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ISO 9001 as a Strategic Planning Model - ISO Update

Written by Kashif Mumtaz

Regardless of the other terms used in ISO 9001:2015, the term, Strategic Direction has not been defined in ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary. However, ISO 9001:2015 contains the following strong linkages to the strategic direction of the organization:

  • Clause 4.1 – External and internal issues must be relevant to the Strategic Direction of the organization.
  • Clause 5.1 – The Quality Policy and Quality Objectives must be compatible with the Strategic Direction of the organization.
  • Clause 5.2 – The Quality Policy must support the Strategic Direction of the organization.
  • Clause 9.3 – Management Review Process must ensure the suitability, adequacy effectiveness and alignment of the Quality Management System with the Strategic Direction of the organization.

Strategic Direction as we believe is the organization vision of where the organization wants to be in the future and the development of an overall Strategic Plan is affected by various internal and external factors. Refer to the clause 4.0 of ISO 9001:2015 Context of the Organization which states that the organization shall determine external and internal issues relevant to its purpose and its strategic direction and those affect its ability to achieve the intended results of its Quality Management System. ISO 9001:2015 further elaborates in Notes (1 – 3) of the clause 4.1 that issues can include positive and negative factors or conditions for consideration – Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and international, national or regional economic environments. Understanding of the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

The strategic planning process is a continual process and if we look at the traditional strategic planning process, it very much resembles with the Plan-Do-Check-Act (PDCA) Cycle of which ISO 9001:2015 is a big promoter to apply this cycle to all organizational processes and the Quality Management System as a whole to implement plans to achieve objectives including strategic.  In addition, various functions within the organization having their own strategies can closely be aligned and integrated within the Context of the Organization which is basically overall strategic plan of the organization highlighting all internal and external factors with their resulting impact on the organization along with the approaches to managing risk(s) at the functional and company-wide levels for the achievement of larger mission of the organization.

Having said that, we can say that framework provided by ISO 9001:2015 can be used by the organizations for strategic planning but when the management rejects QMS as strategic planning model and make intuitive decisions then ISO 9001:2015 cannot address or contribute in the overall strategic planning process.

About the Author

Kashif Mumtaz is serving as QA Manager at Omrania in Riyadh, Saudi Arabia and has more than 17 years’ experience in quality assurance & management systems. He is Chartered Quality Professional (CQP) and holds a master’s degree in Quality Management from UK

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ISO Implementation Process

Preparing for an ISO implementation process of any ISO standard can be overwhelming and stressful for organizations of any size. How an organization prepares for an ISO implementation process will depend on factors such as size and complexity of its processes, the current knowledge and culture related to the standard; i.e., quality, environmental, safety, etc; the maturity of any other existing systems related to the standard wishing to implement, and many others.

6 Tips to Facilitate the ISO Implementation Process

Despite the differences there may be between organizations, there are a few tips that will facilitate the ISO implementation process of any management system.

Know the Standard

It is essential that some personnel knows the management system’s requirements. Everyone does not need to be an expert on the requirements of the specific standard that will be implemented, but key workers need to fully know and understand all of the requirements of the standard.

Keep Everyone Informed

The implementation process is not a task of just a few chosen ones. Everyone needs to be involved in this process. Every worker needs to know what is being implemented, why is it being implemented, which are the benefits for the organization and for themselves, and how they will be involved in the process. When people are informed, they will be more open and willing to collaborate in the implementation.

Analyze the Organization’s Current Situation

Before starting to implement any ISO management system, an organization needs to know its level of compliance with the standard. This will allow the organization to understand beforehand its strengths and weaknesses regarding the ISO management system wishing to implement and estimate the time needed for implementation.

Map Your Processes

Establish and record current processes in order to know the relationships between departments and how the processes flow within the organization. This will allow organizations to plan their implementation by processes and not just by areas and departments.

Review Existing Procedures and Work Instructions

Many processes need written and documented information that will guarantee that activities are carried out in the correct manner. Organizations need to review which processes are documented and how many work instructions there are. It is not the same to develop a few documents and just review work instructions than to develop them from scratch. Organizations need to have an idea of how much time they will have to invest in developing and reviewing documents.

Review Current Training Programs

Evaluate existing training and awareness programs. Training and awareness are an important part in the implementation process and if an organization has not considered training its workers, it would be best to redefine these programs to make sure that a large percentage of workers are trained and informed about policies, procedures, regulations, etc that will be a part of their daily activities.

These are some recommendations that will help your organization prepare for the ISO implementation process of any ISO management system.

