detail. By investing in thorough pre-audit
planning, management can perform the audit more efficiently and effectively. This is an
important part of the auditing process that should not be skipped (Candido, Coelho, and
Peixinho, 2021). In reality, taking the effort to plan and arrange will save you time during the
audit. Each procedure inside the company should have its own detailed audit plan and be on the
most up-to-date audit schedule. The quality manager needs to make sure that everyone from the
board to the employees knows when the audits will be taking place so that they can carry out
their share of the assignment.

The manager is responsible for compiling all documentation pertaining to the process that is
being audited. The supervisor should review all relevant documentation, including process
metrics, work instructions, turtle diagrams, process maps, flowcharts, etc. They should also
gather and examine any control plans and failure mode impacts analysis worksheets that are
relevant (Barbosa et al., 2021). They're supposed to read them over carefully and underline the
parts that will be audited. Putting the documentation to use in this way guarantees it will be kept
as audit records. It's possible that not all of the pertinent requirements of the procedure are
included in the organization's published material. Lack of documentation might be the audit's
initial finding. Several pieces of data and connections need to be checked. Both mandatory and
recommended auditing procedures are included (Aamer et al., 2020). Organizing these into a
spreadsheet offers auditors a road map to follow to check off all the necessary linkages.

3. The Human Aspect of Auditing

The best auditors know from the get-go that they will have to deal with human beings as well as
systems and procedures. Despite the serious nature of an audit, it's often possible to put them at
ease by being friendly and humorous (Latan et al., 2020). It's crucial to convince people being
audited that the primary goal of the process is to spur growth, not to expose wrongdoing. It's also
crucial to assure those being audited that they may speak their minds without repercussions. It is
imperative that auditees be informed of the problems that have been uncovered and that they be
given direction on how to address non-conformances and close out observations. Managers of
quality should make it clear to those being audited that they are free to peruse their audit's notes
and results (Da Fonseca et al., 2019). The group should avoid getting into debates about its
findings. Identifying specific individuals in an audit report is inappropriate and unhelpful.

4. System Audits

It is recommended that the internal audit checklist be used for all system audits. This sort of audit
looks at the quality management system as a whole, comparing the planned activities and broad
system criteria to see whether everything has been met (Aamer, Al-Awlaqi, and Mandahawi,
2020).
 5. Process Audits

An in-depth examination, the process audit ensures that the management system's constituent
processes are functioning as intended and yielding the expected results. Corrective measures and
areas for enhancement are also highlighted at this phase of the process audit. Unique,
susceptible, novel, and high-risk processes might all be the focus of an audit (Fonseca, Cardoso,
and Novoa, 2021).

6. Product Audits

The product audit might be one of a series of audits performed at certain intervals to ensure the
product satisfies all of the criteria set out in the specification document, including those
pertaining to size, functionality, packaging, and labeling (Candido, Coelho, and Peixinho, 2021).

7. Preparing the Audit Report

The audit's worth is on the quality of the summary report it produces. All due care and
consideration must be given to it. The quality manager should have been keeping track of
problems and solutions as they were discovered throughout the audit (Aamer, Al-Awlaqi, and
Mandahawi, 2020). They should have been highlighted in some way so that they may be easily
accessed and noted when they write the report. The summary report ought to properly document
these discoveries and judgments. The audit report typically only restates information that
management already has. The usefulness is in illuminating problems and openings that they are
unaware of. The primary auditor, followed by the Process Owner and Management Team, should
go over this synopsis. Complete any necessary edits to the audit report and then store it away
with the rest of the audit documentation. The quality manager needs to compile an orderly set of
audit documents (Candido, Coelho, and Peixinho, 2021). As additional documentation for the
audit, you should compile any applicable work instructions, flowcharts, notes, and other
paperwork. The findings should be recorded on the corrective action forms. The audit package,
which is now the audit record, should include the audit summary and corrective action forms.
The process owner just needs to see the summary report and the actions taken to fix the problem.
 Audit check sheet

The audit check sheet (Table) below lines out the standards and the follow-up questions used to
ensure

Audit
Sr. Evidence
ISO 9001:2015 clauses Audit Question
No.

1. Context of the Organization

Understanding the organization and its context

1.11 The company must identify both internal and external
factors that have an impact on the effectiveness of the
quality management system in delivering on its stated
goals.
How has the company identified both internal and
external factors that affect its mission and long-term
goals?
What impact do these have on the QMS's capacity to
provide the desired outcome?

1.12 The business must keep an eye on news related to these How do you keep track of and assess data related to
external and internal problems. these internal and external challenges?

NOTE 1 Legal, technological, competitive, commercial, cultural, social, and economic concerns originating at the international,
national, regional, or local levels all contribute to a fuller appreciation of the external context.

