AJB Institute of Quality Management (IQM)

ISO 9001:2015
Quality Management System Requirements

Awash Winery S.C

August 2017

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 ISO 9001:2015 QMS - REQUIREMENTS

ISO 9001:2015

 Clause 1, Scope
 Clause 2, Normative reference
 Clause 3, Terms and definitions
 Clause 4, Context of the Organization
 Clause 5, Leadership
 Clause 6, Planning
 Clause 7, Support
 Clause 8, Operation
 Clause 9, Performance Evaluation
 Clause 10, Improvement

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 ISO 9001:2015 QMS - REQUIREMENTS

In this International Standard, the following verbal

forms are used:

“shall” indicates a requirement;

“should” indicates a recommendation;
“may” indicates a permission;
“can” indicates a possibility or a capability.

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 ISO 9001:2015 QMS - REQUIREMENTS

Clause 1: Scope

ISO 9001:2015 specifies requirement for a quality management

system where an organization:

 Needs to demonstrate its ability to consistently provide products

and services that meet customer and applicable statutory and
regulatory requirements, and
 Aims to enhance customer satisfaction

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 ISO 9001:2015 QMS - REQUIREMENTS

Clause 4, Context of the Organization

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 ISO 9001:2015 QMS Requirements - Context of the Organization

4.1 Understanding the organization and its context

• determine external and internal issues that are relevant
to its purpose and its strategic direction and that affect
its ability to achieve the intended result(s) of its quality
management system.
• SWOT
• PEST
ISO 9001:2015 QMS Requirements - Context of the Organization
 ISO 9001:2015 QMS Requirements - Context of the Organization

 Understanding the internal context can be facilitated by considering

issues arising from
• Product and service offerings
• Governance, organizational structure, roles, and accountability
• Policies and goals, and the strategies that are in place to achieve
them
• Assets like facilities, property, equipment and technology
• Capabilities, understood in terms of resources and knowledge
• Organization’s culture
• Performance of the organization
ISO 9001:2015 QMS Requirements - Context of the Organization
 ISO 9001:2015 QMS Requirements - Context of the Organization

 Understanding the external context can be facilitated by considering issues

arising from
• legal
• technological
• competitive
• market
• cultural
• social
• economic environments, whether international, national, regional or local
ISO 9001:2015 QMS Requirements - Context of the Organization
 ISO 9001:2015 QMS Requirements - Context of the Organization

4.2 Understanding the needs and expectations of interested parties

Determine:
• the interested parties that are relevant to the quality
management system
• the requirements of these interested parties that are
relevant to the quality management system
Examples of customer and end-user needs and expectations, include
• Safety, conformity, dependability, availability, delivery, price, Safety
 ISO 9001:2015 QMS Requirements - Context of the Organization

S.N Interested Parties Needs and Expectations

(Requirements)
 ISO 9001:2015 QMS Requirements - Context of the Organization

4.3 Determining the scope of the quality management system

• determine the boundaries and applicability

• apply all the requirements of ISO 9001:2015 standard if

they are applicable within the determined scope

• shall be available and be maintained as documented

information

• The scope shall state the types of products and services

covered, and provide justification for any exclusion
 ISO 9001:2015 QMS Requirements - Context of the Organization

4.4 Quality management system and its processes

The organization shall:
 Establish, implement, maintain and continually improve a QMS
 Determine the processes needed for the QMS and their
application throughout the organization
 Example of Processes
• Aging, storage, bottling, sanitation management, warehouse
management, delivery, administration, housekeeping,
maintenance, human resources, materials management, risk
management, billing and coding, accounts receivables
 ISO 9001:2015 QMS Requirements - Context of the Organization

The organization shall:

• determine inputs and outputs expected
from these processes;
• determine the sequence and interaction of these processes;

• determine and apply the criteria and methods (including

monitoring, measurements and related performance indicators)
needed to ensure the effective operation and control of these
processes
 An example of process linkage
Customers

Product/Service Realization Processes

Need Aging/
Identification Planning Plantation/ Bottling Delivery
Procurement Fermentation
& review

Management Processes Measurement, Analysis and Resource Management processes

Strategic/Annual planning Improvement Processes Personnel administration
Establishing policy and setting objectives Process monitoring Personnel training
Finance management Product testing /inspection Utilities administration
Internal & External communication Quality system audit Transportation
Outsourcing Customer feedback including compliant Accounting
Ensuring availability of resources monitoring Document control
Management system review Control of non-conforming products Record control
Risk identification and management Data analysis Cafeteria service
Internal and external situation analysis Corrective action Equipment handling
Change management Continual improvement Maintenance
Interested parties requirements customers satisfaction monitoring Equipment Calibration
identification Recruitment
Quality management Authorization
Knowledge management 18
 ISO 9001:2015 QMS Requirements - Context of the Organization

