ISO9001 System Document Package (38) | Work Instruction for Document Preparation and Approval

By: QTank Published: 9/16/2026 Views: 43
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Document Description: This work instruction is a third-level supporting document for the "Document Control Procedure" (the third document in the package). It is used to implement the requirements of ISO 9001:2015, Clause 7.5.2 "Creation and Updating" and Clause 7.5.3 "Control of Documented Information" from "controlled" to "how to write, who reviews, who approves, and when it takes effect." The second-level procedure document answers questions such as "how many levels of documents, who manages, how to mark controlled documents, and how to recycle obsolete documents." This work instruction addresses the most practical issues in the document creation process: who proposes the need for a new document, what content needs to be planned before drafting, how to assign numbers without conflicts, what format elements and headers/footers to include, how to express clauses for executability, which departments need to co-sign, how to divide the responsibilities between reviewers and approvers, whether the document takes effect upon release or after training, what procedures to follow for revising a clause in the first version, and when a new version is required instead of a simple revision. It is applicable to all manufacturing and service enterprises (mechanical processing, electronic assembly, food and cosmetics, textile and apparel, building materials and hardware, engineering services, third-party testing, etc.) that have established or are establishing a quality management system. For small and medium-sized enterprises without a dedicated document control position, the responsibilities in Chapter 3 of this work instruction can be merged into the responsibilities of the management representative and part-time document controller, without changing the procedural logic. This document can be directly used as a third-level document for enterprise release.

1. Purpose

To standardize the requirements and timelines for proposing, drafting, numbering, reviewing, approving, releasing, training, revising, and recycling quality management system documents (quality manual, procedure documents, work instructions, record forms, external documents) within the company. This includes the initiation and drafting of new documents, revision and versioning of existing documents, conversion and adoption of external documents, and design and revision of record forms. The purpose is to clarify the preparers, reviewers, approvers, and their relationships for various types of documents, ensuring that documents are "well-prepared, understandable, implementable, revisable, and controllable." This avoids issues such as unnumbered documents, unapproved documents, conflicting documents, and coexistence of old and new versions. This work instruction is specifically formulated for this purpose.

2. Scope of Application

2.1 This work instruction applies to all documented information creation and updating activities within the company's quality management system, including the initiation and drafting of new documents, revision and versioning of existing documents, conversion and adoption of external documents, and design and revision of record forms.

2.2 Covered document types: Level 1 documents (quality manual), Level 2 documents (procedure documents), Level 3 documents (work instructions, management methods, inspection specifications, process documents, job descriptions), Level 4 documents (record forms, ledgers, drawing templates), and external documents (national standards, industry standards, customer specifications, laws and regulations, supplier technical data).

2.3 The following documents are not applicable to this work instruction and should be executed according to the corresponding professional management requirements, but their numbering, version identification, approval, and archiving requirements must still meet Clauses 4.1 and 4.5:

  • Pure technical drawings, 3D models, program source code, etc., which are managed according to the technical document management regulations;
  • Financial, human resources, administrative, and other internal management systems not part of the quality management system, which are managed according to the company's administrative system management methods;
  • Application materials, certification materials, inspection reports, etc., directly specified by customers or regulations.

2.4 This work instruction does not specify the technical content of the documents but only the methods, format requirements, and approval paths for document creation and updating.

2.5 The company's document preparation and approval follows five bottom lines: no initiation, no drafting; no numbering, no circulation; no co-signing, no submission for approval; no approval, no release; no recycling, no versioning.

3. Responsibilities

3.1 Management Representative (System Responsible Person): Responsible for the overall planning and maintenance of the company's quality management system document structure; responsible for approving the preparation plan of procedure documents; responsible for reviewing the quality manual and submitting it to the General Manager for approval; responsible for resolving discrepancies in document clauses between departments; responsible for organizing the annual document review.

3.2 Document Controller (can be concurrently held by a quality department clerk): Responsible for issuing and registering document numbers, maintaining the "Controlled Document List"; responsible for the initial review of document format, number, version, headers/footers, etc.; responsible for the copying, distribution, recycling, destruction, and archiving of documents; responsible for the on-site collection and obsolescence marking of old versions; responsible for verifying the consistency between electronic and paper versions of documents.

