Following our exit from the EU there has been a return to confidence in our economy.

One of the bellwethers to confidence is the number of organisations looking to ISO 9001. This Quality Management Standard is now the most popular standard in the world, but in the last couple of years applications were put on hold as organisations were unsure about the additional expenditure and controls necessary for this standard.

The CBI have reported a return to confidence and this is reflected in the number of enquiries received in our office.

ISO 9001 is an outward sign that an organisation is committed to quality and is prepared to allow an external body to examine their quality management system. A system which meets the strict criteria will be awarded a certificate of compliance. A certificate which is awarded by an accredited certification body (UKAS in the UK) is recognised worldwide.

More and more ISO9001 is seen as a prerequisite for tender entry. If an organisation does not have 9001 then any tender application is likely to fail at the first hurdle.

We can help organisations to achieve the requirements of ISO 9001 with ease of use and minimal paperwork as a requirement. Our services are guaranteed, of course, and with the company in its 29th year we can back up our claims.

It normally takes a minimum, of six months from the start of a project, to achieve formal certification. The system must be capable of audit and any assessor must audit what is being done rather than what is planned.

This standard is probably the best know standard in the world, it is recognised in its full title in the UK as BS EN ISO 9001:2015.  We have covered this subject before but it is well worth doing it again.

  • BS means it is an adopted British Standard
  • EN means that it is adopted by Europe
  • ISO means that it is adopted internationally

There are over 6 million certifications worldwide and ISO 9001 has long been seen as an entry qualification to tenders and bids.

The Standard is really good business practice and companies holding this qualification have risks and opportunities at the heart of their companies.  This coupled with continual improvement makes both commercial as well as financial sense.

There are 10 sections to the standard and these cover all elements of a company except finance. Finance requirements are different throughout the world and trying to set a common standard would have been difficult.

The 10 sections are:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

Once properly set up, the system in the UK is assessed by a UKAS Accredited Certification Body and a Certificate is issued to demonstrate compliance to this Standard. (Other countries have specific Accreditation Bodies).

This independent certification shows that the company is fully compliant with ISO 9001:2015 and can be accepted without the need to carry out  additional supplier audits.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

There is an air of panic with organisations that have not yet transitioned to the 2015 Standards.  We have been receiving calls from quality and environmental managers to say that they have not yet transitioned and is it too late? 

Although the deadline is 15 September this year it is almost impossible to get an assessor to fit you in.  We have very limited availability to complete the necessary changes to systems but it still may not be possible to meet the deadline. 

Only this afternoon I was discussing availability with one of the certification bodies only to be told that the first available date was end of October 2018.  This is way past the cut-off point and it will mean that any organisation missing this cut-off will be deregistered and will have to make a fresh application.

The organisations leaving it all o the last minute have a number of excuses why they have not addressed this issue before but with a full three-year notice period it simply doesn’t hold water.

We will of course do what we can to offset the de-registration.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

According to a survey carried out with certification bodies in the UK, some 60% of organisations holding ISO 9001 and/or ISO 14001 have not transitioned to the 2015 standards.

The deadline for transition is 14 September 2018 ad it is essential that the transition assessment and any findings from that assessment are cleared.

I heard from one certification body that they expect UKAS to extend the deadline; we cannot stress enough that the deadline will NOT be extended under any circumstance and any organisation failing to transition will automatically be withdrawn from the register of certificated companies.

Any organisation that becomes de-certified will have to undergo a fresh application as though they never had a certificate, i.e. a new application then stage one followed by a stage two before the issue of a certificate can take place. Tenders and orders which mandate certification to 9001 and/or 14001 will be at risk.

The aircraft, defence and space standards AS9100, AS9110 and AS9120 also have a deadline date of 14 September 2018 even though the standard was published a year later than the 9001/14001 standards. Again, automatic de-certification will take place unless transition to the new standards is made.

