ISO/IEC 17050 · Supplier's declaration of conformity
ISO/IEC 17050 supplier's declaration of conformity: requirements and evidence that stand up.
When a supplier states that its product, process or system meets a standard, customers and authorities want to know what stands behind the statement. Sterling's expert and experienced consultants set up the declaration process and the supporting file with your team, so every declaration you sign can be backed up. We help our clients put it into practice and prove it.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced consultants who connect declarations of conformity with your quality and product compliance systems
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify or declare conformity; the supplier signs its own declaration
8,100+ client engagements in 60+ countries.
Why manufacturers choose Sterling
What it is
What is ISO/IEC 17050 and what is it used for?
ISO/IEC 17050 is the ISO and IEC standard "Conformity assessment: Supplier's declaration of conformity", in two parts. Part 1 sets general requirements for a supplier's declaration of conformity, for any sector, where the object declared may be a product, process, management system, person or body. Part 2 sets general requirements for the supporting documentation that substantiates the declaration.
It is the first-party route in conformity assessment: the supplier, not a third party, states conformity and takes responsibility for it. Used well, it gives buyers a consistent, traceable statement; used carelessly, it becomes a signature with nothing behind it.
Current edition. ISO lists ISO/IEC 17050-1:2004 and ISO/IEC 17050-2:2004, both first editions published in October 2004 and most recently confirmed in 2025, with no revision under development.
Who it is for
Who uses ISO/IEC 17050?
Any supplier asked to declare that what it provides meets a specification can use it. Common starting points:
- A customer wants a declaration from you. A buyer asks for a signed statement of conformity with each product or batch.
- Regulation relies on self-declaration. Some product rules let the manufacturer declare conformity, and the file must hold up.
- Your declarations differ by product line. Formats, sign-off and evidence vary, and nobody owns the process.
- A claim was challenged. A complaint or audit asked for the evidence behind a declaration you issued.
A declaration is only as strong as the evidence and the process behind it.
Requirements
What are the main ISO/IEC 17050 requirements?
ISO's summaries describe both parts at title level; the lines below keep to them. The detailed content of a declaration is checked against the standard during the programme.
- Part 1, general requirements: what a supplier's declaration of conformity must meet, in any sector.
- Scope of the object: a product, process, management system, person or body.
- Part 2, supporting documentation: the documents that substantiate the declaration.
- Status: both parts published in 2004 and confirmed by ISO in 2025.
What does a useful declaration file look like?
A controlled declaration template, the list of standards or specifications declared against, test and inspection evidence, the authorised signatory's approval and the retention record. We keep these in Effivity so each declaration links straight to its evidence.
Your engagement
What your ISO/IEC 17050 engagement includes
Sterling builds the process and records behind your declarations, and connects them to the quality system you already run. Your technical teams keep ownership of the test results and the decision to declare.
Scope and gap analysis
Which declarations you issue, against what, and where the evidence sits.
Declaration procedure
Template, review, authorisation and retention rules built with your team.
Effivity ISO & GRC software
Declarations and evidence in Effivity, included at no additional cost.
Training for everyone
Internal auditor training as applicable, and preferential Sterling Academy access with complimentary awareness training for your people.
Internal audit
The declaration process audited, with findings closed on evidence.
Readiness for challenge
Files organised for customers, auditors or authorities who ask for them.
Sterling does not certify, test or declare conformity. The supplier issues and signs its own declaration and remains responsible for it.
Often combined with
Standards organisations pair with ISO/IEC 17050
- CE markingCE marking compliance support for manufacturers: EU rules, technical files, declaration of conformity and quality systems.
- EN 1090EN 1090 certification for steel and aluminium fabricators: factory production control, welding, execution records and support through the notified body's audit.
- EN 71 / ASTM F963EN 71 and ASTM F963 toy safety compliance for manufacturers: product and market mapping, material control, test planning and records that keep lots conforming.
- EU Cyber Resilience ActCyber Resilience Act compliance and requirements for products with digital elements: categories, reporting since September 2026 and CE marking by December 2027.
- EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
- IEC 61508IEC 61508 compliance support for E/E/PE safety-related systems: functional safety management, lifecycle records, SIL evidence and assessment readiness.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of ISO/IEC 17050.
