Quality Policy
Defines management's commitment to quality, measurable objectives, and continuous improvement. It should be endorsed by executive leadership, communicated to employees, and reviewed periodically for relevance and effectiveness.
A well-structured Manual centralizes policy and process, reduces variation, supports compliance with regulatory standards, and provides auditable evidence of controls. It clarifies roles, shortens corrective-action cycles, and helps demonstrate management commitment to quality.
The Quality Management System Manual is used across functions and organizational levels to guide consistent practices, support audits, and document responsibilities.
Maintain signatures, approvals, and version history so auditors and management can verify reviews and demonstrate control.
Defines management's commitment to quality, measurable objectives, and continuous improvement. It should be endorsed by executive leadership, communicated to employees, and reviewed periodically for relevance and effectiveness.
Specifies organizational boundaries, product lines, services, and locations covered by the Manual. A clear scope prevents misapplication of procedures, clarifies responsibilities, and supports consistent audit findings across sites and contractors.
Documented processes for core activities including document control, nonconformance handling, corrective/preventive actions, purchasing, and internal audits. Procedures should reference specific forms, responsibilities, and acceptance criteria to ensure repeatability.
Identifies process owners, approvers, and record custodians with defined authorities and escalation paths. Include authority to accept deviations, request exceptions, and initiate corrective actions to maintain compliance.
Lists required records, retention periods, storage location, and key performance indicators. Establish data sources, measurement frequency, and ownership for reporting to management and evidencing compliance.
Describes nonconformity handling, root-cause analysis, corrective/preventive action workflows, and management review processes, including closed-loop tracking and timelines for verification of effectiveness.
| Field | Configuration |
|---|---|
| Document Owner | Quality manager assigned with edit and approval rights. |
| Approval Workflow | Two-level review: process owner then management. |
| Versioning | Automated version numbers and change log entries. |
| Distribution | Controlled access via central repository with read/write roles. |
Ensure your e-signature and document platform supports secure hosting, access control, and comprehensive audit trails for the Quality Management System Manual.
Complete a formal review at least once every 12 months.
Schedule internal audits at planned intervals yearly or per process risk.
Hold management review meetings quarterly or biannually as documented.
Implement approved revisions within defined ten business days.
Assemble evidence and records at least two weeks before audit.
Identify scope, owners, and initial documentation requirements.
Compile procedures, templates, and process maps for review.
Secure executive sign-off and record approval metadata.
Publish approved Manual and update the document control register.
| Criteria | Electronic Signature | Digital Signature |
|---|---|---|
| Legal Status | accepted under esign/ueta | cryptographic pki-backed |
| Technology | type, click, image, audit trail | x.509 certificate, hash |
| Non-repudiation | relies on audit trail | provides crypto non-repudiation |
| Typical Use | business agreements, approvals | fda records, high-assurance needs |
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | 7-day free trial | Trial varies by vendor | Trial varies by vendor | Trial varies by vendor | Trial varies by vendor |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
| Envelope Cap | No cap | 100 envelopes/user/year | Varies by plan | Varies by plan | Varies by plan |