3.3 Department Heads: Responsible for proposing and applying for the preparation needs of documents within their department's business scope; responsible for designating drafters and ensuring the availability of resources and time; responsible for the business review and executability confirmation of departmental documents; responsible for the co-signing of related departmental documents; responsible for organizing the dissemination and training of departmental documents.

3.4 Drafters: Responsible for drafting documents according to the format requirements in Clause 4.3 of this work instruction; responsible for confirming that the referenced standards, regulations, and customer requirements are current and valid versions; responsible for filling out the drafting section of the "Document Preparation (Revision) Application Form"; responsible for consolidating co-signing comments and completing revisions; responsible for providing a comparison draft of revisions before approval.

3.5 Quality Department: Responsible for reviewing the correspondence and compliance of documents with ISO 9001:2015 standard clauses; responsible for reviewing the completeness of references between documents and existing system documents (whether the referenced procedure documents and record forms exist or are being developed simultaneously); responsible for confirming the auditability of review focus points and acceptance criteria clauses.

3.6 Technical Department (R&D/Process): Responsible for co-signing documents involving product technical requirements, process parameters, inspection methods, and tolerance judgments; responsible for confirming the compliance of technical clauses with drawings, technical conditions, and industry standards.

3.7 Production Department: Responsible for co-signing documents involving work methods, tooling, production rhythm, and on-site execution; responsible for confirming the operability of clauses at actual workstations and proposing revisions for "what is written cannot be done" or "what is done is not written."

3.8 Purchasing Department, Sales Department, Storage Department, and Other Relevant Departments: Responsible for co-signing documents involving departmental responsibilities, input/output interfaces, and cross-departmental timelines; responsible for confirming whether the interface conditions can be accepted.

3.9 General Manager: Responsible for approving the quality manual, quality policy, and quality objectives; responsible for approving documents involving organizational structure adjustments, significant resource investments, and changes in customer commitments; responsible for authorizing the approval authority for other documents (authorization should be in written form and can be included in the "Document Approval Authority Table").

4. Work Procedures

4.1 Document Classification, Grading, and Numbering Rules

4.1.1 Documents are classified into four levels, with the level determining the approval path and distribution scope:

Level Document Type Approval Path Distribution Scope
Level 1 Quality Manual, Quality Policy and Objectives Management Representative review → General Manager approval Entire company, customers, and certification bodies can request
Level 2 Procedure Documents Relevant department co-signing → Management Representative approval Relevant departments within the company
Level 3 Work Instructions, Inspection Specifications, Process Documents Department head review → Management Representative or authorized person approval Relevant positions on-site, controlled distribution
Level 4 Record Forms, Ledger Templates Responsible department review → Quality Department filing and approval Usage positions, can be appended to Level 3 documents

4.1.2 Document numbers use the structure "Company Code - Level Code - Sequence Number - Version Number," with the meanings and compilation rules for each segment as follows:

Segment Code Example Compilation Rule
Company Code QMS Determined by the company abbreviation or system code, unique to the entire company
Level Code SC/PD/WI/QR Level 1 SC, Level 2 PD, Level 3 WI, Level 4 QR, no mixing allowed
Business Domain Code (optional) QM/PR/EN/HR Divided according to quality, production, engineering, human resources, etc., for segmented management
Sequence Number 01, 02, 03 Continuously assigned based on release order, obsolete numbers are not reused
Version Number A/0, A/1, B/0 Uppercase letters for versions (incremental upon versioning), numbers after the slash for revision counts (incremental upon revision)

4.1.3 Numbering example: QMS-PD-QM-03 A/2 indicates a Level 2 procedure document, quality domain, the 3rd document, 2nd revision of Version A. Once issued, the number is fixed and does not change with the document name; if a number change is necessary, the old number must be invalidated and a new number issued, with the corresponding relationship noted in the "Controlled Document List."

4.1.4 The document controller establishes a numbering ledger, implementing "number first, then draft," prohibiting drafters from creating their own numbers. For documents spanning multiple departments in the same business domain, the leading department should obtain the number to avoid the same number being used in two places.