• determine the resources needed for these

processes and ensure their availability
• assign the responsibilities and authorities for these processes
• address the risks and opportunities as determined in
accordance with the requirements of 6.1
• evaluate these processes and implement any changes needed
to ensure that these processes achieve their intended results
• improve the processes and the quality management system
 ISO 9001:2015 QMS Requirements - Context of the Organization

 To the extent necessary, the organization shall:

• maintain documented information to support the

operation of its processes

• retain documented information to have confidence that

the processes are being carried out as planned
 ISO 9001:2015 QMS Requirements

Clause 5: Leadership

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 ISO 9001:2015 QMS Requirements - Leadership

5.1 Leadership and Commitment

Top management shall demonstrate leadership and commitment with respect to
the QMS by:
 taking accountability for the effectiveness of the quality management system
 quality policy and quality objectives are established
 integration of the QMS requirements into the organization's business processes
 promoting the use of the process approach and risk-based thinking
 Provide resources needed
 communicating the importance of effective QMS
 engaging, directing and supporting persons
 promoting improvement
 ISO 9001:2015 QMS Requirements - Leadership

5.1.2 Customer Focus

Top management shall demonstrate leadership and commitment
with respect to customer focus by ensuring that:

• customer and applicable statutory and regulatory

requirements are determined, understood and consistently
met

• the risks and opportunities that can affect conformity

of products and services and the ability to enhance
customer satisfaction are determined and addressed

• the focus on enhancing customer satisfaction is maintained

 ISO 9001:2015 QMS Requirements - Leadership

5.2 Policy
5.2.1 Establishing the quality policy
 establish, implement and maintain a quality policy that:
• is appropriate to the purpose and context of the organization and
supports its strategic direction;
• provides a framework for setting quality objectives;
• includes a commitment to satisfy applicable requirements;
• includes a commitment to continual improvement of the QMS
5.2.2 Communicating the quality policy
• be available and maintained as documented information
• be communicated, understood and applied within the organization
• be available to relevant interested parties
 ISO 9001:2015 QMS Requirements - Leadership

Examples of quality policy

The management and employees of Awash Winery are committed to
deliver safe and quality wine that meets customers and regulatory
requirements.
We are committed to continually improve performance of our quality
management system based on requirements of ISO 9001:2015 to enhance
satisfaction of our customers and interested parties. We always strive to
act proactively towards our quality management system through process
and risk based management.

We are committed to meeting the expectations of our customers and

interested parties all of the time by teamwork, innovation and
competence, exhibiting high ethical standards, a sense of urgency and
respect for the individual.
 ISO 9001:2015 QMS Requirements - Leadership

5.3 Organizational Roles, Responsibilities and Authorities

 Top management shall ensure that responsibilities and authorities are
assigned to relevant roles, communicated and understood within the
organization for:
• ensuring that the QMS conforms to the requirements of ISO 9001:2015
Standard
• ensuring that the processes are delivering their intended outputs
• reporting on the performance of the quality management system and on
opportunities for improvement (see 10.1.), in particular to top
management
• ensuring the promotion of customer focus throughout the organization
• ensuring that the integrity of the quality management system is
maintained when changes to the QMS are planned and implemented
 ISO 9001:2015 QMS Requirements - Planning

Clause 6: Planning

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 ISO 9001:2015 QMS Requirements - Planning

6 Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning for the QMS, the organization shall consider the
issues referred to in 4.1 and the requirements referred to in 4.2
and determine the risks and opportunities that need to be
addressed to:
• give assurance that the QMS can achieve its intended result(s)
• enhance desirable effects
• prevent, or reduce, undesired effects
• achieve improvement

N.B: Risk – effect of uncertainty (ISO 9000:2015)

 ISO 9001:2015 QMS Requirements - Planning

 Examples of risk assessment methodologies:

• Brainstorming
• Process flow diagram analysis
• Failure Mode and Effect Analysis
• Cause and Effect Analysis
• Root cause analysis
 ISO 9001:2015 QMS Requirements - Planning

Examples of risks related to winery operation

 Bottle shocking
 Contamination (during bottling)
 Foam formation (due to CO2 level)
 Level of dissolved oxygen in bottle
 Fire
 Equipments failure
 Employees accidents
 ISO 9001:2015 QMS Requirements - Planning

Risk Management

Risk Identification

Risk Evaluation &

Prioritization

Action Plans
Risk Prevention

Risk Mitigation

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 ISO 9001:2015 QMS Requirements - Planning

Risk Evaluation & Prioritization

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 ISO 9001:2015 QMS Requirements - Planning

6.1.2 The organization shall plan:

 actions to address these risks and opportunities
 how to:
• integrate and implement the actions into its
quality management system processes (see
4.4)
• evaluate the effectiveness of these actions
 Company Name: Document No.:
Logo
ABC 9001:2015 QMS
ISO OF/ABC /004
Requirements - Planning
Form Title: Page No:
Revision
0 Page 1 of 1
Action Plan Form