If you have not transitioned yet, we recommend urgent action should be taken to be ready for the deadline. Time is short and of course you may be ready but cannot get an assessor in to do the two stages necessary for compliance. (assessors are incredibly busy and make bookings many months ahead).

Time is short for transition

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

The deadline for transition to ISO 9001:2015, ISO 14001:2015 and the Aircraft, Space and Defence Standards AS 9100D, AS9110C and AS 9120B is 15 September 2018.

While this may seem a long way off it is important to remember that the transition and correction and acceptance of any corrective action identified by an assessor must be completed satisfactorily by the deadline date.

Both UKAS for the quality and environmental standards and IAQG for the Aircraft, Space and Defence standards have made it very clear that there can be no extensions or relaxation of the deadlines for any reason.  Any organisation missing the deadline will be deregistered.  There is no appeal mechanism.  The organisation will lose certification and will have to start from scratch to regain certification.  There is a fairly big cost involved in this and loss of certification in the intervening period may result in inadmissibility for tenders and/ or cancellation of contracts requiring one or more of the standards as a mandatory requirement.

The revised Standards are quite different in their approach and require more involvement from Senior Directors and Managers.  This can be a problem where the requirement for understanding and operating the standards has, historically, been delegated to others lower down the organisation.

We at Quality Matters have helped a number of Clients to effect the transition and while we have sought to make it simple to use there have been a number of top management who have been  forced to become engaged in the systems.

The Aircraft, Space and Defence Standards were issued at the end of 2016 but the transition dates have been aligned with the ISO standards. I.E.  15 September 2018 ; a fairly tight schedule.

We urge all holders of certification that are affected by these changes to ensure that their transition is carried out in good time to avoid loss of certification.  Remember you may be ready, but assessors are committed to the stage one for transition followed by stage two on site.  Availability may be a governing factor.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

Hardly a day goes by without some organisation announcing that they can get you through ISO 9001 or other Standards cheaply and in double quick time.

There is a single accreditation body in the UK, this is UKAS, the UK Government decided that there should be only one body tasked with authorising certification bodies.  There are a good number of these and the certificates they issue bear the UKAS tick and crown logo.

These certification bodies must reach, and maintain a high standard to continue to claim that they are in fact an accredited certification body.   Regular and strict audits are carried out.  One principle is that no certification body can offer consultancy; this would be a conflict of interest and is prohibited.

On the other side non accredited organisations issue certificates claiming to meet the requirements of which ever standard is covered.  Some even show a logo claiming to be accredited by some other accreditation agency.  This is designed to fool anyone gullible enough to believe it.

UKAS is not a regulator and has no powers to stop these organisations carrying on.

A good number of these non accredited organisations have sprung up; some offer consultancy and certification as a package.  I often say to people who contact me “how can they fail to certify you when they have set up the system?   The sad truth daws on these people when they submit a certificate claiming to show compliance with a Standard only to find that it is not recognised, except by the issuing authority.

One other fact is clear; you cannot set up a system and get it certificated in 30 days (or less in one case) as clearly an assessor must be able to audit what you have done not what you are planning to do.  Evidence is just not there under these timescales.

Beware of non accredited organisations.  If it seems too good to be true it probably isn’t any good.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

9. PERFORMANCE EVALUATION

MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

Details the requirement for the organisation to determine:

  • What needs to be monitored and measured;
  • The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;
  • When monitoring and measuring is performed;
  • When the results from monitoring and measurement are analysed and evaluated.
  • The organisation must evaluate the performance of the quality management system.

The organisation must retain documented information as evidence of the results.

CUSTOMER SATISFACTION

Details the requirement to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled.  The organisation must determine the methods for obtaining, monitoring and reviewing this information.

The methods may include customer surveys, customer feedback on delivered products and services, meeting with customers, market share analysis, compliments, warranty claims and dealer reports.

ANALYSIS AND EVALUATION

Details the requirement for the organisation to analyse and evaluate appropriate data and information arising from monitoring and measurement. 

