LAB-QM-002 — Document Control Policy

1.0 Purpose

This policy establishes a standardized system for the development, review, approval, issuance, distribution, revision, retention, retrieval, and disposal of all Clinical Laboratory documents at Tarangnan Community Hospital (TCH), ensuring an unbroken, traceable chain of custody for every controlled document.

This policy also defines the standard procedure for preparing all Clinical Laboratory documents at TCH — including the Quality Manual, policies, Standard Operating Procedures (SOPs), work instructions, forms, flowcharts, job aids, and visual annexes (infographics) — ensuring every document is written, formatted, and structured consistently regardless of who prepares it or which section it covers.

This policy exists to ensure the Laboratory's documents remain accurate, current, and consistently controlled in a manner that meets applicable national regulatory requirements and the international accreditation standards the Laboratory is pursuing (ISO 15189 and the WHO Laboratory Quality Management System Handbook).

Where Document Control Policy governs the lifecycle of a document (creation, approval, revision, retirement), this policy governs how the document itself is written and formatted.

2.0 Scope

This policy applies to all Clinical Laboratory documents, regardless of format, including: the Quality Manual, policies, Standard Operating Procedures (SOPs), work instructions, forms, flowcharts, quality-related memoranda, job aids, and visual annexes (infographics).

It applies to all Medical Technologists, Laboratory Aides, and authorized management staff involved in creating, reviewing, approving, distributing, revising, retiring, drafting, formatting, or preparing any such document, consistent with the Laboratory's defined scope of service (see Scope of Service and Laboratory User Information Policy).

Records — the objective evidence generated by following a controlled document — are governed separately under Control of Records. This policy governs the controlled documents themselves, not their resulting records.

3.0 Definitions

• Document — any quality-related document governed by this policy: Quality Manual, Policy, SOP, Work Instruction, Form, Flowchart, Job Aid, or Visual Annex. As information and its supporting medium, it may be a policy, procedure, process, or form.
• Master Document — the original, validated, and approved version of a document, carrying the official header/footer and approval signatures.
• Policy — a statement of direction from Laboratory leadership; becomes applicable only once approved per Section 5.3.
• SOP (Standard Operating Procedure) — step-by-step instructions, following CLSI format, describing how a test or process is performed.
• Form — a set of fields or instructions completed by staff when implementing a policy or procedure; a list is treated as a form when used for that purpose. Once completed, a form becomes a record (see Control of Records).
• Flowchart — a pictorial diagram of a technical or administrative process. It often uses geometric symbols, showing the sequence of activities and decisions in a process; also called a "process map."
• Job Aid — a shortened version of an SOP for use directly at the point of testing; supplements but never replaces the full SOP.
• Visual Annex (Infographic) — a one-page visual summary of a single parent controlled document, controlled as an annex of that parent under Section 5.2.6. It carries no independent document number and no content beyond its parent (see Section 5.7.7).
• Record — objective evidence that an activity was performed, an event occurred, or a result was achieved (the output of following a document — see Control of Records, not this policy).
• Controlled Copy — a document issued and tracked under this policy, distinguishable from an Uncontrolled Copy, which is not guaranteed to reflect the current approved version.
• Obsolete Document — a retired document no longer in active use, retained only for the required historical/audit period.
• Template — an approved design or pattern serving as the basis for constructing similar documents (see the approved TCH policy template).
• Draft — a rough or preliminary piece of writing, not yet approved.
• Process — a set of interrelated or interacting activities that transform inputs into outputs; may be documented as a flowchart or table.
• Procedure / SOP — a specified, stepwise set of instructions describing how to complete an activity identified in a process.

4.0 Responsibility

4.1 Hospital Director

• Grants final approval for all Laboratory policies, SOPs, and forms prior to implementation.
• Ensures institutional support for the resources needed to implement (standing governance and policy approval duties are defined in Organization and Governance). this policy.