Months and Weeks

Required July August September October November December January February March April May June
N ACTIVITIES Output Responsibility Resources 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
 ISO 9001:2015 QMS Requirements - Planning

6.2 Quality objectives and planning to achieve them

6.2.1 The organization shall establish quality objectives at relevant functions, levels
and processes needed for the quality management system
 The quality objectives shall:
• be consistent with the quality policy
• be measurable
• take into account applicable requirements
• be relevant to conformity of products and services
and to enhancement of customer satisfaction
• be monitored
• be communicated
• be updated as appropriate
 The organization shall maintain documented information on the quality
objectives
 ISO 9001:2015 QMS Requirements - Planning

An objective is a specific activity that will bring about an improvement

This improvement can be in:

– Operation
– communications or relationship
– personal development

Examples of quality objectives

 Increase customers satisfaction
 Reduce reworks
 Reduce product defects
 Improve competence of personnel
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 ISO 9001:2015 QMS Requirements - Planning

6.2.2 When planning how to achieve its quality

objectives, the organization shall determine:
what will be done
what resources will be required
who will be responsible
when it will be completed
how the results will be evaluated
 ISO 9001:2015 QMS Requirements - Planning

Good objectives should be:

Agreed
Measurable by quantitative means
Achievable but challenging
Time limited
Supported by action plans
Reviewed regularly

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 ISO 9001:2015 QMS Requirements - Planning

Formula for writing quality objectives

To + action word + key result + target date + conditions

Example:
To increase customer satisfaction from 70% to 85% by the end of
September 2017.

To increase the number of orders processed per day by 5 percent

beginning September 7, 2017 on the condition that the computer is operable 95
percent of the time.

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 ISO 9001:2015 QMS Requirements - Planning

Strategic Objective 1
To improve profitability by 2020.

Operational Objective 1
To produce 13,000,000 liter wine in 2010 budget year.

Quality Objectives
o To increase market share from 65% to 75% by June 2010 EC.
o To reduce procurement lead time from 120 days to 60 days by January
2010.
o To reduce wastage rate from 8% to 2% by June 2010.
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 Company Name: Document No.:
Logo
ABC 9001:2015 QMS
ISO OF/ABC /004
Requirements - Planning
Form Title: Page No:
Revision
0 Page 1 of 1
Action Plan Form

Months and Weeks

Required July August September October November December January February March April May June
N ACTIVITIES Output Responsibility Resources 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
 ISO 9001:2015 QMS Requirements

Clause 7: Support

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 ISO 9001:2015 QMS Requirements - 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 QMS
 The organization shall consider:
• the capabilities of, and constraints on, existing internal
resources
• what needs to be obtained from external providers
 ISO 9001:2015 QMS Requirements - Support

7.1.2 People

The organization shall determine and provide the persons

necessary for the effective implementation of its QMS and for
the operation and control of its processes
 ISO 9001:2015 QMS Requirements - Support

7.1.3 Infrastructure

The organization shall determine, provide and maintain the

infrastructure necessary for the operation of its processes and to achieve
conformity of products and services

NOTE Infrastructure can include:

• buildings and associated utilities
• equipment, including hardware and software
• transportation resources
• information and communication technology
 ISO 9001:2015 QMS Requirements - Support

7.1.4 Environment for the operation of processes

Determine, provide and maintain the environment necessary for the
operation of its processes and to achieve conformity of products and
services
suitable environment can be a combination of human and physical factors,
such as:
• social (e.g. non-discriminatory, calm, non-confrontational)
• psychological (e.g. stress-reducing, burnout prevention, emotionally
protective)
• physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise,
the patient for long periods in high or low temperatures)
These factors can differ substantially depending on the products and
services provided
 ISO 9001:2015 QMS Requirements - Support

7.1.5 Monitoring and measuring resources

7.1.5.1 General
• Provide suitable monitoring or measuring resources
• maintain to ensure their continuing fitness for their
purpose
• retain appropriate documented information
 ISO 9001:2015 QMS Requirements - Support

7.1.5.2 Measurement traceability

Measuring equipments shall be:

• calibrated or verified, or both at specified time
• identify in order to determine their status
• safeguard from adjustments, damage or deterioration

 The organization should use appropriate tools and/or

equipment in a suitable environment
 ISO 9001:2015 QMS Requirements - Support

7.1.6 Organizational knowledge

• determine the knowledge necessary for the operation of its processes and to
achieve conformity of products and services
• This knowledge shall be maintained and be made available to the extent necessary
• When addressing changing needs and trends, the organization shall consider its
current knowledge and determine how to acquire or access any necessary
additional knowledge and required updates
• Can be gained by experience
• It is information that is used and shared to achieve the organization’s objectives
based on:
a) internal sources (gained from experience, lessons learned from failure,
b) external sources (standards, conferences, customers, provides)