Note: Make sure that the whole organization is working for the same objectives and pulling in the same direction.

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Become a Third Party Auditor - ISOUpdate.com

An accredited registrar, also called an accredited certification body (CB), is an organization accredited by a recognized accrediting body for its competence to audit and issue certification confirming that an organization meets the requirements of a standard (e.g. ISO 9001 or ISO 14001). There are many benefits of using an accredited registrar when looking to obtain certification for your organization.

Accreditation means an independent, objective body recognizes that an organization is qualified to provide specific services. An accreditation body should assess a registrar’s facilities, procedures and staff against a set of criteria that define acceptable competence levels and capabilities.



There are many registrar companies that offer their services to audit and determine if an organization meets the requirements of a specific standard; however, not all registrars are accredited. An organization may decide to seek certification from any of these registrars, accredited and non-accredited. Nonetheless, choosing an accredited registrar can bring the following benefits to an organization:

  • Organizations can be assured of the registrar’s ability, since the accreditation represents an independent assessment of the registrar’s credibility to perform management system registration.
  • It provides assurance that the certification is based on conformance with internationally accepted practices and procedures, thus offering credibility to the certificate.
  • Many clients and customers require suppliers’ management system is certified by an accredited registrar.
  • Accredited registrars are prohibited to offer both consulting and registration services to one organization, in order to ensure that the value of the certificate will not be compromise due to conflict of interest; on the other hand, some non-accredited registrar do offer both services as one package in order to offer more competitive prices whilst jeopardizing the credibility of the certification.
  • Accreditation assures organizations that a registrar meets specific requirements on an ongoing basis.
  • Accredited registrars can assure that the auditors selected are properly qualified for the industry specialty, and that certification audits will be effective and objective.
  • Accreditation provides an added safeguard against improper and fraudulent activities.
  • In order to maintain accreditation, registrars are pressured to enforce internationally sanctioned registration standards and practices within its organization and among its auditors.
  • Accreditation registrar are often stipulated and supported by local governments.

Organizations that choose an accredited registrar and develop an active relationship with it will ensure the value of its registration certificate, and they can guarantee their customers and clients that their management system has been certified by an unbiased, objective and professional audit.



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All management systems require organizations to conduct internal audits in order to obtain information that will evidence the degree to which requirements are being met. In other words, internal audits check practice against policies, processes and procedures and thoroughly document any differences.

Although internal audits are an important tool for organizations to evaluate their management systems and to uncover areas that are in need of attention, for many, this process induces an enormous amount of stress. For audits to serve as a means to identify gaps and effective solutions, it is essential that these are formal, planned and organized. Other key characteristics internal audits should have are:



They are scheduled
Surprise audits are not welcomed by anyone. A schedule should be set and communicated to everyone, preferably at the beginning of the year. There’s no need to audit all processes at once; different processes can be audited at different times throughout the year, organizations just need to make sure that at the end of the year all processes have been audited.

Auditors are competent
Auditors need to demonstrate in-depth knowledge of the standard which they are auditing against and they should have an understanding of the processes being audited. They should be objective and impartial; this means that they can’t audit a process which they manage or control. Large organizations usually have a team of trained auditors, but that is not necessary; an alternative is to hire the services of an external consultant to perform the internal audits.

They are planned
The audit needs to be confirmed with the process owner. At this stage the auditor should review procedures and previous findings or issues related to the audited process. A checklist with a pre-determined list of questions can be sought to be used during the audit; this checklist should be provided to the auditee so they have time to organize any information.

It’s conducted in an objective and friendly manner
An audit should start with an opening meeting with the auditor and the auditee(s). It’s recommended that the auditor works systematically through the checklist or procedure, while reviewing records, observing the process, analyzing process data and talking to employees. During the audit, the auditor must discuss the findings with the auditee before recording it.

Audit findings are recorded
A closing meeting with the auditee is fundamental so information is not delayed. Here the auditor should point out possible weaknesses and areas for improvement. Findings and their details (these include non-conformities, positive areas and improvement areas) need to be recorded and communicated to the auditee(s) and management.

Findings are monitored
The auditor is responsible for ensuring that corrective actions have been taken to fix any problems found during the audit.

If everyone takes advantage of the positive results internal audits can bring, and if these aid organizations to improve their processes and management system- whether is a quality, environmental or any other system- an internal audit can be considered a success.