4.2 Pathologist

• Reviews and concurs on technical and quality documents prior to approval, verifying scientific and clinical accuracy.
• Reviews and signs relevant SOPs within two (2) months of any new (standing governance and policy review duties are defined in Organization and Governance). appointment to the role (including acting capacity).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Owns and administers the document control system end-to-end: intake of creation/revision requests, drafting or coordinating drafts, tracking review and approval status, and maintaining the master document index.
• Prepares or reviews all newly created or revised Quality documents prior to submission for approval.
• Distributes approved, current documents to all applicable personnel and removes/archives superseded versions from active use.
• Maintains the Policy and Procedure Index Master File and Laboratory Forms Index (see Section 6.0).
• Conducts periodic checks that only current, approved versions are in active use (soft and hard copy).
• Coordinates the annual review cycle for all Laboratory documents.
• Ensures every new or revised document follows this policy's format and content requirements before submission for review/approval.
• Maintains the approved document/SOP templates and confirms new documents use the correct one for their type.
• Verifies technical accuracy, terminology, and completeness of procedure documents before submission.

4.4 Medical Technologists

• Read, understand, and comply with current, approved documents relevant to their role.
• Submit requests for new or revised documents to the Chief Medical Technologist / Laboratory Quality Manager.
• Sign the Policy and Procedure Acknowledgment Sign Page upon notification of a new or revised document.
• Do not alter, copy, or distribute controlled documents without authorization.
• Draft SOPs and forms for procedures within their assigned responsibilities, following this policy's requirements.
• Assess the scientific validity of a procedure before writing its SOP.
• Submit drafts to the Chief Medical Technologist / Laboratory Quality Manager for review.

4.5 Laboratory Aides

• Read, understand, and comply with current, approved documents relevant to their role.
• Submit requests for new or revised documents to the Chief Medical Technologist / Laboratory Quality Manager.
• Sign the Policy and Procedure Acknowledgment Sign Page upon notification of a new or revised document.
• Do not alter, copy, or distribute controlled documents without authorization.
• Read, understand, and comply with approved SOPs and forms relevant to their role.

5.0 Policy / Procedure

5.1 Document Numbering

Document numbering follows the established TCH scheme:

• Policies and SOPs: LAB-QM-[SECTION]-[###]; sectional SOPs use LAB-[DISCIPLINE]-[SECTION]-[###].
• Work Instructions: parent-traceable — WI-QM-[SECTION]-[PARENT NUMBER]-R[#], with letter suffixes (-A, -B, ...) when one parent has several work instructions. A work instruction is a controlled supporting document, not a form.
• Visual Annexes (Infographics): no independent document number. Each infographic is controlled as an annex of its parent document (see Section 5.2.6) and is cited by the register short-code IG-[##] in its parent document and in F-QM-002-B-V0.
• Forms (new forms): parent-traceable — general QM: F-QM-[PARENT NUMBER]-[letter]-V[#] (example: LAB-QM-002 forms are F-QM-002-A-V0, F-QM-002-B-V0, ...); sectional QM: F-QM-[SECTION]-[PARENT NUMBER]-[letter]-V[#]; discipline SOPs: F-[DISCIPLINE]-[SECTION]-[PARENT NUMBER]-[letter]-V[#]. Legacy/general forms retain their registered LAB-F-[###]-[R#] identifiers.

Numbers are assigned sequentially within each series and are never reused, even when a document is retired. The Laboratory Forms Index is the authoritative register of controlled forms; its existing entries remain unchanged unless a deliberate, controlled renumbering is undertaken.

5.2 Document Architecture and Numbering Detail

5.2.1 Quality Management Policies

General laboratory-wide management policies are numbered LAB-QM-###. Sectional management policies extend the number with the applicable section code:

Purpose and function: each policy states the management requirements for its area — what shall be done, who is responsible, and how compliance is demonstrated.

Appropriate content: requirements, responsibilities, controls, acceptance criteria, monitoring expectations, and references to supporting documents.

Shall not contain: bench-level step-by-step instructions (those belong in SOPs or work instructions) or captured data (that belongs on forms).

Examples: Document Control (Document Control Policy); Specimen Collection requirements (Specimen Collection Policy); Hand Hygiene requirements (Hand Hygiene Policy).

5.2.2 Sectional SOP Manuals

Sectional procedure documents are numbered by laboratory discipline and process phase:

The former sectional-manual scheme (LAB-H-QM-###, LAB-H-PRE-###, and similar) is retired. Sectional quality and management requirements now live in the LAB-QM policy series; bench procedures live in the SOP series.

A sectional document shall stay within its own discipline and phase. Laboratory-wide management requirements belong in the LAB-QM series, not in sectional manuals.

5.2.3 Work Instructions

A work instruction provides detailed task-specific instructions that support a parent policy or SOP. It is a controlled supporting document — not a form, not a record, and not an SOP replacement.

