ISO 9001:2015
Quality Management System
WHITE PAPER

ISO 9001:2015 is the first quality management standard to be fully compliant with the new guidelines from Annex SL (“High level structure and identical text for management system standards and common core management system terms and definitions”). It has been developed in response to standards users’ critics that, while current standards have many common components, they are not sufficiently aligned, making it difficult for organizations to rationalize their systems and to interface and integrate them. This means that ISO 9001 is integrated to the high-level structure and common text that will make it totally aligned with all other management systems once the related standards have also adopted the Annex SL guidelines.

 

The adoption of an effective quality management process within an organization will have benefits in a number of areas, examples of which include:

 

• Improved organizational effectiveness and efficiency
• Improved understanding of the business as gained through risk identification and analysis
• Operational resilience which results from implementing risk reduction
• Downtime reduction due to the identification of alternative processes and workarounds
• Protection of stakeholder value
• Increase customer and employee satisfaction
• Increased market share and profit
• Improved organizational culture
• Enhanced continuous improvement
• Process improvement; and
• Avoidance of liability actions.

The usual path for an organization that wishes to be certified against ISO 9001 is the following:

1. Implementation of the management system:

Before being audited, a management system must be in operation for some time. Usually, the minimum time required by the certification bodies is 3 months.

2. Internal audit and review by top management:

Before a management system can be certified, it must have had at least one internal audit report and one management review.

3. Selection of the certification body (registrar):

Each organization can select the certification body (registrar) of its choice

4. Pre-assessment audit (optional):

An organization can choose to perform a pre-audit to identify any possible gap between its current management system and the requirements of the standard

5. Stage 1 audit:

A conformity review of the design of the management system. The main objective is to verify that the management system is designed to meet the requirements of the standard(s) and the objectives of the organization. It is recommended that at least some portion of the Stage 1 audit should be performed on-site at the organization’s premises.

6. Stage 2 audit (On-site visit):

The Stage 2 audit objective is to evaluate whether the declared manage - ment system conforms to all requirements of the standard, is actually being implemented in the organi - zation and can support the organization in achieving its objectives. Stage 2 takes place at the site(s) of the organization’s sites(s) where the management system is implemented.

7. Follow-up audit (optional):

If the auditee has non-conformities that require additional audit before be - ing certified, the auditor will perform a follow-up visit to validate only the action plans linked to the non- conformities (usually one day).

8. Confirmation of registration:

If the organization is compliant with the conditions of the standard, the Registrar confirms the registration and publishes the certificate.

9. Continual improvement and surveillance audits:

Once an organization is registered, surveillance activi - ties are conducted by the Certification Body to ensure that the management system still complies with the standard. The surveillance activities must include on-site visits (at least 1 per year) that allow veri - fying the conformity of the certified client’s management system and can also include: investigations following a complaint, review of a website, a written request for follow-up, etc