BENEFITS OF QUALITY

MANAGEMENT SYSTEMS
Implementing a quality management system affects every aspect of an organization's performance.
Benefits of a documented quality management system include:

 Meeting the customer’s requirements, which helps to instill confidence in the organization, in
turn leading to more customers, more sales, and more repeat business
 Meeting the organization's requirements, which ensures compliance with regulations and
provision of products and services in the most cost- and resource-efficient manner, creating
room for expansion, growth, and profit

These benefits offer additional advantages, including:

 Defining, improving, and controlling processes

 Reducing waste
 Preventing mistakes
 Lowering costs
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction
 Communicating a readiness to produce consistent results

Organizations must adopt an interdisciplinary series of quality

controls to achieve these principles. The nine core elements of a
QMS should include quality objectives, a quality manual,
organizational responsibilities, data management, and other
practices.

1. Quality Policy and Objectives

When you begin creating a quality management system, the first
step should be to draft a quality policy and follow it up with your
objectives. While these are closely related, they’re different parts
of your QMS that work hand-in-hand.

Quality Policy
Before you can do anything meaningful with a new quality
management system, you first need to define what quality means
within your company by writing a quality policy. A quality policy
can also be your company’s mission, values, or statement of
principles. Once you’ve crafted this, you’re then able to set
expectations across the organization, from executives and upper-
level management to supervisors and employees.

When creating the policy, make sure it is both scalable and

flexible in case ISO standards change or are updated and you
need to make adjustments. A quality management system for
startups may be helpful in the beginning, and as you grow, you’ll
need one that expands with you.

Quality Objectives
A pharmaceutical startup in the research phase may have
identified a customer need for affordable therapeutics to treat a
common skin condition. Since the product is being developed, the
organization may create a quality policy with a stated goal: "To
develop a safe, effective treatment for eczema patients which is
available at a lower cost than alternatives."

The creation of quality objectives is a common requirement of

QMS standards, including ISO 9001. These objectives are
designed to encourage organizations to define strategic goals and
a purpose for the QMS. Objectives translate an organization’s
vision into practice by creating a link between customer
requirements and specific, measurable, and attainable goals.
Well-written objectives lend purpose to a quality management
system initiative and establish a customer-centric culture in an
organization.

For example, quality objectives for the pharmaceutical

organization in the research phase could include:

 To obtain total compliance with staff training requirements and raise average
assessment scores from 90% to 95%.
  To successfully implement a QMS software within three months and eliminate paper and
spreadsheet-based record-keeping methods within six months.
 To achieve a successful initial synthesis of the drug and complete all necessary
processes for FDA initial review within 12 months.

Quality objectives should provide a clear vision for every member

of the organization to understand the company's purpose and the
value of a QMS. The objectives should provide a clear metric for
measuring progress against strategic goals, including the timeline
for achievement and a measurable parameter of improvement.

2. Quality Manual
A quality manual is defined as the first documentation of a QMS.
It states the motivation for adopting a QMS framework and the
role of quality within the organization. ISO 9000 requirements for
a quality manual prescribe that this document should:

 Describe the scope of the QMS

 Detail the requirements of the QMS standard or framework
 List any elements of the QMS which are excluded from the implementation
 Reference specific quality procedures used within the organization
 Provide visual documentation of critical processes via flowchart
 Explain the organization’s quality policies and objectives

3. Organizational Structure and Responsibilities

A QMS should include a clear and updated model of the
organization's structure and the responsibilities of all individuals
within the organization.

Within the context of a QMS, “the organization” describes both

people and structure. For a life sciences company in the early
phases of the product development lifecycle, a list of
organizational components might look like this:

 Personnel
  Equipment
 Information systems
 Tools for assessment
 Facilities
 Purchasing and inventory
 Process controls
 Documents and records

The organizational structure documentation should address the

entire product lifecycle using techniques such as flowcharts which
depict the “path of workflow.” Defining responsibilities requires an
organizational chart with clearly defined roles that can be linked to
standard operating procedures (SOPs).