Numbering is parent-traceable: WI-QM-[SECTION]-[PARENT NUMBER]-R[#]. When one parent has several work instructions, letter suffixes distinguish them (WI-QM-IC-001-A-R0, WI-QM-IC-001-B-R0, ...). Every work instruction identifies its parent document in its document-control information.

Example: Hand Hygiene Policy → WI-QM-IC-001-R0.

5.2.4 Forms

A form captures information or documentation required by a parent policy or SOP. A blank form is a controlled document; a completed form becomes a record.

New forms use parent-traceable numbering per Section 5.1:

• General QM parent: F-QM-[PARENT NUMBER]-[letter]-V[#] (example: LAB-QM-002 → F-QM-002-A-V0);
• Sectional QM parent: F-QM-[SECTION]-[PARENT NUMBER]-[letter]-V[#];
• Discipline SOP parent: F-[DISCIPLINE]-[SECTION]-[PARENT NUMBER]-[letter]-V[#] (example: SOP-H-002 → F-H-002-A-V0).

Existing registrations in the Laboratory Forms Index remain authoritative and unchanged.

5.2.5 Records

A record is completed objective evidence that an activity was performed, an event occurred, or a result was achieved. Records originate from controlled forms and carry no independent document number; they are retained per Laboratory Retention Schedule Policy and controlled per Control of Records.

5.2.6 Visual Annexes (Infographics)

An infographic is a one-page visual summary of a single parent controlled document, controlled as an annex of that parent document — not as a document in its own right. It carries no independent document number; the short-code IG-[##] is a register reference only.

• Derived content only. Every statement on an infographic is drawn from its parent document, consistent with Section 5.7.7. An infographic shall not introduce, alter, or omit any requirement of its parent; where the two appear to differ, the parent document governs.
• Life cycle follows the parent. A visual annex is created, reviewed, approved, revised, and retired together with its parent document, through the same change process (Section 5.8, form F-QM-002-A-V0). Revision of a parent document shall include review of its visual annexes.
• Identification. Each visual annex names its parent document and bears its short-code. It is cited in the parent document's Section 7.0 (References) and registered in F-QM-002-B-V0.
• Distribution. The controlled locations are the infographics/ folder of the QMS master files and any posted print at the point of use. A posted print is current only while it matches the registered version; superseded prints shall be removed when the parent is revised.

5.3 Required Document Elements

• Policy/statement documents shall contain, at minimum: Purpose, Scope, Definitions, Responsibility, Policy/Procedure, Records, and References, presented under the approved TCH document header and footer format.
• Technical SOPs shall additionally address, as applicable: Test Principle, Clinical Significance, Safety Precautions, Specimen Requirements, Equipment/Reagent, Calibration, Quality Control, Procedure steps, Calculations, Reporting, Reference Ranges, Critical Results, Performance Parameters, Limitations, Attachments, and References.

5.4 Document Development Steps

Every new or revised document follows these steps:

• Identify the need for a new document (quality or operational).
• Determine the document type (policy, process/flowchart, procedure/ job aid, or form).
• Write the draft.
• Evaluate and verify the draft (technical accuracy, completeness, compliance with this policy's format requirements).
• Determine whether further changes are needed.
• Obtain approval signatures (per Section 5.6).
• Define any staff training requirements arising from the new/revised document.
• Distribute and implement (per Section 5.10).

5.5 General Requirements for All Policies and Procedures

• Written to be realistic, understandable, consistent, and fair.
• Compliant with applicable Philippine laws/regulations and the international accreditation standards TCH is pursuing.
• Reviewed at least annually, or sooner if regulations, methods, or equipment change (see Section 5.8).

5.6 Document Formatting Standards

• Paper/orientation: white, plain A4 size, portrait orientation.
• Font: Arial, size 10, black. Paragraph headings: bold, size 10.
• Emphasis: bold/italic/underline used to highlight important information; white space used to keep documents visually clear.
• Confidentiality disclaimer: every document carries the standard disclaimer already present in the approved TCH policy template's footer — "This document is considered confidential, should not be disclosed or copied under any circumstances. The breach of the confidentiality will cause legal actions."
• Header/footer: every document uses the approved TCH header/footer template; no other header design is used.

