understanding ISO9001 2015 Section 8.4 Control of externally provided processes, products and services

This section covers all parts of the final package ,supplied to customers, which are provided by suppliers who are not part of the compamy. The aim here is to make sure that the company has put in place methods and means for checking that the supplied products, processes and services are supplied to the required specification. Companies are required to keep records of these checks and that they have methods in place for identifying and segregating out of specification products and processes and returning to the supplier to be corrected or replaced..

Where processes or services provided by a supplier are found not to be to specification evidence of actions taken with supplier to correct the problem is required.

These requirements also apply to internal suppliers within a company where different parts of a final product are produced at one or more other sites separate from the final production site.


How will Brexit affect ISO certification?

I keep getting asked this question. The answer is not atall. The ISO standards are International standards which have been adopted as Euronorm standards by Europe. No matter what happens with the Brexit negotiations companie’s ISO certifications will still be valid.

However it is not the case for CE marked products. If the UK leaves Europe without a deal on the 31st October CE marked product will no longer be accepted in Europe. Furthermore where UK companies have built up stocks of CE marked parts to assemble the finished product it is likely that these products will not be accepted in Europe either.

Understanding ISO9001 2015 Section 8.3 Design and development of Products and services

This area of the standard is all about companies having design and development processes in place which ensure that the company provides what the customers have asked for.
So it covers the customer requirement inputs and the design process checks and controls that are in place to ensure the outputs meet the customer requirements.
The Standard also requires documented records of any authorised changes in the customer requirements.

Are you seeking ISO9001/14001 certification?

Are your customers suggesting that or asking you get ISO9001 and/or ISO14001 Certification?

Are you looking to grow your business by expanding your customer base to include customers who require completion of a PQQ before they are prepared to add your company to their Approved Supplier List?

Are you already certified to either of these ISO standards and are unhappy with how the systems are actually working for your company?

If so then Philbrown Consultancy can help. I have a team of associates covering the West and North Midlands, Wales and the South West who can provide the support.for your company.

contact me on 077696 14021 or phil@philbrownconsultancy.co.uk or visit my website http://www.philbrownconsultancy.co.uk

Understanding ISO9001 2015 Section 8 Operation

the first 2 subsections cover operational planning and control as well as requirements for product and services. the second of these is all about companies demonstrating that they have communication systems in place that enables suppliers of goods and services to fully understand what the customer needs.

Operational planning is about having the processes in place to meet the customers requirements and having the process resources and controls in place to ensure the product or service provided satisfies the customers requirements. Where the customer requires specific performance characteristics this will include the provision of suitable test facilities.

Understanding ISO9001 2015; Section 7.5 Documented information

at various places in the Standard the Standard requires companies to record and maintain documented information.

This section details how and in what format information is created and recorded and how it is reviewed to ensure the records are suitable and adequate.

It also requires companies to specify where and in what form the documentation is retained,;who has access to it..

Change control of documented information must be specified. i.e who is authorised to make changes to documented information. It also requires records of the changes to be maintained.

Also any documented information obtained externally which is required to plan and operate the quality management systems must be identified and controlled.

Understanding ISO9001 2015 Section 7.4 Communication

For this section companies are required to have decided what methods of communication they will use for both internal and external communications.The company has to provide documented evidence of what it communicates; when it communicates and the frequency of communication as well as its target audience. . For larger companies there should be a plan detailing how these communications are rolled out to the workforce such as regular team briefings or documents displayed on noticeboards. The company should also specify the methods to be used for external briefings

For internal communications briefings such as the quality objectives and ongoing performance against those quality objectives or changes to the Quality Policy are examples what is required for this section of the standard.

Understanding ISO9001 2015 Sections 7.2 Competence and 7.3 Awareness

Companies are required to demonstrate that they have competence records for all their staff who could impact on the quality management systems. These records can be records of education, on the job training or experience. When competence shortfalls have been identified there is a requirement to keep records of the external or internal training provided and the outcomes of the training.

Awareness is about all the people working for the company have been told about the company’s quality policy and understand how they are required to work to that policy. They should also have been made aware of the Company Quality Objectives. They should be aware of the importance of working to the quality management systems and the implications of not adhering to the specified procedures.

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.

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.