• Benchmarking should be conducted when appropriate inside and outside of the

health service industry.
 ISO 9001:2015 QMS Requirements - Support

7.2 Competence
• determine the necessary competence of person(s)
• ensure that these persons are competent on the basis
of appropriate education, training, or experience;
• where applicable, take actions to acquire the
necessary competence, and evaluate the effectiveness
of the actions taken;
• retain appropriate documented information as
evidence of competence.
 ISO 9001:2015 QMS Requirements - Support

 The organization should ensure that health service

staff have appropriate credentials, for example
• certifications, licenses, and professional
qualifications, when required
 ISO 9001:2015 QMS Requirements - Support

7.3 Awareness
ensure that persons are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the
quality management system, including the
benefits of improved performance;
d) the implications of not conforming with the
quality management system requirements.
 ISO 9001:2015 QMS Requirements - Support

7.4 Communication
determine the internal and external
communications including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
 ISO 9001:2015 QMS Requirements - Support

An example of communication plan

What to Target Mode of
Communicate Audience Communication When/ Frequency Responsibility

Internal Communication
Quality policy Employees Awareness training, Quarterly, Upon policy
meeting, posting inside change, Upon
the compound and recruitment
pamphlet
Status of QMS Top Reporting At the end of every
Implementation Management month,
Any time when
changing
circumstance happen
Quality objectives and Respective Letter of communication, Upon establishment,
action plan Department Awareness training & revision and approval
Heads, posting
Employees
Quality awareness Employees Awareness training, Quarterly
meeting
Lab results
 ISO 9001:2015 QMS Requirements - Support

7.5 Documented information

7.5.1 General

The organization’s QMS shall include:

 documented information required by ISO 9001:2015, and

documented information determined by the organization

 ISO 9001:2015 QMS Requirements - Support

Mandatory documentation of ISO 9001:20015

 Scope of the QMS (clause 4.3)
 Processes needed for the QMS and their interactions (clause 4.4)
 Quality policy (clause 5.2)
 Quality objectives (clause 6.2)
• Criteria for evaluation and selection of suppliers (clause 8.4.1)
 ISO 9001:2015 QMS Requirements - Support

Mandatory records required by ISO 9001:2015

 Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
 Records of training, skills, experience and qualifications (clause 7.2)
 Product/service requirements review records (clause 8.2.3.2)
 Record about design and development outputs review* (clause 8.3.2)
 Records about design and development inputs* (clause 8.3.3)
 Records of design and development controls* (clause 8.3.4)
 Records of design and development outputs *(clause 8.3.5)
 Design and development changes records* (clause 8.3.6)
 Characteristics of product to be produced and service to be provided (clause 8.5.1)
 ISO 9001:2015 QMS Requirements - Support

Mandatory records required by ISO 9001:2015 (contd.)

 Records about customer property (clause 8.5.3)
 Production/service provision change control records (clause 8.5.6)
 Record of conformity of product/service with acceptance criteria (clause 8.6)
 Record of nonconforming outputs (clause 8.7.2)
 Monitoring and measurement results (clause 9.1.1)
 Internal audit program (clause 9.2)
 Results of internal audits (clause 9.2)
 Results of the management review (clause 9.3)
 Results of corrective actions (clause 10.1)
 ISO 9001:2015 QMS Requirements - Support

Non-mandatory documents
 Procedure for determining context of the organization and interested parties
(clauses 4.1 and 4.2)
 Procedure for addressing risks and opportunities (clause 6.1)
 Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
 Procedure for equipment maintenance and measuring equipment (clause
7.1.5)
 Procedure for document and record control (clause 7.5)
 Sales procedure (clause 8.2)
 ISO 9001:2015 QMS Requirements - Support

Non-mandatory documents (contd.)

 Procedure for design and development (clause 8.3)
 Procedure for production and service provision (clause 8.5)
 Warehousing procedure (clause 8.5.4)
 Procedure for management of nonconformities and corrective actions
(clauses 8.7 and 10.2)
 Procedure for monitoring customer satisfaction (clause 9.1.2)
 Procedure for internal audit (clause 9.2)
• Procedure for management review (clause 9.3)
 ISO 9001:2015 QMS Requirements - Support

7.5.2 Creating and updating

When creating and updating documented information, the organization

shall ensure appropriate:

 identification and description (e.g. a title, date, author, or reference

number)
 format (e.g. language, software version, graphics) and media (e.g.
paper, electronic)
 review and approval for suitability and adequacy
 ISO 9001:2015 QMS Requirements - Support

7.5.3 Control of documented information

7.5.3.1 Documented information shall be controlled to ensure:
 it is available and suitable for use, where and when it is needed
 it is adequately protected (e.g. from loss of confidentiality, improper
use, or loss of integrity).
7.5.3.2 For the control of documented information address the following
activities, as applicable:
 distribution, access, retrieval and use
 storage and preservation, including preservation of legibility
 control of changes (e.g. version control)
 retention and disposition
 ISO 9001:2015 QMS Requirements

