Quality Management System

SUPPORT
OPERATION
Group 6
Maribel L. Aguilar
Winie S. Abetria
Jose Danilo A. Bante Jr.
Arlene S. Encanto
Lougen M. Tuala
Benjieler S. Zoleta
Objectives:
a. Discuss the standard requirements of ISO
Quality management system in terms of
Support and Operations
b. Desire for continuous improvement
Plan: Recognize an opportunity and plan a change.
Do: Test the change. Carry out a small-scale study.
Check: Review the test, analyze the results and
identify what you’ve learned.
Act: Take action based on what you learned in the
study step. If the change did not work, go through
the cycle again with a different plan. If you were
successful, incorporate what you learned from the
test into wider changes. Use what you learned to
plan new improvements, beginning the cycle
again.
2. To ensure the provision, availability, and
sustainability and include all the means, applications,
interfaces, and facilities necessary for the realization
of products or services from the design stages
through its delivery and post-delivery activities.
The ability of activities and operations to
achieve expected results and product
requirements according to customer
satisfaction and regulatory requirements
Addressing changing needs and trends, the
organization shall consider its current knowledge
and determine how to acquire or access the
necessary additional knowledge.
The organization shall determine the
internal and external process relevant to
the QMS.
ISO 9001:2015 Clause
7. Support
7.1 Resources
7.1.1 General
The organization shall
determine and provide the
resources needed for the
establishment, implementation,
maintenance and continual
improvement of the quality
management system.
The organization shall consider:
a.The capabilities of, and
constraint on, existing internal
resources;
b.What needs to be obtained
from external providers
7.1.2 people
To ensure that the organization can
consistently meet customer and applicable
statutory and regulatory requirements, the
organization shall provide the persons
necessary for the effective operation of the
quality management system, including the
process needed.
7.1.3 Infrastructure
The organization shall determine,
provide and maintain the
infrastructure for the operation
and its processes to achieve
conformity of products and
services.
7.1.4 Environment for the Operation
of Processes
The environment for the operation of processes (in
the ISO 9001:2008 Standard identified as work
environment) consists of the premises, sites, and
locations where process-related activities are
being carried. The process environment is
supposed to provide the manufacturer or service
provider with the optimal conditions for the
realization processes and thus has a direct effect
on products or services.
The process environment includes not only the
physical locations, but also the influence of
equipment or materials used during the
realization processes. The goal of controlling the
process environment is to determine, define,
direct, monitor, regulate, coordinate, and, when
necessary, document the conditions of the
process environment. It will be done by
introducing the environment to predefined
activities and controls. The activities cover
specific areas, and their parameters are confined
to specified limits or definitions.
The ISO 9001 Standard requirements refer to all areas,
spaces, and halls that serve the organization for operation
and realization of products or services. These conditions are
included under the following categories: physical elements
of work spaces, factors that may influence the processes and
activities, and resources that are three parameters:
1. The ability of activities and operations to achieve
expected results and product requirements according to
customer satisfaction and regulatory requirements
2. The ability of the process environment to support the
resources that operate business activities
3. The ability of the process environment to support the
safety of products—the conditions of protection against
consequences of failure, damage, error, accidents, harm, or
any other event that could be considered as nonconformity
 ISO 9001 Requirements Clause 7.1.5
Measuring and monitoring resources