4. Data Management
Data quality and availability are critical to the success of a QMS
framework to drive continuous improvement and preventative
quality control activities. Organizations with ineffective data
management practices can experience inconsistent product
quality, operating inefficiencies, compliance risks, poor customer
satisfaction, and low profitability.

An organization must be able to provide meaningful data

evidence of effective quality controls. Data management systems
should start by defining the types of data gathered by the
organization and third-party sources. The policy for data
management should address data types, sources, collection
methods, responsibilities, storage, disposal, and analysis.

The types of data required to demonstrate effective QMS

performance can vary significantly between organizations.
However, at a minimum, it should include the following sources:

 Customer satisfaction
 Supplier performance
  Product and process monitoring
 Non-conformances
 Trends
 Preventative or corrective action

5. Processes
The entire QMS approach to quality control is to establish
standardized, replicable processes. Standards for quality
management require organizations to identify and define all
organizational processes which use any resource to transform
inputs into outputs. Virtually every responsibility in the
organization can be tied to a process, including purchasing.

Initial efforts to define processes should create a high-level

picture of how processes serve the organization and intersect with
resources such as employees, machines, or technology. After
identifying processes, organizations can begin to define standards
and success metrics:

 Identify organizational processes

 Define process standards
 Establish methods for measuring success
 Document a standardized approach to ensuring quality output
 Drive continual improvement

6. Customer Satisfaction with Product Quality

A core component of QMS is the requirement for organizations to
monitor customer satisfaction to determine if quality objectives are
achieved. Some standards do not prescribe specific methods for
measuring customer satisfaction since the definition of product
quality and available data can vary significantly between
organizations.

A first step to establishing monitoring systems for customer

satisfaction should be the definition of appropriate methods for
measuring customer attitudes and complaints. This could include:

 Satisfaction surveys
 Complaint procedures
 Analytical applications to measure satisfaction trends
 Management review of customer satisfaction

7. Continuous Improvement

A QMS dictates that continual improvement is an organization-

wide responsibility. However, ISO 9001 is clear that leadership
should play a core role in implementing a quality-driven culture.
Clause 5.1.1 states, "Top management shall demonstrate
leadership and commitment with respect to the quality
management system by taking accountability for effectiveness."

Designing organizational processes to meet QMS standards for

continuous improvement requires clear documentation of controls
across the organization. Improvement documentation should
encompass, at a minimum:

 Quality planning procedures

 Compliance requirements
 Safety design
 Risk-based thinking
 Corrective action (CAPA)
 Gradual and breakthrough improvement
 Innovation
 Assessment and audit of the QMS

8. Quality Instruments
The control and calibration of tools used to measure quality are
integral to the success of a QMS. If machines or equipment are
used to validate products or processes, this equipment must be
carefully controlled and calibrated according to industry
standards. Depending on the instrument, this could involve
periodic calibrations or calibration before every measurement.

The QMS system design within an organization should dictate a

clear policy for the maintenance of quality instruments based on
nationally or internationally recognized standards for each piece
of quality equipment. This documentation should address:

 Intervals for instrument calibration

 Recognized standards for instrument calibration
 Manufacturer instructions for adjustment
 Procedures for identifying and documenting calibration
 Controls against tampering or adjustment post-calibration
 Methods to protect instruments and equipment from damage

In addition to these requirements, the QMS should address

effective documentation of calibration results, including
procedures for maintaining complete records of activities and
calibration results.

9. Document Control and Management

The definition of a document in a quality-driven organization is

broad, according to ISO. It includes all records of:

 Communications
 Evidence
 QMS conformity
 Knowledge sharing

A QMS outlines standards for the types of documentation

necessary to support quality management at a minimum, which
may not be reflective of all the documents needed for accurate
quality control. This generally includes quality objectives, a quality
manual, procedures, process documentation, and records
keeping. Document management systems must contain all
evidence necessary to prove QMS performance objectively.

Effective record-keeping is crucial to the success of the QMS, the

ability to obtain certification with QMS standards, and regulatory
compliance. During QMS design, organizations should create
specific definitions of records within the organization and policies
for document creation, retention, and editing. While QMS
standards do not typically prescribe a method for document
management, being able to capture and retain all supporting
evidence is generally best accomplished with quality management
systems software.