4.1.5 Record form numbers should correspond to the procedure documents or work instructions they belong to, with "-01, -02" added to the form number to avoid a separate numbering system that could lead to broken references.

4.2 Proposal and Initiation of Compilation Needs

4.2.1 When any of the following situations occur, the relevant department should propose the need for document compilation or revision:

  • New customer contracts, new product mass production, new regulations or standards, not covered by existing documents;
  • Nonconformities identified in internal audits, process audits, customer audits, or certification audits, requiring documentation;
  • Document requirements proposed in management reviews, risk and opportunity assessments, or data analysis conclusions;
  • Changes in on-site work methods, equipment, processes, or organizational structure, leading to inconsistencies between documents and reality;
  • Repeated misunderstandings, interface disputes, or parameter inconsistencies in daily operations, requiring written clarification.

4.2.2 The proposer fills out the "Document Preparation (Revision) Application Form," specifying: document name and proposed number, higher-level referenced documents, reasons for compilation and problems to be solved, scope of application and involved departments, expected completion date, suggested drafter, and whether existing documents need to be invalidated or replaced. Applications that only state "improve system documents" without specific issues should be returned by the document controller for supplementation.

4.2.3 The document controller completes the initial review within 1 working day, checking for duplication with existing documents, availability of the number, and whether there are existing documents that can be revised (revising old documents instead of creating new ones).

4.2.4 The approval path is determined by the level as per the list in Clause 4.1.1: compilation needs for Level 1 and Level 2 documents are approved by the management representative; compilation needs for Level 3 and Level 4 documents are approved by the responsible department head and filed with the quality department.

4.2.5 After initiation, a compilation plan is formed, specifying the drafter, co-signing departments, and completion timeline. For new Level 3 documents, the timeline from project approval to co-signing completion is generally controlled within 10 to 15 working days; for single-form documents, it is controlled within 5 working days; for documents involving multiple departments, they can be delivered in stages, but the process should not be suspended for more than 15 working days.

4.3 Format Elements and Language Standards for Document Drafting

4.3.1 The document cover (or first page) should include the following elements: company name and logo, document name, document number, version/revision status, controlled status mark (controlled/uncontrolled), preparer, reviewer, approver, and approval date, release date, effective date, distribution scope or distribution number, page number, and total page count.

4.3.2 The document header should be labeled with: company name, document name, document number; the footer should be labeled with: version/revision status, effective date, page number (Page X of Y). The header and footer should be consistent throughout the document, and handwritten alterations are invalid.

4.3.3 The document structure should follow a unified framework: purpose, scope of application, responsibilities, work procedures (or work content), related records, related documents, appendices, and annexes. If a document must be structured differently (e.g., inspection specifications structured as "inspection items - technical requirements - inspection methods - sampling judgment"), this should be explained on the first page along with the correspondence to the unified framework.

4.3.4 Clause numbering should use a three-level numeric system: "chapter - clause - sub-clause," such as 4.3.2 indicating the 2nd sub-clause of the 3rd clause in the 4th chapter. New clauses should be numbered as "4.3.2a" or the subsequent clauses should be renumbered, avoiding the use of unnumbered segments in finalized documents.

4.3.5 Language standards should adhere to the following requirements, which are key to the document's executability:

Standard Item Requirement Incorrect Example Correct Writing
Responsible Subject Each action must have a clear subject "Regular checks should be conducted" "The production team leader checks before each shift starts"
Degree of Expression Use "shall," "should," or "can" as per standard conventions "Must try to clean thoroughly" "Shall clean, should clean every 4 hours"
Quantity and Time Limits Use verifiable numbers "Report promptly" "Report to the quality department head within 2 hours"
Action Description Use observable verbs "Strengthen process control" "Batch production can only start after the first article inspection is passed and a green label is hung"
No Slogans Do not use slogan-like expressions "Quality is life" Delete, replace with specific requirements
No Ambiguous References Do not use "they" or "relevant personnel" "Relevant departments handle it themselves" Clearly specify the department name

4.3.6 "Shall" indicates a mandatory requirement, and non-compliance constitutes a nonconformity; "Should" indicates a recommended practice, allowing alternatives with justification; "Can" indicates an allowable choice. Drafters should avoid using "Shall" throughout the document and should change non-mandatory practices to "Should" to avoid every "Shall" being a basis for nonconformity during audits.

