8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 Control of changes

ISO 9001 Clause 8.5 is where the magic happens – it’s all about putting your plans into action and making sure your production and service processes run like a dream. This clause is focused on how you actually create your products or deliver your services, making sure that everything is consistent, controlled, and meets the high standards you set. Whether you’re manufacturing a product or providing a service, Clause 8.5 guides you on how to plan, control, and improve your operations to keep quality at its peak. From managing resources to preventing mistakes, this is your go-to playbook for turning ideas into reality and delivering results that make your customers go, Wow!

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.

ISO 9001 Clause 8.5.1 is all about making sure that your production and service processes are running smoothly, efficiently, and consistently, so you deliver top-notch quality every time. This clause lays down the rules for controlling how products are made and how services are provided, ensuring that everything you produce meets your quality standards and customer expectations. It’s like having a quality checklist that keeps your operations on track, from start to finish, so there are no surprises along the way.

What Needs to Be Done to Meet Clause 8.5.1 Requirements 

To comply with Clause 8.5.1, your organization must implement specific controls and actions at every stage of production and service delivery. Here’s a rundown of what you need to do:

1. Documented Information
   • You need to have clear and detailed procedures for your production and service provision processes. This includes work instructions, process flows, and quality control plans to guide your team.
   • Keep records to show that each step has been performed according to the documented requirements.
2. Availability of Resources
   • Ensure that you have the right equipment, tools, materials, and human resources to carry out production or service activities effectively.
   • Regularly check that your equipment is calibrated, maintained, and ready for use to avoid any hiccups during operations.
3. Competence of Personnel
   • Make sure your team members are properly trained and qualified to perform their specific roles. This means everyone involved in production or service provision should know exactly what they’re doing.
   • Provide ongoing training and development to keep skills up-to-date.
4. Monitoring and Measuring Equipment
   • Use appropriate monitoring and measuring equipment to verify that your products and services meet the set requirements.
   • Ensure that this equipment is regularly calibrated, maintained, and validated to deliver accurate measurements.
5. Validation and Verification
   • Before releasing any product or service, validate that it meets all customer and regulatory requirements.
   • Verification steps might include tests, inspections, or performance evaluations to ensure everything is on point.
6. Prevention of Human Errors
   • Implement strategies to minimize or eliminate human errors during production or service delivery. This could include checklists, error-proofing techniques (like poka-yoke), and automated systems.
   • Encourage a culture of continuous improvement where employees are proactive about spotting and fixing issues.
7. Release, Delivery, and Post-Delivery Activities
   • Establish procedures to control how products are packaged, labeled, stored, and shipped to customers.
   • Make sure that products and services are properly checked and approved before delivery to avoid sending out defective items.
8. Special Processes and Equipment
   • If you use special processes (like welding, painting, or software coding) that can’t be verified through inspection alone, you must validate these processes in advance.
   • Keep detailed records of process parameters to ensure consistency and repeatability.

Why Clause 8.5.1 Matters 

Implementing Clause 8.5.1 effectively means you’re not leaving anything to chance when it comes to your production or service processes. It’s about setting up controls that prevent mistakes, maximize efficiency, and ensure that you consistently meet customer expectations. This approach helps you reduce waste, improve productivity, and maintain high-quality standards in everything you do. With solid production and service controls in place, you’re always ready to deliver excellence, boost customer satisfaction, and keep your operations running like a well-oiled machine.