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Difference Between Stage 1 & Stage 2 Audits - ISOUpdate.com

Organizations that have successfully implemented a management system may choose to seek certification by an independent third party audit from a registrar/certification body (CB). Certification can serve as a valuable tool to add credibility and to demonstrate to clients, customers and other stakeholders, that an organization’s management system meets the requirements of a given standard; thus, finding the right registrar is an important decision to be made.

When choosing a registrar, organizations should consider the following:

Accredited or non-accredited.

Organizations should decide if they will contract an accredited registrar or a non-accredited one. Accreditation means that an independent, objective body (an accreditation body) recognizes that an organization is qualified to provide specific services.  Accreditation is not an obligation, and non-accreditation does not necessarily mean that an organization is not reputable; however, accreditation provides confirmation of competence by an independent body.

If an organization is seeking certification as a regulatory or industry requirement, it is important to ensure if they are required to be certified by an accredited registrar; some clients and customers require their suppliers to do so. Organizations should ask the accreditation bodies in their countries for a lists of the registrar they have accredited.

Relevant experience and sector expertise.

There are many standards that an organization can be certified to (ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, ISO 13485, AS9100, TS 16949, ISO/IEC 27001, ISO/IEC 50001, etc.) and when choosing a registrar, organizations should verify the registrar’s experience in the relevant standard.

Also, it is important that the registrar has experience in the organization’s industry sector. Organizations need to ensure that the auditors know and understand the processes involved in their operations.

The cost is important, but…

Cost is an important factor for all organizations; however, not always the most inexpensive registrar is the most appropriate. It is possible that a certificate issued by a low-cost registrar, will not be recognized by clients, customers and other stakeholders. Therefore, even though the cost needs to be considered, it should not be the determining factor for the selection of the registrar.

Meet them before choosing them

Organizations should evaluate several registrar and schedule a meeting with them before making their final choice. This will allow them to “sense” if a good working relationship will be possible to establish. After the certification audit, the registrar auditors will visit the organization once or twice a year if they consider it necessary to maintain certification, so an active and reliable relationship will need to be developed between the two.

Choosing a registrar should not be a decision taken lightly. A good selection process will ensure the credibility and value of the certificate issued, which will ultimately provide a valuable asset to the certified organization.

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Many organizations find themselves in the ethical obligation to improve their occupational health and safety performance.
Many organizations find themselves in the ethical obligation to improve their occupational health and safety performance.

OHSAS 18001 is an internationally applied British Standard for occupational health and safety management systems (OHSMS). This standard establishes requirements for an organization to control its work-related health and safety hazards and improve their performance, by planning, documenting and implementing a verifiable method for reducing and eliminating hazards in the workplace. The benefits of OHSAS 18001 can help your organization improve health and safety. 

Managing occupational health and safety in the workplace brings numerous benefits to all kinds and sizes of organizations. Some of these are:

It guides organizations in their pursue of “zero accidents”.

  • OHSAS 18001 provides a system to identify and effectively manage occupational health and safety hazards in order to minimize health and safety risk.
  • It provides tools and techniques to identify potential causes of accidents and helps organizations improve employee awareness of risks.
  • Incident and accident rates are reduced as a consequence of better control of work-related risks and an improved performance monitoring.
  • Improves the incident investigation process.

Ensures organizations comply with legal requirements.

  • In order for organizations to establish and maintain their OHSMS, they must take into account applicable legal requirements.
  • Ensures organizations commit to comply and communicate all relevant legal information to employees and interested parties.

Improves an organization’s image.

  • OHSAS 18001 drives organizations to set occupational health and safety as a priority, ensuring that appropriate measures are taken to protect staff, employees and everyone associated with their activities.
  • The adoption of international best practice in relation to risk management can improve an organization’s image and credibility among stakeholders, regulators, customers, prospective clients and the public in general.
  • An improved reputation can give organizations a competitive advantage by providing a safe environment to do business.

Improves the workplace environment.

  • Implementing this standard will show employees that an organization is committed to keeping them safe, therefore improving employee motivation, retention and satisfaction.
  • OHSAS 18001 can help organizations put in place clear procedures to decrease absenteeism.
  • Improvement of communication and training will bring greater involvement and commitment from everyone.

Helps organizations save money.

  • Implementing OHSAS 18001 reduces the likelihood of fines and prosecutions.
  • By reducing accident and incident rates and work-related illnesses, it also reduces all the costs associated with them (costly medical claims, lost working days, time and money spent on investigation and paperwork).
  • This standard is recognized by insurers which can bring a decrease in insurance premiums.