Clause 8: Operation

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 ISO 9001:2015 QMS Requirements - Operation

8.1 Operational planning and control

 Plan, implement and control the processes (see 4.4)
needed to meet the requirements for the provision of
products and services, and to implement the actions determined in Clause
6, by:
• determining the requirements for the products and services
• establishing criteria for the processes and the acceptance of products and services
• determining the resources needed
• control of the processes in accordance with the criteria
• determining and keeping documented information to the extent necessary
 Control planned changes
 ensure that outsourced processes are controlled (see 8.4)
 Customers

Product/Service Realization Processes

Need Aging/
Identification Planning Plantation/ Bottling Delivery
Procurement Fermentation
& review

Management Processes Measurement, Analysis and Resource Management processes

Strategic/Annual planning Improvement Processes Personnel administration
Establishing policy and setting objectives Process monitoring Personnel training
Finance management Product testing /inspection Utilities administration
Internal & External communication Quality system audit Transportation
Outsourcing Customer feedback including compliant Accounting
Ensuring availability of resources monitoring Document control
Management system review Control of non-conforming products Record control
Risk identification and management Data analysis Cafeteria service
Internal and external situation analysis Corrective action Equipment handling
Change management Continual improvement Maintenance
Interested parties requirements customers satisfaction monitoring Equipment Calibration
identification Recruitment
Quality management Authorization
Knowledge management 65
 ISO 9001:2015 QMS Requirements - Operation

8.2 Requirements for products and services

8.2.1 Customer communication
Communication with customers shall include:
 providing information relating to products and services
 handling enquiries, contracts or orders, including changes
 obtaining customer feedback relating to products and
services, including customer complaints
 handling or controlling customer property
 establishing specific requirements for
contingency actions, when relevant
 ISO 9001:2015 QMS Requirements - Operation

8.2.2 Determining the requirements related to products and services

When determining the requirements for the products
and services to be offered to customers, ensure that:
 the requirements for the products and services are
defined, including:
• any applicable statutory and regulatory
requirements
• those considered necessary by the organization
 the organization can meet the claims for the
products and services it offers
 ISO 9001:2015 QMS Requirements - Operation

Wine requirements include:

• pH
• free and total sulfur dioxide (by the aeration-oxidation method)
• titratable acidity
• Sugar residue
• alcohol
• protein stability (for whites and low-tannin reds)
• potassium bitartrate stability
• biological stability
 ISO 9001:2015 QMS Requirements - Operation

8.2.3 Review of the requirements for products and services

 ensure that the organization has the ability to meet the requirements
for products and services to be offered to customers
 Conduct a review before committing to supply products and services to
a customer, to include:
• requirements specified by the customer, including the
requirements for delivery and post-delivery activities
• requirements not stated by the customer, but necessary
for the specified or intended use, when known
• requirements specified by the organization
• statutory and regulatory requirements applicable to the products and services
• contract or order requirements differing from those previously expressed
 Retain documented information on the results of the review and any
new requirements
 ISO 9001:2015 QMS Requirements - Operation

 Examples of customer contracts/order subject to review include:

• Are all customer requirements understood?

• Is the organization capable to meet the requirements?
 ISO 9001:2015 QMS Requirements - Operation

8.2.4 Changes to requirements for products and services

• The organization shall ensure that relevant documented information
is amended, and that relevant persons are made aware of the
changed requirements, when the requirements for products and
services are changed
 ISO 9001:2015 QMS Requirements - Operation

8.3 Design and development

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
 ISO 9001:2015 QMS Requirements - Operation

8.4 Control of externally provided processes, products and services

8.4.1 General
 Ensure that externally provided processes,
products and services conform to requirements
 Determine the controls to be applied to externally provided processes,
products and services when:
• products and services from external providers are intended for
incorporation into the organization’s own products and services
• products and services are provided directly to the customer(s) by
external providers on behalf of the organization
• a process, or part of a process, is provided by an external provider as
a result of a decision by the organization
 ISO 9001:2015 QMS Requirements - Operation

 The organization shall determine and apply criteria for the

evaluation, selection, monitoring of performance, and re-
evaluation of external providers, based on their ability to provide
processes or products and services in accordance with
requirements

 The organization shall retain documented information of these

activities and any necessary actions arising from the evaluations
 ISO 9001:2015 QMS Requirements - Operation

8.4.2 Type and extent of control

Ensure that externally provided inputs do not adversely affect the

organization’s ability to meet requirements

The organization shall:

• ensure that externally provided processes remain within the
control of its quality management system
• define both the controls that it intends to apply to an external
provider and those it intends to apply to the resulting output
 ISO 9001:2015 QMS Requirements - Operation