Every Sterling ISO/IEC 17050 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so documents, declaration templates, test evidence, audits, nonconformities, approvals, training records and management review live in one place, the system runs in daily work and the assessor or customer auditor reviews a live system rather than a binder. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Context, scope and interested parties
The scope statement, the internal and external issues and the interested parties are kept in one register and reviewed on a schedule, so the context stays current as the business changes instead of being rewritten before each audit.
Policy, roles and objectives
The policy, the responsibilities and the objectives with their measures, owners and dates live where the people who own them work; progress is reported from the system, not from a separate spreadsheet.
Risks and opportunities
A risk and opportunity register with owners, actions and review dates; treatments tracked to closure and brought to management review automatically.
Competence, awareness and documented information
Training and competence records for every person, linked to Sterling Academy; documents with versions, approvals and distribution, so the current version is the only one in use.
Declarations, evidence and approval
Declaration records linked to their test and inspection evidence, reviewer and signatory approvals and retention dates, each created as the work is done.
Monitoring, internal audit and management review
Audit programmes, findings and follow-up; KPIs on live dashboards; a management review that records its inputs, decisions and actions.
Nonconformity, complaints and corrective action
Raised, investigated and closed with root cause and the evidence that the action worked; recurring issues visible to management before they become a finding.
Your own processes, forms and reports
Forms, fields, workflows and reports adapted to how you work, without code; legal and customer requirements tracked to the processes they affect.
What this means when a declaration is questioned
Customers and authorities ask what the declaration covered, which evidence supported it, who signed it and when. In Effivity each answer is a screen with dates, owners and evidence attached. After the programme, Sustain™ keeps the same workspace running, so every new declaration follows the same route.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS, ISMS and more when you integrate other standards
Sterling Academy · Conformity assessment e-learning
Build conformity awareness across engineering, quality and sales.
Sterling Academy delivers e-learning for the whole workforce and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for engineers, quality staff and sales on what a declaration commits the business to
- Practitioner learning for the people who prepare and sign declarations
- Internal auditor training for the people who will audit the process, as applicable to your standard, as part of the engagement
- Learner progress by department and a training status report for your auditors
- New hires trained as they arrive, so competence evidence stays current
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about ISO/IEC 17050
ISO/IEC 17050 resources
Services for ISO/IEC 17050
Why Sterling
Want declarations of conformity that stand up? Come to Sterling.
Declarations touch design, testing, quality and sales. We connect them into one process with clear owners, so every declaration your company issues is consistent and backed by evidence.
Management systems in 60+ countries since 2003
Systems implemented for manufacturers, suppliers, contractors and service firms across every region we serve, with offices in 21 countries and one engagement team accountable wherever you operate.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with any third-party fees identified separately. No surprises, ever.
A system your people can use
Fewer documents and more control: procedures, records and software connected to the work on the floor, so conformity evidence is produced as the job is done.
Expert and experienced consultants
Consultants who have advised on management systems across sectors and countries since 2003 and who build the conformity side of your system properly the first time.
The Sterling Promise
What the Sterling Promise means for your declaration programme
We stay with you until the agreed ISO/IEC 17050 outcome is achieved, supporting implementation, preparation and the closure of audit findings. Practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the standard, scope, outcome and responsibilities. Your organisation supplies accurate information, keeps ownership of its test results and declarations, and puts the agreed controls into use. Sterling does not give legal advice.
FAQs
Frequently asked questions about ISO/IEC 17050
Can we be certified to ISO/IEC 17050?
No. ISO/IEC 17050 describes a supplier's own declaration, so there is no certificate. What you can show is a declaration that meets Part 1 and a supporting file that meets Part 2, run through a controlled process.
What is the difference between a declaration of conformity and certification?
A declaration is a statement by the supplier itself; certification is a statement by an independent third party. Some customers and regulations accept a declaration, while others require certification by a certification body, so check what your market asks for.
Is ISO/IEC 17050 the same as an EU declaration of conformity?
Not exactly. ISO/IEC 17050 gives general requirements for any supplier's declaration, while EU product laws set their own content and procedures for the EU declaration. Many manufacturers use ISO/IEC 17050 to structure their declaration process and then meet the specific legal format; your legal advisers confirm what applies.
Talk to a consultant
Plan your ISO/IEC 17050 declaration process with confidence.
Tell us about your products, markets and target date. We will help you define the scope, timeline and next steps.
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