Another benefit of OHSAS 18001 is that the standard can be adopted by any organization, regardless of its size or nature, whether it’s a high risk or low risk businesses in the private or public sector.

This standard is compatible with ISO 9001 and ISO 14001 management systems standards, making it easy to integrate it with existing management systems, thus contributing to the improvement of an organization’s overall business performances.

 

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No one can deny the increasing impact of human activities on our environment. Our society is ever more preoccupied and occupied on the many issues affecting our environment today, such as pollution, over-consumption of resources, degradation of ecosystems and biodiversity, and an increasing world population that demands resources in the amount and quality that will ensure a decent and fulfilling life.

Organizations everywhere have implemented environmental management systems (EMS) to ensure compliance with an increasingly stringent legislation, control the impacts of their activities, products or services, and increase sound environmental performance.

Implementing and conforming to an EMS based on the ISO 14001 standard not only shows that an organization is environmentally responsible, but it also brings numerous benefits within the organization by:

  • Identifying cost savings with greater emphasis on resources, waste and energy management.
  • Quantifying, monitoring and controlling the impact of operations on the environment, now and in the future.
  • Increasing profits through potential process improvements and energy conservation.
  • Reducing costs as a result of potentially lower insurance rates.
  • Verifying your systems for recognizing and complying with environmental laws and regulations.
  • Improve environmental performance of supply chain.
  • Ensuring that information is properly documented, communicated and retained.
  • Increasing employee awareness and participation by making it clear that environmental performance is an important part of the organization’s culture
  • Improving management of environmental risks and emergency preparedness and response procedures.

Other benefits of ISO 14001 come from how the organization is seen from outside by interested parties, some of these are:

  • Improved corporate image among business partners, regulatory agencies, and community by showing that the organization is environmentally responsible.
  • Improved relationships with government regulatory agencies; organizations that have implemented ISO 14001 find that regulators are quicker to provide technical support, and find that the regulators are much more supportive in general.
  • Advantage over competitors when tendering for business.
  • Grow access to business partners and potential customers.

ISO 14001 provides organizations with knowledge, tools and techniques to build success over the long term and create new opportunities for development and growth. These tools can be aligned with an organization’s priorities, strategy and decision-making by integrating them with other business requirements and embedding environmental governance into its overall management system, thereby achieving both environmental and economic goals.

The market is driving organizations to demonstrate their success in protecting our environment; more and more people want to be environmentally responsible and they are doing so by choosing products and services that have been designed, produced, developed and delivered in an environmentally friendly way. Therefore, in the near future, ISO 14001 will become a prerequisite for doing business worldwide.

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Today, more and more organizations are deciding to adopt the ISO 9001 standard as a guideline for their quality management system (QMS). With the implementation of ISO 9001, an organization demonstrates its ability to consistently provide products or services that comply with applicable law and meet the demands of its customers. If an organization implements and maintains a successful QMS it will gain a number of benefits.

Benefits of ISO 9001 within the market:

  • Improved image of products or services offered.
  • Level playing field with large companies when bidding for new contracts.
  • Preferential treatment from potential customers who themselves have implemented ISO 9001.
  • Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.
  • For organizations that obtain certification, most certification bodies keep an updated list of certified companies and organizations and provide this list upon request to potential customers or other interested parties.

Benefits of ISO 9001 with customers:

  • Improved customer satisfaction.
  • Obtaining certification will reduce the frequency of audits of the QMS by different customers.
  • Secure customers’ loyalty as their needs and expectations will be continually met, leading to more business opportunities.

Benefits of ISO 9001 for the organization’s QMS:

  • Quality will be seen as everyone’s responsibility instead of being the sole responsibility one person (the quality control inspector or manager).
  • Serve as a means to maintain and improve the effectiveness and adequacy of the QMS, by highlighting areas with potential for improvement.
  • Increase motivation and participation of staff and improve resources management.
  • QMS will provide you with a means of documenting the organization’s experience in a structured manner (quality manual, procedures, instructions, etc).
  • You will generate savings, as the costs of reprocessing, rework, repeat inspections, replacing products, penalties due to delayed deliveries, customer returns, customer complaints and warranty claims will gradually fall.

The biggest benefit to be gained from maintaining a QMS from ISO 9001 is the huge savings an organization can make by considerably reducing the cost of failures. By aiming to consistently produce quality products or services, organizations will reduce waste and thus lower costs. They will have more satisfied customers who will have fewer problems with their product or service.

All these will have a major effect on sales revenue, improve market share and engender in an organization’s customers a higher level of satisfaction.

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