In This Episode…
Phil talks us through the ISO 9001 QMS, the requirements that make up this standard, benefits, the difference between good and bad implementations, and some tips from him to follow if you’re implementing the QMS sometime soon.
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✅ Introducing the episode and introducing Phil and his business
✅ Explaining the ISO 9001 QMS and its requirements – ISO 9001 is a standard designed to assure that companies deliver their customers’ expectations and requirements. Phil goes through the different requirements for the standard:
- Leadership: A commitment from senior management to observe the requirements of the standard and commit the entire company to reach them.
- The way inquiries, quotations, and orders are handled, recorded, and orders linked back to the original inquiry.
- Using approved suppliers: These suppliers are assessed as meeting the businesses’ requirements, this helps if they are also ISO 9001 accredited. Records kept of how the supplier is approved. The business should only use these approved suppliers for purchasing manufacturing materials etc moving forward.
- Noncomformances: These may be internal or external. How are they recorded, investigated, and root causes identified? Actions must be taken to put them right. An internal nonconformance could be a defect in a product, whereas an external one could be where a product is damaged in transit and causes a customer complaint.
- Records of employee competencies: This includes their ability to do their assigned tasks, knowledge of the processes, and skills in operating them. Phil uses a skills matrix to assess employees’ abilities to carry out tasks. A traffic light system may be used where red means they’re incapable of performing this task, amber where they are undergoing training, and green where they’re fully trained and approved to carry out the task. This is helpful for manufacturers who may need to move staff around and quickly need to see who is qualified.
- Setting targets for improvement: They must be meaningful, measurable, and achievable. This could be things like delivery on time (which customers expect) and reducing scrap and rework. These need to be communicated to the stakeholders (operators, team leaders, etc) and regularly reviewed so everyone knows how they are performing.
- Regular review of the business systems: Companies need to maintain and continuously improve their systems.
- Management review: Companies review how they are doing at least annually against the various requirements of the standard. This may include performance targets, productivity, and more.
- Production planning and scheduling: When orders are received what’s the plan to manufacture the goods and what will the load on the factory be? This should be identified and communicated to the workforce. A situation where people who shout loudest get their production done is contrary to the aim of this requirement.
- Control of design and development: This has to be done in an organized way. Records of product designs need to be kept, properly documented, and meet the requirements of specific customers and product ranges.
- Documented information (and analysis of it): Information recorded needs to be readily accessible, meaningful, measurable, and analyzed. Actions need to also be agreed upon based on the information, carried out, and monitor the effects. Most companies that need the ISO 9001 QMS keep a lot of information, but seldom analyze and use it to improve processes, productivity, and product generation.
- Identification and traceability: When the finished product is ready for dispatch it carries identification marks which make it possible to trace it back through the entire production process and provide information about the machine used, operator who made it, the batch of materials or parts used and where they were sourced from, etc. So if there are issues with a product, the others in its batch can be found quickly in the case of a recall, and/or the cause of the issue can be investigated. This is especially important for automated production lines because care needs to be taken to record the parts used in a particular area.
- Control and measuring equipment: Measuring equipment may be used to measure thickness, tolerances, etc. The manufacturer also needs to assure that the equipment is calibrated regularly and the calibrations recorded in a log.
- Continual improvement: The business strives to improve the products, processes, speed, quality, etc. A QMS is live and must evolve and be used over time.
✅ Drawbacks of implementing a QMS – ISO 9001 accreditation can sometimes be used as a ‘badge’ by management rather than a means for real improvement of the business. An example is an MD who congratulates himself on implementing ISO 9001, but then doesn’t follow through on the internal audits of management systems, management review, continuing to look at nonconformances, achieving objectives, and committing to continuous improvement. When the annual audit takes place, they probably will not pass!
✅ The importance of everyone being involved in ISO 9001 QMS implementation – this is from top management down to the individual operator. Renaud recently wrote about the mistake some management make by relying solely on a quality manager to implement the QMS and otherwise not getting involved. Phil also agreed that this isn’t acceptable. He stressed that factory workers are equally as interested in if the company is achieving its targets and how they are contributing.
✅ Communication’s role in staff retention – a dialogue between workforce and management is far better for the company than if workers are kept in a vacuum and unaware of how the business is doing. Senior management needs to demonstrate that operators are a vital cog in the running of the QMS, not just a means to an end.
✅ What’s the difference between ‘good’ and ‘bad’ ISO 9001 implementations? – a good implementation is where (in the case of a 3rd party consultant) the person/s implementing the QMS becomes like a part of the company, gets involved in the ISO systems, but also helps encourage operators to do what the system requires.
Bad implementations are often where a company uses a software package to implement ISO 9001, but there’s no real personal involvement in it. This is not a real live operation and can allow various nonconformances to creep through which will be found by the auditor and can cost the company its accreditation.
✅ Some real examples of QMS implementations that Phil has been involved in – good examples are:
- A company had ISO 9001 put in by a non-approved body and was not actually meeting the requirements of the standard because it was poorly implemented. Phil had to explain the requirements and make sure everyone was working towards them, understood why, and the benefits of what they were doing.
- A supplier to the auto trade required ISO 9001 and 14001 accreditations in order to be considered a tier-one supplier and have the upper hand over competing companies who do not have the certifications.
- A company supplying the UK health service was told at short notice that their contract would not be renewed and so it was necessary to gain the certification as quickly as possible in order to retain their business.
✅ Some tips from Phil for manufacturing companies who are planning to implement ISO 9001 – ensure that you communicate every piece of information about how the company is doing to the people involved in manufacturing the product as they will become far more involved in the business. Also, take note of customer complaints as they’re a source of valuable information and, if handled professionally, will win turn the customers into advocates for your business.
✅ Wrapping up
- Basics about ISO 9001: The Standard and the Certification Process
- The Basics of Quality Management for Buyers (Podcast episode)
- Benefits of ISO 9001 for a Chinese manufacturing organization
- Quality Manager Interview Questions To Test Knowledge Of ISO 9001
- Factory Audit Tips: 10 Signs of a Bad ISO 9001 Implementation
- What Causes A Bad Factory QMS Implementation? [Reason 1]
We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.
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