• take into consideration:

 the potential impact of the externally provided processes,
products and services on the organization’s ability to
consistently meet customer and applicable statutory and
regulatory requirements
 the effectiveness of the controls applied by the external
provider
 determine the verification, or other activities, necessary to
ensure that the externally provided processes, products
and services meet requirements
 ISO 9001:2015 QMS Requirements - Operation

8.4.3 Information for external providers

 ensure the adequacy of requirements prior to their communication to
the external provider
 communicate to external providers your requirements for:
• the processes, products and services to be provided
• the approval of:
 products and services
 methods, processes and equipment
 the release of products and services
• competence, including any required qualification of persons
• the external providers’ interactions with the organization
• control and monitoring of the external providers’ performance to be applied by
the organization
• verification or validation activities that the organization, or its customer, intends
to perform at the external providers’ premises
 ISO 9001:2015 QMS Requirements - Operation

8.5 Production and service provision

8.5.1 Control of production and service provision
Implement production and service provision under controlled conditions.
 Controlled conditions shall include, as applicable:

• the availability of documented information that defines:

o the characteristics of the products and the services,
o the results to be achieved
• the availability and use of suitable monitoring and measuring
resources
• the implementation of monitoring and measurement activities at
appropriate stages
• the use of suitable infrastructure and environment for the operation of
processes
 ISO 9001:2015 QMS Requirements - Operation

8.5.1 Control of production and service provision (cont.)

 the appointment of competent persons, including

any required qualification
 the validation, of special processes
 the implementation of actions to prevent human
error
 the implementation of release, delivery and post-
delivery activities
 ISO 9001:2015 QMS Requirements - Operation

Wine requirements include:

• pH
• free and total sulfur dioxide (by the aeration-oxidation method)
• titratable acidity
• Sugar residue
• alcohol
• protein stability (for whites and low-tannin reds)
• potassium bitartrate stability
• biological stability
 ISO 9001:2015 QMS Requirements - Operation

8.5.2 Identification and traceability

 identify outputs
 identify the status of outputs with respect to monitoring and
measurement requirements
 The organization shall control the unique identification of the
outputs when traceability is a requirement, and shall retain the
documented information necessary to enable traceability
 Label coding is a means by which the winemaker can extend his
quality control into the marketplace
 ISO 9001:2015 QMS Requirements - Operation

8.5.3 Property belonging to customers or external providers

 Exercise care with property belonging to customers or external
providers
 The organization shall identify, verify, protect and safeguard
customers’ or external providers’ property provided for use or
incorporation into the products and services
 When the property of a customer or external provider is lost,
damaged or otherwise found to be unsuitable for use, the
organization shall report this to the customer or external provider
and retain documented information on what has occurred
 Property can include material, components, tools and equipment,
premises, intellectual property and personal data
 ISO 9001:2015 QMS Requirements - Operation

8.5.4 Preservation
 The organization shall preserve the outputs during production
and service provision, to the extent necessary to ensure
conformity to requirements
 Preservation can include identification, handling, contamination
control, packaging, storage, transmission or transportation, and
protection, premises, intellectual property and personal data
 ISO 9001:2015 QMS Requirements - Operation

E.g. The major sources of contamination during bottling include:

 Filter pad drip trays

 Fill bowls
 Corking machines
 Work activity
 ISO 9001:2015 QMS Requirements - Operation

8.5.5 Post-delivery activities

 The organization shall meet requirements for post-delivery

activities associated with the products and services
 ISO 9001:2015 QMS Requirements - Operation

8.5.6 Control of changes

 Review and control changes for production or service
provision, to the extent necessary to ensure continuing
conformity with requirements

 Retain documented information describing the results of

the review of changes, the person(s) authorizing the
change, and any necessary actions arising from the
review
 ISO 9001:2015 QMS Requirements - Operation

8.6 Release of products and services

 Implement planned arrangements, at appropriate
stages, to verify that the product and service
requirements have been met

 Establish and implement acceptance quality levels (AQLs) depending

upon the nature of defect(s) to be detected:
o Major defect (Critical) : 1%
o Minor (Cosmetic) defect 2.5 - 4%
 ISO 9001:2015 QMS Requirements - Operation

8.7 Control of nonconforming outputs

 Ensure that outputs that do not conform to requirements are identified and
controlled to prevent their unintended use or delivery
 Take appropriate action based on the nature of the nonconformity and its effect
on the conformity of products and services
 This shall also apply to nonconforming products and services detected after
delivery of products, during or after the provision of services
 The organization shall deal with nonconforming outputs in one or more of the
following ways:

• Correction
• Segregation, containment, return or suspension of provision of
products and services
• Informing the customer
• Obtaining authorization for acceptance under concession
 ISO 9001:2015 QMS Requirements - Operation

Example of nonconformity
Noncompliance to regulatory requirements
Product defects

