Understanding ISO9001 2015; Section 7.1.6 Organisational Knowledge

This Section requires companies to specify/describe what knowledge is needed for each of the processes/operations carried out by the company to assure conformity of products/services that the customer has asked for.

This knowledge is generally specific to the company and has been gained from experience in the role under supervision and/or on the job training.

This knowledge may also be gained from external sources such as technical papers, conferences or other standards specific to the customer’s products/services.

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Understanding ISO9001 2015; Section 7.1.5 monitoring and measuring resources.

This section concerns the requirement to provide suitable equipment to monitor and measure the key production and process parameters to provide a product / service which meets the customer specifications/requirements. The equipment provided should be suitable for the application and must be maintained so that it continues to be fit for purpose. Records of the maintenance checks must be held as retrievable data. Where calibration of equipment is a requirement this must be done using facilities that are traceable to national standards for that equipment. Calibration records need to retained. Frequency of calibration should be decided by the company based on the critical nature of the parameter being measured. Measurement equipment needs to be clearly and uniquely identified.

The company is also required to list any measuring equipment that is used for checking other aspects of a product /service which are not critical to the performance of the product.or service provided but need to be checked as part of the customer requirements.

understanding ISO9001 2015 Section 7.1 Resources

This section is not only focused on the provision of resources to grow the business, such as people, infrastructure and suitable environment for the employees to work in.

it is equally important that the company provides sufficient resources for the Quality Management Systems that enable the company to comply with the Standard. This is about managing the systems with sufficient suitably qualified people and adequate resources are made available to support the Quality Management Personnel.

understanding ISO9001 2015 Section 6.2 Quality Objectives and planning to achieve them

this section requires companies to set themselves at least two Quality Objectives (KPIs) for the Business which they review regularly and report on at the annual management review. Typical Objectives can be such as; delivery on time performance, scrap/ process reject levels, number and cost of customer complaints.*

The most important point here is that the company senior management put in place an action plan as to how they are going to work towards achieving these targets. Having agreed the plans then these should be communicated to the employees. Also it is a requirement that the company collects, analyses and publishes data for the employees to see how the company is actually performing against these targets.

• a target to grow the business by a stated % is not a Quality Objective in itself it needs to be linked to a Quality Improvement target.

understanding ISO9001 2015. Section 6.1; Actions to address risks and opportunities

This section requires company senior management to identify the various potential threats to the business and to assess the impact on the business and the likelyhood of it happening. having identified the areas of highest risk the company needs to demonstrate that there is in place a plan to reduce the impact of the highest risks and there is a timescale for implementing the plan. This plan needs to be reviewed on a regular agreed frequency.

Most companies create a risk register which includes records of the level of risk, the likely impact and details of the action plan to reduce the identified high risks and date of next review.

Opportunities can include new markets for existing products, new product development, process improvements, factory layout improvements and investments in more efficient process equipment. as well as training staff in new skills. Details of these opportunities are best listed in the management review minutes and should be revisited regularly at the very least at each management review meeting.

understanding ISO9001 2015

Section 5 Leadership

This section is looking at the commitment of senior management to the Quailty Management Systems. Are the senior managers on the site involved actively in all the aspects of the systems? The senior management can no longer assign a member of the company to be the management representative for the QMS. When the company is being assessed for certification to ISO9001 2015 the senior management is required to provide the answers.The key areas in this section are;

accountability for the effectiveness of the QMS

Ensuring the company has a Quality Policy and key improvement targets in place and that these are communicated to the work force.

Integrating the QMS into the company business processes.

Promoting a process approach to the business and evaluating the risks to the business.

communicating to the workforce how important it is to have effective QMS in place and for the company employees to adhere to the process procedures

Most important of all is the commitment to improvement of processes for both providing the customer with his requirements and a commitment to identify opportunities for improvements in the QMS

understanding ISO9001 2015

Section 4 of the standard is headed “Context of the organisation“

What does this mean

This requires companies to identify who and what are the main influencers on the Business. Examples are;- Customers, Suppliers, Employees, Directors and Stakeholders in the Business, legislation and Standards, business location and infrastructure.

The company then needs to decide which of these are the biggest potential risk to the business growth and to develop plans to reduce the risk if possible.

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I have recently had a further 2 consultants join the business to provide additional support for the business. One is based in Telford and the other in Weston super Mare. They are both qualified lead assessors for ISO9001 2015 and ISO14001 2015 in addition to working for 2 UKAS registered companies as external auditors. This now enables the business to expand its customer base to give support to companies based in South West and southern central England and also the North Midlands and counties bordering on the North Midlands from the current area covering West Midlands.
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