Document and Record Control Procedure

Procedure number	00
ISO/IEC 17025 reference	Clause 8.4
Revision	00
Effective date	[Enter date]
Approved by	[Quality Manager / Laboratory Director]

1. Purpose

To establish and maintain a systematic process for the control of all documents and records within the laboratory's Quality Management System (QMS), ensuring that:

• Only current, approved versions of documents are available at all points of use.
• Changes to documents are reviewed and approved before implementation.
• Records are identified, stored, protected, retrievable, and disposed of in a controlled manner.

2. Scope

This procedure applies to all QMS documents and records, whether in paper or electronic form, including but not limited to:

Documents:

• Quality Manual
• Quality Policy and Objectives
• Procedures (this series, 00–21)
• Work instructions and standard operating procedures (SOPs)
• Appendices (forms, templates, checklists, and registers)
• External documents (standards, regulations, manufacturer manuals)

Records:

• Test and calibration results (raw data, worksheets, calculations)
• Equipment calibration certificates
• Training and competence records
• Audit reports
• Management review minutes
• Customer contracts and correspondence affecting laboratory activities

3. References

• ISO/IEC 17025:2017, Clause 7.5 — Technical records
• ISO/IEC 17025:2017, Clause 7.11 — Control of data and information management
• ISO/IEC 17025:2017, Clause 8.3 — Control of management system documents (Option A)
• ISO/IEC 17025:2017, Clause 8.4 — Control of management system records (Option A)

4. Definitions

Term	Definition
Document	Information and its supporting medium that defines, specifies, or describes activities, requirements, or results. Documents are subject to revision control.
Record	A document that states results achieved or provides evidence of activities performed. This includes technical records (observations, data, calculations) and management system records (audit reports, review minutes). Records are not revised — they are retained as-is.
Controlled document	A document issued under the authority of this procedure, with a known revision status and distribution.
Obsolete document	A superseded document that is no longer valid for use.
External document	A document of external origin that the laboratory has identified as necessary for the QMS (e.g., standards, regulations).
Appendix	A supporting document (form, template, checklist, or register) that belongs to a procedure. Appendices are controlled documents subject to revision control. When filled in, they produce records.
Register	A type of appendix that accumulates entries over time (e.g., a list of equipment, a complaint log). Unlike a one-time form, a register is a living document that is updated as new entries arise.
Master copy	The authoritative version of a document, from which all distributed copies are derived.

5. Responsibilities

info

In smaller laboratories, one person may fulfil multiple roles (e.g., the Laboratory Director may also act as Technical Manager). What matters is that the responsibilities are assigned and that the person is aware of each role they hold. Where impartiality could be compromised by combining roles (e.g., authoring and approving the same document), appropriate safeguards should be in place.

Role	Responsibility
Laboratory Director	Ultimate accountability for the QMS (ISO/IEC 17025, clause 5.7). Approves the Quality Manual, Quality Policy, and any documents with strategic significance. Resolves disputes regarding document or record control when escalation is required.
Quality Manager	Overall responsibility for the document and record control system. Assigns document numbers, approves QMS procedures, maintains the List of Internal Documents, and establishes the laboratory's record retention policy. Ensures management system records are complete and properly identified.
Technical Manager	Responsible for technical records (test data, calibration results, method validations). Reviews and approves technical documents and work instructions. Ensures technical records contain sufficient information for reproducibility.
Document author	Drafts or revises documents using the applicable template or format. Coordinates with reviewers and the Quality Manager to ensure accuracy and compliance before submission for approval.
All personnel	Use only current, approved documents. Create legible, complete, and traceable records. Protect records from damage or loss. Report any discrepancies or need for revisions to the Quality Manager.

6. Procedure — Document Control

6.1 Document identification

Every controlled document shall include:

• A unique document number, assigned by the Quality Manager (following the numbering scheme in Appendix 1)
• Document title
• Revision number (starting at 00)
• Effective date
• Page number and total pages (e.g., Page 1 of 5) — where applicable to the document format
• Approval signature or equivalent authorization

6.2 Creation and review

1. The author drafts the document using the applicable template or format.
2. The draft is reviewed by at least one person with relevant knowledge who was not the sole author. In small laboratories where personnel availability is limited, the Quality Manager or Laboratory Director may serve as the sole reviewer.
3. The Quality Manager reviews the document for compliance with the QMS structure and ISO/IEC 17025 requirements.

6.3 Approval

1. Management system procedures and policies are approved by the Quality Manager (or Laboratory Director for the Quality Manual and Quality Policy).
2. Technical documents (work instructions, SOPs, test methods) are approved by the Technical Manager.
3. Approval is recorded by signature (physical or electronic) and date on the document or on a separate approval form.
4. No document shall be distributed or used prior to approval.