4.3.7 Standards, regulations, and customer requirements referenced in the document must be current and valid versions. The drafter should indicate the referenced document number and version (e.g., GB/T 19001-2016, customer specification version number) on the last page or in an appendix, avoiding references to "the latest version" without a specific version.

4.3.8 Documents involving processes should include a process diagram, which can be a flowchart or a "text-based process" described in the order of "input - responsible person - action - output - timeline," for example:

Incoming inspection → Warehouse clerk fills out the inspection form → Quality inspector conducts sampling inspection → Qualified items are labeled green and stored / Unqualified items are labeled red and transferred to the nonconforming product process → Timeline: conclusion within 4 hours

4.3.9 After completing the initial draft, the drafter should self-check three things: whether the clauses conflict with higher-level documents (especially the division of responsibilities in procedure documents), whether the responsibilities align with existing job descriptions, and whether the referenced record forms exist in the Level 4 document list. If there are gaps, the drafter should simultaneously propose the creation of the necessary forms and should not leave requirements without corresponding forms.

4.4 Document Review and Co-signing

4.4.1 The drafter submits the initial draft along with the "Document Preparation (Revision) Application Form" and "Document Co-signing Form" to the document controller. The document controller completes the initial review of elements (number, format, headers/footers, clause numbering, referenced versions, full-width symbols, and typos) within 1 working day. If the format requirements are not met, the drafter should revise and resubmit to avoid format issues occupying the co-signers' time.

4.4.2 Co-signing departments are determined based on the principle "who executes, who co-signs; who hands over, who co-signs; who verifies, who co-signs": departments involved in the actions described in the document must co-sign; departments that receive cross-departmental inputs and outputs must co-sign; departments that set acceptance or judgment standards must co-sign. Co-signing departments are determined at the initiation stage and should not be arbitrarily reduced during the approval process.

4.4.3 Co-signers should focus on reviewing four main contents and provide written feedback in the "Document Co-signing Form":

  • Operability: Whether the department can complete the actions described in the document within the specified timeline and whether the existing resources (people, equipment, systems) can support it.
  • Clear Interfaces: Whether the upstream inputs, recipients, downstream reception times, and actions in case of non-reception are clearly stated.
  • Non-conflicting Responsibilities: Whether the division of responsibilities in the document aligns with existing procedure documents and job descriptions, and whether there are any overlaps or gaps.
  • Traceable Records: Whether the required record forms exist, whether the fields are sufficient, and whether they can be filled out accurately.

4.4.4 Co-signing timeline: Each co-signing department should provide feedback within 2 working days of receiving the document. If no feedback is provided within the deadline and no reason is given, the document controller should request the management representative to mediate, and it should not be assumed as agreement. Co-signing opinions are categorized as "agree," "agree but need revision," or "disagree," and co-signing forms with only a tick and no specific comments are considered invalid.

4.4.5 Handling co-signing opinions: adopted revisions are directly made by the drafter and the changes are retained; unadopted opinions must be justified in the "Document Co-signing Form" and acknowledged in writing by the proposer; if consensus cannot be reached, the management representative should make a decision, which should be recorded in writing and not entered into the approval process verbally.

4.4.6 After co-signing is completed, the drafter prepares a "Revision Explanation," detailing the adoption of co-signing opinions and major changes, to be submitted with the final draft for review, helping the approver grasp the essence of the changes within a limited time.

4.5 Document Approval and Release

4.5.1 Approval authority is executed according to the table below. The same person should not simultaneously prepare and approve the same document (self-preparation and self-approval). In small-scale enterprises, the drafter and reviewer can be the same person, but the approver must be a person from a higher level.