NOTE 2 When trying to grasp the internal context, it helps to think about things like the company's values, its culture knowledge,
and its performance.

1.2 Understanding the needs and expectations of interested parties

1.21 The company must decide whether or not the following
may affect its capacity to reliably deliver products and
services that satisfy both client needs and applicable
statutory and regulatory requirements.
a) those whose concerns should be addressed by the
quality management system;
b) the needs of these stakeholders that should be
addressed by the quality management system.
In what ways have you narrowed down the pool of
potential stakeholders to those most important to the
QMS?
When it comes to the quality management system, how
have you pinpointed exactly what those other entities
need from you?

1.22 The company is obligated to keep tabs on details How do you keep track of who's interested, and what
pertaining to these stakeholders and their needs. they need, and how often do you look at that data?

1.3 Determining the scope of the quality management system

1.31 The quality management system's scope is defined by How have the QMS's constraints and potential
the company in terms of its limits and areas of applications been utilized to define the organization's
application. reach?
 Audit
Sr. Evidence
ISO 9001:2015 clauses Audit Question
No.
1.32 When determining this scope, the organization shall How have:
consider:
The external and internal issues;
a) the external and internal issues referred above.
b) the requirements of relevant interested parties The requirements of relevant interested parties and;
referred to above.
c) the products and services of the organization. The products and services of the organization been
considered when determining the scope of the
organization?

1.33 Organizations are obligated to implement all applicable How did the organization conclude that the International
parts of this International Standard within the scope to Standard applied within the scope given, and how did it
which they apply. put that determination into practice?

1.34 In the event that any requirement(s) of this International How were exceptions to the International Standard's
Standard cannot be implemented, this must not influence standards arrived at? Please elucidate how this doesn't
the organization's capacity or duty to assure compromise the consistency of your goods and services.
conformance of goods and services.

1.35 Accessible and up-to-date documentation detailing the Where can we find this potential? I need to know where Scope
scope must include the following details: the records are kept. required as
Is it clear which goods and services fall under the documente
QMS's purview? d
- quality management-related outputs and information
output types; Does it provide justification for when QMS criteria can't .
- Explanations for why some conditions set out be met in a given situation?
by this International Standard cannot be met.
1.4 Quality management system and its processes
1.41 The organization shall establish, implement, maintain, To what extent is the Quality Management System
and continually enhance a quality management system, (QMS) implemented? Exhibit the workings of this for
including the necessary procedures and their me. How do you ensure that it remains functional and
interrelationships, in accordance with the criteria of this evolves over time? How did we settle on these
International Standard. procedures, and how do they communicate with one
another?
 Audit
Sr. Evidence
ISO 9001:2015 clauses Audit Question
No.
1.42 The organization is responsible for establishing and 2. Where did you get the data used to establish
enforcing the procedures necessary to implement its the QMS processes?
quality management system, including but not limited to
the following:
3. Find out the processes' inputs and outcomes.

a) what materials are needed and what results might be 4. In what order do the processes occur, and how
anticipated from these operations; do they interact with one another?

b) the sequence and interaction of these processes;

5. Is there a set of standards, procedures,
indicators, and results that can be provided?

c) the standards, procedures, measures, and key

performance indicators that guarantee efficient 6. Indicators required for running and regulating
management of these activities; the operations?

7. How can the necessary supplies be acquired?

d) resources, and make sure they're readily available;
8. Just who is responsible for what and how
much power does each person have in those
e) the delineation of who is responsible for what in these procedures?
procedures;

9. How are possibilities and dangers evaluated,

and what contingency plans are developed?
f) risks and opportunities in light of 6.1's criteria, and
take steps to mitigate them as needed;
10. How can we know whether our procedures are
working as planned, and if not, what
adjustments must be made?
g) the tools used to keep tabs on, evaluate, and make
adjustments to processes to guarantee they deliver the
desired results;

h) possibilities for enhancing the procedures and quality

management infrastructure.

1.43 Documentation must be kept for as long as it is needed 1. For what reasons may procedures be carried Documente
to ensure procedures are running smoothly, and the out, and what documentation exists to back up d
company must keep enough of it to be certain that the those reasons?
processes are being carried out as intended. information
2. How is this recorded data kept for future
reference? How can we know for sure that to support
everything is going according to plan? the
operation
of
processes.

Leadership
 Audit
Sr. Evidence
ISO 9001:2015 clauses Audit Question
No.