The results of analysis must be used to evaluate:

  • Conformity of products and services;
  • The degree of customer satisfaction;
  • The performance and effectiveness of the quality management system;
  • If planning has been implemented effectively;
  • The effectiveness of actions taken to address risks and opportunities;
  • The performance of external providers;
  • The need for improvements to the quality management system.

Methods to analyse data can include statistical techniques.

INTERNAL AUDIT

Details the requirements to conduct internal audits at planned intervals to provide information on whether the quality management system:

  • Conforms to:
    • The organisation’s own requirements for its quality management system;
    • The requirements of ISO 9001:2015;
  • Is effectively implemented and maintained.

The organisation must:

  • Plan, establish, implement and maintain an audit programme(s) including the frequency, methods, and responsibilities. Planning requirements and reporting, which must take into consideration the importance of processes concerned, changes affecting the organisation, and the results of previous audits;
  • Define the audit criteria and scope for each audit;
  • Select properly qualified auditors and conduct audits to ensure objectivity and impartiality of the audit process;
  • Ensure that the results of audits are reported to relevant management;
  • Take appropriate corrective actions without undue delay;
  • Retain documented information as evidence of the implementation of the audit programme and the audit results.

 

MANAGEMENT REVIEW

Details the requirement for the organisation to review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with strategic direction of the organisation.

MANAGEMENT REVIEW INPUTS

The management review must be planned and carried out taking into consideration:

  • The status of actions from previous management reviews;
  • Changes in external and internal issues that are relevant to the quality management system;
  • Information on the performance and effectiveness of the quality management system, including trends in:
    • Customer satisfaction and feedback from relevant interested parties;
    • The extent to which quality objectives have been met;
    • Process performance and conformity of products and services;
    • Nonconformities and corrective actions;
    • Monitoring and measurement results;
    • Audit results;
    • The performance of external providers;
  • The adequacy of resources;
  • The effectiveness of actions taken to address risks and opportunities;
  • Opportunities for improvement.

MANAGEMENT REVIEW OUTPUTS

The outputs of the management review must include decisions and actions related to:

  • Opportunities for improvement;
  • Any need for changes to the quality management system;
  • Resource needs;

The organisation must retain documented information as evidence of the results of management reviews.

10. IMPROVEMENT

GENERAL

Details of the requirements for the organisation to determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.  These must include:

  • Improving products and services to meet requirements as well as to address future needs and expectations;
  • Correcting, preventing or reducing undesired effects;
  • Improving the performance and effectiveness of the quality management system;

NONCONFORMITY AND CORRECTIVE ACTION

Details the requirement for the organisation to action nonconformities, including any arising from complaints and must:

  • React to the nonconformity, and as applicable:
    • Take action to control and correct it;
    • Deal with the consequences;
  • Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by:
    • Reviewing and analysing the nonconformity;
    • Determining the cause of nonconformity;
    • Determining if similar nonconformities exist, or could possibly occur;
  • Implement any action needed;
  • Review the effectiveness of any corrective action taken;
  • Update risks and opportunities, determined during planning, if necessary;

Corrective actions must be appropriate to the effects of the nonconformities encountered.

The organisation must retain documented information as evidence of:

  • The nature of the nonconformities and any subsequent actions taken;
  • The results of corrective action.

CONTINUAL IMPROVEMENT

Details the requirement for the organisation to continually improve the suitability, adequacy and effectiveness of the quality management system.

The organisation must consider the results of analysis and evaluation, and the outputs from management reviews, to determine if there are needs or opportunities that must be addressed as part of continual improvement.

Once all this is put into place a formal assessment can take place.  Of course continued compliance is a must and will be checked by the Certification Body.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

 

8. OPERATION

Details the requirement for the planning, implementation and control of the processes needed to meet the requirements for the provision of products and services, and to implement the actions determined in Section 6 (Planning), by:

  • Determining the requirements for the products and services;
  • Establishing the criteria for:
    • The processes;
    • The acceptance of products and services;
  • Determining the resources needed to achieve conformity to the product and service requirements;
  • Implementing control of the processes in accordance with the criteria;
  • Determining and keeping documented information to the extent necessary:
    • To have confidence that the processes have been carried out as planned;
    • To demonstrate the conformity of products and services to their requirements.