Measurement – is a process to
determine the property or value of
something, usually expressed as a
quantity, e.g. temperature, speed,
weight, dimension, etc.
Measurement process – is a set of
operations to determine the value of a
quantity.
An organization provides various products and
services and may use a number of processes to
produce them. ISO 9001 requires:
· Measuring various quality characteristics
(material, dimensional, functional, durability,
safety; etc) of these products and services to
defined criteria to verify conformity to
requirements,
· Monitoring key process variables (temperature,
pressure, flow rate, time, mix rates, concentration
of processing liquids, etc) to ensure these
processes operate within controlled parameters.
Your MMR procedures and controls
(documented or not) must include:
 Determining the specific product or service
quality characteristics or process variables that
need to be measured and monitored;
 Determining the suitability & precision of
MMR needed for such M&M;
 The acceptance criteria for product & service
quality characteristics and process control
variables;
 Ensuring calibration traceability to national or
international standards;
The timing & frequency – when & at what stages of the
realization process to do MM; how often to do it and the
sample size for M&M; etc.
 Responsibility, competence and training for MM
activities;
 How (methods) such MM activities will be performed;
 Performing a risk assessment to evaluate the risks related
to MMR and their use and take appropriate risk
mitigation steps (see clause 6.1);
 Determining what records are needed as evidence that
MMR are fit for purpose, i.e. conducting MM activities &
providing reliable results;
 Using appropriate performance indicators to evaluate the
effectiveness of the use of MMR.
 Applying the PDCA approach to control the process for
using MMR as explained in this section.
ISO 9001 Requirements Clause 7.1.6
Organizational knowledge
OK has been recognized as a vital business
asset. It is specific to each organization and
can be used as a powerful tool to gain
competitive advantage. Many organizations
now identify, capture, internalize and
leverage relevant OK as an important
business strategy. The many ways OK can be
used to add value to an organization include:
Improving products, services and QMS processes.
 Improving employee training and performance.
 Reducing business and QMS risks.
 Making more informed decisions about courses
of action.
 Anticipating, understanding and adapting to
trends and changes in its business environment.
 Exploiting existing and acquired knowledge
assets.
 Developing new opportunities.
 Leveraging OK to gain competitive advantage.
 Promoting a learning environment to further
stimulate creation of new knowledge.
What is organizational knowledge (OK)?
It can be defined as information combined with
experience, context, interpretation, and insight
that is useful in making decisions and taking action
specific to your organization and QMS. Such
information includes:
 Specific technical and procedural information
required to produce conforming products and
services and for controlling QMS processes
needed to produce them. These may include
product and service specifications, drawings,
process flow diagrams,
product and process steps, criteria, work
instructions, or verbal instructions, etc.
 Novel, unique, highly creative and innovative
ways of doing things that are formally encoded in
business processes, practices, methods, etc.
 Lessons learned from past failures, near miss
situations and successes,
 Capturing undocumented knowledge (explicit and
tacit) and experience that resides within the
minds of employees and employee groups,
 Developed or acquired knowledge – patents,
practices, technologies, research & development,
The results of research and improvement projects
for products, services, processes and business
practices,
Knowledge of markets, competitors, customers,
suppliers and interested parties, etc.
 Knowledge acquired through consultants,
conferences, universities, research institutes, etc.
on best practices or to resolve specific business
and QMS problems.
OK is generally of two types;
 Explicit knowledge – that which can
be written down, transferred, and
shared. It is definable and can be
protected by the legal system;
 Tacit knowledge – is know-how that is
usually hard to describe. It can be
demonstrated but difficult to
document as it resides in the minds of
employees. It become evident through
performance and on-the-job training.
Requirements regarding OK were introduced for
the purpose of:
· Safeguarding the organizational knowledge from
loss of knowledge, e.g.
· Through staff turnover;
· Failure to capture and share information;
· Loss or theft by personnel or outsiders.
· Encouraging the organization to acquire
knowledge, e.g.
· Learning from experience;
· Mentoring;
· Benchmarking;
· Building relationships with relevant interested parties.
ISO 9001 Requirements
Clause 7.2 Competence
Planning for competency controls must include
determining – competency criteria; skills
evaluation; identification of training needs; types
of training; provision of training; how training
effectiveness is evaluated. Although training may
end up being the best solution, don’t overlook
other actions, such as, changing processes,
improving procedures, rotating jobs, outsourcing,
or recruiting fully training people.
Criteria for competency must be developed based
on appropriate education, skills, training and
experience for activities, tasks, functions and
processes. The level and detail of such qualifications,
skills, training and experience will depend upon the
complexity of product, process, technology and
customer and regulatory requirements.
Job requirements -Education may be defined as the
process of acquiring general knowledge, developing
the powers of reasoning and judgment to prepare
intellectually for mature life. Education requirements
will vary accordingly and may range from a university
degree, college diploma and high school graduate to
no educational background.
Skills relate to your ability to perform certain tasks
related to your job. Skills may be categorized into
hard and soft skills.
Hard skills deal with specific knowledge & abilities
such as technical, IT, leadership, management,
problem-solving, time management, language, etc.
Hard skills are learned through education.
Soft skills deal with attributes and personality traits
that relate to how well you fit in the organization
and include communicative, inter-personal, verbal,
awareness, flexibility, team-work, etc. Soft skills are
learned through on the job experience.
Work Experience relates to the history of work,
skills and performance that a person has gained
from his/her past employment that can be
matched against the job requirements of the
position an employer is looking to fill. Again this
may vary from an entry level position that may
require little or no experience to a senior level
executive that may require 10 or more years of
related experience
This article is an extract from my
eCourse “Understanding ISO
9001:2015”.