2 Leadership and commitment

Leadership and commitment for the quality management system

Sr.
ISO 9001:2015 clauses
No.
2.1 The top brass have to set an example and prove their
dedication to the quality management system by:
a) accepting responsibility for the quality management
system's efficiency;
b) establishing a quality policy and quality targets for
the quality management system that are in line with the
organization's strategic direction and context;
d) ensuring that the company's quality policy is widely
disseminated, discussed, and followed;
d) confirming that the needs of the QMS have been
incorporated into day-to-day operations;
e) raising people's understanding of process-based
thinking;
f) providing adequate funding for the quality
management system;
g) spreading the word about how crucial it is to have an
efficient quality management system and to follow all of In what ways can you guarantee that the QMS will
its rules;
h) guaranteeing the desired outcomes of the quality
management system;
i) involving, guiding, and sustaining employees so that
they may optimally support the quality management
system's goals;
Customer focus
Audit
Evidence
Audit Question
Provide evidence that upper management has shown
leadership and dedication to the QMS by, for example,
accepting responsibility for the system's success.
Provide evidence that upper management has shown
leadership and dedication to the QMS by, for example,
accepting responsibility for the system's success.
How does management provide information about
quality assurance to employees? Exhibit the
comprehension and use of this for me.
What methods may be used to raise consciousness of the
process method?
How do you make certain that the necessary assets for
the QMS exist?
How do you get the message through that quality
management is crucial?
How do you get the message through that meeting the
QMS standards is crucial?
produce the desired outcomes?
How can you motivate, steer, and back employees so
that they boost QMS performance?
How can you encourage progress that never stops?
When you're in a managerial position, how can you help
your peers step up as leaders in their fields?
 Audit
Sr. Evidence
ISO 9001:2015 clauses Audit Question
No.

To demonstrate their commitment to the customer and to Let's have a look at how the company's senior
set an example, higher management should ensure the management demonstrates vision and commitment to
following. the satisfaction of its customers by anticipating their
needs, meeting those needs, and adhering to all
applicable rules and regulations.
a) demands of customers are determined and met,
together with all mandatory statutory and regulatory
requirements;
How can we recognize opportunities and risks that may
affect product or service conformity?
b) challenges to product/service conformity and
opportunities to boost customer satisfaction have been
identified and countered. How can you figure out what's wrong and how to
correct it if you want to boost client satisfaction?

c) Constant focus is placed on supplying products and

services that meet the requirements of our clientele and
Just how can you keep your company's focus squarely
adhere to all applicable rules and regulations.
on meeting the needs of your consumers while still
adhering to all applicable laws and regulations?

d) Maintaining complete customer satisfaction is a top

priority for us.
How is customer satisfaction maintained?

2.2 Quality policy

2.21 A quality policy must be created, reviewed, and updated How does top management establish, review and
regularly by upper management. maintain a quality policy?

a) consistent with the organization's mission and goals; How is it determined to be appropriate to the purpose
and context of the organization?

b) supports the process of establishing and evaluating

quality goals; Does it offer guidelines for establishing and
reevaluating quality standards?

c) includes a promise to follow all relevant regulations;

Does it guarantee compliance with all relevant
standards?
d) This contains a promise to upgrade the quality
management system on a regular basis.
Does it guarantee the QMS will always be upgraded?
 Audit
Sr. Evidence
ISO 9001:2015 clauses Audit Question
No.
2.22 The quality policy must: To what extent is the quality policy recorded, and where Quality
can I find it? Policy as
document
a) information that may be accessed in written form; information
Provide examples of its use and implementation inside
the company.
b) go out there, be absorbed, and used by everyone
in the company;
How have you disseminated this information to others
who would benefit from it?
c) Whenever necessary, make yourself available to
relevant interested parties.

Five possible findings from internal and external issues

The audit of the company can provide many workable findings. Five possible findings that it
may find through internal and external issues are listed below:

1. Control of production and service:

Process equipment operators should be well versed in the important parameters of process
requirements as outlined in work instructions, technical drawings, or specifications. It is possible
that the audit will guide the organization on how to define criteria for reviewing and approving
processes, provide inspection and laboratory test instructions, and implement new testing
protocols for its waste management systems.

2. Measuring resources

The results of a yearly evaluation that takes into account advances in technology, company goals,
and structural shifts are among the sources of data used to establish levels of competence. In this
context, the audit could suggest certain course-correcting measures. For instance, it may suggest
keeping a training attendance log, copies of certifications, signed applications for the company's
numerous procedures, and education and experience records.
 3. Operational planning

When a new product or service is offered, or an old product is updated, the audit may suggest
adapting or creating new processes and resources to meet the demands of that product.

4. Infrastructure

Offices, factories, warehouses, and distribution hubs could all be on the list of suggested
infrastructure additions.

5. Corrective action

Finally, the audit may discover and suggest that remedial action be taken as a result of a
nonconformity or finding.
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