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9001 Primer

What are the ISO 9001:2015 requirements?
To attain ISO compliance/certification, a company or organization must submit documents that report
its internal processes, procedures and standards. These documents (or Quality Management System)
determines that a company is able to provide quality products and services consistently.
What is ISO 9001:2015?
What are the ISO 9001 Requirements?
Mandatory Requirements — Documents and Records
Non-Mandatory Requirements — But Often Included
ISO Quality Management Systems (QMS)
ISO 9001 Clauses
There are mandatory and non-mandatory requirements; please see below.
What is ISO 9001:2015?
Creating, implementing and maintaining your Quality Management Systems (QMS) is an important
documentary requirement for any company. It formalizes the procedures and policies that promote the
quality of products and services that a company provides.
The international standard that is known as the ISO 9001:2015 gives a list of requirements for a system
that determines that a company is able to provide international-quality products and services
Newest edition published in 2015
International quality standard used world-wide
Improves customer experience and satisfaction
Ten clauses of requirements
Through the implementation of the standard, ISO 9001:2015 aims to improve customer
experience and satisfaction.
It also aims to improve the internal system of a company so that it is able to produce quality services
and products while promoting a culture that is aimed towards growth and continuous improvement.
The ISO stipulates quality management principles, which, when complied with by certified companies,
reassures clients that the company has established a proper Quality Management System.
To put it simply, ISO compliance/certification shows that your company can be trusted.
Moreover, it means that the products and services delivered by a company is of international-quality;
aligned with different companies from countries all over the world.
What are the ISO 9001 Requirements?
All the ISO 9001 requirements are set out by ISO in ten clauses (below).
Mandatory requirements need to be complied with, while non-mandatory requirements may be
submitted for documentation purposes. To be certified compliant with ISO 9001:2015, the following
documents must be submitted.
ISO 9001 Mandatory Requirements — Documents and Records
Monitoring and measuring equipment calibration records
Records of training, skills, experience and qualifications
Product/service requirements review records
Record about design and development outputs review
Record about design and development inputs
Records of design and development controls
Records of design and development outputs
Design and development changes records
Characteristics of product to be produced and service to be provided
Records about customer property
Production/service provision change control records
Record of conformity of product/service with acceptance criteria
Record of nonconforming outputs
Monitoring measurement results
Internal audit program
Results of internal audits
Results of the management review
Results of corrective actions
Non-Mandatory Requirements — But Often Included
Procedure for determining context of the organization and interested parties
Procedure for addressing risks and opportunities
Procedure for competence, training and awareness
Procedure of equipment maintenance and measuring equipment
Procedure for document and record control
Sales procedure
Procedure for design and development
Procedure for production and service provision
Warehousing procedure
Procedure for management of nonconformities and corrective actions
11. Procedure for monitoring customer satisfaction
12. Procedure for internal audit
13. Procedure for management review
PDCA ISO 9001 Clauses
ISO 9001 Clauses - PLAN
1 Scope
2 Normative references
3 Terms and Definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership And Commitment For The Quality Management System
5.1.2 Customer Focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
How to address risk in ISO 90001
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
ISO 9001 Clauses - DO
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Product and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
ISO 9001 Clauses - CHECK
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.2 Customer Satisfaction
9.2 Internal Audit
9.3 Management Review
ISO 9001 Clauses - ACT
10 Improvement
10.1 General
10.2 Nonconformity in ISO 9001
10.2 What is Non-conformance?
10.2 Corrective Action
10.3 Continual Improvement
How many Requirements are there in ISO 9001?
There are over 350 individual ISO 9001 requirement clauses that businesses can use to implement a
quality management system as a formal stepping-stone to begin to continually improve performance
and enhance customer satisfaction.
What are the Documents Required by ISO 9001?
Within ISO 9001 2015, there are 25 occurrences of the requirement to retain and maintain documented
What are Mandatory Documents?
For ISO 9001 certification, the mandatory quality management documentation requirements includes
documented information such as the quality policy, quality objectives, scope of the quality management
system, a description of the organization's processes, management review minutes, internal audit
How can I Prepare ISO 9001:2015?
Effective processes are at the core of ISO 9001:2015. You should begin by reviewing and updating your
quality manual, QMS documentation, and undertaking a thorough gap analysis of your existing
processes to determine the extent to which quality management systems meet the ISO 9001
What are the 3 Key Components of ISO?
Successful quality management and ISO 9001 certification requires risk based thinking, customer focus,
process approach
What are the Most Popular ISO standards?
While there are many international standards that specify requirements, ISO 9001 remains the most
widely adopted quality management system standards in the world. Other popular standards include
ISO 14001 - environmental management, ISO 45001 - occupational health and safety, and ISO 27001 - IT
security and data management systems.
How many Requirements does the ISO 9001:2015 have?
There are over 350 individual ISO 9001 requirements that businesses should adopt and integrate into
their business processes when implementing an effective quality management system. However,
business must also consider and adopt any relevant contractual or customer requirements, and relevant
statutory and regulatory requirements that affect the functionality of products and services.
What are the 7 Key Principles of Quality?
There are 7 key principles of quality management that form the foundation of ISO 9001:2015 and are
relevant to the entire organization.
1. Customer focus - is about how you meet customer and regulatory requirements, assessing
customer satisfaction and exceeding their expectations by the quality of your products and
2. Leadership - is about establishing strategic direction and operational purpose
3. Engagement of people - is about providing sufficient training, knowledge, competence, and
empowerment to improve quality
4. Process approach - is about the Plan, Do, Check, Act (PDCA) cycle and the sequence and
interaction of inputs, activities and outputs
5. Continual improvement - is about innovation, identifying customer needs, opportunities, root
cause analysis, and ability to react to change to ensure continuous improvement
6. Evidence‐based decision making - is about analyzing process data, levels of customer
satisfaction, process performance assessment, and risk-based thinking
7. Relationship management - is about maintaining relationships with relevant interested parties
and providers in the supply chain
What are Quality management principles
The ISO 9000 quality management principles are embodied with in the individual requirements of ISO
9001:2015. Apply the principles in the context of your business's own particular operations by reviewing
and documenting its activities in the context of each principle.
Who is Responsible for Quality?
As stated in the ISO 9001 requirements, top management are clearly responsible for the quality
management system, while all employees are responsible for delivering quality to their individual
aspects of work. Depending on company culture, Top management usually delegate, by appointing
quality professionals to upper-level management teams.
A Quality Systems Manager is often responsible for facilitating the following:
a. development meaningful documents,
b. devising effective manner of delivery and communication of QMS information,
c. analyzing quality management system data and performance evaluation by monitoring and
measuring the achievement of the quality objectives,
d. quality policies,
e. undertaking internal audits and for improving the quality of products and services
f. monitoring the effectiveness of corrective actions