Document Type Reviewer Approver
Quality Manual, Policy and Objectives Management Representative General Manager
Procedure Documents Relevant department co-signing + Management Representative review Management Representative
Level 3 Work Instructions, Inspection Specifications Department head Management Representative or their written authorizer
Level 4 Record Forms Responsible department head Quality Department head
Adopted External Documents Quality Department Management Representative

4.5.2 Approval should be done with a handwritten signature and date. For documents approved through an electronic system, there should be a traceable electronic signature record. If the approver is unavailable and the document is urgent, a written authorization can be given to an agent, with the scope and validity period registered in the "Document Approval Authority Table," and the original approver should sign or confirm afterward.

4.5.3 "Release" and "Effective" are two separate actions and should be marked with separate dates on the cover. Regular documents can be "effective upon release"; for documents involving changes in on-site work methods, inspection standards, safety, and regulatory requirements, a 3 to 7 working day training transition period should be agreed upon, with the document becoming effective after training to avoid coexistence of old and new practices on-site.

4.5.4 After approval, the document is stamped with a control stamp and assigned a distribution number by the document controller, distributed according to the distribution scope, and registered in the "Document Distribution and Recovery Record." The electronic version should be converted to read-only format and stored in the controlled folder, with editing permissions only for the document controller and drafter.

4.6 Document Distribution, Training, and Effectiveness

4.6.1 All documents used on-site must be controlled versions, distributed according to the number of positions, and excess copies should be recovered. Work instructions used at workshop workstations can be displayed on plastic boards or accessed via QR codes, with paper backup copies available in case of network issues to ensure that there are documents to follow in case of equipment failure.

4.6.2 Before the document becomes effective, the responsible department should organize a dissemination and training session: for Level 3 documents, this can be done in team meetings, with participants signing in and the "Training Sign-in Form" retained; for documents involving judgment standards and safety requirements, the training effectiveness should be confirmed (through written tests or on-site questioning).

4.6.3 The document controller should complete the on-site recovery of old versions within 3 working days of the document's effectiveness, verifying that the current documents at workstations, offices, and warehouses are the latest versions. Recovered old versions should be stamped "obsolete" and stored separately, not mixed with controlled documents.

4.6.4 Uncontrolled versions (such as copies submitted to customers or certification bodies) should be stamped "uncontrolled" and marked "uncontrolled, changes not notified," to prevent uncontrolled documents from causing version confusion within the company.

4.7 Document Revision

4.7.1 After a document becomes effective and needs modification, a "Document Revision Application Form" must be filled out, specifying the revised clause, the content before and after revision, the reason for revision (corresponding to internal audit nonconformities, customer requirements, process changes, regulatory updates, etc.), and the expected effective date. Handwritten changes, pasting over, or verbal notifications are prohibited.

4.7.2 Classification and handling of revisions:

Revision Type Criteria Handling Method Approval Requirement
Textual Revision Typos, punctuation, unclear expressions, not affecting requirements or actions Revision status +1, add revision record page Responsible department head review, document controller registration
Clause Revision Adding, deleting, or changing actions, responsibilities, timelines, or judgment standards Revision status +1, update affected forms Re-co-sign and re-approve according to the original approval path
Version Revision Framework adjustment, standard version change, multi-chapter systematic changes Version letter +1, reset revision status Approve according to the original approval path, old version completely invalidated
Temporary Revision Valid for no more than 3 months, applicable to specific batches or short cycles Issue a "Temporary Work Notice" specifying the validity period and conditions for restoration Responsible department head + Quality Department approval

4.7.3 Any revision must be recorded in the "Revision Record" on the last page of the document, including at least: version/revision status, revision date, revised clause number, summary of revised content, reviser, and approver. Historical rows in the revision record should not be deleted or covered.

4.7.4 For revisions affecting multiple documents (e.g., process adjustments affecting the "Production Process Control Procedure," "Process Inspection Work Instruction," and "Process Inspection Record" form), the initiating department should propose a "linked revision list" to initiate all changes at once, avoiding inconsistencies between documents due to partial revisions.

4.7.5 Five working days before the expiration of a temporary revision, the initiating department should confirm whether it should be converted to a formal revision (following the clause revision process) or the original document should be restored (recover and destroy the temporary notice). The temporary notice should not remain effective indefinitely by "continuing to execute after expiration."

