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Understanding the Main Aspects that make up


QMS Audits

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UNDERSTANDING THE MAIN ISSUES THAT MAKE UP QMS AUDIT
For the development of this skill, you need to know and be able to manage audits and interpret the
process of certification under the ISO 9001 management system.

KNOWLEDGE

In this skills unit you will develop the following skills related to disciplinary knowledge:

Distinguish between Participants in an Audit.


Know basic concepts and definitions of interest.
Differentiate the Types of Audits.
Understand the objectives of an audit of a QMS.
Understand the Audits and Certification of the
Know the General Characteristics of an Audit. Company.

SKILLS

In this Skills Unit, you will develop the following skills related to professional knowledge:

Individual Exercise: Analyze the benefits of conducting internal audits in an organization. To be


completed throughout this Skills Unit.
Study Case: Assess whether the management system implemented in the company meets the
requirements of ISO 9001. To be completed throughout this Module / Course.
Debate: Recognize the importance of conducting internal audits in organizations. To be completed
throughout this Skills Unit.

ATTITUDE

In this Skills Unit, you will develop the following attitude in particular:

Encourage Active Listening

SELF-ASSESSMENT
Participants in an Audit.
Concepts and Definitions of Interest.
Types of Audits.
Objectives of an Audit of a QMS.
Audits and Certification of the Company.
General Characteristics of an Audit.

KNOWLEDGE ASSESSMENT TEST

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CONCEPTS AND DEFINITIONS OF INTEREST
The ISO 9000 series of International Standards emphasize the importance of audits as a management
tool for monitoring and verifying the effective implementation of an organization’s policy for quality
management.

Audits are also an essential part of the activities of conformity assessment and the assessment and
monitoring of the supply chain.

Audit

An audit is a systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled process.

ISO 19011 “Guidelines for Audit Management Systems”

It can be said that an audit is the examination by neutral people, of compliance with a particular standard
or procedure.

More simply, the audit is an analysis activity which, starting from an initial point of gathering information,
evaluates it for possible errors, establishes guidelines to correct it.

It is not a "police process", but a technical process in which the auditee has to always see the positive
side of receiving information on the operation of the company.

An audit should not become a simple routine inspection, and not only the individual or audit team, but also
the audited parties themselves participate in its development. The success and effectiveness of an audit
depend on the cooperation of all parties.

Thus, we can conclude that an audit is:

■ A methodical and documented examination.


■ Independent, that is, by persons who have no direct responsibility in the areas to be audited.

Definitions
The following definitions, which are contained in the Rules are essential knowledge:

■ ISO 9000 "Systems Quality Management. Fundamentals and vocabulary ".


■ ISO 14001. “Environmental Management Systems”.
■ ISO 19011 "Guidelines for auditing management systems"

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Understanding the main issues that make up QMS audits

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OBJECTIVES OF AN AUDIT OF A QMS
The audit of a management system of quality management is used in order to verify that the quality
management system has been properly developed, documented, implemented and is being followed
by the organization.

To do so, the auditors perform a comprehensive assessment of the management system and prepare a
detailed report.

In case deviations regarding the system are detected, the company must carry out the corrective actions
needed to address them.

Audit Objectives

■ Study the system documents to determine if they comply with the corresponding reference
standards.
■ Evaluate the capacity management system to ensure compliance with legal and contractual
requirements, regulatory.
■ Check the adequacy of the quality policy system operation and activities of the company.
■ Check the degree of fulfillment of the objectives of the Policy.
■ Establish the level of compliance of the procedures that are part of the management system, and
thus:

- Check that it implements and maintains the QMS

- Check the compliance processes to achieve the objectives of the company and the
implementation of the Environmental Policy.

- Identify risks and opportunities.

- Propose corrective and necessary actions to achieve compliance with the procedures and
objectives improvement.

- Propose modification of the documented information when it is shown that they are not
suitable for the development of the company.

- To prevent the recurrence of problems.

■ Identify areas for potential improvement of the management system.