6.4 Distribution

1. Approved documents are made available to all personnel who need them at their points of use.
2. The Quality Manager maintains a List of Internal Documents (Appendix 1) recording the current revision and distribution of each document.
3. When a new revision is issued, previous copies shall be withdrawn and replaced. For paper-based distribution, the Quality Manager confirms withdrawal from each recipient using the distribution list. Electronic document management systems shall ensure that users can only access the current approved version.

6.5 Revision and change control

1. Any person may request a document change by notifying the Quality Manager.
2. Changes are drafted, reviewed, and approved following the same process as for new documents (sections 6.2 and 6.3).
3. The revision number is incremented with each approved change.
4. A brief description of the change shall be recorded in the document's revision history table:

Revision	Date	Description of change	Approved by
00	[Date]	Initial issue	[Name]
01	[Date]	[Description]	[Name]

5. Where practical, changes in the new revision should be identified (e.g., by marking changed text or listing affected sections).

6.6 Obsolete documents

1. The Quality Manager ensures that obsolete documents are promptly removed from all points of use.
2. If retained for legal or knowledge-preservation purposes, obsolete documents shall be clearly marked as "OBSOLETE — NOT FOR USE" to prevent unintended use.

6.7 External documents

1. The laboratory identifies external documents necessary for the QMS (e.g., ISO standards, regulatory requirements, equipment manuals).
2. These are recorded in the List of External Documents (Appendix 2).
3. The Quality Manager is responsible for monitoring external documents for updates. Monitoring methods may include subscribing to standards body notification services, checking publisher websites at defined intervals, or assigning specific personnel to track specific standards relevant to their area.
4. When an updated version of an external document is identified, the Quality Manager initiates a review of affected internal procedures and coordinates any necessary revisions.

7. Procedure — Record Control

7.1 Identification and creation

1. Records are generated as evidence of conformity to requirements, of the effective operation of the QMS, and of the laboratory's technical activities.
2. Each record shall be legible, readily identifiable, and traceable to the activity it relates to.
3. Technical records shall contain sufficient information to enable repetition of the laboratory activity under conditions as close as possible to the original (ISO/IEC 17025, clause 7.5). The Technical Manager is responsible for ensuring technical records meet this requirement.
4. The Quality Manager is responsible for ensuring management system records (audit reports, review minutes, training records) are complete and properly identified.
5. Forms used to generate records are controlled documents (see Section 6).

7.2 Storage and protection

1. Records shall be stored in a manner that prevents damage, deterioration, or loss.
2. Electronic records shall be backed up at intervals defined by the Quality Manager (e.g., daily, weekly). The person or function responsible for performing backups shall be designated, and backup integrity shall be verified periodically (e.g., through test restores).
3. Paper records shall be stored in a secure, designated location with appropriate environmental controls.
4. The Quality Manager is responsible for the storage of management system records. The Technical Manager is responsible for the storage of technical records (test data, calibration results, method validations).

7.3 Access and retrieval

1. Records shall be retrievable within a reasonable time.
2. Access to records shall be controlled to protect confidentiality and prevent unauthorized modification.
3. The Quality Manager (for management system records) and Technical Manager (for technical records) shall define access permissions as appropriate.

7.4 Retention

1. Records shall be retained for a minimum period defined by:

   • Accreditation body requirements
   • Regulatory or contractual obligations
   • The laboratory's own policy (minimum [X] years from the date of creation, or as specified per record type)

2. The Quality Manager establishes and periodically reviews the laboratory's retention policy, in consultation with the Technical Manager and Laboratory Director.

3. Retention periods for each type of record are defined in the List of Types of Records (Appendix 3).

7.5 Amendments to records

1. If a record requires correction, the original entry shall not be erased or made illegible.
2. The original value shall be crossed out (not deleted), and the corrected value written alongside.
3. All amendments shall be signed or initialed and dated by the person making the correction.
4. Amendments to technical records shall be reviewed or authorized by the Technical Manager.
5. For electronic records, the system shall:
   • Preserve the original entry (no overwriting or deletion)
   • Record the corrected value, the identity of the person making the change, and the date
   • Require a reason for the correction where the system supports it
   • Maintain an audit trail that is accessible for review but protected from modification

7.6 Disposal

1. Record disposal shall be conducted through a periodic review (at least annually). The Quality Manager prepares a list of records that have exceeded their retention period, in consultation with the Technical Manager for technical records.
2. The disposal list is reviewed and authorized by the Laboratory Director before any records are destroyed.
3. Disposal shall be carried out in a manner that ensures confidentiality (e.g., shredding, secure deletion).
4. All disposals shall be documented in the Registry of Records for Retention/Central Archive (Appendix 4).

8. Related documents

Document	Reference
Appendix 1 — List of Internal Documents	00-App-01
Appendix 2 — List of External Documents	00-App-02
Appendix 3 — List of Types of Records	00-App-03
Appendix 4 — Registry of Records for Retention/Central Archive	00-App-04
03 — Quality Manual	Procedure 03

9. Revision history

Revision	Date	Description	Approved by
00	[Date]	Initial issue	[Name]