copyright © 2015 askartsolutions.com

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 Awareness
7.3 Awareness
ISO 9001:2015 states that it is the responsibility of the organization
to ensure that persons carrying out work under its control are aware
of:
1. The quality policy,
2. Any relevant quality objectives,
3. Their own contribution to the effectiveness of the management
system including the benefits of improved performance,
4. Implications of not conforming with the management system
requirements
Comment:
The 2015 update of the standard specifically requires organizations to make
personnel under its control aware of the organization's quality policy, quality
objectives, their own specific contribution as well as importantly the consequences
of not conforming with requirements. Businesses should review their communication
and awareness activities and plans to ensure all affected personnel are included and
address any gaps. A review may also be required to ensure that processes cover the
not conforming with the management system requirements element of the clause.

Depending on the size and culture of the organization, a wide range of methods can
be employed for communication and awareness of the business quality policy and
objectives. From regular meetings, briefings, tool box talks, bulletins, poster
campaigns and publication of quality metrics, to the inclusion and involvement of
individuals in cross functional teams and improvement initiatives.
Job descriptions, training, work instructions and performance reviews are some ways
in which personnel can be made aware of their specific contributions and
(importantly,) implications of non-conformance.
Communication
• Effective communication within a company allows the
Management System to function efficiently, by
providing relevant, meaningful information to the
people who need it. The 2015 revision of ISO 9001
makes it is necessary for a company to decipher the
internal and external communications pertinent to the
management system and put some structure around
it. In doing this it is necessary to know who to
communicate with, how communication will occur and
who is responsible for doing the communication
• When working with communication within a company there is
two main divisions to consider; internal and external. Internal
communication is all levels of the organization, this means the
staff who deliver and implement information, operational staff
and management staff. Internal communication can be delivered
in three main formats; visually, written and face to face. The
format of internal communication is determined by any barriers
within the company.
• Barriers within a company could include language barriers,
illiteracy, some staff working outside the office, technology
within the company, etc. Internal communication is all about
ensuring internal employees have the information they need to be
able to effectively execute their job.
 Categories and examples of internal and
external communication:
a) What is communicated: ​Define and document the topic of communication - what is the information
that is going to be delivered?
b) Frequency of communication; Specify how often this communication is going to take place. This is
typically daily, weekly, monthly, quarterly, yearly. The frequency of the communication depends solely on
the topic of discussion, for example financial communication may be monthly whereas structural or
environmental changes could be yearly.
c) Audience; this can be anyone internal or external to the company and be decided based on the topic of
the communication, for example financial communication may be with only internal employees that handle
cash flow or budget information, structural or environmental may only include any employees that can
make physical changes within the company or work in the department being altered or changed. Quarterly
business reviews may be delivered to the Board of Directors.
d) Mode of Delivery; this can be done in many ways including face to face, visually which would include
power points, videos, dry erase board or written could be a newsletter, email, manual, etc.
e) Communicator; this is typically determined by the topic of communication - who is the person (or
group) responsible for delivering the communication.
​All in all, communication is a really important aspect of running an effective and efficient business;
utilizing a simple structure like a communication matrix can ensure intentional, relevant, and timely
delivery of information.
 Documented information
Documents and Records
• The ISO 9001:2015 standard no longer uses the terms “documents” and
“records”. Both are now called “documented information”. As per the ISO
9000:2015 definition, the term documented information refers to information
that must be controlled and maintained. Therefore, it expects that you also
maintain and control the medium as well as the information.
• The key identifier of a record verses a document is that records are
documented information that is “retained” and documents are documented
information that is “maintained”. A form is a document, when the form is
filled out it becomes a record. Both documents and records most be controlled
following the requirements of the ISO 9001:2015 standard covered in clause
7.5.
• What are the requirements for documentation in the ISO 9001:2015
standard?
• Your documented information must include documents and records that are required by the standard and
essential for your organization’s operations to be effective. ISO 9001:2008 required six specific
procedures in order to be compliant. ISO 9001:2015 no longer requires procedures, but if your
organization needs them to be effective, you must have them.
• Documented information is used as evidence of conformance, provides consistency is how a process is
executed, assists with training and prevents loss of knowledge. If you have a complex or inconsistent
process, it is highly recommended that it be documented. Also, consider documenting any process where
only one employee knows how to execute. This protects the organization from loss of knowledge in the
event that the employee no longer works at the organization.
• The following documented information is still required by the 9001 standard:
• Quality Policy
• Quality Objectives
• QMS Scope
• You are also no longer required to have a quality manual, but if you have one keep it. Your quality
manual is your recipe book for how you manage quality in your organization. A quality manual similar to
ours, can also serve as an introduction (or a table of contents) for the QMS.
• Controlling documented information means that you have a process for identifying, reviewing and
approving documents as well as using an appropriate format and media for the contents of the
documented information. You need to ensure the documented information is available for those that need
to access it, is protected, version controlled and inactive/old versions are disposed of properly.
 Creating and Updating
• You should seek to confirm that when documented information is created or updated,
your organization has ensured that it is appropriately identified and described (e.g. title,
date, author, reference number).
• It must be in an appropriate format (e.g. language, software version, graphics) and on
appropriate media (e.g. paper, electronic). Confirm that documented information is
reviewed and approved for suitability and adequacy.
• You should seek to confirm that when documented information is created or updated,
your organization has ensured that it is appropriately identified and described (e.g. title,
date, author, reference number). It must be in an appropriate format (e.g. language,
software version, graphics) and on appropriate media (e.g. paper, electronic). Confirm
that documented information is reviewed and approved for suitability and adequacy.
• Documents that you use as a business should have clear document control. You will
already be used to doing this. It also expects a clear format and for it to be approved. This
is to prevent anyone just using documents that they see fit.
• It seems slightly unnecessary when you are a SME as there may be a very small team or
even one of you. For larger businesses this is really important so that documents are used
properly and changes that have been incorporated for the good don’t get lost when
someone else doesn’t understand them or removes them.
 Control of Documented Information
Your organization must control the documented
information required by the QMS. A suitable process
must be implemented to define the controls needed to;
approve, review, update, identify changes, identify
revision status and provide access. The documented
information process should define the scope, purpose,
method and responsibilities required to implement
these parameters
• To get the most out of your documented information process, it must
communicated to ensure that staff and other users of the documentation
information understand what they must do in order to manage that information
effectively and efficiently. Demonstrate the organization's arrangements for
controlling documented information required by ISO 9001 and your
organizations own requirements, including:
• Availability e.g. document accessibility (hard copy, electronic media), readily
available at the point of use;
• Suitability e.g. format, media suitable to the environment, ease of
understanding, language, interpretation;
• Protection e.g. document authentication, document markings (official, secret,
restricted, confidential, private, sensitive, classified, unclassified), access
controls (individual, role specific),
• Physical security (master documents, server rooms, libraries) IT security (User
ID, password, servers, download, back up, encryption, ‘read only’,
‘read/write’), protection from corruption and unintended alterations.
OPERATION
JOSE DANILO A. BANTE
Facilitator
8.1 Operation Planning and Control
8.1q1 The organization shall plan, implement and control the
processes, as outlined in 4.4, needed to meet requirements for the
provision of products and services and to implement the actions
determined in 6.1 by
a. Determining requirements for the products and services;
b. Establishing criteria for the processes and for the acceptance of
products and services
c. Determining the resources needed to achieve conformity to
product and service requirements
d. Implementing control of the processes in accordance with
the criteria
e. Retaining documented information to the extent necessary
to have confidence that the processes have been carried out
as planned and to demonstrate conformity of products and
services to requirements
8.1q2 The output of this planning shall be suitable for
the organization’s operations

