1. Quality Management Systems – Requirements4
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
The scope of the organization's quality
management system shall be available and be maintained as documented information.
Described in terms of:
Products and services
Main processes involved
Sites where processes are operated
4.1 Understanding the organization and its context
Who are we?
What processes is our system comprised of?
Which processes are internal and which external?
4.2 Understanding the needs and expectations of interested parties
What are the needs and expectations of interested parties?
Who are interested parties?

2. Customers requirements
4.4 QMS and Processes
First we shall define the processes needed to meet the requirements for the provision of products and services. Requirements for these processes are given in clause 8
The policy of our organization is to create value for the customers at competitive price.
Customers
Customers requirements
4.4.1 The organization shall determine the processes needed for the quality management system and their application
throughout the organization, and shall:
determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) 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;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
4.4.2 Requirements about documented information
The organization determines the extent of documented information on processes, depending on factors such as process complexity or employee competence. ISO 9001:2015 no longer requires certified organizations to maintain an up-to-date quality manual, however the documentation requirement is still part of the standard. It is still necessary to document, maintain and preserve relevant information.

3. Customers requirements
4.4 QMS and Processes
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirements for products and services
A sales process is a set of activities for selling a product or service: 
planning the sale, initial contact, need assessment, presentation, meeting objections, follow-up …
Customers
Customers requirements
Sales
Sales process can be comprised of:
Marketing activities,
Sales management,
Customer relationship management,
Sales literature and tools,
Distribution channels.
See ISO 9001:2015, clause 8.2 Requirements for products and services for details.

4. Customers requirements
4.4 QMS and Processes
8.3 Design and development of products and services
8.3.2 Design and development planning, Design and development inputs, Design and development controls, Design and development outputs, Design and development changes
Design and development is the process of creating a new product and services to be sold by an organization to its customers.
Customers
Customers requirements
Sales
Design and development process can be comprised of:
Research (What to design?)
Design (preliminary and final design) Output is a finished set of drawings that govern how to build a physical prototype.
Design analysis for verifying performance of design solution.
Testing pre-production prototypes.
Hazard analysis to to identify any potential safety issues that may be presented by the product.
Preparing production process and product release to production.
See ISO 9001:2015, clause 8.3 Design and development of products and services for details.
Design

5. Customers requirements
4.4 QMS and Processes
Purchasing is engaged in buying anything you can not produce within the organization, and out-sourcing is something you could produce yourself, but choose not to due to capacity or commercial considerations.
8.4 Control of externally provided
processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
Customers
Customers requirements
Sales
Purchasing process can be comprised of:
Discover potential suppliers,
Evaluate potential suppliers,
Select suppliers,
Develop suppliers,
Manage supplier relationships.
See ISO 9001:2015, clause 8.4 Control of externally provided processes, products and services for details.
Design
Purchasing
Suppliers
Sub-contractors

6. Customers requirements
4.4 QMS and Processes
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
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
An organization must carry out the activities to provide products or services under controlled conditions. These include work instructions, suitable equipment, activities controlling product release, delivery and post-delivery...
Customers
Customers requirements
Sales
Production &
service provision
The organization shall produce or provide services under controlled conditions. Controlled conditions shall include, as applicable: a) the availability of documented information that defines: the activities to be performed; (what is being done)
the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources; c) the implementation of monitoring and measurement activities to verify that the acceptance criteria for products and services, have been met; d) the use of suitable infrastructure and environment for the operation of processes; e) the appointment of competent persons, including any required qualification; f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement; g) the implementation of actions to prevent human error; h) the implementation of release, delivery and post-delivery activities.
See ISO 9001:2015, clause 8.5 Production and service provision for details.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

7. Customers requirements
4.4 QMS and Processes
The release of products and services to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, or approved by a relevant
authority or by
the customer.
Customers
Customers requirements
8.6 Release of products and services
Sales
Production &
service provision
See ISO 9001:2015, clause 8.6 Release of products and services for details.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

8. Customers requirements
4.4 QMS and Processes
The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended
use or delivery.
Customers
Customers requirements
8.7 Control of nonconforming outputs
Sales
Production &
service provision ?
The organization shall deal with nonconforming outputs in one or more of the following ways:
correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
Verification of conformity after correction.
See ISO 9001:2015, clause 8.7 Control of nonconforming outputs for details.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

9. Customers requirements
4.4 QMS and Processes
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes to achieve conformity
of products and services.
Customers
Customers requirements
7 Support
7.1.3 Infrastructure
Sales
Production &
service provision ?
See ISO 9001:2015, clause Infrastructure for details.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