The Role a Quality Management System Plays in a Life

Sciences Company
The products created by pharmaceutical and medical device
companies must go through a rigorous approval process, and part
of that involves measuring their quality. The FDA, EMA, and other
international regulatory agencies all have quality guidelines life
sciences companies must follow, and many of them align with the
guidelines laid out in ISO 9001 and ISO 13485.

So, the QMS your company puts in place helps you follow those
quality guidelines, thus making it easier on you when your
products go through the regulatory agency’s approval process.
Accurate documentation and standardized processes are how
you prove that your data is sound and your product works as
promised.

Make sure you see success with your QMS.

Quality management systems are not designed to provide a
prescriptive checklist for total quality management. Instead, a
QMS is intended to serve as a framework that guides the
organization in achieving quality objectives, continuous
improvement, and customer satisfaction. Use your QMS to keep
your life sciences company’s policies and procedures aligned with
launching and scaling life-saving products.

The most successful QMS implementations balance simplicity

and customization. A QMS needs to be purpose-built to fit an
organization's objectives, industry, and compliance requirements
to have a meaningful impact on culture. Simultaneously, every
customization to the QMS should provide clear value without
needless complexity. The right QMS design is a mixture of
flexibility and standardization. Organizations need enough
standardization to produce consistent results and enough
flexibility for continuous improvement to create a quality-driven
culture. If you're looking for quality management software to help
set the foundation of your QMS, contact us today for a product
demo.
Remote auditing and certification 
Remote audits offer a flexible alternative to traditional audit methods. Our remote audits
offer the same level of quality you’ve come to expect from TUV Rheinland. We are
committed to being a strong and reliable partner. Learn more!
Optimal quality management with ISO 9001 certification
Over a million companies benefit from a quality management system certified
according to ISO 9001, enjoying peak process performance and an international
competitive advantage. ISO 9001 certification ensures that quality orientation is lived by
each of your employees every day.

Our ISO 9001 certification experts know that well designed workflows contribute
decisively to the quality of your products and services. ISO 9001 demands that a quality
management system define who is responsible for which quality-relevant activities and
which procedures must be followed. To establish effective quality management in your
company, we take into account your specific requirements and perspectives. The
standard also requires a control loop, which involves constant internal re-evaluation of
the system, promoting a continuous improvement process (CIP).

With its process-oriented approach, a quality management system according to ISO

9001 is suitable for all industries and companies – from start-ups to global
corporations. We have experience partnering with organizations of all sizes and from all
sectors and are able to provide the resources you need for successful ISO 9001
certification.

Continually improve your quality management

We evaluate and certify your quality management system according to the individual
requirements of your company. Our quality management system experts have many
years of experience.

If you, too, want to optimize your quality management system with certification
according to ISO 9001, please schedule an appointment with our experts!
ISO 9001:2015 – Get the most important information in
our short info clip
How does our ISO 9001 certification help you cut costs and optimize your processes?
What issues do companies have to address in the course of certification in order to
meet the standard requirements? What challenges and opportunities does ISO 9001
bring with it and what does "High Level Structure" offer? Our video explains:

International market opportunities with ISO 9001

certification
7 Reasons for certification according to ISO 9001
With an internationally recognized certification of your quality management system
according to ISO 9001 you can gain competitive advantage and improve your market
entry chances. In addition to fostering a strong customer orientation, certification offers
your customers and business partners a valuable decision-making aid. You can also
increase efficiency within your company and improve your processes and structures.
This allows you to achieve considerable cost savings while minimizing your liability risk.
You also benefit from increased employee motivation through better communication
and more readily available information.

Another benefit: The "High Level Structure" of ISO 9001 facilitates combined
certifications with other standards. If you want to learn more, download our FAQs.
Stages of ISO 9001 certification
Our experts can guide you through the process for certification of your quality
management system, following these steps:

1. Preliminary audit (optional)

2. Certification audit: documentation review and practical application assessment
3. Issue of certification and entry into the online certification database Certipedia
4. Annual surveillance audit
5. Re-certification within three years
Stages of Certification ISO 9001
Stages of your certification according to ISO 9001