Quality Policy and Objectives

Does your organization’s Quality Policy inspire you, or tire you?

First, let’s review US FDA and ISO 13485 requirements and ISO 14969 guidance. After that, I am sharing my current “state of the art” model for a Quality Policy and corresponding Quality Objectives.

Quality Policy Definitions

ISO 9000:2005 – Overall intentions and direction of an organization related to quality as formally expressed by top management.

US FDA 21 CFR 820 – Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

US FDA 21 CFR 820.20 Management responsibility

(a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

ISO 13485, 5.3 Quality policy

Top management shall ensure that the quality policy

(a) is appropriate to the purpose of the organization,
(b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system,
(c) provides a framework for establishing and reviewing quality objectives,
(d) is communicated and understood within the organization, and
(e) is reviewed for continuing suitability.

NOTE: ISO 9001:2008 has same requirements except (b) says: includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system.

ISO 13485, 5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

ISO 13485, 5.4.2 Quality management system planning

Top management shall ensure that the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives.

GUIDANCE – ISO 14969

The quality policy establishes

— a commitment to quality and the continuing effectiveness of the quality management system to meet customer and regulatory requirements,

— the context for quality objectives, and

— the relationship of the organization’s objectives to the customers’ requirements.

It is important that the organization’s quality policy be considered when preparing the overall organization policies related to its business operations (e.g., marketing, sales, finance) in order to ensure that all organization policies are consistent and supportive of each other.
The quality policy should communicate the organization’s commitment to quality and its overall vision of what quality means to the organization’s business and customers. In order to demonstrate that the organization is committed to implementing its quality policy, it will need to identify clear, overall quality goals for the business that are directly relevant to the organization and its customers.
Top management’s commitment to the quality policy should be visible, active, and effectively communicated. For example, a publicly displayed copy of the quality policy signed by top management is one method to show that commitment to both employees and customers. Another method is to present and discuss the quality policy at organization meetings throughout the year. Top management’s commitment is best communicated through its decisions and actions.
All employees need to understand the quality policy and how it affects them. Top management should ensure that the organization decides on the methods which will be used to achieve this understanding.
The quality policy also needs to be reviewed from time to time to determine if it accurately reflects the current quality related goals and objectives of the organization. This review is often carried out during the management review required in 5.6.

Are you still there? Here is what you have been waiting for:

Drum roll please…
Here is a draft Quality Policy that I typically suggest to new clients for consideration.

___________________________________________________________________

ACME MEDICAL, INC. QUALITY POLICY

Acme Medical is committed to providing innovative XYZ DEVICES that meet customer and regulatory requirements.

We maintain an effective quality system by managing product risk and executing objectives related to:

  1. Product development and improvement.
  2. Quality system planning and improvement.
  3. Supplier quality assurance.
  4. Personnel training and competence.
  5. Regulatory compliance and internal/external audits.
  6. Process effectiveness and efficiency.

____________________________________________________________________

I put the Quality Policy in the top-level Quality Manual document that I call “QSM1: Quality System Overview”.  My second Quality Manual document is “QSM2: QS Glossary”, and my third/last Quality Manual document is “QSM3: QS Objectives”.

The framework for the QS Objectives is established by the 6 headings in the Quality Policy. In the QS Objectives document (my QSM3), SMART objectives are listed under each heading.

I suggest re-casting the objectives annually and reporting accomplishments quarterly. In my opinion, the current-year objectives/accomplishments should always fit on one page. Don’t make this too complicated.

Nowadays, quality audits are not restricted to compliance. Compliance is the easy part; we need a quality management system that works, a system that is effective, and hopefully efficient too!

The QS Objectives should be the basis for assessing process effectiveness (and efficiency). They should be used by the process owners to guide them towards continual improvements. They are also used by quality auditors (internal/external) to evaluate process effectiveness.

# Current Quality Policy from Fortune 500 Medical Device Company
We will exceed our customers’ expectations by striving without reserve for unsurpassed product quality, reliability, and patient safety through effective, agile and compliant processes.
We will continuously improve our quality management systems, comply with all applicable regulatory requirements, and deliver excellence to customers through our products, processes, services, and relationships.”

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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