The study of audited procedure and review of their compliance by auditors, along with the creative
contribution of those responsible for the process, provide an opportunity for simplifying and improving the
operation, with its sights set on increasing the quality and cost reduction.

Consequently, audits are performed in order to determine:

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■ The adequacy of the management system of the organization to the specific reference standard.
■ The conformity of the actions of the staff of an organization with reference to the requirements of
your quality program as defined in the documentation.
■ The effectiveness of the various activities that make up the management system of the organization,
and corrective and / or preventive measures adopted.

Keep in mind, however, that the philosophy of management systems is based on prevention rather than
detection of problems, and we must give more importance to:

Audits provide the company Manager objective evidence based on facts. This allows management to
make decisions based on facts, not assumptions.

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GENERAL CHARACTERISTICS OF AN AUDIT
To perform an audit, the reference standard on which such an audit is applied must be deployed and
implemented in the organization.

It is essential to have trained personnel to carry it out. Otherwise, the assessment objectives desired
will not be achieved, and the staff being audited will become very demotivated on being judged by people
they do not believe have sufficient level to do so.

Before performing an audit, the purpose of such an audit should be established, clearly indicating its
limits, so they are not confusing, and any documentation and information that exists on the object to be
audited should be gathered together.

Documentation and information to develop an Audit

■ Statistical data on product quality or process.


■ Information on the status and achievements of the competition.
■ Quality Manual.
■ Process / General Quality Procedures.
■ Technical Instructions.
■ Cost data quality.
■ Technical Specifications.
■ Standards and applicable law.
■ Customer complaints or claims.
■ Reports of previous audits (if applicable).
■ Reports of nonconformity (System and product)
■ Records on corrective and recently implemented or proposed improvement actions.
■ Records and documents required by the reference standard.
■ Information on risks and opportunities.
■ Information on relevant stakeholders and their requirements.
■ Etc.

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When conducting an internal audit by staff of the company, it is necessary that the appointed auditors
have a copy of the Process / Procedure for the Conduct of Audits, drafted and approved prior to the
audit, so that the auditing staff have a pattern to follow, noting their skills and limitations.

Furthermore, the appropriate contacts should be established with the people in charge of the audited
process, to explain the aim of the audit, introduce them to the staff of the audit team and explain the
general lines of conduct they will follow.

In the course of the audit, the auditor must always bear in mind that:

■ Only objective evidence will be evaluated and contrasted.


■ If a possible deficiency detected, it will be investigated until it is confirmed or not, it is determined
whether it is random or systematic and if possible, its causes and effects are identified.
■ It should be a thorough monitoring of the anomalies detected in previous audits.

Checks During the Audit

■ The checks carried out during the audit are, in general, of the following nature:
■ Review of documents applicable to the quality management system, to ensure that the audited
organization has the management system documents required by the implementing rule.
■ Review of records and documentary evidence demonstrating the compliance of the quality
management system.
■ Direct supervision of processes, to ensure that the activities are carried out as provided in the
documentation of the quality management system.

Once the audit is complete, the auditor holds a meeting with the audited party, or delegated person,
who explains the deviations found to get his agreement with them or for him to submit comments. After
the meeting, the auditor shall draw up the corresponding Audit Report.

The audit must not sound like destructive criticism. The positive aspects of the audited system should
be underlined. However, what should be specified in the document or final report of the audit are all the
non-conformities detected and verified on the basis of objective evidence.

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PARTICIPANTS IN AN AUDIT
In an audit process three participants are involved: Client, auditor and auditee. Each one should be clearly
differentiated as sometimes some of the roles can coincide.

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Audit Client
The client is the person or organization requesting an audit.

■ A buyer, actual or potential, who wants to evaluate the ability of a


supplier to supply certain products or commodities that meet his needs or
meet certain, specified requirements. This buyer will be the responsible
client when he requests a third party to audit the provider.
■ An organization that wants to establish audits as part of a continuous
assessment or to detect anomalies in the Management System.
■ The Administration, when it is an official body that requires suppliers of
certain products or special services to undergo an audit by accredited
certification bodies, inspection bodies and other approved bodies.
■ The auditee himself, who may request:
The client can be
- A specialized external organization to assess his system.

