• Iso 9001 Management Review Presentation

Title: ISO 9000 Management Review1ISO 9001Management ReviewMeeting2Management Review Concept. Clause 5.6.1. Top Management shall review the organizationsQMS, at planned intervals, to ensure itscontinuing suitability, adequacy andeffectiveness.

Clause 5.6.2. Management Review Agenda (Input). 1. Results of Audit. 2.

Customer feedback. 3. Process performance and product conformity.

4. Status of corrective and preventive actions. 5. Follow up actions of previous managementreview. 6.

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STANDARD ISSUES Making the Most Of Management Reviews What can you do to add value to QMS review meetings?by GovindRamuISO 9001:2015 requires top management review of anorganization’s quality management system (QMS). This provides an importantopportunity for a quality manager to present to upper management a State of theUnion-style report on the organization’s quality health.I have seen allvarieties of such meetings: from day-long off-site meetings in which the ownerof every business segment presents, to an hour-long ceremonial presentationfeaturing regurgitated graphs, tables and slides packed with text.Managementreview participants often complain that these meetings are a waste of timebecause the information already has been covered. Or, they tell themselves thatit’s just something they must do for International Organization forStandardization (ISO) certification.

Adding valueHow can these meetings be restructured so theyadd value?The key is tounderstand the intent of the management review requirements. ISO 9001:2015clause 9.3.1 states: 'Top management shall review the organization’s qualitymanagement system, at planned intervals, to ensure its continuing suitability,adequacy, effectiveness, and alignment with the strategic direction of theorganization.'

1 The intent is to ensure:. Continuing suitability.

Whathas changed in the organization or the QMS that will render the QMS unsuitableor less suitable?. Adequacy. Sufficiency interms of people, process, infrastructure and operating environment. Effectiveness.

Iso 9001 Management Review Presentation

The 'extentto which planned activities are realized and planned results are achieved.' 2. Alignment with the strategic directionof the organization. Any changes to strategic direction requirerealignment of the QMS.Let’s look atthese requirements in more detail. Continuing suitabilityMany changes take place in an organization overtime due to shifts in policy and strategy or external factors.Let’s use therecent spike in ransomware as an example.

3Computer hacking is becoming more sophisticated, and organizations mustdetermine how to prevent an attack or reduce the impact of one. This is IT-relatedrisk mitigation, so what does it have to do with a QMS? A ransomwareattack can prevent an organization from serving its customers promptly, and itcan compromise private information.

It also can put an organization’sintellectual property at risk by posting documented information in a publicdomain.Because ransomware attacks are wide-reachingand evolving rapidly, it is important for organizations to review any potentialIT vulnerabilities. Perhaps changes must be made to IT policies and proceduresto anticipate and prevent such risks. In the event of an unforeseensophisticated hacking, does the organization have a plan in place for businesscontinuity? AdequacyIf an organization’s manufacturing or servicedelivery has expanded to new territories, or if the organization has launchednew technology products, is the QMS sufficient to handle this businessexpansion?Offeringproducts and services in new territories requires a launch plan that includesobtaining necessary regional certifications, hiring people from the newlocation (to address language and cultural barriers) and setting upinfrastructure (hardware, software, building facilities and transportation, forexample). Demo units may be required in the new territories, and an operatingenvironment must be recreated or simulated to show product functionalities topotential customers.New technologyproducts may require extensive training materials. It shouldn’t be left tosalespeople on the ground to figure out.

A well thought out launch plan willhave all the activities adequately covered so the sales team can provide anexperience that delights customers. EffectivenessEvery organization has its own businessprocesses, initiatives, goals and objectives to improve its bottom line andenhance the customer experience. How effective is the organization at meetingthese goals and objectives?ISO 9001:2015 subclause 9.3.2.c.5 requires the management review toconsider monitoring and measurement results that are relevant to the QMS andassess their effectiveness. Not meeting the results could becaused by inadequate resources, internal and external issues, or a lack ofrisk-based thinking. Should analysis be performed to determine why theresults have not been met? Are there any systemic issues or common themes thatrun through various instances in which results were not met? Alignment with strategic directionOrganizations may occasionally change theirstrategies due to market shift and to enhance their offerings to customers.