4.8 Document Versioning, Obsolescence, Recovery, and Destruction

4.8.1 A new version should be issued in the following situations: the referenced standard or regulation is updated; the company's organizational structure or products undergo significant changes; the document has not been revised for more than 3 years and is confirmed to need overall updates through annual reviews; the same document has been revised more than 5 times, and the clause arrangement is no longer coherent.

4.8.2 When versioning, the document controller issues a versioning notice, specifying the stop date for the old version and the effective date for the new version, with no gap between the two. A common practice is to recover the old version at the end of the workday on the new version's effective date and hang the new version the next workday.

4.8.3 Handling of obsolete documents: obsolete documents should be removed from all usage sites and electronic directories, stamped "obsolete," and registered in the "Document Recovery Record," stored separately from current documents. Obsolete documents retained for technical accumulation or regulatory traceability should be marked "obsolete for traceability only" and access should be restricted.

4.8.4 The destruction of obsolete documents must be confirmed by the responsible department head and the Quality Department, with a destruction record filled out (including the number of copies, method of destruction, and supervisor). Personal disposal is not allowed; obsolete documents containing customer technical data, drawings, or process parameters should be shredded or handled according to confidentiality requirements.

4.8.5 The document controller should conduct a quarterly consistency check between the "Controlled Document List" and actual on-site documents, including: whether the list covers all current documents, whether there are documents outside the list on-site, whether there are documents overdue for revision, and whether old versions have been recovered. The check results should be recorded and used as input for management reviews.

4.9 Identification and Control of External Documents

4.9.1 External documents include national standards, industry standards, customer technical specifications and acceptance criteria, laws and regulations, certification requirements, and supplier technical data. The responsible department should identify the applicability and validity of external documents, fill out the "External Document Registration Form," and include them in the "External Documents" section of the "Controlled Document List."

4.9.2 The validity of standards should be verified at least once a year (preferably in the first quarter), confirming whether they have been replaced through standard information platforms. After a standard update, the impact on existing system documents should be assessed, and revisions should be made according to Clause 4.7 if necessary. If no revisions are needed, an "no impact" assessment record should be issued.

4.9.3 Customer-provided specifications and drawings should have their version and date confirmed upon receipt, and the subsequent update transmission channels should be clarified with the customer. Temporary technical changes notified by email should be converted by the sales or technical department into internal "Temporary Work Notices" or revision forms, and should not be used directly as on-site work references.

4.9.4 External documents should not be copied and distributed arbitrarily, and the original version markings should be maintained. When converting external documents into company-controlled documents (e.g., converting customer inspection specifications into internal "Finished Product Inspection Work Instruction"), the original document source and version should be noted in the converted document, and the drafting, co-signing, and approval processes should be followed according to Clauses 4.3 to 4.5 of this work instruction.

4.10 Document Preparation and Approval Process (Text-based Flowchart)

Proposal of Needs (fill out the "Document Preparation (Revision) Application Form")
 → Initial Review and Number Issuance by Document Controller (1 working day)
 → Project Approval (Level 1 and Level 2 by Management Representative, Level 3 and Level 4 by responsible department head)
 → Drafting by Drafter (including reference verification and form creation needs)
 → Initial Review of Elements by Document Controller (number, format, clause numbering, referenced versions)
 → Co-signing by Relevant Departments (2 working days per department, written comments)
 → Dispute Resolution (Management Representative, General Manager if necessary)
 → Preparation of Revision Explanation and Final Draft
 → Approval (according to the "Document Approval Authority Table")
 → Stamping with Control Stamp and Distribution Number, registering in the "Document Distribution and Recovery Record"
 → Dissemination and Training (team meetings for Level 3 documents, training effectiveness confirmation for documents involving judgment standards)
 → Implementation on Effective Date, completing old version recovery within 3 working days
 → Archiving and Quarterly Consistency Check

Filling Instructions: Each document corresponds to one "Document Preparation (Revision) Application Form," and multiple documents should not be combined on one application form (except for linked revision lists for the same change). The "Document Co-signing Form" must be signed by each department individually and should not be signed by one person for all departments. The "Controlled Document List" should be updated synchronously with each distribution, recovery, and obsolescence, and should not be updated at the end of the quarter. The "Revision Record" page should be updated synchronously with each revision and should not be updated all at once during versioning.