Good Practices for Production and Service Provision

1. Clear Work Instructions and SOPs
   • Develop detailed Standard Operating Procedures (SOPs) and work instructions for each stage of the production or service process.
   • Make sure instructions are easy to understand and accessible to all team members to reduce errors and ensure consistency.
2. Employee Training and Competence Development
   • Regularly train employees on process changes, new equipment, and best practices to keep their skills sharp.
   • Cross-train team members to ensure flexibility in staffing and to avoid production bottlenecks.
3. Real-Time Monitoring and Feedback Loops
   • Implement real-time monitoring of production activities to quickly identify any deviations from set standards.
   • Set up feedback loops with production teams to address issues immediately and make continuous improvements.
4. Visual Management Techniques
   • Use visual tools like Kanban boards, Andon systems, or color-coded labels to communicate production status, inventory levels, and potential issues.
   • Visual signals help streamline communication and keep everyone on the production floor informed and aligned.
5. Process Validation and Calibration Checks
   • Regularly validate and calibrate your equipment to ensure that all measurements and outputs are accurate.
   • Use detailed records of calibration activities to demonstrate compliance with standards and to track equipment performance.
6. Continuous Improvement (Kaizen) Mindset
   • Encourage a culture of continuous improvement where every team member is motivated to suggest process improvements.
   • Hold regular meetings to discuss performance metrics, gather feedback, and implement small changes that add up to big gains over time.
7. Documentation Control and Version Management
   • Ensure that all production and service-related documents are properly controlled and that the latest versions are accessible to relevant personnel.
   • Use document management software to automate version control and approval workflows.
8. Supplier Quality Management
   • Collaborate with suppliers to make sure that raw materials and components meet your quality standards before they enter the production line.
   • Implement regular supplier audits and performance reviews to maintain consistency and improve supply chain reliability.

Benefits of Using These Tools and Practices

• Increased Efficiency: Streamlined processes that minimize waste, reduce errors, and speed up production cycles.
• Enhanced Quality Control: Improved ability to detect, prevent, and correct issues in real-time, leading to consistent product quality.
• Cost Savings: Efficient use of resources, fewer defects, and reduced rework lead to significant cost reductions in production.

Integrating these tools, methodologies, and good practices into your production and service provision helps you align with ISO 9001 Clause 8.5.1 requirements, ensuring your operations are consistent, controlled, and optimized for delivering top-notch quality every time. It’s all about setting your team up for success with a solid foundation for continuous improvement and customer satisfaction.

ISO 9001 Clause 8.5.2 is like the ultimate tracking system for your products and services. It’s all about making sure you can identify and trace every part of your production process, from raw materials to the final product. Think of it as creating a breadcrumb trail that tells you exactly where each piece of your product came from, where it’s been, and where it’s going next. This kind of visibility is key for quality control, helping you catch issues fast and keeping your customers happy with products that are consistent and on point.

What Needs to Be Done to Meet Clause 8.5.2 Requirements 

To stay compliant with ISO 9001 Clause 8.5.2, here’s what you need to focus on:

1. Identification of Products and Services
   • You need to clearly label and identify products at every stage of production and delivery, whether they’re raw materials, components, or finished goods.
   • Use tools like barcodes, serial numbers, or RFID tags to mark each item in a way that makes it easy to track.
2. Traceability Through the Entire Process
   • Make sure you can track the origin, movement, and use of every part or material used in your product. This includes knowing where it came from, how it was used in production, and where it ended up.
   • Keep records that document the entire journey of each item through your process, from supplier to customer.
3. Documented Information
   • Maintain detailed records of identification and traceability data to prove that you have control over every part of your production and service provision.
   • Make sure these records are accurate, up-to-date, and easily accessible for when you need to trace back issues or track product recalls.
4. Link to Customer Requirements
   • Ensure that your traceability system is directly tied to your customer requirements, so you can track which specific product batches were shipped to which customers.
   • This connection is crucial in the event of any recalls or quality issues to quickly identify affected products.
5. Handling Non-Conforming Products
   • If you find a product that doesn’t meet the quality standards, your traceability system should allow you to quickly identify, isolate, and resolve the issue.
   • Make sure non-conforming products are properly labeled to prevent them from being mixed up with good products.
6. Training Your Team
   • Train your employees on the importance of product identification and traceability, so they know exactly how to mark items, keep records, and handle any issues.
   • Empower your team to follow procedures for updating traceability data in real-time as products move through the system.

Why Clause 8.5.2 Matters 

Nailing the requirements of Clause 8.5.2 is like having the ultimate backstage pass to your production line. It gives you the power to see everything happening in real-time, making sure every part is accounted for, every batch is trackable, and any issues can be quickly handled. By staying on top of your identification and traceability game, you reduce risks, boost customer confidence, and keep your operations running smooth like butter.