The output of this planning must be suitable for the organisation’s operations.

The organisation must control planned changes and review the consequences of unintended changes, taking actions to mitigate any adverse effects, as necessary.

The organisation must ensure that any outsourced processes are controlled.

REQUIREMENTS FOR PRODUCTS AND SERVICES

 

CUSTOMER COMMUNICATION

This includes:

  • Providing information relating to products and services;
  • Handling enquiries, contracts or orders, including changes;
  • Obtaining customer feedback relating to products and services, including customer complaints;
  • Handling or controlling customer property;
  • Establishing specific requirements for contingency actions, where relevant.

DETERMINING THE REQUIREMENTS RELATED TO PRODUCTS AND SERVICES

When determining the requirements for products and services to be offered to customers, the following must be addressed:

  • The requirements for the products and services are defined, including:
    • Any applicable statutory and regulatory requirements;
    • Those considered necessary by the organisation
  • The organisation can meet the claims for the products and services it offers.

REVIEW OF REQUIREMENTS RELATED TO PRODUCTS AND SERVICES

The organisation must ensure that it has the ability to meet the requirements for products and services being offered to customers. The organisation must conduct a review before committing to supply products and services to a customer to include:

  • Requirements specified by the customer, including the requirements for delivery and post-delivery activities;
  • Requirements not stated by the customer, but necessary for the specified or intended use, where known;
  • Requirements specified by the organisation;
  • Statutory and regulatory requirements applicable to the products and services;
  • Contract or order requirements differing from those previously expressed are resolved.
  • The customer’s requirements must be confirmed by the organisation before acceptance, when the customer does not provide a documented statement of their requirements.
  • Where internet sales are involved, a formal review is impractical for each order. Instead the review can cover relevant product information, such as catalogue or advertising material.
  • The organisation must retain documented information, as applicable:
    • On the results of the review;
    • On any new requirements for the products and services.

CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES

The organisation must ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
 

DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

Details the requirements that the organisation must establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

DESIGN AND DEVELOPMENT PLANNING

The stages and controls for design and development including:

  • The nature, duration and complexity of the design and development activities;
  • The required process stages, including applicable design and development reviews;
  • The required design and development verification and validation activities;
  • The responsibilities and authorities involved in the design and development process;
  • The internal and external resource needs for the design and development of products and services;
  • The need to control interfaces between persons involved in the design and development process;
  • The need for involvement of customers and users in the design and development process;
  • The requirements for subsequent provision of products and services;
  • The level of control expected for the design and development process by customers and other relevant interested parties;
  • The documented information needed to demonstrate that design and development activities have been met.

DESIGN AND DEVELOPMENT INPUTS

Functional and performance requirements, information derived from previous similar design and development activities, statutory and regulatory requirements, standards or codes of practice that the organisation has committed to implement, potential consequences of failure due to the nature of the products and services.

Inputs must be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs must be resolved

Documented information on design and development inputs must be kept.

DESIGN AND DEVELOPMENT OUTPUTS   

  • Must meet input requirements;
  • Are adequate for the subsequent processes for the provision of products and services;
  • Include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
  • Specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision;

Documented information on design and development inputs must be kept.

CONTROL OF DESIGN AND DEVELOPMENT CHANGES

The organisation must identify, review and control changes made during, or subsequent, to the design and development of products and services, to the extent necessary to endure that there is no adverse impact on conformity to requirements.

Change documented information must include, as appropriate:

  • Design and development changes;
  • The results of reviews;
  • The authorisation of the changes;
  • The actions taken to prevent adverse impacts.