- A member of the organization conducting internal audits to evaluate his


system.

- A Certifying Body to audit his System with a view to obtaining a register


of the company.

- An independent body to determine if the system allows for proper


management of products to be supplied (inspection or regulatory
bodies).

■ Define the objectives of the audit.


■ Define the scope of the audit.
■ Determine the reference standards used.
Customer Functions
■ Select or hire the auditor staff.
■ Determine the duration of the audit.
■ Collaborate at all times with the auditor.

Audit Organization
The audit organization is one that plans and directs the audit process. It also selects and hires auditors
for each audit, ensuring their qualification and suitability

For first-party audits, management appoints the audit organization. In very small companies,
responsibility for planning and conducting internal audits usually falls on the Quality and Management
Representative. Auditors can be internal or outsourced.

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For second party audits, the audit organization can be an audit client (the organization that wants to
audit their suppliers) or may be subcontracted.

For third party audits, the audit organization is always external and independent.

For the special case of certification, the auditing organization, as well as being independent, should be a
national or international accrediting body.

We can distinguish between auditors:

■ Audit team leader: Auditor appointed to lead, plan and act as principal
interlocutor to report deviations found and evaluate corrective actions.
■ Auditor: A person who performs any part of the audit, under the direction of
team leader

Other partners can join auditors, such as trainee auditors, translators and
interpreters or even observers. The latter, observers are usually:
Auditor categories

■ People of the audited organization itself, who have expressed their desire to
attend the audit for personal learning.
■ People belonging to or representatives of a buyer.
■ Own staff of the auditing entity whose aim is to assess the auditor with a
view to registration and qualification.

These observers should remain neutral as to the conduct of the audit and not
interfere in its execution

■ Agreeing with the client's objectives, scope and audit criteria.


■ Agreeing with the customer and audited the date and duration of the audit.
■ Select equipment suitable for the specific audit auditor.
■ Provide resources for conducting the audit.
Functions of Auditor
■ Ensure that the auditor carrying out the audit team according to established
criteria.
■ Receive the audit report prepared by the audit team.
■ Submit the report to the audit client and the auditee.

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Audited Organization
Is it the organization or entity on which the audit is conducted?

It may be:

Types ■ A full organization or just a few production sites.


■ All the quality management system or only some areas, departments, or
functions.

The client and audited party coincide in the same organization or person when
Match between client the latter commissions a third party (a certification authority, for example) to
and Audited Party conduct an audit of its own management system (in order to receive a certificate
and / or be included in a register of certified companies).

■ Link to the auditors to plan the audit


■ Provide access to areas to be audited.
■ Provide information and data required by auditors.
Functions Audited ■ Cooperate with the auditors to provide audit
■ Encourage employees to participate
■ Acting on the findings of the audit
■ Provide resources for corrective and preventive actions

Example of a Summary
A clear example that distinguishes all three, is given in audits of suppliers, in which three members are
involved:

■ On the one hand the audit client, who is the company that requests the services of the supplier.
■ On the other the auditee, who is the supplier.
■ And finally, the auditor, the organization contracted to conduct the audit.

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TYPES OF AUDITS
Audits can be classified, based on their origin, including:

■ Internal audits, conducted for internal purposes by the organization or on its behalf.
■ External audits by auditors who do not belong to the audited organization.

Internal audits are also known as first-party audits, while external audits are known as second- or
third-party audits:

Made for internal purposes by the organization or on


Internal Audits First party
its behalf.

Made by customers of the organization or by others


Second party on their behalf. An example of this is the audits of
suppliers.
External Audits

By independent external organizations that provide


Third party certification or registration in accordance with the
requirements contained in the rule.

In any case, independence of the auditor from the audited activities is a basic requirement. The credibility
of the auditor is based on it, and is seen as objective and independent, so that the credibility of the results
of the audit will not compromised.