The organization shall retain documented information that:

 describes the nonconformity
 describes the actions taken
 describes any concessions obtained
 identifies the authority deciding the action in respect of the
nonconformity
 ISO 9001:2015 QMS Requirements

Clause 9: Performance Evaluation

90
 ISO 9001:2015 QMS Requirements - Performance Evaluation

9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General
The organization shall determine:
• what needs to be monitored and measured;
• the methods for monitoring, measurement, analysis and evaluation
needed to ensure valid results
• when the monitoring and measuring shall be performed
• when the results from monitoring and measurement shall be
analyzed and evaluated
 The organization shall evaluate the performance and the
effectiveness of the quality management system
 The organization shall retain appropriate
documented information as evidence of the results
 ISO 9001:2015 QMS Requirements - Operation

Four areas of quality concern:

• Aging and Storage

• Pre-Bottling
• Bottling
• Warehousing and Bottle Release
 ISO 9001:2015 QMS Requirements - Operation

The principal quality control difficulties of the wine industry include:

• lack of adequate recordkeeping
• fruit quality
• control of phenol extraction
• oxidative and microbiological degradation
 ISO 9001:2015 QMS Requirements - Operation

Wine requirements needed to be verified include:

• free sulphur levels (FSO2)

• dissolved carbon dioxide (DCO2)

• dissolved oxygen (DO)
• turbidity
• residue sugar/density
• temperature
• stability: protein, color, bitartrate, and microbiological
 ISO 9001:2015 QMS Requirements - Performance Evaluation

Sample monitoring and measurement plan form

Monitoring
Monitoring and Monitoring and Monitoring and
Sampling and Reference Analysis Respon-
S.N Measurement Measurement Measurement
Methods Measuremen Standards Method sibility
Parameters Methods Frequency
t Equipments
Effectiveness of
Quality audit Twice/year ISO 9001
QMS
Temperature Direct Measurement Weekly
pH Direct Measurement Weekly
Customer/
Survey Twice/year
interested parties
questionnaire
satisfaction
Sugar level

Approved By: Name ____________________________________Signature ______________________ Date _____________________

 ISO 9001:2015 QMS Requirements - Performance Evaluation

9.1.2 Customer satisfaction

 Monitor customers' perceptions of the degree to which their
needs and expectations have been fulfilled
 Determine methods for obtaining, monitoring and reviewing
this information

 Examples of measurement and monitoring of customer

satisfaction include:
• Product conformance to customers requirements, timely
response to customer questions, customer satisfaction
surveys regarding courtesy of staff, client waiting time
 ISO 9001:2015 QMS Requirements - Performance Evaluation

9.1.3 Analysis and evaluation

 The organization shall analyze and evaluate appropriate data and
information arising from monitoring and measurement
 The results of analysis shall be used to evaluate:
• Conformity of products and services
• The degree of customer satisfaction
• The performance and effectiveness of the quality management system
• If planning has been implemented effectively
• The effectiveness of actions taken to address risks and opportunities
• The performance of external providers
• The need for improvements to the quality management system
ISO 9001:2015 QMS Requirements - Performance Evaluation

98
 ISO 9001:2015 QMS Requirements - Performance Evaluation

9.2 Internal audit

• conduct internal audits at planned intervals
• plan, establish, implement and maintain an audit programme(s)
• define the audit criteria and scope for each audit
• select auditors and conduct audits to ensure objectivity and the
impartiality of the audit process
• Ensure that results of the audits are reported to relevant
management
• take appropriate correction and corrective actions without undue
delay;
• retain documented information
 ISO 9001:2015 QMS Requirements - Performance Evaluation

9.3 Management review

9.3.1 General
Review the organization's QMS, at planned intervals, to ensure its
continuing suitability, adequacy, effectiveness and alignment with
the strategic direction of the organization

9.3.2 Management review inputs

 the status of actions from previous management
reviews
 changes in external and internal issues
 ISO 9001:2015 QMS Requirements - Performance Evaluation

 information on the performance and effectiveness of the QMS,

including trends in:
• customer satisfaction and feedback from relevant interested parties
• the extent to which quality objectives have been met
• process performance and conformity of products and services
• nonconformities and corrective actions
• monitoring and measurement results
• audit results
• the performance of external providers
 the adequacy of resources
 the effectiveness of actions taken to address risks and opportunities
(see .6.1)
 opportunities for improvement
 ISO 9001:2015 QMS Requirements - Performance Evaluation

9.3.3 Management review outputs

The outputs of the management review shall include
decisions and actions related to:
• opportunities for improvement
• any need for changes to the quality management system
• resource needs

 The organization shall retain documented information as

evidence of the results of management reviews
 ISO 9001:2015 QMS Requirements

Clause 10: Improvement

103
 ISO 9001:2015 QMS Requirements - Improvement

10.1 General
 Determine and select opportunities for improvement
and implement any necessary actions to meet customer
requirements and enhance customer satisfaction
 This includes:
• improving products and services to meet requirements
as well as to address future needs and expectations
• correcting, preventing or reducing undesired effects
• improving the performance and effectiveness of the
quality management system
 ISO 9001:2015 QMS Requirements - Improvement

