ISO 9001 Clause: 8.6 Release of Products and Services

ISO 9001 Clause 8.6 is all about making sure your products and services are good to go before they reach your customers. This clause sets the standards for the final checks and balances you need to do to confirm that everything you’ve produced meets the quality requirements and customer expectations. It’s like the last pit stop before your products hit the road, ensuring that they’re flawless, compliant, and ready to impress. Getting this stage right means that every item or service you deliver is top-notch and meets your high standards, protecting your brand’s rep and boosting customer satisfaction.

ISO 9000 Quality management systems — Fundamentals and vocabulary

3.7.6 product

output (3.7.5) of an organization (3.2.1) that can be produced without any transaction taking place between the organization and the customer (3.2.4)
Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between provider (3.2.5) and customer, but can often involve this service (3.7.7) element upon its delivery to the customer.
Note 2 to entry: The dominant element of a product is that it is generally tangible.
Note 3 to entry: Hardware is tangible and its amount is a countable characteristic (3.10.1) (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are often referred to as goods. Software consists of information (3.8.2) regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver’s license).

3.7.7 service

output (3.7.5) of an organization (3.2.1) with at least one activity necessarily performed between the organization and the customer (3.2.4)
Note 1 to entry: The dominant elements of a service are generally intangible.
Note 2 to entry: Service often involves activities at the interface with the customer to establish customer requirements (3.6.4) as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.
Note 3 to entry: Provision of a service can involve, for example, the following: — an activity performed on a customer-supplied tangible product (3.7.6) (e.g. a car to be repaired); — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); — the delivery of an intangible product (e.g. the delivery of information (3.8.2) in the context of knowledge transmission); — the creation of ambience for the customer (e.g. in hotels and restaurants);
Note 4 to entry: A service is generally experienced by the customer.

3.12.7 release

permission to proceed to the next stage of a process (3.4.1) or the next process
Note 1 to entry: In English, in the context of software and documents (3.8.5), the word “release” is frequently used to refer to a version of the software or the document itself.

Crush Clause 8.6: Your Ultimate Quality Control Game Plan

ISO 9001 Clause 8.6 focuses on the final step before your product or service reaches the customer. It’s all about making sure that what you’re delivering actually meets the quality requirements and standards you promised. This clause requires you to have a clear, controlled process for checking, inspecting, and verifying that each product or service is up to scratch before it goes out the door. It’s your safety net to catch any issues before they land in your customer’s hands, turning a potential problem into a win for your quality game.

What Needs to Be Done to Meet Clause 8.6 Requirements 

To nail the requirements of ISO 9001 Clause 8.6, here’s what your organization needs to focus on to ensure a smooth release of your products and services:

  1. Verify Quality Before Release
    • You need to inspect and verify that your products or services meet the specified requirements and quality standards before you release them to customers.
    • Set up quality checkpoints or stages in your production process where these inspections take place, so nothing slips through the cracks.
  2. Use Documented Information as Proof
    • Keep detailed records of each inspection and verification step as proof that your products and services were checked and met the necessary standards.
    • This documentation can include test reports, inspection results, approval records, or sign-offs from relevant team members, showing that the product or service is ready to be released.
  3. Authorization for Release
    • Make sure that only authorized personnel can give the green light to release a product or service. This means that the people responsible for quality should have the final say.
    • Clearly define who in your team has the authority to approve products and services before they go to the customer, so there’s no confusion or mistakes.
  4. Non-Conforming Products Are No-Go
    • If a product or service doesn’t meet the required standards during the verification process, it must be withheld from release until the issues are corrected.
    • Have a clear process in place to handle non-conforming products, including rework, repair, or disposal, and make sure it’s documented to track the corrective actions.
  5. Communicate the Release Status
    • Clearly communicate the status of the product or service release to all relevant teams, including production, quality control, and logistics.
    • Use labeling, tagging, or digital systems to indicate whether an item is approved for release or needs further action.
  6. Meet Customer and Regulatory Requirements
    • Ensure that the release of products and services also aligns with any specific customer or regulatory requirements.
    • Double-check that any legal, safety, or industry standards are fully met before giving the go-ahead for the release.