Example row (Document Revision Application Form):

Item Example Content
Document Number and Name QMS-WI-PR-05 "Finished Product Inspection Work Instruction"
Revised Clause Number 4.3.2, 4.5.1
Content Before Revision Visual inspection at 400mm distance, 300lx illumination; sampling ratio 5%
Content After Revision Visual inspection at 500mm distance, 800lx illumination; sampling ratio according to GB/T 2828.1 general inspection level II, AQL 1.0
Reason for Revision Customer quality agreement update in 2026, specifying inspection conditions and sampling standards; internal audit nonconformity 2026-03 involving no basis for sampling ratio
Affected Other Documents "Process Inspection Work Instruction" 4.2, "Finished Product Inspection Record" form adding "inspection conditions" field
Expected Effective Date Effective 5 working days after training

5. Related Records

Record Form Number Example Key Points of Content Custodian and Retention Period
"Document Preparation (Revision) Application Form" QMS-QR-QM-31 Document name, proposed number, higher-level referenced documents, reasons for preparation and problems to be solved, scope of application and involved departments, drafter, expected completion date, replacement or obsolescence of documents, approval comments Quality Department, 3 years
"Document Co-signing Form" QMS-QR-QM-32 Document name and number, co-signing departments, co-signers, co-signing date, agree/need revision/disagree, specific revision comments, reasons for non-adoption, proposer's acknowledgment signature Quality Department, 3 years
"Controlled Document List" QMS-QR-QM-33 Document number, document name, version/revision status, responsible department, effective date, distribution scope, storage location, notes (correspondence of obsolete numbers) Quality Department, long-term
"Document Distribution and Recovery Record" QMS-QR-QM-34 Document number and name, version, distribution number, receiving department and signatory, distribution date, recovery date, recovery and obsolescence handling of recovered copies, document controller's signature Quality Department, 3 years
"Document Revision Application Form" QMS-QR-QM-35 Document number, revised clause number, content before revision, content after revision, reason for revision, affected other documents and forms, expected effective date, review and approval comments Quality Department, 3 years
"Temporary Work Notice" QMS-QR-QM-36 Notice number, applicable products and batches, temporary work content, temporary reason, validity period, conditions for restoring the original document, approver, distribution positions Quality Department, 3 years
"Revision Record" Page (attached to each document) Attached to the end of each document Version/revision status, revision date, revised clause number, summary of revised content, reviser, approver Archived with the document, long-term
"External Document Registration Form" QMS-QR-QM-37 External document name, standard number/specification number, version and date, source, receipt date, scope of application, validity verification record, impact assessment conclusion Quality Department, long-term
"Document Review Record" QMS-QR-QM-38 Review date, participating departments and personnel, reviewed document list, applicability evaluation, items to be revised, responsible person and timeline for revision, conclusion Quality Department, 3 years

Filling Instructions: Each document corresponds to one "Document Preparation (Revision) Application Form," and multiple documents should not be combined on one form (except for linked revision lists for the same change). The "Document Co-signing Form" must be signed by each department individually and should not be signed by one person for all departments. The "Controlled Document List" should be updated synchronously with each distribution, recovery, and obsolescence, and should not be updated at the end of the quarter. The "Revision Record" page should be updated synchronously with each revision and should not be updated all at once during versioning.

6. Related Documents

  • "Document Control Procedure" (QMS-PD-QM-01)
  • "Record Control Procedure" (QMS-PD-QM-02)
  • "Knowledge Management Procedure" (QMS-PD-QM-06)
  • "Change Management Procedure" (QMS-PD-QM-12)
  • "Job Description and Qualification Compilation Guide" (QMS-WI-HR-01)
  • "Record Filling and Archiving Work Instruction" (Package Document 39)
  • GB/T 19001-2016 "Quality Management System - Requirements," Clause 7.5