10. 4.4 QMS and Processes ? Interested parties
The process of management of the company
4.2 Understanding the needs and
expectations of interested parties
5.1.2 Customer focus
Customers
Customers requirements
Sales
Production &
service provision ?
See ISO 9001:2015, clause 4.2 Understanding the needs and expectations of interested parties and Customer focus for details.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

11. 4.4 QMS and Processes ? Interested parties
The process of management of the company
9.1.2 Customer satisfaction
The organization shall monitor customers'
perceptions of the degree to which their needs and expectations have been fulfilled.
Customers
Customers requirements
Sales
Production &
service provision ?
See ISO 9001:2015, clause Customer satisfaction for details.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

12. 4.4 QMS and Processes ? Interested parties 5.2 Policy
6 Planning
The process of management of the company
Customers
Customers requirements
Sales
Production &
service provision ?
Strategic planning determines the entire long term direction of your organization.
Operational planning is the day-by-day and month by month planning for what your organization is doing. Each process owner should know what organization is expecting of his/hers process, what to measure and how and when to report to top management.
The two forms of planning must be aligned and synchronized.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

13. 4.4 QMS and Processes ? Interested parties
7.1 Resources: The organization shall determine and provide the resources needed for the QMS
The process of management of the company
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring and measuring
Organizational knowledge
Customers
Customers requirements
Sales
Production &
service provision ?
Top management shall provide resources for operation of processes.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

14. 4.4 QMS and Processes ? Interested parties
The process of management of the company
Monitoring of the operating costs of the system.
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring and measuring
Organizational knowledge
Accounting
Customers
Customers requirements
Not ISO 9001:2015 requirement
Sales
Production &
service provision ?
Controlling costs and especially quality costs is a very useful way to show the efficiency and effectiveness of quality management system and it provides valuable data about possible quality problems that needs to be addressed with improvement project. For quality improvement projects estimation should be made about annual cost of present problem or situation, annual savings potential of new situation (or problem elimination) and costs to implement the improvements and return on investment for the project.
Design
Purchasing
Maintenance
Suppliers
Sub-contractors

15. 4.4 QMS and Processes ? Interested parties
The process of management of the company
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring and measuring
Organizational knowledge
Accounting
Customers QA
Customers requirements
Sales
Production &
service provision ?
QA function is coordinating activities needed for assuring quality and is reporting directly to top management.
Design
Purchasing
Maintenance
9.1 Monitoring, measurement, analysis and evaluation
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
Suppliers
Sub-contractors

16. 4.4 QMS and Processes ? Interested parties
The process of management of the company
Resources
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring and measuring
Organizational knowledge
Accounting
Customers QA
Customers requirements
Sales
Production &
service provision ?
This is how processes are connected by inputs and outputs in a QMS.
Design
Purchasing
Maintenance
Legend:
Suppliers
Value adding processes
Supporting processes
Sub-contractors
External parties
Monitoring, inspection, maesuring

17. QMS Interaction Chart Sequence and interaction of processes
Leadership and management
Project manage- ment
Human resources
Finance resources
IT management
Product planning, sales and marketing
Design & development,
purchasing
Production, inspection and testing
Customer (requirements, needs and expectations)
Customer (satisfaction)
Quality management
Accounting (outsourced)
Suppliers 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 C B A
3.1
3.2
Example of documenting sequence and interaction of processes. Each line connecting processes is numbered. On the next slide a table is shown with description of information or material products transferred from one process to another.
Sequence and interaction of processes

18. Process inputs and outputs
4.4 QMS Example cont.
Process inputs and outputs
Nr.
Description 1
Market requirements 2
Business plan, Quality policy, quality objectives 3,
Customers orders
3.1
Proposals, Contracts
3.2
Design and development support to sales and marketing 4
Customer requirements 5
Product 6
Product inspection and test documentation 7
Production documentation, purchase orders 8
Purchased products, prototypes from vendors 9
Tested prototypes and documentation 10
Customer satisfaction data 11
Reporting of quality related information (nonconformities statistics, status of corrective actions, management review reports, audit reports, risk reports (FMEA, FTA …) 12
Quality related information from processes 13
Accounting information from processes 14
Accounting reports 15
Customer requirements, project change requests 16
Project deliverables 17
Project progress reports A
Human, financial and IT resources B
Information about quality and accounting C
Project management information (tasks, schedules, deliverables)