Quality Policy and Objectives

Does your organization’s Quality Policy inspire you, or tire you?
Are you Quality Objectives follow a framework established by the Policy statement?

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

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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.

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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 categories listed 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.”