5.7 Writing Guidance by Document Type

5.7.1 Quality Management Policy

• Purpose: state management requirements and direction for an area.
• When used: whenever laboratory-wide or sectional management control is required.
• Level of detail: requirements and responsibilities only.
• Typical contents: Purpose, Scope, Definitions, Responsibility, Policy/Procedure, Records, References.
• Shall not contain: step-by-step bench procedure or data-capture fields.
• Example: Document Control Policy.

5.7.2 Standard Operating Procedure (SOP)

• Purpose: define how a test or process is performed.
• When used: for any recurring technical or administrative process.
• Level of detail: complete, stepwise, executable at the bench.
• Typical contents: title; purpose; pre-examination, examination, and post-examination instructions; preparer name; approving signatures and dates.
• Writing rules: start every instructional step with an action verb; adapt manufacturer instructions to TCH's own equipment and setting; verify all calculations; refer to roles by title, never by personal name.
• Shall not contain: unverified formulas or steps that contradict the parent policy.
• Example: a Chemistry analytical procedure under LAB-C-ANA-###.

5.7.3 Work Instruction

• Purpose: explain one specific task in detail, supporting a parent policy/SOP.
• When used: the task needs more operational detail than the parent document should carry.
• Level of detail: single-task depth with exact actions, settings, and screens/steps as applicable.
• Typical contents: parent-document identification, task steps, safety/quality notes.
• Examples: analyzer startup/shutdown; daily maintenance; an LIS task; specimen packaging or label preparation; an equipment-specific task; a calculation/reference task. Parent-traceable example: Hand Hygiene Policy → WI-QM-IC-001-R0.
• Shall not contain: new requirements that conflict with the parent document; it shall never be classified as a form.

5.7.4 Form

• Purpose: capture information required by a parent policy/SOP.
• When used: whenever implementation of the parent document must be documented.
• Level of detail: fields only, ordered as the information is actually generated during the activity.
• Typical contents: hospital name/logo, department identifier, form number and revision, field labels, signature/date blocks.
• Shall not contain: instructional paragraphs belonging to an SOP or work instruction.
• Example: F-QM-002-A-V0 Document Management Form (parent LAB-QM-002).

5.7.5 Log

• Purpose: capture recurring entries over time against one activity.
• When used: events repeat (temperatures, occurrences, maintenance).
• Level of detail: tabular rows with fixed columns.
• Typical contents: date/time, item/subject, result/observation, initials.
• Shall not contain: narrative procedure text.
• Example: an occurrence log supporting Occurrence Management Policy.

5.7.6 Checklist

• Purpose: confirm defined items were completed or verified.
• When used: multi-point tasks prone to omission.
• Level of detail: checkbox lines grouped logically.
• Typical contents: item list, verifier initials/date.
• Shall not contain: open-ended data fields meant for a form/log.
• Example: a monthly equipment-check checklist supporting Equipment Temperature Monitoring Policy.

5.7.7 Visual Aid / Poster / Quick Guide

• Purpose: present a concise point-of-use aid derived from an approved parent controlled document.
• When used: steps must be visible where the task is performed.
• Level of detail: abbreviated steps/graphics only.
• Typical contents: parent document reference, essential steps, critical warnings.
• Shall not contain: new or conflicting requirements; anything absent from the approved parent document. Printing does not make a poster a form.
• Parent-traceable example: Hand Hygiene Policy → WI-QM-IC-001-R0 Hand Hygiene Technique / Point-of-Use Guide.

Every SOP shall include, at minimum: Title, Purpose, Pre- examination / Examination / Post-examination instructions, name of the person preparing the SOP, and signatures of approving officials with approval dates.

5.8 Creation, Change, and Cancellation

Document creation, change, and approval follow the controlled lifecycle sequence (see Figure 1).

Figure 1 — Controlled document lifecycle and approval flow

• A staff member or the Chief Medical Technologist identifies the need for a new, changed, or cancelled document and completes F-QM-002-A-V0 (Document Change, Annual Review, and Disposal Form).
• A draft is prepared, following Section 5.3's required elements and the approved header/footer template.
• The draft is reviewed by the Pathologist and approved by the Hospital Director before it becomes an active controlled document. - Technical documents: prepared by the responsible technologist, reviewed by the Pathologist, approved by the Hospital Director. - Quality documents: prepared by the Chief Medical Technologist / Laboratory Quality Manager, reviewed by the Pathologist, approved by the Hospital Director.
• New documents and forms are logged in the Master Document Register and Staff Reading Acknowledgment (F-QM-002-B-V0).
• Version numbering starts at V0 for a new document; any major revision increments the version (V1, V2...). Minor corrections (e.g. spelling) do not require re-issue or re-acknowledgment by staff.
• The effective date is set at least two (2) weeks after the approval date.

