ISO 9001:2015 Checklist
Management System Requirements
1.0 Context
The Organisation
Have you determined internal and external issues that will impact on our quality system?
Interested Parties
Have you determined what internal and external interested parties are relevant to the quality system and what are their requirements?
Scope
Have you determined the boundaries of the quality system and documented the scope?
2.0 Leadership
Leadership & Commitment
Can you demonstrate top management is providing leadership and commitment to the quality system?
Customer Focus
Do you ensure customer focus by understanding and meeting requirements and ensuring customer satisfaction is maintained?
Quality Policy
Have you a documented quality policy that is communicated and available?
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Roles & Responsibilities
Are roles and responsibilities for quality communicated and understood?
3.0 Planning
Risk & Opportunities
Have you determined the quality risks and opportunities related to your organization?
Do you have plans to address them?
Scope
Have you determined the boundaries of the quality system and documented the scope?
Quality Objectives
Have you established quality objectives?
Do you monitor, measure and communicate them?
Do you have plans to address them?
Have you maintained records?
Change
Are changes to the quality system planned and controlled?
4.0 Support
Resources
Have you determined and ensured necessary resources are in place for the quality system including people, infrastructure and work environment?
Organisational Knowledge
Do you have processes to retail and share organizational knowledge?
Awareness
Have you ensured that personnel are aware of our policy, relevant objectives and their responsibilities?
Control of Documents
Do you ensure documents and records are controlled?
Measurement
Is measuring equipment calibrated?
Have you maintained records?
Competence
Do you ensure competence of personnel?
Do you maintain records?
Communication
Have you determined processes for internal and external communication relevant to quality?
5.0 Operations
Operational Planning and Control
Have you established and maintained procedures to meet the requirements of the quality system?
Design & Development
Have you ensured design processes are controlled including inputs, outputs, changes to designs, verification processes and reviews?
Do you maintain records?
Product & Service Provision
Is production and service provision undertaken in a controlled way?
Is documentation in regard to the product or service available?
Customer & External Supplier Property
Do you safeguard property belonging to customers or external suppliers while under our control? If damaged or lost are records maintained?
Post Delivery
Do you have processes to manage post-delivery requirements including contractual requirements, warranty and maintenance?
Release of Products & Services
Do you ensure products and services are released to customers in a controlled manner?
Do you maintain records demonstrating conformity of the product was determined and traceability of person authorizing release?
Requirements for Products & Services
Do you ensure customer communicate is appropriate?
Have you determined customer, statutory and regulatory requirements for our products and services?
Do you maintain records?
External Providers
Do you have processes to manage selection, evaluation and monitoring of suppliers and contractors?
Do you maintain records?
Do you communicate effectively with suppliers and contractors?
Identification & Traceability
Are outputs identifiable, are records suitable for traceability maintained?
Preservation
Do you have processes to manage preservation during production such as controls for packaging, handling, storage and transportation?
Control of Changes
Do you review and control changes to production or service pro- vision?
Do you maintain records including authorization?
Non-Conforming Outputs
Are nonconforming outputs controlled to prevent release?
Do you maintain records?
6.0 Performance Evaluation
Monitoring & Measurement
Do you monitor things such as processes, operational controls, equipment that requires maintenance or calibration?
Do you measure things such as KPIs, performance against targets?
Do you analyses and evaluate this information?
Do you maintain records?
Management Review
Does our top management review our quality system at planned intervals?
Do you maintain records?
Customer Satisfaction
Do you assess, monitor and review customer perception?
Internal Audit
Do you plan and conduct internal audits to ensure the quality system
conforms to requirements and is implemented effectively?
Do you maintain records?
7.0 Improvement
Non-Conformity & Corrective Action
Do you have processes for reporting, investigating and taking action to manage incidents and corrective action?
Do you maintain records?
Internal Audit
Do you continually improve the quality system?
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What is ISO 9001 Certification?
ISO 9001 is the international standard for quality assurance. ISO 9001 certification, at its simplest, is making sure your business fully understands what your customers want and makes sure you can deliver on those requirements efficiently.
Why do I need ISO 9001 Certification?
The main reason organisation seek ISO 9001 certification is because external stakeholders like your customers, regulators and governments want an independent assessment that you have a system in place that will deliver quality products and services.
What are the benefits of ISO 9001 Certification?
Companies often initially seek ISO 9001 certification for external reasons such as getting on preferred supplier lists, improving company image and responding to customer demands. The benefits of this are obvious – more work.
How can I get certified?
Getting ISO certification is a lot easier than you might think, We take you through the three step audit process from your initial enquiry to the final certification decision.
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Contact us and speak to one of our helpful team about your ISO certification needs. We can offer certification to smaller, niche standards and to other non-accredited (non ISO) standards as well.
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