8.1q3 The organization shall control planned changes

and review the consequences of unintended changes,
taking action to mitigate any adverse effects, as
necessary.

8.1q4 The organization shall ensure that outsourced

processes are controlled in accordance with 8.4
8.2 Determination of requirements for products
and services
8.2.1 Customer communication
8.2.1q1 The organization shall establish the processes for
communicating with customers in relation to:
a. Information relating to products and services;
b. Enquires, contracts or order handling, including changes;
c. Obtaining customer views and perceptions, including customer
complaints;
d. The handling or treatment of customer property, if applicable;
e. Specific requirements for contingency actions, when relevant.
8.2.2 Determination of requirements related to products
and services
8.2.2q1 The organization shall establish, implement and maintain a
process to determine the requirements for the process for the
products and services to be offered to potential customers

8.2.2q2 The organization shall ensure that;

a. Products and service requirements (including those considered
necessary by the organization) and applicable statutory and
regulatory requirements, are defined;
b. It has the ability to meet the defined requirements and substantiate
the claims for the products and services it offers
8.2.3 Review of the requirements related to
products and services
8.2.3q1 The organization shall review, as applicable:
a. Requirements specified by the customer, including requirements for
delivery and post-delivery activities;
b. Requirements not stated by the customer, but necessary for the
customers’ specified or intended use, when known
c. Additional statutory and regulatory requirements applicable to the
products and services
d. Contract or order requirements differing from those previously
expressed.
NOTE: Requirements can also include those arising from relevant interested
parties
8.2.3q2 the review shall be conducted prior to the
organization’s commitment to supply products and
services to the customer and shall ensure contract or
order requirements differing form those previously
defined are resolved.