5.8.1 Process/System Change Approval (Distinct from Document Approval)

A change to a laboratory process, method, or system (e.g., a new workflow step, a change in how an examination is performed, or a change to the Laboratory Information System per Laboratory Information Management Policy Section 5.7) shall be authorized before it is implemented in practice, by the role responsible for that process/system per its own governing policy. This authorization is distinct from, and precedes, the formal revision of the controlled document that records the change under Sections 5.8(1)–(6) above: a process/system shall not be changed on the strength of a document revision alone, and a document revision shall not be represented as authorizing a process/system change that has not itself been separately authorized.

5.9 Review and Revision

• All documents are reviewed at least annually by the Chief Medical Technologist / Laboratory Quality Manager (or the Pathologist, for documents requiring clinical review), tracked on F-QM-002-A-V0 (Part 3 — Annual Periodic Review Schedule & Verification).
• If no changes result from a review, this is documented in standard text ("No changes, revisions, or amendments made") on F-QM-002-A-V0 and in the document's own Review/Document History block; no staff re-acknowledgment is required.
• If changes result, the change summary is documented on the same form, the version number is incremented, and affected staff are notified and sign F-QM-002-B-V0 (Staff Reading Acknowledgment).
• Changes in accreditation standards, regulations, methods, or equipment that affect a document's content trigger an out-of-cycle review, independent of the annual schedule.

5.10 Document Control and Distribution

• All Laboratory documents are the property of TCH; alteration or modification is restricted to the author, a designated reviewer, or a designee, and only after Hospital Director approval.
• The Laboratory shall maintain a designated controlled location for the master electronic documents and an appropriate backup/recovery arrangement, managed by the Chief Medical Technologist / Laboratory Quality Manager.
• Controlled Copies are distributed as: - a master soft copy, in non-editable format (e.g., locked PDF), under the controlled location in item 2; and - a physical controlled copy, stamped or marked as such, kept in a designated Laboratory document binder/folder accessible at the point of use; and - the integrated QMS panel inside the laboratory information system (LUIB), where staff read the current approved documents.
• The Chief Medical Technologist / Laboratory Quality Manager conducts periodic checks to confirm only current, approved versions remain in circulation, and removes superseded copies from active use.
• Uncontrolled Copies (e.g., printed for reference or training) are clearly marked as such and are not guaranteed to reflect the current version.

5.11 Obsolete and Retired Documents

• Superseded documents are stamped or marked "Obsolete" and removed from active circulation immediately upon a revision's effective date.
• Obsolete documents are retained per the laboratory records retention schedule (Laboratory Retention Schedule Policy), then destroyed by shredding (physical) or secure deletion (electronic), logged on F-QM-002-A-V0 (Part 4 — Obsolete/Retired Document Disposal).

5.12 Retention

Retention periods for controlled documents follow applicable national and international regulatory requirements, tracked in the Master Document Register and Staff Reading Acknowledgment (F-QM-002-B-V0). Detailed retention schedules for records (as opposed to controlled documents) are addressed in Control of Records and Laboratory Retention Schedule Policy.

6.0 Records

Implementation of this policy uses the following controlled forms under the parent-traceable numbering rule (Section 5.1):

Completed forms are records: they are retained per Laboratory Retention Schedule Policy and controlled per Control of Records.

This policy does not introduce new forms beyond those listed above. Work instructions derived from a parent document use parent-traceable numbering (WI-[PARENT]-[LETTER]-V[#]) and are supporting controlled documents, not forms.

7.0 References

• DOH-Philippines QMS Tool, Section 1 — Management Review; Section 3 — Service Delivery
• DOH Administrative Order No. 2021-0037, Annex B1 — Technical Standards for Clinical Laboratories
• ISO 15189:2022, Section 8 — Management System Requirements
• WHO LQMS Handbook, Chapter 16 — Documents and Records

Companion policies:

• Control of Records — governs records (the output of following controlled documents), not controlled documents themselves
• Scope of Service and Laboratory User Information Policy — defines the scope this policy applies within