Usage Instructions

1. Three Adaptations Based on Company Reality

  1. Adaptation to Organizational Structure: Replace department names in Chapter 3 responsibilities with actual department names in the company (e.g., "Technical Department" to "Production Technology Department"). In companies where one person holds multiple positions, responsibilities can be combined into one position, but the three roles of "preparation - review - approval" must not be held by the same person, which is a common requirement for audit independence.
  2. Adaptation to Product Type: Manufacturing companies should retain Clause 4.9 for controlling customer drawings and specifications. Pure service companies can replace "inspection specifications, process documents" with "service specifications, work process cards," and "workstation plastic boards" with "desk cards or system pop-up prompts," with the rest of the chapters' logic unchanged.
  3. Adaptation to Scale: For companies with fewer than 100 employees and no dedicated document control position, the document controller's responsibilities can be merged into the quality department clerk, and the quarterly consistency check can be changed to a monthly check synchronized with distribution. Such companies do not need to pursue a complete numbering system, but the two rules "number first, then draft" and "old versions must be recovered" cannot be omitted.

2. Audit Focus Points

  • Version Consistency with On-site: Auditors will randomly check the version numbers of on-site workstation documents against the "Controlled Document List." If an old version is found at any workstation, Clause 7.5.3 will be deemed nonconforming, which is a common cause of serious nonconformities.
  • Evidence Chain for Creation and Updating: Auditors will check a recently revised document, tracing the "Document Revision Application Form" → co-signing records → approval signatures → revision record page → training records → old version recovery records. Any missing link in the chain will be deemed nonconforming.
  • Approval Authority Matching: Check whether the approvers match the "Document Approval Authority Table" and whether there are any instances of self-preparation and self-approval, overstepping authority, or unauthorized proxy signatures.
  • Clause Executability: Auditors often ask on-site employees, "Which clause in this document is your responsibility?" and "How long does it take to complete it?" If employees cannot answer or their actual practices do not match the document, it indicates that the document is not implemented, and Clause 7.5.2 will be deemed not effectively planned.
  • Control of Obsolete Documents: Check whether obsolete documents are stamped "obsolete," stored separately from current documents, and whether access to retained obsolete documents is controlled to prevent them from being "revived" on-site.
  • Effectiveness of External Documents: Check whether referenced national standards are current and whether impact assessments and document revisions have been completed after standard updates.

3. Common Errors

  1. Numbering After Writing: The drafter creates a number, and the document controller later confirms it, resulting in duplicate numbers or a chaotic numbering system that does not match the list.
  2. Inconsistent Formats: Some documents have headers with numbers, others do not; some use "4.3.2" numbering, others use "four, (three)," reflecting a lack of true control over document formats.
  3. Formal Co-signing: Co-signing forms have signatures from all departments but no specific comments; or the drafter signs for all departments at once, making the process appear complete but actually ineffective, which is a common source of nonconformities.
  4. Overuse of "Shall": Writing recommended practices as "Shall," leading to nonconformities if the executing department cannot meet the requirements, effectively setting traps for themselves. Recommended practices should be distinguished using "Shall," "Should," and "Can" as per standard conventions.
  5. No Traceability in Revisions: Directly modifying the original document, re-printing a new version, and never updating the revision record page, making it impossible to trace changes.
  6. No Training for New Versions: New versions are released and hung without training, leading to teams continuing to operate according to old practices, resulting in the typical "new document, old practice" issue.
  7. Incomplete Recovery of Old Versions: Copies retained in offices, warehouses, spare parts cabinets, or by employees are not fully recovered, leading to nonconformities if old versions are found during certification audits.
  8. Long-term Temporary Notices: Temporary work notices with "valid until further notice" remain in place for years, effectively becoming formal documents without approval.
  9. Referencing "Latest Version": Writing "follow the latest national standard" without specifying the standard number and year, making it impossible to verify the basis during audits and posing a risk of version mismatch.
  10. Two Sets of Documents: On-site simplified work cards and a separate set of formal documents in the system file cabinet, used to应付 audits, leading to serious nonconformities if on-site audits do not match and losing the guiding role of documents.

Number first, then draft; co-sign and approve before effectiveness

Knowledge code: 2.3.1

Version: v20260809

Author: QTank QTank is dedicated to providing systematic professional knowledge, methodologies, and practical tools for quality management practitioners, helping enterprises continuously improve their quality capabilities.