8.2.3q3 Where the customer does not provide a

customer a documented statement of their
requirement if the customer requirements shall be
confirmed by the organization before acceptance
8.2.3q4 documented information describing the results
of review, including any new or changed requirements
for the products and services, shall be retained

8.2.3q5 where requirements for products and services

are changed, the organization shall ensure that relevant
documented information is amended and that relevant
personnel are made aware of the changed requirments
8.3 Design and Development of Products and Services
8.3.1 General

8.3.1q1 Where the detailed requirements of the organization’s products

and services are not already established or not defined by the customer or
by other interested parties, such that they are adequate for subsequent
production or service provision, the organization shall establish,
implement and maintain a design and development process.

NOTE 1: The organization can also apply the requirements given in 8.5 to
the development of processes for production and services provision.
NOTE 2: For services, design and development planning can address the
whole service delivery process. The organization can therefore choose to
consider the requirements of clauses 8.3 and 8.5 together.
8.3.2 Design and Development Planning
8.3.2q1 in determining the stages and control for design and
development, the organization shall consider:
a. The nature, duration and complexity of the design and
development activities;
b. Requirements that specify particular process stages, including
applicable design and development reviews
c. The required design and development verification and validation;
d. The responsibilities and authorities involved in the design and
development process;
e. The need to control interfaces between
individuals and parties involved in the design and
development process;
f. The need for involvement of customer and user
groups in the design and development process;
g. The necessary documented information to
confirm that design and development
requirements have been met.
8.3.3 Design and Development Inputs
8.3.3q1 the organization shall determine:
a. Requirements essential for the specific type of products
and services being designed and developed, including, as
applicable, functional and performance requirements;
b. Applicable statutory and regulatory requirements;
c. Standards or codes of practice that the organization has
committed to implement
d. Internal and external resource needs for the design and
development of products and services

e. The potential consequences of failure due to the nature of

products and services

f. The level of control expected of the design and development

process by customers and other relevant interested parties
8.3.3q2 Inputs shall be adequate for design and
development purposes, complete and unambiguous.
Conflicts among inputs shall be resolved
8.3.4 Design and development controls
8.3.4q1 The controls applied to design and development process shall ensure
that:
a. The results to be achieved by the design and development reviews are
clearly defined
b. Design and development reviews are conducted as planned
c. Verification is conducted to ensure that the design and development
outputs have met the design and development input requirements
d. Validation is conducted to ensure that the resulting products and
services are capable of meeting the requirements for the specified
application or intended use (when known)
8.3.5 Design and Development outputs
8.3.5q1 The organization shall ensure that the design and development
outputs:
a. Meet the input requirements for the design and development;
b. Are adequate for subsequent processes for the provision pf
products and services
c. Include or reference monitoring and measuring requirements, and
acceptance criteria as applicable
d. Ensure products to be produced, or services to be provided, are fit
for intended purpose and their safe and proper use
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION
QUALITY MANAGEMENT SYSTEM