CONTROL OF EXTERNALLY PROVIDED PRODUCTS AND SERVICES

Details the requirements the organisation must ensure that externally provided processes, products and services conform to requirements.  The organisation must determine the controls to be applied to externally provided processes, products and services, when:

  • Products and services from external providers are intended for incorporation into the organisation’s own products and services;
  • Products and services are provided directly to the customer(s) by external providers on behalf of the organisation;
  • A process, or part of a process, is provided by an external provider as a result of a decision by the organisation.

The organisation must determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or product and services in accordance with requirements.

The organisation must retain documented information of these activities and any necessary actions arising from the evaluations.

TYPE AND EXTENT OF CONTROL

The organisation must ensure that externally provided processes, products and services do not adversely affect the organisations ability to consistently deliver conforming products to its customers.

INFORMATION FOR EXTERNAL PROVIDERS

Details the requirements that the organisation must ensure the adequacy of requirements prior to their communication to the external provider.  The organisation must communicate to external providers its requirements for:

  • The processes, products or services to be provided;
  • The approval of:
    • Products and services
    • Methods, processes and equipment;
    • The release of products and services;
    • The external providers’ interactions with the organisation;
    • Control and monitoring of the external providers’ performance to be applied to the organisation;
    • Verification or validation activities that the organisation, or its customer intends to perform at the external providers’ premises.

  
 

PRODUCTION AND SERVICE PROVISION

CONTROL OF PRODUCTION AND SERVICE PROVISION-  

Details of the controlled conditions in place for actual product manufacture or service delivery.   Controls must be sufficient to ensure that there is quality of consistent conformance to the specification. These may include, as applicable:

  • The availability of documented information that defines:
    • The characteristics of the products to be produced, the services to be provided, or the activities to be performed;
    • The results to be achieved;
  • The availability and use of suitable monitoring and measuring resources;
  • The implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control processes or outputs, and acceptance criteria for products and services, have been met;
  • The use of suitable infrastructure and environment for the operation of processes;
  • The appointment of competent persons, including any required qualification;
  • The validation, and periodic re-validation, of the ability to achieve planned results of the processes for production And service provision;
  • The implementation of actions to prevent human error;
  • The implementation of release, delivery and post-delivery activities.

IDENTIFICATION AND TRACEABILITY

Details the requirements that the organisation must use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

The organisation must identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

The organisation must control the unique identification of the outputs when traceability is a requirement, and must retain documented information necessary to enable traceability.

PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

The organisation must exercise care with property belonging to customers or external providers while under the organisation’s control or being used by the organisation.

The organisation must identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products or services.

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organisation must report this to the customer or external provider and retain documented information on what has occurred.

This property can include material, components, tools and equipment, premises, intellectual; property and personal data.

PRESERVATION

Details the requirement for the organisation to preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.

Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

POST DELIVERY ACTIVITIES

Details the requirements for post-delivery activities associated with products and services.  The following must be considered:

  • Statutory and regulatory requirements;
  • The potential undesired consequences associated with its products and services;
  • The nature, use and intended lifetime of its products and services;
  • Customer requirements;
  • Customer feedback;
  • Warranty and servicing, where appropriate and recycling or final disposal.

CONTROL OF CHANGES

Details the requirement to review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organisation must retain documented information describing the results of the review of changes, the person(s) authorising the change, and any necessary actions arising from the change, and any necessary actions arising from the review.

RELEASE OF PRODUCTS AND SERVICES

Details the planned arrangements, at appropriate stages, to verify that the product or service requirements have been met.

The release of products and services to the customer must not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

The organisation must retain documented information on the release of products and services.  The documented information must include:

  • Evidence of conformity with acceptance criteria;
  • Traceability to the person(s) authorising the release.

CONTROL OF NONCONFORMING PROCESS OUTPUTS

Details the requirements to ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

The organisation must take appropriate action based on the nature of the nonconformity of products and services.  This must also apply to nonconforming products and services.  This must also apply to nonconforming products and services detected after delivery of products, during or after provision of services.