Forexample, an organization may offer services online, outsource services orpartner with a joint venture to manufacture products. All of these scenariosrequire a QMS to be realigned.Offeringservices online requires developing a website, offering on-site support andmanaging the website’s content. This, in turn, requires hiring a softwaredevelopment team and training virtual support personnel to handle onlineservice requests and customer feedback. Documented information should bereadily available online for support personnel to access from anywhere, andrecords and transaction information may require cloud storage.If services areoutsourced, controls must be in place to ensure quality and continuity ofservices. 4 A manufacturing joint venture brings potential challengesregarding differences in QMS processes and controls, so an alignment betweenthe joint venture partners’ QMSs is required to effectively run the business.What ifmanagement review meetings addressed the above-mentioned intent of the ISO9001:2015 management review requirements?

Could theface-to-face time with senior management be more valuable? This is a refreshingapproach to the traditional way of just covering requirements on the surface bypresenting volumes of graphs, tables and slides. Myths debunkedThere are many different misperceptions aboutconducting a management review meeting, such as:. There must be one annual management review.

Management reviews should cover all requirementsin one meeting. All senior management should be present at theannual meeting.

Management review should follow the ISO standardrequirement sequence (for example, subsections 9.3.2.a through f).Theseexpectations have evolved over time—likely to make auditingeasier—without keeping in mind that management review helps to improvebusiness. In a typical organization, the outcome of a management review isreviewed periodically—weekly, monthly, quarterly or annually, for example(see Table 1). The performance results are reviewed as a business activityirrespective of whether an organization is ISO 9001 certified. For largeorganizations, it is unlikely that all senior managers will be present at thesemeetings.

However, the information should be made available for comments anddecision making when appropriate.One of the majorchanges we made in our organization was to move away from arranging themanagement review presentation in the sequence of ISO 9001 requirements.Instead, we rearranged the contents consistent with other managementpresentation agendas. Our senior management was familiar with this format,which helped improve engagement with the content.We were notsaying, 'Now presenting ISO 9001:2015 clause 9.3.2.a.' We used appropriatecaptions, such as business segment highlights and lowlights, challenges,improvement actions and next steps. This kept the conversation relevant to ourorganization and didn’t give the impression that it was simply satisfying anISO 9001 requirement.To help internaland external auditors, we cross-referenced a relevant ISO 9001:2015 requirementin the top right-hand corner of the presentation. The main intent of ourmanagement review was to help senior leaders understand our presentationcontent so they could engage with it and provide value-added feedback. It wasnot for mere ISO 9001 compliance.Qualityprofessionals must be innovative in how they implement QMSs and bring value totheir organizations. Every organization is different, and every organization’svalues, culture and beliefs are different.

Move away from the rigid,prescriptive approach to QMS implementation of the past. QMSs exist to helporganizations, not the other way around. You should not compromise the intentof meeting ISO 9001 requirements, but you also should be flexible andopen-minded when integrating a QMS into existing organizational processes toaccomplish your objectives. References and Note. International Organization for Standardization(ISO), ISO 9001:2015 Quality managementsystems—Requirements.

ISO 9000:2015 Quality management systems—Fundamentalsand vocabulary, subclause 3.7.11. 'Ransomware' isdefined as a type of malicious software that threatens to publish the victim’sdata or perpetually block access to it unless a ransom is paid. For moreinformation, visit. Govind Ramu, 'External Demands,' QualityProgress, April 2016, pp.

50-51.Govind Ramu is senior directorof global quality management systems at SunPowerCorp. In San Jose, CA. He is a licensed professional engineer from Ontario,Canada.

He also is the chair of the U.S. Technical Advisory Group toInternational Organization for Standardization Technical Committee 176,subcommittee 1 on ISO 9000:2015 standards. Ramu is anASQ fellow, ASQ Crosby Medal recipient and holds six ASQ certifications:manager of quality/organizational excellence, engineer, Six Sigma Black Belt,auditor, software quality engineer and reliability engineer.

He is a regularcontributor to QP’s Expert Answers department, author of The Certified Six Sigma Yellow Belt Handbook (ASQQuality Press, 2016), co-author of The Certified SixSigma Green Belt Handbook, second edition (ASQ Quality Press, 2015) anda contributing author of The Lean Handbook (ASQQuality Press, 2012).