ISO 13485 Procedures and Quality Manual Template with Policy, Objectives and Scope Examples
ISO 13485:2016 expects a quality manual, a documented policy and objectives, and procedures for specific processes. This template builds the manual outline from your details and lists the procedures you need, with scope, policy and objective examples to adapt.
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ISO 13485 Quality Manual, Procedures List, Policy and Objectives Template
Quality Manual: Alder Medical Components Inc
Issue date: 2026-11-01 Top management: General Manager Management representative: Quality and Regulatory Manager Regulatory frameworks: FDA 21 CFR Part 820, EU MDR as supplier to legal manufacturers
1. Scope and justified non-applicability (clauses 1 and 4.2.2)
Scope: Contract manufacture, cleaning, assembly and packaging of Class II orthopaedic instrument components
Non-applicable requirements: Clause 7.3 design and development is not applicable because designs are owned and controlled by customers. Clause 7.5.7 sterilization process validation is not applicable because products are shipped non-sterile.
2. Quality policy (clause 5.3)
We commit to supplying safe, conforming medical device components, to meeting customer and applicable regulatory requirements, and to maintaining the effectiveness of our quality management system through measurable objectives and continual improvement.
The policy is communicated, understood and reviewed for continuing suitability at management review.
3. Quality objectives (clause 5.4.1)
| Objective | Measure | Owner | Review |
|---|---|---|---|
| Customer returns below 500 ppm and on-time delivery above 97 percent for the year | Returns ppm, on-time delivery percent | General Manager | Quarterly |
| Zero overdue complaint investigations | Open complaint age | Quality and Regulatory Manager | Monthly |
| All process validations current | Validation due dates | Manufacturing engineering | Quarterly |
4. Organization and responsibilities (org chart table)
| Role | Reports to | Quality responsibility |
|---|---|---|
| General Manager | Board | Policy, objectives, resources, management review |
| Quality and Regulatory Manager | General Manager | QMS maintenance, regulatory liaison, complaints |
| Production manager | General Manager | Process control, device history records |
| Quality engineer / inspection | Quality and Regulatory Manager | Inspection, nonconformance, CAPA |
| Purchasing | General Manager | Supplier evaluation and approved supplier list |
5. Procedures to document
| Procedure | Clause | Status |
|---|---|---|
| Control of documents | 4.2.4 | |
| Control of records | 4.2.5 | |
| Software validation for QMS and production | 4.1.6, 7.6, 7.5.6 | |
| Competence, training and awareness | 6.2 | |
| Risk management | 7.1 | |
| Purchasing and supplier evaluation | 7.4.1 | |
| Identification and traceability | 7.5.8, 7.5.9 | |
| Process validation | 7.5.6 | |
| Control of monitoring and measuring equipment | 7.6 | |
| Feedback and complaint handling | 8.2.1, 8.2.2 | |
| Regulatory reporting | 8.2.3 | |
| Internal audit | 8.2.4 | |
| Control of nonconforming product | 8.3 | |
| Corrective and preventive action | 8.5.2, 8.5.3 |
Approvals
A starting point, not legal or regulatory advice. Confirm the clause numbers against your copy of ISO 13485:2016, add procedures your regulations require, and justify every non-applicable clause. The certificate is issued by your certification body, so there is no template for it: a typical certificate states the organization, scope, standard and validity dates.
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Optional review of on-prem AI search across procedures and device records.
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What the quality manual must contain
Clause 4.2.2 requires a quality manual that states the scope of the QMS including details and justification for any exclusion or non-application, references the documented procedures, and describes how processes interact. Unlike ISO 9001, a manual is mandatory in ISO 13485. Your scope should name the device types and activities you perform, such as contract manufacture, sterilization or distribution, and your role as a manufacturer, supplier or importer.
Policy, objectives and scope examples
Keep the policy short and specific: a commitment to meet requirements, to maintain QMS effectiveness and to provide a frame for objectives. Objectives should be measurable and consistent with the policy, for example complaint investigation time, returns per million, or validations kept current. For scope, include regulated activity and justify every non-applicable clause: design and development, sterilization, installation or servicing are the usual candidates.
- A policy states commitments, an objective states a measurable target.
- Non-applicability can only be claimed where regulation allows it.
- Name the regulatory frameworks that apply to your products and markets.
Procedures and the documentation toolkit
ISO 13485 names a number of processes that need documented procedures: document and record control, risk management, competence, purchasing, traceability, process validation, equipment control, complaint handling, regulatory reporting, internal audit, nonconforming product and corrective and preventive action. The table in this template gives you a starting checklist. Each procedure should state purpose, scope, responsibility, steps and records, while keeping the number of pages small enough that people read it.
Frequently Asked Questions
Is a quality manual mandatory in ISO 13485?
Yes. Clause 4.2.2 requires a quality manual that includes the scope, justification for any non-applicable requirements, references to documented procedures and a description of how processes interact. This differs from ISO 9001.
What procedures are required by ISO 13485?
The standard requires documented procedures for document control, record control, software validation, competence, purchasing, traceability, process validation, equipment control, complaints, regulatory reporting, internal audit, nonconforming product and corrective and preventive action, among others. Check each clause for exact requirements.
Can a contract manufacturer exclude design and development?
Where the organization is not design responsible and regulation allows, clause 7.3 can be declared non-applicable. You must justify it in the quality manual and still cover design inputs you receive from customers through contract review and document control.
What does an ISO 13485 certificate show?
It shows the organization name and site, the scope of certification, the standard and edition, the issuing certification body and validity dates. It is issued after audit by the certification body, so you cannot produce your own.
Netray can give your quality team a private assistant over your QMS documents and records, on your own servers, so procedures and evidence are quick to find.
Related Tools
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