OPERATIONS
QMS OPERATIONS
8.4 CONTROL OF EXTERNALLY PROVIDED PRODUCTS AND SERVICES
• 8.4.1 General
• 8.4.2 Type and Extent of Control of External Provision
• 8.4.3 Information for External Providers
QMS OPERATIONS
• 8.5 PRODUCTION AND SERVICE PROVISION
• 8.5.1 Control of production and service provision
• 8.5.2 Identification and traceability
• 8.5.3 Property belonging to customers or external providers
QMS OPERATIONS
• 8.5.4 Preservation
• 8.5.5 Post-delivery activities
• 8.5.6 Control of changes
 Benjieler S. Zoleta
Educ 205- School Management Organization
• 8.7 Control of Nonconforming Outputs
• ISO 9001:2015 Standard Control of Nonconforming Output Requirements
• As soon as nonconforming outputs are detected within the organization,
they must be identified, recorded, and controlled; and most importantly,
they must be treated. The objective is to prevent the release, delivery, or
use of nonconformity products or services by the customers. Treating and
managing nonconformities is one of the basic objectives of the ISO 9001
Standard. Nonconforming outputs refer to the outputs of processes that do
not fulfill a requirement that is a need or an expectation of one of the
interested parties of the organization that is stated, implied, or obligated.
Controlling the nonconforming outputs is planning activities for detecting
nonconforming outputs and deciding what is to be done with them. And
the ISO 9001 Standard specifically mentions what options one has.
• When planning the process for handling nonconforming products, the next
issues are expected:
• 1. The organization shall maintain a documented procedure that
describes the method of detecting and controlling non-conforming
products. The documentation of the procedure must be controlled and
introduced to the documents control process in the organization as
required in paragraph 4.2.4 – control of documents
• 2. As soon as a non-conforming product was detected and must be
segregated from other products in. The organization must initiate an action
in order to identify and eliminate the use of non-conforming product
• 3. Releasing a non-conforming product must be approved by a prior
authorized function. The release would be under concession. Concession
can be made by an authorized person or by the customer but anyway
documented
• 4. The organization is required to maintain records that describe the
nonconformities detected and the actions that were taken to
eliminate them. The records are to be introduced to the records
control process as required in paragraph 4.2.5– control of records
• 5. When nonconformity is detected after delivering the product,
actions must be taken relevant to the nature of the nonconformities
• 6. When a nonconforming product was re-processed, it must be re-
validated in order to ensure that it meets the requirements
(customer’s or regulatory).
Detecting the Nonconforming Outputs
• First thing is first. I want to make sure that we are talking about the
same thing when we are referring to nonconforming output. A
Nonconforming output: a product or process result that does not conform
to its specified requirements:
•
• Customer’s requirements: Functionality or intended use requirements
• Regulatory requirements
• We may look at it in another way: nonconformity is where a result was
not achieved according to a specific requirement. The requirement refers
to both products that were detected in house and products that were
already delivered to the customer.
• Controlling the nonconforming outputs will allow the organization to
minimize their effect. Nonconformance can occur in raw materials,
components, in goods that are in process or finished goods, or service
operations. When nonconforming outputs are detected, the first step is to
identify them. In order to effectively identify nonconforming outputs, one
must understand which quality tools will indicate that a process output is
nonconforming. The ISO 9001 Standard requires quite a few controls that
may be of use:
• *Verification activities
• *Monitoring, measurement, analysis, and evaluation activities
• *Controls of external providers
• *Release activities
• Reaction to Nonconformity
• As soon as nonconforming outputs are detected, the organization must
react to them. The ISO 9001 Standard expects several basic actions for
managing nonconformity.
• Identifying the Nonconforming Outputs
• After spotting the nonconforming outputs, one must identify them as a
means of classifying them. The standards specifically demand the
identification of nonconforming outputs in an injective manner. This means
that each nonconforming product or service will be identified
independently (physically as well as logically). The objective of the
classification is to prevent the use of those outputs before it is decided
what is to be done with them.
• Control of Nonconforming Output Responsibilities and Authorities
• The organization is required to determine the authorities and
responsible parties to handle nonconforming products. The definition shall
refer to all stages of the process; from the detection of the nonconforming
product until the closure of the case. The definition shall be documented
on the required procedure mentioned above.
• Procedure for Control of Nonconforming Output
• The ISO 9001 Standard does not requires defining and maintaining a
documented procedure describing precisely how a nonconforming output
or any other component of the product shall be handled when one is
detected – but you may keep the existing procedure (required by the ISO
9001:2008 Standard). The process will specify steps tools, actions and
required records while handling a nonconforming product. Of course, as
any other procedures of the QMS, the process of controlling
nonconforming product shall be controlled under the documents control
process within the organization. In other words, this process is under the
quality management system, required to be controlled and would appear
on the list of the controlled procedures in your quality manual guide.
• Control of Nonconforming Output – Determination of disposition
• Clause 8.7 refers to the immediate necessary action regarding the
nonconforming product:
• * Segregation of the nonconforming product
• *Notification to the customer
• *Notifications to the relevant parties; organizational, internal,
external, or governmental
• *Short term corrective action
• You may determine the method according to the nature of your
product or processes but you must document it. Everybody must
know what they are required to do when a nonconforming product is
detected; service call center, the logistics, salesmen, production
manager, quality manager – everybody who is related and has a part
in the realization of the product.
APPLICATION
 Knowing the standard requirements of ISO
9001-2015, how will you improve the quality
of management system in terms of Support
and Operations?