This independence is particularly critical in conducting internal audits to check the adequacy of the
system.

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On the other hand, audits to assess compliance of the activities undertaken in relation to the system
documentation itself, can be carried out by the company's own auditors without the independence
condition being compromised, provided that these auditors are not directly involved in the activities being
audited.

Furthermore, internal audits are much more accessible to all types of businesses and have the
advantage that the audit staff have a greater knowledge of the production process. This may mean that
the audit time is shorter, and therefore they can be done more frequently, so that the audits become a
regular and routine means of monitoring and improving.

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AUDITS AND CERTIFICATION OF THE COMPANY
Once the management system in place, the next step is for the organization to be able to assure itself and
others that the system works effectively as part of a pre-established quality policy and its products /
service have the required quality.

Therefore the audit and certification arise as vital tools to meet these needs.

Certification
Certification is a way to confirm, in general, to people outside the company, that the organization is able to
ensure the quality of its products.

It is a certificate issued by an officially recognized body where compliance with the management
system of the company according to the standard on which the system is based, is confirmed.

That is to say, after the audit the certification identifies the conformity of a product or system with the
requirements contained in Standard.

The system certification is voluntary and carried out by a private, independent body of the organization,
which must be accredited by an accreditation body.

For example, in the case of Spain, the entity must be accredited by ENAC (National Accreditation Body).

Benefits of Certification

■ Improving the external image of the company increasing its credibility.


■ Increased transparency.
■ Increased consumer confidence, distributors and government authorities.
■ Increase the competitive ability of the organization.
■ Access to new markets and customer specifications.
■ It involves an effective business case.
■ Reduces the number of internal audits by customers.

Once the entity grants the certificate, the certificate has a limited validity. At the end of that time period it
is necessary to perform another audit for renewal, thus checking that the conditions for granting the
certificate are maintained.

Generally, after obtaining the certificate it has a validity period of three years, once this period another
audit for renewal is performed and in the course of the follow-up audits are performed annually.

DOCUMENT FOR THE DOWNLOAD (Through the platform)


Accessing this Competency Unit through the platform, you can download the General
Scheme of a certification process.

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SKILLS

INDIVIDUAL WORK

Download from the platform the individual/s work/s (IW) related/s with this unit and complete
Competition/s following the instructions in the file "instructions for the preparation and resolution of
an Individual Job ".

You can access this file through the main window "Virtual Campus" within the section Resources
documentation / general documentation.

CASE STUDY

Download from the platform the Case Study (CS) related to the Units of competence of the module or
theme of the course and computer tells, by following the instructions given in the file "instructions for
the preparation and resolution of a Case Study “.

You can access this file through the main window "Virtual Campus" within the section Resources
>Documentation/General Documentation

DISCUSSION

Follows the instructions in the paragraph skills> Discussion Student Guide and debate along with the
rest of his teammates in the different open topics.

You can access the guide the student through the main window. "Virtual Campus”. Within the resources
section/documentation.

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ATTITUDE

ACTIVE LISTENING

Listen, understand and comprehend the communication issued by the person who speaks or gives an
opinion.

The act of listening is probably the most important tool available to a person to influence others.

But to influence others it is necessary to focus efforts on first understanding what the other person wants
to tell us.

Listening means being able to accept what the other person expresses, and in no way ignore what the
other has to say.

To really listen is a difficult task. It is customary to pay attention to half or only a part of what we are told.
Moreover, we pretend to be listening with phrases like: "If I'm listening, continue," when in fact the person
has long been disconnected from what they are discussing.

It is essential in any process of active listening in order to hear the truth the other person says:

■ Summarize what was discussed with the other person.


■ Ask questions to get more information if possible.
■ Identify and clarify the issue that focused the conversation.

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NOTES

Understanding the main issues that make up QMS audits

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Understand the Main Issues to Meet an Audit QMS

 Bureau Veritas Formación, S.A. Unipersonal

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