Why Clause 8.6 Matters 

Clause 8.6 is like your quality control checkpoint before your product or service hits the world. It makes sure you’re only delivering the best to your customers by catching any last-minute issues and confirming that everything is on point. By strictly following these steps, you minimize the risk of defects, reduce rework costs, and boost customer satisfaction by consistently delivering high-quality products and services. It’s all about making sure your brand reputation stays solid, your customers stay happy, and your quality game stays unbeatable!

tools & methodologies for Release of Products and Services

To ace the requirements of ISO 9001 Clause 8.6, you need to use a mix of the right tools, methodologies, and best practices that guarantee your products and services are in perfect shape before reaching your customers. Here’s a breakdown of what can help you level up your quality control game for smooth product and service releases:

  • 5tools
  • Quality Management Software (QMS)

    • Tools like MasterControl, ETQ Reliance, and Intelex provide a centralized platform to manage quality checks, inspection records, and approval workflows.
    • These tools help streamline the release process, track non-conformities, and ensure that products meet the required standards before they go out the door.
  • Statistical Process Control (SPC) Software

    • Platforms like Minitab and SPC XL help you monitor production data in real-time and identify variations that might impact product quality.
    • SPC software ensures that the final product meets specifications by flagging any inconsistencies early in the process.
  • Document Management Systems (DMS)

    • Systems like SharePoint, DocuWare, and M-Files help keep all inspection and test records organized and easily accessible.
    • DMS ensures that you have the latest versions of all documents and provides an audit trail for verification activities.
  • ERP Systems with Quality Modules

    • Software like SAP, Oracle NetSuite, and Microsoft Dynamics 365 integrates production, quality, and inventory management.
    • These systems provide a holistic view of product status, making it easier to track and authorize releases quickly and accurately.
    • 5methodologies
    • First Article Inspection (FAI)

      • FAI involves a detailed inspection of the first produced item to verify that it meets all quality and design specifications.
      • This methodology helps catch issues early in the process, reducing the risk of defective products reaching the customer.
    • Acceptance Sampling

      • Acceptance sampling is a statistical method used to inspect a batch of products to determine if they meet quality standards.
      • It’s a cost-effective way to ensure quality without checking every single item, saving time while maintaining high standards.
    • Inspection Checklists and Criteria

      • Develop clear inspection checklists and criteria to ensure that all products and services are reviewed consistently.
      • Checklists help your team verify that every detail has been inspected and that nothing is overlooked before releasing the product.
    • Root Cause Analysis (RCA)

      • If non-conformities are detected during the release process, RCA helps identify the underlying cause of the problem.
      • Techniques like the 5 Whys or Fishbone Diagrams can be used to drill down to the root cause and implement corrective actions.

    Seal the Deal: Pro Tips for Flawless Product Releases

    Good Practices for Product and Service Release

    1. Detailed Documentation of Quality Checks
      • Keep a comprehensive record of all inspections, test results, and approvals as evidence that your product or service meets the required standards.
      • Accurate documentation is crucial for traceability and helps demonstrate compliance during audits.
    2. Clear Authorization Protocols
      • Establish clear protocols for who has the authority to approve the release of products or services.
      • Make sure that only qualified and authorized personnel can sign off on product releases, ensuring that no low-quality items slip through.
    3. Non-Conformance Management Process
      • Develop a structured process for dealing with non-conforming products, including how to isolate, rework, or scrap them.
      • This practice helps ensure that defective products never reach the customer and reduces the impact on your brand’s reputation.
    4. Regular Training and Skill Development
      • Provide ongoing training to your team on quality control techniques, inspection procedures, and best practices.
      • Keeping your team’s skills up-to-date ensures that they can accurately assess products and make informed decisions on releases.
    5. Continuous Improvement Loop
      • Use feedback from the release process to make continuous improvements to your quality management system.
      • Regularly review and update your release procedures based on lessons learned, customer feedback, and process performance data.
    6. Labeling and Status Indicators
      • Use visual indicators like labels, tags, or color-coded status markers to clearly show the release status of each product.
      • This makes it easy for your team to identify whether an item is approved, pending, or non-conforming at a glance.

    Benefits of Using These Tools and Practices

    Applying these tools, methodologies, and best practices ensures that your products and services are always in peak condition before they reach your customers. They help streamline the release process, reduce errors, and keep your operations smooth and efficient. With these strategies in place, you’ll be consistently delivering high-quality products that exceed customer expectations while maintaining compliance with ISO 9001 standards.

    Conclusion

    ISO 9001 Clause 8.6 is the final checkpoint in your quality journey, making sure that every product and service you release is up to the highest standards. It’s all about verifying that your goods meet the specified requirements before they ever reach your customers, creating that wow factor with every delivery. By establishing clear inspection processes, authorizing the right people for approval, and documenting every step, you build trust, consistency, and confidence in your brand. Mastering this clause means you’re not just meeting expectations – you’re smashing them and setting the bar higher every time.

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