Good Practices for Identification and Traceability

1. Clear and Consistent Labeling
   • Ensure that all products and materials are labeled consistently and clearly at each stage of production.
   • Use color-coded labels or visual indicators to quickly identify product status, such as approved, in-process, or non-conforming.
2. Real-Time Data Updates
   • Keep traceability data up-to-date in real-time as products move through the production and delivery stages.
   • Automated systems can help minimize errors, reduce manual data entry, and provide instant visibility into product status.
3. Training and Awareness
   • Regularly train your employees on the importance of traceability, proper labeling techniques, and the use of tracking tools.
   • Encourage a culture of accountability, where everyone on the team knows the role they play in maintaining accurate traceability.
4. Detailed Documentation and Record-Keeping
   • Maintain comprehensive records of all identification and traceability activities, including batch numbers, production dates, and inspection results.
   • Keep these records organized and easily accessible to ensure that information can be quickly retrieved when needed.
5. Non-Conformance Management
   • Develop procedures to identify, isolate, and handle non-conforming products in real-time.
   • Use quarantine areas or designated spots to store non-conforming items, preventing them from mixing with good products.
6. Regular Audits and Reviews
   • Conduct regular internal audits to ensure that your traceability processes are working effectively.
   • Use audit findings to identify gaps, update procedures, and continuously improve your traceability system.
7. Supplier Coordination
   • Collaborate closely with your suppliers to ensure that their materials come with clear identification and traceability information.
   • Align your traceability standards with your suppliers to create a seamless flow of information from start to finish.

Why These Tools and Practices Matter 

Using the right tools, methodologies, and practices for identification and traceability helps ensure that you have complete control over your production processes. It makes it easier to spot issues quickly, manage product recalls efficiently, and maintain a high level of customer satisfaction. With these tools in place, your operations will be smooth, transparent, and always on top of their game.

ISO 9001 Clause 8.5.3 is all about taking good care of any property that customers or external providers (like suppliers) give you to use during production or service delivery. This can include physical items like tools, materials, equipment, or even intellectual property like data, drawings, and confidential information. The goal of this clause is to ensure that you protect and manage this property as if it were your own, preventing any damage, loss, or misuse.

What Needs to Be Done to Meet Clause 8.5.3 Requirements

To meet the requirements of ISO 9001 Clause 8.5.3, your organization must take specific actions to handle and protect customer and supplier property effectively. Here’s what you need to do:

1. Identify Customer or Supplier Property
   • Clearly identify any property provided by customers or external providers when it arrives at your facility. This can include items like raw materials, tools, software, prototypes, or even intellectual property like designs and data.
   • Properly label or tag these items to avoid confusion with your own materials or equipment.
2. Inspect and Verify the Property
   • Check all incoming property for any signs of damage, defects, or discrepancies as soon as it’s received. This ensures that you’re not working with faulty materials that could impact your production.
   • Record the condition of the property and report any issues back to the customer or supplier immediately to resolve them.
3. Protect and Safeguard the Property
   • Take all necessary steps to protect customer or supplier property from loss, theft, damage, or deterioration. This includes setting up secure storage areas, applying appropriate handling techniques, and controlling access to sensitive information.
   • For intellectual property, ensure that data and designs are securely stored, with restricted access to authorized personnel only.
4. Document the Use and Location of the Property
   • Maintain accurate records of how the property is used, where it is stored, and when it is moved or used in production. This helps you track its location and condition at all times.
   • Implement a tracking system to monitor the movement of customer or supplier items throughout your facility.
5. Report Any Issues or Damage Immediately
   • If any customer or supplier property gets damaged, lost, or is found to be unusable, you must inform them immediately.
   • Document what happened, the impact of the issue, and the corrective actions taken to prevent it from happening again.
6. Ensure Accountability
   • Assign responsibility to specific individuals or departments for managing and protecting customer and supplier property.
   • Make sure your team knows how to handle these items properly and what to do if they encounter any issues.
7. Review and Update Procedures Regularly
   • Regularly review your processes for handling customer and supplier property to ensure they meet ISO 9001 standards and adapt to any changes in your operations.
   • Update your procedures based on feedback, audits, and lessons learned to continuously improve your property management approach.

Why Clause 8.5.3 Matters

Taking good care of customer and supplier property under ISO 9001 Clause 8.5.3 is about showing respect for your partners’ resources and maintaining their trust. By protecting these items and managing them carefully, you minimize the risk of production delays, quality issues, or loss of valuable assets. This clause helps build solid relationships with your customers and suppliers by demonstrating that you’re a responsible partner who values their property as much as your own. It’s all about turning that trust into a competitive advantage.