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, including any arising from
complaints, the organization shall:
 react to the nonconformity and, as applicable:
• take action to control and correct it
• deal with the consequences
 evaluate the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not recur or occur elsewhere, by:
• reviewing and analyzing the nonconformity
• determining the causes of the nonconformity
• determining if similar nonconformities exist, or could
potentially occur
 ISO 9001:2015 QMS Requirements - Improvement

 implement any action needed

 review the effectiveness of any corrective action taken
 update risks and opportunities determined during planning, if
necessary
 make changes to the quality management system, if necessary
 Corrective actions shall be appropriate to the effects of the
non-conformities encountered
 ISO 9001:2015 QMS Requirements - Improvement

10.2.2 The organization shall retain documented information as

evidence of:

 the nature of the nonconformities and any subsequent

actions taken;
 the results of any corrective action
 ISO 9001:2015 QMS Requirements - Improvement

10.3 Continual improvement

 Continually improve the suitability, adequacy and effectiveness

of the QMS

 Consider the results of:

• analysis and evaluation, and
• the inputs from management review

Opportunities for
improvement
 ISO 9001:2015 QMS Documentation

ISO 9001:2015 QMS Documentation

Why we need documented information?

Communication of information
Evidence of conformity
Knowledge sharing

109
 ISO 9001:2015 QMS Documentation

The type and extent of the documented information will depend

on:

Organization’s size
Organization’s complexity
Organization’s culture
Organization’s personnel competence

110
 ISO 9001:2015 QMS Documentation

Document Mediums

– Paper
– Electronic
– Photographic
– Master Sample
– Other

111
 ISO 9001:2015 QMS Documentation

Documentation Requirements of ISO 9001:2015 QMS

(7.5 Documented information)
7.5.1 General

The organization’s QMS shall include:

 documented information required by ISO 9001:2015, and

documented information determined by the organization

 ISO 9001:2015 QMS Documentation

Documented information required by ISO 9001:2015

 Mandatory documentation of ISO 9001:20015

 Scope of the QMS (clause 4.3)
 Processes needed for the QMS and their interaction (clause 4.4)
 Quality policy (clause 5.2)
 Quality objectives (clause 6.2)
• Criteria for evaluation and selection of suppliers (clause 8.4.1)
 ISO 9001:2015 QMS Documentation

 Mandatory records required by ISO 9001:2015

 Monitoring and measuring equipment calibration records (clause 7.1.5.1)
 Records of training, skills, experience and qualifications (clause 7.2)
 Product/service requirements review records (clause 8.2.3.2)
 Record about design and development outputs review (clause 8.3.2)
 Records about design and development inputs (clause 8.3.3)
 Records of design and development controls (clause 8.3.4)
 Records of design and development outputs (clause 8.3.5)
 Design and development changes records (clause 8.3.6)
 Characteristics of product to be produced and service to be provided (clause 8.5.1)
 ISO 9001:2015 QMS Documentation

 Mandatory records required by ISO 9001:2015 (contd.)

 Records about customer property (clause 8.5.3)
 Production/service provision change control records (clause 8.5.6)
 Record of conformity of product/service with acceptance criteria (clause 8.6)
 Record of nonconforming outputs (clause 8.7.2)
 Monitoring and measurement results (clause 9.1.1)
 Internal audit program (clause 9.2)
 Results of internal audits (clause 9.2)
 Results of the management review (clause 9.3)
 Results of corrective actions (clause 10.1)
 ISO 9001:2015 QMS Documentation

Non-mandatory documents (documented information determined

by the organization)
 Procedure for determining context of the organization and interested parties
(clauses 4.1 and 4.2)
 Procedure for addressing risks and opportunities (clause 6.1)
 Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
 Procedure for equipment maintenance and measuring equipment (clause
7.1.5)
 Procedure for document and record control (clause 7.5)
 Sales procedure (clause 8.2)
 ISO 9001:2015 QMS Documentation

Non-mandatory documents (documented information determined by the

organization) (contd.)
 Procedure for design and development (clause 8.3)
 Procedure for production and service provision (clause 8.5)
 Warehousing procedure (clause 8.5.4)
 Procedure for management of nonconformities and corrective actions (clauses
8.7 and 10.2)
 Procedure for monitoring customer satisfaction (clause 9.1.2)
 Procedure for internal audit (clause 9.2)
• Procedure for management review (clause 9.3)
 ISO 9001:2015 QMS Documentation

Non-mandatory documents (documented information determined by

the organization) (contd.)

• Process maps, process flowcharts, and/or process descriptions

• Organization charts
• Specifications
• Work and/or test instructions
• Approved suppliers lists
• Monitoring and measurement plans
• etc.

118