The organisation must deal with nonconforming products and services in one of the following ways;

  • Correction;
  • Segregation, containment, return or suspension of  provision of products and services;
  • Informing the customer
  • Obtaining authorisation for acceptance under concession.

Conformity to the requirements to the requirements must be verified when nonconforming outputs are corrected.

The organisation must retain documented information that:

  • Describes the nonconformity;
  • Describes the actions taken;
  • Describes any concessions obtained;
  • Identifies the authority deciding the action taken in respect to the nonconformity.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

6. PLANNING FOR THE QUALITY MANAGEMENT SYSTEM

Details the requirements for concepts of risk (and opportunity).

  • ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES – The requirement to understand the risks and opportunities relevant to the scope of the organisation and determine actions, objectives and plans to address them.
  • The risks and opportunities use the inputs that the organisation has identified in understanding its context and the views from interested parties.
  • Options to address risks and opportunities can include:

    • Avoiding risk;
    • Taking risk in order to pursue an opportunity eliminating the risk source;
    • Changing the likelihood or consequences;
    • Sharing the risk; or
    • Retaining risk by informed decision.
  • Opportunities:

    • Can lead to the adoption of new practices:
    • Launching new products;
    • Opening new markets;
    • Addressing new clients;
    • Building partnerships;
    • Using new technology and other desirable and viable possibilities to address the organisation’s or its customers’ needs.
  • QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM – The requirement for the organisation to set quality objectives at relevant functions, levels and processes needed for the quality management system.  These objectives must be SMART (Specific, Measurable, Achievable, Realistic and Timely) and can include:

    • Market position/growth;
    • Process effectiveness/efficiency;
    • Maintenance of present position;
    • Reduction in costs of quality;
    • Improvements in product conformity;
    • Reduction in defects/poor service;
    • Improved customer/client satisfaction.

    Objectives can be part of staff development/appraisals and records need to be kept on levels of achievement.

    • What will be done?
    • What resources will be required?
    • Who will be responsible?
    • When will it be completed?
    • How the results will be evaluated?

  • PLANNING OF CHANGES- The requirement is to ensure changes and the impact of changes are considered in terms of risk and are effectively planned, controlled and managed.

7. SUPPORT

Details the requirement for the activities for People, Infrastructure, Environment for the Operation of Processes and Monitoring and Measurement Resources, Measurement Traceability, together with Organisational Knowledge Procedural Requirements of the quality management system.

  • RESOURCES –   The requirement for the resources needed for the establishment, implementation, maintenance and continual improvement of  the quality management, including the requirement for externally supplied resources.
  • PEOPLE – Determine and provide the persons necessary for effective implementation of the quality management system and for the operation and control of its processes.
  • INFRASTRUCTURE – Determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
  • ENVIRONMENT FOR THE OPERATION OF ITS PROCESSES – Determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
  • These can be a combination of social, psychological and physical.
  • MONITORING AND MEASURING RESOURCES – The requirement to determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.  Documented information as evidence of fitness for purpose of the monitoring and measurement resources are kept.
  • MEASUREMENT TRACEABILITY – When measurement traceability is a requirement, or is considered to be an essential part of providing confidence in the validity of measuring results, measuring equipment must be:

    • Calibrated, or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.  Where no standard exists the basis for calibration or verification must be documented.
    • Identified in order to determine their status
    • Safeguarded from adjustments that would invalidate the calibration status.
    • Where equipment is found to be unfit for its intended purpose then the validity of previous measurements must be reviewed.
  • ORGANISATIONAL KNOWLEDGE – Determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.   This knowledge must be maintained and be made available to the extent necessary.  
  • This knowledge can be from internal resources (e.g. intellectual property, knowledge specific to the organisation, gained from experience, lessons learned from failures and successful projects, capturing and sharing undocumented knowledge and experience, the results of improvements in processes, products and services).
  • External sources (e.g. standards, academia, conferences, gathering knowledge for customers or external providers).
  • COMPETENCE –  The requirement to determine the necessary competence of persons doing work under its control that affects the performance and effectiveness of the quality management system; where competence criteria are not met then the training required to acquire such competence.   There is a requirement to manage recruitment, induction and ongoing training and maintain documented information.
  • AWARENESS – The requirement to ensure that staff are made aware of the relevance of the quality policy, relevant quality objectives and their activities and how they contribute to the achievement of quality objectives.  Conversely the implications of not contributing to the specific and overall quality management system.
  • COMMUNICATION – The requirement for the organisation to determine the internal and external communications relevant to the quality management system including:

    • On what it will communicate?
    • When to communicate?
    • With whom to communicate?
    • How to communicate?
    • Who communicates?
  • DOCUMENTED INFORMATION – the requirement for documented information required by ISO 9001:2015 and documented information determined by the organisation as being necessary for the effectiveness of the quality management system.

There is no longer a requirement for mandatory documented procedures or manuals, but there is a requirement to maintain documented evidence of the system being operated.

In practice many organisations will maintain manuals and procedures to act as a guide and ensure operations are carried out effectively and efficiently.     
    
Documents, documented information can be in any format.                                           

  • CREATING AND UPDATING – When creating and updating documented information the following must be observed;

    • Identification and description (e.g. Title, date, version, author, or reference number).
    • Format (e.g. language, software version, graphics) and media (e.g. Paper or electronic).
    • Review and approval for suitability and adequacy.
  • CONTROL OF DOCUMENTED INFORMATION –  Documented information required by the quality management system and by ISO 9001:2015 must be controlled to ensure:

    • It is available and suitable for use, where and when it is needed;
    • It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

  • The following activities must be addressed, as appropriate:

    • Distribution, access, retrieval and use;
    • Storage, preservation, including preservation of legibility;
    • Control, of changes (e.g. version control);
    • Retention and disposition.

Documented information of external origin determined by the organisation to be necessary for the planning and operation of the quality management system is identified, as appropriate and controlled.

Documented information retained as evidence of conformity is protected from unintended alterations.

The official blog for independent Management Training
Consultancy, Quality Matters Limited.

All management standards issued since 2012 follow the Hi Level structure (HLS) set out in Annex SL of the ISO systems standard and each will have ten identical clauses.  This will make it easier to integrate standards and will simplify documentation. 

The ten clauses are:
 

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

ISO 9001 is a Model for quality management systems. It is a quality system certification scheme where a company’s processes are assessed to a quality standard.  This standard has been agreed in this country, the European Union and Internationally.

The Standard, which is now on its sixth generation, was first known as BS 5750.

Formal assessment of an organisation’s quality management system is carried out by an independent and accredited third party certification body.  If all the requirements are met, a certificate of conformity is issued.  Regular surveillance visits are carried out, subsequently, to ensure that the standard is being maintained.

Accreditation of the Certification Bodies (CB’s)  in the UK is carried out by UKAS (United Kingdom Accreditation Service)  UKAS is the sole accreditor in the UK.

A register of quality competent firms is maintained by the Stationery Office (TSO) under subscription and is used as a reference for purchasing authorities.

The market-place is becoming ever more competitive. It is clear that only the companies providing goods or services of the required quality are going to be able to compete.

Put very simply BS EN ISO 9001 sets out the requirements of a quality management system which supports the delivery of a product or service, through the application of effective and continually improving systems, assuring conformity to customer and applicable legal requirements, whilst enhancing customer satisfaction.

Today’s Global Market means that companies throughout the world are able to offer their goods and services on equal terms.   The use of the internet and E-commerce for business makes it vital that we are able to compete.

        ISO 9001 makes it easier to compete in that market-place.

Product liability laws require a company to prove that it has taken all necessary and reasonable steps to produce safe products that minimise the risk to users.

  • ISO 9001 helps provide such assurance.
  • ISO 9001 requires 7 main sections (4-10) to be addressed before certification can take place.  

The 2015 standard does not allow any clauses to be excluded, unlike previous versions.

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Consultancy, Quality Matters Limited.