ISO 9001 Clause 8.5.4 is all about making sure your products and materials are kept safe and in top condition throughout every stage of the production process. It focuses on preserving the quality of your products, from the moment they’re made to when they reach your customer. The goal is to protect your goods from damage, deterioration, or loss during handling, storage, packaging, and delivery. Think of it as the ultimate care plan for your products, making sure they arrive to your customers in the same perfect condition as when they left your facility.

What Needs to Be Done to Meet Clause 8.5.4 Requirements

To comply with ISO 9001 Clause 8.5.4, here’s what your organization needs to do to preserve your products like a pro:

1. Implement Proper Handling Techniques
   • Establish guidelines for handling materials and products to avoid any kind of damage, contamination, or mishandling.
   • Train your team on best practices for safely moving, lifting, and transporting items within your facility.
2. Use Protective Packaging
   • Make sure that all products are packaged in a way that protects them from physical damage, moisture, dust, and other environmental factors.
   • Use packaging materials like bubble wrap, shrink wrap, foam inserts, or protective covers to keep items secure during transit.
3. Control Storage Conditions
   • Store your products in a clean, organized, and well-ventilated space that maintains appropriate temperature, humidity, and other conditions needed to preserve their quality.
   • Label storage areas clearly, and set up designated zones for different types of materials to prevent mix-ups and contamination.
4. Monitor Environmental Factors
   • Regularly monitor the storage environment to ensure it meets the required conditions, such as temperature control for sensitive items or humidity control for delicate products.
   • Use sensors or automated systems to alert your team if conditions fall outside the specified range.
5. Implement FIFO or FEFO Systems
   • Use the First-In, First-Out (FIFO) or First-Expired, First-Out (FEFO) methods to manage inventory, ensuring that older or more time-sensitive products are used or shipped before newer ones.
   • This helps reduce waste and ensures that products reach customers in their best condition.
6. Plan for Transportation and Delivery
   • When arranging transportation and delivery, choose shipping methods that align with your preservation needs to minimize damage or delays.
   • Use temperature-controlled shipping for perishable goods or fragile items, and provide instructions to your logistics partners on how to handle the products.
7. Record and Document Preservation Activities
   • Keep detailed records of all preservation activities, including storage conditions, packaging methods, and any special handling instructions.
   • Document any incidents of damage or quality issues and the corrective actions taken to address them.

Why Clause 8.5.4 Matters 

Preservation under ISO 9001 Clause 8.5.4 is all about taking care of your products from the production floor to the customer’s door. By ensuring that your products are protected throughout their journey, you’re minimizing risks, reducing waste, and delivering top-quality goods that meet customer expectations. Mastering this clause helps build customer trust and satisfaction, showing that you’re committed to maintaining high standards every step of the way.

ISO 9001 Clause 8.5.5 focuses on the actions your organization needs to take even after the product or service has been delivered to the customer. It’s like making sure you don’t just drop the mic after delivering your goods—you keep the energy going strong! This clause requires you to consider what happens after delivery, from customer support to maintenance and dealing with potential issues that might come up later. It’s all about providing ongoing value and keeping that customer satisfaction level high long after the initial transaction.

What Needs to Be Done to Meet Clause 8.5.5 Requirements 

To comply with ISO 9001 Clause 8.5.5, your organization must have a clear game plan for managing everything that happens post-delivery. Here’s what you need to focus on to keep those customer vibes going strong:

1. Understand the Scope of Post-Delivery Activities
   • Identify what specific post-delivery activities are required for your products or services, such as installation, maintenance, repair, or customer support.
   • Consider what kind of support your customers might need based on the nature of your product, industry standards, or contractual agreements.
2. Determine Customer Requirements
   • Talk to your customers to understand their expectations for after-sales service and support. This could include warranty terms, technical assistance, or return policies.
   • Make sure you align your post-delivery services with what the customer expects and what you promised during the sales process.
3. Create a Clear Procedure for Handling Issues
   • Develop a process to deal with any problems or non-conformities that might arise after the product has been delivered. This includes how to handle returns, replacements, repairs, and technical issues.
   • Ensure your team is trained on these procedures so they can respond quickly and effectively to customer concerns.
4. Gather Feedback and Act on It
   • Collect customer feedback on your products and services to identify any areas for improvement. This feedback can help you understand what’s working well and what needs to be upgraded.
   • Use this information to improve future products, services, and post-delivery processes to better meet customer needs.
5. Risk Assessment and Planning
   • Assess any risks associated with post-delivery activities, such as potential product failures, safety issues, or unexpected maintenance needs.
   • Develop a plan to manage these risks, including contingency plans to minimize any negative impact on the customer experience.
6. Documentation and Record Keeping
   • Maintain detailed records of all post-delivery activities, including customer support interactions, maintenance schedules, and any corrective actions taken.
   • This documentation helps you track trends, identify recurring issues, and provide evidence of your commitment to ongoing quality.
7. Continuous Improvement
   • Regularly review your post-delivery processes to ensure they are effective and meet the evolving needs of your customers.
   • Make improvements based on feedback, performance data, and lessons learned from previous experiences to stay ahead of customer expectations.

Why Clause 8.5.5 Matters

ISO 9001 Clause 8.5.5 is all about delivering more than just a product or service; it’s about delivering an experience that lasts. By staying involved even after the sale, you show your customers that you’re committed to their satisfaction for the long haul. This approach builds loyalty, enhances your brand reputation, and turns your customers into your biggest fans. Nailing post-delivery activities not only keeps your quality game strong but also sets you apart as a brand that genuinely cares about its customers.

ISO 9001 Clause 8.5.6 deals with how you manage and control changes within your production and service processes. This clause is like your playbook for making sure that any adjustments, tweaks, or updates to your operations are handled in a controlled way. It’s all about making sure that changes don’t mess up the quality of your products or services, and that everyone involved knows exactly what’s going on. Whether it’s a small tweak or a big change, the goal is to keep everything smooth and ensure that the change actually adds value to your process.

What Needs to Be Done to Meet Clause 8.5.6 Requirements

To comply with ISO 9001 Clause 8.5.6, here’s what your organization needs to do to control changes like a pro:

1. Evaluate the Impact of the Change
   • Before making any changes, take a step back and evaluate how the change will impact your product or service quality, timelines, costs, and customer requirements.
   • Consider the potential risks and benefits associated with the change to make sure it’s worth implementing.
2. Plan and Document the Change
   • Make a detailed plan of what the change involves, including who will be responsible, the steps to be taken, and any resources needed.
   • Document all aspects of the change clearly, including the reason for the change, the expected outcome, and how it will be implemented.
3. Get Approval Before Making Changes
   • Make sure that any proposed changes are reviewed and approved by authorized personnel before they’re put into action. This step helps prevent unexpected issues from popping up after the change is made.
   • Only go ahead with changes when they’ve been officially signed off by the decision-makers.
4. Communicate the Changes Effectively
   • Keep everyone in the loop about what’s happening. Make sure your team understands what the change is, why it’s happening, and how it will affect their daily tasks.
   • Share updated procedures or instructions with relevant team members so they know exactly how to handle the new process.
5. Update Relevant Documentation
   • Update any existing documents that might be affected by the change, such as process instructions, training materials, and quality control checklists.
   • Keep a record of all the changes, including the date, details of the change, and who authorized it, to maintain traceability.
6. Monitor and Measure the Effects of the Change
   • Once the change is implemented, keep a close eye on how it impacts the product or service quality. This will help you see if the change is delivering the expected results.
   • Use metrics, data, and feedback to assess the effectiveness of the change and identify any areas for further improvement.
7. Take Corrective Action if Needed
   • If the change leads to any issues or doesn’t achieve the desired outcome, take immediate corrective action to fix the problem.
   • Analyze the root cause of any issues and adjust your process to prevent similar problems in the future.

Why Clause 8.5.6 Matters 

ISO 9001 Clause 8.5.6 is essential for keeping your operations under control when change is necessary. It ensures that changes are planned, approved, communicated, and monitored to minimize disruption and avoid unintended consequences. By managing changes effectively, you’ll keep your production processes steady, your service delivery consistent, and your customers happy. This clause turns change from a potential risk into an opportunity for improvement, making sure your business stays adaptable and ahead of the game!